risperidone ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
antipsychotics, risperidone derivatives 2389 106266-06-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • risperidone
  • ripedon
  • rispadal
  • risperdal
  • risperidal
  • R 64,766
  • okedi
A selective blocker of DOPAMINE D2 RECEPTORS and SEROTONIN 5-HT2 RECEPTORS that acts as an atypical antipsychotic agent. It has been shown to improve both positive and negative symptoms in the treatment of SCHIZOPHRENIA.
  • Molecular weight: 410.49
  • Formula: C23H27FN4O2
  • CLOGP: 2.71
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 0
  • TPSA: 61.94
  • ALOGS: -3.38
  • ROTB: 4
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
5 mg O
2.70 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.29 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 3 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.56 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 66 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1.10 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 5.40 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.10 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 3.20 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class EIF2AK3,GRK2,PDK1,PDK2,PDK4 5
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 1.687 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 1 High 1
rat-kpuu-brain Rat brain Kpuu 0.238 % High 1

Approvals:

DateAgencyCompanyOrphan
Dec. 29, 1993 FDA JANSSEN PHARMS
Feb. 14, 2022 EMA LABORATORIOS FARMACEUTICOS ROVI, S.A.

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Suicide attempt 2118.57 11.49 1263 111696 74136 90441352
Extrapyramidal disorder 2117.35 11.49 788 112171 15515 90499973
Hyperprolactinaemia 1996.03 11.49 577 112382 4856 90510632
Neuroleptic malignant syndrome 1747.91 11.49 671 112288 14425 90501063
Galactorrhoea 1396.37 11.49 423 112536 4249 90511239
Blood prolactin increased 1339.17 11.49 387 112572 3250 90512238
Dystonia 1117.44 11.49 503 112456 16316 90499172
Sedation 1095.90 11.49 706 112253 47465 90468023
Drug interaction 1082.18 11.49 1517 111442 274936 90240552
Intentional overdose 1076.76 11.49 910 112049 92924 90422564
Schizophrenia 1003.42 11.49 450 112509 14464 90501024
Aggression 977.54 11.49 532 112427 26136 90489352
Intentional self-injury 976.02 11.49 549 112410 28785 90486703
Dyskinesia 947.73 11.49 582 112377 35952 90479536
Hallucination, auditory 896.48 11.49 425 112534 15550 90499938
Somnolence 880.19 11.49 1189 111770 207895 90307593
Blood prolactin abnormal 858.54 11.49 268 112691 2998 90512490
Akathisia 835.52 11.49 363 112596 10796 90504692
Sexual dysfunction 818.36 11.49 284 112675 4520 90510968
Anosognosia 814.02 11.49 262 112697 3260 90512228
Disturbance in social behaviour 808.84 11.49 272 112687 3916 90511572
Tardive dyskinesia 774.38 11.49 342 112617 10588 90504900
Treatment noncompliance 764.20 11.49 582 112377 51145 90464343
Psychotic disorder 760.59 11.49 478 112481 30752 90484736
Metabolic disorder 758.43 11.49 302 112657 7168 90508320
Parkinsonism 721.92 11.49 352 112607 13713 90501775
Amenorrhoea 679.65 11.49 319 112640 11403 90504085
Personality change 671.02 11.49 275 112684 7046 90508442
Suicidal ideation 642.51 11.49 613 112346 73242 90442246
Catatonia 636.35 11.49 251 112708 5805 90509683
Hypothermia 624.79 11.49 330 112629 15245 90500243
Toxicity to various agents 613.23 11.49 1202 111757 286644 90228844
Agitation 593.31 11.49 562 112397 66536 90448952
Delusion 554.47 11.49 293 112666 13547 90501941
Abnormal behaviour 540.06 11.49 342 112617 22286 90493202
Completed suicide 535.36 11.49 775 112184 144283 90371205
Oculogyric crisis 506.51 11.49 168 112791 2311 90513177
Joint swelling 476.00 11.49 41 112918 503259 90012229
Salivary hypersecretion 458.94 11.49 225 112734 8867 90506621
Device leakage 456.29 11.49 231 112728 9760 90505728
Arthralgia 455.54 11.49 201 112758 778321 89737167
Pain 445.81 11.49 355 112604 995986 89519502
Electrocardiogram QT prolonged 422.93 11.49 486 112473 71970 90443518
Infusion related reaction 416.69 11.49 26 112933 416754 90098734
Muscle rigidity 404.54 11.49 241 112718 14068 90501420
Arthropathy 401.70 11.49 12 112947 366230 90149258
Overdose 389.30 11.49 702 112257 157007 90358481
Synovitis 389.21 11.49 4 112955 329748 90185740
Rheumatoid arthritis 386.73 11.49 15 112944 362599 90152889
Hypomania 383.94 11.49 198 112761 8699 90506789
Sopor 383.13 11.49 286 112673 24358 90491130
Pemphigus 376.81 11.49 6 112953 326858 90188630
Syringe issue 375.86 11.49 153 112806 3849 90511639
Mania 373.76 11.49 228 112731 13896 90501592
Depressed level of consciousness 353.97 11.49 445 112514 72339 90443149
Hand deformity 352.54 11.49 3 112956 296359 90219129
Rash 350.21 11.49 288 112671 795812 89719676
Altered state of consciousness 347.33 11.49 299 112660 31233 90484255
Systemic lupus erythematosus 346.04 11.49 28 112931 361868 90153620
Alopecia 345.51 11.49 95 112864 494976 90020512
Glossodynia 344.15 11.49 13 112946 321766 90193722
Abdominal discomfort 341.82 11.49 87 112872 477241 90038247
Restlessness 330.61 11.49 307 112652 35413 90480075
Paranoia 305.24 11.49 194 112765 12714 90502774
Jaundice cholestatic 299.22 11.49 175 112784 9868 90505620
Tremor 298.49 11.49 617 112342 152556 90362932
Device malfunction 292.10 11.49 228 112731 20749 90494739
Sinusitis 281.95 11.49 45 112914 343043 90172445
Pericarditis 281.87 11.49 13 112946 270138 90245350
Diarrhoea 278.52 11.49 465 112494 938725 89576763
Peripheral swelling 275.80 11.49 86 112873 413020 90102468
Tachycardia 273.68 11.49 606 112353 157067 90358421
Contraindicated product administered 265.30 11.49 41 112918 320098 90195390
Swelling 262.81 11.49 97 112862 418961 90096527
Coma 258.89 11.49 382 112577 72250 90443238
Pruritus 258.14 11.49 180 112779 541345 89974143
Fatigue 257.60 11.49 672 112287 1153351 89362137
Stomatitis 252.40 11.49 25 112934 274673 90240815
Hallucination 245.38 11.49 354 112605 65605 90449883
Helicobacter infection 243.05 11.49 9 112950 226841 90288647
Hypersensitivity 240.31 11.49 134 112825 454543 90060945
Folliculitis 234.37 11.49 4 112955 204349 90311139
Drug intolerance 232.12 11.49 135 112824 447456 90068032
Nasopharyngitis 229.94 11.49 110 112849 406994 90108494
Psoriatic arthropathy 228.75 11.49 14 112945 228321 90287167
Headache 228.12 11.49 458 112501 862288 89653200
Pleurothotonus 227.65 11.49 79 112880 1256 90514232
Psychomotor hyperactivity 224.78 11.49 160 112799 12653 90502835
Discomfort 218.67 11.49 39 112920 274296 90241192
Persecutory delusion 209.99 11.49 95 112864 3113 90512375
Delirium 203.93 11.49 421 112538 103938 90411550
Cogwheel rigidity 203.02 11.49 82 112877 2020 90513468
Blood creatine phosphokinase increased 201.44 11.49 230 112729 33793 90481695
Muscle injury 200.36 11.49 4 112955 176650 90338838
Wound 191.77 11.49 69 112890 302911 90212577
Blood glucose increased 191.73 11.49 389 112570 94857 90420631
Hypotension 190.63 11.49 857 112102 324540 90190948
Pneumonia aspiration 190.57 11.49 245 112714 40695 90474793
Fibromyalgia 188.85 11.49 19 112940 206250 90309238
Dyspnoea 187.85 11.49 524 112435 880431 89635057
Irritability 184.49 11.49 225 112734 35437 90480051
Wrong patient received product 184.34 11.49 89 112870 3388 90512100
Diabetes mellitus 181.00 11.49 305 112654 64570 90450918
Lower respiratory tract infection 180.54 11.49 45 112914 250614 90264874
Irritable bowel syndrome 180.16 11.49 23 112936 207425 90308063
Impaired healing 178.77 11.49 37 112922 234162 90281326
Urinary retention 177.46 11.49 227 112732 37517 90477971
Hyperammonaemic encephalopathy 176.90 11.49 80 112879 2619 90512869
Weight increased 176.09 11.49 1003 111956 416924 90098564
Urticaria 175.75 11.49 85 112874 312649 90202839
Blister 175.67 11.49 50 112909 254948 90260540
Psychotic symptom 174.11 11.49 75 112884 2181 90513307
Cholelithiasis 169.84 11.49 264 112695 52242 90463246
Hallucination, visual 169.76 11.49 175 112784 22917 90492571
Drug hypersensitivity 165.22 11.49 201 112758 463408 90052080
Social avoidant behaviour 164.91 11.49 82 112877 3331 90512157
Disturbance in attention 162.43 11.49 244 112715 46865 90468623
Rhabdomyolysis 162.01 11.49 255 112704 51001 90464487
Mutism 160.56 11.49 66 112893 1703 90513785
Disorientation 160.03 11.49 234 112725 43880 90471608
Therapeutic product effect decreased 159.72 11.49 73 112886 277498 90237990
Psychomotor retardation 157.48 11.49 89 112870 4700 90510788
Drug abuse 152.46 11.49 325 112634 82022 90433466
Hyponatraemia 151.60 11.49 437 112522 133101 90382387
Osteoarthritis 149.21 11.49 31 112928 195699 90319789
Dysarthria 149.14 11.49 254 112705 54228 90461260
Urinary incontinence 149.10 11.49 208 112751 37358 90478130
Respiratory depression 148.23 11.49 136 112823 15439 90500049
Hallucinations, mixed 147.99 11.49 92 112867 5797 90509691
Infection 145.54 11.49 142 112817 361952 90153536
Intentional product use issue 143.09 11.49 46 112913 216846 90298642
Mental impairment 141.89 11.49 137 112822 16583 90498905
C-reactive protein abnormal 140.21 11.49 4 112955 127425 90388063
Antipsychotic drug level increased 140.09 11.49 76 112883 3703 90511785
Hypoaesthesia 139.77 11.49 112 112847 314098 90201390
Asthma-chronic obstructive pulmonary disease overlap syndrome 139.73 11.49 83 112876 4816 90510672
Gastrointestinal disorder 137.86 11.49 74 112885 256613 90258875
Total lung capacity increased 137.84 11.49 83 112876 4938 90510550
Product dose omission issue 137.48 11.49 722 112237 290965 90224523
Joint range of motion decreased 136.77 11.49 8 112951 135635 90379853
Pain in extremity 134.97 11.49 221 112738 450308 90065180
Drooling 132.22 11.49 78 112881 4468 90511020
Inflammation 130.65 11.49 31 112928 178561 90336927
Serotonin syndrome 130.28 11.49 196 112763 37691 90477797
Sluggishness 129.64 11.49 85 112874 5874 90509614
Sinus tachycardia 127.03 11.49 167 112792 28346 90487142
Pituitary tumour benign 126.58 11.49 59 112900 2073 90513415
Migraine 126.26 11.49 40 112919 190352 90325136
Treatment failure 124.66 11.49 117 112842 303811 90211677
Mastitis 124.51 11.49 65 112894 2928 90512560
Bursitis 123.47 11.49 11 112948 131643 90383845
Ill-defined disorder 122.33 11.49 39 112920 184852 90330636
Abdominal pain upper 121.89 11.49 141 112818 332533 90182955
Sudden death 119.20 11.49 103 112856 10806 90504682
Bradycardia 118.93 11.49 298 112661 83549 90431939
Dyspepsia 117.29 11.49 50 112909 198110 90317378
Arthritis 116.70 11.49 32 112927 167283 90348205
Mobility decreased 114.49 11.49 87 112872 250647 90264841
Hypertonia 113.29 11.49 74 112885 5081 90510407
Asthma 113.19 11.49 82 112877 242078 90273410
Pulmonary fibrosis 112.62 11.49 5 112954 107498 90407990
Night sweats 112.44 11.49 14 112945 128752 90386736
Hyperthermia 111.75 11.49 97 112862 10238 90505250
Psychiatric symptom 111.48 11.49 83 112876 7035 90508453
Seizure 111.16 11.49 430 112529 152199 90363289
Logorrhoea 109.96 11.49 58 112901 2669 90512819
Psychiatric decompensation 109.90 11.49 52 112907 1891 90513597
Cough 109.51 11.49 182 112777 368780 90146708
Lip dry 108.10 11.49 4 112955 100951 90414537
Mental disorder 108.01 11.49 165 112794 32153 90483335
Injury 107.26 11.49 56 112903 197293 90318195
Affective disorder 106.95 11.49 84 112875 7709 90507779
Polydipsia 106.07 11.49 66 112893 4165 90511323
Nausea 105.71 11.49 882 112077 1109434 89406054
Apathy 104.28 11.49 96 112863 10944 90504544
Oromandibular dystonia 104.05 11.49 36 112923 567 90514921
Ataxia 103.47 11.49 120 112839 17922 90497566
Musculoskeletal pain 103.30 11.49 42 112917 171209 90344279
Increased appetite 102.85 11.49 98 112861 11667 90503821
Maternal exposure during pregnancy 102.84 11.49 182 112777 359881 90155607
Rabbit syndrome 102.50 11.49 31 112928 309 90515179
Miosis 100.50 11.49 88 112871 9396 90506092
Somatic symptom disorder of pregnancy 99.46 11.49 24 112935 89 90515399
Cognitive disorder 98.76 11.49 247 112712 69160 90446328
Gestational diabetes 97.98 11.49 91 112868 10491 90504997
Contusion 96.91 11.49 102 112857 251114 90264374
COVID-19 96.15 11.49 45 112914 168798 90346690
Fall 95.76 11.49 969 111990 480841 90034647
Inappropriate affect 95.61 11.49 39 112920 986 90514502
Withdrawal syndrome 94.32 11.49 128 112831 22396 90493092
Torticollis 93.59 11.49 51 112908 2507 90512981
Stupor 92.81 11.49 67 112892 5415 90510073
Bradykinesia 92.80 11.49 73 112886 6715 90508773
Generalised tonic-clonic seizure 90.64 11.49 159 112800 34744 90480744
Breast cancer stage III 88.22 11.49 4 112955 84443 90431045
Obsessive-compulsive disorder 87.77 11.49 60 112899 4444 90511044
Embolism venous 87.06 11.49 55 112904 3565 90511923
Cardio-respiratory arrest 87.02 11.49 222 112737 62918 90452570
Thinking abnormal 86.39 11.49 89 112870 11643 90503845
Leukopenia 86.17 11.49 299 112660 100411 90415077
Sciatica 86.17 11.49 12 112947 101370 90414118
Condition aggravated 86.14 11.49 1126 111833 594419 89921069
Sarcoidosis 85.97 11.49 85 112874 10588 90504900
Blood bilirubin increased 85.60 11.49 176 112783 43294 90472194
Wound infection 84.99 11.49 15 112944 106387 90409101
Grip strength decreased 83.48 11.49 9 112950 92567 90422921
Electroencephalogram abnormal 83.24 11.49 56 112903 4040 90511448
Refusal of examination 83.18 11.49 24 112935 200 90515288
Back pain 82.09 11.49 170 112789 317005 90198483
Hip arthroplasty 81.66 11.49 3 112956 76205 90439283
Peripheral venous disease 81.49 11.49 6 112953 83915 90431573
Hepatotoxicity 81.47 11.49 178 112781 45664 90469824
Nasal polyps 80.95 11.49 83 112876 10797 90504691
Loss of consciousness 80.18 11.49 367 112592 139871 90375617
Blood cholesterol increased 79.61 11.49 85 112874 207927 90307561
Impulsive behaviour 78.98 11.49 40 112919 1690 90513798
Knee arthroplasty 77.85 11.49 7 112952 83175 90432313
Eosinophil count decreased 77.74 11.49 49 112910 3163 90512325
Exposure to contaminated device 77.68 11.49 15 112944 10 90515478
Hospitalisation 77.57 11.49 341 112618 127759 90387729
Febrile neutropenia 77.45 11.49 51 112908 158298 90357190
Myocarditis 76.13 11.49 90 112869 13716 90501772
Pulmonary embolism 76.02 11.49 344 112615 130476 90385012
Dysphagia 75.83 11.49 309 112650 111969 90403519
Paraesthesia 75.61 11.49 122 112837 250204 90265284
Liver injury 75.54 11.49 61 112898 170506 90344982
Device use confusion 74.66 11.49 14 112945 6 90515482
Respiratory dyskinesia 74.23 11.49 17 112942 47 90515441
Poisoning deliberate 74.11 11.49 97 112862 16389 90499099
Flat affect 73.59 11.49 38 112921 1673 90513815
Inappropriate antidiuretic hormone secretion 72.96 11.49 105 112854 19400 90496088
Personality change due to a general medical condition 72.89 11.49 23 112936 267 90515221
Breast discharge 72.15 11.49 34 112925 1225 90514263
Anxiety 71.87 11.49 644 112315 309128 90206360
Lung disorder 70.99 11.49 50 112909 149833 90365655
Needle issue 70.57 11.49 87 112872 13847 90501641
Lower limb fracture 70.08 11.49 11 112948 85002 90430486
Malaise 69.82 11.49 436 112523 585550 89929938
Intentional product misuse 69.80 11.49 258 112701 89346 90426142
Red blood cell sedimentation rate increased 69.67 11.49 10 112949 82585 90432903
Lethargy 69.08 11.49 204 112755 62935 90452553
Psoriasis 69.05 11.49 50 112909 147704 90367784
Medication error 68.69 11.49 247 112712 84405 90431083
Chest pain 67.91 11.49 190 112769 319455 90196033
Psychomotor skills impaired 67.48 11.49 43 112916 2829 90512659
Spasmodic dysphonia 67.38 11.49 17 112942 79 90515409
Incoherent 66.91 11.49 53 112906 4924 90510564
Granulocytopenia 66.72 11.49 59 112900 6382 90509106
Accidental exposure to product 65.84 11.49 156 112803 42210 90473278
Bradyphrenia 65.77 11.49 63 112896 7549 90507939
Product administration error 65.56 11.49 118 112841 26305 90489183
Prolactin-producing pituitary tumour 65.39 11.49 17 112942 91 90515397
Erythema 65.29 11.49 116 112843 229130 90286358
Dry mouth 65.23 11.49 80 112879 183979 90331509
Malignant catatonia 64.68 11.49 20 112939 216 90515272
Psychotic behaviour 64.01 11.49 26 112933 650 90514838
Drug level increased 63.86 11.49 120 112839 27642 90487846
Rhinitis allergic 63.72 11.49 91 112868 16694 90498794
Hyperphagia 63.27 11.49 41 112918 2777 90512711
Antipsychotic drug level above therapeutic 63.19 11.49 32 112927 1352 90514136
Torsade de pointes 63.15 11.49 86 112873 15096 90500392
Hyperreflexia 63.09 11.49 58 112901 6599 90508889
Oedema 62.97 11.49 95 112864 200200 90315288
Speech disorder 62.52 11.49 160 112799 45425 90470063
Product use issue 62.31 11.49 207 112752 329712 90185776
Hypertension 62.23 11.49 326 112633 457206 90058282
Substance-induced psychotic disorder 62.04 11.49 41 112918 2871 90512617
Neuropathy peripheral 61.88 11.49 48 112911 136922 90378566
Anticholinergic syndrome 61.81 11.49 40 112919 2703 90512785
Ileus paralytic 61.70 11.49 51 112908 5034 90510454
Disease progression 61.03 11.49 63 112896 156552 90358936
Self-destructive behaviour 61.03 11.49 23 112936 468 90515020
Cardiac murmur 60.95 11.49 93 112866 18101 90497387
Road traffic accident 60.78 11.49 29 112930 107597 90407891
Orthostatic hypotension 60.70 11.49 150 112809 41677 90473811
Wheezing 60.40 11.49 129 112830 237951 90277537
Autonomic nervous system imbalance 60.32 11.49 43 112916 3407 90512081
Protrusion tongue 59.93 11.49 21 112938 344 90515144
Injection site reaction 59.86 11.49 20 112939 92060 90423428
Intellectual disability 59.49 11.49 30 112929 1256 90514232
Chest discomfort 59.39 11.49 51 112908 138314 90377174
Metabolic syndrome 59.26 11.49 34 112925 1848 90513640
Lactation disorder 59.10 11.49 22 112937 432 90515056
Asthenia 59.07 11.49 406 112553 533345 89982143
Hypersexuality 59.01 11.49 24 112935 602 90514886
Tic 58.78 11.49 34 112925 1877 90513611
Floppy iris syndrome 58.65 11.49 16 112943 106 90515382
Impaired self-care 58.62 11.49 33 112926 1729 90513759
Drug withdrawal syndrome 58.57 11.49 118 112841 28605 90486883
Malignant neoplasm progression 58.53 11.49 30 112929 106840 90408648
Thermal burn 58.49 11.49 56 112903 6706 90508782
Adjustment disorder with depressed mood 58.28 11.49 3 112956 56750 90458738
Hypokinesia 57.98 11.49 84 112875 15613 90499875
Plasma cell mastitis 57.29 11.49 13 112946 34 90515454
Bronchitis 56.83 11.49 64 112895 152863 90362625
Autoimmune disorder 56.74 11.49 13 112946 76731 90438757
Hepatic enzyme increased 56.67 11.49 244 112715 360492 90154996
Mydriasis 56.42 11.49 81 112878 14931 90500557
Osteoporosis 56.08 11.49 25 112934 96506 90418982
Herpes zoster 55.79 11.49 24 112935 94620 90420868
Hypotonia 55.72 11.49 70 112889 11356 90504132
Homicidal ideation 55.63 11.49 32 112927 1748 90513740
Bipolar disorder 55.31 11.49 62 112897 8923 90506565
Confusional state 54.79 11.49 728 112231 385477 90130011
Dementia 54.71 11.49 103 112856 23758 90491730
Refusal of treatment by patient 54.39 11.49 50 112909 5688 90509800
Aphasia 53.35 11.49 145 112814 42667 90472821
Muscular weakness 53.24 11.49 111 112848 206555 90308933
Movement disorder 53.07 11.49 114 112845 28905 90486583
Hyperammonaemia 52.96 11.49 52 112907 6423 90509065
Abulia 52.85 11.49 23 112936 686 90514802
Gait inability 52.58 11.49 63 112896 146393 90369095
Mental status changes 52.39 11.49 148 112811 44531 90470957
Anaemia 52.19 11.49 244 112715 352558 90162930
Product container issue 52.11 11.49 33 112926 2148 90513340
Mood swings 52.06 11.49 93 112866 20609 90494879
Upper respiratory tract infection 51.85 11.49 50 112909 128268 90387220
Cardiac arrest 51.59 11.49 263 112696 104672 90410816
Gynaecomastia 51.50 11.49 17 112942 230 90515258
Rhinorrhoea 51.10 11.49 23 112936 88293 90427195
Exostosis 51.02 11.49 4 112955 53130 90462358
Injection site pain 50.26 11.49 87 112872 173612 90341876
Live birth 50.02 11.49 18 112941 79089 90436399
Reduced facial expression 49.73 11.49 34 112925 2519 90512969
Menstrual disorder 49.65 11.49 49 112910 6089 90509399
Faecaloma 49.43 11.49 63 112896 10368 90505120
Diabetes insipidus 49.29 11.49 37 112922 3175 90512313
Soliloquy 48.95 11.49 18 112941 341 90515147
Musculoskeletal stiffness 48.78 11.49 197 112762 296335 90219153
Diabetic coma 48.65 11.49 22 112937 720 90514768
Bipolar I disorder 48.49 11.49 31 112928 2051 90513437
Laryngitis 48.23 11.49 4 112955 50749 90464739
Myoclonus 48.06 11.49 86 112873 19082 90496406
Product tampering 47.97 11.49 19 112940 444 90515044
Idiopathic intracranial hypertension 47.85 11.49 38 112921 3543 90511945
Grandiosity 47.77 11.49 17 112942 292 90515196
Unresponsive to stimuli 47.39 11.49 129 112830 37992 90477496
Abdominal pain 47.29 11.49 294 112665 395427 90120061
Disease recurrence 46.39 11.49 127 112832 37526 90477962
Fluid retention 46.37 11.49 26 112933 88065 90427423
Muscle spasms 46.20 11.49 160 112799 251723 90263765
Rash pruritic 45.14 11.49 23 112936 82191 90433297
Major depression 45.04 11.49 59 112900 9976 90505512
Negativism 44.50 11.49 18 112941 445 90515043
Myalgia 44.31 11.49 95 112864 175030 90340458
Negative symptoms in schizophrenia 44.07 11.49 13 112946 118 90515370
Sleep disorder due to a general medical condition 44.01 11.49 3 112956 44735 90470753
Insurance issue 43.96 11.49 61 112898 10897 90504591
Phagophobia 43.80 11.49 11 112948 50 90515438
Adulterated product 43.75 11.49 17 112942 377 90515111
Activation syndrome 43.66 11.49 15 112944 231 90515257
Water intoxication 43.49 11.49 19 112940 572 90514916
Compartment syndrome 43.48 11.49 33 112926 2879 90512609
Back injury 43.42 11.49 4 112955 46618 90468870
Cystoid macular oedema 43.37 11.49 29 112930 2071 90513417
Hepatocellular injury 43.24 11.49 105 112854 28853 90486635
Echolalia 42.85 11.49 16 112943 317 90515171
Breast hyperplasia 42.48 11.49 16 112943 325 90515163
Taste disorder 42.47 11.49 12 112947 61534 90453954
Sinus bradycardia 42.43 11.49 76 112883 16876 90498612
Hepatic cirrhosis 42.43 11.49 13 112946 63240 90452248
Foot deformity 42.35 11.49 11 112948 59640 90455848
Immunodeficiency 42.23 11.49 3 112956 43231 90472257
Influenza like illness 42.14 11.49 24 112935 80587 90434901
Abnormal weight gain 41.56 11.49 31 112928 2634 90512854
Encephalopathy 41.56 11.49 140 112819 46304 90469184
Injection site erythema 41.43 11.49 37 112922 98465 90417023
Frequent bowel movements 41.38 11.49 10 112949 56925 90458563
Bundle branch block right 41.29 11.49 42 112917 5411 90510077
Hostility 41.29 11.49 29 112930 2244 90513244
Paradoxical drug reaction 41.12 11.49 43 112916 5723 90509765
Dry skin 40.89 11.49 30 112929 88043 90427445
Wrong product administered 40.67 11.49 49 112910 7616 90507872
Liver function test increased 40.58 11.49 28 112931 84827 90430661
Weight decreased 40.50 11.49 292 112667 379618 90135870
Parkinsonian gait 40.24 11.49 18 112941 574 90514914
Obsessive thoughts 39.78 11.49 18 112941 590 90514898
Acute psychosis 39.72 11.49 32 112927 3046 90512442
Wrong patient 39.67 11.49 20 112939 837 90514651
Influenza 39.15 11.49 71 112888 139193 90376295
Decreased appetite 38.90 11.49 292 112667 376248 90139240
Bronchiectasis 38.87 11.49 86 112873 22244 90493244
Dementia with Lewy bodies 38.84 11.49 16 112943 415 90515073
Lupus-like syndrome 38.75 11.49 7 112952 48839 90466649
Flushing 38.73 11.49 32 112927 88459 90427029
Brain injury 38.68 11.49 48 112911 7690 90507798
Throat irritation 38.59 11.49 7 112952 48688 90466800
Breast discomfort 38.58 11.49 18 112941 634 90514854
Coeliac disease 38.57 11.49 5 112954 44605 90470883
Wrong technique in product usage process 38.46 11.49 184 112775 71387 90444101
Cerebral atrophy 38.30 11.49 41 112918 5605 90509883
Mood altered 38.07 11.49 73 112886 17071 90498417
Distractibility 38.01 11.49 17 112942 542 90514946
Electrocardiogram abnormal 37.88 11.49 55 112904 10243 90505245
Compulsions 37.85 11.49 13 112946 200 90515288
Myelosuppression 37.82 11.49 10 112949 53581 90461907
Schizoaffective disorder 37.81 11.49 39 112920 5108 90510380
Wrong dose 37.65 11.49 26 112933 1958 90513530
Hypernatraemia 37.27 11.49 52 112907 9335 90506153
Oropharyngeal spasm 37.00 11.49 14 112945 288 90515200
Eye movement disorder 36.84 11.49 42 112917 6156 90509332
Diet refusal 36.75 11.49 17 112942 587 90514901
Binge eating 36.72 11.49 17 112942 588 90514900
Foreign body 36.66 11.49 28 112931 2466 90513022
Product reconstitution quality issue 36.61 11.49 11 112948 107 90515381
Somatic symptom disorder 36.60 11.49 32 112927 3409 90512079
Potentiating drug interaction 36.46 11.49 40 112919 5622 90509866
Emotional poverty 36.42 11.49 15 112944 389 90515099
Screaming 36.18 11.49 33 112926 3717 90511771
Oesophageal atresia 36.06 11.49 17 112942 613 90514875
Communication disorder 36.01 11.49 31 112928 3235 90512253
Colitis ulcerative 35.97 11.49 15 112944 60251 90455237
Hemivertebra 35.64 11.49 11 112948 118 90515370
Prescribed underdose 35.55 11.49 25 112934 74994 90440494
Pulse abnormal 35.53 11.49 30 112929 3049 90512439
Oligomenorrhoea 35.41 11.49 20 112939 1055 90514433
Withdrawal catatonia 35.28 11.49 12 112947 179 90515309
Intracranial pressure increased 35.26 11.49 43 112916 6768 90508720
Megacolon 35.08 11.49 26 112933 2188 90513300
Respiratory arrest 34.89 11.49 106 112853 33205 90482283
Stereotypy 34.67 11.49 15 112944 441 90515047
Hypercholesterolaemia 34.54 11.49 45 112914 100847 90414641
Encephalitis autoimmune 34.49 11.49 25 112934 2033 90513455
Blepharospasm 34.40 11.49 13 112946 55432 90460056
Device expulsion 34.36 11.49 5 112954 40881 90474607
Pyrexia 34.31 11.49 598 112361 659887 89855601
Nasal congestion 34.28 11.49 32 112927 83382 90432106
Behaviour disorder 33.83 11.49 35 112924 4600 90510888
Blood triglycerides increased 33.56 11.49 61 112898 13700 90501788
Depressive symptom 33.45 11.49 37 112922 5248 90510240
Hyperlactacidaemia 33.42 11.49 33 112926 4103 90511385
Morbid thoughts 33.16 11.49 17 112942 737 90514751
Dyspnoea exertional 33.07 11.49 25 112934 72263 90443225
Tension 32.81 11.49 31 112928 3651 90511837
Onychomycosis 32.77 11.49 4 112955 37372 90478116
Substance abuse 32.76 11.49 37 112922 5369 90510119
Precocious puberty 32.65 11.49 13 112946 308 90515180
Tachypnoea 32.60 11.49 78 112881 21231 90494257
Pituitary tumour 32.55 11.49 18 112941 911 90514577
Self-injurious ideation 32.50 11.49 29 112930 3174 90512314
Anger 32.42 11.49 60 112899 13660 90501828
Drug reaction with eosinophilia and systemic symptoms 32.36 11.49 122 112837 42636 90472852
Antipsychotic drug level below therapeutic 32.31 11.49 13 112946 317 90515171
Neck pain 32.13 11.49 58 112901 113905 90401583
Disorganised speech 31.82 11.49 23 112936 1862 90513626
Bone pain 31.62 11.49 19 112940 61964 90453524
Claustrophobia 31.51 11.49 20 112939 1307 90514181
Metabolic acidosis 31.27 11.49 145 112814 55531 90459957
Regurgitation 31.14 11.49 24 112935 2142 90513346
Macular degeneration 31.10 11.49 5 112954 37965 90477523
Menstruation irregular 31.04 11.49 44 112915 8016 90507472
Breast enlargement 30.97 11.49 22 112937 1733 90513755
Status epilepticus 30.96 11.49 71 112888 18803 90496685
Loss of libido 30.96 11.49 20 112939 1347 90514141
Hypotonic urinary bladder 30.93 11.49 7 112952 18 90515470
Walking aid user 30.65 11.49 4 112955 35502 90479986
Resting tremor 30.64 11.49 17 112942 866 90514622
Polyuria 30.40 11.49 49 112910 9991 90505497
Neurological symptom 30.33 11.49 40 112919 6807 90508681
Poriomania 30.10 11.49 9 112950 86 90515402
Fear 30.05 11.49 65 112894 16557 90498931
Productive cough 30.01 11.49 31 112928 77032 90438456
Drug use disorder 29.87 11.49 44 112915 8299 90507189
Slow response to stimuli 29.78 11.49 18 112941 1078 90514410
Liver disorder 29.67 11.49 67 112892 121202 90394286
Altered visual depth perception 29.40 11.49 13 112946 403 90515085
Areflexia 29.25 11.49 29 112930 3624 90511864
Breast engorgement 28.80 11.49 9 112950 101 90515387
Circulatory collapse 28.71 11.49 82 112877 24822 90490666
Posture abnormal 28.41 11.49 25 112934 2686 90512802
Educational problem 28.37 11.49 14 112945 559 90514929
Blood pressure systolic increased 28.23 11.49 19 112940 58326 90457162
Brugada syndrome 27.75 11.49 13 112946 462 90515026
Depressed mood 27.62 11.49 130 112829 50092 90465396
Polydipsia psychogenic 27.59 11.49 9 112950 117 90515371
Joint stiffness 27.55 11.49 34 112925 78008 90437480
Target skin lesion 27.45 11.49 9 112950 119 90515369
Deep vein thrombosis 27.44 11.49 202 112757 91418 90424070
Colitis 27.39 11.49 28 112931 69914 90445574
Chorea 27.36 11.49 22 112937 2088 90513400
Staring 27.34 11.49 20 112939 1650 90513838
Locked-in syndrome 27.32 11.49 13 112946 479 90515009
Pemphigoid 27.26 11.49 44 112915 8982 90506506
Breast tenderness 27.20 11.49 24 112935 2588 90512900
Delusion of reference 27.05 11.49 9 112950 125 90515363
Head injury 27.01 11.49 93 112866 31095 90484393
Underdose 26.97 11.49 136 112823 53881 90461607
Neoplasm progression 26.66 11.49 11 112948 44475 90471013
Mycobacterium ulcerans infection 26.54 11.49 7 112952 40 90515448
Tobacco interaction 26.43 11.49 8 112951 80 90515408
Frontotemporal dementia 26.36 11.49 12 112947 399 90515089
Ear pain 26.34 11.49 20 112939 57682 90457806
Oropharyngeal pain 26.30 11.49 66 112893 115121 90400367
Interstitial lung disease 26.23 11.49 34 112925 76371 90439117
Lung neoplasm malignant 26.14 11.49 78 112881 24195 90491293
Bedridden 26.08 11.49 51 112908 12097 90503391
Dementia Alzheimer's type 26.07 11.49 16 112943 985 90514503
Basal cell carcinoma 26.03 11.49 5 112954 33384 90482104
Accidental overdose 25.98 11.49 86 112873 28187 90487301
Incontinence 25.98 11.49 54 112905 13381 90502107
Alcohol abuse 25.95 11.49 21 112938 2012 90513476
Hypophagia 25.93 11.49 101 112858 35836 90479652
Flank pain 25.87 11.49 67 112892 19155 90496333
Bladder dilatation 25.87 11.49 16 112943 999 90514489
Poisoning 25.80 11.49 58 112901 15159 90500329
Cystitis 25.80 11.49 27 112932 66691 90448797
Cardiac output decreased 25.79 11.49 16 112943 1004 90514484
Drug resistance 25.68 11.49 90 112869 30359 90485129
Posturing 25.59 11.49 13 112946 553 90514935
Full blood count abnormal 25.50 11.49 7 112952 36590 90478898
Ulcer 25.47 11.49 5 112954 32877 90482611
Transient aphasia 25.45 11.49 7 112952 48 90515440
Affect lability 25.39 11.49 64 112895 17999 90497489
Sleep disorder 25.28 11.49 144 112815 197886 90317602
Respiratory tract infection 25.07 11.49 22 112937 59056 90456432
Ear infection 25.05 11.49 30 112929 69745 90445743
Device occlusion 25.03 11.49 43 112916 9239 90506249
Endocarditis fibroplastica 24.98 11.49 5 112954 5 90515483
Dizziness 24.97 11.49 552 112407 588732 89926756
Haematochezia 24.92 11.49 31 112928 70882 90444606
Syncope 24.91 11.49 264 112695 132399 90383089
Euphoric mood 24.58 11.49 32 112927 5377 90510111
Hypoglycaemia 24.46 11.49 160 112799 69688 90445800
Injury associated with device 24.45 11.49 29 112930 4435 90511053
Dysphoria 24.30 11.49 34 112925 6120 90509368
Type 1 diabetes mellitus 24.30 11.49 30 112929 4782 90510706
Alcohol interaction 24.27 11.49 19 112940 1735 90513753
Ventricular extrasystoles 24.16 11.49 52 112907 13198 90502290
Postmortem blood drug level 24.05 11.49 8 112951 111 90515377
Optic nerve injury 24.04 11.49 13 112946 629 90514859
Personality disorder 24.04 11.49 50 112909 12394 90503094
Injection site bruising 24.04 11.49 18 112941 52289 90463199
Mouth ulceration 23.77 11.49 10 112949 39964 90475524
Antidiuretic hormone abnormality 23.76 11.49 6 112953 28 90515460
Brain contusion 23.61 11.49 13 112946 652 90514836
Nightmare 23.57 11.49 70 112889 21655 90493833
Drug withdrawal syndrome neonatal 23.54 11.49 21 112938 2298 90513190
Lack of spontaneous speech 23.44 11.49 9 112950 193 90515295
Hyporesponsive to stimuli 23.43 11.49 18 112941 1599 90513889
Neglect of personal appearance 23.42 11.49 8 112951 121 90515367
Product leakage 23.36 11.49 17 112942 1391 90514097
Skin ulcer 23.31 11.49 17 112942 50058 90465430
Cytotoxic oedema 23.31 11.49 9 112950 196 90515292
Gaze palsy 23.19 11.49 18 112941 1623 90513865
Attention-seeking behaviour 23.12 11.49 7 112952 70 90515418
Labelled drug-drug interaction medication error 22.98 11.49 54 112905 14528 90500960
Disability 22.97 11.49 11 112948 40734 90474754
Wound complication 22.94 11.49 29 112930 4734 90510754
Injection site pruritus 22.90 11.49 20 112939 53814 90461674
Nystagmus 22.89 11.49 36 112923 7191 90508297
Arrhythmia 22.86 11.49 109 112850 42223 90473265
Eating disorder 22.84 11.49 82 112877 27991 90487497
CYP2D6 polymorphism 22.69 11.49 7 112952 75 90515413
Maternal drugs affecting foetus 22.66 11.49 30 112929 5125 90510363
Pica 22.65 11.49 6 112953 35 90515453
Mucosal inflammation 22.64 11.49 23 112936 57602 90457886
Caput succedaneum 22.64 11.49 5 112954 11 90515477
Feeling hot 22.62 11.49 39 112920 77969 90437519
Myocarditis septic 22.50 11.49 6 112953 36 90515452
Tourette's disorder 22.34 11.49 5 112954 12 90515476
Adverse drug reaction 22.27 11.49 233 112726 116468 90399020
Choreoathetosis 22.21 11.49 12 112947 580 90514908
Hypoosmolar state 22.19 11.49 9 112950 224 90515264
Gamma-glutamyltransferase increased 22.18 11.49 100 112859 37852 90477636
Hot flush 21.98 11.49 25 112934 59463 90456025
Convulsive threshold lowered 21.94 11.49 11 112948 455 90515033
Neonatal tachypnoea 21.88 11.49 8 112951 149 90515339
Multiple organ dysfunction syndrome 21.86 11.49 32 112927 68304 90447184
Nuchal rigidity 21.78 11.49 13 112946 761 90514727
Anaphylactic reaction 21.70 11.49 48 112911 87476 90428012
Vomiting projectile 21.65 11.49 18 112941 1791 90513697
Sinus congestion 21.60 11.49 4 112955 27420 90488068
Plasma cell myeloma 21.56 11.49 12 112947 40816 90474672
Nephrogenic diabetes insipidus 21.50 11.49 14 112945 956 90514532
Sinus disorder 21.50 11.49 8 112951 34439 90481049
Inappropriate schedule of product administration 21.36 11.49 283 112676 149650 90365838
Grimacing 21.22 11.49 11 112948 488 90515000
Injection site nodule 21.17 11.49 27 112932 4446 90511042
Anti-transglutaminase antibody increased 21.06 11.49 5 112954 17 90515471
Parachute mitral valve 21.05 11.49 7 112952 97 90515391
Agranulocytosis 21.03 11.49 93 112866 34909 90480579
Pulmonary mass 21.01 11.49 5 112954 28767 90486721
Attention deficit hyperactivity disorder 20.99 11.49 26 112933 4158 90511330
Amaurosis 20.94 11.49 13 112946 817 90514671
Drug abuser 20.88 11.49 21 112938 2669 90512819
Opisthotonus 20.80 11.49 10 112949 377 90515111
Gastroenteritis viral 20.79 11.49 6 112953 30349 90485139
Phobia 20.78 11.49 10 112949 378 90515110
Blunted affect 20.69 11.49 9 112950 268 90515220
Skin exfoliation 20.57 11.49 33 112926 67880 90447608
Indifference 20.56 11.49 8 112951 178 90515310
Disruptive mood dysregulation disorder 20.52 11.49 4 112955 3 90515485
Product substitution issue 20.47 11.49 59 112900 17949 90497539
Suspiciousness 20.46 11.49 10 112949 391 90515097
Aspiration 20.40 11.49 54 112905 15639 90499849
Obsessive-compulsive symptom 20.36 11.49 7 112952 108 90515380
Food craving 20.34 11.49 18 112941 1949 90513539
Electrocardiogram T wave inversion 20.29 11.49 24 112935 3659 90511829
Hypersomnia 20.24 11.49 66 112893 21465 90494023
Anticonvulsant drug level increased 20.21 11.49 17 112942 1719 90513769
Diverticulitis 20.19 11.49 16 112943 45171 90470317
Oesophageal food impaction 20.18 11.49 9 112950 285 90515203
Full blood count decreased 20.09 11.49 6 112953 29683 90485805
Pre-existing disease 19.92 11.49 8 112951 194 90515294
Suicidal behaviour 19.91 11.49 21 112938 2823 90512665
Fibrin D dimer increased 19.85 11.49 29 112930 5431 90510057
Laboratory test abnormal 19.76 11.49 14 112945 41840 90473648
Atrioventricular block second degree 19.71 11.49 26 112933 4426 90511062
Therapy interrupted 19.69 11.49 20 112939 50088 90465400
Optic atrophy 19.66 11.49 16 112943 1545 90513943
Paroxysmal perceptual alteration 19.64 11.49 6 112953 62 90515426
Cellulitis 19.58 11.49 54 112905 91283 90424205
Urinary tract infection staphylococcal 19.56 11.49 10 112949 431 90515057
Chronic obstructive pulmonary disease 19.45 11.49 158 112801 73671 90441817
Choking 19.45 11.49 45 112914 11988 90503500
CYP2C19 polymorphism 19.35 11.49 5 112954 26 90515462
Gastrointestinal sounds abnormal 19.30 11.49 26 112933 4517 90510971
Product packaging quantity issue 19.30 11.49 16 112943 1586 90513902
Pneumonitis 19.29 11.49 16 112943 44154 90471334
Shock 19.25 11.49 79 112880 28699 90486789
Rectal haemorrhage 19.21 11.49 47 112912 82697 90432791
Merycism 19.16 11.49 9 112950 322 90515166
Chills 19.06 11.49 92 112867 131889 90383599
Product physical issue 19.05 11.49 29 112930 5631 90509857
Pain in jaw 19.03 11.49 19 112940 47966 90467522
Oral herpes 18.97 11.49 9 112950 33515 90481973
Intestinal obstruction 18.90 11.49 94 112865 37037 90478451
Decreased gait velocity 18.90 11.49 5 112954 29 90515459
Dyslipidaemia 18.82 11.49 40 112919 10067 90505421
Macroprolactinaemia 18.72 11.49 4 112955 7 90515481
Paraesthesia oral 18.70 11.49 8 112951 31651 90483837
Anaphylactic shock 18.66 11.49 8 112951 31609 90483879
Pleural effusion 18.64 11.49 74 112885 111917 90403571
Muscle enzyme increased 18.59 11.49 8 112951 232 90515256
Adrenal insufficiency 18.59 11.49 7 112952 29914 90485574
Osteonecrosis of jaw 18.56 11.49 13 112946 39090 90476398
Cardiac failure congestive 18.55 11.49 62 112897 98632 90416856
Long QT syndrome 18.53 11.49 24 112935 4013 90511475
Device dislocation 18.52 11.49 8 112951 31474 90484014
Joint dislocation 18.44 11.49 17 112942 44565 90470923
Neonatal respiratory distress syndrome 18.41 11.49 21 112938 3080 90512408
Ulcer haemorrhage 18.40 11.49 5 112954 26316 90489172
Enuresis 18.40 11.49 22 112937 3392 90512096
Meige's syndrome 18.37 11.49 4 112955 8 90515480
Amimia 18.33 11.49 6 112953 79 90515409
CSF pressure increased 18.32 11.49 7 112952 148 90515340
Maternal exposure timing unspecified 18.32 11.49 3 112956 22480 90493008
Cataract 18.32 11.49 39 112920 72053 90443435
Stress 18.30 11.49 47 112912 81348 90434140
Cortisol increased 18.27 11.49 10 112949 496 90514992
Feeling guilty 18.23 11.49 11 112948 657 90514831
Hypervolaemia 18.22 11.49 9 112950 32748 90482740
Trismus 18.10 11.49 26 112933 4795 90510693
C-reactive protein increased 18.07 11.49 142 112817 181247 90334241
Renal impairment 18.05 11.49 206 112753 105215 90410273
Breast pain 17.99 11.49 40 112919 10378 90505110
Victim of crime 17.91 11.49 12 112947 860 90514628
Incorrect dose administered 17.70 11.49 163 112796 78767 90436721
Pulmonary vein occlusion 17.61 11.49 6 112953 90 90515398
Freezing phenomenon 17.59 11.49 16 112943 1796 90513692
Rash erythematous 17.58 11.49 34 112925 65070 90450418
Metastases to bone 17.54 11.49 5 112954 25500 90489988
Accidental exposure to product by child 17.50 11.49 14 112945 1319 90514169
Dyslalia 17.49 11.49 11 112948 707 90514781
Patient elopement 17.46 11.49 7 112952 169 90515319
Haematocrit decreased 17.28 11.49 100 112859 41732 90473756
Hypoxic-ischaemic encephalopathy 17.27 11.49 25 112934 4643 90510845
Congenital ureteric anomaly 17.25 11.49 6 112953 96 90515392
Blood calcium decreased 17.24 11.49 8 112951 30174 90485314
Prescribed overdose 17.23 11.49 63 112896 97562 90417926
Tongue biting 17.20 11.49 17 112942 2116 90513372
Schizophreniform disorder 17.14 11.49 6 112953 98 90515390
Supraventricular tachycardia 17.12 11.49 52 112907 16284 90499204
Skin haemorrhage 17.10 11.49 3 112956 21377 90494111
Hysterical psychosis 17.07 11.49 3 112956 0 90515488
Orthodontic procedure 16.98 11.49 4 112955 13 90515475
Leukocytosis 16.88 11.49 80 112879 30910 90484578
Toxic encephalopathy 16.86 11.49 35 112924 8664 90506824
Adverse reaction 16.78 11.49 8 112951 29704 90485784
Fear of death 16.73 11.49 13 112946 1174 90514314
Palmar-plantar erythrodysaesthesia syndrome 16.68 11.49 7 112952 28016 90487472
Eczema 16.67 11.49 25 112934 52845 90462643
Delusional disorder, unspecified type 16.62 11.49 9 112950 437 90515051
Facial spasm 16.61 11.49 11 112948 773 90514715
Oppositional defiant disorder 16.61 11.49 5 112954 49 90515439
Hypoprolactinaemia 16.54 11.49 4 112955 15 90515473
Pulmonary arterial hypertension 16.48 11.49 6 112953 26181 90489307
Somatic delusion 16.47 11.49 10 112949 604 90514884
Tachyphrenia 16.43 11.49 15 112944 1691 90513797
Hirsutism 16.40 11.49 15 112944 1695 90513793
Neurological decompensation 16.36 11.49 21 112938 3480 90512008
Retinal ischaemia 16.36 11.49 9 112950 451 90515037
Akinesia 16.21 11.49 15 112944 1721 90513767
Cataract cortical 16.17 11.49 5 112954 54 90515434
Eye pruritus 16.11 11.49 8 112951 29019 90486469
Brain oedema 16.08 11.49 53 112906 17332 90498156
Xanthopsia 16.01 11.49 7 112952 211 90515277
Clostridium difficile infection 15.99 11.49 13 112946 36232 90479256
Sedation complication 15.98 11.49 52 112907 16892 90498596
Skin discolouration 15.96 11.49 19 112940 44296 90471192
Haemodynamic instability 15.88 11.49 41 112918 11698 90503790
Frostbite 15.71 11.49 7 112952 221 90515267
Tubulointerstitial nephritis 15.62 11.49 6 112953 25337 90490151
Affective ambivalence 15.61 11.49 4 112955 20 90515468
Spinal shock 15.61 11.49 4 112955 20 90515468
Procedural complication 15.55 11.49 27 112932 5851 90509637
Victim of abuse 15.48 11.49 6 112953 132 90515356
Negative thoughts 15.43 11.49 12 112947 1085 90514403
Retinal exudates 15.32 11.49 10 112949 686 90514802
Parkinsonism hyperpyrexia syndrome 15.31 11.49 7 112952 235 90515253
Conversion disorder 15.30 11.49 16 112943 2130 90513358
Oral candidiasis 15.29 11.49 13 112946 35442 90480046
Pneumonia 15.29 11.49 645 112314 637414 89878074
Neuropsychiatric symptoms 15.25 11.49 10 112949 691 90514797
Transient tachypnoea of the newborn 15.20 11.49 6 112953 139 90515349
Meningism 15.09 11.49 9 112950 526 90514962
Respiratory alkalosis 15.05 11.49 20 112939 3428 90512060
Blood pressure systolic abnormal 15.01 11.49 3 112956 19475 90496013
Obsessive rumination 14.99 11.49 3 112956 3 90515485
Illness anxiety disorder 14.92 11.49 6 112953 146 90515342
Product monitoring error 14.90 11.49 23 112936 4521 90510967
Severe myoclonic epilepsy of infancy 14.86 11.49 5 112954 72 90515416
Cholangitis sclerosing 14.84 11.49 16 112943 2205 90513283
Drug tolerance decreased 14.84 11.49 11 112948 32119 90483369
Diabetic ketoacidosis 14.78 11.49 65 112894 24342 90491146
Feelings of worthlessness 14.74 11.49 8 112951 390 90515098
Nephrolithiasis 14.73 11.49 24 112935 49061 90466427
Acute generalised exanthematous pustulosis 14.72 11.49 44 112915 13659 90501829
Asterixis 14.66 11.49 14 112945 1671 90513817
Hypotonia neonatal 14.61 11.49 13 112946 1417 90514071
Dysgeusia 14.59 11.49 27 112932 52533 90462955
Anticonvulsant drug level above therapeutic 14.58 11.49 9 112950 560 90514928
Electrocardiogram T wave amplitude decreased 14.55 11.49 8 112951 400 90515088
Anhedonia 14.52 11.49 39 112920 11392 90504096
Multiple sclerosis relapse 14.40 11.49 27 112932 52278 90463210
Pressure of speech 14.40 11.49 10 112949 760 90514728
Oxygen saturation decreased 14.34 11.49 77 112882 107406 90408082
Onychophagia 14.32 11.49 5 112954 81 90515407
Muscle twitching 14.31 11.49 64 112895 24138 90491350
Hypochloraemia 14.30 11.49 17 112942 2605 90512883
Hyperhidrosis 14.25 11.49 244 112715 136061 90379427
CSF glucose decreased 14.21 11.49 5 112954 83 90515405
Bruxism 14.19 11.49 22 112937 4341 90511147
Product dose omission in error 14.14 11.49 4 112955 20499 90494989
Body mass index increased 14.10 11.49 13 112946 1484 90514004
Abortion threatened 14.10 11.49 9 112950 594 90514894
Oral pain 14.07 11.49 12 112947 32671 90482817
Device breakage 14.06 11.49 44 112915 14000 90501488
Liver function test abnormal 14.04 11.49 110 112849 50735 90464753
Pseudohallucination 14.04 11.49 6 112953 171 90515317
Tenderness 14.04 11.49 8 112951 26860 90488628
Hyperdynamic left ventricle 14.02 11.49 7 112952 287 90515201
Blood glucose 13.90 11.49 4 112955 33 90515455
Product use in unapproved indication 13.82 11.49 531 112428 335705 90179783
Pregnancy 13.82 11.49 36 112923 62011 90453477
Removal of foreign body from eye 13.78 11.49 3 112956 6 90515482
Hepatitis acute 13.69 11.49 37 112922 10850 90504638
Dermatosis 13.67 11.49 9 112950 626 90514862
Localised infection 13.64 11.49 13 112946 33549 90481939
Osteomyelitis 13.56 11.49 9 112950 27837 90487651
Electrocardiogram U wave present 13.54 11.49 5 112954 96 90515392
Flight of ideas 13.50 11.49 8 112951 462 90515026
Brief psychotic disorder, with postpartum onset 13.49 11.49 4 112955 37 90515451
Cerebrovascular stenosis 13.49 11.49 4 112955 37 90515451
Hepatic cytolysis 13.49 11.49 75 112884 30841 90484647
Toxic leukoencephalopathy 13.48 11.49 10 112949 843 90514645
Vomiting 13.47 11.49 825 112134 787468 89728020
Haemoptysis 13.43 11.49 13 112946 33307 90482181
Schizoaffective disorder bipolar type 13.42 11.49 6 112953 191 90515297
Surgery 13.42 11.49 22 112937 44865 90470623
Diabetic neuropathy 13.41 11.49 22 112937 4552 90510936
Parkinson's disease 13.37 11.49 11 112948 1079 90514409
Weight fluctuation 13.35 11.49 4 112955 19745 90495743
Loss of personal independence in daily activities 13.35 11.49 107 112852 135998 90379490
Oesophageal achalasia 13.26 11.49 9 112950 659 90514829
Orthostatic intolerance 13.23 11.49 12 112947 1342 90514146
Polyserositis 13.20 11.49 9 112950 664 90514824
Blood sodium increased 13.19 11.49 18 112941 3164 90512324
Antidepressant drug level above therapeutic 13.19 11.49 8 112951 482 90515006
Physical assault 13.14 11.49 10 112949 876 90514612
Epileptic psychosis 13.13 11.49 4 112955 41 90515447
Metastases to liver 13.13 11.49 10 112949 28797 90486691
Injection site swelling 13.11 11.49 35 112924 59804 90455684
Product packaging issue 13.09 11.49 13 112946 1628 90513860
Vaginal discharge 13.05 11.49 4 112955 19460 90496028
Retinal vein occlusion 13.01 11.49 16 112943 2540 90512948
Colour blindness 12.98 11.49 7 112952 337 90515151
Gastrointestinal haemorrhage 12.98 11.49 63 112896 90185 90425303
Skin disorder 12.94 11.49 16 112943 36690 90478798
Candida infection 12.92 11.49 14 112945 34043 90481445
Atlantoaxial subluxation 12.92 11.49 3 112956 9 90515479
Blood gonadotrophin increased 12.92 11.49 3 112956 9 90515479
Verbal abuse 12.90 11.49 5 112954 110 90515378
Hyponatraemic seizure 12.90 11.49 8 112951 502 90514986
Musculoskeletal discomfort 12.89 11.49 5 112954 20986 90494502
Vocal cord dysfunction 12.86 11.49 10 112949 904 90514584
Snoring 12.85 11.49 23 112936 5103 90510385
Regressive behaviour 12.84 11.49 6 112953 212 90515276
Cytopenia 12.81 11.49 3 112956 17446 90498042
Blood pressure increased 12.78 11.49 171 112788 197046 90318442
Dialysis hypotension 12.74 11.49 6 112953 216 90515272
Subileus 12.73 11.49 19 112940 3625 90511863
Gastric lavage 12.71 11.49 4 112955 46 90515442
Ideas of reference 12.70 11.49 5 112954 115 90515373
Somnolence neonatal 12.70 11.49 5 112954 115 90515373
Drug ineffective for unapproved indication 12.68 11.49 133 112826 66511 90448977
Blood pressure decreased 12.66 11.49 146 112813 74749 90440739
Delirium tremens 12.66 11.49 5 112954 116 90515372
Foetal death 12.62 11.49 5 112954 20718 90494770
Bronchospasm 12.61 11.49 5 112954 20704 90494784
Sitting disability 12.57 11.49 7 112952 359 90515129
Type 2 diabetes mellitus 12.54 11.49 178 112781 203066 90312422
Off label use 12.49 11.49 1562 111397 1100690 89414798
Thrombosis 12.45 11.49 48 112911 73203 90442285
Blood osmolarity decreased 12.44 11.49 10 112949 949 90514539
Eye haematoma 12.42 11.49 5 112954 122 90515366
Product prescribing error 12.41 11.49 72 112887 30073 90485415
Cardiovascular symptom 12.38 11.49 5 112954 123 90515365
Retrograde amnesia 12.29 11.49 8 112951 546 90514942
Cleft lip and palate 12.25 11.49 9 112950 747 90514741
Breast abscess 12.09 11.49 14 112945 2086 90513402
Pregnancy with contraceptive patch 12.06 11.49 3 112956 13 90515475
Respiratory disorder 11.99 11.49 41 112918 64775 90450713
Poor personal hygiene 11.98 11.49 7 112952 394 90515094
Ventricular septal defect 11.97 11.49 23 112936 5384 90510104
Food interaction 11.95 11.49 11 112948 1253 90514235
Platelet count decreased 11.95 11.49 111 112848 136858 90378630
Cyanosis 11.92 11.49 52 112907 19403 90496085
Bone disorder 11.91 11.49 7 112952 23113 90492375
Deja vu 11.88 11.49 5 112954 137 90515351
Psychotic disorder due to a general medical condition 11.88 11.49 6 112953 252 90515236
Apallic syndrome 11.84 11.49 9 112950 787 90514701
Anembryonic gestation 11.81 11.49 8 112951 584 90514904
Antipsychotic drug level decreased 11.79 11.49 7 112952 406 90515082
Mucosal dryness 11.77 11.49 17 112942 3150 90512338
Syndactyly 11.77 11.49 8 112951 587 90514901
Therapeutic product effect prolonged 11.77 11.49 7 112952 407 90515081
Pupillary light reflex tests abnormal 11.73 11.49 6 112953 259 90515229
Enlarged cerebral perivascular spaces 11.71 11.49 3 112956 15 90515473
Postpartum disorder 11.71 11.49 3 112956 15 90515473
Gambling 11.71 11.49 6 112953 260 90515228
Femur fracture 11.65 11.49 25 112934 46057 90469431
Neurodegenerative disorder 11.65 11.49 7 112952 415 90515073
Violence-related symptom 11.58 11.49 8 112951 603 90514885
Macrosomia 11.56 11.49 4 112955 63 90515425
Dermatillomania 11.56 11.49 6 112953 267 90515221
Injection site rash 11.52 11.49 8 112951 24165 90491323
Vasculitis 11.51 11.49 7 112952 22686 90492802
Head banging 11.49 11.49 7 112952 425 90515063

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Gynaecomastia 4798.35 13.61 1692 125746 10875 42483022
Extrapyramidal disorder 2680.82 13.61 1197 126241 15215 42478682
Neuroleptic malignant syndrome 1946.67 13.61 1048 126390 20424 42473473
Dystonia 1366.23 13.61 697 126741 12093 42481804
Psychotic disorder 1322.20 13.61 914 126524 28294 42465603
Aggression 1221.00 13.61 1030 126408 43133 42450764
Sedation 1168.44 13.61 862 126576 29613 42464284
Hyperprolactinaemia 1149.21 13.61 372 127066 1751 42492146
Akathisia 1137.88 13.61 577 126861 9874 42484023
Weight increased 1066.48 13.61 1457 125981 106526 42387371
Treatment noncompliance 1044.00 13.61 880 126558 36792 42457105
Suicide attempt 949.57 13.61 911 126527 45189 42448708
Emotional disorder 921.11 13.61 426 127012 5888 42488009
Hallucination, auditory 869.02 13.61 546 126892 14318 42479579
Blood prolactin increased 828.83 13.61 297 127141 2001 42491896
Tardive dyskinesia 814.65 13.61 403 127035 6521 42487376
Parkinsonism 770.07 13.61 448 126990 10175 42483722
Catatonia 689.37 13.61 348 127090 5891 42488006
Obesity 676.93 13.61 486 126952 15973 42477924
Intentional self-injury 634.64 13.61 453 126985 14749 42479148
Somnolence 629.15 13.61 1336 126102 139769 42354128
Dyskinesia 600.15 13.61 542 126896 24848 42469049
Agitation 586.50 13.61 836 126602 63478 42430419
Salivary hypersecretion 577.68 13.61 377 127061 10566 42483331
Delusion 560.38 13.61 415 127023 14319 42479578
Suicidal ideation 556.86 13.61 703 126735 47458 42446439
Paranoia 537.79 13.61 397 127041 13629 42480268
Emotional distress 534.30 13.61 418 127020 15675 42478222
Abnormal weight gain 532.23 13.61 185 127253 1125 42492772
Muscle rigidity 523.35 13.61 368 127070 11691 42482206
Priapism 509.30 13.61 287 127151 6120 42487777
Increased appetite 497.62 13.61 318 127120 8588 42485309
Drug interaction 497.34 13.61 1838 125600 265161 42228736
Intentional overdose 476.57 13.61 674 126764 50782 42443115
Galactorrhoea 468.67 13.61 134 127304 371 42493526
Abnormal behaviour 463.46 13.61 479 126959 25972 42467925
Diarrhoea 448.40 13.61 432 127006 460417 42033480
Oculogyric crisis 415.29 13.61 167 127271 1598 42492299
Febrile neutropenia 408.45 13.61 41 127397 185662 42308235
Device malfunction 393.71 13.61 313 127125 12014 42481883
Obsessive-compulsive disorder 384.75 13.61 244 127194 6499 42487398
Psychiatric decompensation 368.08 13.61 201 127237 4021 42489876
Product dose omission issue 365.12 13.61 1152 126286 153213 42340684
Sexual dysfunction 334.72 13.61 224 127214 6551 42487346
Schizophrenia 322.28 13.61 261 127177 10289 42483608
Arthralgia 317.30 13.61 109 127329 205129 42288768
Blood creatine phosphokinase increased 310.32 13.61 535 126903 47803 42446094
Dyspnoea 309.08 13.61 532 126906 442089 42051808
Psychomotor skills impaired 308.66 13.61 193 127245 5011 42488886
Device leakage 302.72 13.61 249 127189 10036 42483861
Psychotic symptom 301.71 13.61 146 127292 2244 42491653
Rash 297.23 13.61 236 127202 276718 42217179
Blood prolactin abnormal 294.58 13.61 113 127325 942 42492955
Nausea 293.63 13.61 459 126979 396340 42097557
Disinhibition 281.50 13.61 164 127274 3731 42490166
Pneumonia 277.07 13.61 527 126911 421622 42072275
Tearfulness 270.64 13.61 154 127284 3346 42490551
Tic 266.37 13.61 134 127304 2249 42491648
Depressive symptom 259.49 13.61 155 127283 3698 42490199
Restlessness 257.25 13.61 374 127064 28875 42465022
Rhabdomyolysis 255.20 13.61 655 126783 77364 42416533
Antipsychotic drug level below therapeutic 253.20 13.61 143 127295 3061 42490836
Overdose 250.81 13.61 788 126650 104476 42389421
Anaemia 249.02 13.61 283 127155 279995 42213902
Psychomotor hyperactivity 243.36 13.61 226 127212 10732 42483165
Syringe issue 236.98 13.61 200 127238 8356 42485541
Tachycardia 234.65 13.61 750 126688 100337 42393560
Depression suicidal 232.84 13.61 136 127302 3109 42490788
Anxiety 232.35 13.61 831 126607 117729 42376168
Serotonin syndrome 230.96 13.61 333 127105 25512 42468385
Cogwheel rigidity 224.27 13.61 109 127329 1692 42492205
Irritability 223.52 13.61 343 127095 27785 42466112
Malignant neoplasm progression 223.06 13.61 30 127408 108370 42385527
Pleurothotonus 222.31 13.61 96 127342 1115 42492782
Pruritus 221.69 13.61 146 127292 188625 42305272
Euphoric mood 219.30 13.61 170 127268 6283 42487614
Mania 214.15 13.61 207 127231 10340 42483557
Hypothermia 209.04 13.61 221 127217 12294 42481603
Coma 207.48 13.61 480 126958 53074 42440823
Sepsis 202.38 13.61 179 127259 199155 42294742
Emotional poverty 201.44 13.61 77 127361 635 42493262
Pain 193.62 13.61 270 127168 244578 42249319
Disturbance in social behaviour 191.65 13.61 98 127340 1705 42492192
Death 189.64 13.61 747 126691 470438 42023459
Sedation complication 187.72 13.61 114 127324 2805 42491092
Tremor 186.94 13.61 676 126762 96253 42397644
Device use confusion 184.93 13.61 39 127399 3 42493894
Sopor 182.27 13.61 211 127227 12991 42480906
Depressed level of consciousness 181.48 13.61 426 127012 47544 42446353
Therapeutic product effect variable 181.09 13.61 114 127324 2995 42490902
Pain in extremity 180.15 13.61 114 127324 150490 42343407
Psychomotor retardation 178.73 13.61 129 127309 4270 42489627
Back pain 178.45 13.61 101 127337 141675 42352222
Overweight 170.19 13.61 100 127338 2312 42491585
Persecutory delusion 169.26 13.61 115 127323 3449 42490448
Anosognosia 166.58 13.61 75 127363 969 42492928
Asthenia 164.81 13.61 373 127065 280420 42213477
Cough 161.06 13.61 177 127261 177926 42315971
Fatigue 158.86 13.61 717 126721 434924 42058973
Hallucination 157.11 13.61 452 126986 57055 42436842
Apathy 155.83 13.61 157 127281 8249 42485648
Disease progression 155.61 13.61 121 127317 143535 42350362
Oromandibular dystonia 150.87 13.61 60 127378 556 42493341
Product administration error 141.95 13.61 221 127217 18122 42475775
Delirium 139.80 13.61 409 127029 52110 42441787
Atrial fibrillation 139.61 13.61 127 127311 139466 42354431
Metabolic disorder 138.96 13.61 115 127323 4673 42489224
Mental impairment 137.78 13.61 177 127261 12140 42481757
Delusion of grandeur 136.24 13.61 81 127357 1915 42491982
Medication error 135.96 13.61 304 127134 32850 42461047
Insomnia 134.20 13.61 703 126735 117550 42376347
Drooling 132.64 13.61 107 127331 4192 42489705
Electrocardiogram QT prolonged 132.07 13.61 378 127060 47567 42446330
Wrong patient received product 131.89 13.61 99 127339 3484 42490413
Foreign body 131.24 13.61 63 127375 950 42492947
Septic shock 130.95 13.61 55 127383 91617 42402280
Peripheral swelling 130.82 13.61 53 127385 90217 42403680
Psychiatric symptom 129.67 13.61 105 127333 4136 42489761
Nasopharyngitis 128.94 13.61 45 127393 83951 42409946
Speech disorder 128.47 13.61 275 127163 28846 42465051
Acute kidney injury 127.60 13.61 615 126823 366722 42127175
Infusion related reaction 127.03 13.61 16 127422 60790 42433107
Breast enlargement 126.75 13.61 49 127389 418 42493479
Cardiac failure congestive 126.11 13.61 49 127389 85553 42408344
Drug hypersensitivity 124.73 13.61 71 127367 99318 42394579
Torticollis 124.35 13.61 67 127371 1303 42492594
Soliloquy 122.51 13.61 52 127386 577 42493320
Dyspnoea exertional 118.58 13.61 8 127430 50140 42443757
Schizoaffective disorder 116.66 13.61 73 127365 1897 42492000
Pneumonia aspiration 116.46 13.61 372 127066 49706 42444191
Seizure 116.30 13.61 686 126752 119875 42374022
Joint swelling 116.09 13.61 30 127408 67992 42425905
Homicidal ideation 115.95 13.61 83 127355 2711 42491186
Social avoidant behaviour 115.12 13.61 89 127349 3275 42490622
Sluggishness 113.95 13.61 94 127344 3802 42490095
Myocarditis 112.89 13.61 203 127235 18735 42475162
Enuresis 112.59 13.61 81 127357 2667 42491230
Abdominal pain 111.62 13.61 253 127185 190218 42303679
Disturbance in attention 111.58 13.61 264 127174 29602 42464295
Withdrawal syndrome 111.53 13.61 176 127262 14599 42479298
Pyrexia 111.52 13.61 706 126732 393336 42100561
Wrong product administered 111.24 13.61 114 127324 6112 42487785
Haemoglobin decreased 110.75 13.61 140 127298 132331 42361566
Hallucination, visual 108.70 13.61 212 127226 20808 42473089
Headache 108.14 13.61 361 127077 239008 42254889
Thrombosis 106.37 13.61 36 127402 68475 42425422
Blunted affect 105.42 13.61 41 127397 356 42493541
Thinking abnormal 104.85 13.61 118 127320 7043 42486854
Completed suicide 103.62 13.61 565 126873 95900 42397997
Breast discharge 103.14 13.61 25 127413 25 42493872
Self-destructive behaviour 103.08 13.61 40 127398 345 42493552
Neuropathy peripheral 102.59 13.61 92 127346 101761 42392136
Interstitial lung disease 101.41 13.61 54 127384 78408 42415489
Dysarthria 101.16 13.61 305 127133 39502 42454395
Decreased appetite 100.31 13.61 273 127165 192864 42301033
Prostate cancer 100.27 13.61 9 127429 44634 42449263
Erythema 98.40 13.61 108 127330 108685 42385212
Urinary incontinence 98.32 13.61 207 127231 21461 42472436
Cytokine release syndrome 97.31 13.61 10 127428 44517 42449380
Hospitalisation 97.09 13.61 460 126978 73870 42420027
Dyslipidaemia 97.05 13.61 130 127308 9288 42484609
Needle issue 96.96 13.61 125 127313 8602 42485295
Product reconstitution quality issue 96.72 13.61 33 127405 188 42493709
Ascites 96.71 13.61 25 127413 56653 42437244
Infection 96.22 13.61 116 127322 111952 42381945
Affective disorder 95.55 13.61 103 127335 5857 42488040
Delusional disorder, persecutory type 95.46 13.61 37 127401 318 42493579
Product use in unapproved indication 95.22 13.61 905 126533 183551 42310346
Hyperthermia 95.21 13.61 150 127288 12424 42481473
Refusal of treatment by patient 94.75 13.61 97 127341 5194 42488703
Behaviour disorder 94.46 13.61 111 127327 6943 42486954
Productive cough 93.41 13.61 20 127418 51547 42442350
Pancytopenia 92.73 13.61 130 127308 117613 42376284
Rheumatoid arthritis 91.54 13.61 10 127428 42430 42451467
Myelosuppression 91.30 13.61 8 127430 40453 42453444
Polydipsia 90.94 13.61 88 127350 4400 42489497
Drug ineffective 90.65 13.61 2493 124945 627704 41866193
Product quality issue 89.61 13.61 178 127260 17704 42476193
Metabolic syndrome 89.47 13.61 62 127376 1921 42491976
Incorrect dose administered 89.24 13.61 354 127084 52620 42441277
Spasmodic dysphonia 88.16 13.61 39 127399 482 42493415
Acute myocardial infarction 87.82 13.61 32 127406 58133 42435764
Hypertonia 86.52 13.61 90 127348 4911 42488986
Stomatitis 86.25 13.61 22 127416 50307 42443590
Arthritis 85.63 13.61 12 127426 42053 42451844
Chills 85.48 13.61 93 127345 93973 42399924
COVID-19 84.54 13.61 135 127303 115813 42378084
Paraesthesia 84.52 13.61 58 127380 73401 42420496
Confusional state 84.35 13.61 818 126620 166779 42327118
Gastrointestinal haemorrhage 84.05 13.61 101 127337 97625 42396272
Eye movement disorder 83.77 13.61 88 127350 4857 42489040
Blood triglycerides increased 83.01 13.61 161 127277 15735 42478162
Oedema peripheral 82.75 13.61 177 127261 135899 42357998
Accidental overdose 82.54 13.61 228 127210 28102 42465795
Type 2 diabetes mellitus 82.11 13.61 175 127263 18296 42475601
Underdose 81.24 13.61 164 127274 16502 42477395
Mutism 81.14 13.61 52 127386 1410 42492487
Polydipsia psychogenic 81.08 13.61 27 127411 141 42493756
Chest discomfort 80.43 13.61 45 127393 63571 42430326
Gaze palsy 79.99 13.61 57 127381 1848 42492049
Cytomegalovirus infection 79.89 13.61 4 127434 32302 42461595
Psychosexual disorder 79.84 13.61 26 127412 125 42493772
Cognitive disorder 79.57 13.61 254 127184 33918 42459979
Anger 79.45 13.61 141 127297 12877 42481020
Water intoxication 79.41 13.61 34 127404 386 42493511
Plasma cell myeloma 79.25 13.61 22 127416 47556 42446341
Diabetes mellitus 78.56 13.61 372 127066 59715 42434182
Opisthotonus 77.83 13.61 38 127400 596 42493301
Asthma 77.46 13.61 45 127393 62269 42431628
Bradykinesia 76.91 13.61 88 127350 5348 42488549
Cerebrovascular accident 76.77 13.61 107 127331 97053 42396844
Sinusitis 76.69 13.61 23 127415 47269 42446628
Malignant catatonia 76.51 13.61 34 127404 425 42493472
Paroxysmal perceptual alteration 76.48 13.61 28 127410 202 42493695
Leukopenia 76.37 13.61 432 127006 74314 42419583
Abdominal pain upper 75.80 13.61 81 127357 82528 42411369
Sudden death 75.60 13.61 159 127279 16470 42477427
Wheezing 74.85 13.61 35 127403 54746 42439151
Urticaria 74.39 13.61 67 127371 73969 42419928
Toxicity to various agents 73.91 13.61 1026 126412 228110 42265787
Myocardial infarction 73.17 13.61 164 127274 123845 42370052
Intrusive thoughts 72.84 13.61 33 127405 433 42493464
Chronic obstructive pulmonary disease 72.38 13.61 50 127388 63064 42430833
Weight decreased 70.94 13.61 350 127088 207598 42286299
Oropharyngeal spasm 70.26 13.61 26 127412 194 42493703
Incoherent 69.96 13.61 78 127360 4607 42489290
Intentional product use issue 69.82 13.61 67 127371 71766 42422131
Product label confusion 69.79 13.61 28 127410 266 42493631
Hyperkalaemia 69.34 13.61 83 127355 80375 42413522
Device breakage 69.19 13.61 69 127369 3580 42490317
Multiple organ dysfunction syndrome 68.83 13.61 115 127323 96920 42396977
Prescribed overdose 68.81 13.61 132 127306 12795 42481102
Antipsychotic drug level increased 68.50 13.61 77 127361 4589 42489308
Personality change 68.42 13.61 85 127353 5634 42488263
Colitis 68.01 13.61 27 127411 46545 42447352
Malaise 67.90 13.61 365 127073 211791 42282106
Anticholinergic syndrome 67.77 13.61 48 127390 1541 42492356
Blood pressure increased 67.60 13.61 126 127312 101802 42392095
Haemoptysis 67.03 13.61 27 127411 46140 42447757
Pneumonitis 66.36 13.61 21 127417 41697 42452200
Inappropriate affect 65.91 13.61 36 127402 720 42493177
Illusion 65.68 13.61 40 127398 989 42492908
Abdominal discomfort 65.53 13.61 77 127361 75178 42418719
Pleural effusion 65.43 13.61 119 127319 97047 42396850
Myalgia 65.30 13.61 117 127321 95963 42397934
Blood creatinine increased 64.46 13.61 146 127292 109857 42384040
Stupor 64.22 13.61 62 127376 3091 42490806
Coronary artery disease 63.69 13.61 41 127397 53679 42440218
Psoriasis 63.45 13.61 33 127405 48571 42445326
Staring 63.35 13.61 46 127392 1537 42492360
Hypersexuality 62.58 13.61 47 127391 1655 42492242
Gout 62.08 13.61 6 127432 28049 42465848
Suicidal behaviour 62.04 13.61 45 127393 1501 42492396
Sinus tachycardia 61.94 13.61 168 127270 20485 42473412
Obsessive-compulsive symptom 61.75 13.61 24 127414 208 42493689
Systemic infection 61.69 13.61 77 127361 5128 42488769
Vomiting 61.03 13.61 563 126875 289160 42204737
Sexually inappropriate behaviour 60.86 13.61 32 127406 591 42493306
Respiratory failure 60.72 13.61 189 127249 127943 42365954
Hypotonia 60.71 13.61 105 127333 9394 42484503
Diabetic hyperosmolar coma 60.03 13.61 30 127408 496 42493401
Flat affect 60.00 13.61 38 127400 1009 42492888
Hypersensitivity 59.90 13.61 77 127361 72293 42421604
Posture abnormal 59.88 13.61 54 127384 2467 42491430
Substance-induced psychotic disorder 59.20 13.61 57 127381 2832 42491065
Psoriatic arthropathy 58.97 13.61 4 127434 24963 42468934
Haematochezia 58.56 13.61 53 127385 58383 42435514
Dry skin 58.54 13.61 36 127402 48302 42445595
Diet refusal 58.22 13.61 25 127413 286 42493611
Hyperammonaemic encephalopathy 57.62 13.61 55 127383 2703 42491194
Paradoxical drug reaction 57.62 13.61 71 127367 4667 42489230
Protrusion tongue 57.19 13.61 23 127415 220 42493677
Rhinalgia 57.11 13.61 46 127392 1798 42492099
Drug abuse 56.96 13.61 520 126918 104251 42389646
Bacterial infection 56.63 13.61 8 127430 27871 42466026
Self-injurious ideation 56.58 13.61 46 127392 1822 42492075
Bacteraemia 56.36 13.61 5 127433 25035 42468862
Accidental exposure to product 56.34 13.61 161 127277 20232 42473665
Cardiac failure 56.20 13.61 150 127288 106706 42387191
Hypoaesthesia 56.14 13.61 79 127359 71384 42422513
Blepharospasm 55.31 13.61 40 127398 1328 42492569
Epilepsy 55.08 13.61 188 127250 25983 42467914
Off label use 55.04 13.61 2381 125057 635954 41857943
Herpes zoster 54.41 13.61 24 127414 38853 42455044
Dizziness 54.37 13.61 480 126958 248774 42245123
Compulsive sexual behaviour 54.12 13.61 23 127415 256 42493641
Conduction disorder 54.10 13.61 51 127387 2467 42491430
Lower respiratory tract infection 53.76 13.61 28 127410 41178 42452719
Dysgeusia 52.99 13.61 18 127420 34171 42459726
Neuralgia 52.95 13.61 7 127431 25640 42468257
Product container issue 51.95 13.61 33 127405 881 42493016
Dysphemia 51.72 13.61 44 127394 1858 42492039
Obsessive thoughts 51.32 13.61 32 127406 826 42493071
Grandiosity 51.09 13.61 23 127415 297 42493600
Acute psychosis 50.98 13.61 46 127392 2103 42491794
Rectal haemorrhage 50.90 13.61 44 127394 49562 42444335
Epistaxis 50.41 13.61 76 127362 66750 42427147
Chest pain 50.37 13.61 230 127208 139300 42354597
Lymphocyte count abnormal 50.28 13.61 46 127392 2141 42491756
Swelling 50.13 13.61 54 127384 54831 42439066
Staphylococcal infection 49.97 13.61 25 127413 37618 42456279
Erectile dysfunction 49.86 13.61 176 127262 24737 42469160
Hypomagnesaemia 49.68 13.61 12 127426 28476 42465421
Influenza 49.57 13.61 68 127370 62107 42431790
Anaphylactic shock 49.57 13.61 6 127432 23511 42470386
Painful erection 49.06 13.61 23 127415 328 42493569
Rebound effect 49.05 13.61 83 127355 7296 42486601
Upper respiratory tract infection 48.89 13.61 33 127405 42140 42451757
Major depression 48.86 13.61 70 127368 5328 42488569
Upper gastrointestinal haemorrhage 48.64 13.61 15 127423 30284 42463613
Lung disorder 48.57 13.61 43 127395 47880 42446017
Haemorrhage 48.52 13.61 66 127372 60497 42433400
Fluid retention 48.40 13.61 17 127421 31602 42462295
Floppy iris syndrome 47.67 13.61 22 127416 302 42493595
Lymphadenopathy 47.65 13.61 20 127418 33345 42460552
Hypophosphataemia 47.64 13.61 4 127434 20941 42472956
Hallucinations, mixed 47.57 13.61 55 127383 3380 42490517
Diverticulitis 47.53 13.61 6 127432 22767 42471130
Depressed mood 47.49 13.61 166 127272 23218 42470679
Basal cell carcinoma 47.42 13.61 6 127432 22727 42471170
Ideas of reference 47.41 13.61 14 127424 45 42493852
Adverse event 47.30 13.61 167 127271 23473 42470424
Bradyphrenia 47.28 13.61 68 127370 5194 42488703
Cerebral haemorrhage 47.21 13.61 29 127409 38937 42454960
Physical assault 46.88 13.61 33 127405 1049 42492848
Screaming 46.82 13.61 42 127396 1905 42491992
Diabetic coma 46.82 13.61 32 127406 969 42492928
Nephrolithiasis 46.62 13.61 26 127412 36804 42457093
Generalised tonic-clonic seizure 46.61 13.61 179 127259 26200 42467697
Muscle spasms 46.60 13.61 119 127319 85925 42407972
Parkinsonian gait 46.05 13.61 26 127412 556 42493341
Hypometabolism 45.82 13.61 18 127420 161 42493736
Thrombocytopenia 45.74 13.61 357 127081 189922 42303975
Altered state of consciousness 45.66 13.61 191 127247 29068 42464829
International normalised ratio increased 45.56 13.61 46 127392 48122 42445775
Hostility 45.33 13.61 29 127409 784 42493113
Leukaemia 45.28 13.61 70 127368 5702 42488195
Impaired self-care 45.13 13.61 34 127404 1203 42492694
Pneumocystis jirovecii pneumonia 45.12 13.61 10 127428 25171 42468726
Hallucination, olfactory 45.01 13.61 20 127418 250 42493647
Anaphylactic reaction 44.97 13.61 37 127401 42706 42451191
Abdominal distension 44.67 13.61 92 127346 71643 42422254
Myoclonus 44.52 13.61 132 127306 16933 42476964
Inappropriate antidiuretic hormone secretion 44.15 13.61 129 127309 16412 42477485
Hypervolaemia 43.91 13.61 8 127430 23117 42470780
Hypoxia 43.88 13.61 89 127349 69697 42424200
Frequent bowel movements 43.82 13.61 6 127432 21401 42472496
Skin exfoliation 43.68 13.61 36 127402 41517 42452380
Rebound psychosis 43.62 13.61 18 127420 185 42493712
Platelet count decreased 43.42 13.61 240 127198 138341 42355556
Osteoarthritis 43.11 13.61 10 127428 24395 42469502
Bruxism 42.95 13.61 42 127396 2127 42491770
Rabbit syndrome 42.84 13.61 12 127426 30 42493867
Eosinophilic pneumonia acute 42.74 13.61 28 127410 789 42493108
Renal impairment 42.64 13.61 177 127261 110051 42383846
Chronic kidney disease 42.57 13.61 47 127391 47194 42446703
Product substitution issue 42.37 13.61 100 127338 11190 42482707
Waxy flexibility 42.37 13.61 15 127423 97 42493800
Dysphagia 42.11 13.61 366 127072 72353 42421544
Choking 42.07 13.61 71 127367 6227 42487670
Oropharyngeal pain 42.06 13.61 39 127399 42471 42451426
Alcohol abuse 41.88 13.61 56 127382 3993 42489904
Migraine 41.86 13.61 12 127426 25402 42468495
Feeling guilty 41.71 13.61 21 127417 353 42493544
Illness anxiety disorder 41.70 13.61 17 127421 169 42493728
Palmar-plantar erythrodysaesthesia syndrome 41.59 13.61 6 127432 20576 42473321
Melaena 41.44 13.61 33 127405 38713 42455184
Eyelid function disorder 41.09 13.61 17 127421 176 42493721
Bronchopulmonary aspergillosis 40.84 13.61 5 127433 19424 42474473
Blood pressure fluctuation 40.28 13.61 15 127423 26893 42467004
Mental disorder 40.14 13.61 132 127306 17897 42476000
Miosis 39.94 13.61 109 127329 13337 42480560
Tourette's disorder 39.50 13.61 13 127425 65 42493832
Tumour lysis syndrome 39.49 13.61 9 127429 22222 42471675
Adrenal insufficiency 39.46 13.61 5 127433 18919 42474978
Prostatic specific antigen increased 39.14 13.61 3 127435 16922 42476975
Tubulointerstitial nephritis 38.89 13.61 23 127415 31525 42462372
Arteriosclerosis coronary artery 38.79 13.61 5 127433 18672 42475225
Arthropathy 38.77 13.61 20 127418 29577 42464320
Clostridium difficile infection 38.63 13.61 10 127428 22649 42471248
Benign prostatic hyperplasia 38.46 13.61 8 127430 21044 42472853
Autism spectrum disorder 38.32 13.61 46 127392 2942 42490955
Logorrhoea 37.30 13.61 44 127394 2763 42491134
Head titubation 37.24 13.61 21 127417 448 42493449
Accidental death 37.17 13.61 46 127392 3037 42490860
Homosexuality 37.14 13.61 12 127426 56 42493841
Condition aggravated 37 13.61 1031 126407 259723 42234174
Disorientation 36.93 13.61 210 127228 36179 42457718
Reduced facial expression 36.73 13.61 33 127405 1500 42492397
Haematuria 36.09 13.61 74 127364 57725 42436172
Bone pain 36.06 13.61 13 127425 23779 42470118
Oscillopsia 36.04 13.61 17 127421 246 42493651
COVID-19 pneumonia 35.98 13.61 10 127428 21603 42472294
Product physical issue 35.82 13.61 46 127392 3153 42490744
Negative symptoms in schizophrenia 35.72 13.61 13 127425 92 42493805
Wrong technique in product usage process 35.65 13.61 234 127204 42401 42451496
Antipsychotic drug level above therapeutic 35.52 13.61 30 127408 1254 42492643
Angina pectoris 35.20 13.61 28 127410 32868 42461029
Pulmonary fibrosis 34.99 13.61 18 127420 26663 42467234
Respiratory dyskinesia 34.94 13.61 9 127429 14 42493883
Schizophreniform disorder 34.93 13.61 12 127426 70 42493827
Social anxiety disorder 34.74 13.61 22 127416 584 42493313
Neutrophil count increased 34.67 13.61 134 127304 19670 42474227
Retrograde ejaculation 34.67 13.61 21 127417 514 42493383
Granulocytopenia 34.66 13.61 70 127368 7044 42486853
Tachyphrenia 34.52 13.61 31 127407 1408 42492489
Hypomania 34.47 13.61 40 127398 2468 42491429
Heart rate decreased 34.42 13.61 35 127403 36497 42457400
Incontinence 34.23 13.61 68 127370 6762 42487135
Candida infection 34.15 13.61 11 127427 21599 42472298
Impulsive behaviour 33.87 13.61 39 127399 2386 42491511
Imprisonment 33.52 13.61 22 127416 622 42493275
Intentional product misuse 33.50 13.61 307 127131 61593 42432304
Full blood count decreased 33.33 13.61 10 127428 20550 42473347
Transient ischaemic attack 33.32 13.61 31 127407 33708 42460189
Hyperkinesia 33.18 13.61 36 127402 2062 42491835
Fungal infection 33.06 13.61 9 127429 19713 42474184
Activation syndrome 32.93 13.61 14 127424 156 42493741
Ulcer 32.74 13.61 5 127433 16436 42477461
Asphyxia 32.62 13.61 75 127363 8251 42485646
Muscle twitching 32.53 13.61 93 127345 11687 42482210
Hyperphagia 32.44 13.61 32 127406 1638 42492259
Pulmonary mass 32.27 13.61 5 127433 16260 42477637
Communication disorder 32.22 13.61 41 127397 2784 42491113
Libido decreased 32.12 13.61 56 127382 5042 42488855
Oral candidiasis 32.09 13.61 3 127435 14402 42479495
Neoplasm malignant 31.89 13.61 14 127424 22729 42471168
Appendicitis 31.69 13.61 11 127427 20602 42473295
Pseudomonas infection 31.35 13.61 5 127433 15918 42477979
Poisoning 31.29 13.61 106 127332 14593 42479304
Eating disorder 31.24 13.61 82 127356 9803 42484094
Skin ulcer 31.08 13.61 19 127419 25582 42468315
Dementia 30.91 13.61 114 127324 16366 42477531
Device related infection 30.87 13.61 11 127427 20268 42473629
Negativism 30.75 13.61 18 127420 413 42493484
Renal failure 30.75 13.61 278 127160 143448 42350449
Gastrointestinal disorder 30.62 13.61 58 127380 46595 42447302
Muscular weakness 30.49 13.61 137 127301 83361 42410536
Type 1 diabetes mellitus 30.40 13.61 57 127381 5430 42488467
Bladder dilatation 30.29 13.61 31 127407 1659 42492238
Wolff-Parkinson-White syndrome 30.29 13.61 15 127423 243 42493654
Depression 30.09 13.61 484 126954 110879 42383018
Hyperbilirubinaemia 30.06 13.61 12 127426 20623 42473274
Brain injury 30.04 13.61 69 127369 7586 42486311
White blood cell count decreased 29.95 13.61 200 127238 110196 42383701
Product label issue 29.75 13.61 16 127422 310 42493587
Mood swings 29.74 13.61 75 127363 8751 42485146
Delusional disorder, unspecified type 29.68 13.61 22 127416 759 42493138
Facial spasm 29.59 13.61 14 127424 204 42493693
Localised infection 29.43 13.61 12 127426 20361 42473536
Hot flush 29.43 13.61 15 127423 22336 42471561
Laboratory test abnormal 29.40 13.61 16 127422 22962 42470935
Mucosal inflammation 29.34 13.61 65 127373 49309 42444588
Obstructive airways disorder 29.20 13.61 19 127419 24740 42469157
Jaw clicking 29.02 13.61 10 127428 59 42493838
Crying 28.90 13.61 61 127377 6333 42487564
Full blood count abnormal 28.86 13.61 28 127410 29848 42464049
Slow speech 28.81 13.61 31 127407 1759 42492138
Excessive eye blinking 28.77 13.61 20 127418 623 42493274
Blister 28.66 13.61 24 127414 27466 42466431
Drug withdrawal syndrome 28.57 13.61 134 127304 21415 42472482
Accidental exposure to product by child 28.55 13.61 29 127409 1538 42492359
Urinary retention 28.49 13.61 220 127218 41994 42451903
Night sweats 28.46 13.61 12 127426 19957 42473940
Blood pressure systolic increased 28.45 13.61 25 127413 27943 42465954
Clostridium difficile colitis 28.38 13.61 14 127424 21238 42472659
Ejaculation failure 28.23 13.61 22 127416 819 42493078
Hyperphosphataemia 28.20 13.61 3 127435 13001 42480896
Small intestinal obstruction 28.20 13.61 8 127430 17053 42476844
Decreased gait velocity 28.20 13.61 13 127425 178 42493719
Renal disorder 28.18 13.61 27 127411 28953 42464944
Faeces discoloured 28.08 13.61 8 127430 17006 42476891
Flushing 28.02 13.61 42 127396 36986 42456911
Tongue movement disturbance 27.66 13.61 12 127426 141 42493756
Cellulitis 27.64 13.61 93 127345 61492 42432405
Osteomyelitis 27.54 13.61 10 127428 18213 42475684
Eczema 27.44 13.61 37 127401 34049 42459848
Grimacing 27.38 13.61 16 127422 366 42493531
Sinus bradycardia 27.24 13.61 102 127336 14751 42479146
Rhinorrhoea 27.16 13.61 33 127405 31761 42462136
Hepatic failure 27.14 13.61 45 127393 38055 42455842
Oral pain 27.08 13.61 3 127435 12593 42481304
Trismus 26.99 13.61 38 127400 2846 42491051
Illness 26.95 13.61 21 127417 24909 42468988
Nodule 26.91 13.61 3 127435 12531 42481366
Prolactin-producing pituitary tumour 26.87 13.61 9 127429 48 42493849
Ileus paralytic 26.87 13.61 66 127372 7575 42486322
Akinesia 26.82 13.61 35 127403 2437 42491460
Proteinuria 26.62 13.61 18 127420 22965 42470932
Wrong drug 26.58 13.61 12 127426 156 42493741
Bronchitis 26.54 13.61 64 127374 47137 42446760
Propulsive gait 26.47 13.61 6 127432 3 42493894
Conversion disorder 26.42 13.61 18 127420 542 42493355
Impaired healing 26.39 13.61 9 127429 17044 42476853
Therapy interrupted 26.34 13.61 17 127421 22233 42471664
Faecaloma 26.26 13.61 58 127380 6212 42487685
Shock haemorrhagic 26.14 13.61 8 127430 16234 42477663
Stereotypy 26.07 13.61 21 127417 821 42493076
Musculoskeletal pain 26.03 13.61 37 127401 33303 42460594
Tobacco user 25.88 13.61 18 127420 561 42493336
Myasthenia gravis 25.88 13.61 8 127430 16129 42477768
Oedema 25.83 13.61 75 127363 51926 42441971
Product dispensing error 25.83 13.61 65 127373 7574 42486323
Derealisation 25.78 13.61 21 127417 834 42493063
Meconium aspiration syndrome 25.71 13.61 9 127429 56 42493841
Hallucination, tactile 25.63 13.61 18 127420 570 42493327
Hyperammonaemia 25.63 13.61 66 127372 7800 42486097
Stress 25.62 13.61 59 127379 44153 42449744
Graft versus host disease 25.58 13.61 4 127434 12921 42480976
Rash pruritic 25.54 13.61 38 127400 33565 42460332
Product packaging issue 25.52 13.61 20 127418 751 42493146
Arteriosclerosis 25.34 13.61 11 127427 17978 42475919
Self esteem decreased 25.16 13.61 17 127421 505 42493392
Hypogammaglobulinaemia 25.14 13.61 3 127435 11888 42482009
Feeling hot 25.11 13.61 20 127418 23462 42470435
Dysphoria 25.08 13.61 36 127402 2744 42491153
Lung neoplasm malignant 24.99 13.61 13 127425 19134 42474763
Dementia with Lewy bodies 24.98 13.61 21 127417 872 42493025
Flatulence 24.97 13.61 23 127415 25129 42468768
Mydriasis 24.96 13.61 70 127368 8700 42485197
Pulmonary oedema 24.91 13.61 79 127359 53193 42440704
Choreoathetosis 24.86 13.61 23 127415 1086 42492811
Growth hormone-producing pituitary tumour 24.72 13.61 11 127427 138 42493759
Tachypnoea 24.66 13.61 129 127309 21533 42472364
Posturing 24.55 13.61 17 127421 526 42493371
Keratoconus 24.23 13.61 11 127427 145 42493752
Electrocardiogram abnormal 24.15 13.61 76 127362 10069 42483828
Injection site bruising 24.14 13.61 3 127435 11522 42482375
Exposure to contaminated device 24.08 13.61 5 127433 0 42493897
Gastrooesophageal reflux disease 23.80 13.61 63 127375 44960 42448937
Oral discharge 23.77 13.61 11 127427 152 42493745
Movement disorder 23.76 13.61 97 127341 14601 42479296
Gastric hypomotility 23.71 13.61 12 127426 204 42493693
Arachnoid cyst 23.62 13.61 13 127425 264 42493633
Klebsiella infection 23.61 13.61 3 127435 11329 42482568
Device occlusion 23.61 13.61 67 127371 8383 42485514
Activated partial thromboplastin time prolonged 23.58 13.61 9 127429 15894 42478003
Strabismus 23.56 13.61 32 127406 2316 42491581
Myelodysplastic syndrome 23.54 13.61 20 127418 22725 42471172
Urinary tract infection 23.49 13.61 187 127251 99097 42394800
Flight of ideas 23.43 13.61 14 127424 334 42493563
Sinus arrhythmia 23.26 13.61 20 127418 857 42493040
Progressive supranuclear palsy 23.24 13.61 8 127430 47 42493850
Posterior reversible encephalopathy syndrome 23.16 13.61 5 127433 12816 42481081
Lymphoma 23.15 13.61 7 127431 14314 42479583
Neuroleptic-induced deficit syndrome 23.14 13.61 7 127431 25 42493872
Erection increased 23.11 13.61 16 127422 495 42493402
Hyponatraemia 23.08 13.61 429 127009 101033 42392864
Abulia 23.06 13.61 18 127420 672 42493225
Musculoskeletal stiffness 22.94 13.61 269 127169 57496 42436401
Colitis ischaemic 22.90 13.61 60 127378 7166 42486731
Pituitary tumour benign 22.89 13.61 21 127417 981 42492916
Cataract 22.88 13.61 35 127403 30569 42463328
Discomfort 22.82 13.61 25 127413 25194 42468703
Product packaging quantity issue 22.78 13.61 24 127414 1329 42492568
Drug screen false positive 22.77 13.61 20 127418 882 42493015
Haematotoxicity 22.67 13.61 3 127435 10982 42482915
Cytopenia 22.65 13.61 12 127426 17485 42476412
Nephropathy toxic 22.62 13.61 11 127427 16827 42477070
Liquid product physical issue 22.58 13.61 19 127419 790 42493107
Acute myeloid leukaemia 22.51 13.61 20 127418 22236 42471661
Lung infiltration 22.32 13.61 7 127431 13982 42479915
Flashback 22.29 13.61 10 127428 128 42493769
Mastication disorder 22.22 13.61 27 127411 1749 42492148
Enteritis 22.21 13.61 3 127435 10813 42483084
Wrong patient 22.07 13.61 17 127421 622 42493275
Visceral congestion 22.04 13.61 20 127418 921 42492976
Prader-Willi syndrome 22.02 13.61 6 127432 13 42493884
Ventricular fibrillation 22.00 13.61 35 127403 30088 42463809
End stage renal disease 21.97 13.61 11 127427 16547 42477350
Inadequate diet 21.88 13.61 10 127428 134 42493763
Metabolic function test abnormal 21.88 13.61 12 127426 242 42493655
Hepatitis C virus test positive 21.88 13.61 13 127425 307 42493590
No adverse event 21.87 13.61 53 127385 38968 42454929
Bone marrow failure 21.84 13.61 41 127397 33052 42460845
Psychotic behaviour 21.81 13.61 20 127418 934 42492963
Neck pain 21.80 13.61 35 127403 29979 42463918
Self esteem inflated 21.74 13.61 5 127433 3 42493894
Breast disorder 21.71 13.61 6 127432 14 42493883
Electroencephalogram abnormal 21.69 13.61 35 127403 2957 42490940
Hyponatraemic syndrome 21.58 13.61 11 127427 190 42493707
Pulmonary haemorrhage 21.51 13.61 4 127434 11393 42482504
Dopamine dysregulation syndrome 21.46 13.61 16 127422 557 42493340
Inflammation 21.41 13.61 43 127395 33804 42460093
Dextrocardia 21.36 13.61 8 127430 62 42493835
Visual acuity reduced 21.34 13.61 13 127425 17537 42476360
Aptyalism 21.32 13.61 14 127424 396 42493501
Procedural complication 21.14 13.61 42 127396 4177 42489720
Ventricular tachycardia 21.13 13.61 36 127402 30124 42463773
Heat stroke 21.10 13.61 21 127417 1087 42492810
Coronary artery stenosis 21.03 13.61 3 127435 10376 42483521
Therapeutic product effect incomplete 20.94 13.61 313 127125 70626 42423271
Tension 20.91 13.61 31 127407 2433 42491464
Bipolar disorder 20.81 13.61 40 127398 3882 42490015
Shunt malfunction 20.75 13.61 12 127426 269 42493628
Hernia 20.66 13.61 4 127434 11069 42482828
Iron deficiency 20.63 13.61 4 127434 11057 42482840
Dermatillomania 20.62 13.61 8 127430 69 42493828
Gastric infection 20.54 13.61 24 127414 1492 42492405
Influenza like illness 20.53 13.61 40 127398 31800 42462097
Coronary artery occlusion 20.46 13.61 4 127434 10993 42482904
Osteonecrosis 20.37 13.61 11 127427 15854 42478043
Product complaint 20.36 13.61 51 127387 5926 42487971
Selective mutism 20.32 13.61 8 127430 72 42493825
Deafness 20.22 13.61 7 127431 13133 42480764
Gender dysphoria 20.21 13.61 7 127431 42 42493855
Cerebral atrophy 20.17 13.61 46 127392 5033 42488864
Hyperventilation 20.11 13.61 35 127403 3147 42490750
Infertility 20.09 13.61 11 127427 221 42493676
Injection site swelling 20.05 13.61 13 127425 16960 42476937
Coagulopathy 20.02 13.61 22 127416 22140 42471757
Hypoacusis 19.90 13.61 16 127422 18686 42475211
Circadian rhythm sleep disorder 19.90 13.61 15 127423 531 42493366
Low birth weight baby 19.88 13.61 3 127435 9952 42483945
Rash macular 19.87 13.61 13 127425 16878 42477019
Alcoholic coma 19.85 13.61 8 127430 77 42493820
Cholecystitis 19.84 13.61 7 127431 12981 42480916
Squamous cell carcinoma 19.83 13.61 7 127431 12975 42480922
Cholangitis 19.75 13.61 4 127434 10723 42483174
Respiratory muscle weakness 19.67 13.61 9 127429 121 42493776
Corneal reflex decreased 19.60 13.61 10 127428 173 42493724
Pulmonary hypertension 19.57 13.61 25 127413 23544 42470353
Dehydration 19.56 13.61 302 127136 141465 42352432
Withdrawal catatonia 19.53 13.61 11 127427 234 42493663
Cerebellar atrophy 19.52 13.61 17 127421 741 42493156
Drug withdrawal syndrome neonatal 19.52 13.61 42 127396 4419 42489478
Rapid eye movement sleep behaviour disorder 19.48 13.61 12 127426 303 42493594
Rash maculo-papular 19.43 13.61 53 127385 37450 42456447
Psychotic disorder due to a general medical condition 19.41 13.61 8 127430 82 42493815
Motor dysfunction 19.36 13.61 61 127377 8085 42485812
Hip fracture 19.35 13.61 8 127430 13464 42480433
Cyclothymic disorder 19.28 13.61 9 127429 127 42493770
Orthostatic hypertension 19.27 13.61 14 127424 468 42493429
Cardiac disorder 19.26 13.61 78 127360 48854 42445043
Acute respiratory distress syndrome 19.26 13.61 38 127400 30070 42463827
Foetal alcohol syndrome 19.24 13.61 8 127430 84 42493813
Oesophageal carcinoma 19.19 13.61 3 127435 9693 42484204
Renal tubular necrosis 19.16 13.61 16 127422 18338 42475559
Fall 18.97 13.61 870 126568 233650 42260247
Post procedural complication 18.87 13.61 7 127431 12583 42481314
Cytomegalovirus viraemia 18.84 13.61 4 127434 10373 42483524
Metastases to central nervous system 18.78 13.61 4 127434 10351 42483546
Blood phosphorus increased 18.71 13.61 7 127431 12518 42481379
Skin disorder 18.66 13.61 14 127424 16930 42476967
Distal intestinal obstruction syndrome 18.64 13.61 14 127424 493 42493404
Paraphilia 18.59 13.61 8 127430 92 42493805
Loss of libido 18.41 13.61 33 127405 3037 42490860
Arrhythmia 18.40 13.61 193 127245 40124 42453773
Boredom 18.40 13.61 6 127432 29 42493868
Malignant melanoma 18.40 13.61 3 127435 9397 42484500
Suspiciousness 18.39 13.61 13 127425 416 42493481
Ejaculation disorder 18.38 13.61 19 127419 1029 42492868
Throat irritation 18.31 13.61 8 127430 13028 42480869
Orthostatic hypotension 18.28 13.61 155 127283 30415 42463482
Borderline personality disorder 18.12 13.61 13 127425 426 42493471
Antisocial behaviour 18.12 13.61 13 127425 426 42493471
Vasculitis 18.04 13.61 17 127421 18377 42475520
C-reactive protein abnormal 18.03 13.61 3 127435 9258 42484639
Breast tenderness 17.97 13.61 17 127421 826 42493071
Skin cancer 17.82 13.61 6 127432 11456 42482441
Poriomania 17.79 13.61 8 127430 103 42493794
Neutropenic sepsis 17.79 13.61 13 127425 15933 42477964
Skin pressure mark 17.78 13.61 7 127431 63 42493834
Meningeal disorder 17.71 13.61 12 127426 358 42493539
Neglect of personal appearance 17.71 13.61 12 127426 358 42493539
Breath sounds abnormal 17.67 13.61 7 127431 12086 42481811
Abdominal pain lower 17.67 13.61 7 127431 12085 42481812
Colitis ulcerative 17.65 13.61 32 127406 26143 42467754
Skin lesion 17.64 13.61 34 127404 27140 42466757
Libido increased 17.64 13.61 18 127420 960 42492937
Laryngeal dyspnoea 17.59 13.61 8 127430 106 42493791
Tendonitis 17.58 13.61 4 127434 9890 42484007
Enterococcal infection 17.54 13.61 7 127431 12032 42481865
Hypercalcaemia 17.35 13.61 17 127421 18041 42475856
Hepatic cirrhosis 17.31 13.61 20 127418 19682 42474215
Product confusion 17.30 13.61 10 127428 224 42493673
Pneumonia bacterial 17.24 13.61 13 127425 15679 42478218
Pressure of speech 17.21 13.61 14 127424 555 42493342
Intestinal pseudo-obstruction 17.20 13.61 27 127411 2228 42491669
Somatic dysfunction 17.19 13.61 6 127432 37 42493860
Musculoskeletal chest pain 17.18 13.61 6 127432 11198 42482699
Depersonalisation/derealisation disorder 17.16 13.61 15 127423 657 42493240
Epstein-Barr virus infection 17.13 13.61 4 127434 9714 42484183
Ataxia 16.98 13.61 94 127344 16031 42477866
Hunger 16.86 13.61 25 127413 1963 42491934
Product leakage 16.77 13.61 16 127422 786 42493111
Persistent depressive disorder 16.64 13.61 13 127425 486 42493411
Viral diarrhoea 16.63 13.61 11 127427 315 42493582
Nasal congestion 16.58 13.61 40 127398 29461 42464436
Delusional perception 16.57 13.61 9 127429 178 42493719
Somatic hallucination 16.54 13.61 6 127432 42 42493855
Huntington's disease 16.54 13.61 6 127432 42 42493855
Enteritis necroticans 16.50 13.61 4 127434 4 42493893
Taste disorder 16.48 13.61 5 127433 10202 42483695
Tinnitus 16.46 13.61 39 127399 28899 42464998
Feminisation acquired 16.42 13.61 6 127432 43 42493854
Vascular stenosis 16.39 13.61 9 127429 182 42493715
Sputum discoloured 16.29 13.61 5 127433 10127 42483770
Substance use 16.28 13.61 23 127415 1728 42492169
Tuberculosis 16.21 13.61 5 127433 10094 42483803
Embolism venous 16.21 13.61 24 127414 1882 42492015
Angina unstable 16.12 13.61 7 127431 11441 42482456
Systemic lupus erythematosus 16.12 13.61 4 127434 9320 42484577
Hypocalcaemia 16.12 13.61 42 127396 30131 42463766
Blood potassium increased 16.09 13.61 19 127419 18517 42475380
Renal cyst 16.06 13.61 5 127433 10034 42483863
Eye pruritus 16.04 13.61 7 127431 11405 42482492
Injection site pain 16.02 13.61 104 127334 57694 42436203
Vertigo 16.01 13.61 51 127387 34296 42459601
Intellectual disability 16.01 13.61 24 127414 1903 42491994
Gingival pain 15.99 13.61 3 127435 8491 42485406
Gingival bleeding 15.97 13.61 3 127435 8482 42485415
Myopathy toxic 15.90 13.61 15 127423 726 42493171
Leukocytosis 15.89 13.61 147 127291 29561 42464336
Lethargy 15.89 13.61 212 127226 46678 42447219
Tooth disorder 15.83 13.61 8 127430 11971 42481926
Hypoalbuminaemia 15.82 13.61 14 127424 15596 42478301
Nuchal rigidity 15.82 13.61 13 127425 523 42493374
Red blood cell sedimentation rate decreased 15.81 13.61 10 127428 265 42493632
Bulimia nervosa 15.75 13.61 6 127432 49 42493848
Blood cholesterol increased 15.68 13.61 135 127303 26606 42467291
Oxygen saturation decreased 15.68 13.61 121 127317 64566 42429331
Frontotemporal dementia 15.67 13.61 10 127428 269 42493628
Attention deficit hyperactivity disorder 15.64 13.61 31 127407 3077 42490820
Panic attack 15.62 13.61 70 127368 10975 42482922
Autonomic nervous system imbalance 15.59 13.61 31 127407 3085 42490812
Blood glucose fluctuation 15.48 13.61 39 127399 4548 42489349
Acute coronary syndrome 15.47 13.61 13 127425 14852 42479045
Rash erythematous 15.42 13.61 47 127391 32044 42461853
Abscess 15.40 13.61 12 127426 14236 42479661
Thought blocking 15.40 13.61 8 127430 144 42493753
Pulmonary alveolar haemorrhage 15.37 13.61 13 127425 14803 42479094
Somatic symptom disorder 15.33 13.61 15 127423 760 42493137
Blood loss anaemia 15.31 13.61 5 127433 9731 42484166
Delusion of reference 15.24 13.61 7 127431 95 42493802
Neutrophil hypersegmented morphology present 15.24 13.61 4 127434 7 42493890
Ischaemic gastritis 15.24 13.61 4 127434 7 42493890
Long QT syndrome 15.24 13.61 31 127407 3136 42490761
Cholinergic syndrome 15.21 13.61 14 127424 657 42493240
CSF pressure increased 15.19 13.61 5 127433 25 42493872
Injection site erythema 15.19 13.61 23 127415 20172 42473725
Muscle contracture 15.08 13.61 20 127418 1415 42492482
Hypokinesia 15.06 13.61 64 127374 9807 42484090
Homicide 15.00 13.61 16 127422 899 42492998
Secondary tic 14.89 13.61 4 127434 8 42493889
Sinus disorder 14.82 13.61 3 127435 8047 42485850
Blood chloride decreased 14.82 13.61 36 127402 4103 42489794
Pneumothorax 14.81 13.61 30 127408 23513 42470384
Burning sensation 14.80 13.61 25 127413 20988 42472909
Hypokalaemia 14.77 13.61 140 127298 71581 42422316
Mobility decreased 14.72 13.61 55 127383 35251 42458646
Saccadic eye movement 14.69 13.61 8 127430 159 42493738
Exhibitionism 14.69 13.61 6 127432 60 42493837
Musculoskeletal discomfort 14.66 13.61 5 127433 9471 42484426
Loss of personal independence in daily activities 14.65 13.61 88 127350 49728 42444169
Photosensitivity reaction 14.64 13.61 10 127428 12692 42481205
Drug withdrawal convulsions 14.60 13.61 19 127419 1319 42492578
Portal vein cavernous transformation 14.57 13.61 4 127434 9 42493888
Acanthosis nigricans 14.56 13.61 8 127430 162 42493735
Staphylococcal sepsis 14.53 13.61 8 127430 11406 42482491
Drug delivery system malfunction 14.47 13.61 12 127426 489 42493408
Chronic tic disorder 14.45 13.61 3 127435 0 42493897
Blood creatine phosphokinase BB increased 14.45 13.61 3 127435 0 42493897
Meige's syndrome 14.45 13.61 3 127435 0 42493897
Heart rate irregular 14.42 13.61 16 127422 16034 42477863
Olfactory nerve disorder 14.34 13.61 6 127432 64 42493833
Haemorrhoids 14.34 13.61 18 127420 17079 42476818
Compulsions 14.28 13.61 9 127429 237 42493660
Ischaemic stroke 14.27 13.61 28 127410 22205 42471692
Blood albumin decreased 14.23 13.61 15 127423 15387 42478510
Xanthoma 14.21 13.61 7 127431 112 42493785
Convulsive threshold lowered 14.18 13.61 12 127426 503 42493394
Dysphonia 14.15 13.61 41 127397 28409 42465488
Premature baby 14.15 13.61 30 127408 23123 42470774
Bipolar I disorder 14.06 13.61 15 127423 843 42493054
Joint range of motion decreased 14.05 13.61 3 127435 7750 42486147
Rash papular 14.01 13.61 9 127429 11802 42482095
Hepatic cancer 13.97 13.61 4 127434 8476 42485421
Transfusion 13.93 13.61 7 127431 10507 42483390
Blood bilirubin increased 13.86 13.61 72 127366 42180 42451717
Glucose tolerance impaired 13.85 13.61 35 127403 4089 42489808
Immobile 13.78 13.61 28 127410 2830 42491067
Haemodynamic instability 13.76 13.61 74 127364 12483 42481414
Illogical thinking 13.75 13.61 4 127434 12 42493885
Therapeutic hypothermia 13.75 13.61 4 127434 12 42493885
Hangover 13.75 13.61 17 127421 1121 42492776
Forced expiratory volume decreased 13.73 13.61 3 127435 7627 42486270
Dissociative amnesia 13.72 13.61 6 127432 72 42493825
Glossoptosis 13.69 13.61 8 127430 183 42493714
Meningioma 13.63 13.61 21 127417 1706 42492191

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Extrapyramidal disorder 4360.04 11.90 1726 199632 27141 110360800
Neuroleptic malignant syndrome 3577.57 11.90 1572 199786 32487 110355454
Gynaecomastia 3171.65 11.90 1023 200335 8467 110379474
Hyperprolactinaemia 2638.41 11.90 815 200543 5760 110382181
Dystonia 2230.47 11.90 1040 200318 24765 110363176
Aggression 2088.08 11.90 1316 200042 57894 110330047
Suicide attempt 2038.65 11.90 1610 199748 101784 110286157
Sedation 1857.61 11.90 1301 200057 68382 110319559
Psychotic disorder 1818.17 11.90 1141 200217 49796 110338145
Akathisia 1674.55 11.90 752 200606 16361 110371580
Drug interaction 1623.69 11.90 3103 198255 497080 109890861
Blood prolactin increased 1561.41 11.90 503 200855 4139 110383802
Hallucination, auditory 1552.88 11.90 819 200539 25578 110362363
Treatment noncompliance 1409.02 11.90 1123 200235 71867 110316074
Intentional self-injury 1400.17 11.90 864 200494 36565 110351376
Dyskinesia 1350.98 11.90 952 200406 50494 110337447
Parkinsonism 1346.67 11.90 703 200655 21484 110366457
Catatonia 1318.08 11.90 562 200796 10738 110377203
Somnolence 1314.05 11.90 2115 199243 295334 110092607
Galactorrhoea 1291.09 11.90 424 200934 3731 110384210
Tardive dyskinesia 1275.53 11.90 580 200778 12999 110374942
Suicidal ideation 1111.17 11.90 1095 200263 92842 110295099
Intentional overdose 1103.31 11.90 1282 200076 131219 110256722
Agitation 1086.93 11.90 1179 200179 111872 110276069
Schizophrenia 1085.60 11.90 606 200752 21220 110366721
Sexual dysfunction 1050.65 11.90 441 200917 8089 110379852
Salivary hypersecretion 1037.27 11.90 545 200813 16876 110371065
Delusion 985.26 11.90 586 200772 23169 110364772
Blood prolactin abnormal 949.61 11.90 330 201028 3505 110384436
Abnormal behaviour 878.24 11.90 658 200700 38381 110349560
Muscle rigidity 856.34 11.90 538 200820 23493 110364448
Disturbance in social behaviour 824.84 11.90 320 201038 4738 110383203
Anosognosia 813.90 11.90 299 201059 3775 110384166
Paranoia 792.48 11.90 499 200859 21875 110366066
Oculogyric crisis 786.90 11.90 287 201071 3545 110384396
Arthralgia 756.42 11.90 240 201118 779392 109608549
Hypothermia 744.83 11.90 510 200848 25792 110362149
Metabolic disorder 739.43 11.90 368 200990 10142 110377799
Pain 620.69 11.90 499 200859 954456 109433485
Personality change 609.25 11.90 328 201030 10674 110377267
Joint swelling 594.43 11.90 59 201299 442786 109945155
Device leakage 593.74 11.90 368 200990 15680 110372261
Rash 585.19 11.90 389 200969 820575 109567366
Diarrhoea 575.29 11.90 741 200617 1138764 109249177
Toxicity to various agents 551.66 11.90 2024 199334 478531 109909410
Completed suicide 548.70 11.90 1301 200057 241080 110146861
Infusion related reaction 543.80 11.90 39 201319 381123 110006818
Mania 543.75 11.90 384 200974 20412 110367529
Overdose 543.47 11.90 1268 200090 232526 110155415
Psychiatric decompensation 540.58 11.90 246 201112 5519 110382422
Blood creatine phosphokinase increased 524.31 11.90 656 200702 72421 110315520
Priapism 524.17 11.90 242 201116 5619 110382322
Sopor 502.10 11.90 463 200895 36083 110351858
Rhabdomyolysis 499.17 11.90 833 200525 119568 110268373
Restlessness 492.53 11.90 559 200799 55700 110332241
Product dose omission issue 491.51 11.90 1493 199865 320289 110067652
Electrocardiogram QT prolonged 488.47 11.90 781 200577 108179 110279762
Device malfunction 488.07 11.90 391 200967 25167 110362774
Weight increased 484.37 11.90 1771 199587 417873 109970068
Syringe issue 477.76 11.90 266 201092 9259 110378682
Rheumatoid arthritis 466.82 11.90 18 201340 299595 110088346
Pleurothotonus 461.09 11.90 173 201185 2325 110385616
Psychomotor hyperactivity 460.93 11.90 344 201014 19933 110368008
Emotional disorder 459.05 11.90 314 201044 15846 110372095
Depressed level of consciousness 459.03 11.90 772 200586 111506 110276435
Amenorrhoea 458.13 11.90 256 201102 8975 110378966
Coma 443.26 11.90 781 200577 117088 110270853
Psychotic symptom 443.23 11.90 190 201168 3677 110384264
Tachycardia 438.52 11.90 1146 200212 225499 110162442
Pruritus 438.19 11.90 258 201100 581302 109806639
Tremor 437.65 11.90 1067 200291 201165 110186776
Psychomotor skills impaired 432.07 11.90 225 201133 6833 110381108
Peripheral swelling 425.29 11.90 106 201252 403928 109984013
Arthropathy 417.08 11.90 27 201331 287495 110100446
Increased appetite 399.55 11.90 280 201078 14697 110373244
Irritability 398.19 11.90 463 200895 47346 110340595
Dyspnoea 397.01 11.90 895 200463 1105977 109281964
Cogwheel rigidity 392.16 11.90 172 201186 3526 110384415
Abdominal discomfort 372.89 11.90 126 201232 393732 109994209
Hand deformity 371.35 11.90 5 201353 218501 110169440
Serotonin syndrome 371.09 11.90 497 200861 58656 110329285
Headache 367.08 11.90 654 200704 881723 109506218
Nasopharyngitis 366.73 11.90 130 201228 394231 109993710
Sinusitis 364.75 11.90 53 201305 296635 110091306
Hypomania 364.74 11.90 229 201129 9981 110377960
Systemic lupus erythematosus 359.83 11.90 27 201331 254311 110133630
Stomatitis 349.67 11.90 41 201317 270201 110117740
Pemphigus 348.11 11.90 9 201349 214561 110173380
Obsessive-compulsive disorder 346.29 11.90 196 201162 7045 110380896
Glossodynia 336.92 11.90 16 201342 221988 110165953
Delirium 336.36 11.90 753 200605 134272 110253669
Drug hypersensitivity 334.09 11.90 207 201151 453883 109934058
Nausea 333.86 11.90 1146 200212 1234544 109153397
Persecutory delusion 332.87 11.90 182 201176 6109 110381832
Hallucination 330.69 11.90 632 200726 100800 110287141
Hypersensitivity 323.28 11.90 166 201192 403832 109984109
Febrile neutropenia 322.03 11.90 89 201269 316678 110071263
Pneumonia aspiration 321.96 11.90 551 200807 80682 110307259
Psychomotor retardation 319.85 11.90 191 201167 7601 110380340
Fatigue 318.18 11.90 1143 200215 1214815 109173126
Swelling 315.78 11.90 122 201236 350919 110037022
Alopecia 308.42 11.90 139 201219 364614 110023327
Pain in extremity 307.64 11.90 261 201097 486857 109901084
Abnormal weight gain 304.76 11.90 143 201215 3448 110384493
Depressive symptom 303.79 11.90 190 201168 8224 110379717
Psoriatic arthropathy 302.44 11.90 13 201345 196748 110191193
Duodenal ulcer perforation 289.97 11.90 7 201351 177693 110210248
Wrong patient received product 288.09 11.90 169 201189 6505 110381436
Altered state of consciousness 287.39 11.90 434 200924 57192 110330749
Lower respiratory tract infection 275.41 11.90 54 201304 243052 110144889
Tic 274.73 11.90 132 201226 3361 110384580
Urticaria 273.50 11.90 119 201239 318738 110069203
Hallucination, visual 268.90 11.90 346 201012 39259 110348682
Folliculitis 268.34 11.90 8 201350 167645 110220296
Social avoidant behaviour 263.99 11.90 148 201210 5221 110382720
Device use confusion 262.56 11.90 51 201307 9 110387932
Helicobacter infection 258.09 11.90 19 201339 181858 110206083
Tearfulness 256.99 11.90 163 201195 7232 110380709
Pericarditis 256.07 11.90 45 201313 219069 110168872
Sluggishness 256.03 11.90 164 201194 7403 110380538
Emotional distress 250.02 11.90 356 201002 44491 110343450
Contraindicated product administered 249.97 11.90 71 201287 248196 110139745
Apathy 249.18 11.90 219 201139 16020 110371921
Oromandibular dystonia 249.17 11.90 91 201267 1128 110386813
Depression suicidal 248.18 11.90 137 201221 4687 110383254
Anxiety 248.16 11.90 1263 200095 343815 110044126
Fibromyalgia 247.92 11.90 16 201342 170893 110217048
Emotional poverty 247.90 11.90 87 201271 953 110386988
Mental impairment 241.96 11.90 250 201108 22389 110365552
Drug abuse 240.96 11.90 791 200567 176620 110211321
Abdominal pain upper 239.36 11.90 172 201186 348939 110039002
Discomfort 238.40 11.90 50 201308 214657 110173284
Dysarthria 237.94 11.90 494 200864 83627 110304314
Irritable bowel syndrome 233.45 11.90 17 201341 164198 110223743
Blister 230.82 11.90 64 201294 227312 110160629
Impaired healing 230.74 11.90 40 201318 196677 110191264
Drug intolerance 230.49 11.90 240 201118 406272 109981669
Hyperammonaemic encephalopathy 230.35 11.90 136 201222 5298 110382643
Disturbance in attention 229.36 11.90 408 200950 61587 110326354
Cough 228.09 11.90 304 201054 461337 109926604
Drooling 225.04 11.90 148 201210 6991 110380950
Hypoaesthesia 223.11 11.90 149 201209 314074 110073867
Osteoarthritis 221.21 11.90 34 201324 182589 110205352
Mutism 218.95 11.90 109 201249 3004 110384937
Wound 209.88 11.90 82 201276 234355 110153586
Seizure 209.59 11.90 878 200480 220307 110167634
Myocarditis 209.44 11.90 266 201092 29789 110358152
C-reactive protein abnormal 208.24 11.90 6 201352 129689 110258252
Asthma 205.89 11.90 99 201259 250192 110137749
Torticollis 203.82 11.90 105 201253 3116 110384825
Anaemia 203.17 11.90 433 200925 546653 109841288
Infection 201.76 11.90 217 201141 361983 110025958
Hypertonia 200.90 11.90 147 201211 8259 110379682
Urinary incontinence 198.34 11.90 334 201024 48253 110339688
Bursitis 198.26 11.90 9 201349 129909 110258032
Hyperthermia 197.48 11.90 218 201140 21054 110366887
Back pain 196.05 11.90 232 201126 370764 110017177
Affective disorder 195.73 11.90 163 201195 11078 110376863
Thinking abnormal 194.82 11.90 185 201173 14955 110372986
Withdrawal syndrome 194.24 11.90 262 201096 31118 110356823
Intentional product use issue 192.10 11.90 106 201252 247800 110140141
Inflammation 191.31 11.90 57 201301 193181 110194760
Sudden death 191.08 11.90 229 201129 24166 110363775
Antipsychotic drug level increased 189.09 11.90 132 201226 6883 110381058
Urinary retention 188.67 11.90 402 200956 69281 110318660
Joint range of motion decreased 187.36 11.90 8 201350 121824 110266117
Jaundice cholestatic 187.02 11.90 178 201180 14430 110373511
Asthenia 186.07 11.90 638 200720 688361 109699580
Paraesthesia 185.91 11.90 139 201219 276382 110111559
Gastrointestinal disorder 185.25 11.90 105 201253 241847 110146094
Bradykinesia 184.88 11.90 155 201203 10633 110377308
Arthritis 184.04 11.90 40 201318 167546 110220395
Medication error 183.68 11.90 513 200845 104853 110283088
Schizoaffective disorder 183.48 11.90 97 201261 3039 110384902
Muscle injury 182.97 11.90 21 201337 140786 110247155
Sinus tachycardia 179.16 11.90 304 201054 44189 110343752
Migraine 178.58 11.90 46 201312 171606 110216335
Speech disorder 178.14 11.90 365 200993 61204 110326737
Malignant neoplasm progression 173.71 11.90 51 201307 174516 110213425
Malaise 171.46 11.90 637 200721 671182 109716759
Disorientation 171.30 11.90 390 200968 70281 110317660
Cognitive disorder 169.53 11.90 443 200915 87068 110300873
Polydipsia 169.31 11.90 128 201230 7560 110380381
Soliloquy 167.53 11.90 65 201293 962 110386979
Delusion of grandeur 167.48 11.90 82 201276 2178 110385763
Night sweats 166.76 11.90 23 201335 133960 110253981
Psychiatric symptom 165.43 11.90 136 201222 9077 110378864
Disinhibition 163.97 11.90 90 201268 3044 110384897
Spasmodic dysphonia 163.93 11.90 55 201303 520 110387421
Mobility decreased 162.63 11.90 117 201241 237305 110150636
Behaviour disorder 162.01 11.90 137 201221 9510 110378431
Maternal exposure during pregnancy 161.42 11.90 136 201222 254747 110133194
Ill-defined disorder 159.44 11.90 44 201314 156809 110231132
Lip dry 159.33 11.90 5 201353 100078 110287863
Musculoskeletal pain 158.94 11.90 67 201291 182956 110204985
Hallucinations, mixed 157.51 11.90 129 201229 8564 110379377
Erythema 157.44 11.90 179 201179 291268 110096673
Therapeutic product effect decreased 151.51 11.90 133 201225 244183 110143758
Malignant catatonia 149.14 11.90 54 201304 652 110387289
Antipsychotic drug level below therapeutic 146.96 11.90 69 201289 1666 110386275
Product administration error 146.83 11.90 252 201106 36965 110350976
Self-destructive behaviour 146.20 11.90 56 201302 799 110387142
Injury 145.93 11.90 70 201288 177195 110210746
Enuresis 144.12 11.90 91 201267 4005 110383936
Inappropriate affect 142.16 11.90 67 201291 1632 110386309
Homicidal ideation 141.35 11.90 86 201272 3541 110384400
Dysphagia 139.45 11.90 602 200756 152998 110234943
Incoherent 138.93 11.90 118 201240 8240 110379701
Peripheral venous disease 138.42 11.90 3 201355 84114 110303827
Blood glucose increased 138.19 11.90 542 200816 131954 110255987
Stupor 138.03 11.90 117 201241 8148 110379793
Hyponatraemia 137.43 11.90 769 200589 216884 110171057
Abdominal pain 137.01 11.90 477 200881 512512 109875429
Hospitalisation 135.97 11.90 567 200791 141926 110246015
Logorrhoea 135.31 11.90 94 201264 4863 110383078
Lung disorder 135.14 11.90 80 201278 179967 110207974
Wrong product administered 133.61 11.90 130 201228 10830 110377111
Wheezing 133.28 11.90 161 201197 255069 110132872
Pneumonia 132.82 11.90 993 200365 875721 109512220
Refusal of treatment by patient 131.76 11.90 121 201237 9373 110378568
Blunted affect 131.39 11.90 46 201312 500 110387441
Euphoric mood 131.35 11.90 117 201241 8710 110379231
Hypersexuality 130.77 11.90 66 201292 1874 110386067
Sciatica 130.07 11.90 10 201348 92389 110295552
Breast cancer stage III 129.49 11.90 3 201355 79114 110308827
Anticholinergic syndrome 128.31 11.90 86 201272 4194 110383747
Mental disorder 127.96 11.90 243 201115 38548 110349393
Intentional product misuse 126.92 11.90 529 200829 132375 110255566
Accidental overdose 124.45 11.90 285 201073 51549 110336392
Metabolic syndrome 124.01 11.90 76 201282 3171 110384770
Substance-induced psychotic disorder 123.21 11.90 92 201266 5332 110382609
Myelosuppression 122.73 11.90 14 201344 94326 110293615
Rabbit syndrome 122.06 11.90 40 201318 349 110387592
Pulmonary fibrosis 121.29 11.90 20 201338 102022 110285919
Chest discomfort 121.24 11.90 84 201274 173764 110214177
Product reconstitution quality issue 120.48 11.90 39 201319 326 110387615
Generalised tonic-clonic seizure 119.70 11.90 290 201068 54390 110333551
Disease progression 118.07 11.90 163 201195 243871 110144070
Miosis 117.38 11.90 171 201187 21812 110366129
Leukopenia 117.03 11.90 559 200799 148232 110239709
Condition aggravated 115.57 11.90 1929 199429 732907 109655034
Obesity 114.42 11.90 459 200899 112892 110275049
Needle issue 113.54 11.90 151 201207 17689 110370252
Floppy iris syndrome 113.50 11.90 37 201321 317 110387624
Product container issue 113.13 11.90 56 201302 1524 110386417
Inappropriate antidiuretic hormone secretion 112.83 11.90 213 201145 33638 110354303
Confusional state 112.34 11.90 1326 200032 467354 109920587
Total lung capacity increased 112.33 11.90 85 201273 5027 110382914
Wound infection 112.25 11.90 20 201338 96445 110291496
COVID-19 111.38 11.90 171 201187 244889 110143052
Product use in unapproved indication 111.35 11.90 1275 200083 446102 109941839
Hypotonia 110.72 11.90 140 201218 15605 110372336
Incorrect dose administered 108.90 11.90 425 200933 103216 110284725
Anger 107.57 11.90 152 201206 18855 110369086
Hypotension 107.17 11.90 1439 199919 522410 109865531
Contusion 106.86 11.90 162 201196 233199 110154742
Chest pain 106.58 11.90 341 201017 376034 110011907
Ataxia 104.78 11.90 193 201165 29915 110358026
Pituitary tumour benign 104.57 11.90 65 201293 2782 110385159
Grip strength decreased 104.04 11.90 12 201346 80162 110307779
Bradycardia 103.86 11.90 558 200800 154959 110232982
Gaze palsy 103.44 11.90 69 201289 3338 110384603
Dyspepsia 103.40 11.90 117 201241 190848 110197093
Drug ineffective 103.21 11.90 3552 197806 1516988 108870953
Mastitis 103.16 11.90 62 201296 2496 110385445
Polydipsia psychogenic 102.63 11.90 34 201324 308 110387633
Dyspnoea exertional 102.42 11.90 31 201327 104029 110283912
Blood triglycerides increased 102.36 11.90 168 201190 23758 110364183
Flat affect 101.76 11.90 61 201297 2444 110385497
Lower limb fracture 101.04 11.90 10 201348 75338 110312603
Paroxysmal perceptual alteration 99.87 11.90 32 201326 258 110387683
Sedation complication 99.62 11.90 150 201208 19705 110368236
Myoclonus 99.45 11.90 199 201159 32799 110355142
Granulocytopenia 98.99 11.90 119 201239 12596 110375345
Decreased appetite 98.63 11.90 488 200870 475358 109912583
Protrusion tongue 98.15 11.90 36 201322 452 110387489
Opisthotonus 98.00 11.90 41 201317 745 110387196
Respiratory dyskinesia 97.49 11.90 24 201334 60 110387881
Knee arthroplasty 97.47 11.90 5 201353 64943 110322998
Oropharyngeal spasm 97.30 11.90 36 201322 464 110387477
Psoriasis 97.13 11.90 68 201290 139925 110248016
Herpes zoster 96.80 11.90 38 201320 108341 110279600
Foreign body 96.62 11.90 63 201295 2932 110385009
Asthma-chronic obstructive pulmonary disease overlap syndrome 96.21 11.90 85 201273 6259 110381682
Embolism venous 96.21 11.90 77 201281 4946 110382995
Diabetes mellitus 96.00 11.90 397 200961 98984 110288957
Fall 95.82 11.90 1587 199771 601895 109786046
Major depression 95.41 11.90 107 201251 10514 110377427
Drug withdrawal syndrome 94.42 11.90 212 201146 37842 110350099
Muscle spasms 94.31 11.90 231 201127 277926 110110015
Eye movement disorder 94.30 11.90 102 201256 9626 110378315
Neuropathy peripheral 93.67 11.90 113 201245 179164 110208777
Bradyphrenia 93.33 11.90 111 201247 11617 110376324
Impaired self-care 92.81 11.90 58 201300 2506 110385435
Productive cough 92.75 11.90 46 201312 114259 110273682
Paradoxical drug reaction 91.80 11.90 101 201257 9716 110378225
Oedema 91.18 11.90 151 201207 209825 110178116
Frequent bowel movements 89.43 11.90 12 201346 71378 110316563
Hip arthroplasty 88.08 11.90 3 201355 55810 110332131
Obsessive-compulsive symptom 88.01 11.90 30 201328 299 110387642
Cardiac failure congestive 87.92 11.90 87 201271 150913 110237028
Dyslipidaemia 87.89 11.90 126 201232 15839 110372102
Cytokine release syndrome 87.64 11.90 12 201346 70294 110317647
Posture abnormal 87.07 11.90 69 201289 4369 110383572
Sepsis 86.89 11.90 305 201053 327041 110060900
Injection site pain 86.89 11.90 118 201240 177804 110210137
Injection site reaction 86.82 11.90 27 201331 89043 110298898
Obsessive thoughts 86.74 11.90 44 201314 1263 110386678
Fluid retention 86.00 11.90 32 201326 94275 110293666
Somatic symptom disorder of pregnancy 85.89 11.90 23 201335 89 110387852
Parkinsonian gait 85.79 11.90 41 201317 1031 110386910
Psychosexual disorder 85.54 11.90 25 201333 142 110387799
Ileus paralytic 85.14 11.90 106 201252 11631 110376310
Pyrexia 85.04 11.90 1139 200219 897126 109490815
Diet refusal 84.59 11.90 38 201320 826 110387115
Cholelithiasis 84.43 11.90 281 201077 63141 110324800
Electroencephalogram abnormal 84.36 11.90 78 201280 6095 110381846
Myalgia 84.08 11.90 174 201184 222207 110165734
Staring 84.04 11.90 57 201301 2835 110385106
Refusal of examination 83.91 11.90 27 201331 221 110387720
Sexually inappropriate behaviour 83.65 11.90 35 201323 636 110387305
Weight decreased 83.26 11.90 505 200853 467552 109920389
Reduced facial expression 83.09 11.90 62 201296 3589 110384352
Road traffic accident 83.03 11.90 46 201312 107352 110280589
Antipsychotic drug level above therapeutic 82.84 11.90 53 201305 2387 110385554
Interstitial lung disease 82.60 11.90 79 201279 139255 110248686
Cytomegalovirus infection 82.31 11.90 4 201354 54440 110333501
Ascites 82.13 11.90 33 201325 92775 110295166
Bronchitis 82.01 11.90 99 201259 156933 110231008
Live birth 81.73 11.90 14 201344 69470 110318471
Muscular weakness 81.38 11.90 210 201148 248258 110139683
Lethargy 81.28 11.90 362 200996 93214 110294727
Gait inability 81.23 11.90 77 201281 136299 110251642
Dry mouth 81.17 11.90 150 201208 199798 110188143
Upper respiratory tract infection 80.77 11.90 72 201286 131256 110256685
Colitis 80.31 11.90 43 201315 102280 110285661
Intellectual disability 79.90 11.90 48 201310 1931 110386010
Liver injury 79.43 11.90 94 201264 150319 110237622
Sleep disorder due to a general medical condition 78.24 11.90 4 201354 52108 110335833
Chills 78.23 11.90 142 201216 190438 110197503
Hyperphagia 78.22 11.90 59 201299 3472 110384469
Breast discharge 78.06 11.90 37 201321 913 110387028
Respiratory depression 77.97 11.90 177 201181 31824 110356117
Treatment failure 77.18 11.90 253 201105 276981 110110960
Autonomic nervous system imbalance 76.99 11.90 72 201286 5708 110382233
Loss of consciousness 76.35 11.90 615 200743 195691 110192250
Vomiting 76.27 11.90 1183 200175 909492 109478449
Red blood cell sedimentation rate increased 75.84 11.90 24 201334 78278 110309663
Mydriasis 75.81 11.90 141 201217 22016 110365925
Dizziness 75.56 11.90 860 200498 697333 109690608
Hypertension 75.51 11.90 581 200777 509503 109878438
Faecaloma 75.33 11.90 113 201245 14795 110373146
Sinus bradycardia 75.11 11.90 166 201192 29317 110358624
Abulia 75.09 11.90 40 201318 1273 110386668
Grandiosity 74.87 11.90 31 201327 548 110387393
Water intoxication 74.69 11.90 36 201322 923 110387018
Suicidal behaviour 74.31 11.90 57 201301 3440 110384501
Mood swings 74.12 11.90 142 201216 22670 110365271
Influenza 73.97 11.90 121 201237 168980 110218961
Rhinorrhoea 73.72 11.90 48 201310 102618 110285323
Brain injury 73.66 11.90 106 201252 13370 110374571
Hyperammonaemia 73.58 11.90 107 201251 13625 110374316
Injection site erythema 73.29 11.90 40 201318 94136 110293805
Autoimmune disorder 73.16 11.90 15 201343 65468 110322473
Off label use 72.59 11.90 3380 197978 1496805 108891136
Impulsive behaviour 72.57 11.90 55 201303 3260 110384681
Psychotic behaviour 72.02 11.90 40 201318 1385 110386556
Systemic infection 71.74 11.90 89 201269 9730 110378211
Cardio-respiratory arrest 71.56 11.90 407 200951 115429 110272512
Bipolar disorder 71.27 11.90 85 201273 8922 110379019
Erectile dysfunction 71.04 11.90 124 201234 18432 110369509
Taste disorder 70.97 11.90 16 201342 65371 110322570
Oropharyngeal pain 70.94 11.90 85 201273 135191 110252750
Osteoporosis 70.82 11.90 35 201323 87117 110300824
Alcohol abuse 70.71 11.90 64 201294 4865 110383076
Insomnia 69.76 11.90 981 200377 359609 110028332
Self-injurious ideation 69.47 11.90 60 201298 4286 110383655
Feeling guilty 69.13 11.90 34 201324 912 110387029
Tachypnoea 68.81 11.90 192 201166 39203 110348738
Anaphylactic reaction 68.70 11.90 64 201294 114236 110273705
Choking 68.59 11.90 109 201249 15001 110372940
Dementia 68.27 11.90 167 201191 31506 110356435
Poisoning deliberate 67.93 11.90 149 201209 26182 110361759
Poisoning 67.62 11.90 158 201200 28947 110358994
Rectal haemorrhage 67.53 11.90 71 201287 119762 110268179
Negativism 66.73 11.90 33 201325 896 110387045
Overweight 66.59 11.90 70 201288 6394 110381547
Negative symptoms in schizophrenia 66.53 11.90 22 201336 198 110387743
Hostility 66.36 11.90 48 201310 2648 110385293
Dry skin 66.22 11.90 59 201299 107594 110280347
Neck pain 66.03 11.90 76 201282 123054 110264887
Haematochezia 65.61 11.90 68 201290 115456 110272485
Depressed mood 65.20 11.90 251 201107 60558 110327383
Intrusive thoughts 65.19 11.90 30 201328 691 110387250
Hypokinesia 65.02 11.90 131 201227 21695 110366246
Conduction disorder 64.85 11.90 56 201302 3999 110383942
Full blood count abnormal 64.39 11.90 12 201346 56040 110331901
Back injury 64.32 11.90 6 201352 47393 110340548
Septic shock 64.09 11.90 118 201240 157410 110230531
Adjustment disorder with depressed mood 63.94 11.90 4 201354 43879 110344062
Electrocardiogram abnormal 63.94 11.90 119 201239 18590 110369351
Lymphocyte count abnormal 63.87 11.90 45 201313 2381 110385560
Gastrointestinal haemorrhage 63.84 11.90 128 201230 165390 110222551
Product physical issue 63.77 11.90 61 201297 4975 110382966
Breast enlargement 63.15 11.90 39 201319 1650 110386291
Autism spectrum disorder 62.90 11.90 41 201317 1907 110386034
Movement disorder 62.19 11.90 176 201182 36228 110351713
Orthostatic hypotension 61.90 11.90 262 201096 65987 110321954
Communication disorder 61.85 11.90 60 201298 4979 110382962
Activation syndrome 61.81 11.90 24 201334 356 110387585
Pneumonitis 61.78 11.90 31 201327 76500 110311441
Pulmonary embolism 61.48 11.90 629 200729 213845 110174096
Anaphylactic shock 61.48 11.90 10 201348 51536 110336405
Hyperreflexia 61.46 11.90 81 201277 9404 110378537
Laryngitis 61.39 11.90 4 201354 42407 110345534
Blood pressure increased 61.25 11.90 252 201106 258121 110129820
Throat irritation 60.38 11.90 12 201346 53540 110334401
Compulsive sexual behaviour 60.36 11.90 22 201336 271 110387670
Rash pruritic 60.02 11.90 54 201304 98015 110289926
Diabetic coma 59.99 11.90 35 201323 1333 110386608
Coeliac disease 59.87 11.90 5 201353 43182 110344759
Device breakage 59.33 11.90 97 201261 13672 110374269
Bladder dilatation 59.07 11.90 43 201315 2396 110385545
Gestational diabetes 58.91 11.90 70 201288 7319 110380622
Diabetic hyperosmolar coma 58.80 11.90 30 201328 872 110387069
Blood cholesterol increased 58.35 11.90 159 201199 184626 110203315
Stereotypy 58.21 11.90 31 201327 986 110386955
Tourette's disorder 58.19 11.90 16 201342 70 110387871
Osteonecrosis of jaw 57.98 11.90 9 201349 48008 110339933
Blood pressure systolic increased 57.97 11.90 40 201318 82951 110304990
Cerebral atrophy 57.97 11.90 77 201281 9008 110378933
Screaming 57.82 11.90 57 201301 4824 110383117
Hepatic enzyme increased 57.66 11.90 345 201013 320547 110067394
Therapeutic product effect variable 57.09 11.90 44 201314 2674 110385267
Dysgeusia 57.02 11.90 28 201330 69957 110317984
Exostosis 56.91 11.90 8 201350 45948 110341993
Ideas of reference 56.88 11.90 19 201339 177 110387764
Flushing 56.86 11.90 64 201294 104672 110283269
Acute psychosis 56.79 11.90 57 201301 4930 110383011
Hypervolaemia 55.94 11.90 11 201347 49449 110338492
Nasal congestion 55.64 11.90 58 201300 98224 110289717
Somatic symptom disorder 55.40 11.90 46 201312 3113 110384828
Personality change due to a general medical condition 55.18 11.90 21 201337 294 110387647
Hepatic cirrhosis 55.18 11.90 27 201331 67599 110320342
Thrombosis 55.16 11.90 70 201288 108592 110279349
Dysphemia 55.15 11.90 51 201307 3986 110383955
Accidental exposure to product 54.92 11.90 208 201150 49800 110338141
Liver disorder 54.85 11.90 110 201248 142133 110245808
Drug level increased 54.50 11.90 201 201157 47518 110340423
Plasma cell mastitis 54.47 11.90 13 201345 27 110387914
Rebound effect 54.17 11.90 97 201261 14709 110373232
Dementia with Lewy bodies 54.08 11.90 30 201328 1036 110386905
Eosinophilic pneumonia acute 53.65 11.90 35 201323 1630 110386311
Loss of libido 53.65 11.90 45 201313 3088 110384853
Feeling hot 53.59 11.90 52 201306 91054 110296887
Basal cell carcinoma 53.51 11.90 9 201349 45261 110342680
Sarcoidosis 53.37 11.90 88 201270 12491 110375450
Bone pain 53.16 11.90 26 201332 65107 110322834
Delusional disorder, persecutory type 53.04 11.90 25 201333 609 110387332
Eosinophil count decreased 52.98 11.90 60 201298 5958 110381983
Skin ulcer 52.56 11.90 25 201333 63620 110324321
Influenza like illness 52.55 11.90 50 201308 88362 110299579
Blood pressure fluctuation 52.35 11.90 36 201322 74788 110313153
Hepatocellular injury 51.83 11.90 206 201152 50436 110337505
Colitis ulcerative 51.80 11.90 39 201319 77324 110310617
Haemoptysis 51.72 11.90 33 201325 71321 110316620
Mental status changes 51.39 11.90 274 201084 75848 110312093
Accidental death 51.16 11.90 54 201304 4955 110382986
Injection site bruising 50.93 11.90 15 201343 51248 110336693
Bundle branch block right 50.82 11.90 85 201273 12206 110375735
Neuralgia 50.38 11.90 13 201345 48465 110339476
Libido decreased 50.27 11.90 58 201300 5877 110382064
Ulcer 50.02 11.90 9 201349 43107 110344834
Breast hyperplasia 49.82 11.90 17 201341 170 110387771
Posturing 49.74 11.90 29 201329 1103 110386838
Hypometabolism 49.47 11.90 17 201341 174 110387767
Tachyphrenia 49.18 11.90 38 201320 2318 110385623
Hyperkinesia 48.96 11.90 43 201315 3141 110384800
Pleural effusion 48.87 11.90 163 201195 177546 110210395
Oral candidiasis 48.48 11.90 11 201347 44749 110343192
Wrong technique in product usage process 48.21 11.90 298 201060 87050 110300891
Delusional disorder, unspecified type 47.75 11.90 26 201332 865 110387076
Immunodeficiency 47.54 11.90 7 201351 38831 110349110
Hepatotoxicity 47.53 11.90 235 201123 63165 110324776
Diverticulitis 47.40 11.90 19 201339 53503 110334438
Decreased gait velocity 47.35 11.90 17 201341 200 110387741
Pneumocystis jirovecii pneumonia 47.31 11.90 10 201348 42725 110345216
Illness anxiety disorder 47.30 11.90 18 201340 252 110387689
Liver function test increased 47.10 11.90 55 201303 88493 110299448
Ear pain 46.97 11.90 19 201339 53207 110334734
Rhinalgia 46.76 11.90 46 201312 3883 110384058
Adrenal insufficiency 46.76 11.90 10 201348 42380 110345561
Leukocytosis 46.56 11.90 208 201150 53620 110334321
Nasal polyps 46.41 11.90 85 201273 13115 110374826
Rebound psychosis 46.14 11.90 20 201338 398 110387543
Arrhythmia 45.99 11.90 249 201109 69326 110318615
Hot flush 45.90 11.90 32 201326 66004 110321937
Choreoathetosis 45.88 11.90 32 201326 1666 110386275
Injection site pruritus 45.72 11.90 18 201340 51240 110336701
Prostate cancer 45.58 11.90 7 201351 37634 110350307
Atrial fibrillation 45.53 11.90 239 201119 229403 110158538
Finger deformity 45.41 11.90 4 201354 33088 110354853
Clostridium difficile infection 45.37 11.90 19 201339 52110 110335831
Metastases to bone 45.29 11.90 3 201355 31369 110356572
Attention deficit hyperactivity disorder 45.14 11.90 48 201310 4443 110383498
Incontinence 45.04 11.90 96 201262 16539 110371402
Distractibility 44.74 11.90 25 201333 876 110387065
Idiopathic intracranial hypertension 44.69 11.90 45 201313 3907 110384034
Wrong patient 44.65 11.90 30 201328 1469 110386472
Multiple organ dysfunction syndrome 44.63 11.90 135 201223 151575 110236366
Plasma cell myeloma 44.40 11.90 30 201328 62906 110325035
Mood altered 44.27 11.90 111 201247 21264 110366677
Product packaging quantity issue 44.21 11.90 32 201326 1767 110386174
Skin exfoliation 43.93 11.90 57 201301 87594 110300347
Echolalia 43.87 11.90 21 201337 530 110387411
Bipolar I disorder 43.73 11.90 35 201323 2248 110385693
Hypercholesterolaemia 43.58 11.90 61 201297 90776 110297165
Product tampering 43.52 11.90 20 201338 459 110387482
C-reactive protein 43.49 11.90 3 201355 30328 110357613
Dysphoria 43.37 11.90 56 201302 6372 110381569
Cystitis 43.31 11.90 34 201324 66002 110321939
Foot deformity 43.28 11.90 17 201341 48463 110339478
Illusion 43.28 11.90 33 201325 1974 110385967
Neutrophil count increased 43.02 11.90 150 201208 34502 110353439
Accidental exposure to product by child 42.91 11.90 40 201318 3158 110384783
Pulmonary mass 42.82 11.90 8 201350 37293 110350648
Frontotemporal dementia 42.45 11.90 22 201336 661 110387280
Hyperlactacidaemia 42.14 11.90 63 201295 8223 110379718
Schizophreniform disorder 42.12 11.90 15 201343 172 110387769
Waxy flexibility 41.99 11.90 17 201341 283 110387658
Asphyxia 41.96 11.90 85 201273 14130 110373811
Tension 41.96 11.90 49 201309 5029 110382912
Disorganised speech 41.81 11.90 40 201318 3263 110384678
Device expulsion 41.68 11.90 4 201354 30887 110357054
Gout 41.64 11.90 8 201350 36558 110351383
Unresponsive to stimuli 41.29 11.90 227 201131 63563 110324378
Binge eating 41.20 11.90 21 201337 609 110387332
Joint stiffness 41.18 11.90 37 201321 67206 110320735
Delusion of reference 41.10 11.90 16 201342 239 110387702
Prescribed underdose 40.95 11.90 35 201323 65139 110322802
Resting tremor 40.88 11.90 30 201328 1693 110386248
Prolactin-producing pituitary tumour 40.51 11.90 14 201344 146 110387795
Physical assault 40.11 11.90 29 201329 1599 110386342
Retrograde ejaculation 39.99 11.90 18 201340 393 110387548
Nephrolithiasis 39.87 11.90 37 201321 66175 110321766
Neglect of personal appearance 39.87 11.90 18 201340 396 110387545
Wolff-Parkinson-White syndrome 39.79 11.90 18 201340 398 110387543
Potentiating drug interaction 39.71 11.90 74 201284 11569 110376372
Underdose 39.70 11.90 224 201134 63330 110324611
Compulsions 39.62 11.90 18 201340 402 110387539
Aphasia 39.57 11.90 212 201146 58785 110329156
Eating disorder 39.54 11.90 135 201223 30723 110357218
Phagophobia 39.49 11.90 11 201347 51 110387890
Candida infection 39.43 11.90 19 201339 47990 110339951
Wrong dose 39.19 11.90 35 201323 2614 110385327
Rhinitis allergic 39.16 11.90 95 201263 17827 110370114
Oscillopsia 39.14 11.90 18 201340 414 110387527
Shock 39.01 11.90 197 201161 53391 110334550
Oral pain 38.99 11.90 10 201348 37434 110350507
Palmar-plantar erythrodysaesthesia syndrome 38.98 11.90 13 201345 41012 110346929
Onychomycosis 38.78 11.90 11 201347 38520 110349421
Polyuria 38.73 11.90 94 201264 17644 110370297
Slow speech 38.51 11.90 39 201319 3409 110384532
Insurance issue 38.16 11.90 69 201289 10543 110377398
Bacterial infection 38.14 11.90 18 201340 46018 110341923
Pain in jaw 38.02 11.90 23 201335 51154 110336787
Educational problem 37.99 11.90 19 201339 529 110387412
Social anxiety disorder 37.89 11.90 23 201335 943 110386998
Visceral congestion 37.87 11.90 26 201332 1319 110386622
Stress 37.66 11.90 85 201273 105263 110282678
Therapy interrupted 37.56 11.90 22 201336 49800 110338141
Nuchal rigidity 37.52 11.90 25 201333 1207 110386734
Acute myocardial infarction 37.52 11.90 59 201299 83718 110304223
Long QT syndrome 37.46 11.90 55 201303 7063 110380878
Haemoglobin decreased 37.36 11.90 282 201076 248445 110139496
Pulmonary arterial hypertension 37.35 11.90 7 201351 32561 110355380
Precocious puberty 37.24 11.90 17 201341 384 110387557
Hypomagnesaemia 37.23 11.90 33 201325 60337 110327604
Facial spasm 37.19 11.90 22 201336 860 110387081
Tubulointerstitial nephritis 36.82 11.90 27 201331 54257 110333684
Withdrawal catatonia 36.61 11.90 17 201341 400 110387541
Hallucination, olfactory 36.54 11.90 19 201339 575 110387366
Morbid thoughts 36.35 11.90 22 201336 897 110387044
Epistaxis 36.24 11.90 119 201239 130253 110257688
Strabismus 36.24 11.90 38 201320 3461 110384480
Metastases to liver 35.81 11.90 10 201348 35376 110352565
Oedema peripheral 35.79 11.90 404 200954 328256 110059685
Blood pressure diastolic abnormal 35.75 11.90 3 201355 25812 110362129
Haemodynamic instability 35.58 11.90 107 201251 22781 110365160
Coronary artery disease 35.54 11.90 47 201311 71643 110316298
Lactation disorder 35.43 11.90 15 201343 281 110387660
Mouth ulceration 35.25 11.90 22 201336 48116 110339825
Eczema 35.23 11.90 48 201310 72245 110315696
Bronchopulmonary aspergillosis 35.16 11.90 6 201352 29857 110358084
Grimacing 34.86 11.90 21 201337 849 110387092
Fungal infection 34.81 11.90 25 201333 50781 110337160
Ejaculation failure 34.63 11.90 16 201342 372 110387569
Compartment syndrome 34.54 11.90 48 201310 5862 110382079
Torsade de pointes 34.52 11.90 105 201253 22495 110365446
Tenderness 34.47 11.90 6 201352 29431 110358510
Menstrual disorder 34.37 11.90 43 201315 4741 110383200
Hyperhidrosis 34.36 11.90 505 200853 186793 110201148
Hypophosphataemia 34.29 11.90 9 201349 33173 110354768
Hypernatraemia 34.23 11.90 90 201268 17743 110370198
Blood pressure systolic abnormal 34.11 11.90 3 201355 24847 110363094
Substance abuse 33.83 11.90 72 201286 12391 110375550
Convulsive threshold lowered 33.74 11.90 22 201336 1024 110386917
Abdominal distension 33.72 11.90 184 201174 174919 110213022
Lupus-like syndrome 33.72 11.90 16 201342 40776 110347165
Gastrooesophageal reflux disease 33.64 11.90 191 201167 179785 110208156
Product leakage 33.57 11.90 26 201332 1592 110386349
Flight of ideas 33.48 11.90 20 201338 796 110387145
Ear infection 33.33 11.90 39 201319 62693 110325248
Oral herpes 33.30 11.90 12 201346 36068 110351873
Self esteem decreased 33.15 11.90 22 201336 1055 110386886
Bacteraemia 32.99 11.90 18 201340 42372 110345569
Status epilepticus 32.77 11.90 129 201229 31442 110356499
Heart rate decreased 32.76 11.90 63 201295 82693 110305248
Pregnancy 32.61 11.90 27 201331 51040 110336901
Localised infection 32.46 11.90 19 201339 43029 110344912
Muscle twitching 32.44 11.90 124 201234 29811 110358130
Cardiac arrest 32.44 11.90 521 200837 196232 110191709
Adverse drug reaction 32.37 11.90 314 201044 105245 110282696
Eyelid function disorder 32.35 11.90 17 201341 526 110387415
Injection site swelling 32.20 11.90 39 201319 61751 110326190
Poriomania 32.19 11.90 13 201345 215 110387726
Erection increased 32.10 11.90 15 201343 358 110387583
Suspiciousness 32.00 11.90 19 201339 748 110387193
Walking aid user 31.92 11.90 4 201354 25071 110362870
Trismus 31.91 11.90 49 201309 6547 110381394
Angina pectoris 31.75 11.90 40 201318 62255 110325686
Sinus disorder 31.75 11.90 10 201348 32718 110355223
Tobacco user 31.75 11.90 19 201339 759 110387182
Nodule 31.60 11.90 10 201348 32621 110355320
Homosexuality 31.59 11.90 9 201349 46 110387895
Skin haemorrhage 31.51 11.90 4 201354 24823 110363118
Labelled drug-drug interaction medication error 31.45 11.90 121 201237 29181 110358760
Akinesia 31.34 11.90 36 201322 3631 110384310
Ejaculation disorder 31.19 11.90 17 201341 567 110387374
Pressure of speech 31.17 11.90 23 201335 1309 110386632
Metastases to lung 31.08 11.90 3 201355 23060 110364881
Cellulitis 31.05 11.90 121 201237 125895 110262046
Hypersomnia 31.04 11.90 117 201241 27944 110359997
Skin disorder 30.89 11.90 20 201338 42893 110345048
Slow response to stimuli 30.88 11.90 27 201331 1961 110385980
Osteomyelitis 30.80 11.90 14 201344 36586 110351355
Food craving 30.70 11.90 27 201331 1976 110385965
Diabetes insipidus 30.66 11.90 48 201310 6522 110381419
Respiratory failure 30.54 11.90 248 201110 215084 110172857
Hypertriglyceridaemia 30.47 11.90 81 201277 16073 110371868
Laboratory test abnormal 29.79 11.90 22 201336 44057 110343884
Chorea 29.76 11.90 33 201325 3202 110384739
Breast tenderness 29.74 11.90 30 201328 2610 110385331
Growth hormone-producing pituitary tumour 29.58 11.90 11 201347 144 110387797
Small intestinal obstruction 29.25 11.90 11 201347 32202 110355739
Drug resistance 29.04 11.90 189 201169 56185 110331756
Respiratory tract infection 28.81 11.90 54 201304 71563 110316378
Thermal burn 28.80 11.90 52 201306 7936 110380005
Uveitis 28.80 11.90 3 201355 21707 110366234
COVID-19 pneumonia 28.57 11.90 16 201342 37127 110350814
Cataract 28.52 11.90 64 201294 79421 110308520
Device occlusion 28.50 11.90 76 201282 15109 110372832
Device dislocation 28.50 11.90 11 201347 31693 110356248
Eye pruritus 28.43 11.90 12 201346 32763 110355178
Sinus congestion 28.33 11.90 10 201348 30449 110357492
Megacolon 28.26 11.90 37 201321 4268 110383673
Product prescribing error 28.24 11.90 175 201183 51156 110336785
Keratoconus 27.98 11.90 11 201347 169 110387772
Mucosal inflammation 27.95 11.90 86 201272 96055 110291886
Product dispensing error 27.89 11.90 79 201279 16266 110371675
Blood bilirubin increased 27.89 11.90 235 201123 75737 110312204
Antipsychotic drug level decreased 27.80 11.90 22 201336 1390 110386551
Cardiac murmur 27.50 11.90 103 201255 24525 110363416
Drug tolerance decreased 27.47 11.90 8 201350 27532 110360409
Liquid product physical issue 27.44 11.90 23 201335 1577 110386364
Propulsive gait 27.24 11.90 6 201352 7 110387934
Illness 27.23 11.90 69 201289 82102 110305839
Product label issue 27.07 11.90 19 201339 999 110386942
Affect lability 26.99 11.90 85 201273 18552 110369389
Myocardial infarction 26.88 11.90 222 201136 191861 110196080
Breast discomfort 26.86 11.90 15 201343 525 110387416
Atrioventricular block second degree 26.67 11.90 51 201307 8130 110379811
Oligomenorrhoea 26.65 11.90 18 201340 889 110387052
Pica 26.65 11.90 9 201349 87 110387854
Paraesthesia oral 26.64 11.90 14 201344 33657 110354284
Tongue spasm 26.61 11.90 10 201348 135 110387806
Cystoid macular oedema 26.51 11.90 29 201329 2771 110385170
Hypoprolactinaemia 26.37 11.90 7 201351 26 110387915
Boredom 26.37 11.90 7 201351 26 110387915
Device related infection 26.36 11.90 20 201338 39499 110348442
Disability 26.32 11.90 11 201347 30212 110357729
Excessive eye blinking 26.27 11.90 24 201334 1846 110386095
Tobacco interaction 26.21 11.90 10 201348 141 110387800
Death 26.17 11.90 1024 200334 697845 109690096
Parkinson's disease 26.14 11.90 22 201336 1517 110386424
Chronic kidney disease 26.11 11.90 63 201295 76228 110311713
Pseudohallucination 26.09 11.90 11 201347 204 110387737
Breast engorgement 26.07 11.90 8 201350 55 110387886
Loss of personal independence in daily activities 26.03 11.90 163 201195 149857 110238084
Lymphadenopathy 25.79 11.90 48 201310 63787 110324154
Sneezing 25.75 11.90 13 201345 31971 110355970
Claustrophobia 25.65 11.90 22 201336 1557 110386384
Faeces discoloured 25.58 11.90 15 201343 33933 110354008
Substance use 25.57 11.90 27 201331 2479 110385462
Bone disorder 25.52 11.90 4 201354 21188 110366753
Metabolic acidosis 25.52 11.90 286 201072 99458 110288483
Blood pressure diastolic decreased 25.46 11.90 17 201341 35868 110352073
Psychotic disorder due to a general medical condition 25.40 11.90 12 201346 294 110387647
Intracranial pressure increased 25.36 11.90 58 201300 10477 110377464
Obstructive airways disorder 25.27 11.90 28 201330 46121 110341820
Cerebellar atrophy 25.15 11.90 21 201337 1432 110386509
Attention-seeking behaviour 25.06 11.90 9 201349 106 110387835
Oxygen saturation decreased 25.00 11.90 175 201183 156807 110231134
Prader-Willi syndrome 24.97 11.90 6 201352 13 110387928
Poor personal hygiene 24.95 11.90 15 201343 604 110387337
Product confusion 24.92 11.90 11 201347 229 110387712
Cerebrovascular stenosis 24.84 11.90 10 201348 164 110387777
Colitis ischaemic 24.84 11.90 80 201278 17670 110370271
Hallucination, tactile 24.82 11.90 18 201340 997 110386944
Somatic hallucination 24.70 11.90 8 201350 67 110387874
Haemorrhage 24.68 11.90 105 201253 106587 110281354
Imprisonment 24.57 11.90 16 201342 743 110387198
Product packaging issue 24.57 11.90 22 201336 1649 110386292
Drug delivery system malfunction 24.51 11.90 18 201340 1017 110386924
Pseudomonas infection 24.48 11.90 10 201348 27843 110360098
Full blood count decreased 24.44 11.90 14 201344 32085 110355856
Tongue movement disturbance 24.34 11.90 14 201344 519 110387422
Product complaint 24.30 11.90 68 201290 13904 110374037
Head titubation 24.30 11.90 20 201338 1337 110386604
Fear 24.26 11.90 95 201263 23098 110364843
Dermatillomania 24.23 11.90 12 201346 327 110387614
Encephalitis autoimmune 24.22 11.90 31 201327 3497 110384444
Stiff tongue 24.21 11.90 5 201353 3 110387938
Self esteem inflated 24.21 11.90 5 201353 3 110387938
Melaena 24.15 11.90 56 201302 68701 110319240
Mastication disorder 24.15 11.90 31 201327 3507 110384434
Graft versus host disease 23.94 11.90 3 201355 18803 110369138
Dementia Alzheimer's type 23.92 11.90 17 201341 912 110387029
Immobile 23.87 11.90 47 201311 7655 110380286
Decreased activity 23.79 11.90 58 201300 10916 110377025
Cyclothymic disorder 23.72 11.90 11 201347 258 110387683
Pulmonary hypertension 23.68 11.90 40 201318 55180 110332761
Language disorder 23.68 11.90 32 201326 3806 110384135
Product administered to patient of inappropriate age 23.66 11.90 48 201310 7988 110379953
CSF pressure increased 23.64 11.90 11 201347 260 110387681
Meige's syndrome 23.62 11.90 5 201353 4 110387937
Ulcer haemorrhage 23.56 11.90 6 201352 22565 110365376
Spinal pain 23.46 11.90 3 201355 18512 110369429
Electrolyte imbalance 23.45 11.90 131 201227 36897 110351044
Inappropriate schedule of product administration 23.42 11.90 510 200848 203127 110184814
Gastric disorder 23.40 11.90 16 201342 33341 110354600
Pemphigoid 23.34 11.90 84 201274 19623 110368318
Acute myeloid leukaemia 23.30 11.90 21 201337 38089 110349852
Neoplasm malignant 23.27 11.90 20 201338 37123 110350818
Sinus arrhythmia 23.25 11.90 24 201334 2146 110385795
Gastroenteritis viral 23.24 11.90 14 201344 31212 110356729
Rash erythematous 23.22 11.90 74 201284 81758 110306183
Neoplasm progression 23.18 11.90 52 201306 64543 110323398
Musculoskeletal discomfort 23.18 11.90 7 201351 23531 110364410
Product dose omission in error 23.14 11.90 7 201351 23505 110364436
Oral discharge 23.08 11.90 11 201347 275 110387666
Gambling disorder 23.06 11.90 24 201334 2167 110385774
Tooth infection 23.00 11.90 6 201352 22210 110365731
Crying 22.89 11.90 100 201258 25528 110362413
Neuroleptic-induced deficit syndrome 22.88 11.90 6 201352 21 110387920
Helplessness 22.87 11.90 12 201346 370 110387571
Vasculitis 22.86 11.90 19 201339 35854 110352087
Alcoholic coma 22.85 11.90 8 201350 87 110387854
Pre-existing disease 22.84 11.90 10 201348 204 110387737
Dysphonia 22.73 11.90 67 201291 75862 110312079
Selective mutism 22.68 11.90 8 201350 89 110387852
Cholinergic syndrome 22.54 11.90 19 201339 1313 110386628
Platelet count decreased 22.51 11.90 290 201068 230153 110157788
Hyperbilirubinaemia 22.48 11.90 14 201344 30657 110357284
Sleep disorder 22.48 11.90 242 201116 198402 110189539
Gastric hypomotility 22.40 11.90 11 201347 294 110387647
Blepharospasm 22.38 11.90 41 201317 54810 110333131
Aptyalism 22.29 11.90 16 201342 872 110387069
Altered visual depth perception 22.19 11.90 13 201345 499 110387442
Product substitution issue 22.16 11.90 92 201266 22969 110364972
Respiratory disorder 22.09 11.90 62 201296 71320 110316621
Type 1 diabetes mellitus 21.99 11.90 50 201308 8997 110378944
Drug abuser 21.82 11.90 37 201321 5372 110382569
Heat stroke 21.82 11.90 22 201336 1913 110386028
Cytopenia 21.73 11.90 14 201344 30102 110357839
Orthostatic intolerance 21.72 11.90 23 201335 2118 110385823
Skin infection 21.62 11.90 7 201351 22502 110365439
Brugada syndrome 21.57 11.90 20 201338 1568 110386373
Hyperglycaemic hyperosmolar nonketotic syndrome 21.54 11.90 27 201331 2982 110384959
Skin discolouration 21.53 11.90 35 201323 49011 110338930
Gender dysphoria 21.47 11.90 7 201351 60 110387881
Regurgitation 21.41 11.90 29 201329 3456 110384485
Haemorrhoids 21.40 11.90 20 201338 35652 110352289
Exhibitionism 21.37 11.90 7 201351 61 110387880
Chronic tic disorder 21.24 11.90 4 201354 0 110387941
Intervertebral disc protrusion 21.21 11.90 12 201346 27686 110360255
Violence-related symptom 21.19 11.90 16 201342 943 110386998
Anti-transglutaminase antibody increased 21.17 11.90 6 201352 30 110387911
Urinary tract infection 21.14 11.90 443 200915 325839 110062102
Proteinuria 21.13 11.90 25 201333 39993 110347948
Procedural complication 21.04 11.90 47 201311 8358 110379583
Multiple sclerosis relapse 20.99 11.90 37 201321 50203 110337738
Nephropathy toxic 20.90 11.90 12 201346 27466 110360475
Appendicitis 20.85 11.90 13 201345 28451 110359490
Merycism 20.82 11.90 11 201347 344 110387597
Benign prostatic hyperplasia 20.74 11.90 4 201354 18230 110369711
Thought blocking 20.65 11.90 10 201348 259 110387682
Adulterated product 20.63 11.90 17 201341 1138 110386803
Lack of spontaneous speech 20.58 11.90 10 201348 261 110387680
Electrocardiogram T wave inversion 20.51 11.90 37 201321 5643 110382298
Chronic sinusitis 20.49 11.90 10 201348 25074 110362867
Depression 20.47 11.90 738 200620 316597 110071344
Radiculopathy 20.45 11.90 5 201353 19331 110368610
Shunt malfunction 20.40 11.90 11 201347 359 110387582
Hyperkalaemia 20.36 11.90 154 201204 135642 110252299
Myocarditis septic 20.25 11.90 6 201352 36 110387905
Myelodysplastic syndrome 20.24 11.90 23 201335 37461 110350480
Respiratory arrest 20.18 11.90 178 201180 58121 110329820
Vascular device infection 20.15 11.90 3 201355 16509 110371432
Libido increased 20.15 11.90 24 201334 2515 110385426
Hyponatraemic seizure 20.14 11.90 14 201344 725 110387216
Body mass index increased 20.12 11.90 23 201335 2307 110385634
Skin necrosis 20.12 11.90 7 201351 21505 110366436
Drug screen false positive 20.08 11.90 18 201340 1351 110386590
Agranulocytosis 20.07 11.90 186 201172 61574 110326367
Antidiuretic hormone abnormality 20 11.90 7 201351 76 110387865
Obsessive-compulsive personality disorder 19.99 11.90 8 201350 129 110387812
Blood sodium increased 19.97 11.90 36 201322 5487 110382454
Pulmonary toxicity 19.96 11.90 4 201354 17742 110370199
Myoglobin blood increased 19.86 11.90 31 201327 4201 110383740
CYP2C19 polymorphism 19.84 11.90 6 201352 39 110387902
Deafness 19.84 11.90 12 201346 26697 110361244
Derealisation 19.83 11.90 22 201336 2136 110385805
Hypercalcaemia 19.82 11.90 34 201324 46623 110341318
Paraphilia 19.76 11.90 7 201351 79 110387862
Injection site rash 19.64 11.90 9 201349 23410 110364531
Device difficult to use 19.62 11.90 5 201353 18800 110369141
Tooth disorder 19.59 11.90 15 201343 29494 110358447
CADASIL 19.59 11.90 6 201352 41 110387900
Transfusion 19.55 11.90 11 201347 25461 110362480
Oppositional defiant disorder 19.47 11.90 12 201346 506 110387435
Blood sodium decreased 19.45 11.90 128 201230 38191 110349750
CYP2D6 polymorphism 19.45 11.90 7 201351 83 110387858
Areflexia 19.42 11.90 40 201318 6729 110381212
Delusional perception 19.36 11.90 11 201347 398 110387543
Glucose tolerance impaired 19.24 11.90 50 201308 9787 110378154
Bedridden 19.23 11.90 61 201297 13364 110374577
Victim of abuse 19.22 11.90 7 201351 86 110387855
Tinnitus 19.17 11.90 52 201306 60488 110327453
Injection site urticaria 19.11 11.90 4 201354 17211 110370730
Olfactory nerve disorder 19.10 11.90 6 201352 45 110387896
Epilepsy 19.08 11.90 272 201086 99937 110288004
Hepatitis C virus test positive 19.07 11.90 11 201347 410 110387531
Ageusia 19.06 11.90 6 201352 19639 110368302
Procedural pain 19.01 11.90 22 201336 35543 110352398
Bulimia nervosa 19.01 11.90 10 201348 310 110387631
High density lipoprotein decreased 19.01 11.90 36 201322 5697 110382244
Skin pressure mark 19.01 11.90 7 201351 89 110387852
Pulse abnormal 18.93 11.90 30 201328 4119 110383822
Metastases to central nervous system 18.78 11.90 9 201349 22808 110365133
Cardiac failure 18.73 11.90 235 201123 187391 110200550
Neutrophilia 18.69 11.90 51 201307 10278 110377663
Ankylosing spondylitis 18.68 11.90 3 201355 15609 110372332
Blood chloride decreased 18.52 11.90 47 201311 9068 110378873
Enteritis necroticans 18.48 11.90 4 201354 4 110387937
Somatic dysfunction 18.45 11.90 6 201352 51 110387890
Disruptive mood dysregulation disorder 18.35 11.90 5 201353 21 110387920
Therapy partial responder 18.33 11.90 123 201235 36938 110351003
Arterial occlusive disease 18.19 11.90 3 201355 15305 110372636
Spinal stenosis 18.17 11.90 6 201352 19050 110368891
Somatic delusion 18.12 11.90 13 201345 708 110387233
Skin cancer 18.04 11.90 5 201353 17779 110370162
Feelings of worthlessness 18.03 11.90 12 201346 578 110387363
Tonic convulsion 18.01 11.90 25 201333 3049 110384892
Electrocardiogram QT interval abnormal 18.01 11.90 10 201348 346 110387595
Shock haemorrhagic 17.90 11.90 14 201344 27233 110360708
Optic nerve injury 17.90 11.90 13 201345 722 110387219
Hyporesponsive to stimuli 17.88 11.90 24 201334 2836 110385105
Hypoglycaemia 17.86 11.90 304 201054 115800 110272141
Haematotoxicity 17.84 11.90 8 201350 21074 110366867
Dyslalia 17.84 11.90 17 201341 1380 110386561
Hypoventilation 17.83 11.90 43 201315 8038 110379903
White blood cell count decreased 17.78 11.90 302 201056 229088 110158853
Endocarditis fibroplastica 17.64 11.90 5 201353 25 110387916
Anhedonia 17.63 11.90 65 201293 15363 110372578
Nephrogenic diabetes insipidus 17.60 11.90 22 201336 2423 110385518
Respiratory symptom 17.60 11.90 3 201355 14942 110372999
Drug withdrawal convulsions 17.57 11.90 22 201336 2427 110385514
Camptocormia 17.57 11.90 11 201347 477 110387464
Circadian rhythm sleep disorder 17.54 11.90 15 201343 1057 110386884
Pleuritic pain 17.41 11.90 4 201354 16136 110371805
Bruxism 17.36 11.90 32 201326 4962 110382979
Hypoxic-ischaemic encephalopathy 17.34 11.90 45 201313 8802 110379139
Limb injury 17.33 11.90 26 201332 37610 110350331
Mass 17.33 11.90 7 201351 19623 110368318
Type 2 diabetes mellitus 17.32 11.90 223 201135 177009 110210932
Onychophagia 17.27 11.90 7 201351 117 110387824
Musculoskeletal stiffness 17.23 11.90 383 200975 279439 110108502
Macroprolactinaemia 17.21 11.90 4 201354 7 110387934
Electrocardiogram QT interval 17.20 11.90 9 201349 276 110387665
Rapid eye movement sleep behaviour disorder 17.17 11.90 12 201346 627 110387314
Macular degeneration 17.14 11.90 9 201349 21650 110366291
Hernia 17.14 11.90 7 201351 19493 110368448
Post procedural complication 17.14 11.90 14 201344 26644 110361297
Hyperventilation 17.02 11.90 45 201313 8902 110379039
Kidney infection 17.01 11.90 13 201345 25586 110362355
Photosensitivity reaction 17 11.90 13 201345 25576 110362365
Hepatic cytolysis 16.99 11.90 164 201194 54889 110333052
Posterior reversible encephalopathy syndrome 16.99 11.90 22 201336 33839 110354102
Upper-airway cough syndrome 16.97 11.90 4 201354 15853 110372088
Foot fracture 16.94 11.90 13 201345 25533 110362408
Target skin lesion 16.94 11.90 9 201349 285 110387656
Eye infection 16.91 11.90 3 201355 14515 110373426
Dry eye 16.87 11.90 49 201309 55744 110332197
Orthodontic procedure 16.86 11.90 4 201354 8 110387933
Osteonecrosis 16.85 11.90 22 201336 33719 110354222
Mycobacterium ulcerans infection 16.84 11.90 7 201351 125 110387816
Coronary artery occlusion 16.83 11.90 4 201354 15768 110372173
Cyanosis 16.74 11.90 102 201256 29639 110358302
Surgery 16.71 11.90 31 201327 41252 110346689
Acanthosis nigricans 16.67 11.90 8 201350 203 110387738
Intentional product misuse to child 16.64 11.90 8 201350 204 110387737
Electrocardiogram T wave amplitude decreased 16.61 11.90 13 201345 808 110387133
Feminisation acquired 16.60 11.90 5 201353 32 110387909
Motor dysfunction 16.57 11.90 88 201270 24318 110363623
Tumour lysis syndrome 16.52 11.90 19 201339 30782 110357159
Petit mal epilepsy 16.48 11.90 40 201318 7507 110380434
Metabolic function test abnormal 16.46 11.90 12 201346 670 110387271
Schizoaffective disorder bipolar type 16.46 11.90 9 201349 302 110387639
Hypotonic urinary bladder 16.46 11.90 6 201352 74 110387867
Tendonitis 16.39 11.90 14 201344 26069 110361872
Disease recurrence 16.33 11.90 176 201182 60608 110327333
Ventricular extrasystoles 16.31 11.90 83 201275 22558 110365383
Klebsiella infection 16.31 11.90 8 201350 20001 110367940
Blood calcium decreased 16.28 11.90 25 201333 35820 110352121
International normalised ratio increased 16.25 11.90 92 201266 86680 110301261
Tuberculosis 16.25 11.90 6 201352 17768 110370173
Dermatosis 16.16 11.90 14 201344 1004 110386937
Distal intestinal obstruction syndrome 16.08 11.90 14 201344 1011 110386930
Head banging 16.04 11.90 11 201347 557 110387384
Pulmonary haemorrhage 16.01 11.90 5 201353 16451 110371490
Flashback 16.00 11.90 10 201348 432 110387509
Secondary tic 15.97 11.90 4 201354 11 110387930
Orthostatic hypertension 15.96 11.90 14 201344 1021 110386920
Hypocalcaemia 15.95 11.90 63 201295 65303 110322638
Hysterical psychosis 15.93 11.90 3 201355 0 110387941
Creatinine renal clearance decreased 15.93 11.90 10 201348 21805 110366136
Drug dependence 15.93 11.90 150 201208 49870 110338071
Encephalopathy 15.83 11.90 221 201137 80834 110307107
Sudden cardiac death 15.81 11.90 33 201325 5604 110382337
Infusion site pain 15.73 11.90 6 201352 17413 110370528
Lip swelling 15.68 11.90 44 201314 50623 110337318
Brain contusion 15.66 11.90 17 201341 1611 110386330
Swelling face 15.66 11.90 101 201257 92220 110295721
Flatulence 15.62 11.90 46 201312 52103 110335838
Painful erection 15.60 11.90 8 201350 235 110387706
Viral diarrhoea 15.60 11.90 11 201347 583 110387358
C-reactive protein increased 15.58 11.90 291 201067 217628 110170313
Liver function test abnormal 15.55 11.90 193 201165 68757 110319184
Skin fissures 15.53 11.90 13 201345 24445 110363496
Foetal death 15.39 11.90 5 201353 16040 110371901
Drug ineffective for unapproved indication 15.36 11.90 268 201090 102570 110285371
Feeling of despair 15.35 11.90 26 201332 3772 110384169
Vomiting projectile 15.34 11.90 20 201338 2298 110385643
Blood glucose 15.32 11.90 5 201353 43 110387898
Sputum discoloured 15.25 11.90 17 201341 27928 110360013
Brief psychotic disorder with marked stressors 15.23 11.90 9 201349 351 110387590
Intestinal obstruction 15.18 11.90 156 201202 53071 110334870
Arteriosclerosis coronary artery 15.16 11.90 14 201344 25104 110362837
Visual acuity reduced 15.04 11.90 22 201336 32151 110355790
Haematuria 15.02 11.90 89 201269 82916 110305025
Aphthous ulcer 15.01 11.90 10 201348 21126 110366815
Malignant melanoma 14.95 11.90 6 201352 16885 110371056
Gingival pain 14.92 11.90 5 201353 15731 110372210
Athetosis 14.83 11.90 7 201351 171 110387770
Huntington's disease 14.83 11.90 4 201354 16 110387925
Myopathy toxic 14.82 11.90 15 201343 1310 110386631
Exposure during pregnancy 14.79 11.90 215 201143 167209 110220732
Transient ischaemic attack 14.78 11.90 63 201295 63919 110324022
Thought insertion 14.74 11.90 5 201353 49 110387892
Tooth fracture 14.74 11.90 3 201355 13164 110374777
Back disorder 14.72 11.90 10 201348 20912 110367029
Abscess 14.67 11.90 17 201341 27452 110360489
Peripheral sensory neuropathy 14.64 11.90 6 201352 16674 110371267
Blood parathyroid hormone decreased 14.62 11.90 3 201355 13086 110374855
Blood pressure diastolic increased 14.61 11.90 8 201350 18799 110369142
Tooth abscess 14.59 11.90 8 201350 18781 110369160
Limb discomfort 14.57 11.90 33 201325 40821 110347120
Lung infiltration 14.55 11.90 14 201344 24614 110363327
Red blood cell elliptocytes present 14.54 11.90 7 201351 179 110387762
Joint injury 14.51 11.90 32 201326 39962 110347979
Eye pain 14.43 11.90 45 201313 50054 110337887
Upper gastrointestinal haemorrhage 14.42 11.90 45 201313 50051 110337890
Gastric ulcer 14.34 11.90 32 201326 39795 110348146
Aspiration 14.31 11.90 100 201258 30433 110357508
Odynophagia 14.24 11.90 4 201354 14097 110373844
Circulatory collapse 14.23 11.90 130 201228 42863 110345078
Feeling cold 14.23 11.90 25 201333 33962 110353979
Abdominal pain lower 14.22 11.90 29 201329 37254 110350687
Hyperphosphataemia 14.21 11.90 6 201352 16375 110371566
Gangrene 14.15 11.90 6 201352 16335 110371606
Cholangitis 14.14 11.90 6 201352 16329 110371612
Injection site warmth 14.12 11.90 7 201351 17398 110370543
Affective ambivalence 14.11 11.90 4 201354 20 110387921
Dialysis hypotension 14.06 11.90 7 201351 193 110387748
Sarcopenia 14.05 11.90 14 201344 1200 110386741
Menstruation irregular 14.05 11.90 32 201326 5765 110382176
Temperature intolerance 14.01 11.90 4 201354 13946 110373995
Extrasystoles 14.00 11.90 40 201318 8278 110379663
Enterococcal infection 13.98 11.90 10 201348 20356 110367585
Hypoosmolar state 13.97 11.90 9 201349 410 110387531
Corneal reflex decreased 13.96 11.90 10 201348 543 110387398
Respiratory muscle weakness 13.95 11.90 9 201349 411 110387530
Breast pain 13.93 11.90 45 201313 9955 110377986
Hyperglycaemia 13.90 11.90 225 201133 84865 110303076
Congestive cardiomyopathy 13.88 11.90 57 201301 14162 110373779
Palpitations 13.88 11.90 205 201153 159007 110228934
Atrioventricular block first degree 13.86 11.90 57 201301 14168 110373773
Thought withdrawal 13.86 11.90 3 201355 3 110387938
Kleefstra syndrome 13.86 11.90 3 201355 3 110387938
Tongue thrust 13.86 11.90 3 201355 3 110387938
Bronchospasm 13.82 11.90 21 201337 30218 110357723
Progressive multifocal leukoencephalopathy 13.82 11.90 15 201343 24941 110363000
Negative thoughts 13.80 11.90 16 201342 1630 110386311
Muscle contracture 13.78 11.90 21 201337 2787 110385154
Pancytopenia 13.75 11.90 284 201074 209329 110178612
Saccadic eye movement 13.73 11.90 7 201351 203 110387738
Renal cyst 13.73 11.90 8 201350 18164 110369777
Social problem 13.71 11.90 17 201341 1857 110386084
Prostatic specific antigen increased 13.70 11.90 3 201355 12508 110375433
Enteritis 13.69 11.90 9 201349 19147 110368794
Pituitary tumour 13.68 11.90 14 201344 1239 110386702
Excessive masturbation 13.68 11.90 6 201352 123 110387818
Lacrimation increased 13.66 11.90 22 201336 30928 110357013
Mixed delusion 13.65 11.90 4 201354 23 110387918
Product quality issue 13.61 11.90 207 201151 77092 110310849
Intestinal pseudo-obstruction 13.60 11.90 23 201335 3333 110384608
Fat redistribution 13.59 11.90 6 201352 125 110387816
Blood glucose abnormal 13.59 11.90 53 201305 12863 110375078
Genital hypoaesthesia 13.58 11.90 7 201351 208 110387733
Gallbladder disorder 13.57 11.90 11 201347 21018 110366923
Pelvic pain 13.57 11.90 6 201352 15936 110372005
Drug use disorder 13.55 11.90 67 201291 18007 110369934
Inadequate diet 13.54 11.90 8 201350 312 110387629
Persistent depressive disorder 13.47 11.90 15 201343 1462 110386479
Normal newborn 13.46 11.90 12 201346 21884 110366057
Neutropenic sepsis 13.44 11.90 22 201336 30724 110357217
Cytotoxic oedema 13.41 11.90 9 201349 440 110387501
Inferiority complex 13.40 11.90 3 201355 4 110387937
Caffeine consumption 13.40 11.90 3 201355 4 110387937
Upper limb fracture 13.39 11.90 11 201347 20877 110367064
Product use issue 13.38 11.90 449 200909 311246 110076695
Pulmonary vein occlusion 13.37 11.90 6 201352 130 110387811
Hunger 13.37 11.90 34 201324 6570 110381371
Immune system disorder 13.32 11.90 4 201354 13497 110374444
Premature delivery 13.31 11.90 22 201336 30610 110357331
Progressive supranuclear palsy 13.31 11.90 7 201351 217 110387724
Poor venous access 13.29 11.90 15 201343 24507 110363434
Musculoskeletal chest pain 13.22 11.90 20 201338 28827 110359114
Antisocial personality disorder 13.20 11.90 5 201353 69 110387872
Vascular dementia 13.20 11.90 12 201346 917 110387024
Product monitoring error 13.19 11.90 41 201317 8886 110379055
Cardiac disorder 13.17 11.90 83 201275 76197 110311744
Immunosuppression 13.16 11.90 8 201350 17751 110370190
Epileptic psychosis 13.14 11.90 5 201353 70 110387871
Epstein-Barr virus infection 13.13 11.90 9 201349 18729 110369212
Endocarditis 13.12 11.90 4 201354 13367 110374574
Drug dose omission by device 13.11 11.90 5 201353 14511 110373430
Viral infection 13.10 11.90 51 201307 53088 110334853
Libido disorder 13.05 11.90 8 201350 334 110387607
Blood pressure abnormal 12.95 11.90 13 201345 22411 110365530
Hypoacusis 12.90 11.90 28 201330 35163 110352778
Breath odour 12.89 11.90 17 201341 1975 110385966
Labile blood pressure 12.87 11.90 19 201339 2452 110385489
Rash papular 12.82 11.90 19 201339 27620 110360321
Visual impairment 12.81 11.90 170 201188 134258 110253683
Exposure via skin contact 12.78 11.90 4 201354 13143 110374798
Laryngeal dyspnoea 12.75 11.90 8 201350 348 110387593
Xanthoma 12.75 11.90 7 201351 237 110387704
Myopathy 12.75 11.90 16 201342 24944 110362997
Neutrophil hypersegmented morphology present 12.74 11.90 4 201354 30 110387911
Hyponatraemic syndrome 12.73 11.90 11 201347 786 110387155
Cerebrovascular accident 12.67 11.90 243 201115 181041 110206900
Gastrointestinal pain 12.67 11.90 3 201355 11857 110376084
Poverty of thought content 12.65 11.90 5 201353 78 110387863
Removal of foreign body from eye 12.65 11.90 3 201355 6 110387935
Deep vein thrombosis 12.64 11.90 339 201019 139548 110248393
Blood phosphorus increased 12.62 11.90 7 201351 16333 110371608
Therapeutic hypothermia 12.62 11.90 4 201354 31 110387910
Brief psychotic disorder, with postpartum onset 12.62 11.90 4 201354 31 110387910
Tongue paralysis 12.62 11.90 10 201348 633 110387308
Optic atrophy 12.58 11.90 19 201339 2502 110385439
Bulbar palsy 12.57 11.90 8 201350 357 110387584
Secretion discharge 12.56 11.90 11 201347 20233 110367708
Tooth extraction 12.55 11.90 4 201354 12987 110374954
Lipid metabolism disorder 12.47 11.90 10 201348 644 110387297
Skin lesion 12.45 11.90 50 201308 51581 110336360
Rash macular 12.42 11.90 33 201325 38653 110349288
Indifference 12.41 11.90 8 201350 365 110387576
Cataract cortical 12.41 11.90 6 201352 155 110387786
Cardiac output decreased 12.39 11.90 17 201341 2052 110385889
Xanthopsia 12.37 11.90 8 201350 367 110387574
Aphonia 12.35 11.90 4 201354 12856 110375085
Hypogammaglobulinaemia 12.35 11.90 11 201347 20065 110367876
Intestinal dilatation 12.34 11.90 23 201335 3597 110384344
Gastritis 12.32 11.90 53 201305 53646 110334295
HIV test positive 12.27 11.90 6 201352 159 110387782
Breath sounds abnormal 12.24 11.90 17 201341 25387 110362554
Bone density decreased 12.21 11.90 7 201351 16035 110371906
Oesophageal carcinoma 12.15 11.90 3 201355 11521 110376420
Musculoskeletal disorder 12.13 11.90 14 201344 22650 110365291
Anticonvulsant drug level increased 12.13 11.90 20 201338 2838 110385103
Myoglobinuria 12.12 11.90 13 201345 1215 110386726
Enterocolitis 12.12 11.90 10 201348 18939 110369002
Polyserositis 12.11 11.90 12 201346 1022 110386919
Burning sensation 12.11 11.90 75 201283 69137 110318804
Femur fracture 12.07 11.90 41 201317 44428 110343513
Electrocardiogram U-wave abnormality 12.04 11.90 5 201353 89 110387852
Conversion disorder 12.02 11.90 18 201340 2352 110385589
Thrombocytopenia 12.00 11.90 516 200842 348369 110039572
Ischaemic gastritis 12 11.90 4 201354 37 110387904
Coronary artery stenosis 11.99 11.90 5 201353 13753 110374188
Trisomy 21 11.99 11.90 5 201353 90 110387851
Throat tightness 11.98 11.90 27 201331 33462 110354479
Blood glucose fluctuation 11.98 11.90 36 201322 7662 110380279
Belligerence 11.96 11.90 7 201351 268 110387673
Blood test abnormal 11.96 11.90 21 201337 28533 110359408
Blood urine present 11.91 11.90 16 201342 24229 110363712
Peritonitis 11.91 11.90 26 201332 32581 110355360
Parkinsonian rest tremor 11.90 11.90 8 201350 392 110387549

FDA Adverse Event Reporting System (Pediatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Tricuspid valve incompetence 28.36 26.54 12 448 96 113397

Pharmacologic Action:

SourceCodeDescription
ATC N05AX08 NERVOUS SYSTEM
PSYCHOLEPTICS
ANTIPSYCHOTICS
Other antipsychotics
FDA EPC N0000175430 Atypical Antipsychotic
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35471 psychotropic drug
CHEBI has role CHEBI:35474 anxiolytic drug
CHEBI has role CHEBI:37890 ฮฑ-adrenergic antagonist
CHEBI has role CHEBI:37955 H<small><sub>1</sub></small>-receptor antagonist
CHEBI has role CHEBI:48279 serotonergic antagonist
CHEBI has role CHEBI:48561 dopaminergic antagonist
CHEBI has role CHEBI:65191 second generation antipsychotic
CHEBI has role CHEBI:76779 EC 3.4.21.26 (prolyl oligopeptidase) inhibitor
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D011619 Psychotropic Drugs
MeSH PA D012702 Serotonin Antagonists
MeSH PA D014150 Antipsychotic Agents
MeSH PA D015259 Dopamine Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018490 Serotonin Agents
MeSH PA D018492 Dopamine Antagonists

Related Drugs by ATC class:

N05AX Other antipsychotics 11 drugs
aripiprazolebrexpiprazolecariprazineiloperidonemosapraminepaliperidonepimavanserinprothipendyltrospiumxanomelinezotepine

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Mixed bipolar I disorder indication 16506000 DOID:3312
Schizophrenia indication 58214004 DOID:5419
Bipolar disorder in remission indication 85248005
Bipolar affective disorder, current episode manic indication 191618007
Infantile autism indication 408857007
Bipolar affective disorder, current episode depression off-label use 191627008 DOID:3312
Toxoplasmosis associated with acquired immunodeficiency syndrome off-label use 421666009
Depression Treatment Adjunct off-label use
Priapism contraindication 6273006 DOID:9286
Suicidal thoughts contraindication 6471006
Asthenia contraindication 13791008
Neuroleptic malignant syndrome contraindication 15244003 DOID:14464
Senile dementia contraindication 15662003
Agranulocytosis contraindication 17182001 DOID:12987
Myocardial infarction contraindication 22298006 DOID:5844
Hypovolemia contraindication 28560003
Orthostatic hypotension contraindication 28651003
Parkinsonism contraindication 32798002
Dehydration contraindication 34095006
Dysphagia contraindication 40739000
Conduction disorder of the heart contraindication 44808001
Low blood pressure contraindication 45007003
Chronic heart failure contraindication 48447003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Hyperlipidemia contraindication 55822004 DOID:1168
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Cerebrovascular disease contraindication 62914000 DOID:6713
Substance abuse contraindication 66214007
Diabetes mellitus contraindication 73211009 DOID:9351
Diffuse Lewy body disease contraindication 80098002
Hyperglycemia contraindication 80394007 DOID:4195
Leukopenia contraindication 84828003 DOID:615
Tardive dyskinesia contraindication 102449007
Seizure disorder contraindication 128613002
Cerebrovascular accident contraindication 230690007
Disease of liver contraindication 235856003 DOID:409
Metabolic syndrome X contraindication 237602007 DOID:14221
Hyperprolactinemia contraindication 237662005 DOID:12700
Retention of urine contraindication 267064002
Neutropenic disorder contraindication 303011007 DOID:1227
At risk for aspiration contraindication 371736008
Fever contraindication 386661006
Hypothermia contraindication 386689009
Impaired cognition contraindication 386806002
Breastfeeding (mother) contraindication 413712001
Myocardial ischemia contraindication 414795007 DOID:3393
Obesity contraindication 414916001 DOID:9970
Carcinoma of female breast contraindication 447782002
Smokes tobacco daily contraindication 449868002
Predisposed to Torsades de Pointes Cardiac Arrhythmias contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 7.78 Basic
pKa2 3.45 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
120MG PERSERIS KIT INDIVIOR N210655 July 27, 2018 DISCN FOR SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 10406160 June 26, 2026 METHOD OF TREATING SCHIZOPHRENIA
90MG PERSERIS KIT INDIVIOR N210655 July 27, 2018 DISCN FOR SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 10406160 June 26, 2026 METHOD OF TREATING SCHIZOPHRENIA
120MG PERSERIS KIT INDIVIOR N210655 July 27, 2018 DISCN FOR SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 10058554 Sept. 26, 2026 ADMINISTRATION OF RISPERIDONE
90MG PERSERIS KIT INDIVIOR N210655 July 27, 2018 DISCN FOR SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 10058554 Sept. 26, 2026 ADMINISTRATION OF RISPERIDONE
120MG PERSERIS KIT INDIVIOR N210655 July 27, 2018 DISCN FOR SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 11110093 Nov. 5, 2026 TREATING SCHIZOPHRENIA
90MG PERSERIS KIT INDIVIOR N210655 July 27, 2018 DISCN FOR SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 11110093 Nov. 5, 2026 TREATING SCHIZOPHRENIA
100MG/0.28ML (100MG/0.28ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 8221778 Nov. 12, 2027 TREATMENT OF BIPOLAR DISORDER
100MG/0.28ML (100MG/0.28ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 8221778 Nov. 12, 2027 TREATMENT OF SCHIZOPHRENIA
100MG/0.28ML (100MG/0.28ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 8741327 Nov. 12, 2027 TREATMENT OF SCHIZOPHRENIA
125MG/0.35ML (125MG/0.35ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 8221778 Nov. 12, 2027 TREATMENT OF SCHIZOPHRENIA
125MG/0.35ML (125MG/0.35ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 8741327 Nov. 12, 2027 TREATMENT OF SCHIZOPHRENIA
150MG/0.42ML (150MG/0.42ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 8221778 Nov. 12, 2027 TREATMENT OF SCHIZOPHRENIA
150MG/0.42ML (150MG/0.42ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 8741327 Nov. 12, 2027 TREATMENT OF SCHIZOPHRENIA
200MG/0.56ML (200MG/0.56ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 8221778 Nov. 12, 2027 TREATMENT OF SCHIZOPHRENIA
200MG/0.56ML (200MG/0.56ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 8741327 Nov. 12, 2027 TREATMENT OF SCHIZOPHRENIA
250MG/0.7ML (250MG/0.7ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 8221778 Nov. 12, 2027 TREATMENT OF SCHIZOPHRENIA
250MG/0.7ML (250MG/0.7ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 8741327 Nov. 12, 2027 TREATMENT OF SCHIZOPHRENIA
50MG/0.14ML (50MG/0.14ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 8221778 Nov. 12, 2027 TREATMENT OF BIPOLAR DISORDER
50MG/0.14ML (50MG/0.14ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 8221778 Nov. 12, 2027 TREATMENT OF SCHIZOPHRENIA
50MG/0.14ML (50MG/0.14ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 8741327 Nov. 12, 2027 TREATMENT OF SCHIZOPHRENIA
75MG/0.21ML (75MG/0.21ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 8221778 Nov. 12, 2027 TREATMENT OF BIPOLAR DISORDER
75MG/0.21ML (75MG/0.21ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 8221778 Nov. 12, 2027 TREATMENT OF SCHIZOPHRENIA
75MG/0.21ML (75MG/0.21ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 8741327 Nov. 12, 2027 TREATMENT OF SCHIZOPHRENIA
120MG PERSERIS KIT INDIVIOR N210655 July 27, 2018 DISCN FOR SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 10376590 Feb. 13, 2028 METHOD OF TREATING SCHIZOPHRENIA
120MG PERSERIS KIT INDIVIOR N210655 July 27, 2018 DISCN FOR SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 11013809 Feb. 13, 2028 TREATING SCHIZOPHRENIA
120MG PERSERIS KIT INDIVIOR N210655 July 27, 2018 DISCN FOR SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 11712475 Feb. 13, 2028 TREATING SCHIZOPHRENIA
120MG PERSERIS KIT INDIVIOR N210655 July 27, 2018 DISCN FOR SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 9186413 Feb. 13, 2028 TREATMENT OF SCHIZOPHRENIA
90MG PERSERIS KIT INDIVIOR N210655 July 27, 2018 DISCN FOR SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 10376590 Feb. 13, 2028 METHOD OF TREATING SCHIZOPHRENIA
90MG PERSERIS KIT INDIVIOR N210655 July 27, 2018 DISCN FOR SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 11013809 Feb. 13, 2028 TREATING SCHIZOPHRENIA
90MG PERSERIS KIT INDIVIOR N210655 July 27, 2018 DISCN FOR SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 11712475 Feb. 13, 2028 TREATING SCHIZOPHRENIA
90MG PERSERIS KIT INDIVIOR N210655 July 27, 2018 DISCN FOR SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 9186413 Feb. 13, 2028 TREATMENT OF SCHIZOPHRENIA
100MG RISVAN LABS FARMS ROVI SA N214835 March 29, 2024 DISCN FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10182982 May 31, 2031 TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTRATION OF EXTENDED RELEASE INJECTABLE COMPOSITION
100MG RISVAN LABS FARMS ROVI SA N214835 March 29, 2024 DISCN FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10195138 May 31, 2031 TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTRATION OF EXTENDED RELEASE INJECTABLE COMPOSITION
100MG RISVAN LABS FARMS ROVI SA N214835 March 29, 2024 DISCN FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11007139 May 31, 2031 TREATMENT OF SCHIZOPHRENIA IN ADULTS BY INTRAMUSCULAR ADMINISTRATION OF EXTENDED RELEASE INJECTABLE COMPOSITION
100MG RISVAN LABS FARMS ROVI SA N214835 March 29, 2024 DISCN FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11173110 May 31, 2031 ADMINISTRATION OF RISPERIDONE IN EXTENDED RELEASE INJECTABLE SUSPENSION FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS
100MG RISVAN LABS FARMS ROVI SA N214835 March 29, 2024 DISCN FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11241377 May 31, 2031 INTRAMUSCULAR ADMINISTRATION OF RISPERIDONE IN EXTENDED RELEASE INJECTABLE SUSPENSION FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS
100MG RISVAN LABS FARMS ROVI SA N214835 March 29, 2024 DISCN FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11752092 May 31, 2031 ADMINISTRATION OF RISPERIDONE IN EXTENDED RELEASE INJECTABLE SUSPENSION FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS
100MG RISVAN LABS FARMS ROVI SA N214835 March 29, 2024 DISCN FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11752094 May 31, 2031 TREATMENT OF SCHIZOPHRENIA IN ADULTS BY INTRAMUSCULAR ADMINISTRATION OF EXTENDED RELEASE INJECTABLE COMPOSITION
100MG RISVAN LABS FARMS ROVI SA N214835 March 29, 2024 DISCN FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11759416 May 31, 2031 INTRAMUSCULAR ADMINISTRATION OF RISPERIDONE IN EXTENDED RELEASE INJECTABLE SUSPENSION FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS
75MG RISVAN LABS FARMS ROVI SA N214835 March 29, 2024 DISCN FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10182982 May 31, 2031 TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTRATION OF EXTENDED RELEASE INJECTABLE COMPOSITION
75MG RISVAN LABS FARMS ROVI SA N214835 March 29, 2024 DISCN FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10195138 May 31, 2031 TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTRATION OF EXTENDED RELEASE INJECTABLE COMPOSITION
75MG RISVAN LABS FARMS ROVI SA N214835 March 29, 2024 DISCN FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11007139 May 31, 2031 TREATMENT OF SCHIZOPHRENIA IN ADULTS BY INTRAMUSCULAR ADMINISTRATION OF EXTENDED RELEASE INJECTABLE COMPOSITION
75MG RISVAN LABS FARMS ROVI SA N214835 March 29, 2024 DISCN FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11173110 May 31, 2031 ADMINISTRATION OF RISPERIDONE IN EXTENDED RELEASE INJECTABLE SUSPENSION FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS
75MG RISVAN LABS FARMS ROVI SA N214835 March 29, 2024 DISCN FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11241377 May 31, 2031 INTRAMUSCULAR ADMINISTRATION OF RISPERIDONE IN EXTENDED RELEASE INJECTABLE SUSPENSION FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS
75MG RISVAN LABS FARMS ROVI SA N214835 March 29, 2024 DISCN FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11752092 May 31, 2031 ADMINISTRATION OF RISPERIDONE IN EXTENDED RELEASE INJECTABLE SUSPENSION FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS
75MG RISVAN LABS FARMS ROVI SA N214835 March 29, 2024 DISCN FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11752094 May 31, 2031 TREATMENT OF SCHIZOPHRENIA IN ADULTS BY INTRAMUSCULAR ADMINISTRATION OF EXTENDED RELEASE INJECTABLE COMPOSITION
75MG RISVAN LABS FARMS ROVI SA N214835 March 29, 2024 DISCN FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11759416 May 31, 2031 INTRAMUSCULAR ADMINISTRATION OF RISPERIDONE IN EXTENDED RELEASE INJECTABLE SUSPENSION FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS
12.5MG RYKINDO SHANDONG LUYE N212849 Jan. 13, 2023 DISCN FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10098882 April 10, 2032 TREATMENT OF SCHIZOPHRENIA IN ADULTS
12.5MG RYKINDO SHANDONG LUYE N212849 Jan. 13, 2023 DISCN FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10406161 April 10, 2032 TREATMENT OF SCHIZOPHRENIA IN ADULTS
12.5MG RYKINDO SHANDONG LUYE N212849 Jan. 13, 2023 DISCN FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9446135 April 10, 2032 TREATMENT OF SCHIZOPHRENIA IN ADULTS
12.5MG RYKINDO SHANDONG LUYE N212849 Jan. 13, 2023 DISCN FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9532991 April 10, 2032 TREATMENT OF SCHIZOPHRENIA IN ADULTS
25MG RYKINDO SHANDONG LUYE N212849 Jan. 13, 2023 RX FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10098882 April 10, 2032 TREATMENT OF SCHIZOPHRENIA IN ADULTS
25MG RYKINDO SHANDONG LUYE N212849 Jan. 13, 2023 RX FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10406161 April 10, 2032 TREATMENT OF SCHIZOPHRENIA IN ADULTS
25MG RYKINDO SHANDONG LUYE N212849 Jan. 13, 2023 RX FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9446135 April 10, 2032 TREATMENT OF SCHIZOPHRENIA IN ADULTS
25MG RYKINDO SHANDONG LUYE N212849 Jan. 13, 2023 RX FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9532991 April 10, 2032 TREATMENT OF SCHIZOPHRENIA IN ADULTS
37.5MG RYKINDO SHANDONG LUYE N212849 Jan. 13, 2023 DISCN FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10098882 April 10, 2032 TREATMENT OF SCHIZOPHRENIA IN ADULTS
37.5MG RYKINDO SHANDONG LUYE N212849 Jan. 13, 2023 DISCN FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10406161 April 10, 2032 TREATMENT OF SCHIZOPHRENIA IN ADULTS
37.5MG RYKINDO SHANDONG LUYE N212849 Jan. 13, 2023 DISCN FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9446135 April 10, 2032 TREATMENT OF SCHIZOPHRENIA IN ADULTS
37.5MG RYKINDO SHANDONG LUYE N212849 Jan. 13, 2023 DISCN FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9532991 April 10, 2032 TREATMENT OF SCHIZOPHRENIA IN ADULTS
50MG RYKINDO SHANDONG LUYE N212849 Jan. 13, 2023 DISCN FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10098882 April 10, 2032 TREATMENT OF SCHIZOPHRENIA IN ADULTS
50MG RYKINDO SHANDONG LUYE N212849 Jan. 13, 2023 DISCN FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10406161 April 10, 2032 TREATMENT OF SCHIZOPHRENIA IN ADULTS
50MG RYKINDO SHANDONG LUYE N212849 Jan. 13, 2023 DISCN FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9446135 April 10, 2032 TREATMENT OF SCHIZOPHRENIA IN ADULTS
50MG RYKINDO SHANDONG LUYE N212849 Jan. 13, 2023 DISCN FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9532991 April 10, 2032 TREATMENT OF SCHIZOPHRENIA IN ADULTS
100MG/0.28ML (100MG/0.28ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 12128132 Sept. 11, 2040 TREATMENT OF BIPOLAR DISORDER
100MG/0.28ML (100MG/0.28ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 12128132 Sept. 11, 2040 TREATMENT OF SCHIZOPHRENIA
100MG/0.28ML (100MG/0.28ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 12383493 Sept. 11, 2040 TREATMENT OF BIPOLAR DISORDER
100MG/0.28ML (100MG/0.28ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 12383493 Sept. 11, 2040 TREATMENT OF SCHIZOPHRENIA
125MG/0.35ML (125MG/0.35ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 12128132 Sept. 11, 2040 TREATMENT OF SCHIZOPHRENIA
125MG/0.35ML (125MG/0.35ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 12383493 Sept. 11, 2040 TREATMENT OF SCHIZOPHRENIA
150MG/0.42ML (150MG/0.42ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 12128132 Sept. 11, 2040 TREATMENT OF SCHIZOPHRENIA
150MG/0.42ML (150MG/0.42ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 12383493 Sept. 11, 2040 TREATMENT OF SCHIZOPHRENIA
200MG/0.56ML (200MG/0.56ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 12128132 Sept. 11, 2040 TREATMENT OF SCHIZOPHRENIA
200MG/0.56ML (200MG/0.56ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 12383493 Sept. 11, 2040 TREATMENT OF SCHIZOPHRENIA
250MG/0.7ML (250MG/0.7ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 12128132 Sept. 11, 2040 TREATMENT OF SCHIZOPHRENIA
250MG/0.7ML (250MG/0.7ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 12383493 Sept. 11, 2040 TREATMENT OF SCHIZOPHRENIA
50MG/0.14ML (50MG/0.14ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 12128132 Sept. 11, 2040 TREATMENT OF BIPOLAR DISORDER
50MG/0.14ML (50MG/0.14ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 12128132 Sept. 11, 2040 TREATMENT OF SCHIZOPHRENIA
50MG/0.14ML (50MG/0.14ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 12383493 Sept. 11, 2040 TREATMENT OF BIPOLAR DISORDER
50MG/0.14ML (50MG/0.14ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 12383493 Sept. 11, 2040 TREATMENT OF SCHIZOPHRENIA
75MG/0.21ML (75MG/0.21ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 12128132 Sept. 11, 2040 TREATMENT OF BIPOLAR DISORDER
75MG/0.21ML (75MG/0.21ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 12128132 Sept. 11, 2040 TREATMENT OF SCHIZOPHRENIA
75MG/0.21ML (75MG/0.21ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 12383493 Sept. 11, 2040 TREATMENT OF BIPOLAR DISORDER
75MG/0.21ML (75MG/0.21ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 12383493 Sept. 11, 2040 TREATMENT OF SCHIZOPHRENIA
100MG/0.28ML (100MG/0.28ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 12329851 March 17, 2042 A METHOD OF SWITCHING A PATIENT FROM DAILY ORAL RISPERIDONE THERAPY TO A LONG-ACTING INJECTABLE RISPERIDONE FORMULATION
125MG/0.35ML (125MG/0.35ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 12329851 March 17, 2042 A METHOD OF SWITCHING A PATIENT FROM DAILY ORAL RISPERIDONE THERAPY TO A LONG-ACTING INJECTABLE RISPERIDONE FORMULATION
150MG/0.42ML (150MG/0.42ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 12329851 March 17, 2042 A METHOD OF SWITCHING A PATIENT FROM DAILY ORAL RISPERIDONE THERAPY TO A LONG-ACTING INJECTABLE RISPERIDONE FORMULATION
200MG/0.56ML (200MG/0.56ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 12329851 March 17, 2042 A METHOD OF SWITCHING A PATIENT FROM DAILY ORAL RISPERIDONE THERAPY TO A LONG-ACTING INJECTABLE RISPERIDONE FORMULATION
250MG/0.7ML (250MG/0.7ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 12329851 March 17, 2042 A METHOD OF SWITCHING A PATIENT FROM DAILY ORAL RISPERIDONE THERAPY TO A LONG-ACTING INJECTABLE RISPERIDONE FORMULATION
50MG/0.14ML (50MG/0.14ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 12329851 March 17, 2042 A METHOD OF SWITCHING A PATIENT FROM DAILY ORAL RISPERIDONE THERAPY TO A LONG-ACTING INJECTABLE RISPERIDONE FORMULATION
75MG/0.21ML (75MG/0.21ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 12329851 March 17, 2042 A METHOD OF SWITCHING A PATIENT FROM DAILY ORAL RISPERIDONE THERAPY TO A LONG-ACTING INJECTABLE RISPERIDONE FORMULATION

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
100MG/0.28ML (100MG/0.28ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS April 28, 2026 NEW PRODUCT
125MG/0.35ML (125MG/0.35ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS April 28, 2026 NEW PRODUCT
150MG/0.42ML (150MG/0.42ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS April 28, 2026 NEW PRODUCT
200MG/0.56ML (200MG/0.56ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS April 28, 2026 NEW PRODUCT
250MG/0.7ML (250MG/0.7ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS April 28, 2026 NEW PRODUCT
50MG/0.14ML (50MG/0.14ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS April 28, 2026 NEW PRODUCT
75MG/0.21ML (75MG/0.21ML) UZEDY TEVA N213586 April 28, 2023 RX SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS April 28, 2026 NEW PRODUCT
37.5MG/VIAL RISPERIDONE NANOMI A211220 Sept. 2, 2025 RX POWDER INTRAMUSCULAR May 9, 2026 COMPETITIVE GENERIC THERAPY
50MG/VIAL RISPERIDONE NANOMI A211220 Sept. 2, 2025 RX POWDER INTRAMUSCULAR May 9, 2026 COMPETITIVE GENERIC THERAPY
25MG/VIAL RISPERIDONE NANOMI A211220 Sept. 2, 2025 RX POWDER INTRAMUSCULAR May 12, 2026 COMPETITIVE GENERIC THERAPY
100MG RISVAN LABS FARMS ROVI SA N214835 March 29, 2024 DISCN FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR March 29, 2027 NEW PRODUCT
75MG RISVAN LABS FARMS ROVI SA N214835 March 29, 2024 DISCN FOR SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR March 29, 2027 NEW PRODUCT

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
D(2) dopamine receptor GPCR ANTAGONIST Ki 8.49 WOMBAT-PK CHEMBL
5-hydroxytryptamine receptor 2A GPCR ANTAGONIST Ki 9.36 WOMBAT-PK CHEMBL
Beta-1 adrenergic receptor GPCR Ki 5.30 PDSP
Beta-2 adrenergic receptor GPCR Ki 5.30 PDSP
Alpha-2A adrenergic receptor GPCR Ki 8 WOMBAT-PK
Sigma non-opioid intracellular receptor 1 Membrane receptor Ki 5.37 CHEMBL
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 6.79 WOMBAT-PK
Sodium-dependent serotonin transporter Transporter Ki 5.85 CHEMBL
5-hydroxytryptamine receptor 1A GPCR Ki 6.44 WOMBAT-PK
5-hydroxytryptamine receptor 2B GPCR Ki 7.42 WOMBAT-PK
5-hydroxytryptamine receptor 2C GPCR ANTAGONIST Ki 7.70 WOMBAT-PK
5-hydroxytryptamine receptor 6 GPCR Ki 6.65 CHEMBL
5-hydroxytryptamine receptor 7 GPCR Ki 8.47 WOMBAT-PK
Alpha-1A adrenergic receptor GPCR Ki 8.55 WOMBAT-PK
Alpha-2B adrenergic receptor GPCR Ki 7.77 WOMBAT-PK
D(3) dopamine receptor GPCR ANTAGONIST Ki 8.07 WOMBAT-PK
D(1B) dopamine receptor GPCR Ki 7.02 PDSP
Histamine H1 receptor GPCR Ki 7.48 WOMBAT-PK
Histamine H2 receptor GPCR Ki 6.92 PDSP
Muscarinic acetylcholine receptor M1 GPCR Ki 5.55 CHEMBL
Muscarinic acetylcholine receptor M2 GPCR Ki 5.43 PDSP
Muscarinic acetylcholine receptor M3 GPCR Ki 5 PDSP
Muscarinic acetylcholine receptor M4 GPCR Ki 5.54 PDSP
5-hydroxytryptamine receptor 1B GPCR ANTAGONIST Ki 7.49 WOMBAT-PK
5-hydroxytryptamine receptor 1D GPCR ANTAGONIST Ki 7.60 WOMBAT-PK
Alpha-2C adrenergic receptor GPCR Ki 8.50 WOMBAT-PK
Cytochrome P450 2D6 Enzyme IC50 5.28 DRUG MATRIX
D(4) dopamine receptor GPCR ANTAGONIST Ki 8 WOMBAT-PK
Alpha-1D adrenergic receptor GPCR ANTAGONIST Ki 7.40 IUPHAR
Alpha-1B adrenergic receptor GPCR Ki 8.48 WOMBAT-PK
Glycine receptor subunit alpha-1 Ion channel EC50 6.49 CHEMBL
5-hydroxytryptamine receptor 5A GPCR Ki 6.69 WOMBAT-PK
5-hydroxytryptamine receptor 1F GPCR ANTAGONIST Ki 5.90 IUPHAR
5-hydroxytryptamine receptor 1E GPCR ANTAGONIST Ki 5.90 IUPHAR
Histamine H3 receptor GPCR Ki 5.96 CHEMBL
Solute carrier family 22 member 2 Transporter IC50 4.96 CHEMBL
Multidrug and toxin extrusion protein 1 Transporter IC50 5.80 CHEMBL
D(1A) dopamine receptor GPCR Ki 7.68 CHEMBL
Histone H1.0 Nuclear other Ki 7.85 CHEMBL
Alpha-1B adrenergic receptor GPCR Ki 8.97 DRUG MATRIX
Alpha-1A adrenergic receptor GPCR Ki 7.89 CHEMBL
Histamine H1 receptor GPCR Ki 7.66 CHEMBL
D(2) dopamine receptor GPCR Ki 8.74 CHEMBL
5-hydroxytryptamine receptor 1A GPCR Ki 6.89 CHEMBL
5-hydroxytryptamine receptor 2A GPCR Ki 9.82 CHEMBL
5-hydroxytryptamine receptor 7 GPCR Ki 8.85 CHEMBL
Beta-1 adrenergic receptor GPCR Ki 4.66 CHEMBL
Alpha-2A adrenergic receptor GPCR Ki 7.60 CHEMBL
D(2) dopamine receptor GPCR IC50 7.64 CHEMBL
5-hydroxytryptamine receptor 2C GPCR Ki 7.84 CHEMBL
5-hydroxytryptamine receptor 1A GPCR IC50 6.37 CHEMBL
Histamine H1 receptor GPCR IC50 7.10 CHEMBL
D(3) dopamine receptor GPCR Ki 8.01 CHEMBL
5-hydroxytryptamine receptor 6 GPCR ANTAGONIST Ki 6.40 IUPHAR
Transporter Transporter Ki 4.55 CHEMBL
Serotonin 1 (5-HT1) receptor GPCR Ki 6.47 CHEMBL
Serotonin 2 (5-HT2) receptor GPCR Ki 9.85 CHEMBL
Serotonin 2 (5-HT2) receptor GPCR IC50 8.82 CHEMBL
D(1A) dopamine receptor GPCR Ki 7.66 CHEMBL

External reference:

IDSource
4020840 VUID
N0000148350 NUI
D00426 KEGG_DRUG
4020840 VANDF
C0073393 UMLSCUI
CHEBI:8871 CHEBI
CHEMBL85 ChEMBL_ID
D018967 MESH_DESCRIPTOR_UI
DB00734 DRUGBANK_ID
5073 PUBCHEM_CID
96 IUPHAR_LIGAND_ID
6085 INN_ID
L6UH7ZF8HC UNII
152318 RXNORM
1259 MMSL
146973 MMSL
5429 MMSL
d03180 MMSL
004392 NDDF
108386000 SNOMEDCT_US
386840002 SNOMEDCT_US
8NU PDB_CHEM_ID
L6UH7ZF8HC INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 0615-8196 TABLET 0.25 mg ORAL ANDA 33 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 0615-8197 TABLET 0.50 mg ORAL ANDA 33 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 0615-8198 TABLET 1 mg ORAL ANDA 33 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 0615-8265 TABLET 3 mg ORAL ANDA 33 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 0615-8288 TABLET 2 mg ORAL ANDA 33 sections
risperidone HUMAN PRESCRIPTION DRUG LABEL 1 0904-7360 TABLET, FILM COATED 0.25 mg ORAL ANDA 31 sections
risperidone HUMAN PRESCRIPTION DRUG LABEL 1 0904-7361 TABLET, FILM COATED 0.50 mg ORAL ANDA 31 sections
risperidone HUMAN PRESCRIPTION DRUG LABEL 1 0904-7362 TABLET, FILM COATED 1 mg ORAL ANDA 31 sections
risperidone HUMAN PRESCRIPTION DRUG LABEL 1 0904-7363 TABLET, FILM COATED 2 mg ORAL ANDA 31 sections
risperidone HUMAN PRESCRIPTION DRUG LABEL 1 0904-7364 TABLET, FILM COATED 3 mg ORAL ANDA 31 sections
risperidone HUMAN PRESCRIPTION DRUG LABEL 1 0904-7365 TABLET, FILM COATED 4 mg ORAL ANDA 31 sections
Risperidone Human Prescription Drug Label 1 13107-119 TABLET, FILM COATED 0.25 mg ORAL ANDA 32 sections
Risperidone Human Prescription Drug Label 1 13107-120 TABLET, FILM COATED 0.50 mg ORAL ANDA 32 sections
Risperidone Human Prescription Drug Label 1 13107-121 TABLET, FILM COATED 1 mg ORAL ANDA 32 sections
Risperidone Human Prescription Drug Label 1 13107-122 TABLET, FILM COATED 2 mg ORAL ANDA 32 sections
Risperidone Human Prescription Drug Label 1 13107-123 TABLET, FILM COATED 3 mg ORAL ANDA 32 sections
Risperidone Human Prescription Drug Label 1 13107-124 TABLET, FILM COATED 4 mg ORAL ANDA 32 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 13668-035 TABLET 0.25 mg ORAL ANDA 30 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 13668-036 TABLET 0.50 mg ORAL ANDA 30 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 13668-037 TABLET 1 mg ORAL ANDA 30 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 13668-038 TABLET 2 mg ORAL ANDA 30 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 13668-039 TABLET 3 mg ORAL ANDA 30 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 13668-040 TABLET 4 mg ORAL ANDA 30 sections
RISPERIDONE HUMAN PRESCRIPTION DRUG LABEL 1 16590-641 TABLET 2 mg ORAL ANDA 30 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 17856-0380 SOLUTION 1 mg ORAL ANDA 17 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 17856-0673 SOLUTION 1 mg ORAL ANDA 20 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 17856-0674 SOLUTION 1 mg ORAL ANDA 20 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 17856-1002 SOLUTION 1 mg ORAL ANDA 32 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 21695-072 TABLET 0.25 mg ORAL ANDA 31 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 21695-087 TABLET 0.50 mg ORAL ANDA 31 sections