lorazepam ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
diazepam derivatives 1606 846-49-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • ativan
  • Wy 4036
  • Wy-4036
  • lorazepam
A benzodiazepine used as an anti-anxiety agent with few side effects. It also has hypnotic, anticonvulsant, and considerable sedative properties and has been proposed as a preanesthetic agent.
  • Molecular weight: 321.16
  • Formula: C15H10Cl2N2O2
  • CLOGP: 2.37
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 2
  • TPSA: 61.69
  • ALOGS: -4.26
  • ROTB: 1

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
2.50 mg O
2.50 mg P
2.50 mg SL

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.08 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.44 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 93 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1.30 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.09 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 17 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Sept. 30, 1977 FDA VALEANT INTL

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
Sopor 1829.87 9.61 1161 243557 18718 50341688
Drug abuse 1195.02 9.61 1460 243258 58386 50302020
Completed suicide 560.16 9.61 1652 243066 130237 50230169
Suicide attempt 495.59 9.61 894 243824 50838 50309568
Intentional self-injury 403.94 9.61 528 244190 22584 50337822
Somnolence 402.45 9.61 1649 243069 153336 50207070
Neuroleptic malignant syndrome 378.16 9.61 360 244358 10770 50349636
Intentional overdose 369.79 9.61 886 243832 61618 50298788
Overdose 362.70 9.61 1184 243534 98543 50261863
Bradyphrenia 355.38 9.61 270 244448 5882 50354524
Agitation 342.29 9.61 781 243937 52603 50307803
Contraindicated product administered 334.07 9.61 151 244567 148807 50211599
Pemphigus 318.18 9.61 93 244625 120073 50240333
Coma 315.93 9.61 787 243931 56092 50304314
Drug ineffective 309.31 9.61 2513 242205 816820 49543586
Systemic lupus erythematosus 303.88 9.61 150 244568 140472 50219934
Drug intolerance 272.75 9.61 398 244320 218706 50141700
Delirium 258.49 9.61 571 244147 37621 50322785
Arthropathy 246.39 9.61 240 244478 157666 50202740
Treatment failure 237.86 9.61 190 244528 137447 50222959
Joint swelling 234.96 9.61 524 244194 244762 50115644
Alopecia 234.31 9.61 524 244194 244523 50115883
Catatonia 233.70 9.61 172 244546 3564 50356842
Toxicity to various agents 230.55 9.61 1787 242931 210712 50149694
Hand deformity 228.63 9.61 99 244619 100100 50260306
Rheumatoid arthritis 224.66 9.61 397 244321 202153 50158253
Glossodynia 214.57 9.61 148 244570 115421 50244985
Drug withdrawal syndrome 209.62 9.61 409 244309 24672 50335734
Therapeutic product effect decreased 196.21 9.61 221 244497 135829 50224577
Swelling 193.20 9.61 428 244290 200444 50159962
Serotonin syndrome 175.77 9.61 377 244341 24336 50336070
Anti-cyclic citrullinated peptide antibody positive 175.46 9.61 61 244657 70526 50289880
Drug interaction 171.58 9.61 1594 243124 198027 50162379
Poisoning 170.82 9.61 253 244465 12176 50348230
Hypersensitivity 168.13 9.61 509 244209 214652 50145754
Arthralgia 168.01 9.61 1338 243380 437364 49923042
Abdominal discomfort 167.74 9.61 567 244151 231074 50129332
Suicidal ideation 165.97 9.61 617 244101 54768 50305638
Anxiety 165.81 9.61 1444 243274 176162 50184244
Mydriasis 161.66 9.61 227 244491 10400 50350006
Tachycardia 160.61 9.61 926 243792 98837 50261569
Psychotic disorder 160.04 9.61 337 244381 21475 50338931
Disorientation 154.64 9.61 449 244269 35035 50325371
Synovitis 152.02 9.61 227 244491 123638 50236768
Mania 149.73 9.61 222 244496 10694 50349712
Maternal exposure during pregnancy 149.06 9.61 346 244372 159432 50200974
Drug dependence 146.97 9.61 307 244411 19452 50340954
Pneumonia aspiration 146.53 9.61 404 244314 30600 50329806
Confusional state 144.63 9.61 1454 243264 184474 50175932
Restlessness 140.42 9.61 349 244369 24824 50335582
Bradykinesia 138.63 9.61 130 244588 3813 50356593
Pain 137.93 9.61 1972 242746 576931 49783475
Infusion related reaction 137.56 9.61 394 244324 169163 50191243
Rash 134.50 9.61 1410 243308 436061 49924345
Depressed level of consciousness 131.57 9.61 549 244169 51404 50309002
Rheumatoid factor positive 127.55 9.61 41 244677 49818 50310588
Respiratory depression 124.53 9.61 215 244503 11795 50348611
Wound 118.40 9.61 206 244512 105588 50254818
Pericarditis 108.90 9.61 132 244586 78557 50281849
Akathisia 108.07 9.61 164 244554 8065 50352341
Mobility decreased 106.58 9.61 138 244580 79810 50280596
Hepatic enzyme increased 106.50 9.61 326 244392 137054 50223352
Drug hypersensitivity 102.70 9.61 751 243967 250259 50110147
Speech disorder 97.43 9.61 385 244333 35163 50325243
Muscle rigidity 96.77 9.61 172 244546 9657 50350749
Lower respiratory tract infection 96.30 9.61 197 244521 95004 50265402
Psychomotor hyperactivity 95.77 9.61 166 244552 9135 50351271
Discomfort 95.26 9.61 242 244476 108138 50252268
Slow speech 93.95 9.61 65 244653 1217 50359189
Hypothermia 93.24 9.61 190 244528 11826 50348580
Mental status changes 93.16 9.61 385 244333 35887 50324519
Product use issue 90.58 9.61 393 244325 149082 50211324
Dysarthria 89.85 9.61 389 244329 37014 50323392
Extrapyramidal disorder 88.84 9.61 184 244534 11586 50348820
Withdrawal syndrome 86.89 9.61 233 244485 17357 50343049
Blister 86.18 9.61 177 244541 85241 50275165
Abnormal behaviour 85.88 9.61 249 244469 19409 50340997
Schizophrenia 84.11 9.61 138 244580 7259 50353147
Delusion 83.06 9.61 168 244550 10401 50350005
Tremor 82.79 9.61 885 243833 114018 50246388
Off label use 82.66 9.61 1709 243009 472717 49887689
Tardive dyskinesia 81.69 9.61 135 244583 7144 50353262
Sinusitis 80.39 9.61 489 244229 170069 50190337
Injection site pain 78.72 9.61 274 244444 110750 50249656
Sedation 77.90 9.61 324 244394 30286 50330120
Aggression 77.80 9.61 252 244466 20864 50339542
Bezoar 77.49 9.61 59 244659 1289 50359117
Gastric pH decreased 77.14 9.61 45 244673 617 50359789
Device expulsion 76.79 9.61 22 244696 28800 50331606
Seizure 76.32 9.61 889 243829 116985 50243421
Depression 74.31 9.61 1168 243550 164255 50196151
Derealisation 74.23 9.61 52 244666 994 50359412
Hyponatraemia 73.75 9.61 750 243968 95389 50265017
Respiratory arrest 72.00 9.61 312 244406 29697 50330709
Incontinence 71.76 9.61 153 244565 9832 50350574
Pneumonia viral 70.40 9.61 122 244596 6712 50353694
Hallucination 69.82 9.61 425 244293 46232 50314174
Hallucination, auditory 68.75 9.61 157 244561 10571 50349835
Drooling 66.53 9.61 82 244636 3302 50357104
Infection 66.16 9.61 527 244191 172427 50187979
Psychomotor retardation 65.87 9.61 82 244636 3336 50357070
Unresponsive to stimuli 65.76 9.61 308 244410 30301 50330105
Soft tissue disorder 65.56 9.61 91 244627 4123 50356283
Nasopharyngitis 64.84 9.61 608 244110 192319 50168087
Injection site erythema 63.78 9.61 170 244548 74766 50285640
Peripheral swelling 62.95 9.61 664 244054 205272 50155134
Dehydration 62.73 9.61 1061 243657 151388 50209018
Knee arthroplasty 62.47 9.61 49 244669 35797 50324609
Cardiac arrest 62.44 9.61 649 244069 83002 50277404
Substance abuse 61.11 9.61 87 244631 4037 50356369
Salivary hypersecretion 60.64 9.61 112 244606 6479 50353927
Cogwheel rigidity 59.45 9.61 57 244661 1720 50358686
Dissociation 59.33 9.61 64 244654 2227 50358179
Feeling of despair 58.74 9.61 60 244658 1958 50358448
Electrocardiogram QT prolonged 58.69 9.61 441 244277 51445 50308961
Hip arthroplasty 57.73 9.61 38 244680 30391 50330015
Electrocardiogram QRS complex prolonged 57.15 9.61 97 244621 5247 50355159
Dystonia 56.93 9.61 156 244562 11770 50348636
Psoriatic arthropathy 54.04 9.61 90 244628 46942 50313464
Therapeutic product effect incomplete 53.96 9.61 243 244475 91272 50269134
Stupor 53.70 9.61 76 244642 3507 50356899
Hypokinesia 53.60 9.61 155 244563 12062 50348344
Status epilepticus 53.06 9.61 164 244554 13242 50347164
Hallucinations, mixed 52.79 9.61 81 244637 4022 50356384
Pruritus 52.70 9.61 1010 243708 282558 50077848
Febrile neutropenia 52.67 9.61 712 244006 96955 50263451
Mental disorder 51.50 9.61 227 244491 21764 50338642
Mutism 51.39 9.61 47 244671 1334 50359072
Depersonalisation/derealisation disorder 51.01 9.61 44 244674 1154 50359252
Alcohol interaction 50.52 9.61 57 244661 2087 50358319
Loss of consciousness 50.36 9.61 746 243972 103607 50256799
Therapeutic response decreased 50.10 9.61 95 244623 47136 50313270
Paranoia 50.03 9.61 136 244582 10212 50350194
Impaired healing 49.60 9.61 172 244546 69614 50290792
Duodenal ulcer perforation 49.04 9.61 91 244627 45520 50314886
Dyskinesia 49.03 9.61 265 244453 27596 50332810
Sinus tachycardia 47.44 9.61 217 244501 21137 50339269
Narcotic bowel syndrome 46.39 9.61 19 244699 111 50360295
Psoriasis 45.78 9.61 175 244543 68825 50291581
H1N1 influenza 45.61 9.61 47 244671 1550 50358856
Fall 44.84 9.61 2014 242704 332918 50027488
Mood swings 44.68 9.61 174 244544 15780 50344626
Folliculitis 44.20 9.61 76 244642 39149 50321257
Cardio-respiratory arrest 44.01 9.61 426 244292 53466 50306940
Miosis 43.41 9.61 95 244623 6215 50354191
Red blood cell sedimentation rate increased 43.22 9.61 47 244671 29369 50331037
Injection site reaction 42.95 9.61 113 244605 49919 50310487
Rheumatic fever 42.90 9.61 14 244704 16853 50343553
Interstitial lung disease 42.74 9.61 124 244594 53052 50307354
Sleep disorder due to general medical condition, insomnia type 42.18 9.61 54 244664 31393 50329013
Tachypnoea 41.66 9.61 160 244558 14417 50345989
Parosmia 41.59 9.61 76 244642 4360 50356046
Somatic symptom disorder 41.30 9.61 49 244669 1895 50358511
COVID-19 41.12 9.61 104 244614 46558 50313848
Persecutory delusion 40.86 9.61 54 244664 2333 50358073
Injection site pruritus 40.52 9.61 84 244634 40327 50320079
Ill-defined disorder 40.00 9.61 133 244585 54521 50305885
Condition aggravated 40.00 9.61 1112 243606 295946 50064460
Muscle injury 39.93 9.61 74 244644 37037 50323369
Diabetes insipidus 39.73 9.61 53 244665 2311 50358095
Urinary retention 39.45 9.61 239 244479 25951 50334455
Bone erosion 39.40 9.61 5 244713 11682 50348724
Musculoskeletal stiffness 39.33 9.61 414 244304 128067 50232339
Helicobacter infection 39.15 9.61 117 244601 49585 50310821
Brain injury 38.52 9.61 88 244630 5926 50354480
Pain in extremity 38.40 9.61 1015 243703 271850 50088556
Respiratory failure 38.35 9.61 637 244081 90544 50269862
Hypoxia 38.31 9.61 397 244321 50726 50309680
Myocardial depression 38.21 9.61 25 244693 425 50359981
Constipation 37.44 9.61 1169 243549 184539 50175867
Product dose omission issue 37.18 9.61 645 244073 183193 50177213
C-reactive protein abnormal 37.05 9.61 48 244670 27761 50332645
Coma scale abnormal 36.49 9.61 75 244643 4696 50355710
Crying 36.47 9.61 195 244523 20221 50340185
Irritable bowel syndrome 36.41 9.61 127 244591 51314 50309092
Decorticate posture 36.38 9.61 21 244697 282 50360124
Small intestinal obstruction 36.22 9.61 164 244554 15904 50344502
Nightmare 36.13 9.61 164 244554 15922 50344484
Insomnia 36.11 9.61 1104 243614 173761 50186645
C-reactive protein increased 35.97 9.61 182 244536 66292 50294114
Myoclonus 35.90 9.61 152 244566 14318 50346088
Skin necrosis 35.79 9.61 5 244713 10862 50349544
Alcohol abuse 35.67 9.61 45 244673 1856 50358550
Disorganised speech 35.47 9.61 33 244685 958 50359448
Injection site swelling 35.36 9.61 95 244623 41678 50318728
Abortion spontaneous 35.36 9.61 95 244623 41677 50318729
Encephalopathy 35.05 9.61 281 244437 33430 50326976
Hallucination, visual 34.99 9.61 166 244552 16416 50343990
Victim of sexual abuse 34.89 9.61 25 244693 496 50359910
Cytomegalovirus infection 34.66 9.61 22 244696 17940 50342466
Panic attack 34.05 9.61 184 244534 19158 50341248
Multiple-drug resistance 33.93 9.61 59 244659 3255 50357151
Headache 33.77 9.61 2056 242662 504479 49855927
Swollen joint count increased 33.42 9.61 15 244703 14858 50345548
Drug use disorder 33.17 9.61 56 244662 3016 50357390
Toxic epidermal necrolysis 32.58 9.61 32 244686 20960 50339446
Inflammation 32.42 9.61 153 244565 56759 50303647
Dysphagia 32.39 9.61 541 244177 76977 50283429
Nicotine dependence 31.90 9.61 26 244692 629 50359777
Exposure during pregnancy 31.57 9.61 404 244314 120611 50239795
Blood prolactin increased 31.50 9.61 55 244663 3044 50357362
Feeling jittery 31.48 9.61 122 244596 11038 50349368
Emotional disorder 31.46 9.61 127 244591 11709 50348697
Disturbance in attention 30.83 9.61 257 244461 30929 50329477
Erythema 30.79 9.61 510 244208 145904 50214502
Pallor 30.79 9.61 205 244513 22994 50337412
Cerebral microhaemorrhage 30.78 9.61 13 244705 83 50360323
Anaphylactic shock 29.83 9.61 32 244686 20123 50340283
Computerised tomogram thorax abnormal 29.62 9.61 35 244683 1348 50359058
Oral pain 29.57 9.61 215 244503 24818 50335588
Parkinsonism 29.41 9.61 102 244616 8745 50351661
Hyperammonaemic encephalopathy 29.37 9.61 42 244676 1957 50358449
Hyperhidrosis 29.31 9.61 601 244117 88825 50271581
Pulseless electrical activity 29.25 9.61 86 244632 6755 50353651
Aspiration 29.24 9.61 105 244613 9159 50351247
Feeling of body temperature change 29.20 9.61 65 244653 4302 50356104
Drug eruption 29.18 9.61 43 244675 23563 50336843
Lethargy 28.99 9.61 366 244352 49066 50311340
Psychiatric decompensation 28.89 9.61 33 244685 1225 50359181
Intentional product misuse 28.69 9.61 349 244369 46385 50314021
Accidental exposure to product by child 28.61 9.61 30 244688 1010 50359396
Restless legs syndrome 28.51 9.61 152 244566 15745 50344661
Loss of personal independence in daily activities 28.37 9.61 210 244508 69840 50290566
Blood pH decreased 28.18 9.61 46 244672 2409 50357997
Injection site bruising 27.93 9.61 88 244630 36680 50323726
Apnoea 27.36 9.61 85 244633 6881 50353525
Pancreatic fibrosis 27.25 9.61 12 244706 86 50360320
Skin ulcer 27.20 9.61 84 244634 35234 50325172
Adverse event 27.13 9.61 114 244604 43649 50316757
Respiratory acidosis 26.95 9.61 77 244641 5951 50354455
Plasma cell myeloma 26.76 9.61 250 244468 31072 50329334
Electroencephalogram abnormal 26.76 9.61 55 244663 3444 50356962
Live birth 26.65 9.61 24 244694 16384 50344022
Mouth ulceration 26.65 9.61 60 244658 27964 50332442
Granulocytopenia 26.55 9.61 70 244648 5161 50355245
Hyperreflexia 26.50 9.61 69 244649 5049 50355357
Mental impairment 26.46 9.61 122 244596 11922 50348484
Red blood cell sedimentation rate abnormal 26.44 9.61 24 244694 16319 50344087
Renal ischaemia 26.05 9.61 22 244696 560 50359846
Macrocytosis 25.94 9.61 41 244677 2089 50358317
Hepatic function abnormal 25.69 9.61 77 244641 32604 50327802
Aphasia 25.65 9.61 230 244488 28264 50332142
Basal cell carcinoma 25.64 9.61 46 244672 23310 50337096
Morbid thoughts 25.32 9.61 21 244697 521 50359885
Accidental overdose 24.96 9.61 171 244547 19362 50341044
Hypotension 24.83 9.61 1384 243334 234085 50126321
Hypochloraemia 24.78 9.61 35 244683 1612 50358794
Acute psychosis 24.68 9.61 41 244677 2179 50358227
PCO2 increased 24.60 9.61 29 244689 1114 50359292
Coma scale 24.53 9.61 9 244709 37 50360369
Mitochondrial encephalomyopathy 24.49 9.61 8 244710 21 50360385
Atelectasis 23.98 9.61 161 244557 18109 50342297
Encephalitis autoimmune 23.95 9.61 30 244688 1228 50359178
Intentional product use issue 23.87 9.61 247 244471 76671 50283735
Urticaria 23.24 9.61 464 244254 129097 50231309
Bradypnoea 23.13 9.61 48 244670 3026 50357380
PO2 increased 23.13 9.61 24 244694 798 50359608
Hypertonia 23.12 9.61 56 244662 3917 50356489
Cataract 23.10 9.61 134 244584 47166 50313240
Haematotoxicity 23.02 9.61 5 244713 7890 50352516
Homicide 22.98 9.61 17 244701 355 50360051
Respiratory distress 22.95 9.61 237 244481 30252 50330154
Myelosuppression 22.90 9.61 19 244699 13498 50346908
Echolalia 22.82 9.61 13 244705 170 50360236
Mood altered 22.81 9.61 122 244596 12651 50347755
Foot deformity 22.78 9.61 36 244682 19174 50341232
Neurosensory hypoacusis 22.74 9.61 14 244704 213 50360193
Menstrual disorder 22.71 9.61 59 244659 4311 50356095
Schizophreniform disorder 22.67 9.61 10 244708 72 50360334
Obsessive-compulsive disorder 22.65 9.61 50 244668 3290 50357116
Gastrointestinal disorder 22.58 9.61 321 244397 94135 50266271
Generalised tonic-clonic seizure 22.48 9.61 210 244508 26100 50334306
Withdrawal catatonia 22.35 9.61 9 244709 50 50360356
Malaise 22.11 9.61 1363 243355 334169 50026237
Hypophagia 22.05 9.61 218 244500 27510 50332896
Pneumocystis jirovecii pneumonia 22.02 9.61 23 244695 14640 50345766
Osteoporosis 21.99 9.61 127 244591 44752 50315654
Poisoning deliberate 21.92 9.61 86 244632 7826 50352580
Renal impairment 21.86 9.61 247 244471 75414 50284992
Screaming 21.83 9.61 46 244672 2932 50357474
Blood creatine phosphokinase increased 21.80 9.61 209 244509 26158 50334248
Bradycardia 21.78 9.61 435 244283 63991 50296415
Femur fracture 21.76 9.61 100 244618 37364 50323042
Bipolar disorder 21.68 9.61 77 244641 6680 50353726
Antipsychotic drug level increased 21.61 9.61 47 244671 3062 50357344
Communication disorder 21.53 9.61 39 244679 2222 50358184
Ataxia 21.52 9.61 127 244591 13659 50346747
Patient uncooperative 21.39 9.61 12 244706 152 50360254
Behaviour disorder 21.34 9.61 40 244678 2340 50358066
Ear infection 21.28 9.61 60 244658 25910 50334496
Change of bowel habit 21.26 9.61 34 244684 1750 50358656
Wrong patient received product 21.09 9.61 33 244685 1667 50358739
Homicidal ideation 21.06 9.61 33 244685 1669 50358737
Ventricular hypokinesia 20.96 9.61 54 244664 3926 50356480
Asthenia 20.94 9.61 1803 242915 317239 50043167
Failure to thrive 20.87 9.61 73 244645 6285 50354121
Muscle disorder 20.86 9.61 57 244661 4293 50356113
Emotional distress 20.72 9.61 221 244497 28442 50331964
Leukocytosis 20.70 9.61 183 244535 22396 50338010
Myocardial fibrosis 20.61 9.61 21 244697 683 50359723
Grip strength decreased 20.58 9.61 17 244701 12104 50348302
Skin maceration 20.55 9.61 8 244710 40 50360366
Tremor neonatal 20.49 9.61 10 244708 93 50360313
Wrong drug 20.35 9.61 11 244707 129 50360277
Neutropenic sepsis 20.35 9.61 23 244695 14124 50346282
Tenosynovitis 20.30 9.61 13 244705 10552 50349854
Osteoarthritis 20.20 9.61 223 244495 68383 50292023
Psychomotor skills impaired 20.16 9.61 36 244682 2028 50358378
Vomiting 20.16 9.61 2533 242185 458225 49902181
Sacroiliitis 20.07 9.61 41 244677 2556 50357850
Major depression 20.03 9.61 76 244642 6808 50353598
Sputum purulent 20.01 9.61 24 244694 939 50359467
Blood bicarbonate decreased 19.86 9.61 42 244676 2683 50357723
Alcohol use 19.75 9.61 35 244683 1960 50358446
Mean cell haemoglobin increased 19.52 9.61 37 244681 2183 50358223
Solar urticaria 19.36 9.61 8 244710 48 50360358
Refusal of treatment by patient 19.24 9.61 61 244657 4992 50355414
Protein C increased 19.13 9.61 10 244708 109 50360297
Haemophagocytic lymphohistiocytosis 18.94 9.61 9 244709 8624 50351782
Pulmonary embolism 18.86 9.61 634 244084 101070 50259336
Death 18.80 9.61 1822 242896 323557 50036849
Device issue 18.79 9.61 43 244675 19929 50340477
Depressed mood 18.72 9.61 249 244469 33774 50326632
Muscle spasticity 18.72 9.61 34 244684 17150 50343256
Panniculitis 18.45 9.61 9 244709 8494 50351912
Alcohol poisoning 18.37 9.61 32 244686 1768 50358638
Urinary incontinence 18.34 9.61 213 244505 27995 50332411
Affective disorder 18.34 9.61 61 244657 5120 50355286
Rapid eye movements sleep abnormal 18.30 9.61 10 244708 120 50360286
Alcoholism 18.12 9.61 30 244688 1590 50358816
Joint injury 18.10 9.61 50 244668 21739 50338667
Abdominal pain 18.08 9.61 1351 243367 234877 50125529
Galactorrhoea 18.07 9.61 49 244669 3674 50356732
Drop attacks 18.04 9.61 19 244699 643 50359763
Rhesus antigen positive 18.01 9.61 10 244708 124 50360282
Persistent left superior vena cava 17.98 9.61 7 244711 35 50360371
Device difficult to use 17.88 9.61 13 244705 9873 50350533
Phagophobia 17.82 9.61 7 244711 36 50360370
Thymus disorder 17.75 9.61 12 244706 216 50360190
Hypotonia 17.58 9.61 82 244636 8052 50352354
Metabolic alkalosis 17.53 9.61 40 244678 2691 50357715
Staring 17.44 9.61 28 244690 1446 50358960
Self-medication 17.42 9.61 36 244682 2263 50358143
Tendonitis 17.36 9.61 34 244684 16671 50343735
Monocyte count decreased 17.29 9.61 32 244686 1854 50358552
Suspected suicide attempt 17.14 9.61 9 244709 99 50360307
Pregnancy 17.14 9.61 79 244639 29498 50330908
Hyperchloraemia 17.14 9.61 19 244699 682 50359724
Metabolic encephalopathy 16.99 9.61 59 244659 5062 50355344
Neonatal behavioural syndrome 16.94 9.61 7 244711 42 50360364
Gastrointestinal sounds abnormal 16.81 9.61 47 244671 3587 50356819
Delusion of grandeur 16.78 9.61 10 244708 143 50360263
Inappropriate antidiuretic hormone secretion 16.76 9.61 115 244603 13028 50347378
Hypokalaemia 16.69 9.61 550 244168 87442 50272964
Computerised tomogram thorax 16.66 9.61 10 244708 145 50360261
Autonomic nervous system imbalance 16.51 9.61 36 244682 2349 50358057
Anxiety disorder 16.50 9.61 47 244671 3626 50356780
Premature delivery 16.35 9.61 59 244659 23604 50336802
Paralysis 16.33 9.61 84 244634 8580 50351826
Compartment syndrome 16.16 9.61 32 244686 1950 50358456
Tracheal atresia 16.10 9.61 6 244712 26 50360380
Hypervigilance 16.07 9.61 13 244705 311 50360095
Device use error 16.05 9.61 3 244715 5263 50355143
Hyperprolactinaemia 16.04 9.61 44 244674 3321 50357085
Logorrhoea 16 9.61 35 244683 2289 50358117
Asthma 16.00 9.61 320 244398 89017 50271389
Cardiac failure 15.93 9.61 265 244453 75775 50284631
Dementia 15.90 9.61 132 244586 15865 50344541
Uveitis 15.88 9.61 13 244705 9297 50351109
Atonic seizures 15.68 9.61 17 244701 595 50359811
Pruritus allergic 15.68 9.61 23 244695 1097 50359309
Cardiac malposition 15.57 9.61 7 244711 53 50360353
Immunodeficiency 15.57 9.61 30 244688 14798 50345608
Suspected suicide 15.47 9.61 59 244659 5298 50355108
No adverse event 15.41 9.61 97 244621 33481 50326925
Angioedema 15.23 9.61 113 244605 37563 50322843
Respiratory alkalosis 15.19 9.61 36 244682 2483 50357923
Platelet production decreased 15.12 9.61 4 244714 3 50360403
Anomalous pulmonary venous connection 15.04 9.61 7 244711 58 50360348
Upper respiratory tract infection 15.03 9.61 226 244492 65672 50294734
Central nervous system necrosis 15.02 9.61 9 244709 130 50360276
Nausea 14.94 9.61 3733 240985 701665 49658741
Bone density decreased 14.87 9.61 19 244699 11056 50349350
Psychotic behaviour 14.83 9.61 16 244702 557 50359849
Apathy 14.80 9.61 74 244644 7474 50352932
Blood sodium decreased 14.80 9.61 162 244556 20985 50339421
Therapy cessation 14.77 9.61 70 244648 25941 50334465
Unintentional medical device removal 14.75 9.61 4 244714 5431 50354975
Device malfunction 14.68 9.61 32 244686 15089 50345317
Morose 14.66 9.61 6 244712 35 50360371
Squamous cell carcinoma of the oral cavity 14.63 9.61 12 244706 293 50360113
Acute generalised exanthematous pustulosis 14.61 9.61 13 244705 8925 50351481
Electrocardiogram T wave abnormal 14.47 9.61 33 244685 2220 50358186
Tooth hypoplasia 14.45 9.61 7 244711 64 50360342
Product complaint 14.43 9.61 100 244618 11366 50349040
Visceral congestion 14.39 9.61 12 244706 300 50360106
Skin reaction 14.37 9.61 21 244697 11547 50348859
Respiratory disorder 14.36 9.61 90 244628 31097 50329309
Anger 14.35 9.61 99 244619 11234 50349172
Transient aphasia 14.25 9.61 6 244712 38 50360368
Joint stiffness 14.20 9.61 87 244631 30221 50330185
Diaphragmatic rupture 14.15 9.61 11 244707 248 50360158
Loss of libido 14.15 9.61 23 244695 1200 50359206
Lupus-like syndrome 14.12 9.61 15 244703 9476 50350930
Sleep disorder 14.12 9.61 370 244348 56913 50303493
Hepatocellular injury 14.05 9.61 71 244647 25876 50334530
pH urine increased 14.04 9.61 13 244705 375 50360031
Cough 14.01 9.61 991 243727 240273 50120133
Vision blurred 14.00 9.61 488 244230 78159 50282247
Oppositional defiant disorder 13.99 9.61 6 244712 40 50360366
Joint effusion 13.97 9.61 26 244692 12995 50347411
Ductus arteriosus premature closure 13.93 9.61 12 244706 314 50360092
Areflexia 13.90 9.61 37 244681 2743 50357663
Osteonecrosis of jaw 13.90 9.61 96 244622 32430 50327976
Brain death 13.88 9.61 37 244681 2746 50357660
Deep vein thrombosis 13.85 9.61 458 244260 72846 50287560
Nervousness 13.85 9.61 199 244519 27452 50332954
Balance disorder 13.84 9.61 443 244275 70147 50290259
Schizoaffective disorder 13.82 9.61 32 244686 2174 50358232
Suicidal behaviour 13.69 9.61 33 244685 2301 50358105
Irritability 13.61 9.61 203 244515 28223 50332183
Polyarthritis 13.60 9.61 11 244707 7916 50352490
Muscle twitching 13.60 9.61 124 244594 15307 50345099
Oxygen saturation abnormal 13.55 9.61 36 244682 2666 50357740
Injection site rash 13.53 9.61 37 244681 16140 50344266
Pressure of speech 13.52 9.61 15 244703 539 50359867
Therapeutic product ineffective 13.51 9.61 23 244695 1247 50359159
Bulimia nervosa 13.51 9.61 13 244705 394 50360012
Laryngitis 13.50 9.61 20 244698 10936 50349470
Liver disorder 13.49 9.61 115 244603 37107 50323299
Inappropriate affect 13.42 9.61 18 244700 789 50359617
Cognitive disorder 13.31 9.61 293 244425 43830 50316576
Secondary immunodeficiency 13.29 9.61 22 244696 1166 50359240
Hypotonia neonatal 13.28 9.61 20 244698 977 50359429
Drug screen false positive 13.21 9.61 18 244700 801 50359605
Pleurothotonus 13.11 9.61 23 244695 1278 50359128
Vasoconstriction 13.07 9.61 14 244704 483 50359923
Drug tolerance decreased 13.06 9.61 15 244703 9145 50351261
Antidepressant drug level below therapeutic 13.01 9.61 3 244715 0 50360406
Thinking abnormal 12.97 9.61 85 244633 9482 50350924
Ulcer 12.90 9.61 52 244666 20148 50340258
Induced abortion failed 12.88 9.61 10 244708 225 50360181
Cyanosis 12.87 9.61 121 244597 15063 50345343
Vulvar basal cell carcinoma 12.85 9.61 5 244713 25 50360381
Euthanasia 12.85 9.61 5 244713 25 50360381
Gastrooesophageal reflux disease 12.81 9.61 471 244247 75957 50284449
Therapy interrupted 12.79 9.61 52 244666 20100 50340306
Cerebellar haematoma 12.77 9.61 12 244706 353 50360053
Drug level increased 12.75 9.61 146 244572 19122 50341284
Neutrophil Pelger-Huet anomaly present 12.74 9.61 7 244711 85 50360321
Congenital pneumonia 12.68 9.61 4 244714 9 50360397
Inappropriate schedule of product administration 12.65 9.61 258 244460 71573 50288833
Urine ketone body present 12.64 9.61 32 244686 2301 50358105
Blood creatine increased 12.64 9.61 52 244666 4835 50355571
Non-small cell lung cancer 12.63 9.61 37 244681 2900 50357506
Coeliac disease 12.62 9.61 14 244704 8671 50351735
Medication error 12.61 9.61 245 244473 35859 50324547
Incoherent 12.56 9.61 47 244671 4183 50356223
Left ventricle outflow tract obstruction 12.55 9.61 10 244708 234 50360172
Sensory loss 12.54 9.61 72 244646 7666 50352740
Myocardial reperfusion injury 12.53 9.61 5 244713 27 50360379
Tachyphrenia 12.53 9.61 22 244696 1223 50359183
Drug abuser 12.52 9.61 36 244682 2792 50357614
Carbohydrate antigen 125 increased 12.51 9.61 33 244685 2434 50357972
Surgery 12.49 9.61 90 244628 30115 50330291
Anaphylactic reaction 12.46 9.61 185 244533 53870 50306536
Disease progression 12.45 9.61 575 244143 95291 50265115
Bronchiectasis 12.45 9.61 19 244699 10264 50350142
False positive investigation result 12.44 9.61 14 244704 511 50359895
Wheezing 12.42 9.61 218 244500 61829 50298577
Fear 12.36 9.61 116 244602 14433 50345973
Enthesopathy 12.32 9.61 10 244708 7183 50353223
Hypersexuality 12.32 9.61 13 244705 441 50359965
Stereotypy 12.30 9.61 12 244706 370 50360036
Gastric ulcer 12.29 9.61 57 244661 21248 50339158
Red cell distribution width increased 12.19 9.61 77 244641 8482 50351924
Injection site warmth 12.14 9.61 31 244687 13835 50346571
Rabbit syndrome 12.12 9.61 11 244707 309 50360097
Leukopenia neonatal 12.10 9.61 5 244713 30 50360376
Toxicologic test abnormal 12.09 9.61 15 244703 608 50359798
Hypoaesthesia oral 12.02 9.61 91 244627 10637 50349769
Arterial spasm 12.01 9.61 6 244712 59 50360347
Chronic obstructive pulmonary disease 12.00 9.61 341 244377 53094 50307312
Hypopnoea 11.96 9.61 31 244687 2262 50358144
Parachute mitral valve 11.94 9.61 7 244711 97 50360309
Newborn persistent pulmonary hypertension 11.93 9.61 8 244710 142 50360264
Tachyphylaxis 11.86 9.61 10 244708 254 50360152
Hypoprolactinaemia 11.86 9.61 4 244714 12 50360394
Depressive delusion 11.86 9.61 4 244714 12 50360394
Autologous bone marrow transplantation therapy 11.86 9.61 4 244714 12 50360394
Blood immunoglobulin M decreased 11.83 9.61 16 244702 707 50359699
Fibromyalgia 11.82 9.61 293 244425 44685 50315721
Febrile bone marrow aplasia 11.81 9.61 8 244710 6303 50354103
Hypercapnia 11.79 9.61 49 244669 4578 50355828
Impaired driving ability 11.75 9.61 44 244674 3917 50356489
Hypernatraemia 11.72 9.61 61 244657 6260 50354146
Acute respiratory failure 11.70 9.61 200 244518 28582 50331824
Water intoxication 11.69 9.61 12 244706 394 50360012
Hypoxic-ischaemic encephalopathy 11.66 9.61 43 244675 3799 50356607
Drug screen negative 11.66 9.61 10 244708 260 50360146
Device dislocation 11.64 9.61 59 244659 21487 50338919
Melaena 11.62 9.61 79 244639 26785 50333621
Glaucoma 11.59 9.61 38 244680 15648 50344758
Bone marrow failure 11.57 9.61 82 244636 27542 50332864
Dependence 11.53 9.61 27 244691 1848 50358558
Basophil count increased 11.52 9.61 17 244701 815 50359591
Pleural adhesion 11.51 9.61 7 244711 104 50360302
White blood cell count decreased 11.50 9.61 682 244036 116040 50244366
Pupillary reflex impaired 11.47 9.61 27 244691 1854 50358552
Disease recurrence 11.42 9.61 54 244664 20027 50340379
Respiratory rate decreased 11.36 9.61 37 244681 3071 50357335
Neuropsychiatric symptoms 11.33 9.61 14 244704 565 50359841
Gait disturbance 11.31 9.61 857 243861 149148 50211258
Bronchitis 11.29 9.61 401 244317 103758 50256648
Polydipsia 11.25 9.61 37 244681 3087 50357319
Schizoaffective disorder bipolar type 11.23 9.61 7 244711 109 50360297
Kluver-Bucy syndrome 11.19 9.61 4 244714 15 50360391
Gallbladder disorder 11.14 9.61 127 244591 16615 50343791
Drug diversion 11.13 9.61 16 244702 749 50359657
Lymphocyte count decreased 11.13 9.61 184 244534 26123 50334283
Periorbital haemorrhage 11.12 9.61 6 244712 70 50360336
Delusional perception 11.10 9.61 9 244709 216 50360190
Blood magnesium decreased 11.04 9.61 92 244626 11068 50349338
Haemoglobin urine 11.01 9.61 7 244711 113 50360293
Incision site complication 11.01 9.61 14 244704 582 50359824
Natural killer cell count 10.99 9.61 4 244714 16 50360390
Amegakaryocytic thrombocytopenia 10.99 9.61 4 244714 16 50360390
Eczema eyelids 10.96 9.61 7 244711 114 50360292
Patient restraint 10.95 9.61 3 244715 3 50360403
Benzodiazepine drug level 10.95 9.61 3 244715 3 50360403
Anti-neuronal antibody positive 10.95 9.61 3 244715 3 50360403
Antidepressant drug level decreased 10.95 9.61 3 244715 3 50360403
Rash pruritic 10.94 9.61 164 244554 47682 50312724
Tuberculosis 10.94 9.61 20 244698 10063 50350343
Pathogen resistance 10.93 9.61 7 244711 5682 50354724
Finger deformity 10.91 9.61 7 244711 5675 50354731
Waxy flexibility 10.91 9.61 7 244711 115 50360291
Osteoradionecrosis 10.91 9.61 7 244711 115 50360291
Blood albumin increased 10.87 9.61 17 244701 858 50359548
Systolic hypertension 10.84 9.61 12 244706 430 50359976
Drug resistance 10.84 9.61 51 244667 18938 50341468
Limbic encephalitis 10.83 9.61 9 244709 224 50360182
Dysmetropsia 10.77 9.61 6 244712 75 50360331
Inflammatory marker increased 10.73 9.61 7 244711 5627 50354779
Liver injury 10.71 9.61 73 244645 24733 50335673
Injection site haemorrhage 10.68 9.61 60 244658 21286 50339120
Wound infection fungal 10.65 9.61 7 244711 120 50360286
On and off phenomenon 10.57 9.61 22 244696 1390 50359016
Cardiac failure congestive 10.53 9.61 319 244399 84063 50276343
Oropharyngeal swelling 10.49 9.61 16 244702 790 50359616
Abortion spontaneous complete 10.49 9.61 3 244715 4 50360402
Platelet morphology abnormal 10.49 9.61 3 244715 4 50360402
Tri-iodothyronine free decreased 10.48 9.61 10 244708 300 50360106
Antidepressant drug level above therapeutic 10.45 9.61 11 244707 372 50360034
Affective ambivalence 10.44 9.61 4 244714 19 50360387
Disinhibition 10.43 9.61 16 244702 794 50359612
Tongue movement disturbance 10.40 9.61 9 244709 237 50360169
Hyponatraemic syndrome 10.40 9.61 13 244705 531 50359875
Cerebral atrophy 10.40 9.61 47 244671 4554 50355852
Reversible cerebral vasoconstriction syndrome 10.39 9.61 28 244690 2091 50358315
Wrong strength 10.39 9.61 5 244713 45 50360361
Apallic syndrome 10.35 9.61 14 244704 619 50359787
Benzodiazepine drug level increased 10.35 9.61 8 244710 179 50360227
Cyclic vomiting syndrome 10.29 9.61 5 244713 46 50360360
Foot operation 10.29 9.61 7 244711 5503 50354903
Gallbladder cholesterolosis 10.20 9.61 15 244703 717 50359689
Floppy infant 10.18 9.61 6 244712 84 50360322
Hypomania 10.17 9.61 46 244672 4459 50355947
Patent ductus arteriosus 10.16 9.61 41 244677 3779 50356627
Scleral haemorrhage 10.12 9.61 4 244714 21 50360385
Impaired work ability 10.11 9.61 33 244685 13607 50346799
Urine abnormality 10.08 9.61 58 244660 6180 50354226
Hyperthyroidism 10.07 9.61 28 244690 12147 50348259
Neutrophil count increased 10.05 9.61 109 244609 14086 50346320
Genital herpes simplex 10.01 9.61 8 244710 188 50360218
Ear pain 9.97 9.61 88 244630 28195 50332211
Culture urine positive 9.96 9.61 38 244680 3413 50356993
Antidepressant drug level increased 9.94 9.61 9 244709 252 50360154
Drug clearance decreased 9.92 9.61 19 244699 1130 50359276
Cholangitis infective 9.91 9.61 8 244710 191 50360215
Panic disorder 9.89 9.61 29 244689 2274 50358132
Intestinal strangulation 9.88 9.61 6 244712 89 50360317
Oedema 9.86 9.61 261 244457 69920 50290486
Amnesia 9.85 9.61 271 244447 41989 50318417
Macrophages increased 9.82 9.61 4 244714 23 50360383
Hepatic cytolysis 9.78 9.61 15 244703 8088 50352318
Crush injury 9.74 9.61 3 244715 6 50360400
Brain herniation 9.72 9.61 35 244683 3057 50357349
Sciatica 9.69 9.61 62 244656 21320 50339086
Dysaesthesia pharynx 9.68 9.61 7 244711 141 50360265
Morbihan disease 9.68 9.61 4 244714 24 50360382
Malnutrition 9.68 9.61 102 244616 13087 50347319
Impaired quality of life 9.67 9.61 9 244709 6047 50354359
Posture abnormal 9.65 9.61 27 244691 2062 50358344

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
Sopor 788.36 10.11 542 138106 10392 29425487
Drug abuse 370.00 10.11 1012 137636 78871 29357008
Agitation 353.59 10.11 758 137890 50546 29385333
Neuroleptic malignant syndrome 331.98 10.11 394 138254 15754 29420125
Bradyphrenia 289.82 10.11 203 138445 4011 29431868
Catatonia 285.97 10.11 206 138442 4262 29431617
Intentional self-injury 272.73 10.11 314 138334 12147 29423732
Sedation 250.31 10.11 356 138292 17049 29418830
Aggression 227.58 10.11 510 138138 35031 29400848
Completed suicide 217.08 10.11 918 137730 89328 29346551
Suicide attempt 215.64 10.11 487 138161 33623 29402256
Psychotic disorder 203.14 10.11 352 138296 20002 29415877
Somnolence 200.40 10.11 922 137726 93033 29342846
Delirium 187.01 10.11 504 138144 38893 29396986
Anxiety 154.20 10.11 799 137849 84566 29351313
Schizophrenia 141.23 10.11 164 138484 6401 29429478
Confusional state 140.40 10.11 1053 137595 126824 29309055
Extrapyramidal disorder 130.56 10.11 204 138444 10627 29425252
Hallucination, auditory 118.87 10.11 183 138465 9410 29426469
Drug dependence 118.82 10.11 287 138361 20694 29415185
Drug withdrawal syndrome 118.36 10.11 261 138387 17723 29418156
Intentional overdose 116.09 10.11 421 138227 38107 29397772
Dysarthria 113.58 10.11 361 138287 30550 29405329
Restlessness 109.79 10.11 288 138360 21857 29414022
Interstitial lung disease 107.45 10.11 69 138579 57649 29378230
Overdose 107.39 10.11 691 137957 79128 29356751
Muscle rigidity 100.80 10.11 168 138480 9243 29426636
Suicidal ideation 93.51 10.11 366 138282 34350 29401529
Mental status changes 93.09 10.11 367 138281 34560 29401319
Respiratory depression 82 10.11 190 138458 13333 29422546
Abnormal behaviour 79.45 10.11 264 138384 22863 29413016
Parkinsonism 78.05 10.11 130 138518 7148 29428731
Tachycardia 75.82 10.11 590 138058 71820 29364059
Toxicity to various agents 75.59 10.11 1188 137460 172473 29263406
Depressed level of consciousness 70.25 10.11 351 138297 36591 29399288
Disorientation 69.85 10.11 299 138349 29216 29406663
Akathisia 69.08 10.11 118 138530 6624 29429255
Acute kidney injury 68.06 10.11 857 137791 264410 29171469
Delusion 67.36 10.11 157 138491 11059 29424820
Joint swelling 65.23 10.11 82 138566 49548 29386331
Bradykinesia 64.13 10.11 80 138568 3367 29432512
Renal impairment 60.49 10.11 188 138460 81145 29354734
Granulocytopenia 58.91 10.11 103 138545 5891 29429988
Unresponsive to stimuli 57.50 10.11 252 138396 24874 29411005
Withdrawal syndrome 55.54 10.11 144 138504 10848 29425031
Seizure 54.18 10.11 671 137977 92452 29343427
Speech disorder 53.93 10.11 236 138412 23280 29412599
Mental impairment 53.85 10.11 127 138521 9014 29426865
Hallucination 52.84 10.11 375 138273 44337 29391542
Rheumatoid arthritis 52.60 10.11 44 138604 32108 29403771
Anaemia 52.29 10.11 647 138001 200304 29235575
Psychomotor hyperactivity 51.56 10.11 117 138531 8096 29427783
Paranoia 50.53 10.11 130 138518 9747 29426132
Product dose omission issue 49.97 10.11 257 138391 96126 29339753
Ataxia 49.71 10.11 147 138501 11956 29423923
Dystonia 48.52 10.11 127 138521 9622 29426257
Psoriasis 48.08 10.11 48 138600 32179 29403700
Electrocardiogram QT prolonged 47.40 10.11 311 138337 35826 29400053
Major depression 47.28 10.11 73 138575 3762 29432117
Dyskinesia 47.28 10.11 203 138445 19858 29416021
Cytomegalovirus infection 47.09 10.11 25 138623 23190 29412689
Refusal of treatment by patient 46.57 10.11 81 138567 4613 29431266
Blood creatine phosphokinase increased 45.78 10.11 337 138311 40307 29395572
Sedation complication 45.67 10.11 42 138606 1240 29434639
Poverty of speech 45.24 10.11 22 138626 210 29435669
Hypokinesia 44.55 10.11 105 138543 7449 29428430
Treatment failure 44.52 10.11 65 138583 36874 29399005
Drug ineffective 44.12 10.11 1332 137316 361838 29074041
COVID-19 43.77 10.11 63 138585 35951 29399928
Miosis 43.67 10.11 108 138540 7901 29427978
Pruritus 43.43 10.11 345 138303 116504 29319375
Peripheral swelling 42.15 10.11 155 138493 63584 29372295
Hyperkalaemia 40.79 10.11 149 138499 61243 29374636
Stupor 40.72 10.11 57 138591 2687 29433192
Salivary hypersecretion 40.49 10.11 100 138548 7309 29428570
Arthralgia 40.36 10.11 439 138209 139178 29296701
Myelosuppression 40.14 10.11 5 138643 12222 29423657
Multiple organ dysfunction syndrome 40.10 10.11 156 138492 62960 29372919
Serotonin syndrome 39.58 10.11 175 138473 17337 29418542
Sinus tachycardia 39.05 10.11 157 138491 14912 29420967
Antipsychotic drug level increased 38.96 10.11 61 138587 3182 29432697
Visceral congestion 38.53 10.11 26 138622 482 29435397
Homicide 38.22 10.11 33 138615 895 29434984
Withdrawal catatonia 38.05 10.11 15 138633 81 29435798
Gait spastic 37.84 10.11 29 138619 661 29435218
Psoriatic arthropathy 37.71 10.11 11 138637 14680 29421199
Hepatic function abnormal 37.43 10.11 80 138568 39179 29396700
Self-injurious ideation 37.19 10.11 41 138607 1510 29434369
Irritability 36.95 10.11 203 138445 21949 29413930
Drug screen positive 36.94 10.11 65 138583 3736 29432143
Needle fatigue 36.88 10.11 27 138621 573 29435306
Psychotic symptom 36.75 10.11 39 138609 1375 29434504
Coma 36.69 10.11 313 138335 39137 29396742
Dysphoria 36.46 10.11 47 138601 2045 29433834
Movement disorder 36.17 10.11 118 138530 10119 29425760
Depression 36.00 10.11 580 138068 84567 29351312
Drug reaction with eosinophilia and systemic symptoms 36.00 10.11 47 138601 27945 29407934
Confabulation 35.87 10.11 16 138632 123 29435756
Dyspnoea 34.71 10.11 1219 137429 325513 29110366
Victim of child abuse 34.70 10.11 30 138618 815 29435064
Synovitis 34.44 10.11 5 138643 10885 29424994
Bone marrow failure 34.37 10.11 47 138601 27402 29408477
Diet refusal 34.19 10.11 20 138628 285 29435594
Treatment noncompliance 33.92 10.11 212 138436 24015 29411864
Cardiac failure congestive 33.86 10.11 215 138433 76366 29359513
Drug withdrawal convulsions 33.74 10.11 34 138614 1127 29434752
Hyperammonaemic encephalopathy 33.58 10.11 44 138604 1946 29433933
Negativism 32.85 10.11 21 138627 354 29435525
Cardiac failure 32.84 10.11 227 138421 79060 29356819
Status epilepticus 32.53 10.11 118 138530 10676 29425203
Respiratory arrest 32.47 10.11 220 138428 25613 29410266
Relapsing-remitting multiple sclerosis 32.13 10.11 27 138621 705 29435174
Insomnia 31.88 10.11 589 138059 88172 29347707
Myocardial infarction 31.78 10.11 347 138301 109949 29325930
Cholestasis 31.62 10.11 38 138610 23424 29412455
Drug interaction 30.75 10.11 1173 137475 196212 29239667
Anaphylactic shock 30.72 10.11 12 138636 13324 29422555
Off label use 30.62 10.11 1128 137520 299672 29136207
Oropharyngeal spasm 30.51 10.11 15 138633 147 29435732
Oral discharge 30.39 10.11 14 138634 117 29435762
Amnesia 30.38 10.11 196 138452 22447 29413432
Tremor 30.36 10.11 499 138149 73039 29362840
Hypersensitivity 30.35 10.11 136 138512 52767 29383112
Affect lability 30.29 10.11 56 138592 3346 29432533
Acute myocardial infarction 29.95 10.11 121 138527 48317 29387562
Pneumonia aspiration 29.82 10.11 283 138365 36454 29399425
Febrile neutropenia 29.64 10.11 712 137936 111528 29324351
Gastrointestinal haemorrhage 29.45 10.11 235 138413 79298 29356581
Rash 29.34 10.11 672 137976 189147 29246732
Mental disorder 29.19 10.11 129 138519 12776 29423103
Hangover 29.10 10.11 29 138619 948 29434931
Psychotic behaviour 29.10 10.11 24 138624 610 29435269
Poisoning 29.07 10.11 108 138540 9885 29425994
Psychomotor retardation 29.06 10.11 51 138597 2925 29432954
Drug resistance 28.91 10.11 35 138613 21505 29414374
Pain in extremity 28.87 10.11 355 138293 110078 29325801
Mutism 28.53 10.11 25 138623 692 29435187
Antipsychotic drug level decreased 28.14 10.11 27 138621 842 29435037
Paradoxical drug reaction 28.11 10.11 48 138600 2693 29433186
Haematuria 28.09 10.11 109 138539 44030 29391849
Pleurothotonus 27.63 10.11 29 138619 1009 29434870
Incoherent 27.61 10.11 60 138588 4032 29431847
Parathyroid gland enlargement 27.39 10.11 13 138635 117 29435762
Lethargy 26.87 10.11 282 138366 37298 29398581
Impulsive behaviour 26.83 10.11 39 138609 1904 29433975
Sexually inappropriate behaviour 26.79 10.11 19 138629 383 29435496
Substance abuse 26.51 10.11 81 138567 6706 29429173
Parkinsonian gait 26.40 10.11 20 138628 448 29435431
Rhinitis perennial 26.32 10.11 15 138633 203 29435676
Upper respiratory fungal infection 26.30 10.11 13 138635 129 29435750
Diarrhoea 26.23 10.11 1284 137364 331414 29104465
Multiple drug therapy 25.98 10.11 18 138630 349 29435530
Angioedema 25.72 10.11 71 138577 31844 29404035
Melaena 25.39 10.11 69 138579 31107 29404772
Transplant rejection 25.35 10.11 6 138642 9206 29426673
Myocardial fibrosis 25.21 10.11 28 138620 1040 29434839
Anger 24.74 10.11 109 138539 10781 29425098
Logorrhoea 24.71 10.11 41 138607 2247 29433632
Muscle spasticity 24.70 10.11 64 138584 4819 29431060
Coronary artery disease 24.51 10.11 115 138533 44075 29391804
Drug intolerance 24.49 10.11 130 138518 48249 29387630
Injection site pain 24.10 10.11 75 138573 32371 29403508
Mania 23.85 10.11 92 138556 8571 29427308
Forced expiratory volume 23.67 10.11 11 138637 94 29435785
Panic reaction 23.64 10.11 30 138618 1285 29434594
Delusion of grandeur 23.54 10.11 18 138630 409 29435470
Micturition urgency 23.34 10.11 65 138583 5108 29430771
Hypoglycaemia 23.32 10.11 132 138516 48214 29387665
Adjustment disorder 23.21 10.11 26 138622 975 29434904
Pathogen resistance 22.91 10.11 5 138643 8111 29427768
Hyperosmolar state 22.78 10.11 17 138631 372 29435507
Persecutory delusion 22.63 10.11 38 138610 2103 29433776
Alcohol withdrawal syndrome 22.61 10.11 30 138618 1343 29434536
Cerebrovascular accident 22.52 10.11 241 138407 76670 29359209
Anaphylactic reaction 22.47 10.11 61 138587 27512 29408367
Failure to thrive 22.31 10.11 83 138565 7601 29428278
Jaundice 22.27 10.11 67 138581 29229 29406650
Full blood count abnormal 22.04 10.11 133 138515 14880 29420999
Social avoidant behaviour 22.01 10.11 45 138603 2897 29432982
Nervousness 21.89 10.11 108 138540 11198 29424681
Thinking abnormal 21.88 10.11 64 138584 5172 29430707
Urticaria 21.88 10.11 158 138490 54502 29381377
Bipolar disorder 21.87 10.11 48 138600 3247 29432632
Priapism 21.86 10.11 58 138590 4430 29431449
Erythema 21.70 10.11 238 138410 75368 29360511
Neologism 21.60 10.11 6 138642 7 29435872
Cerebral infarction 21.33 10.11 53 138595 24622 29411257
Illusion 21.21 10.11 21 138627 681 29435198
Prostate cancer 21.16 10.11 56 138592 25471 29410408
Epstein-Barr virus infection 21.07 10.11 3 138645 6626 29429253
Panic attack 20.98 10.11 86 138562 8240 29427639
Aspiration 20.97 10.11 99 138549 10081 29425798
Inappropriate antidiuretic hormone secretion 20.86 10.11 104 138544 10828 29425051
Hallucination, visual 20.77 10.11 131 138517 14884 29420995
Arthritis 20.65 10.11 55 138593 24964 29410915
Growth hormone deficiency 20.44 10.11 13 138635 217 29435662
Blood creatine phosphokinase 20.42 10.11 9 138639 67 29435812
Bladder cancer 20.40 10.11 11 138637 10116 29425763
Eczema 20.16 10.11 21 138627 13805 29422074
Communication disorder 19.90 10.11 38 138610 2327 29433552
Flight of ideas 19.83 10.11 15 138633 335 29435544
Arthropathy 19.66 10.11 45 138603 21509 29414370
Middle insomnia 19.45 10.11 65 138583 5643 29430236
Oedema peripheral 19.42 10.11 355 138293 103202 29332677
Contraindicated product administered 19.33 10.11 35 138613 18231 29417648
Orgasmic sensation decreased 19.33 10.11 8 138640 50 29435829
Blood sodium decreased 19.30 10.11 127 138521 14640 29421239
Renal disorder 19.16 10.11 49 138599 22546 29413333
Cerebral haemorrhage 19.11 10.11 79 138569 31347 29404532
Visual acuity reduced 19.10 10.11 25 138623 14851 29421028
Affective disorder 19.03 10.11 44 138604 3082 29432797
Premature ejaculation 18.88 10.11 10 138638 116 29435763
Dysphagia 18.85 10.11 362 138286 54564 29381315
Drug eruption 18.70 10.11 31 138617 16710 29419169
Pyrexia 18.55 10.11 1132 137516 286490 29149389
Intentional product misuse 18.53 10.11 246 138402 34415 29401464
Tubulointerstitial nephritis 18.49 10.11 34 138614 17609 29418270
Plasma cell myeloma 18.45 10.11 260 138388 36855 29399024
Hypertonic bladder 18.35 10.11 28 138620 1428 29434451
Atrial fibrillation 18.33 10.11 367 138281 105279 29330600
Hyperprolactinaemia 18.28 10.11 26 138622 1244 29434635
Sexual relationship change 18.22 10.11 6 138642 17 29435862
Schizoaffective disorder 18.20 10.11 24 138624 1068 29434811
Faecaloma 18.18 10.11 52 138596 4150 29431729
Memory impairment 17.94 10.11 255 138393 36215 29399664
Intentional product use issue 17.92 10.11 121 138527 42377 29393502
Sexual dysfunction 17.89 10.11 64 138584 5750 29430129
Haematuria traumatic 17.59 10.11 11 138637 178 29435701
Negative thoughts 17.56 10.11 18 138630 609 29435270
Balance disorder 17.43 10.11 252 138396 35918 29399961
Liver disorder 17.35 10.11 69 138579 27680 29408199
Haematotoxicity 17.22 10.11 5 138643 6694 29429185
Anxiolytic therapy 17.07 10.11 6 138642 22 29435857
Floppy infant 17.02 10.11 9 138639 104 29435775
Perseveration 16.95 10.11 9 138639 105 29435774
Angina pectoris 16.94 10.11 70 138578 27780 29408099
Oculogyric crisis 16.91 10.11 26 138622 1335 29434544
Neutropenic sepsis 16.88 10.11 18 138630 11709 29424170
Therapeutic product effect decreased 16.71 10.11 76 138572 29375 29406504
Staring 16.65 10.11 26 138622 1353 29434526
C-reactive protein abnormal 16.58 10.11 5 138643 6531 29429348
Monoparesis 16.54 10.11 31 138617 1872 29434007
Basal cell carcinoma 16.50 10.11 34 138614 16876 29419003
Immune reconstitution inflammatory syndrome 16.42 10.11 8 138640 7794 29428085
Haemophagocytic lymphohistiocytosis 16.42 10.11 15 138633 10489 29425390
Pulmonary fibrosis 16.36 10.11 30 138618 15552 29420327
Hyperventilation 16.35 10.11 35 138613 2327 29433552
Cough 16.23 10.11 461 138187 126266 29309613
Loss of consciousness 16.10 10.11 458 138190 73598 29362281
Myalgia 16.07 10.11 247 138401 73772 29362107
Nephropathy toxic 16.06 10.11 16 138632 10740 29425139
Altered state of consciousness 16.03 10.11 153 138495 19736 29416143
Urinary incontinence 15.97 10.11 132 138516 16349 29419530
Nasal congestion 15.97 10.11 41 138607 18838 29417041
Disturbance in attention 15.90 10.11 162 138486 21262 29414617
Homicidal ideation 15.89 10.11 36 138612 2488 29433391
Skin ulcer 15.87 10.11 41 138607 18799 29417080
Infection 15.70 10.11 259 138389 76492 29359387
Herpes zoster 15.63 10.11 80 138568 29972 29405907
Posturing 15.63 10.11 15 138633 468 29435411
Loose associations 15.56 10.11 7 138641 55 29435824
Hepatic cytolysis 15.49 10.11 10 138638 8337 29427542
Suicidal behaviour 15.47 10.11 25 138623 1340 29434539
Drug therapy enhancement 15.44 10.11 6 138642 31 29435848
Thrombocytopenia 15.41 10.11 498 138150 134325 29301554
Purple glove syndrome 15.35 10.11 7 138641 57 29435822
Pneumocystis jirovecii pneumonia 15.33 10.11 35 138613 16744 29419135
Injection site swelling 15.26 10.11 13 138635 9404 29426475
Proteinuria 15.23 10.11 32 138616 15772 29420107
Fall 15.20 10.11 994 137654 176184 29259695
Hypoxia 15.16 10.11 309 138339 47070 29388809
Polyneuropathy 15.02 10.11 21 138627 12131 29423748
Myelodysplastic syndrome 14.77 10.11 39 138609 17755 29418124
Self esteem decreased 14.77 10.11 15 138633 502 29435377
Testicular atrophy 14.77 10.11 15 138633 502 29435377
Infusion related reaction 14.74 10.11 133 138515 43753 29392126
Sleep disorder 14.71 10.11 177 138471 24209 29411670
Blood urea nitrogen/creatinine ratio decreased 14.70 10.11 6 138642 36 29435843
Fear 14.46 10.11 85 138563 9419 29426460
Pressure of speech 14.40 10.11 14 138634 444 29435435
Soliloquy 14.33 10.11 13 138635 377 29435502
Shoshin beriberi 14.20 10.11 7 138641 69 29435810
Myocarditis 14.18 10.11 94 138554 10862 29425017
Emotional disorder 14.10 10.11 53 138595 4878 29431001
Body temperature increased 14.09 10.11 116 138532 14349 29421530
Epidural lipomatosis 14.03 10.11 17 138631 694 29435185
Septic shock 13.84 10.11 208 138440 62352 29373527
Gingival oedema 13.83 10.11 4 138644 6 29435873
Coordination abnormal 13.80 10.11 68 138580 7046 29428833
Drop attacks 13.79 10.11 15 138633 544 29435335
Hepatocellular carcinoma 13.66 10.11 8 138640 7030 29428849
Hepatic failure 13.64 10.11 89 138559 31423 29404456
Renal failure 13.57 10.11 438 138210 118161 29317718
Slow speech 13.55 10.11 19 138629 897 29434982
Cognitive disorder 13.50 10.11 169 138479 23330 29412549
Derealisation 13.36 10.11 15 138633 564 29435315
Blood prolactin increased 13.34 10.11 25 138623 1509 29434370
Immunosuppressant drug level increased 13.32 10.11 3 138645 4762 29431117
Child abuse 13.31 10.11 10 138638 221 29435658
Ascites 13.18 10.11 109 138539 36510 29399369
Hepatocellular injury 13.17 10.11 53 138595 21190 29414689
Vascular stenosis 13.06 10.11 9 138639 173 29435706
Glycosylated haemoglobin increased 12.99 10.11 15 138633 9411 29426468
Generalised tonic-clonic seizure 12.92 10.11 142 138506 18997 29416882
Injection site erythema 12.84 10.11 29 138619 13927 29421952
Pneumonia 12.84 10.11 1310 137338 318862 29117017
Rebound effect 12.82 10.11 29 138619 2002 29433877
Hallucination, olfactory 12.67 10.11 9 138639 182 29435697
Rhabdomyolysis 12.65 10.11 374 138274 60434 29375445
Congenital pulmonary valve atresia 12.64 10.11 6 138642 54 29435825
Transient acantholytic dermatosis 12.59 10.11 7 138641 90 29435789
Depressed mood 12.50 10.11 125 138523 16323 29419556
Poor sucking reflex 12.45 10.11 11 138637 308 29435571
Skin necrosis 12.42 10.11 4 138644 5008 29430871
Dystonic tremor 12.42 10.11 9 138639 188 29435691
Therapeutic product effect incomplete 12.39 10.11 121 138527 39184 29396695
Hypercapnia 12.32 10.11 42 138606 3684 29432195
COVID-19 pneumonia 12.23 10.11 16 138632 9506 29426373
Electroencephalogram abnormal 12.22 10.11 31 138617 2304 29433575
Accident at work 12.10 10.11 15 138633 627 29435252
Dyspnoea exertional 12.07 10.11 111 138537 36379 29399500
Lip swelling 12.07 10.11 25 138623 12385 29423494
Cardiac disorder 12.05 10.11 114 138534 37149 29398730
Feelings of worthlessness 12.03 10.11 10 138638 257 29435622
Arachnoid cyst 12.02 10.11 9 138639 198 29435681
Peritonitis bacterial 11.97 10.11 6 138642 5750 29430129
Blood alkaline phosphatase decreased 11.96 10.11 15 138633 635 29435244
Staphylococcal infection 11.95 10.11 84 138564 29156 29406723
Chronic kidney disease 11.95 10.11 111 138537 36305 29399574
End stage renal disease 11.91 10.11 11 138637 7653 29428226
Progressive multifocal leukoencephalopathy 11.88 10.11 14 138634 8705 29427174
Drooling 11.75 10.11 36 138612 2985 29432894
Creutzfeldt-Jakob disease 11.73 10.11 5 138643 34 29435845
Echolalia 11.71 10.11 10 138638 267 29435612
Drug tolerance 11.70 10.11 29 138619 2124 29433755
Waxy flexibility 11.66 10.11 7 138641 105 29435774
Tuberculosis 11.58 10.11 10 138638 7186 29428693
Mobility decreased 11.58 10.11 72 138576 25708 29410171
Lung disorder 11.56 10.11 89 138559 30273 29405606
Gastric ulcer 11.54 10.11 31 138617 14030 29421849
Pancreatitis acute 11.53 10.11 67 138581 24318 29411561
Pulmonary tuberculosis 11.51 10.11 3 138645 4312 29431567
General physical health deterioration 11.49 10.11 381 138267 102476 29333403
Ureteric obstruction 11.45 10.11 20 138628 1143 29434736
Hepatotoxicity 11.44 10.11 44 138604 17823 29418056
Product use issue 11.39 10.11 171 138477 51273 29384606
Blood osmolarity increased 11.39 10.11 11 138637 346 29435533
Tachyphrenia 11.37 10.11 20 138628 1149 29434730
Hypertensive crisis 11.35 10.11 12 138636 7836 29428043
Blood chloride abnormal 11.31 10.11 4 138644 15 29435864
Selective mutism 11.30 10.11 6 138642 70 29435809
Impaired reasoning 11.27 10.11 7 138641 112 29435767
Nephrolithiasis 11.25 10.11 71 138577 25263 29410616
Bronchopulmonary aspergillosis allergic 11.24 10.11 13 138635 505 29435374
Impaired driving ability 11.23 10.11 30 138618 2301 29433578
Cytotoxic oedema 11.21 10.11 8 138640 163 29435716
Head injury 11.18 10.11 120 138528 15961 29419918
Tangentiality 11.16 10.11 7 138641 114 29435765
Respiratory acidosis 11.14 10.11 45 138603 4283 29431596
Device issue 11.14 10.11 12 138636 7768 29428111
Mood swings 11.13 10.11 65 138583 7186 29428693
Neonatal tachypnoea 11.12 10.11 8 138640 165 29435714
Bronchopulmonary aspergillosis 11.07 10.11 26 138622 12318 29423561
Muscle mass 11.04 10.11 9 138639 225 29435654
Thought withdrawal 11.04 10.11 3 138645 3 29435876
Anorectal operation 11.04 10.11 3 138645 3 29435876
Pulse pressure increased 11.04 10.11 3 138645 3 29435876
Skin laceration 10.93 10.11 89 138559 10973 29424906
Apnoea 10.91 10.11 57 138591 6045 29429834
Product use in unapproved indication 10.87 10.11 317 138331 86558 29349321
Injection site pruritus 10.86 10.11 7 138641 5842 29430037
Foetal exposure during pregnancy 10.78 10.11 104 138544 33763 29402116
Pharyngeal paraesthesia 10.75 10.11 12 138636 448 29435431
Hypocalcaemia 10.75 10.11 55 138593 20610 29415269
Blood potassium decreased 10.74 10.11 117 138531 15617 29420262
Thrombotic microangiopathy 10.73 10.11 15 138633 8666 29427213
Aplastic anaemia 10.69 10.11 66 138582 7444 29428435
Iatrogenic injury 10.68 10.11 15 138633 709 29435170
Malaise 10.63 10.11 626 138022 158976 29276903
Dementia with Lewy bodies 10.60 10.11 14 138634 624 29435255
Nerve degeneration 10.49 10.11 8 138640 181 29435698
Hypomania 10.48 10.11 28 138620 2147 29433732
Lactic acidosis 10.45 10.11 91 138557 30156 29405723
Frequent bowel movements 10.42 10.11 17 138631 9222 29426657
Grandiosity 10.42 10.11 10 138638 312 29435567
Genital pain 10.38 10.11 8 138640 184 29435695
Feeling jittery 10.34 10.11 39 138609 3594 29432285
Mydriasis 10.30 10.11 56 138592 6029 29429850
Blood uric acid abnormal 10.29 10.11 6 138642 85 29435794
Emotional distress 10.27 10.11 105 138543 13790 29422089
Acute coronary syndrome 10.24 10.11 27 138621 12298 29423581
Venous angioma of brain 10.24 10.11 4 138644 21 29435858
Wrong technique in product usage process 10.22 10.11 96 138552 31332 29404547
Cerebral atrophy 10.21 10.11 42 138606 4030 29431849

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
Sopor 2425.27 9.55 1610 311307 28051 64157764
Drug abuse 1401.84 9.55 2393 310524 129981 64055834
Completed suicide 760.05 9.55 2605 310312 221809 63964006
Intentional self-injury 704.87 9.55 785 312132 28259 64157556
Neuroleptic malignant syndrome 661.27 9.55 707 312210 24289 64161526
Agitation 597.84 9.55 1323 311594 87044 64098771
Bradyphrenia 584.92 9.55 432 312485 8974 64176841
Suicide attempt 537.70 9.55 1113 311804 69894 64115921
Somnolence 500.23 9.55 2135 310782 201510 63984305
Catatonia 487.42 9.55 356 312561 7264 64178551
Delirium 390.29 9.55 965 311952 68229 64117586
Overdose 384.75 9.55 1664 311253 157902 64027913
Intentional overdose 383.28 9.55 1131 311786 88813 64097002
Psychotic disorder 297.65 9.55 572 312345 34006 64151809
Drug withdrawal syndrome 290.95 9.55 535 312382 30756 64155059
Coma 283.68 9.55 1003 311914 86612 64099203
Toxicity to various agents 262.47 9.55 2806 310111 360707 63825108
Confusional state 258.44 9.55 2156 310761 258988 63926827
Aggression 252.47 9.55 637 312280 45595 64140220
Drug dependence 247.17 9.55 518 312399 32794 64153021
Sedation 235.58 9.55 580 312337 40882 64144933
Anxiety 231.12 9.55 1729 311188 200920 63984895
Restlessness 222.30 9.55 553 312364 39232 64146583
Suicidal ideation 219.01 9.55 766 312151 65776 64120039
Joint swelling 209.71 9.55 458 312459 214924 63970891
Serotonin syndrome 203.88 9.55 531 312386 38751 64147064
Poisoning 199.52 9.55 371 312546 21508 64164307
Disorientation 198.94 9.55 660 312257 55168 64130647
Contraindicated product administered 196.20 9.55 142 312775 107687 64078128
Respiratory depression 193.45 9.55 381 312536 23062 64162753
Extrapyramidal disorder 181.38 9.55 334 312583 19218 64166597
Tachycardia 181.20 9.55 1295 311622 148284 64037531
Dysarthria 178.61 9.55 664 312253 58742 64127073
Schizophrenia 177.42 9.55 244 312673 10924 64174891
Drug intolerance 176.25 9.55 408 312509 187584 63998231
Muscle rigidity 170.36 9.55 305 312612 17168 64168647
Depressed level of consciousness 168.32 9.55 812 312105 80624 64105191
Drug interaction 167.51 9.55 2575 310342 359508 63826307
Rheumatoid arthritis 164.34 9.55 344 312573 163950 64021865
Treatment failure 161.79 9.55 197 312720 116619 64069196
Akathisia 161.49 9.55 237 312680 11273 64174542
Arthropathy 161.28 9.55 210 312707 120757 64065058
Bradykinesia 160.29 9.55 178 312739 6382 64179433
Hallucination, auditory 157.93 9.55 290 312627 16649 64169166
Speech disorder 156.25 9.55 554 312363 47887 64137928
Arthralgia 155.30 9.55 1385 311532 440875 63744940
Interstitial lung disease 149.39 9.55 152 312765 97580 64088235
Drug ineffective 149.34 9.55 3030 309887 837217 63348598
Psychomotor hyperactivity 145.72 9.55 256 312661 14195 64171620
Therapeutic product effect decreased 144.97 9.55 209 312708 115142 64070673
Synovitis 141.60 9.55 163 312754 98927 64086888
Mental status changes 140.48 9.55 629 312288 60533 64125282
Mania 139.63 9.55 269 312648 16017 64169798
Abnormal behaviour 136.68 9.55 416 312501 33206 64152609
Withdrawal syndrome 134.88 9.55 330 312587 23162 64162653
Hypersensitivity 134.78 9.55 494 312423 195958 63989857
Pneumonia aspiration 132.72 9.55 605 312312 58666 64127149
Delusion 128.84 9.55 276 312641 17738 64168077
Pemphigus 126.90 9.55 68 312849 60633 64125182
Mydriasis 126.51 9.55 249 312668 15063 64170752
Hand deformity 124.52 9.55 75 312842 62696 64123119
Systemic lupus erythematosus 121.72 9.55 118 312799 77494 64108321
Rash 120.08 9.55 1537 311380 457012 63728803
Anti-cyclic citrullinated peptide antibody positive 104.37 9.55 55 312862 49507 64136308
Hypokinesia 103.78 9.55 241 312676 16355 64169460
Unresponsive to stimuli 102.32 9.55 500 312417 49893 64135922
Psychomotor retardation 101.39 9.55 125 312792 5018 64180797
Swelling 100.20 9.55 418 312499 159800 64026015
Slow speech 99.29 9.55 81 312836 1956 64183859
Infusion related reaction 98.62 9.55 436 312481 164031 64021784
Hallucination 98.03 9.55 647 312270 72141 64113674
Alopecia 97.70 9.55 442 312475 165248 64020567
Seizure 95.53 9.55 1233 311684 165659 64020156
Respiratory arrest 95.20 9.55 508 312409 52477 64133338
Off label use 93.06 9.55 2349 310568 630457 63555358
Tremor 90.76 9.55 1109 311808 147121 64038694
Mobility decreased 90.70 9.55 174 312743 85666 64100149
Electrocardiogram QT prolonged 89.92 9.55 677 312240 78771 64107044
Drug hypersensitivity 89.90 9.55 730 312187 237085 63948730
Paranoia 87.88 9.55 224 312693 16128 64169687
Peripheral swelling 86.59 9.55 626 312291 208527 63977288
Dystonia 85.84 9.55 243 312674 18622 64167193
Stupor 85.72 9.55 125 312792 5910 64179905
Salivary hypersecretion 84.80 9.55 184 312733 11929 64173886
Depression 84.72 9.55 1304 311613 181987 64003828
Granulocytopenia 84.11 9.55 168 312749 10272 64175543
Miosis 83.34 9.55 193 312724 13073 64172742
Cytomegalovirus infection 83.30 9.55 38 312879 37161 64148654
COVID-19 82.83 9.55 117 312800 65023 64120792
Derealisation 80.45 9.55 63 312854 1432 64184383
Parkinsonism 79.44 9.55 199 312718 14174 64171641
Dyskinesia 79.38 9.55 390 312527 38998 64146817
Rheumatoid factor positive 79.32 9.55 35 312882 34903 64150912
Status epilepticus 76.16 9.55 255 312662 21408 64164407
Hypothermia 75.45 9.55 240 312677 19616 64166199
Mental disorder 73.22 9.55 288 312629 26157 64159658
Febrile neutropenia 72.67 9.55 1297 311620 186360 63999455
Injection site pain 72.56 9.55 286 312631 111122 64074693
Hyperammonaemic encephalopathy 71.09 9.55 93 312824 3965 64181850
Substance abuse 70.67 9.55 146 312771 9146 64176669
Bezoar 70.38 9.55 69 312848 2134 64183681
Psoriasis 69.26 9.55 153 312764 71550 64114265
Renal impairment 68.79 9.55 379 312538 134638 64051177
Glossodynia 68.46 9.55 131 312786 64565 64121250
Drooling 68.17 9.55 105 312812 5214 64180601
Gastric pH decreased 67.63 9.55 43 312874 692 64185123
Mutism 67.40 9.55 65 312852 1969 64183846
Pruritus 67.26 9.55 1088 311829 311312 63874503
Acute kidney injury 66.59 9.55 1665 311252 447575 63738240
Sinus tachycardia 66.50 9.55 321 312596 31867 64153948
Infection 65.57 9.55 577 312340 184303 64001512
Pain 65.43 9.55 2117 310800 551394 63634421
Hepatic enzyme increased 63.90 9.55 369 312548 129574 64056241
Injection site erythema 63.63 9.55 157 312760 70643 64115172
Hepatic function abnormal 63.13 9.55 136 312781 64177 64121638
Homicide 63.01 9.55 49 312868 1102 64184713
Cardiac arrest 62.92 9.55 1074 311843 152990 64032825
Lower respiratory tract infection 62.82 9.55 241 312676 94373 64091442
Anaphylactic shock 61.90 9.55 35 312882 30293 64155522
Mental impairment 61.60 9.55 197 312720 16146 64169669
Pain in extremity 61.50 9.55 1067 311850 302018 63883797
Abdominal discomfort 61.18 9.55 577 312340 181745 64004070
Psoriatic arthropathy 60.95 9.55 72 312845 43209 64142606
Maternal exposure during pregnancy 60.02 9.55 250 312667 95634 64090181
Product dose omission issue 59.66 9.55 630 312287 194117 63991698
Loss of consciousness 59.41 9.55 1031 311886 147334 64038481
Pericarditis 59.07 9.55 135 312782 62381 64123434
Persecutory delusion 58.88 9.55 86 312831 4072 64181743
Withdrawal catatonia 58.70 9.55 24 312893 139 64185676
Incontinence 58.31 9.55 159 312758 11922 64173893
Feeling of despair 58.18 9.55 67 312850 2501 64183314
Hallucinations, mixed 58.17 9.55 105 312812 5947 64179868
Myelosuppression 57.12 9.55 22 312895 23808 64162007
Tardive dyskinesia 57.08 9.55 133 312784 9045 64176770
Major depression 56.17 9.55 120 312797 7696 64178119
Dissociation 55.87 9.55 71 312846 2940 64182875
Antipsychotic drug level increased 54.69 9.55 93 312824 5022 64180793
Refusal of treatment by patient 54.24 9.55 123 312794 8216 64177599
Fall 53.89 9.55 2505 310412 414321 63771494
Sinusitis 51.92 9.55 455 312462 145473 64040342
Depersonalisation/derealisation disorder 51.71 9.55 51 312866 1589 64184226
Visceral congestion 51.65 9.55 38 312879 784 64185031
Device expulsion 51.52 9.55 19 312898 21117 64164698
Bone marrow failure 50.82 9.55 97 312820 47855 64137960
Blister 50.74 9.55 211 312706 80756 64105059
Drug eruption 49.94 9.55 61 312856 36075 64149740
Ataxia 49.85 9.55 226 312691 21858 64163957
Feeling jittery 49.37 9.55 138 312779 10497 64175318
Hyponatraemia 48.76 9.55 1000 311917 147339 64038476
Erythema 48.45 9.55 628 312289 186442 63999373
Apnoea 48.15 9.55 135 312782 10287 64175528
Disturbance in attention 47.58 9.55 352 312565 40722 64145093
Mood swings 47.36 9.55 189 312728 17279 64168536
Blood creatine phosphokinase increased 47.28 9.55 463 312454 58095 64127720
Nasopharyngitis 46.54 9.55 670 312247 195403 63990412
Skin necrosis 46.45 9.55 7 312910 14322 64171493
Somatic symptom disorder 46.18 9.55 51 312866 1817 64183998
Product use issue 45.96 9.55 492 312425 151223 64034592
Emotional disorder 45.74 9.55 150 312767 12457 64173358
Schizoaffective disorder 45.73 9.55 47 312870 1540 64184275
C-reactive protein abnormal 45.72 9.55 44 312873 29003 64156812
Intentional product misuse 45.56 9.55 544 312373 71751 64114064
Hallucination, visual 45.40 9.55 260 312657 27574 64158241
Insomnia 45.33 9.55 1269 311648 196567 63989248
Therapeutic response decreased 45.13 9.55 118 312799 52070 64133745
Cogwheel rigidity 44.81 9.55 62 312855 2791 64183024
Dysphagia 44.46 9.55 747 312170 106065 64079750
Skin ulcer 43.98 9.55 92 312825 43882 64141933
Parosmia 43.96 9.55 80 312837 4560 64181255
Electrocardiogram QRS complex prolonged 43.95 9.55 121 312796 9123 64176692
Cardiac failure congestive 43.90 9.55 413 312504 130167 64055648
Blood prolactin increased 42.93 9.55 68 312849 3460 64182355
Red blood cell sedimentation rate increased 42.87 9.55 53 312864 31182 64154633
Tenosynovitis 42.76 9.55 4 312913 11829 64173986
Injection site swelling 42.65 9.55 85 312832 41268 64144547
Lethargy 42.61 9.55 539 312378 72055 64113760
Inflammation 42.27 9.55 168 312749 65132 64120683
Hypoxia 42.17 9.55 631 312286 87518 64098297
Poverty of speech 41.51 9.55 29 312888 550 64185265
Injection site pruritus 41.42 9.55 75 312842 37751 64148064
Cardiac failure 41.42 9.55 426 312491 131947 64053868
Angioedema 41.33 9.55 157 312760 61664 64124151
Coma scale abnormal 41.26 9.55 106 312811 7668 64178147
Acute myocardial infarction 41.05 9.55 186 312731 69532 64116283
Disorganised speech 40.70 9.55 45 312872 1605 64184210
Myocardial infarction 40.63 9.55 563 312354 165258 64020557
Intentional product use issue 40.60 9.55 283 312634 95081 64090734
Cardio-respiratory arrest 40.54 9.55 687 312230 97706 64088109
Myocardial depression 40.34 9.55 27 312890 476 64185339
Haematotoxicity 40.24 9.55 7 312910 12889 64172926
Knee arthroplasty 40.10 9.55 43 312874 26956 64158859
Gastrointestinal haemorrhage 40.10 9.55 429 312488 131883 64053932
Irritability 39.81 9.55 310 312607 36436 64149379
Urticaria 39.45 9.55 491 312426 146826 64038989
Wound 39.30 9.55 214 312703 76263 64109552
Osteonecrosis of jaw 39.26 9.55 84 312833 39741 64146074
Drug withdrawal convulsions 39.20 9.55 50 312867 2078 64183737
Dehydration 39.20 9.55 1351 311566 215412 63970403
Pleurothotonus 39.16 9.55 52 312865 2250 64183565
Myocardial fibrosis 38.82 9.55 43 312874 1537 64184278
Discomfort 38.51 9.55 232 312685 80646 64105169
Logorrhoea 38.48 9.55 70 312847 3989 64181826
Delusion of grandeur 38.30 9.55 28 312889 572 64185243
Psychotic behaviour 38.16 9.55 35 312882 994 64184821
Neutropenic sepsis 38.11 9.55 34 312883 23238 64162577
Echolalia 37.63 9.55 23 312894 344 64185471
Amnesia 37.20 9.55 378 312539 47891 64137924
Anaemia 36.99 9.55 1482 311435 377198 63808617
Bone erosion 36.83 9.55 6 312911 11589 64174226
Drug screen positive 36.70 9.55 84 312833 5645 64180170
Drug reaction with eosinophilia and systemic symptoms 36.69 9.55 137 312780 54080 64131735
Incoherent 36.69 9.55 96 312821 7022 64178793
Pathogen resistance 36.63 9.55 8 312909 12535 64173280
Drop attacks 36.62 9.55 34 312883 981 64184834
Negativism 36.58 9.55 30 312887 730 64185085
Respiratory acidosis 36.42 9.55 118 312799 9737 64176078
Sleep disorder 36.19 9.55 446 312471 59263 64126552
Melaena 35.79 9.55 136 312781 53412 64132403
Transplant rejection 35.63 9.55 20 312897 17381 64168434
Enthesopathy 35.52 9.55 3 312914 9635 64176180
Decorticate posture 35.43 9.55 21 312896 296 64185519
Electroencephalogram abnormal 35.25 9.55 78 312839 5125 64180690
Communication disorder 35.24 9.55 64 312853 3642 64182173
H1N1 influenza 35.23 9.55 49 312868 2217 64183598
Duodenal ulcer perforation 35 9.55 72 312845 34553 64151262
Mood altered 34.93 9.55 162 312755 15817 64169998
Malaise 34.88 9.55 1569 311348 394678 63791137
Plasma cell myeloma 33.70 9.55 357 312560 45718 64140097
Multiple organ dysfunction syndrome 33.54 9.55 322 312595 101091 64084724
Osteoporosis 33.52 9.55 99 312818 41981 64143834
Accidental exposure to product by child 33.18 9.55 50 312867 2435 64183380
Panic attack 33.05 9.55 194 312723 20759 64165056
Victim of child abuse 33.03 9.55 30 312887 841 64184974
Victim of sexual abuse 33.01 9.55 22 312895 385 64185430
Drug resistance 32.99 9.55 76 312841 35026 64150789
Psychotic symptom 32.89 9.55 46 312871 2092 64183723
Pneumocystis jirovecii pneumonia 32.83 9.55 52 312865 27582 64158233
Therapeutic product effect incomplete 32.79 9.55 332 312585 103150 64082665
Failure to thrive 32.69 9.55 118 312799 10286 64175529
Aspiration 32.47 9.55 165 312752 16720 64169095
Hyperreflexia 32.45 9.55 92 312825 7056 64178759
C-reactive protein increased 32.40 9.55 299 312618 94610 64091205
Haemophagocytic lymphohistiocytosis 32.26 9.55 23 312894 17586 64168229
Needle fatigue 32.12 9.55 25 312892 563 64185252
Blood sodium decreased 32.09 9.55 249 312668 29233 64156582
Pneumonia viral 31.99 9.55 97 312820 7725 64178090
Inappropriate antidiuretic hormone secretion 31.75 9.55 201 312716 22088 64163727
Sleep disorder due to general medical condition, insomnia type 31.62 9.55 49 312868 26221 64159594
Helicobacter infection 31.47 9.55 89 312828 38273 64147542
Basal cell carcinoma 31.28 9.55 64 312853 30774 64155041
Myoclonus 31.25 9.55 219 312698 24899 64160916
Affective disorder 31.16 9.55 86 312831 6494 64179321
Blood pH decreased 30.96 9.55 67 312850 4335 64181480
Injection site reaction 30.88 9.55 119 312798 46545 64139270
Dyspnoea 30.80 9.55 3036 309881 715638 63470177
Soft tissue disorder 30.43 9.55 56 312861 3220 64182595
Sexually inappropriate behaviour 30.23 9.55 22 312895 446 64185369
Coronary artery disease 30.02 9.55 171 312746 60262 64125553
Liver disorder 29.83 9.55 145 312772 53206 64132609
Nervousness 29.65 9.55 245 312672 29311 64156504
Brain injury 29.61 9.55 111 312806 9854 64175961
Hip arthroplasty 29.55 9.55 36 312881 21315 64164500
Arthritis 29.50 9.55 262 312655 83552 64102263
Homicidal ideation 29.40 9.55 55 312862 3202 64182613
Febrile bone marrow aplasia 29.38 9.55 9 312908 11246 64174569
Generalised tonic-clonic seizure 29.23 9.55 309 312608 39548 64146267
Behaviour disorder 29.23 9.55 66 312851 4396 64181419
Pancreatic fibrosis 29.16 9.55 13 312904 96 64185719
Narcotic bowel syndrome 28.85 9.55 17 312900 237 64185578
Staring 28.70 9.55 46 312871 2364 64183451
Hypoglycaemia 28.65 9.55 288 312629 89604 64096211
Gait spastic 28.61 9.55 28 312889 864 64184951
Acute psychosis 28.59 9.55 59 312858 3693 64182122
Oropharyngeal spasm 28.36 9.55 17 312900 245 64185570
Urinary incontinence 28.29 9.55 284 312633 35867 64149948
Hyperkalaemia 28.23 9.55 334 312583 100795 64085020
Tubulointerstitial nephritis 28.19 9.55 68 312849 30841 64154974
Injection site bruising 27.95 9.55 87 312830 36286 64149529
Parkinsonian gait 27.89 9.55 27 312890 822 64184993
Red blood cell sedimentation rate abnormal 27.70 9.55 23 312894 16283 64169532
Alcohol abuse 27.68 9.55 68 312849 4784 64181031
Suicidal behaviour 27.63 9.55 50 312867 2837 64182978
Diabetes insipidus 27.55 9.55 65 312852 4456 64181359
Treatment noncompliance 27.31 9.55 327 312590 43155 64142660
Hepatocellular injury 27.03 9.55 120 312797 45115 64140700
Nicotine dependence 26.95 9.55 26 312891 788 64185027
Hyperhidrosis 26.85 9.55 795 312122 124125 64061690
Anaphylactic reaction 26.72 9.55 209 312708 68455 64117360
Alcohol interaction 26.52 9.55 63 312854 4338 64181477
Myelodysplastic syndrome 26.50 9.55 59 312858 27520 64158295
Impaired driving ability 26.31 9.55 65 312852 4589 64181226
Pneumonia 26.19 9.55 2348 310569 557228 63628587
Confabulation 26.13 9.55 20 312897 439 64185376
Mouth ulceration 26.08 9.55 76 312841 32368 64153447
Kidney transplant rejection 25.94 9.55 7 312910 9504 64176311
Obsessive-compulsive disorder 25.89 9.55 66 312851 4752 64181063
Menstrual disorder 25.74 9.55 53 312864 3312 64182503
Prostate cancer 25.71 9.55 35 312882 19760 64166055
Balance disorder 25.68 9.55 560 312357 83366 64102449
Drug screen false positive 25.66 9.55 28 312889 984 64184831
Cholestasis 25.65 9.55 121 312796 44751 64141064
Crying 25.49 9.55 176 312741 19914 64165901
Antipsychotic drug level decreased 25.48 9.55 27 312890 917 64184898
Haematuria 25.47 9.55 180 312737 60291 64125524
Macrocytosis 25.45 9.55 44 312873 2408 64183407
Computerised tomogram thorax abnormal 25.42 9.55 39 312878 1930 64183885
Restless legs syndrome 25.41 9.55 156 312761 16960 64168855
Headache 25.31 9.55 2218 310699 527249 63658566
Self-injurious ideation 25.22 9.55 51 312866 3146 64182669
Alcohol withdrawal syndrome 25.11 9.55 37 312880 1766 64184049
Wrong patient received product 25.04 9.55 56 312861 3706 64182109
Urinary retention 25.02 9.55 356 312561 48845 64136970
Galactorrhoea 24.98 9.55 51 312866 3168 64182647
Rhinitis perennial 24.91 9.55 15 312902 218 64185597
Foot deformity 24.83 9.55 26 312891 16478 64169337
Anger 24.35 9.55 145 312772 15596 64170219
Hyperprolactinaemia 24.29 9.55 58 312859 4007 64181808
Social avoidant behaviour 24.04 9.55 62 312855 4495 64181320
Psychiatric decompensation 24.01 9.55 43 312874 2420 64183395
Ulcer 23.93 9.55 47 312870 22943 64162872
Encephalitis autoimmune 23.88 9.55 37 312880 1847 64183968
Cough 23.86 9.55 1210 311707 300938 63884877
Cerebral infarction 23.86 9.55 110 312807 40934 64144881
Head injury 23.80 9.55 254 312663 32588 64153227
Oedema peripheral 23.65 9.55 809 312108 209508 63976307
Hepatic cytolysis 23.64 9.55 20 312897 14029 64171786
Movement disorder 23.50 9.55 185 312732 21815 64164000
Oral discharge 23.40 9.55 15 312902 245 64185570
Emotional distress 23.06 9.55 272 312645 35766 64150049
Illusion 23.00 9.55 33 312884 1537 64184278
Device issue 22.97 9.55 47 312870 22601 64163214
Hyperchloraemia 22.95 9.55 26 312891 953 64184862
Gastrointestinal disorder 22.89 9.55 302 312615 89407 64096408
Cataract 22.87 9.55 150 312767 51112 64134703
Impulsive behaviour 22.84 9.55 44 312873 2619 64183196
Live birth 22.76 9.55 13 312904 11191 64174624
Pressure of speech 22.48 9.55 26 312891 975 64184840
Pulmonary tuberculosis 22.45 9.55 4 312913 7240 64178575
Transplant dysfunction 22.39 9.55 3 312914 6705 64179110
Bipolar disorder 22.37 9.55 78 312839 6683 64179132
Visual acuity reduced 22.24 9.55 63 312854 27078 64158737
Atelectasis 22.21 9.55 216 312701 27050 64158765
Encephalopathy 22.19 9.55 405 312512 58414 64127401
Depressed mood 22.18 9.55 300 312617 40712 64145103
Cerebral microhaemorrhage 22.01 9.55 13 312904 182 64185633
Relapsing-remitting multiple sclerosis 21.95 9.55 27 312890 1081 64184734
Coma scale 21.89 9.55 9 312908 53 64185762
Morbid thoughts 21.83 9.55 22 312895 704 64185111
Accidental overdose 21.79 9.55 254 312663 33303 64152512
Impaired healing 21.74 9.55 188 312729 60285 64125530
Adverse event 21.69 9.55 108 312809 39381 64146434
Forced expiratory volume 21.64 9.55 10 312907 81 64185734
Panniculitis 21.61 9.55 8 312909 8871 64176944
Orgasmic sensation decreased 21.38 9.55 8 312909 35 64185780
Wrong technique in product usage process 21.19 9.55 207 312710 64767 64121048
Dyspnoea exertional 21.16 9.55 242 312675 73488 64112327
Rapid eye movements sleep abnormal 21.11 9.55 14 312903 243 64185572
Angina pectoris 21.10 9.55 130 312787 44951 64140864
Condition aggravated 21.03 9.55 1539 311378 370887 63814928
Renal disorder 21.02 9.55 94 312823 35271 64150544
Atrial fibrillation 20.92 9.55 651 312266 170438 64015377
Hyperthyroidism 20.85 9.55 35 312882 18144 64167671
Diarrhoea 20.83 9.55 3133 309784 719571 63466244
Small intestinal obstruction 20.82 9.55 190 312727 23383 64162432
Waxy flexibility 20.72 9.55 14 312903 251 64185564
Premature ejaculation 20.71 9.55 9 312908 62 64185753
Hypercapnia 20.66 9.55 83 312834 7611 64178204
Tendonitis 20.65 9.55 42 312875 20240 64165575
Patient uncooperative 20.47 9.55 19 312898 548 64185267
Oedema 20.46 9.55 318 312599 91617 64094198
Immunodeficiency 20.45 9.55 29 312888 16095 64169720
Self-medication 20.45 9.55 55 312862 4090 64181725
Disinhibition 20.40 9.55 38 312879 2205 64183610
Neurosensory hypoacusis 20.35 9.55 13 312904 211 64185604
Loss of personal independence in daily activities 20.33 9.55 239 312678 72215 64113600
Hyperosmolar state 20.28 9.55 20 312897 623 64185192
Skin maceration 20.21 9.55 8 312909 42 64185773
Solar urticaria 20.12 9.55 9 312908 67 64185748
Hypochloraemia 20.12 9.55 36 312881 2025 64183790
PCO2 increased 20.10 9.55 32 312885 1635 64184180
Musculoskeletal stiffness 20.02 9.55 450 312467 122756 64063059
Pulmonary fibrosis 19.89 9.55 76 312841 29802 64156013
Parathyroid gland enlargement 19.88 9.55 11 312906 135 64185680
Testicular atrophy 19.69 9.55 15 312902 327 64185488
Altered state of consciousness 19.58 9.55 275 312642 37627 64148188
Polyneuropathy 19.58 9.55 42 312875 19852 64165963
Epstein-Barr virus infection 19.56 9.55 19 312898 12469 64173346
Mitochondrial encephalomyopathy 19.40 9.55 7 312910 27 64185788
Diet refusal 19.32 9.55 22 312895 811 64185004
Drug use disorder 19.31 9.55 69 312848 5985 64179830
Drug abuser 19.21 9.55 67 312850 5741 64180074
Bradycardia 19.19 9.55 728 312189 117491 64068324
Acute generalised exanthematous pustulosis 19.14 9.55 24 312893 14034 64171781
Ill-defined disorder 19.10 9.55 130 312787 43922 64141893
Feeling of body temperature change 19.03 9.55 59 312858 4755 64181060
Bronchopulmonary aspergillosis 19.02 9.55 40 312877 19045 64166770
Tachypnoea 19.02 9.55 205 312712 26366 64159449
Device difficult to use 19.02 9.55 12 312905 9786 64176029
Cognitive disorder 18.96 9.55 374 312543 54713 64131102
Muscle disorder 18.95 9.55 60 312857 4891 64180924
Feelings of worthlessness 18.94 9.55 17 312900 469 64185346
Chronic obstructive pulmonary disease 18.93 9.55 465 312452 70583 64115232
Priapism 18.91 9.55 52 312865 3918 64181897
Medication error 18.83 9.55 344 312573 49622 64136193
Affect lability 18.82 9.55 90 312827 8900 64176915
Renal failure 18.80 9.55 706 312211 180982 64004833
Gastric ulcer 18.80 9.55 79 312838 30155 64155660
Hypophagia 18.78 9.55 283 312634 39304 64146511
Metabolic encephalopathy 18.77 9.55 83 312834 7942 64177873
Polyarthritis 18.72 9.55 12 312905 9703 64176112
Osteonecrosis 18.67 9.55 72 312845 28157 64157658
Tachyphrenia 18.61 9.55 33 312884 1843 64183972
Rheumatic fever 18.57 9.55 11 312906 9283 64176532
Coronary artery bypass 18.49 9.55 3 312914 5812 64180003
Monocyte count decreased 18.42 9.55 42 312875 2815 64183000
Aspergillus infection 18.36 9.55 32 312885 16347 64169468
Electrocardiogram J wave 18.30 9.55 8 312909 56 64185759
Hangover 18.29 9.55 33 312884 1868 64183947
Unintentional medical device removal 18.29 9.55 5 312912 6729 64179086
Cytomegalovirus infection reactivation 18.23 9.55 3 312914 5753 64180062
Loose associations 18.18 9.55 8 312909 57 64185758
Acute coronary syndrome 17.99 9.55 42 312875 19268 64166547
Rhesus antigen positive 17.98 9.55 10 312907 124 64185691
Gait disturbance 17.76 9.55 1013 311904 171142 64014673
Coronary artery stenosis 17.75 9.55 17 312900 11231 64174584
Poisoning deliberate 17.73 9.55 119 312798 13339 64172476
Hypomania 17.66 9.55 64 312853 5590 64180225
Phagophobia 17.65 9.55 7 312910 37 64185778
Drug screen negative 17.64 9.55 13 312904 269 64185546
Autonomic nervous system imbalance 17.61 9.55 52 312865 4080 64181735
Hypertonia 17.60 9.55 69 312848 6256 64179559
Leukocytosis 17.59 9.55 269 312648 37471 64148344
Thinking abnormal 17.58 9.55 106 312811 11450 64174365
Cerebral atrophy 17.53 9.55 76 312841 7209 64178606
Prescribed overdose 17.52 9.55 163 312754 20168 64165647
Cytomegalovirus viraemia 17.51 9.55 16 312901 10812 64175003
BK virus infection 17.51 9.55 7 312910 7405 64178410
Cerebrovascular accident 17.43 9.55 521 312396 137062 64048753
Irritable bowel syndrome 17.36 9.55 108 312809 37261 64148554
Faecaloma 17.28 9.55 93 312824 9635 64176180
Immune reconstitution inflammatory syndrome 17.28 9.55 21 312896 12449 64173366
Wrong drug 17.25 9.55 12 312905 226 64185589
Mucormycosis 17.23 9.55 7 312910 7334 64178481
Impaired quality of life 17.21 9.55 5 312912 6466 64179349
Device use error 17.21 9.55 5 312912 6466 64179349
Haematuria traumatic 17.20 9.55 11 312906 179 64185636
Coordination abnormal 17.19 9.55 128 312789 14836 64170979
Tuberculosis 16.99 9.55 23 312894 13015 64172800
Blood creatine phosphokinase 16.88 9.55 9 312908 102 64185713
Protein C increased 16.88 9.55 9 312908 102 64185713
Thrombosis 16.88 9.55 241 312676 70401 64115414
Anxiolytic therapy 16.86 9.55 6 312911 22 64185793
Drug therapy enhancement 16.86 9.55 6 312911 22 64185793
Joint injury 16.85 9.55 56 312861 22891 64162924
Bladder cancer 16.84 9.55 17 312900 10957 64174858
Hepatocellular carcinoma 16.72 9.55 10 312907 8393 64177422
Device malfunction 16.71 9.55 38 312879 17595 64168220
Abortion spontaneous 16.71 9.55 64 312853 25079 64160736
Dementia 16.66 9.55 164 312753 20602 64165213
Monoparesis 16.61 9.55 41 312876 2893 64182922
Screaming 16.59 9.55 46 312871 3483 64182332
Computerised tomogram thorax 16.57 9.55 10 312907 146 64185669
Endophthalmitis 16.55 9.55 3 312914 5362 64180453
Abulia 16.52 9.55 21 312896 870 64184945
Erysipelas 16.45 9.55 12 312905 9069 64176746
Paradoxical drug reaction 16.41 9.55 66 312851 6054 64179761
Micturition urgency 16.39 9.55 96 312821 10263 64175552
Herpes zoster 16.27 9.55 278 312639 78909 64106906
Infective pulmonary exacerbation of cystic fibrosis 16.20 9.55 20 312897 11776 64174039
Thrombocytopenia 16.20 9.55 904 312013 222897 63962918
Soliloquy 16.15 9.55 17 312900 573 64185242
Oral pain 16.07 9.55 204 312713 27289 64158526
Attention deficit hyperactivity disorder 15.99 9.55 39 312878 2731 64183084
Skin toxicity 15.98 9.55 6 312911 6596 64179219
Dermatitis exfoliative 15.92 9.55 16 312901 10336 64175479
Posturing 15.91 9.55 22 312895 990 64184825
Respiratory rate decreased 15.90 9.55 53 312864 4438 64181377
Fluid retention 15.82 9.55 199 312718 59407 64126408
PO2 increased 15.78 9.55 27 312890 1465 64184350
Child abuse 15.73 9.55 11 312906 209 64185606
Thrombotic microangiopathy 15.70 9.55 36 312881 16619 64169196
Diabetes mellitus inadequate control 15.68 9.55 52 312865 21269 64164546
Fear 15.56 9.55 158 312759 20013 64165802
Joint effusion 15.40 9.55 26 312891 13447 64172368
Rhabdomyolysis 15.40 9.55 567 312350 91159 64094656
Blood bicarbonate decreased 15.37 9.55 55 312862 4774 64181041
Sexual relationship change 15.33 9.55 5 312912 13 64185802
Neologism 15.33 9.55 5 312912 13 64185802
Muscle injury 15.28 9.55 71 312846 26366 64159449
Shock haemorrhagic 15.26 9.55 37 312880 16754 64169061
Pyrexia 15.26 9.55 2429 310488 556215 63629600
Diaphragmatic rupture 15.24 9.55 11 312906 220 64185595
Muscle mass 15.22 9.55 14 312903 399 64185416
Gout 15.22 9.55 53 312864 21360 64164455
End stage renal disease 15.21 9.55 17 312900 10458 64175357
Hallucination, tactile 15.19 9.55 15 312902 468 64185347
Femur fracture 15.17 9.55 100 312817 34035 64151780
Nasal congestion 15.16 9.55 201 312716 59457 64126358
Growth hormone deficiency 15.13 9.55 13 312904 338 64185477
Respiratory distress 15.01 9.55 346 312571 51985 64133830
Folliculitis 14.99 9.55 85 312832 29992 64155823
Dermatitis exfoliative generalised 14.97 9.55 5 312912 5911 64179904
Grip strength decreased 14.96 9.55 21 312896 11703 64174112
Sacroiliitis 14.89 9.55 40 312877 2972 64182843
Dysphoria 14.85 9.55 51 312866 4337 64181478
Laryngitis 14.84 9.55 19 312898 11012 64174803
Upper respiratory tract infection 14.80 9.55 256 312661 72529 64113286
Chronic kidney disease 14.77 9.55 195 312722 57724 64128091
Renal ischaemia 14.76 9.55 22 312895 1061 64184754
Arthritis bacterial 14.67 9.55 10 312907 7829 64177986
Respiratory failure 14.66 9.55 938 311979 160245 64025570
Pulseless electrical activity 14.65 9.55 109 312808 12630 64173185
Ear infection 14.65 9.55 61 312856 23343 64162472
Focal dyscognitive seizures 14.60 9.55 42 312875 3248 64182567
Nightmare 14.58 9.55 161 312756 20832 64164983
Morose 14.50 9.55 6 312911 36 64185779
Water intoxication 14.42 9.55 18 312899 732 64185083
Carbohydrate antigen 125 increased 14.32 9.55 30 312887 1898 64183917
Bronchitis 14.22 9.55 410 312507 108333 64077482
Toxic skin eruption 14.20 9.55 47 312870 19237 64166578
Myositis 14.18 9.55 37 312880 16340 64169475
Cellulitis 14.12 9.55 346 312571 93311 64092504
Glaucoma 14.10 9.55 37 312880 16311 64169504
Coronary arterial stent insertion 14.07 9.55 5 312912 5687 64180128
Acute graft versus host disease 14.02 9.55 14 312903 9070 64176745
Shoshin beriberi 13.97 9.55 7 312910 69 64185746
Gastric cancer 13.97 9.55 7 312910 6486 64179329
Gallbladder disorder 13.91 9.55 135 312782 16895 64168920
Hypervigilance 13.89 9.55 14 312903 448 64185367
Schizophreniform disorder 13.88 9.55 9 312908 150 64185665
Oculogyric crisis 13.88 9.55 35 312882 2503 64183312
Finger deformity 13.81 9.55 4 312913 5182 64180633
Device adhesion issue 13.81 9.55 4 312913 5182 64180633
Myopathy 13.79 9.55 42 312875 17638 64168177
Osteoarthritis 13.78 9.55 220 312697 63116 64122699
Enuresis 13.74 9.55 37 312880 2753 64183062
Platelet production decreased 13.70 9.55 4 312913 6 64185809
Exposure during pregnancy 13.69 9.55 280 312637 77395 64108420
Drug specific antibody present 13.67 9.55 4 312913 5150 64180665
Rash pruritic 13.65 9.55 196 312721 57208 64128607
Bundle branch block right 13.65 9.55 91 312826 10178 64175637
Vasoconstriction 13.58 9.55 16 312901 612 64185203
Clumsiness 13.57 9.55 36 312881 2655 64183160
Sneezing 13.56 9.55 34 312883 15217 64170598
Sluggishness 13.53 9.55 59 312858 5611 64180204
Lung disorder 13.49 9.55 210 312707 60490 64125325
Proteinuria 13.47 9.55 79 312838 27644 64158171
Blood albumin increased 13.45 9.55 24 312893 1347 64184468
Suspected suicide attempt 13.40 9.55 11 312906 268 64185547
Mean cell haemoglobin increased 13.37 9.55 40 312877 3162 64182653
Bradypnoea 13.33 9.55 55 312862 5104 64180711
Benzodiazepine drug level increased 13.32 9.55 10 312907 213 64185602
Therapy interrupted 13.31 9.55 51 312866 19985 64165830
Delusional perception 13.28 9.55 12 312905 334 64185481
Grandiosity 13.24 9.55 15 312902 550 64185265
Uveitis 13.21 9.55 26 312891 12682 64173133
Eosinophilic pneumonia 13.20 9.55 3 312914 4574 64181241
Coeliac disease 13.16 9.55 10 312907 7402 64178413
Dependence 13.15 9.55 31 312886 2124 64183691
Foreign body aspiration 13.10 9.55 11 312906 277 64185538
Thymus disorder 13.08 9.55 10 312907 219 64185596
Nephrolithiasis 13.08 9.55 142 312775 43541 64142274
Soft tissue swelling 13.08 9.55 21 312896 1081 64184734
Lupus-like syndrome 13.06 9.55 14 312903 8777 64177038
Self esteem decreased 13.03 9.55 19 312898 898 64184917
Prostate tenderness 13 9.55 3 312914 0 64185815
Therapeutic product ineffective 12.98 9.55 25 312892 1488 64184327
Vomiting 12.95 9.55 2940 309977 548177 63637638
Blunted affect 12.92 9.55 13 312904 415 64185400
Blood creatinine increased 12.87 9.55 533 312384 135249 64050566
Swollen joint count increased 12.87 9.55 11 312906 7678 64178137
Surgery 12.87 9.55 82 312835 28131 64157684
Vulvar basal cell carcinoma 12.83 9.55 5 312912 25 64185790
Dysmetropsia 12.79 9.55 7 312910 84 64185731
Stereotypy 12.78 9.55 18 312899 824 64184991
Injection site warmth 12.77 9.55 29 312888 13433 64172382
Sputum purulent 12.72 9.55 22 312895 1204 64184611
Polydipsia 12.71 9.55 59 312858 5762 64180053
Alcoholism 12.71 9.55 41 312876 3376 64182439
Change of bowel habit 12.69 9.55 33 312884 2405 64183410
Nephropathy toxic 12.69 9.55 43 312874 17471 64168344
Alcohol use 12.64 9.55 50 312867 4552 64181263
Euthanasia 12.64 9.55 6 312911 52 64185763
Colitis ulcerative 12.63 9.55 63 312854 22965 64162850
Skin exfoliation 12.61 9.55 148 312769 44737 64141078
Intraocular pressure increased 12.58 9.55 13 312904 8289 64177526
Myocardial reperfusion injury 12.52 9.55 5 312912 27 64185788
Apallic syndrome 12.50 9.55 18 312899 841 64184974
Diabetic ketoacidosis 12.49 9.55 89 312828 29756 64156059
Upper respiratory fungal infection 12.48 9.55 11 312906 296 64185519
Heart rate increased 12.48 9.55 592 312325 98083 64087732
Lip swelling 12.46 9.55 97 312820 31810 64154005
Injection site haemorrhage 12.43 9.55 68 312849 24210 64161605
Psychomotor skills impaired 12.41 9.55 44 312873 3801 64182014
Induced abortion failed 12.39 9.55 9 312908 182 64185633
Pseudophaeochromocytoma 12.37 9.55 7 312910 90 64185725
Echopraxia 12.37 9.55 5 312912 28 64185787
Nephrotic syndrome 12.34 9.55 17 312900 9550 64176265
Electroconvulsive therapy 12.30 9.55 7 312910 91 64185724
Perseveration 12.27 9.55 12 312905 370 64185445
Hyporesponsive to stimuli 12.24 9.55 27 312890 1770 64184045
Skin reaction 12.22 9.55 26 312891 12326 64173489
Aphasia 12.21 9.55 272 312645 40634 64145181
Bronchiectasis 12.20 9.55 32 312885 14108 64171707
Drug clearance decreased 12.17 9.55 34 312883 2585 64183230
Creatinine renal clearance decreased 12.17 9.55 33 312884 14388 64171427
Myalgia 12.16 9.55 637 312280 157980 64027835
Dystonic tremor 12.14 9.55 9 312908 188 64185627
Nocardiosis 12.11 9.55 4 312913 4763 64181052
Differential white blood cell count abnormal 12.11 9.55 27 312890 1783 64184032
Exposure via breast milk 12.09 9.55 17 312900 777 64185038
Pancytopenia 12.06 9.55 570 312347 142739 64043076
Panic disorder 12.04 9.55 35 312882 2722 64183093
Flight of ideas 12 9.55 16 312901 695 64185120
Middle insomnia 12.00 9.55 105 312812 12772 64173043
Pain in jaw 11.99 9.55 133 312784 40622 64145193
Inappropriate affect 11.94 9.55 22 312895 1266 64184549
Anxiety disorder 11.82 9.55 43 312874 3762 64182053
Hypotonia 11.82 9.55 94 312823 11118 64174697
Tangentiality 11.76 9.55 8 312909 145 64185670
Partial seizures 11.75 9.55 68 312849 7239 64178576
Semen volume decreased 11.73 9.55 6 312911 62 64185753
Polydipsia psychogenic 11.70 9.55 9 312908 199 64185616
Memory impairment 11.69 9.55 518 312399 85164 64100651
Acute respiratory failure 11.61 9.55 321 312596 49613 64136202
Neonatal hypoxia 11.61 9.55 4 312913 13 64185802
Nerve degeneration 11.60 9.55 10 312907 261 64185554
Sexual dysfunction 11.59 9.55 62 312855 6409 64179406
Rash erythematous 11.59 9.55 166 312751 48467 64137348
Negative thoughts 11.58 9.55 22 312895 1296 64184519
Brain abscess 11.55 9.55 3 312914 4178 64181637
Muscle twitching 11.55 9.55 142 312775 18856 64166959
Hepatotoxicity 11.53 9.55 131 312786 39831 64145984
Klebsiella bacteraemia 11.49 9.55 31 312886 2309 64183506
Labelled drug-food interaction medication error 11.49 9.55 6 312911 65 64185750
Toxicologic test abnormal 11.45 9.55 21 312896 1204 64184611
Hypoprolactinaemia 11.39 9.55 4 312913 14 64185801
Aortic valve stenosis 11.36 9.55 4 312913 4576 64181239
Rabbit syndrome 11.30 9.55 11 312906 337 64185478
Forced expiratory volume decreased 11.28 9.55 10 312907 6857 64178958
Blood potassium decreased 11.24 9.55 266 312651 40133 64145682
Multiple drug therapy 11.21 9.55 30 312887 2224 64183591
Injection site rash 11.16 9.55 39 312878 15703 64170112
Psychiatric symptom 11.16 9.55 60 312857 6213 64179602
Graft versus host disease in skin 11.16 9.55 6 312911 5341 64180474
Pallor 10.99 9.55 256 312661 38525 64147290
Neck mass 10.99 9.55 3 312914 4041 64181774
Natural killer cell count 10.97 9.55 4 312913 16 64185799
Cerebral haemorrhage 10.94 9.55 178 312739 50912 64134903
Hepatitis B reactivation 10.94 9.55 5 312912 4884 64180931
Psychopathic personality 10.94 9.55 3 312914 3 64185812
Thought withdrawal 10.94 9.55 3 312914 3 64185812
Antidepressant drug level below therapeutic 10.94 9.55 3 312914 3 64185812
Abortion spontaneous complete 10.94 9.55 3 312914 3 64185812
Inflammatory marker increased 10.92 9.55 15 312902 8436 64177379
Full blood count abnormal 10.91 9.55 204 312713 29553 64156262
Sputum discoloured 10.89 9.55 47 312870 17809 64168006
Selective mutism 10.89 9.55 6 312911 73 64185742
Eczema 10.85 9.55 92 312825 29628 64156187
Accidental exposure to product 10.84 9.55 79 312838 26285 64159530
Libido decreased 10.83 9.55 49 312868 4735 64181080
Ureteric obstruction 10.82 9.55 31 312886 2391 64183424
Autoimmune haemolytic anaemia 10.81 9.55 11 312906 7065 64178750
Epidural lipomatosis 10.80 9.55 17 312900 860 64184955
Amegakaryocytic thrombocytopenia 10.78 9.55 4 312913 17 64185798
Clonus 10.78 9.55 58 312859 6009 64179806
Sensitivity to weather change 10.77 9.55 10 312907 6704 64179111
Peritonitis bacterial 10.76 9.55 17 312900 9026 64176789
Cardiac failure chronic 10.75 9.55 17 312900 9024 64176791
Antidepressant drug level increased 10.74 9.55 11 312906 359 64185456
Accident at work 10.73 9.55 18 312899 961 64184854
Aplastic anaemia 10.72 9.55 109 312808 13811 64172004
Eye disorder 10.71 9.55 51 312866 18818 64166997
Premature delivery 10.70 9.55 50 312867 18539 64167276
Post-injection delirium sedation syndrome 10.68 9.55 13 312904 515 64185300
Bacterial test positive 10.59 9.55 62 312855 6628 64179187
Hypertensive crisis 10.55 9.55 49 312868 18199 64167616
Blood creatine increased 10.53 9.55 72 312845 8120 64177695
Ultrasound abdomen abnormal 10.53 9.55 7 312910 122 64185693
Granuloma 10.52 9.55 10 312907 6631 64179184
Angina unstable 10.52 9.55 39 312878 15428 64170387
Refusal of treatment by relative 10.51 9.55 15 312902 695 64185120
Neutrophil count increased 10.44 9.55 176 312741 24998 64160817
Affective ambivalence 10.43 9.55 4 312913 19 64185796
Constipation 10.41 9.55 1268 311649 228069 63957746
Daydreaming 10.39 9.55 16 312901 794 64185021
Food craving 10.39 9.55 22 312895 1402 64184413
Jaundice 10.39 9.55 169 312748 48343 64137472
Stevens-Johnson syndrome 10.39 9.55 111 312806 34138 64151677
Hepatitis 10.37 9.55 157 312760 45425 64140390
Immunoglobulins decreased 10.37 9.55 21 312896 1297 64184518
Injury 10.36 9.55 350 312567 55642 64130173
Varicella zoster virus infection 10.35 9.55 3 312914 3885 64181930
Haemoglobin urine 10.33 9.55 7 312910 126 64185689
Haematochezia 10.33 9.55 244 312673 66129 64119686
Pneumoconiosis 10.31 9.55 9 312908 239 64185576
Asthma 10.30 9.55 368 312549 94857 64090958
Red cell distribution width increased 10.26 9.55 98 312819 12211 64173604
Metabolic alkalosis 10.25 9.55 42 312875 3886 64181929
Schizoaffective disorder bipolar type 10.24 9.55 7 312910 128 64185687
Atypical femur fracture 10.21 9.55 5 312912 4693 64181122
Left ventricle outflow tract obstruction 10.21 9.55 10 312907 309 64185506
Feeling guilty 10.20 9.55 16 312901 807 64185008
Blood osmolarity increased 10.20 9.55 13 312904 540 64185275
Squamous cell carcinoma of the oral cavity 10.19 9.55 12 312905 459 64185356
Posture abnormal 10.17 9.55 38 312879 3368 64182447
B-cell lymphoma 10.16 9.55 7 312910 5450 64180365
Disability 10.16 9.55 28 312889 12144 64173671
Purpura 10.15 9.55 46 312871 17200 64168615
Product storage error 10.13 9.55 32 312885 13286 64172529
Depressive delusion 10.11 9.55 4 312913 21 64185794
On and off phenomenon 10.08 9.55 31 312886 2488 64183327
Gallbladder cholesterolosis 10.01 9.55 13 312904 550 64185265
Phonophobia 10.00 9.55 12 312905 468 64185347
Drug monitoring procedure incorrectly performed 9.98 9.55 11 312906 391 64185424
Rales 9.97 9.55 39 312878 15190 64170625
Cutaneous vasculitis 9.96 9.55 10 312907 6463 64179352
Pancreatitis acute 9.96 9.55 147 312770 42708 64143107
Wound infection fungal 9.92 9.55 8 312909 190 64185625
Liver injury 9.91 9.55 95 312822 29837 64155978
Nodule 9.90 9.55 49 312868 17898 64167917
Immature granulocyte count increased 9.88 9.55 12 312905 474 64185341
Hypopnoea 9.84 9.55 36 312881 3158 64182657
Foot fracture 9.78 9.55 50 312867 18107 64167708
Drug level increased 9.77 9.55 226 312691 33970 64151845
Septic shock 9.76 9.55 415 312502 105022 64080793
Deja vu 9.75 9.55 5 312912 52 64185763
Disseminated intravascular coagulation 9.74 9.55 105 312812 32243 64153572
Assisted suicide 9.73 9.55 3 312914 6 64185809
Gerstmann's syndrome 9.73 9.55 3 312914 6 64185809
Hyponatraemic syndrome 9.69 9.55 15 312902 748 64185067
Morbihan disease 9.67 9.55 4 312913 24 64185791
Post procedural infection 9.66 9.55 20 312897 9577 64176238
Disease recurrence 9.60 9.55 102 312815 31408 64154407
Eczema eyelids 9.57 9.55 7 312910 143 64185672

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
Nasal congestion 27.29 24.56 9 400 25 84244
Hypotonia neonatal 25.92 24.56 23 386 644 83625

Pharmacologic Action:

SourceCodeDescription
ATC N05BA06 NERVOUS SYSTEM
PSYCHOLEPTICS
ANXIOLYTICS
Benzodiazepine derivatives
ATC N05BA56 NERVOUS SYSTEM
PSYCHOLEPTICS
ANXIOLYTICS
Benzodiazepine derivatives
FDA CS M0002356 Benzodiazepines
MeSH PA D014151 Anti-Anxiety Agents
MeSH PA D000927 Anticonvulsants
MeSH PA D000932 Antiemetics
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D018682 GABA Agents
MeSH PA D018757 GABA Modulators
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D006993 Hypnotics and Sedatives
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D011619 Psychotropic Drugs
MeSH PA D014149 Tranquilizing Agents
FDA EPC N0000175694 Benzodiazepine
CHEBI has role CHEBI:35717 hypnotics

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Myoclonic seizure indication 37356005
Atonic seizure indication 42365007
Anxiety indication 48694002
Absence seizure indication 79631006
Lennox-Gastaut syndrome indication 230418006
Status epilepticus indication 230456007 DOID:1824
Panic disorder indication 371631005 DOID:594
Sedation as Adjunct to Anesthesia indication
Induce Anterograde Amnesia indication
Delirium off-label use 2776000
Alcohol withdrawal delirium off-label use 8635005
General anesthesia off-label use 50697003
Seizure disorder off-label use 128613002
Alcohol withdrawal syndrome off-label use 191480000
Insomnia off-label use 193462001
Spasticity off-label use 221360009
Chemotherapy-induced nausea and vomiting off-label use 236084000
Akathisia off-label use 285145004
Local anesthesia off-label use 386761002
Cocaine-Associated Acute Ischemic Heart Disease off-label use
Manic Bipolar Disorder Adjunct Treatment off-label use
Sedation in Intubated Patients off-label use
Suicidal thoughts contraindication 6471006
Hepatic encephalopathy contraindication 13920009 DOID:13413
Alcohol intoxication contraindication 25702006
Depressive disorder contraindication 35489007
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Substance abuse contraindication 66214007
Sleep apnea contraindication 73430006 DOID:0050847
Decreased respiratory function contraindication 80954004
Open-angle glaucoma contraindication 84494001 DOID:1067
Kidney disease contraindication 90708001 DOID:557
Hypoalbuminemia contraindication 119247004
Liver function tests abnormal contraindication 166603001
Disease of liver contraindication 235856003 DOID:409
Syncope contraindication 271594007
Pregnancy, function contraindication 289908002
Severe chronic obstructive pulmonary disease contraindication 313299006
At risk for aspiration contraindication 371736008
Angle-closure glaucoma contraindication 392291006 DOID:13550
Breastfeeding (mother) contraindication 413712001
Chronic lung disease contraindication 413839001
Central nervous system depression contraindication 418072004
Porphyria contraindication 418470004




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 8.09 acidic
pKa2 11.41 acidic
pKa3 0.63 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
1.5MG LOREEV XR ALMATICA N214826 Feb. 16, 2022 RX CAPSULE, EXTENDED RELEASE ORAL 8999393 Jan. 8, 2034 ONCE DAILY TREATMENT OF ANXIETY DISORDER IN ADULTS
1MG LOREEV XR ALMATICA N214826 Aug. 27, 2021 RX CAPSULE, EXTENDED RELEASE ORAL 8999393 Jan. 8, 2034 ONCE DAILY TREATMENT OF ANXIETY DISORDER IN ADULTS
2MG LOREEV XR ALMATICA N214826 Aug. 27, 2021 RX CAPSULE, EXTENDED RELEASE ORAL 8999393 Jan. 8, 2034 ONCE DAILY TREATMENT OF ANXIETY DISORDER IN ADULTS
3MG LOREEV XR ALMATICA N214826 Aug. 27, 2021 RX CAPSULE, EXTENDED RELEASE ORAL 8999393 Jan. 8, 2034 ONCE DAILY TREATMENT OF ANXIETY DISORDER IN ADULTS

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
GABA-A receptor alpha-1/beta-3/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR IC50 8.46 WOMBAT-PK CHEMBL
Fatty acid-binding protein, liver Unclassified Ki 4.89 CHEMBL

External reference:

IDSource
4017848 VUID
N0000146205 NUI
D00365 KEGG_DRUG
4017848 VANDF
C0024002 UMLSCUI
CHEBI:6539 CHEBI
CHEMBL249262 ChEMBL_ID
CHEMBL580 ChEMBL_ID
CHEMBL399057 ChEMBL_ID
DB00186 DRUGBANK_ID
D008140 MESH_DESCRIPTOR_UI
3958 PUBCHEM_CID
5884 IUPHAR_LIGAND_ID
2809 INN_ID
O26FZP769L UNII
202479 RXNORM
2104 MMSL
3795 MMSL
4995 MMSL
d00149 MMSL
001460 NDDF
19225000 SNOMEDCT_US
387106007 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Lorazepam HUMAN PRESCRIPTION DRUG LABEL 1 0054-3532 SOLUTION, CONCENTRATE 2 mg ORAL ANDA 19 sections
Lorazepam HUMAN PRESCRIPTION DRUG LABEL 1 0093-3425 TABLET 0.50 mg ORAL ANDA 21 sections
Lorazepam HUMAN PRESCRIPTION DRUG LABEL 1 0093-3425 TABLET 0.50 mg ORAL ANDA 21 sections
Lorazepam HUMAN PRESCRIPTION DRUG LABEL 1 0093-3426 TABLET 1 mg ORAL ANDA 21 sections
Lorazepam HUMAN PRESCRIPTION DRUG LABEL 1 0093-3426 TABLET 1 mg ORAL ANDA 21 sections
Lorazepam HUMAN PRESCRIPTION DRUG LABEL 1 0093-3427 TABLET 2 mg ORAL ANDA 21 sections
Lorazepam HUMAN PRESCRIPTION DRUG LABEL 1 0093-3427 TABLET 2 mg ORAL ANDA 21 sections
Lorazepam HUMAN PRESCRIPTION DRUG LABEL 1 0121-0770 LIQUID 2 mg ORAL ANDA 21 sections
Ativan HUMAN PRESCRIPTION DRUG LABEL 1 0187-0063 TABLET 0.50 mg ORAL NDA 20 sections
Ativan HUMAN PRESCRIPTION DRUG LABEL 1 0187-0064 TABLET 1 mg ORAL NDA 20 sections
Ativan HUMAN PRESCRIPTION DRUG LABEL 1 0187-0065 TABLET 2 mg ORAL NDA 20 sections
Lorazepam HUMAN PRESCRIPTION DRUG LABEL 1 0409-1539 INJECTION, SOLUTION 4 mg INTRAMUSCULAR ANDA 33 sections
Lorazepam HUMAN PRESCRIPTION DRUG LABEL 1 0409-1539 INJECTION, SOLUTION 4 mg INTRAMUSCULAR ANDA 33 sections
Lorazepam HUMAN PRESCRIPTION DRUG LABEL 1 0409-1985 INJECTION, SOLUTION 2 mg INTRAMUSCULAR ANDA 33 sections
Lorazepam HUMAN PRESCRIPTION DRUG LABEL 1 0409-1985 INJECTION, SOLUTION 2 mg INTRAMUSCULAR ANDA 33 sections
Lorazepam HUMAN PRESCRIPTION DRUG LABEL 1 0409-6778 INJECTION, SOLUTION 2 mg INTRAMUSCULAR ANDA 33 sections
Lorazepam HUMAN PRESCRIPTION DRUG LABEL 1 0409-6778 INJECTION, SOLUTION 2 mg INTRAMUSCULAR ANDA 33 sections
Lorazepam HUMAN PRESCRIPTION DRUG LABEL 1 0409-6778 INJECTION, SOLUTION 2 mg INTRAMUSCULAR ANDA 33 sections
Lorazepam HUMAN PRESCRIPTION DRUG LABEL 1 0409-6778 INJECTION, SOLUTION 2 mg INTRAMUSCULAR ANDA 33 sections
Lorazepam HUMAN PRESCRIPTION DRUG LABEL 1 0409-6779 INJECTION, SOLUTION 4 mg INTRAMUSCULAR ANDA 33 sections
Lorazepam HUMAN PRESCRIPTION DRUG LABEL 1 0409-6779 INJECTION, SOLUTION 4 mg INTRAMUSCULAR ANDA 33 sections
Lorazepam HUMAN PRESCRIPTION DRUG LABEL 1 0409-6780 INJECTION, SOLUTION 2 mg INTRAMUSCULAR ANDA 33 sections
Lorazepam HUMAN PRESCRIPTION DRUG LABEL 1 0409-6780 INJECTION, SOLUTION 2 mg INTRAMUSCULAR ANDA 33 sections
Lorazepam HUMAN PRESCRIPTION DRUG LABEL 1 0409-6781 INJECTION, SOLUTION 4 mg INTRAMUSCULAR ANDA 33 sections
Lorazepam HUMAN PRESCRIPTION DRUG LABEL 1 0409-6781 INJECTION, SOLUTION 4 mg INTRAMUSCULAR ANDA 33 sections
Lorazepam HUMAN PRESCRIPTION DRUG LABEL 1 0591-0240 TABLET 0.50 mg ORAL ANDA 20 sections
Lorazepam HUMAN PRESCRIPTION DRUG LABEL 1 0591-0241 TABLET 1 mg ORAL ANDA 20 sections
Lorazepam HUMAN PRESCRIPTION DRUG LABEL 1 0591-0242 TABLET 2 mg ORAL ANDA 20 sections
Lorazepam HUMAN PRESCRIPTION DRUG LABEL 1 0615-8075 TABLET 0.50 mg ORAL ANDA 13 sections
Lorazepam HUMAN PRESCRIPTION DRUG LABEL 1 0615-8076 TABLET 1 mg ORAL ANDA 13 sections