mirtazapine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
psychoactive 1816 85650-52-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • mirtazapine
  • mepirzapin
  • mepirzepine
  • mirtabene
  • mirtazepine
  • mirtazipine
A piperazinoazepine tetracyclic compound that enhances the release of NOREPINEPHRINE and SEROTONIN through blockage of presynaptic ALPHA-2 ADRENERGIC RECEPTORS. It also blocks both 5-HT2 and 5-HT3 serotonin receptors and is a potent HISTAMINE H1 RECEPTOR antagonist. It is used for the treatment of depression, and may also be useful for the treatment of anxiety disorders.
  • Molecular weight: 265.36
  • Formula: C17H19N3
  • CLOGP: 3.07
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 0
  • TPSA: 19.37
  • ALOGS: -2.38
  • ROTB: 0
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
30 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.50 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 2 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 2.83 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 50 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 4.20 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 8 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.15 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 15 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
June 14, 1996 FDA ORGANON USA INC

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
Intentional overdose 851.89 10.10 840 111678 73312 63303192
Serotonin syndrome 647.13 10.10 479 112039 28203 63348301
Toxicity to various agents 630.32 10.10 1367 111151 245883 63130621
Suicide attempt 569.35 10.10 618 111900 60300 63316204
Intentional self-injury 566.08 10.10 423 112095 25264 63351240
Drug abuse 509.10 10.10 635 111883 71883 63304621
Completed suicide 490.20 10.10 905 111613 144768 63231736
Sopor 479.50 10.10 361 112157 21803 63354701
Drug interaction 440.06 10.10 1135 111383 227996 63148508
Suicidal ideation 427.57 10.10 540 111978 61881 63314623
Hyponatraemia 387.37 10.10 704 111814 111196 63265308
Electrocardiogram QT prolonged 384.14 10.10 500 112018 59030 63317474
Somnolence 330.33 10.10 873 111645 177812 63198692
Overdose 327.07 10.10 666 111852 114412 63262092
Agitation 303.11 10.10 447 112071 59310 63317194
Systemic lupus erythematosus 292.43 10.10 20 112498 208898 63167606
Pemphigus 288.41 10.10 8 112510 183718 63192786
Joint swelling 280.45 10.10 115 112403 327551 63048953
Arthropathy 276.13 10.10 43 112475 234749 63141755
Glossodynia 247.78 10.10 18 112500 178858 63197646
Infusion related reaction 247.15 10.10 65 112453 245456 63131048
Rheumatoid arthritis 241.10 10.10 75 112443 253744 63122760
Depressed level of consciousness 235.84 10.10 407 112111 61671 63314833
Restlessness 227.77 10.10 271 112247 29182 63347322
Treatment failure 226.11 10.10 40 112478 199003 63177501
Tremor 222.12 10.10 624 111894 131615 63244889
Rash 218.02 10.10 415 112103 560456 62816048
Alopecia 216.40 10.10 169 112349 337367 63039137
Synovitis 209.21 10.10 39 112479 186879 63189625
Disorientation 207.09 10.10 300 112218 39152 63337352
Contraindicated product administered 203.66 10.10 66 112452 217582 63158922
Swelling 203.12 10.10 118 112400 275260 63101244
Muscle rigidity 202.64 10.10 166 112352 11334 63365170
Tachycardia 198.84 10.10 558 111960 117598 63258906
Inappropriate antidiuretic hormone secretion 197.73 10.10 186 112332 15276 63361228
Coma 197.73 10.10 385 112133 63979 63312525
Neuroleptic malignant syndrome 195.79 10.10 166 112352 11890 63364614
Fall 191.85 10.10 1270 111248 391064 62985440
Abdominal discomfort 191.71 10.10 172 112346 320713 63055791
Sinusitis 185.13 10.10 85 112433 226568 63149936
Drug ineffective 181.85 10.10 1099 111419 1043666 62332838
Confusional state 181.25 10.10 864 111654 235516 63140988
Disturbance in attention 174.22 10.10 272 112246 37917 63338587
Therapeutic product effect decreased 168.06 10.10 66 112452 193121 63183383
Drug intolerance 167.55 10.10 180 112338 308481 63068023
Dissociation 163.75 10.10 87 112431 2832 63373672
Pericarditis 161.84 10.10 21 112497 131558 63244946
Hypersensitivity 155.18 10.10 174 112344 292511 63083993
Dyskinesia 154.50 10.10 234 112284 31768 63344736
Depersonalisation/derealisation disorder 154.33 10.10 66 112452 1306 63375198
Pain 152.28 10.10 736 111782 739892 62636612
Akathisia 150.71 10.10 127 112391 9019 63367485
Nasopharyngitis 148.56 10.10 139 112379 254118 63122386
Helicobacter infection 142.09 10.10 5 112513 92780 63283724
Duodenal ulcer perforation 139.83 10.10 3 112515 87206 63289298
Mydriasis 136.24 10.10 135 112383 11821 63364683
Arthralgia 135.25 10.10 536 111982 569174 62807330
Anxiety 135.21 10.10 750 111768 216791 63159713
Discomfort 133.19 10.10 65 112453 167309 63209195
Gastric pH decreased 131.18 10.10 50 112468 724 63375780
Restless legs syndrome 126.27 10.10 160 112358 18371 63358133
Urinary retention 126.11 10.10 207 112311 30094 63346410
Drug hypersensitivity 125.63 10.10 224 112294 310463 63066041
Depressed mood 124.11 10.10 241 112277 39950 63336554
Derealisation 122.45 10.10 54 112464 1154 63375350
Peripheral swelling 122.34 10.10 176 112342 265766 63110738
Mania 121.63 10.10 129 112389 12238 63364266
Nightmare 120.27 10.10 159 112359 19035 63357469
Drug withdrawal syndrome 117.55 10.10 189 112329 27005 63349499
Product use issue 116.93 10.10 131 112387 220389 63156115
Aggression 113.67 10.10 172 112346 23326 63353178
Dysarthria 112.76 10.10 240 112278 42471 63334033
Feeling of despair 112.59 10.10 63 112455 2276 63374228
Psoriatic arthropathy 111.58 10.10 15 112503 91505 63284999
Hallucination 111.58 10.10 278 112240 54539 63321965
Delirium 111.07 10.10 264 112254 50277 63326227
Folliculitis 110.51 10.10 3 112515 70314 63306190
Wound 109.29 10.10 78 112440 163185 63213319
Seizure 109.00 10.10 495 112023 132139 63244365
Cogwheel rigidity 108.49 10.10 58 112460 1912 63374592
Impaired healing 107.25 10.10 25 112493 102517 63273987
Hallucination, visual 106.02 10.10 150 112368 19148 63357356
Dystonia 100.04 10.10 123 112395 13696 63362808
Tardive dyskinesia 96.87 10.10 96 112422 8406 63368098
Hyperhidrosis 95.04 10.10 411 112107 107425 63269079
Poisoning 94.47 10.10 119 112399 13581 63362923
Psychotic disorder 91.66 10.10 164 112354 25548 63350956
Withdrawal syndrome 87.82 10.10 140 112378 19857 63356647
Muscle injury 86.48 10.10 8 112510 65337 63311167
Blister 85.59 10.10 63 112455 129751 63246753
Hepatic enzyme increased 85.25 10.10 142 112376 202186 63174318
Depression 81.63 10.10 612 111906 195880 63180624
H1N1 influenza 81.43 10.10 46 112472 1693 63374811
Loss of consciousness 81.29 10.10 419 112099 117702 63258802
Urticaria 80.95 10.10 105 112413 165697 63210807
Rheumatoid factor negative 80.85 10.10 33 112485 578 63375926
Labelled drug-drug interaction medication error 79.37 10.10 108 112410 13291 63363213
Irritable bowel syndrome 78.78 10.10 24 112494 82388 63294116
Lower respiratory tract infection 78.78 10.10 71 112447 132236 63244268
Injection site pain 78.07 10.10 69 112449 129731 63246773
Parkinsonism 77.32 10.10 94 112424 10345 63366159
Intentional product use issue 76.90 10.10 68 112450 127824 63248680
General physical health deterioration 75.20 10.10 612 111906 200790 63175714
Drooling 74.87 10.10 59 112459 3809 63372695
Hypertonia 73.55 10.10 63 112455 4574 63371930
Hallucination, auditory 72.40 10.10 101 112417 12723 63363781
Myoclonus 70.93 10.10 112 112406 15756 63360748
Knee arthroplasty 70.77 10.10 7 112511 54199 63322305
Infection 70.50 10.10 192 112326 228981 63147523
Speech disorder 68.38 10.10 192 112326 40437 63336067
Asphyxia 67.12 10.10 68 112450 6113 63370391
Schizophrenia 66.33 10.10 85 112433 9867 63366637
Arthritis 65.73 10.10 65 112453 115856 63260648
C-reactive protein abnormal 65.65 10.10 4 112514 46092 63330412
Pleurothotonus 64.03 10.10 36 112482 1313 63375191
Drug dependence 62.80 10.10 136 112382 24347 63352157
Altered state of consciousness 62.28 10.10 138 112380 25092 63351412
Mood swings 62.00 10.10 114 112404 18134 63358370
Incontinence 61.81 10.10 89 112429 11543 63364961
Gastrointestinal disorder 61.12 10.10 86 112432 131153 63245351
Pruritus 59.86 10.10 385 112133 361068 63015436
Delusion 59.59 10.10 89 112429 11928 63364576
Intestinal pseudo-obstruction 59.25 10.10 30 112488 882 63375622
Maternal exposure during pregnancy 56.60 10.10 200 112318 219862 63156642
Headache 56.48 10.10 787 111731 632454 62744050
Sedation 56.33 10.10 174 112344 38635 63337869
Accidental overdose 55.86 10.10 126 112392 23183 63353321
Depressive symptom 55.63 10.10 51 112467 4051 63372453
Extrapyramidal disorder 55.60 10.10 91 112427 13193 63363311
Hip arthroplasty 55.32 10.10 9 112509 47637 63328867
Fatigue 55.27 10.10 1178 111340 886850 62489654
Product monitoring error 55.21 10.10 53 112465 4463 63372041
Stomatitis 54.21 10.10 102 112416 138623 63237881
Injection site erythema 53.99 10.10 41 112477 83133 63293371
Hyperkinesia 53.78 10.10 35 112483 1669 63374835
Impulsive behaviour 53.63 10.10 34 112484 1549 63374955
Ventricular fibrillation 53.37 10.10 84 112434 11783 63364721
Suspected suicide 53.36 10.10 62 112456 6506 63369998
Gestational diabetes 53.29 10.10 70 112448 8326 63368178
Hypophagia 52.87 10.10 148 112370 31111 63345393
Poisoning deliberate 52.68 10.10 81 112437 11137 63365367
Feeling jittery 52.33 10.10 89 112429 13314 63363190
Feeling of body temperature change 51.59 10.10 53 112465 4844 63371660
Injection site pruritus 51.32 10.10 9 112509 45107 63331397
Rhabdomyolysis 51.25 10.10 183 112335 43768 63332736
Parosmia 51.12 10.10 59 112459 6147 63370357
Abnormal dreams 50.89 10.10 77 112441 10439 63366065
Cardiac arrest 50.83 10.10 309 112209 92236 63284268
Hallucinations, mixed 50.39 10.10 52 112466 4777 63371727
Psychomotor retardation 50.32 10.10 47 112471 3823 63372681
Off label use 50.06 10.10 868 111650 673594 62702910
On and off phenomenon 49.06 10.10 34 112484 1801 63374703
Cough 48.85 10.10 311 112207 292432 63084072
Neonatal seizure 48.64 10.10 22 112496 500 63376004
Product prescribing error 47.98 10.10 128 112390 26161 63350343
Therapeutic product ineffective 47.77 10.10 33 112485 1739 63374765
Polydipsia 47.73 10.10 44 112474 3520 63372984
Circulatory collapse 47.54 10.10 114 112404 21824 63354680
Muscle disorder 47.39 10.10 51 112467 4918 63371586
Abnormal behaviour 47.14 10.10 112 112406 21314 63355190
Device expulsion 46.95 10.10 4 112514 34918 63341586
Syncope 46.67 10.10 362 112156 117023 63259481
Major depression 46.54 10.10 64 112454 7954 63368550
Unresponsive to stimuli 45.76 10.10 148 112370 33668 63342836
Drug withdrawal syndrome neonatal 45.22 10.10 34 112484 2047 63374457
Product administration error 44.94 10.10 113 112405 22284 63354220
Menstrual disorder 44.58 10.10 51 112467 5262 63371242
Blood prolactin increased 44.51 10.10 42 112476 3461 63373043
Nasal congestion 44.39 10.10 31 112487 65629 63310875
Ill-defined disorder 43.90 10.10 48 112470 81707 63294797
Dysphagia 43.82 10.10 288 112230 88297 63288207
Pallor 43.39 10.10 136 112382 30432 63346072
Psychomotor hyperactivity 43.22 10.10 72 112446 10591 63365913
Acute motor-sensory axonal neuropathy 43.05 10.10 17 112501 272 63376232
Liver injury 43.04 10.10 27 112491 60493 63316011
Hypokalaemia 42.87 10.10 323 112195 103481 63273023
Anger 42.55 10.10 78 112440 12378 63364126
Bradyphrenia 42.46 10.10 57 112461 6923 63369581
Decreased appetite 42.27 10.10 652 111866 250400 63126104
Cyanosis 42.21 10.10 93 112425 16842 63359662
Hypertonia neonatal 42.21 10.10 16 112502 228 63376276
Bradykinesia 42.19 10.10 49 112469 5139 63371365
Pain in extremity 41.68 10.10 381 112137 331105 63045399
Product dose omission issue 41.12 10.10 245 112273 234068 63142436
Panic reaction 40.09 10.10 43 112475 4131 63372373
Panic attack 40.02 10.10 108 112410 22223 63354281
Hypotension 39.60 10.10 691 111827 271913 63104591
Generalised tonic-clonic seizure 39.27 10.10 127 112391 28889 63347615
Osteoarthritis 39.12 10.10 68 112450 95275 63281229
Miosis 38.69 10.10 56 112462 7297 63369207
Chorea 38.58 10.10 28 112490 1596 63374908
Cardio-respiratory arrest 38.01 10.10 208 112310 59751 63316753
Sleep paralysis 37.95 10.10 20 112498 640 63375864
Erythema 37.42 10.10 172 112346 175579 63200925
Psychotic symptom 37.28 10.10 27 112491 1534 63374970
Aphasia 37.28 10.10 136 112382 32864 63343640
Intentional product misuse 37.07 10.10 209 112309 60708 63315796
Irritability 36.98 10.10 132 112386 31562 63344942
Galactorrhoea 36.77 10.10 41 112477 4114 63372390
Persecutory delusion 36.50 10.10 34 112484 2756 63373748
Hypoaesthesia oral 36.44 10.10 75 112443 12958 63363546
Coma scale abnormal 35.91 10.10 45 112473 5108 63371396
Psoriasis 35.69 10.10 62 112456 86895 63289609
Asthma 35.47 10.10 112 112406 127449 63249055
Phagophobia 35.38 10.10 10 112508 51 63376453
Paranoia 34.79 10.10 69 112449 11610 63364894
Injection site bruising 33.73 10.10 16 112502 41894 63334610
Epilepsy 33.55 10.10 115 112403 26950 63349554
Aspiration 33.40 10.10 65 112453 10786 63365718
Bursitis 33.27 10.10 12 112506 37029 63339475
Opisthotonus 33.16 10.10 15 112503 341 63376163
Respiratory arrest 33.13 10.10 130 112388 32515 63343989
Blood cholesterol increased 32.61 10.10 74 112444 93958 63282546
Paralysis 32.57 10.10 61 112457 9839 63366665
Autonomic nervous system imbalance 32.44 10.10 32 112486 2786 63373718
Tonic clonic movements 32.42 10.10 24 112494 1411 63375093
Haematemesis 32.41 10.10 123 112395 30289 63346215
Back pain 32.15 10.10 306 112212 263839 63112665
Hepatocellular injury 31.91 10.10 114 112404 27267 63349237
Emotional disorder 31.69 10.10 72 112446 13307 63363197
Inflammation 31.68 10.10 61 112457 82212 63294292
Neonatal asphyxia 31.58 10.10 14 112504 303 63376201
Immune reconstitution inflammatory syndrome 31.52 10.10 46 112472 6038 63370466
Fracture 31.44 10.10 91 112427 19493 63357011
Abulia 31.40 10.10 16 112502 477 63376027
Systemic infection 31.37 10.10 40 112478 4620 63371884
Affective disorder 31.17 10.10 46 112472 6100 63370404
Anticholinergic syndrome 31.11 10.10 29 112489 2353 63374151
Myelosuppression 31.10 10.10 3 112515 23700 63352804
Histrionic personality disorder 31.05 10.10 9 112509 51 63376453
Red blood cell sedimentation rate increased 30.76 10.10 20 112498 43962 63332542
Mental disorder 30.28 10.10 108 112410 25811 63350693
Self-injurious ideation 30.25 10.10 30 112488 2629 63373875
Urinary hesitation 30.04 10.10 28 112490 2272 63374232
Sinus tachycardia 29.98 10.10 103 112415 24165 63352339
Fibromyalgia 29.79 10.10 61 112457 80359 63296145
Status epilepticus 29.67 10.10 76 112442 15157 63361347
Bradypnoea 29.66 10.10 34 112484 3516 63372988
Blood lactic acid decreased 29.66 10.10 11 112507 147 63376357
Hyperreflexia 29.50 10.10 44 112474 5890 63370614
Chemical burn of oral cavity 29.31 10.10 9 112509 64 63376440
Rhonchi 29.18 10.10 29 112489 2547 63373957
Therapeutic drug monitoring analysis not performed 29.18 10.10 22 112496 1330 63375174
Cognitive disorder 29.15 10.10 184 112334 55631 63320873
Pneumonia aspiration 29.15 10.10 130 112388 34410 63342094
Sensory loss 28.72 10.10 59 112459 10179 63366325
Therapeutic product effect incomplete 28.67 10.10 119 112399 124937 63251567
Crush syndrome 28.01 10.10 10 112508 119 63376385
Wheezing 27.95 10.10 82 112436 95513 63280991
Sleep disorder 27.81 10.10 243 112275 81323 63295181
Progressive multifocal leukoencephalopathy 27.67 10.10 67 112451 12904 63363600
Acute respiratory distress syndrome 27.44 10.10 98 112420 23436 63353068
Postural tremor 27.14 10.10 13 112505 338 63376166
Antipsychotic drug level decreased 27.07 10.10 13 112505 340 63376164
Agranulocytosis 27.07 10.10 102 112416 25032 63351472
Indifference 26.94 10.10 10 112508 134 63376370
Musculoskeletal stiffness 26.88 10.10 204 112314 184414 63192090
Ballismus 26.87 10.10 10 112508 135 63376369
Euphoric mood 26.86 10.10 38 112480 4849 63371655
Joint range of motion decreased 26.68 10.10 12 112506 32416 63344088
Merycism 26.68 10.10 12 112506 269 63376235
Tremor neonatal 26.67 10.10 10 112508 138 63376366
Blood bilirubin decreased 26.55 10.10 17 112501 788 63375716
Vitamin B1 decreased 26.52 10.10 11 112507 201 63376303
Osteoporosis 26.26 10.10 38 112480 57300 63319204
Pyelonephritis 26.06 10.10 80 112438 17698 63358806
Incoherent 26.05 10.10 36 112482 4494 63372010
Acute psychosis 26.01 10.10 27 112491 2498 63374006
Sensorimotor disorder 25.90 10.10 14 112504 472 63376032
Substance abuse 25.86 10.10 37 112481 4770 63371734
Helplessness 25.78 10.10 12 112506 292 63376212
Language disorder 25.74 10.10 25 112493 2135 63374369
Postmortem blood drug level increased 25.67 10.10 15 112503 589 63375915
Injection site reaction 25.63 10.10 40 112478 58484 63318020
Social avoidant behaviour 25.61 10.10 29 112489 2959 63373545
Norepinephrine increased 25.57 10.10 8 112510 61 63376443
Hypotonia 25.45 10.10 53 112465 9232 63367272
Newborn persistent pulmonary hypertension 25.43 10.10 11 112507 224 63376280
Adverse event 25.23 10.10 51 112467 67508 63308996
Parkinsonian gait 25.04 10.10 14 112504 505 63375999
Cerebral ventricle dilatation 25.04 10.10 18 112500 1011 63375493
Blood sodium decreased 24.95 10.10 97 112421 24155 63352349
Salivary hypersecretion 24.92 10.10 47 112471 7619 63368885
Tongue movement disturbance 24.81 10.10 12 112506 319 63376185
Electrocardiogram abnormal 24.70 10.10 52 112466 9127 63367377
Agitation neonatal 24.59 10.10 14 112504 523 63375981
Foetal exposure during pregnancy 24.53 10.10 117 112401 31845 63344659
Vertigo 24.52 10.10 186 112332 59701 63316803
Visceral congestion 24.50 10.10 12 112506 328 63376176
Injection site swelling 24.37 10.10 29 112489 47543 63328961
Upper gastrointestinal haemorrhage 24.15 10.10 81 112437 18771 63357733
Rhinorrhoea 24.07 10.10 50 112468 65527 63310977
Mental impairment 23.93 10.10 67 112451 14084 63362420
Stoma site discharge 23.91 10.10 21 112497 1577 63374927
Apathy 23.88 10.10 50 112468 8744 63367760
Facial nerve disorder 23.84 10.10 14 112504 555 63375949
CYP3A4 polymorphism 23.66 10.10 8 112510 80 63376424
Orgasm abnormal 23.57 10.10 8 112510 81 63376423
Macular degeneration 23.47 10.10 7 112511 24369 63352135
Cerebellar syndrome 23.23 10.10 30 112488 3509 63372995
Neonatal respiratory failure 23.11 10.10 11 112507 282 63376222
Fungal infection 22.89 10.10 19 112499 36855 63339649
Upper respiratory tract infection 22.82 10.10 72 112446 81975 63294529
Activation syndrome 22.75 10.10 10 112508 212 63376292
Radial nerve palsy 22.71 10.10 13 112505 491 63376013
Bipolar I disorder 22.67 10.10 22 112496 1877 63374627
Tachycardia paroxysmal 22.58 10.10 11 112507 297 63376207
Neuropathy peripheral 22.58 10.10 114 112404 113553 63262951
Neonatal hypoxia 22.42 10.10 14 112504 621 63375883
Torsade de pointes 22.36 10.10 63 112455 13288 63363216
Sudden death 22.32 10.10 54 112464 10395 63366109
Swollen tongue 22.24 10.10 121 112397 34679 63341825
Acute abdomen 22.20 10.10 20 112498 1553 63374951
Alkalosis hypochloraemic 22.03 10.10 9 112509 158 63376346
Death 22.01 10.10 841 111677 373540 63002964
Drug reaction with eosinophilia and systemic symptoms 21.86 10.10 118 112400 33718 63342786
Hypothermia 21.70 10.10 63 112455 13518 63362986
Dementia 21.69 10.10 78 112440 18716 63357788
Thinking abnormal 21.67 10.10 54 112464 10589 63365915
Antidepressant drug level above therapeutic 21.66 10.10 12 112506 425 63376079
Freezing phenomenon 21.65 10.10 18 112500 1254 63375250
Mutism 21.59 10.10 20 112498 1610 63374894
Suicidal behaviour 21.59 10.10 25 112493 2614 63373890
Lower limb fracture 21.49 10.10 8 112510 24213 63352291
Bradycardia 21.36 10.10 211 112307 73016 63303488
Vagus nerve disorder 21.30 10.10 8 112510 111 63376393
Sialoadenitis 21.15 10.10 20 112498 1652 63374852
Herpes zoster 21.13 10.10 75 112443 82387 63294117
Drug tolerance decreased 20.97 10.10 3 112515 17470 63359034
Gamma-glutamyltransferase increased 20.86 10.10 117 112401 33914 63342590
Anaemia macrocytic 20.70 10.10 28 112490 3426 63373078
Infantile vomiting 20.67 10.10 8 112510 121 63376383
Orthostatic hypotension 20.65 10.10 122 112396 36038 63340466
Non-cardiogenic pulmonary oedema 20.62 10.10 14 112504 717 63375787
Cataract 20.52 10.10 44 112474 57009 63319495
Hypnagogic hallucination 20.51 10.10 9 112509 190 63376314
Lactic acidosis 20.48 10.10 127 112391 38160 63338344
Serum serotonin increased 20.25 10.10 9 112509 196 63376308
Reduced facial expression 20.21 10.10 21 112497 1945 63374559
Therapy non-responder 20.15 10.10 68 112450 75833 63300671
Natural killer cell count decreased 20.14 10.10 6 112512 38 63376466
Gastrooesophageal reflux disease 20.11 10.10 94 112424 95545 63280959
Akinesia 20.05 10.10 19 112499 1574 63374930
Breast discomfort 20.05 10.10 12 112506 493 63376011
Cerebral mass effect 20.02 10.10 15 112503 898 63375606
Blood pressure increased 20.01 10.10 187 112331 161875 63214629
Purple glove syndrome 19.92 10.10 9 112509 204 63376300
Respiratory disorder neonatal 19.92 10.10 17 112501 1228 63375276
Retinal detachment 19.91 10.10 37 112481 5932 63370572
Thymus disorder 19.84 10.10 10 112508 291 63376213
Anaphylactic reaction 19.83 10.10 56 112462 66044 63310460
Alcoholism 19.74 10.10 20 112498 1798 63374706
Clonus 19.73 10.10 32 112486 4604 63371900
Abnormal weight gain 19.63 10.10 20 112498 1810 63374694
Eosinophilic cellulitis 19.50 10.10 6 112512 43 63376461
Thirst 19.49 10.10 62 112456 13979 63362525
Bradycardia neonatal 19.46 10.10 15 112503 937 63375567
Giant cell arteritis 19.24 10.10 22 112496 2269 63374235
Drop attacks 19.09 10.10 13 112505 669 63375835
Bipolar disorder 19.04 10.10 43 112475 7917 63368587
Stupor 18.86 10.10 30 112488 4245 63372259
Sporotrichosis 18.82 10.10 6 112512 49 63376455
Acute kidney injury 18.77 10.10 605 111913 262810 63113694
Aptyalism 18.71 10.10 12 112506 558 63375946
Migraine 18.67 10.10 107 112411 103239 63273265
Pulmonary fibrosis 18.61 10.10 26 112492 39783 63336721
Tachyphrenia 18.47 10.10 17 112501 1357 63375147
Cytomegalovirus infection 18.46 10.10 7 112511 20945 63355559
Arrhythmia 18.24 10.10 123 112395 38017 63338487
Tearfulness 18.20 10.10 29 112489 4110 63372394
Neglect of personal appearance 18.20 10.10 7 112511 104 63376400
Hyperthermia 18.16 10.10 46 112472 9110 63367394
Bulimia nervosa 18.14 10.10 11 112507 463 63376041
Hallucination, synaesthetic 18.11 10.10 6 112512 56 63376448
Nephrolithiasis 18.09 10.10 29 112489 41955 63334549
Premature labour 18.08 10.10 56 112462 12448 63364056
Bundle branch block right 17.96 10.10 32 112486 4966 63371538
Agonal rhythm 17.94 10.10 5 112513 24 63376480
Illusion 17.92 10.10 15 112503 1055 63375449
Humerus fracture 17.90 10.10 45 112473 8871 63367633
Hypotonia neonatal 17.90 10.10 16 112502 1230 63375274
Compulsive shopping 17.84 10.10 13 112505 746 63375758
Brief psychotic disorder with marked stressors 17.83 10.10 6 112512 59 63376445
Regressive behaviour 17.80 10.10 8 112510 179 63376325
Blood pressure diastolic decreased 17.77 10.10 9 112509 22697 63353807
Balance disorder 17.69 10.10 228 112290 84194 63292310
Negative thoughts 17.64 10.10 14 112504 913 63375591
Pulse absent 17.54 10.10 33 112485 5341 63371163
Skin exfoliation 17.44 10.10 31 112487 43071 63333433
Exostosis 17.43 10.10 5 112513 17857 63358647
Aspartate aminotransferase decreased 17.40 10.10 13 112505 775 63375729
False positive investigation result 17.22 10.10 12 112506 641 63375863
Febrile neutropenia 17.18 10.10 131 112387 118318 63258186
Potentiating drug interaction 17.10 10.10 29 112489 4327 63372177
Mobility decreased 17.10 10.10 135 112383 121024 63255480
Ear infection 16.84 10.10 26 112492 38187 63338317
Post-traumatic stress disorder 16.83 10.10 32 112486 5219 63371285
Vasodilatation 16.82 10.10 21 112497 2374 63374130
Vitamin B12 decreased 16.80 10.10 26 112492 3594 63372910
Cellulitis orbital 16.80 10.10 11 112507 530 63375974
Homicidal ideation 16.74 10.10 18 112500 1734 63374770
Drug dose titration not performed 16.73 10.10 11 112507 534 63375970
Hyperphagia 16.51 10.10 18 112500 1761 63374743
Thyroxine free decreased 16.50 10.10 12 112506 686 63375818
Skin ulcer 16.50 10.10 32 112486 43013 63333491
Medulloblastoma 16.48 10.10 5 112513 34 63376470
COVID-19 16.44 10.10 125 112393 112978 63263526
Abdominal pain upper 16.43 10.10 262 112256 206182 63170322
Therapeutic response decreased 16.41 10.10 55 112463 61470 63315034
Spina bifida 16.40 10.10 13 112505 846 63375658
Blood pressure diastolic abnormal 16.32 10.10 3 112515 14539 63361965
Parkinson's disease 16.23 10.10 15 112503 1204 63375300
Cardiac output increased 16.22 10.10 8 112510 222 63376282
Product quality issue 16.19 10.10 24 112494 35841 63340663
Cardiac hypertrophy 16.17 10.10 14 112504 1031 63375473
Platelet count decreased 16.11 10.10 130 112388 115992 63260512
Oedema 16.10 10.10 104 112414 97518 63278986
Sinus congestion 16.06 10.10 6 112512 18117 63358387
Logorrhoea 16.04 10.10 21 112497 2489 63374015
Decubitus ulcer 16.04 10.10 48 112470 10472 63366032
Pulmonary renal syndrome 16.01 10.10 10 112508 444 63376060
Empty sella syndrome 16.00 10.10 5 112513 38 63376466
Tinnitus 15.92 10.10 113 112405 35515 63340989
Medication error 15.91 10.10 152 112366 52132 63324372
Faecaloma 15.86 10.10 40 112478 7901 63368603
Grip strength decreased 15.77 10.10 10 112508 22277 63354227
Lip dry 15.72 10.10 4 112514 15466 63361038
Essential tremor 15.68 10.10 14 112504 1074 63375430
Aspergillus test positive 15.65 10.10 9 112509 343 63376161
Skull fracture 15.61 10.10 14 112504 1081 63375423
Hyperacusis 15.60 10.10 19 112499 2094 63374410
Gait disturbance 15.55 10.10 430 112088 182748 63193756
Binge eating 15.46 10.10 10 112508 472 63376032
Transferrin saturation decreased 15.43 10.10 12 112506 760 63375744
Skin necrosis 15.40 10.10 3 112515 13947 63362557
Drowning 15.25 10.10 10 112508 483 63376021
Stoma site inflammation 15.25 10.10 10 112508 483 63376021
Catatonia 15.24 10.10 28 112490 4449 63372055
Snoring 15.23 10.10 27 112491 4175 63372329
Pyroglutamic acidosis 15.20 10.10 11 112507 624 63375880
Tenosynovitis 15.16 10.10 3 112515 13792 63362712
Creatinine renal clearance decreased 15.13 10.10 5 112513 16303 63360201
Resuscitation 15.08 10.10 14 112504 1130 63375374
Respiratory depression 15.05 10.10 56 112462 13659 63362845
Dyspraxia 15.01 10.10 8 112510 262 63376242
Accidental death 14.97 10.10 18 112500 1958 63374546
Granulocytopenia neonatal 14.94 10.10 4 112514 16 63376488
Loss of libido 14.94 10.10 15 112503 1334 63375170
Contusion 14.94 10.10 182 112336 149862 63226642
Heart rate decreased 14.88 10.10 37 112481 45523 63330981
Formication 14.82 10.10 27 112491 4264 63372240
Sinus disorder 14.81 10.10 13 112505 24540 63351964
Enterococcus test positive 14.78 10.10 14 112504 1159 63375345
Developmental hip dysplasia 14.73 10.10 15 112503 1357 63375147
Pulmonary vein occlusion 14.70 10.10 6 112512 105 63376399
Eyelid myoclonus 14.65 10.10 6 112512 106 63376398
Pneumonia 14.64 10.10 661 111857 456106 62920398
Refusal of treatment by patient 14.63 10.10 31 112487 5466 63371038
Ear pain 14.59 10.10 26 112492 36092 63340412
Communication disorder 14.58 10.10 20 112498 2480 63374024
Psychiatric decompensation 14.46 10.10 15 112503 1386 63375118
Maternal drugs affecting foetus 14.46 10.10 30 112488 5212 63371292
Pyrexia 14.44 10.10 684 111834 469794 62906710
Liver disorder 14.31 10.10 48 112470 53639 63322865
Nystagmus 14.21 10.10 33 112485 6187 63370317
B-lymphocyte count increased 14.16 10.10 6 112512 116 63376388
Congenital hand malformation 14.15 10.10 8 112510 295 63376209
Palmar-plantar erythrodysaesthesia syndrome 14.11 10.10 12 112506 23003 63353501
C-reactive protein increased 14.08 10.10 104 112414 94603 63281901
Neck pain 14.06 10.10 69 112449 69249 63307255
Shared psychotic disorder 14.06 10.10 4 112514 21 63376483
Compulsive sexual behaviour 14.04 10.10 5 112513 59 63376445
Intestinal mucosal atrophy 13.94 10.10 3 112515 3 63376501
Injection site rash 13.92 10.10 8 112510 18801 63357703
Antidepressant drug level increased 13.83 10.10 8 112510 308 63376196
Optic nerve disorder 13.82 10.10 12 112506 887 63375617
Bronchitis 13.82 10.10 148 112370 124787 63251717
Stoma site hypergranulation 13.69 10.10 8 112510 314 63376190
Injury 13.68 10.10 75 112443 73172 63303332
Anal infection 13.68 10.10 5 112513 64 63376440
Dysdiadochokinesis 13.66 10.10 6 112512 127 63376377
Dystrophic calcification 13.61 10.10 6 112512 128 63376376
Tendonitis 13.60 10.10 9 112509 19606 63356898
Fluid retention 13.55 10.10 57 112461 59629 63316875
Polydipsia psychogenic 13.54 10.10 5 112513 66 63376438
Interstitial lung disease 13.51 10.10 60 112458 61848 63314656
Affect lability 13.49 10.10 47 112471 11104 63365400
Eye haematoma 13.47 10.10 5 112513 67 63376437
Extensor plantar response 13.47 10.10 14 112504 1297 63375207
Rabbit syndrome 13.47 10.10 8 112510 324 63376180
Ataxia 13.43 10.10 58 112460 15137 63361367
Intrusive thoughts 13.37 10.10 7 112511 221 63376283
Injection site haemorrhage 13.36 10.10 14 112504 24300 63352204
Obsessive-compulsive symptom 13.27 10.10 5 112513 70 63376434
Dyspnoea at rest 13.25 10.10 25 112493 4054 63372450
Viral infection 13.25 10.10 27 112491 35636 63340868
Foot deformity 13.21 10.10 18 112500 27835 63348669
Immunodeficiency 13.12 10.10 10 112508 20244 63356260
Long QT syndrome 13.10 10.10 22 112496 3257 63373247
Failure to thrive 13.08 10.10 35 112483 7163 63369341
Chronic spontaneous urticaria 13.06 10.10 13 112505 1144 63375360
Abdominal rigidity 13.04 10.10 17 112501 2007 63374497
Insomnia 12.97 10.10 485 112033 214767 63161737
Dreamy state 12.96 10.10 4 112514 29 63376475
Blood pressure systolic increased 12.90 10.10 42 112476 47355 63329149
Increased appetite 12.89 10.10 42 112476 9588 63366916
Myocardial infarction 12.88 10.10 114 112404 99779 63276725
Gambling 12.87 10.10 7 112511 239 63376265
Glassy eyes 12.84 10.10 5 112513 77 63376427
Paranasal sinus inflammation 12.83 10.10 9 112509 486 63376018
Cerebral atrophy 12.83 10.10 28 112490 5038 63371466
Food craving 12.78 10.10 15 112503 1591 63374913
Retrograde amnesia 12.75 10.10 9 112509 491 63376013
Secretion discharge 12.75 10.10 3 112515 12228 63364276
Fibula agenesis 12.73 10.10 3 112515 6 63376498
Selective eating disorder 12.73 10.10 17 112501 2055 63374449
Generalised anxiety disorder 12.71 10.10 17 112501 2057 63374447
Orthostatic intolerance 12.69 10.10 13 112505 1184 63375320
Kussmaul respiration 12.66 10.10 7 112511 247 63376257
Basophil count decreased 12.60 10.10 6 112512 154 63376350
Hyperlactacidaemia 12.58 10.10 20 112498 2829 63373675
Lipohypertrophy 12.56 10.10 10 112508 655 63375849
Repetitive speech 12.47 10.10 8 112510 372 63376132
Phaeochromocytoma 12.45 10.10 9 112509 510 63375994
Blood glucose fluctuation 12.40 10.10 26 112492 4550 63371954
Hemianopia homonymous 12.39 10.10 10 112508 668 63375836
Chemical burns of eye 12.39 10.10 5 112513 85 63376419
Basal cell carcinoma 12.38 10.10 19 112499 27972 63348532
Personality disorder 12.38 10.10 30 112488 5781 63370723
Influenza 12.35 10.10 128 112390 108594 63267910
Visual acuity reduced transiently 12.28 10.10 6 112512 163 63376341
Antiphospholipid antibodies 12.25 10.10 6 112512 164 63376340
Stoma site erythema 12.25 10.10 13 112505 1234 63375270
Somnambulism 12.22 10.10 29 112489 5514 63370990
Joint injury 12.21 10.10 21 112497 29551 63346953
Cerebellar haematoma 12.19 10.10 8 112510 387 63376117
Ocular hyperaemia 12.18 10.10 16 112502 25128 63351376
Joint stiffness 12.17 10.10 36 112482 41833 63334671
Agoraphobia 12.17 10.10 8 112510 388 63376116
Blood creatine phosphokinase increased 12.17 10.10 94 112424 30336 63346168
Snake bite 12.13 10.10 3 112515 8 63376496
Adverse drug reaction 12.11 10.10 87 112431 79627 63296877
Disorganised speech 12.09 10.10 13 112505 1252 63375252
Chest pain 12.03 10.10 291 112227 215668 63160836
Injection site warmth 11.92 10.10 6 112512 15189 63361315
Flushing 11.87 10.10 81 112437 75006 63301498
Rash pruritic 11.85 10.10 60 112458 59739 63316765
Cholestasis 11.81 10.10 91 112427 29343 63347161
No adverse event 11.75 10.10 36 112482 41369 63335135
Coeliac disease 11.74 10.10 4 112514 12793 63363711
Hyporesponsive to stimuli 11.72 10.10 12 112506 1092 63375412
Inappropriate affect 11.69 10.10 11 112507 903 63375601
Eye irritation 11.68 10.10 13 112505 21958 63354546
Laryngeal granuloma 11.63 10.10 3 112515 10 63376494
Tachypnoea 11.62 10.10 61 112457 17241 63359263
Mixed anxiety and depressive disorder 11.53 10.10 7 112511 295 63376209
Nephropathy toxic 11.50 10.10 40 112478 9439 63367065
Peripheral paralysis 11.46 10.10 5 112513 104 63376400
Nail avulsion 11.41 10.10 6 112512 191 63376313
Female sexual arousal disorder 11.41 10.10 4 112514 45 63376459
Product complaint 11.41 10.10 49 112469 12760 63363744
Antipsychotic drug level below therapeutic 11.41 10.10 7 112511 301 63376203
Somatic delusion 11.39 10.10 9 112509 583 63375921
Haemoptysis 11.32 10.10 21 112497 28705 63347799
Respiratory failure 11.30 10.10 248 112270 101610 63274894
Central nervous system inflammation 11.30 10.10 6 112512 195 63376309
Labelled drug-disease interaction issue 11.25 10.10 4 112514 47 63376457
Oropharyngeal pain 11.24 10.10 110 112408 94377 63282127
Post viral fatigue syndrome 11.22 10.10 7 112511 310 63376194
Product confusion 11.21 10.10 3 112515 12 63376492
Acne 11.10 10.10 15 112503 23278 63353226
Adrenal cyst 11.08 10.10 5 112513 113 63376391
Ageusia 11.08 10.10 51 112467 13677 63362827
Prescribed overdose 10.95 10.10 28 112490 34125 63342379
Hypernatraemia 10.93 10.10 34 112484 7575 63368929
Compulsions 10.92 10.10 6 112512 209 63376295
Glomerular filtration rate decreased 10.90 10.10 50 112468 13391 63363113
Electrocardiogram T wave inversion 10.89 10.10 21 112497 3460 63373044
Somatic symptom disorder 10.83 10.10 18 112500 2642 63373862
Stoma site infection 10.83 10.10 10 112508 802 63375702
Gamma-glutamyltransferase abnormal 10.79 10.10 7 112511 332 63376172
Large for dates baby 10.74 10.10 8 112510 475 63376029
Dyspnoea 10.70 10.10 1018 111500 660295 62716209
Decreased interest 10.64 10.10 20 112498 3234 63373270
Acquired epidermolysis bullosa 10.62 10.10 4 112514 56 63376448
Productive cough 10.59 10.10 67 112451 63141 63313363
Bifascicular block 10.58 10.10 5 112513 126 63376378
Infantile apnoea 10.56 10.10 11 112507 1022 63375482
Anaphylactic shock 10.49 10.10 16 112502 23617 63352887
Drug withdrawal headache 10.49 10.10 4 112514 58 63376446
Granulocyte percentage 10.49 10.10 4 112514 58 63376446
Pharyngeal erythema 10.47 10.10 14 112504 1694 63374810
Walking aid user 10.46 10.10 3 112515 10714 63365790
Arachnoid cyst 10.40 10.10 6 112512 230 63376274
Pharyngitis streptococcal 10.39 10.10 3 112515 10669 63365835
Metamyelocyte count increased 10.38 10.10 6 112512 231 63376273
Mean cell haemoglobin concentration decreased 10.35 10.10 21 112497 3591 63372913
HIV-associated neurocognitive disorder 10.33 10.10 5 112513 133 63376371
Transposition of the great vessels 10.28 10.10 6 112512 235 63376269
Ocular discomfort 10.27 10.10 23 112495 4210 63372294
Poor feeding infant 10.23 10.10 7 112511 363 63376141
Haemorrhage intracranial 10.21 10.10 49 112469 13370 63363134
Poverty of thought content 10.21 10.10 3 112515 18 63376486
Pulmonary embolism 10.20 10.10 275 112243 116409 63260095
Polyneuropathy 10.19 10.10 52 112466 14537 63361967
Tic 10.16 10.10 13 112505 1507 63374997
Deformity 10.13 10.10 4 112514 11680 63364824

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
Toxicity to various agents 589.64 10.79 1346 76670 199016 34679899
Intentional overdose 500.49 10.79 550 77466 43124 34835791
Intentional self-injury 419.30 10.79 302 77714 13469 34865446
Completed suicide 380.32 10.79 739 77277 97429 34781486
Suicide attempt 358.15 10.79 439 77577 38677 34840238
Suicidal ideation 301.87 10.79 410 77606 39978 34838937
Serotonin syndrome 298.54 10.79 290 77726 19643 34859272
Agitation 277.67 10.79 476 77540 56923 34821992
Drug abuse 254.91 10.79 633 77383 98463 34780452
Overdose 254.90 10.79 601 77415 90458 34788457
Somnolence 241.07 10.79 666 77350 110450 34768465
Confusional state 232.05 10.79 778 77238 143382 34735533
Sopor 195.78 10.79 184 77832 11952 34866963
Coma 181.60 10.79 348 77668 45330 34833585
Extrapyramidal disorder 171.80 10.79 176 77840 12704 34866211
Restlessness 141.50 10.79 225 77791 25257 34853658
Anxiety 141.05 10.79 515 77501 98913 34780002
Sedation 140.09 10.79 202 77814 20804 34858111
Aggression 129.96 10.79 276 77740 38688 34840227
Drug interaction 118.57 10.79 886 77130 225060 34653855
Depressed level of consciousness 112.41 10.79 276 77740 42565 34836350
Fall 111.22 10.79 804 77212 202081 34676834
Withdrawal syndrome 109.40 10.79 137 77879 12318 34866597
Accidental overdose 101.20 10.79 170 77846 19970 34858945
Depressed mood 101.01 10.79 166 77850 19151 34859764
Poisoning deliberate 100.65 10.79 105 77911 7739 34871176
Delirium 100.50 10.79 269 77747 43722 34835193
Hallucination, auditory 99.78 10.79 128 77888 11789 34867126
Psychotic disorder 99.23 10.79 188 77828 24264 34854651
Restless legs syndrome 98.65 10.79 107 77909 8247 34870668
Intrusive thoughts 98.59 10.79 34 77982 281 34878634
Hallucination, visual 97.26 10.79 156 77860 17635 34861280
Neuroleptic malignant syndrome 96.33 10.79 156 77860 17778 34861137
Febrile neutropenia 95.16 10.79 99 77917 136750 34742165
Drug withdrawal syndrome 95.14 10.79 164 77852 19670 34859245
Insomnia 87.99 10.79 461 77555 103446 34775469
Parkinsonism 87.09 10.79 99 77917 8039 34870876
Tremor 86.89 10.79 390 77626 82197 34796718
Bradyphrenia 79.78 10.79 74 77942 4724 34874191
Electrocardiogram QT prolonged 79.41 10.79 236 77780 40716 34838199
Mania 79.38 10.79 102 77914 9409 34869506
Dyskinesia 78.48 10.79 162 77854 22251 34856664
Nightmare 78.40 10.79 126 77890 14265 34864650
Akathisia 75.73 10.79 92 77924 8017 34870898
Inappropriate antidiuretic hormone secretion 71.32 10.79 113 77903 12640 34866275
Disorientation 69.87 10.79 197 77819 32991 34845924
Pneumonia aspiration 67.05 10.79 226 77790 41677 34837238
Wrong patient received product 66.90 10.79 52 77964 2602 34876313
Logorrhoea 66.58 10.79 50 77966 2376 34876539
Systemic infection 63.72 10.79 68 77948 5144 34873771
Abnormal behaviour 63.50 10.79 159 77857 24810 34854105
Antidepressant drug level above therapeutic 63.46 10.79 23 77993 223 34878692
Pruritus 62.71 10.79 140 77876 141841 34737074
Depression 62.71 10.79 401 77615 96697 34782218
Homicidal ideation 62.13 10.79 50 77966 2632 34876283
Tachyphrenia 60.93 10.79 37 77979 1232 34877683
Interstitial lung disease 60.86 10.79 35 77981 65247 34813668
Myoclonus 59.46 10.79 113 77903 14612 34864303
Panic attack 58.96 10.79 88 77928 9344 34869571
Illusion 58.31 10.79 31 77985 796 34878119
Paranoia 58.15 10.79 100 77916 11968 34866947
Muscle twitching 57.24 10.79 91 77925 10207 34868708
Hypomania 56.83 10.79 45 77971 2314 34876601
Psychomotor hyperactivity 56.22 10.79 87 77929 9535 34869380
Disturbance in attention 54.60 10.79 154 77862 25791 34853124
Poisoning 52.08 10.79 96 77920 12130 34866785
Apathy 51.16 10.79 70 77946 6862 34872053
Tachycardia 51.02 10.79 344 77672 84428 34794487
Hallucination 51.01 10.79 239 77777 51259 34827656
Muscle rigidity 50.47 10.79 87 77929 10431 34868484
Delusion 49.84 10.79 96 77920 12539 34866376
Bradykinesia 49.74 10.79 52 77964 3841 34875074
Analgesic drug level above therapeutic 47.79 10.79 20 77996 293 34878622
Mood swings 46.95 10.79 72 77944 7829 34871086
Cough 46.57 10.79 175 77841 149965 34728950
General physical health deterioration 46.56 10.79 464 77552 127805 34751110
On and off phenomenon 46.40 10.79 41 77975 2456 34876459
Pyrexia 46.21 10.79 498 77518 332515 34546400
Nasopharyngitis 45.95 10.79 53 77963 69915 34809000
Off label use 45.64 10.79 661 77355 418863 34460052
Priapism 45.56 10.79 56 77960 4938 34873977
Loss of consciousness 44.21 10.79 326 77690 82341 34796574
Delusion of grandeur 43.66 10.79 29 77987 1131 34877784
Miosis 43.33 10.79 77 77939 9458 34869457
Respiratory depression 42.94 10.79 105 77911 16140 34862775
Tardive dyskinesia 42.02 10.79 58 77958 5732 34873183
Anger 41.71 10.79 86 77930 11798 34867117
Rash 40.95 10.79 310 77706 222442 34656473
Pulmonary congestion 40.76 10.79 93 77923 13672 34865243
Arthralgia 40.26 10.79 219 77797 169822 34709093
Illness anxiety disorder 39.95 10.79 15 78001 162 34878753
Mental disorder 39.88 10.79 98 77918 15111 34863804
Sleep disorder 39.78 10.79 158 77858 31530 34847385
Infusion related reaction 39.59 10.79 36 77980 53021 34825894
Myocardial infarction 38.94 10.79 139 77877 120946 34757969
Pneumonia 38.47 10.79 574 77442 362053 34516862
Drug ineffective 37.85 10.79 756 77260 455995 34422920
Feelings of worthlessness 37.65 10.79 17 77999 302 34878613
Disease progression 37.52 10.79 120 77896 107957 34770958
Dystonia 37.50 10.79 78 77938 10767 34868148
Antipsychotic drug level above therapeutic 37.41 10.79 27 77989 1206 34877709
Drug hypersensitivity 36.68 10.79 78 77938 80451 34798464
Drug dependence 36.44 10.79 128 77888 24089 34854826
Altered state of consciousness 36.19 10.79 123 77893 22770 34856145
Loss of libido 36.08 10.79 36 77980 2516 34876399
Renal failure 35.58 10.79 160 77856 130397 34748518
Vestibular disorder 35.33 10.79 25 77991 1082 34877833
Cardiac failure congestive 35.21 10.79 84 77932 83186 34795729
Atrial fibrillation 35.17 10.79 147 77869 122246 34756669
Urinary retention 34.17 10.79 166 77850 36122 34842793
Seizure 34.10 10.79 371 77645 104486 34774429
Thinking abnormal 33.79 10.79 54 77962 6083 34872832
Electrocardiogram abnormal 33.74 10.79 68 77948 9179 34869736
Suspected suicide 33.62 10.79 47 77969 4701 34874214
Dysphoria 33.52 10.79 33 77983 2269 34876646
Respiratory arrest 32.95 10.79 137 77879 27906 34851009
Product prescribing error 32.64 10.79 119 77897 22808 34856107
Platelet count decreased 32.44 10.79 147 77869 119570 34759345
Hyponatraemic coma 32.18 10.79 9 78007 33 34878882
Myelosuppression 32.02 10.79 3 78013 19262 34859653
Blood creatine phosphokinase increased 31.91 10.79 190 77826 44667 34834248
Hyponatraemia 31.87 10.79 303 77713 82388 34796527
Stomatitis 31.54 10.79 29 77987 42485 34836430
Pleurothotonus 31.22 10.79 24 77992 1181 34877734
Rheumatoid arthritis 30.92 10.79 24 77992 38214 34840701
Nasal discomfort 30.79 10.79 27 77989 1601 34877314
Cytomegalovirus infection 30.71 10.79 10 78006 26125 34852790
Dysarthria 30.55 10.79 156 77860 34626 34844289
Irritability 30.10 10.79 122 77894 24568 34854347
Rhabdomyolysis 29.96 10.79 257 77759 67906 34811009
Accidental death 29.95 10.79 32 77984 2424 34876491
Injection site pain 29.66 10.79 26 77990 38979 34839936
Rhinalgia 29.56 10.79 22 77994 1031 34877884
Asphyxia 29.53 10.79 54 77962 6781 34872134
Decreased gait velocity 29.49 10.79 12 78004 163 34878752
Prostate cancer 29.46 10.79 27 77989 39622 34839293
Asthma 29.44 10.79 31 77985 42625 34836290
Substance abuse 28.85 10.79 57 77959 7584 34871331
Catatonia 28.75 10.79 45 77971 4980 34873935
Selective eating disorder 28.75 10.79 27 77989 1751 34877164
Pleural effusion 28.67 10.79 90 77926 81456 34797459
Persecutory delusion 28.65 10.79 32 77984 2548 34876367
Bipolar disorder 28.52 10.79 38 77978 3631 34875284
Erythema 28.47 10.79 102 77914 88678 34790237
Sudden cardiac death 28.26 10.79 38 77978 3663 34875252
Aptyalism 28.22 10.79 15 78001 385 34878530
Platypnoea 28.05 10.79 8 78008 32 34878883
Urticaria 27.92 10.79 61 77955 62316 34816599
Arthritis 27.54 10.79 18 77998 31328 34847587
Herpes zoster 27.30 10.79 22 77994 34377 34844538
Joint swelling 27.28 10.79 58 77958 59832 34819083
Alcohol use 27.02 10.79 35 77981 3253 34875662
Thrombocytopenia 26.57 10.79 222 77794 156025 34722890
Urogenital haemorrhage 26.54 10.79 18 77998 727 34878188
Mental impairment 26.52 10.79 66 77950 10256 34868659
Intentional product use issue 26.36 10.79 59 77957 59757 34819158
Hyperreflexia 26.15 10.79 34 77982 3172 34875743
Neutrophil count increased 26.12 10.79 91 77925 17055 34861860
Dry skin 26.11 10.79 19 77997 31268 34847647
Feeling jittery 25.95 10.79 38 77978 3965 34874950
Macrophages increased 25.81 10.79 11 78005 169 34878746
Pressure of speech 25.23 10.79 15 78001 480 34878435
Depersonalisation/derealisation disorder 25.18 10.79 16 78000 578 34878337
Oesophageal obstruction 24.87 10.79 15 78001 493 34878422
Product monitoring error 24.74 10.79 39 77977 4342 34874573
Cogwheel rigidity 24.73 10.79 22 77994 1330 34877585
Benign gastrointestinal neoplasm 24.63 10.79 10 78006 135 34878780
Hallucinations, mixed 24.28 10.79 30 77986 2659 34876256
Congenital cerebrovascular anomaly 24.08 10.79 6 78010 12 34878903
Sarcopenia 24.07 10.79 14 78002 430 34878485
Inappropriate schedule of product administration 23.89 10.79 66 77950 62230 34816685
Sepsis 23.86 10.79 247 77769 166314 34712601
Progressive multifocal leukoencephalopathy 23.59 10.79 61 77955 9703 34869212
Affective disorder 23.50 10.79 38 77978 4322 34874593
Alcoholism 23.50 10.79 31 77985 2934 34875981
Patient elopement 23.29 10.79 7 78009 35 34878880
Cardiac failure 22.98 10.79 115 77901 91133 34787782
Wrong product administered 22.86 10.79 42 77974 5292 34873623
Upper respiratory tract infection 22.84 10.79 24 77992 33035 34845880
Mood altered 22.75 10.79 57 77959 8895 34870020
Diarrhoea 22.73 10.79 680 77336 389232 34489683
Brain oedema 22.50 10.79 75 77941 13746 34865169
Sinusitis 22.49 10.79 36 77980 41366 34837549
Dementia with Lewy bodies 22.48 10.79 16 78000 699 34878216
IVth nerve disorder 22.37 10.79 6 78010 18 34878897
Autoscopy 22.07 10.79 11 78005 246 34878669
Septic shock 22.06 10.79 84 77932 71750 34807165
Multiple organ dysfunction syndrome 21.96 10.79 92 77924 76474 34802441
Postictal state 21.88 10.79 17 77999 850 34878065
Urinary hesitation 21.75 10.79 29 77987 2773 34876142
Sensory level abnormal 21.67 10.79 6 78010 21 34878894
Neuropathy peripheral 21.51 10.79 104 77912 83159 34795756
Back pain 21.16 10.79 172 77844 121617 34757298
Postoperative respiratory failure 21.02 10.79 9 78007 140 34878775
Tumour lysis syndrome 20.99 10.79 6 78010 17053 34861862
Dementia 20.97 10.79 73 77943 13675 34865240
Activation syndrome 20.94 10.79 8 78008 91 34878824
Dissociation 20.92 10.79 22 77994 1636 34877279
Slow speech 20.88 10.79 19 77997 1183 34877732
Schizophrenia 20.79 10.79 54 77962 8612 34870303
Cold sweat 20.73 10.79 59 77957 9928 34868987
Appendicitis 20.61 10.79 4 78012 14803 34864112
Homicide 20.53 10.79 17 77999 932 34877983
Ascites 20.46 10.79 46 77970 46525 34832390
Congenital hyperinsulinaemic hypoglycaemia 20.43 10.79 4 78012 0 34878915
Cytokine release syndrome 20.28 10.79 13 78003 22864 34856051
Hyperhidrosis 20.24 10.79 258 77758 75434 34803481
Abulia 20.20 10.79 14 78002 586 34878329
Antipsychotic drug level increased 19.91 10.79 33 77983 3832 34875083
Hypersomnia 19.90 10.79 67 77949 12340 34866575
White blood cell count decreased 19.87 10.79 128 77888 95317 34783598
Dysgraphia 19.83 10.79 25 77991 2262 34876653
Myelodysplastic syndrome 19.83 10.79 9 78007 19199 34859716
Feeling guilty 19.70 10.79 11 78005 312 34878603
Circulatory collapse 19.63 10.79 96 77920 20942 34857973
Haemoglobin decreased 19.44 10.79 174 77842 120598 34758317
Parkinsonian gait 19.44 10.79 13 78003 513 34878402
Malignant neoplasm progression 19.40 10.79 116 77900 87930 34790985
Oesophageal haemorrhage 19.39 10.79 19 77997 1299 34877616
Nervousness 19.28 10.79 67 77949 12539 34866376
Helplessness 19.12 10.79 7 78009 70 34878845
Hyperarousal 19.05 10.79 6 78010 36 34878879
Acute psychosis 19.01 10.79 22 77994 1821 34877094
Lymphocyte count abnormal 19 10.79 18 77998 1180 34877735
Hypertonia 18.92 10.79 34 77982 4212 34874703
Nephrolithiasis 18.82 10.79 24 77992 30309 34848606
Epilepsy 18.59 10.79 96 77920 21399 34857516
Peripheral swelling 18.40 10.79 98 77918 76443 34802472
Gout 18.40 10.79 10 78006 19243 34859672
Acute myocardial infarction 18.38 10.79 60 77956 53659 34825256
Depressive symptom 18.33 10.79 27 77989 2832 34876083
Intentional device misuse 18.31 10.79 9 78007 195 34878720
Perforated ulcer 18.31 10.79 9 78007 195 34878720
Verbal abuse 18.15 10.79 9 78007 199 34878716
Infant irritability 18.14 10.79 6 78010 43 34878872
Fear 18.08 10.79 58 77958 10418 34868497
Arthropathy 18.07 10.79 20 77996 26887 34852028
Hyperkinesia 18.06 10.79 21 77995 1747 34877168
Obsessive-compulsive disorder 18.06 10.79 39 77977 5525 34873390
Tracheal pain 18.02 10.79 6 78010 44 34878871
Derealisation 17.95 10.79 13 78003 584 34878331
Prescription drug used without a prescription 17.81 10.79 23 77993 2131 34876784
Bladder cancer 17.81 10.79 7 78009 16271 34862644
Hypervigilance 17.78 10.79 8 78008 141 34878774
Respiratory disorder neonatal 17.73 10.79 20 77996 1610 34877305
Abdominal discomfort 17.71 10.79 71 77945 59764 34819151
Respiratory rate decreased 17.68 10.79 24 77992 2335 34876580
Fear of weight gain 17.67 10.79 4 78012 4 34878911
Ejaculation disorder 17.63 10.79 16 78000 993 34877922
Osteonecrosis of jaw 17.52 10.79 9 78007 17880 34861035
Sinus tachycardia 17.49 10.79 81 77935 17279 34861636
Drug withdrawal syndrome neonatal 17.45 10.79 30 77986 3589 34875326
JC virus infection 17.36 10.79 23 77993 2185 34876730
Implant site extravasation 17.34 10.79 11 78005 396 34878519
Tubulointerstitial nephritis 17.24 10.79 13 78003 21011 34857904
Rapid eye movement sleep behaviour disorder 17.23 10.79 8 78008 152 34878763
Hyperbilirubinaemia 17.22 10.79 8 78008 16835 34862080
Hangover 17.07 10.79 16 78000 1035 34877880
Arachnoid cyst 16.93 10.79 9 78007 231 34878684
Self esteem decreased 16.81 10.79 12 78004 527 34878388
Loose associations 16.76 10.79 6 78010 56 34878859
Acute myeloid leukaemia 16.73 10.79 10 78006 18260 34860655
Hanging 16.59 10.79 8 78008 166 34878749
Amnestic disorder 16.55 10.79 9 78007 242 34878673
Incoherent 16.55 10.79 33 77983 4419 34874496
Eosinophilic myocarditis 16.55 10.79 12 78004 540 34878375
Alcohol interaction 16.54 10.79 26 77990 2887 34876028
Acute kidney injury 16.49 10.79 537 77479 304451 34574464
Ejaculation failure 16.48 10.79 14 78002 795 34878120
Coma scale abnormal 16.48 10.79 31 77985 3977 34874938
Stoma site infection 16.47 10.79 14 78002 796 34878119
Respiratory tract infection 16.41 10.79 12 78004 19700 34859215
Basal cell carcinoma 16.32 10.79 12 78004 19646 34859269
Rash erythematous 16.30 10.79 19 77997 24958 34853957
Product use issue 16.30 10.79 79 77937 63137 34815778
Neutropenia 16.26 10.79 249 77767 156529 34722386
Urine sodium decreased 16.13 10.79 8 78008 177 34878738
Blood creatinine increased 16.10 10.79 135 77881 94841 34784074
Product prescribing issue 16.07 10.79 22 77994 2157 34876758
Frenulum breve 16.05 10.79 4 78012 8 34878907
Rapid eye movements sleep abnormal 16.00 10.79 8 78008 180 34878735
Gait disturbance 15.99 10.79 273 77743 84867 34794048
Dissociative disorder 15.92 10.79 11 78005 458 34878457
Speech disorder 15.89 10.79 105 77911 25581 34853334
Eosinophilic pleural effusion 15.88 10.79 9 78007 263 34878652
Tricuspid valve sclerosis 15.87 10.79 5 78011 30 34878885
JC virus CSF test positive 15.84 10.79 7 78009 118 34878797
Bezoar 15.77 10.79 16 78000 1141 34877774
Splenomegaly 15.73 10.79 7 78009 15110 34863805
COVID-19 15.63 10.79 105 77911 77445 34801470
Posture abnormal 15.61 10.79 22 77994 2217 34876698
Mastication disorder 15.61 10.79 17 77999 1316 34877599
Abnormal weight gain 15.39 10.79 15 78001 1019 34877896
Stupor 15.32 10.79 25 77991 2866 34876049
Blood ethanol increased 15.23 10.79 11 78005 492 34878423
Potentiating drug interaction 15.15 10.79 34 77982 4943 34873972
Temperature regulation disorder 15.14 10.79 13 78003 749 34878166
Neonatal respiratory distress syndrome 15.12 10.79 30 77986 4004 34874911
Loss of proprioception 15.05 10.79 10 78006 390 34878525
Ataxia 14.98 10.79 66 77950 13787 34865128
Sinus bradycardia 14.97 10.79 63 77953 12900 34866015
Bronchopulmonary aspergillosis 14.93 10.79 7 78009 14652 34864263
Antisocial behaviour 14.90 10.79 10 78006 397 34878518
Frequent bowel movements 14.83 10.79 5 78011 12782 34866133
Drug dispensed to wrong patient 14.83 10.79 11 78005 513 34878402
Major depression 14.78 10.79 32 77984 4540 34874375
Mumps 14.78 10.79 6 78010 81 34878834
Neonatal hyponatraemia 14.71 10.79 6 78010 82 34878833
Oedema peripheral 14.66 10.79 184 77832 119628 34759287
Hyporesponsive to stimuli 14.51 10.79 15 78001 1093 34877822
Small for dates baby 14.47 10.79 29 77987 3898 34875017
Electrocardiogram QRS complex prolonged 14.41 10.79 33 77983 4861 34874054
Palmar-plantar erythrodysaesthesia syndrome 14.28 10.79 10 78006 16785 34862130
Housebound 14.23 10.79 8 78008 230 34878685
Balance disorder 14.20 10.79 146 77870 40508 34838407
Suspiciousness 14.04 10.79 9 78007 330 34878585
Xanthoma 13.97 10.79 6 78010 94 34878821
Paradoxical drug reaction 13.88 10.79 26 77990 3325 34875590
Osmotic demyelination syndrome 13.85 10.79 13 78003 842 34878073
Sexual dysfunction 13.83 10.79 38 77978 6265 34872650
Metabolic syndrome 13.83 10.79 18 77998 1681 34877234
Sleep deficit 13.75 10.79 11 78005 574 34878341
Limited symptom panic attack 13.75 10.79 5 78011 49 34878866
Blood pressure increased 13.71 10.79 128 77888 87974 34790941
Spinal cord injury thoracic 13.69 10.79 6 78010 99 34878816
Visceral oedema 13.64 10.79 6 78010 100 34878815
Product dose omission issue 13.49 10.79 187 77829 119524 34759391
Failure to thrive 13.40 10.79 46 77970 8555 34870360
Drug reaction with eosinophilia and systemic symptoms 13.39 10.79 34 77982 32978 34845937
Sensory disturbance 13.32 10.79 37 77979 6140 34872775
Behaviour disorder 13.25 10.79 32 77984 4878 34874037
Eczema 13.17 10.79 13 78003 18423 34860492
Locked-in syndrome 13.16 10.79 8 78008 267 34878648
Sepsis neonatal 13.13 10.79 8 78008 268 34878647
Fluid retention 13.12 10.79 25 77991 26862 34852053
Abnormal dreams 13.12 10.79 42 77974 7536 34871379
Paresis 13.10 10.79 20 77996 2166 34876749
Staphylococcal infection 13.09 10.79 34 77982 32726 34846189
Feeling abnormal 13.07 10.79 206 77810 63029 34815886
Renal disorder 13.05 10.79 23 77993 25457 34853458
Hepatic failure 12.93 10.79 37 77979 34494 34844421
Infection 12.93 10.79 135 77881 90780 34788135
Chest pain 12.90 10.79 202 77814 126560 34752355
Bacteraemia 12.87 10.79 15 78001 19702 34859213
Pneumocystis jirovecii pneumonia 12.86 10.79 15 78001 19695 34859220
Nephropathy toxic 12.83 10.79 6 78010 12582 34866333
Blood pressure fluctuation 12.75 10.79 23 77993 25226 34853689
Non-alcoholic steatohepatitis 12.72 10.79 13 78003 935 34877980
Insulin resistance 12.62 10.79 11 78005 647 34878268
Hypersensitivity 12.62 10.79 82 77934 60953 34817962
Alcohol poisoning 12.61 10.79 26 77990 3567 34875348
Pseudomonas infection 12.47 10.79 6 78010 12376 34866539
Blood pressure systolic increased 12.42 10.79 20 77996 22932 34855983
Convulsive threshold lowered 12.40 10.79 10 78006 528 34878387
Lung disorder 12.39 10.79 38 77978 34658 34844257
Psychomotor retardation 12.32 10.79 26 77990 3624 34875291
Dyspnoea 12.29 10.79 702 77314 376080 34502835
Psychomotor skills impaired 12.24 10.79 27 77989 3879 34875036
Light chain disease 12.21 10.79 6 78010 130 34878785
Obstructive airways disorder 12.18 10.79 10 78006 15484 34863431
Inferior vena caval occlusion 12.17 10.79 4 78012 28 34878887
Chronic kidney disease 12.13 10.79 49 77967 41161 34837754
Mitral valve sclerosis 12.13 10.79 6 78010 132 34878783
Amnesia 12.11 10.79 101 77915 26462 34852453
Acute pulmonary oedema 12.09 10.79 40 77976 7303 34871612
COVID-19 pneumonia 12.08 10.79 12 78004 16955 34861960
Swelling 12.08 10.79 51 77965 42315 34836600
Pelvic fracture 12.01 10.79 21 77995 2546 34876369
Skin cancer 11.99 10.79 4 78012 10293 34868622
Psychotic symptom 11.96 10.79 17 77999 1726 34877189
Consciousness fluctuating 11.96 10.79 14 78002 1173 34877742
Decreased interest 11.95 10.79 20 77996 2340 34876575
Cardiogenic shock 11.93 10.79 26 77990 26592 34852323
Haematemesis 11.91 10.79 104 77912 27607 34851308
Polypectomy 11.89 10.79 10 78006 560 34878355
Tension 11.78 10.79 19 77997 2156 34876759
Influenza 11.71 10.79 64 77952 49602 34829313
Hepatic function abnormal 11.69 10.79 55 77961 44308 34834607
Bronchitis 11.67 10.79 51 77965 41912 34837003
Fungal infection 11.66 10.79 11 78005 15924 34862991
Radial nerve injury 11.60 10.79 4 78012 33 34878882
Pneumonia bacterial 11.59 10.79 6 78010 11866 34867049
Social avoidant behaviour 11.48 10.79 23 77993 3091 34875824
Hypothermia 11.46 10.79 51 77965 10697 34868218
Initial insomnia 11.43 10.79 23 77993 3101 34875814
Respiratory failure 11.39 10.79 172 77844 108400 34770515
Lymphocyte count decreased 11.39 10.79 88 77928 22534 34856381
Shock 11.35 10.79 23 77993 24156 34854759
Panic disorder 11.34 10.79 14 78002 1240 34877675
Cerebellar ataxia 11.34 10.79 13 78003 1065 34877850
Electric shock 11.32 10.79 6 78010 153 34878762
Hepatic steatosis 11.32 10.79 75 77941 18287 34860628
Pancytopenia 11.32 10.79 147 77869 95010 34783905
Diverticulitis 11.24 10.79 17 77999 19987 34858928
Respiratory tract haemorrhage 11.20 10.79 14 78002 1256 34877659
Hyperthermia 11.14 10.79 50 77966 10527 34868388
Agitated depression 11.14 10.79 7 78009 248 34878667
Serum serotonin increased 11.07 10.79 5 78011 89 34878826
Panic reaction 11.04 10.79 15 78001 1460 34877455
Rash maculo-papular 11.01 10.79 30 77986 28421 34850494
Blood bilirubin increased 10.98 10.79 46 77970 38250 34840665
Dysaesthesia 10.97 10.79 19 77997 2286 34876629
Drug abuser 10.92 10.79 26 77990 3928 34874987
Bladder dilatation 10.91 10.79 15 78001 1477 34877438
Accidental poisoning 10.90 10.79 11 78005 779 34878136
Hypoxia 10.90 10.79 75 77941 55020 34823895
Alcohol problem 10.87 10.79 5 78011 93 34878822
Treatment noncompliance 10.83 10.79 103 77913 27997 34850918
Inflammation 10.83 10.79 30 77986 28265 34850650
Erectile dysfunction 10.80 10.79 81 77935 20556 34858359

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
Toxicity to various agents 1149.79 9.84 2610 160749 418930 79162099
Intentional overdose 942.32 9.84 1123 162236 104837 79476192
Serotonin syndrome 844.73 9.84 716 162643 44311 79536718
Completed suicide 782.90 9.84 1622 161737 244145 79336884
Suicide attempt 763.71 9.84 895 162464 82037 79498992
Intentional self-injury 698.98 9.84 559 162800 31860 79549169
Drug abuse 680.64 9.84 1206 162153 161485 79419544
Suicidal ideation 655.32 9.84 795 162564 75545 79505484
Sopor 598.81 9.84 515 162844 32495 79548534
Overdose 528.69 9.84 1166 162193 183040 79397989
Somnolence 507.14 9.84 1346 162013 237635 79343394
Agitation 478.46 9.84 786 162573 98929 79482100
Drug interaction 457.00 9.84 1870 161489 413313 79167716
Electrocardiogram QT prolonged 381.42 9.84 673 162686 89713 79491316
Confusional state 373.32 9.84 1462 161897 316535 79264494
Coma 341.93 9.84 683 162676 99966 79481063
Hyponatraemia 325.87 9.84 950 162409 176898 79404131
Restlessness 294.33 9.84 417 162942 46075 79534954
Fall 274.66 9.84 1823 161536 485806 79095223
Depressed level of consciousness 272.65 9.84 608 162751 96044 79484985
Tremor 259.04 9.84 852 162507 169231 79411798
Disorientation 253.94 9.84 459 162900 62317 79518712
Neuroleptic malignant syndrome 251.08 9.84 296 163063 27263 79553766
Inappropriate antidiuretic hormone secretion 248.69 9.84 288 163071 26025 79555004
Infusion related reaction 246.65 9.84 82 163277 230155 79350874
Synovitis 242.75 9.84 17 163342 150717 79430312
Joint swelling 236.15 9.84 150 163209 288496 79292533
Restless legs syndrome 227.98 9.84 242 163117 19850 79561179
Rheumatoid arthritis 220.25 9.84 76 163283 208394 79372635
Arthropathy 216.02 9.84 49 163310 177062 79403967
Aggression 214.31 9.84 379 162980 50579 79530450
Extrapyramidal disorder 212.28 9.84 247 163112 22432 79558597
Muscle rigidity 207.27 9.84 229 163130 19653 79561376
Delirium 206.50 9.84 503 162856 84124 79496905
Disturbance in attention 206.16 9.84 372 162987 50429 79530600
Anxiety 202.94 9.84 1026 162333 247486 79333543
Akathisia 201.02 9.84 187 163172 13072 79567957
Rash 195.24 9.84 575 162784 577783 79003246
Depressed mood 194.18 9.84 353 163006 48127 79532902
Drug withdrawal syndrome 187.46 9.84 289 163070 34429 79546600
Hallucination, visual 184.56 9.84 278 163081 32451 79548578
Tachycardia 183.42 9.84 786 162573 176982 79404047
Systemic lupus erythematosus 183.11 9.84 18 163341 121131 79459898
Nasopharyngitis 181.52 9.84 152 163207 253729 79327300
Mania 181.23 9.84 205 163154 18055 79562974
Nightmare 180.23 9.84 243 163116 25618 79555411
Dyskinesia 178.04 9.84 325 163034 44448 79536581
Psychotic disorder 174.18 9.84 308 163051 41094 79539935
Pemphigus 170.21 9.84 8 163351 99574 79481455
Arthralgia 169.63 9.84 602 162757 571201 79009828
Sinusitis 169.09 9.84 95 163264 195406 79385623
Withdrawal syndrome 167.19 9.84 239 163120 26615 79554414
Drug hypersensitivity 157.57 9.84 230 163129 298686 79282343
Accidental overdose 156.98 9.84 287 163072 39294 79541735
Dissociation 155.42 9.84 99 163260 3922 79577107
Glossodynia 154.49 9.84 16 163343 103321 79477708
Hallucination, auditory 154.30 9.84 201 163158 20492 79560537
Depersonalisation/derealisation disorder 152.23 9.84 75 163284 1787 79579242
Swelling 150.93 9.84 133 163226 216578 79364451
Parkinsonism 147.54 9.84 176 163183 16408 79564621
Sedation 144.64 9.84 325 163034 51570 79529459
Urinary retention 141.76 9.84 340 163019 56290 79524739
Poisoning deliberate 140.57 9.84 183 163176 18645 79562384
Therapeutic product effect decreased 136.90 9.84 83 163276 163780 79417249
Abdominal discomfort 135.00 9.84 190 163169 250537 79330492
Treatment failure 134.72 9.84 92 163267 170394 79410635
General physical health deterioration 133.41 9.84 993 162366 274245 79306784
Poisoning 131.73 9.84 207 163152 25065 79555964
Cogwheel rigidity 129.33 9.84 80 163279 3008 79578021
Alopecia 128.90 9.84 171 163188 231184 79349845
Peripheral swelling 126.50 9.84 224 163135 269393 79311636
Hypersensitivity 125.64 9.84 215 163144 262024 79319005
Derealisation 124.72 9.84 63 163296 1586 79579443
Helicobacter infection 124.55 9.84 4 163355 69700 79511329
Dystonia 123.84 9.84 184 163175 21215 79559814
Hallucination 119.36 9.84 417 162942 85328 79495701
Pericarditis 119.01 9.84 33 163326 104203 79476826
Dysarthria 118.69 9.84 356 163003 67266 79513763
Contraindicated product administered 117.96 9.84 90 163269 157448 79423581
Loss of consciousness 117.61 9.84 665 162694 167278 79413751
Myoclonus 116.63 9.84 206 163153 27454 79553575
Seizure 115.10 9.84 721 162638 188113 79392916
Pain 114.80 9.84 908 162451 702894 78878135
Drug intolerance 112.90 9.84 232 163127 263887 79317142
Tardive dyskinesia 112.33 9.84 123 163236 10448 79570581
Drug ineffective 111.01 9.84 1555 161804 1079358 78501671
Mydriasis 108.32 9.84 156 163203 17487 79563542
Gastric pH decreased 107.76 9.84 47 163312 839 79580190
Cough 106.03 9.84 390 162969 366399 79214630
Feeling of despair 105.43 9.84 68 163291 2753 79578276
Psychomotor hyperactivity 103.47 9.84 149 163210 16700 79564329
Intrusive thoughts 102.19 9.84 39 163320 485 79580544
Urticaria 102.01 9.84 138 163221 185063 79395966
Bradyphrenia 99.76 9.84 116 163243 10524 79570505
Folliculitis 99.59 9.84 3 163356 55377 79525652
Duodenal ulcer perforation 97.05 9.84 11 163348 66200 79514829
Mood swings 96.98 9.84 158 163201 19722 79561307
Drug dependence 96.93 9.84 240 163119 40529 79540500
Depression 94.90 9.84 764 162595 216026 79365003
Injection site pain 94.88 9.84 76 163283 129762 79451267
Pruritus 94.62 9.84 451 162908 394197 79186832
Hyperhidrosis 94.53 9.84 582 162777 150910 79430119
Hypertonia 94.51 9.84 94 163265 7138 79573891
Pneumonia aspiration 94.34 9.84 327 163032 66640 79514389
Impaired healing 94.18 9.84 31 163328 87624 79493405
Delusion 93.83 9.84 158 163201 20265 79560764
Abnormal behaviour 93.66 9.84 221 163138 36200 79544829
Febrile neutropenia 93.63 9.84 209 163150 230790 79350239
Systemic infection 92.57 9.84 107 163252 9645 79571384
Arthritis 92.07 9.84 61 163298 114819 79466210
Product use issue 91.61 9.84 182 163177 209640 79371389
Altered state of consciousness 89.82 9.84 244 163115 43578 79537451
Psoriatic arthropathy 88.47 9.84 25 163334 77974 79503055
Pleurothotonus 87.56 9.84 58 163301 2458 79578571
Intentional product use issue 87.19 9.84 110 163249 152002 79429027
Off label use 86.73 9.84 1323 162036 905892 78675137
Product prescribing error 85.42 9.84 243 163116 44570 79536459
Discomfort 85.14 9.84 79 163280 125538 79455491
Asphyxia 84.52 9.84 112 163247 11608 79569421
Suspected suicide 80.83 9.84 104 163255 10472 79570557
Antidepressant drug level above therapeutic 79.43 9.84 35 163324 641 79580388
Anger 79.15 9.84 133 163226 17029 79564000
Logorrhoea 78.91 9.84 68 163291 4297 79576732
Paranoia 78.43 9.84 142 163217 19290 79561739
Feeling jittery 78.04 9.84 113 163246 12728 79568301
Schizophrenia 77.06 9.84 124 163235 15316 79565713
On and off phenomenon 76.55 9.84 59 163300 3181 79577848
Miosis 76.36 9.84 125 163234 15664 79565365
Irritable bowel syndrome 76.29 9.84 17 163342 62224 79518805
Rhabdomyolysis 75.91 9.84 414 162945 102717 79478312
Hallucinations, mixed 74.57 9.84 81 163278 6818 79574211
Blister 74.26 9.84 81 163278 119395 79461634
Product monitoring error 73.50 9.84 91 163268 8815 79572214
Respiratory arrest 73.36 9.84 272 163087 57278 79523751
Homicidal ideation 73.17 9.84 59 163300 3398 79577631
Bradykinesia 72.60 9.84 86 163273 7957 79573072
Hepatic enzyme increased 72.53 9.84 167 163192 182443 79398586
Stomatitis 72.38 9.84 118 163241 146639 79434390
Panic attack 71.23 9.84 155 163204 24061 79556968
Respiratory depression 70.33 9.84 167 163192 27463 79553566
Illusion 70.13 9.84 44 163315 1697 79579332
Speech disorder 69.97 9.84 258 163101 54187 79526842
Irritability 67.88 9.84 212 163147 40932 79540097
Depressive symptom 66.97 9.84 74 163285 6349 79574680
Muscle injury 66.53 9.84 10 163349 48551 79532478
Asthma 66.27 9.84 109 163250 134986 79446043
Incontinence 65.63 9.84 110 163249 14054 79566975
Infection 64.66 9.84 265 163094 241447 79339582
Knee arthroplasty 63.85 9.84 7 163352 43241 79537788
Myelosuppression 63.55 9.84 5 163354 40291 79540738
Tachyphrenia 62.99 9.84 44 163315 2036 79578993
Mental disorder 62.86 9.84 173 163186 31129 79549900
Labelled drug-drug interaction medication error 62.82 9.84 160 163199 27490 79553539
Insomnia 62.35 9.84 772 162587 244398 79336631
Wrong patient received product 62.16 9.84 61 163298 4557 79576472
Substance abuse 61.61 9.84 91 163268 10435 79570594
Erythema 61.49 9.84 242 163117 223048 79357981
Drooling 61.24 9.84 68 163291 5866 79575163
Abnormal dreams 60.20 9.84 94 163265 11318 79569711
Interstitial lung disease 59.88 9.84 86 163273 112514 79468515
H1N1 influenza 59.80 9.84 46 163313 2473 79578556
Nasal congestion 59.53 9.84 42 163317 76510 79504519
Loss of libido 59.34 9.84 47 163312 2638 79578391
Feeling of body temperature change 58.38 9.84 63 163296 5263 79575766
Apathy 57.77 9.84 99 163260 12878 79568151
Gastrointestinal disorder 57.73 9.84 101 163258 122104 79458925
Major depression 57.48 9.84 81 163278 8899 79572130
Lower respiratory tract infection 57.31 9.84 111 163248 129109 79451920
Psychomotor retardation 57.27 9.84 67 163292 6117 79574912
Injection site pruritus 57.26 9.84 9 163350 42274 79538755
Osteoarthritis 56.72 9.84 57 163302 87252 79493777
Myocardial infarction 55.65 9.84 192 163167 183937 79397092
Sleep disorder 55.21 9.84 332 163027 85345 79495684
Urinary hesitation 54.92 9.84 55 163304 4211 79576818
Injection site erythema 54.38 9.84 48 163311 78149 79502880
Back pain 53.89 9.84 383 162976 303797 79277232
Product administration error 53.37 9.84 165 163194 31681 79549348
Wound 53.10 9.84 98 163261 116081 79464948
Pain in extremity 53.08 9.84 484 162875 364054 79216975
Pyrexia 50.85 9.84 1033 162326 677676 78903353
Circulatory collapse 50.51 9.84 181 163178 37487 79543542
Persecutory delusion 50.22 9.84 56 163303 4853 79576176
Electrocardiogram abnormal 50.22 9.84 108 163251 16629 79564400
Pneumonia 49.73 9.84 1004 162355 659242 78921787
Abulia 49.37 9.84 29 163330 991 79580038
Aptyalism 48.60 9.84 26 163333 739 79580290
Hyperreflexia 48.37 9.84 72 163287 8313 79572716
Cardiac arrest 47.72 9.84 551 162808 171545 79409484
Delusion of grandeur 47.40 9.84 32 163327 1400 79579629
Epilepsy 47.05 9.84 187 163172 40673 79540356
Helplessness 46.11 9.84 20 163339 352 79580677
Cytomegalovirus infection 45.94 9.84 15 163344 42629 79538400
Intestinal pseudo-obstruction 45.86 9.84 40 163319 2569 79578460
Incoherent 45.74 9.84 67 163292 7625 79573404
Bursitis 45.55 9.84 9 163350 35835 79545194
Priapism 45.42 9.84 51 163308 4454 79576575
Hip arthroplasty 45.39 9.84 9 163350 35747 79545282
Coma scale abnormal 45.10 9.84 71 163288 8607 79572422
Acute psychosis 45.04 9.84 49 163310 4131 79576898
Blood prolactin increased 44.94 9.84 48 163311 3963 79577066
Bipolar disorder 44.20 9.84 66 163293 7641 79573388
Fatigue 44.04 9.84 1512 161847 928215 78652814
Accidental death 43.99 9.84 49 163310 4242 79576787
Analgesic drug level above therapeutic 43.90 9.84 21 163338 468 79580561
Inflammation 43.81 9.84 78 163281 93675 79487354
Unresponsive to stimuli 43.79 9.84 228 163131 55560 79525469
Galactorrhoea 43.29 9.84 45 163314 3601 79577428
Therapeutic product ineffective 43.24 9.84 34 163325 1888 79579141
Injection site bruising 43.17 9.84 15 163344 40987 79540042
Thinking abnormal 43.07 9.84 88 163271 13073 79567956
Herpes zoster 43.00 9.84 78 163281 93005 79488024
Polydipsia 42.90 9.84 60 163299 6545 79574484
Menstrual disorder 42.65 9.84 47 163312 4020 79577009
Progressive multifocal leukoencephalopathy 42.51 9.84 115 163244 20485 79560544
Hyperkinesia 42.35 9.84 39 163320 2690 79578339
Impulsive behaviour 42.23 9.84 40 163319 2860 79578169
Gestational diabetes 42.12 9.84 58 163301 6235 79574794
Syncope 41.76 9.84 556 162803 178893 79402136
Bronchitis 41.68 9.84 133 163226 130511 79450518
Feelings of worthlessness 41.49 9.84 21 163338 531 79580498
Device expulsion 41.37 9.84 3 163356 25858 79555171
Antipsychotic drug level above therapeutic 40.88 9.84 34 163325 2046 79578983
Upper respiratory tract infection 40.69 9.84 78 163281 91090 79489939
Cardiac failure congestive 40.69 9.84 152 163207 142250 79438779
Ill-defined disorder 40.55 9.84 45 163314 65830 79515199
Parosmia 40.13 9.84 60 163299 6954 79574075
Mental impairment 40.01 9.84 107 163252 18929 79562100
Affective disorder 39.07 9.84 65 163294 8254 79572775
Headache 38.86 9.84 1031 162328 652741 78928288
Maternal exposure during pregnancy 38.84 9.84 146 163213 136392 79444637
Intentional product misuse 38.70 9.84 330 163029 94835 79486194
Parkinsonian gait 38.29 9.84 24 163335 924 79580105
Rhinorrhoea 37.65 9.84 61 163298 76013 79505016
Activation syndrome 37.56 9.84 16 163343 269 79580760
Panic reaction 37.43 9.84 47 163312 4618 79576411
Fungal infection 36.47 9.84 20 163339 41728 79539301
Sinus tachycardia 36.32 9.84 161 163198 36747 79544282
Thrombocytopenia 36.11 9.84 358 163001 264901 79316128
Platelet count decreased 35.98 9.84 242 163117 194422 79386607
Product dose omission issue 35.85 9.84 329 163030 247208 79333821
Muscle disorder 35.82 9.84 51 163308 5656 79575373
Muscle twitching 35.80 9.84 122 163237 24642 79556387
Abnormal weight gain 35.73 9.84 35 163324 2609 79578420
Dysphagia 35.63 9.84 395 162964 121741 79459288
Injection site swelling 35.16 9.84 27 163332 47105 79533924
Blood creatine phosphokinase increased 35.15 9.84 244 163115 65846 79515183
Anaphylactic shock 34.86 9.84 15 163344 35981 79545048
Generalised tonic-clonic seizure 34.84 9.84 180 163179 43730 79537299
Social avoidant behaviour 34.71 9.84 46 163313 4768 79576261
Cataract 34.47 9.84 46 163313 62074 79518955
Osteoporosis 34.38 9.84 36 163323 54076 79526953
Acute motor-sensory axonal neuropathy 34.24 9.84 17 163342 412 79580617
Blood pressure increased 34.15 9.84 273 163086 211087 79369942
Catatonia 34.09 9.84 63 163296 8693 79572336
Psoriasis 33.91 9.84 84 163275 89503 79491526
Fracture 33.83 9.84 110 163249 21691 79559338
Phagophobia 33.79 9.84 10 163349 52 79580977
Neuropathy peripheral 33.49 9.84 162 163197 141143 79439886
Fibromyalgia 33.36 9.84 50 163309 64290 79516739
Diarrhoea 33.11 9.84 1471 161888 879018 78702011
Illness anxiety disorder 32.25 9.84 14 163345 247 79580782
Merycism 32.09 9.84 14 163345 250 79580779
Septic shock 31.96 9.84 136 163223 122665 79458364
Hypotonia 31.90 9.84 77 163282 12793 79568236
Multiple organ dysfunction syndrome 30.78 9.84 134 163225 120112 79460917
Sleep paralysis 30.52 9.84 18 163341 620 79580409
Wrong product administered 30.37 9.84 61 163298 8951 79572078
Liver injury 30.33 9.84 43 163316 56571 79524458
Hypomania 30.28 9.84 55 163304 7489 79573540
Blood pressure diastolic decreased 30.22 9.84 12 163347 30204 79550825
Haematemesis 30.21 9.84 197 163162 52067 79528962
Feeling guilty 30.18 9.84 20 163339 848 79580181
Anticholinergic syndrome 29.96 9.84 37 163322 3574 79577455
Cardio-respiratory arrest 29.87 9.84 347 163012 108163 79472866
Cognitive disorder 29.77 9.84 245 163114 69681 79511348
Decreased gait velocity 29.59 9.84 12 163347 177 79580852
Disease progression 29.37 9.84 239 163120 184123 79396906
Blood pressure systolic increased 29.30 9.84 58 163301 66928 79514101
Hypoaesthesia oral 29.29 9.84 79 163280 14045 79566984
Serum serotonin increased 29.11 9.84 14 163345 316 79580713
Joint range of motion decreased 29.00 9.84 16 163343 33266 79547763
Platypnoea 28.73 9.84 8 163351 32 79580997
Hyponatraemic coma 28.27 9.84 9 163350 62 79580967
Pressure of speech 28.22 9.84 22 163337 1206 79579823
Acute myeloid leukaemia 28.16 9.84 14 163345 30871 79550158
Hypophagia 28.08 9.84 174 163185 45193 79535836
Wheezing 28.08 9.84 133 163226 116531 79464498
Agranulocytosis 28.06 9.84 173 163186 44857 79536172
Bradypnoea 28.04 9.84 47 163312 6005 79575024
Nephrolithiasis 28.03 9.84 41 163318 53250 79527779
Thrombotic microangiopathy 27.98 9.84 4 163355 20165 79560864
Ejaculation failure 27.77 9.84 14 163345 351 79580678
Mutism 27.67 9.84 29 163330 2343 79578686
Cytokine release syndrome 27.66 9.84 20 163339 35978 79545051
Basal cell carcinoma 27.14 9.84 22 163337 37353 79543676
Sarcopenia 27.12 9.84 15 163344 456 79580573
Hyperthermia 27.08 9.84 90 163269 17947 79563082
Language disorder 26.78 9.84 33 163326 3181 79577848
Fluid retention 26.77 9.84 65 163294 69744 79511285
Potentiating drug interaction 26.57 9.84 57 163302 8762 79572267
Heart rate decreased 26.55 9.84 66 163293 70250 79510779
Posture abnormal 26.43 9.84 36 163323 3830 79577199
JC virus infection 26.32 9.84 36 163323 3845 79577184
Stupor 26.20 9.84 49 163310 6823 79574206
Rash erythematous 26.15 9.84 49 163310 57720 79523309
Ataxia 25.99 9.84 111 163248 24928 79556101
Alcoholism 25.96 9.84 35 163324 3688 79577341
Antipsychotic drug level increased 25.93 9.84 45 163314 5912 79575117
Balance disorder 25.83 9.84 313 163046 98544 79482485
COVID-19 25.76 9.84 203 163156 157471 79423558
Stoma site discharge 25.75 9.84 27 163332 2182 79578847
Gastrooesophageal reflux disease 25.58 9.84 118 163241 104128 79476901
Tonic clonic movements 25.20 9.84 27 163332 2237 79578792
Benign gastrointestinal neoplasm 25.20 9.84 10 163349 139 79580890
Crush syndrome 25.19 9.84 11 163348 197 79580832
Pleural effusion 25.16 9.84 184 163175 145078 79435951
Sudden death 25.10 9.84 102 163257 22409 79558620
Self-injurious ideation 25.06 9.84 34 163325 3604 79577425
Premature labour 25.01 9.84 54 163305 8336 79572693
Pallor 24.97 9.84 182 163177 49880 79531149
Anaphylactic reaction 24.83 9.84 88 163271 83655 79497374
Palmar-plantar erythrodysaesthesia syndrome 24.69 9.84 19 163340 33115 79547914
Psychotic symptom 24.61 9.84 29 163330 2668 79578361
Hypothermia 24.52 9.84 102 163257 22644 79558385
Dyspnoea 24.51 9.84 1472 161887 855553 78725476
Akinesia 24.42 9.84 32 163327 3280 79577749
Neutrophil count increased 24.37 9.84 122 163237 29274 79551755
Stoma site infection 24.13 9.84 22 163337 1498 79579531
Chemical burn of oral cavity 24.10 9.84 8 163351 64 79580965
Reduced facial expression 24.03 9.84 29 163330 2736 79578293
Dissociative disorder 24.01 9.84 17 163342 804 79580225
Clonus 23.90 9.84 47 163312 6793 79574236
Medication error 23.81 9.84 230 163129 68412 79512617
Inappropriate schedule of product administration 23.76 9.84 168 163191 133460 79447569
Autoimmune disorder 23.75 9.84 3 163356 16609 79564420
Status epilepticus 23.71 9.84 108 163251 24933 79556096
Erectile dysfunction 23.67 9.84 75 163284 14589 79566440
Emotional disorder 23.60 9.84 74 163285 14313 79566716
Pulmonary congestion 23.55 9.84 114 163245 26986 79554043
Red blood cell sedimentation rate increased 23.53 9.84 36 163323 45906 79535123
Hyporesponsive to stimuli 23.42 9.84 25 163334 2063 79578966
Suicidal behaviour 23.37 9.84 31 163328 3216 79577813
Somnambulism 23.33 9.84 42 163317 5679 79575350
Mood altered 23.28 9.84 85 163274 17762 79563267
Formication 23.26 9.84 39 163320 4984 79576045
Dementia 23.09 9.84 106 163253 24553 79556476
Alcohol use 23.02 9.84 38 163321 4793 79576236
Oedema 22.92 9.84 147 163212 119433 79461596
IVth nerve disorder 22.88 9.84 6 163353 18 79581011
Blood cholesterol increased 22.85 9.84 91 163268 83629 79497400
Bulimia nervosa 22.76 9.84 11 163348 251 79580778
Ejaculation disorder 22.66 9.84 14 163345 525 79580504
Injection site reaction 22.63 9.84 49 163310 54736 79526293
Bladder cancer 22.62 9.84 6 163353 19520 79561509
Blood pressure systolic abnormal 22.62 9.84 4 163355 17243 79563786
Food craving 22.51 9.84 22 163337 1635 79579394
Tongue movement disturbance 22.49 9.84 13 163346 431 79580598
Transplant rejection 22.47 9.84 6 163353 19431 79561598
Gait disturbance 22.36 9.84 570 162789 206936 79374093
Rhonchi 22.35 9.84 34 163325 4002 79577027
Histrionic personality disorder 22.27 9.84 7 163352 46 79580983
Obsessive-compulsive disorder 22.27 9.84 42 163317 5885 79575144
Euphoric mood 22.21 9.84 49 163310 7677 79573352
Norepinephrine increased 22.18 9.84 8 163351 84 79580945
Chest pain 22.17 9.84 426 162933 281878 79299151
Sudden cardiac death 22.13 9.84 39 163320 5186 79575843
Migraine 22.09 9.84 98 163261 87395 79493634
Skin necrosis 22.04 9.84 5 163354 18082 79562947
Macrophages increased 22.03 9.84 11 163348 270 79580759
Communication disorder 22.00 9.84 34 163325 4056 79576973
Cyanosis 21.94 9.84 106 163253 25076 79555953
Therapeutic product effect incomplete 21.93 9.84 185 163174 141460 79439569
Increased appetite 21.90 9.84 64 163295 11914 79569115
Blood lactic acid decreased 21.84 9.84 11 163348 275 79580754
Opisthotonus 21.73 9.84 15 163344 681 79580348
Oropharyngeal pain 21.70 9.84 133 163226 109220 79471809
Decreased interest 21.69 9.84 32 163327 3665 79577364
Productive cough 21.67 9.84 100 163259 88231 79492798
Sepsis 21.64 9.84 405 162954 269023 79312006
Glassy eyes 21.59 9.84 9 163350 143 79580886
False positive investigation result 21.49 9.84 18 163341 1094 79579935
Tendonitis 21.43 9.84 11 163348 23819 79557210
Urogenital haemorrhage 21.37 9.84 17 163342 960 79580069
Indifference 21.24 9.84 11 163348 292 79580737
Influenza 21.11 9.84 167 163192 129439 79451590
Neglect of personal appearance 21.09 9.84 9 163350 152 79580877
Paralysis 20.91 9.84 67 163292 13110 79567919
Malignant neoplasm progression 20.88 9.84 178 163181 135812 79445217
Osteomyelitis 20.73 9.84 22 163337 32843 79548186
Hypersomnia 20.71 9.84 98 163261 22988 79558041
Ear infection 20.67 9.84 24 163335 34408 79546621
Oesophageal obstruction 20.64 9.84 17 163342 1009 79580020
Myelodysplastic syndrome 20.59 9.84 19 163340 30282 79550747
Sensory loss 20.56 9.84 66 163293 12925 79568104
Congenital cerebrovascular anomaly 20.49 9.84 5 163354 10 79581019
Chorea 20.43 9.84 25 163334 2392 79578637
Blood pressure diastolic abnormal 20.26 9.84 7 163352 19195 79561834
White blood cell count decreased 20.18 9.84 268 163091 188020 79393009
Hallucination, synaesthetic 20.17 9.84 7 163352 65 79580964
Tumour lysis syndrome 20.15 9.84 12 163347 23927 79557102
Vestibular disorder 20.12 9.84 25 163334 2430 79578599
Blood bilirubin decreased 19.95 9.84 17 163342 1058 79579971
Pyroglutamic acidosis 19.93 9.84 17 163342 1059 79579970
Electrocardiogram QRS complex prolonged 19.92 9.84 58 163301 10775 79570254
Immune reconstitution inflammatory syndrome 19.84 9.84 68 163291 13773 79567256
Grip strength decreased 19.81 9.84 10 163349 21859 79559170
Pseudomonas infection 19.79 9.84 9 163350 20894 79560135
CYP3A4 polymorphism 19.71 9.84 7 163352 70 79580959
Postmortem blood drug level increased 19.70 9.84 15 163344 794 79580235
Therapeutic drug monitoring analysis not performed 19.66 9.84 22 163337 1914 79579115
Dysphoria 19.62 9.84 35 163324 4699 79576330
Blood sodium decreased 19.62 9.84 126 163233 33129 79547900
Sputum discoloured 19.61 9.84 10 163349 21733 79559296
Respiratory rate decreased 19.51 9.84 37 163322 5206 79575823
Failure to thrive 19.51 9.84 61 163298 11783 79569246
Cold sweat 19.49 9.84 83 163276 18616 79562413
Faecaloma 19.45 9.84 60 163299 11504 79569525
Hypotension 19.23 9.84 1094 162265 439223 79141806
Obsessive-compulsive personality disorder 19.20 9.84 8 163351 127 79580902
Rapid eye movements sleep abnormal 19.19 9.84 10 163349 269 79580760
Aspiration 19.13 9.84 87 163272 20071 79560958
Prostate cancer 19.11 9.84 24 163335 33244 79547785
Autonomic nervous system imbalance 18.89 9.84 34 163325 4596 79576433
Alcohol interaction 18.89 9.84 35 163324 4839 79576190
Salivary hypersecretion 18.77 9.84 68 163291 14156 79566873
Fear 18.76 9.84 92 163267 21894 79559135
Lung disorder 18.71 9.84 93 163266 80464 79500565
Lymphocyte count abnormal 18.66 9.84 19 163340 1484 79579545
Thymus disorder 18.60 9.84 10 163349 287 79580742
Pulmonary fibrosis 18.60 9.84 39 163320 44073 79536956
Hypervigilance 18.58 9.84 12 163347 487 79580542
Treatment noncompliance 18.56 9.84 176 163183 52092 79528937
Tracheal pain 18.53 9.84 6 163353 44 79580985
Amnestic disorder 18.43 9.84 13 163346 611 79580418
Acute myocardial infarction 18.43 9.84 88 163271 76948 79504081
Postictal state 18.39 9.84 21 163338 1868 79579161
Sensorimotor disorder 18.38 9.84 15 163344 879 79580150
Binge eating 18.36 9.84 12 163347 497 79580532
Postoperative respiratory failure 18.32 9.84 9 163350 213 79580816
Paresis 18.30 9.84 32 163327 4229 79576800
Postural tremor 18.27 9.84 14 163345 748 79580281
Rash pruritic 18.22 9.84 80 163279 71549 79509480
Sinus congestion 18.17 9.84 9 163350 19887 79561142
Vertigo 18.16 9.84 219 163140 68863 79512166
Coronary artery disease 17.98 9.84 71 163288 65403 79515626
Bipolar I disorder 17.96 9.84 22 163337 2107 79578922
Negative thoughts 17.94 9.84 18 163341 1381 79579648
Stoma site erythema 17.94 9.84 20 163339 1733 79579296
Sinus disorder 17.89 9.84 12 163347 22452 79558577
Breast discomfort 17.80 9.84 11 163348 413 79580616
Hanging 17.75 9.84 8 163351 155 79580874
Lower limb fracture 17.70 9.84 13 163346 23202 79557827
Drug dose titration not performed 17.52 9.84 14 163345 796 79580233
Eosinophilic pleural effusion 17.37 9.84 10 163349 329 79580700
Sensory disturbance 17.35 9.84 69 163290 15008 79566021
Eosinophilic cellulitis 17.34 9.84 7 163352 102 79580927
Arrhythmia 17.33 9.84 197 163162 61075 79519954
Decreased appetite 17.19 9.84 862 162497 341556 79239473
Stoma site inflammation 17.16 9.84 13 163346 683 79580346
JC virus CSF test positive 17.16 9.84 8 163351 168 79580861
Injury 17.13 9.84 91 163268 77405 79503624
Antidepressant drug level decreased 17.12 9.84 4 163355 6 79581023
Regressive behaviour 17.11 9.84 8 163351 169 79580860
Natural killer cell count decreased 17.07 9.84 6 163353 58 79580971
Drug tolerance decreased 17.04 9.84 3 163356 12975 79568054
Drowning 17.00 9.84 14 163345 831 79580198
Dementia with Lewy bodies 16.98 9.84 14 163345 832 79580197
Loose associations 16.98 9.84 6 163353 59 79580970
Contusion 16.96 9.84 209 163150 148567 79432462
Pulmonary toxicity 16.93 9.84 3 163356 12911 79568118
Drug screen positive 16.92 9.84 38 163321 6025 79575004
Product prescribing issue 16.89 9.84 30 163329 4015 79577014
Blood osmolarity decreased 16.84 9.84 17 163342 1314 79579715
Bezoar 16.84 9.84 24 163335 2664 79578365
Tachypnoea 16.82 9.84 118 163241 31945 79549084
Skin lesion 16.81 9.84 38 163321 41806 79539223
Osteonecrosis of jaw 16.77 9.84 40 163319 43186 79537843
Pulmonary oedema 16.76 9.84 264 163095 87990 79493039
Facial nerve disorder 16.74 9.84 13 163346 709 79580320
Dysaesthesia 16.71 9.84 37 163322 5811 79575218
Thirst 16.67 9.84 79 163280 18540 79562489
Skin ulcer 16.66 9.84 56 163303 54094 79526935
Purple glove syndrome 16.60 9.84 9 163350 263 79580766
Homicide 16.59 9.84 16 163343 1170 79579859
Hepatotoxicity 16.57 9.84 52 163307 51300 79529729
Foot deformity 16.47 9.84 15 163344 24059 79556970
Disorganised speech 16.46 9.84 21 163338 2096 79578933
Neck pain 16.42 9.84 89 163270 75328 79505701
Somatic symptom disorder 16.41 9.84 23 163336 2514 79578515
Renal disorder 16.31 9.84 39 163320 42066 79538963
Hyperarousal 16.30 9.84 5 163354 30 79580999
Tricuspid valve sclerosis 16.30 9.84 5 163354 30 79580999
Acne 16.27 9.84 19 163340 27171 79553858
Drop attacks 16.22 9.84 15 163344 1040 79579989
Death 16.20 9.84 1359 162000 565155 79015874
Patient elopement 16.14 9.84 6 163353 69 79580960
Oesophageal haemorrhage 16.12 9.84 19 163340 1748 79579281
Rhinalgia 16.12 9.84 22 163337 2345 79578684
Psychiatric decompensation 16.04 9.84 29 163330 3934 79577095
Respiratory acidosis 16.03 9.84 55 163304 11145 79569884
Nasal discomfort 16.01 9.84 35 163324 5448 79575581
Ascites 16 9.84 90 163269 75472 79505557
Dyspraxia 16.00 9.84 9 163350 283 79580746
Disinhibition 15.99 9.84 23 163336 2575 79578454
Bradycardia 15.98 9.84 377 162982 135180 79445849
Resuscitation 15.86 9.84 22 163337 2382 79578647
Haemoptysis 15.84 9.84 60 163299 55939 79525090
Tachycardia paroxysmal 15.81 9.84 10 163349 391 79580638
Hepatocellular injury 15.79 9.84 158 163201 47435 79533594
Suspiciousness 15.76 9.84 12 163347 635 79580394
Atrial fibrillation 15.71 9.84 298 163061 197588 79383441
Repetitive speech 15.70 9.84 10 163349 396 79580633
Epstein-Barr virus infection 15.65 9.84 5 163354 14411 79566618
Lip dry 15.62 9.84 6 163353 15412 79565617
Immunodeficiency 15.57 9.84 13 163346 21755 79559274
Oral herpes 15.57 9.84 20 163339 27434 79553595
Bacterial infection 15.55 9.84 25 163334 31255 79549774
Agonal rhythm 15.41 9.84 6 163353 79 79580950
Creatinine renal clearance decreased 15.34 9.84 10 163349 18992 79562037
Flushing 15.19 9.84 112 163247 88156 79492873
Diverticulitis 15.19 9.84 46 163313 45890 79535139
C-reactive protein increased 15.18 9.84 180 163179 128847 79452182
Abdominal pain upper 15.13 9.84 346 163013 223473 79357556
Gout 15.13 9.84 17 163342 24732 79556297
Injection site haemorrhage 15.09 9.84 21 163338 27849 79553180
Brain oedema 15.08 9.84 96 163263 25167 79555862
Vasodilatation 15.07 9.84 25 163334 3166 79577863
Hypokinesia 15.03 9.84 78 163281 18982 79562047
Cerebral mass effect 14.97 9.84 19 163340 1887 79579142
Skin exfoliation 14.97 9.84 60 163299 55040 79525989
Vitamin B1 decreased 14.96 9.84 11 163348 552 79580477
Prostatism 14.95 9.84 6 163353 86 79580943
Dry skin 14.94 9.84 80 163279 67915 79513114
Self esteem decreased 14.93 9.84 14 163345 988 79580041
Drug abuser 14.93 9.84 36 163323 5977 79575052
Circadian rhythm sleep disorder 14.90 9.84 12 163347 690 79580339
Staphylococcal infection 14.89 9.84 65 163294 58230 79522799
Obstructive airways disorder 14.85 9.84 26 163333 31433 79549596
Drug dispensed to wrong patient 14.84 9.84 12 163347 694 79580335
Psychomotor skills impaired 14.81 9.84 33 163326 5204 79575825
Antidepressant drug level increased 14.72 9.84 10 163349 442 79580587
Sexual dysfunction 14.69 9.84 42 163317 7721 79573308
Somatic delusion 14.66 9.84 12 163347 706 79580323
Snoring 14.55 9.84 34 163325 5532 79575497
Loss of personal independence in daily activities 14.55 9.84 137 163222 102443 79478586
Ocular hyperaemia 14.54 9.84 22 163337 28184 79552845
Full blood count abnormal 14.50 9.84 39 163320 40435 79540594
Violence-related symptom 14.47 9.84 12 163347 719 79580310
Haemoglobin decreased 14.29 9.84 346 163013 221773 79359256
Aspergillus infection 14.26 9.84 11 163348 19150 79561879
Sensory level abnormal 14.24 9.84 7 163352 166 79580863
Blood pressure fluctuation 14.20 9.84 80 163279 67065 79513964
Hypernatraemia 14.19 9.84 63 163296 14388 79566641
Respiratory tract congestion 14.17 9.84 12 163347 19942 79561087
Limited symptom panic attack 14.17 9.84 5 163354 49 79580980
Therapy non-responder 14.09 9.84 121 163238 92184 79488845
Wrong technique in product usage process 14.06 9.84 91 163268 73784 79507245
Rash maculo-papular 14.04 9.84 63 163296 56015 79525014
Anorgasmia 14.04 9.84 15 163344 1239 79579790
Hypervolaemia 13.93 9.84 43 163316 42647 79538382
Hypokalaemia 13.88 9.84 390 162969 143650 79437379
Second primary malignancy 13.86 9.84 6 163353 14344 79566685
Bone density decreased 13.85 9.84 5 163354 13342 79567687
Cachexia 13.80 9.84 52 163307 11031 79569998
Orgasm abnormal 13.79 9.84 7 163352 178 79580851
Behaviour disorder 13.79 9.84 36 163323 6277 79574752
Cardiac output increased 13.76 9.84 8 163351 268 79580761
Eyelid myoclonus 13.76 9.84 6 163353 107 79580922
Loss of proprioception 13.71 9.84 12 163347 774 79580255
Convulsive threshold lowered 13.67 9.84 13 163346 934 79580095
Tenderness 13.64 9.84 17 163342 23625 79557404
Oesophageal carcinoma 13.64 9.84 3 163356 11081 79569948
Giant cell arteritis 13.60 9.84 22 163337 2729 79578300
Visceral oedema 13.56 9.84 6 163353 111 79580918
Panic disorder 13.55 9.84 23 163336 2969 79578060
Sciatica 13.49 9.84 30 163329 33192 79547837
Hypnagogic hallucination 13.48 9.84 7 163352 187 79580842
Hyperphagia 13.43 9.84 21 163338 2531 79578498
Therapeutic response decreased 13.42 9.84 81 163278 66772 79514257
Frequent bowel movements 13.42 9.84 25 163334 29514 79551515
Hypertension 13.41 9.84 548 162811 330444 79250585
Liver disorder 13.38 9.84 90 163269 72327 79508702
Hepatic steatosis 13.36 9.84 127 163232 37611 79543418
Affect lability 13.34 9.84 52 163307 11207 79569822
Compulsive shopping 13.33 9.84 12 163347 804 79580225
Disseminated intravascular coagulation 13.25 9.84 34 163325 35808 79545221
Dysgraphia 13.24 9.84 27 163332 4005 79577024
Poverty of thought content 13.19 9.84 5 163354 61 79580968
Spinal cord injury thoracic 13.04 9.84 6 163353 122 79580907
Mass 13.04 9.84 10 163349 17462 79563567
Abdominal rigidity 13.02 9.84 23 163336 3065 79577964
Swollen tongue 13.02 9.84 139 163220 42431 79538598
Blood osmolarity increased 13.01 9.84 11 163348 677 79580352
Oxygen saturation decreased 12.99 9.84 186 163173 128861 79452168
Pharyngitis streptococcal 12.98 9.84 3 163356 10711 79570318
Neoplasm progression 12.98 9.84 58 163301 51624 79529405
Cytomegalovirus viraemia 12.97 9.84 5 163354 12816 79568213
Surgery 12.97 9.84 30 163329 32736 79548293
Haemolysis 12.96 9.84 5 163354 12807 79568222
Thrombosis 12.94 9.84 110 163249 83990 79497039
Blood ethanol increased 12.94 9.84 11 163348 682 79580347
Electroencephalogram abnormal 12.92 9.84 32 163327 5402 79575627
Antiphospholipid antibodies 12.91 9.84 6 163353 125 79580904
Generalised anxiety disorder 12.87 9.84 19 163340 2178 79578851
Kussmaul respiration 12.86 9.84 9 163350 418 79580611
Dependence 12.84 9.84 20 163339 2402 79578627
Polydipsia psychogenic 12.83 9.84 7 163352 207 79580822
Upper-airway cough syndrome 12.80 9.84 4 163355 11689 79569340
Enthesopathy 12.65 9.84 4 163355 11604 79569425
Sneezing 12.61 9.84 13 163346 19670 79561359
Joint effusion 12.59 9.84 11 163348 18003 79563026
Antipsychotic drug level decreased 12.59 9.84 14 163345 1210 79579819
Dystrophic calcification 12.57 9.84 6 163353 133 79580896
Increased tendency to bruise 12.54 9.84 3 163356 10461 79570568
Feeling drunk 12.53 9.84 29 163330 4690 79576339
Impaired self-care 12.51 9.84 21 163338 2686 79578343
Mucosal inflammation 12.48 9.84 97 163262 75483 79505546
Foot fracture 12.48 9.84 16 163343 21965 79559064
Emotional poverty 12.47 9.84 12 163347 875 79580154
Renal failure 12.39 9.84 315 163044 200653 79380376
Conjunctivitis 12.37 9.84 21 163338 25694 79555335
Light chain disease 12.36 9.84 7 163352 223 79580806
Pathogen resistance 12.34 9.84 7 163352 14335 79566694
Libido decreased 12.30 9.84 31 163328 5290 79575739
Ear pain 12.29 9.84 31 163328 32838 79548191
Kidney congestion 12.27 9.84 8 163351 330 79580699
Musculoskeletal stiffness 12.27 9.84 269 163090 174739 79406290
Mitral valve incompetence 12.26 9.84 25 163334 28540 79552489
Mental status changes 12.23 9.84 199 163160 66760 79514269
Ulcer 12.22 9.84 27 163332 29945 79551084
Coeliac disease 12.21 9.84 4 163355 11347 79569682
Feeling hot 12.19 9.84 72 163287 59662 79521367
Pulmonary vein occlusion 12.18 9.84 6 163353 143 79580886
Accidental exposure to product 12.14 9.84 29 163330 31293 79549736
B-lymphocyte count increased 12.10 9.84 6 163353 145 79580884
Mean cell haemoglobin decreased 12.10 9.84 34 163325 6190 79574839
Gastric cancer 12.04 9.84 3 163356 10176 79570853
Pulmonary arterial hypertension 12.03 9.84 25 163334 28341 79552688
Hangover 11.99 9.84 18 163341 2094 79578935
Laryngeal granuloma 11.98 9.84 3 163356 7 79581022
Arachnoid cyst 11.97 9.84 8 163351 344 79580685
Nystagmus 11.95 9.84 46 163313 9858 79571171
Coagulopathy 11.94 9.84 36 163323 35970 79545059
Inferior vena caval occlusion 11.94 9.84 4 163355 33 79580996
Post-traumatic stress disorder 11.88 9.84 29 163330 4852 79576177
Aphasia 11.79 9.84 147 163212 46585 79534444
Hyperthyroidism 11.76 9.84 17 163342 22192 79558837
No adverse event 11.76 9.84 38 163321 37154 79543875
Rabbit syndrome 11.75 9.84 8 163351 355 79580674
Skin infection 11.74 9.84 12 163347 18233 79562796
Visceral congestion 11.71 9.84 12 163347 944 79580085
Injection site warmth 11.67 9.84 8 163351 14799 79566230
Pulmonary renal syndrome 11.63 9.84 10 163349 630 79580399
Hyperprolactinaemia 11.61 9.84 28 163331 4648 79576381
Cellulitis orbital 11.59 9.84 11 163348 788 79580241
Lack of application site rotation 11.58 9.84 5 163354 87 79580942
Drug withdrawal headache 11.53 9.84 5 163354 88 79580941
Medulloblastoma 11.53 9.84 5 163354 88 79580941
Alkalosis hypochloraemic 11.52 9.84 9 163350 495 79580534
Eye haematoma 11.50 9.84 6 163353 162 79580867
Haematotoxicity 11.44 9.84 9 163350 15510 79565519
Essential tremor 11.43 9.84 15 163344 1540 79579489
Injection site urticaria 11.42 9.84 6 163353 12820 79568209
Toxicologic test abnormal 11.39 9.84 14 163345 1346 79579683
Implant site extravasation 11.36 9.84 11 163348 808 79580221
Injection site rash 11.34 9.84 12 163347 17942 79563087
Bronchial aspiration procedure 11.32 9.84 7 163352 263 79580766
Disability 11.32 9.84 11 163348 17109 79563920
Hyperuricaemia 11.29 9.84 5 163354 11794 79569235
Haemophagocytic lymphohistiocytosis 11.29 9.84 17 163342 21820 79559209
Torsade de pointes 11.29 9.84 73 163286 19239 79561790
Sialoadenitis 11.28 9.84 17 163342 1984 79579045
Radial nerve injury 11.26 9.84 4 163355 40 79580989
Pneumocystis jirovecii pneumonia 11.15 9.84 32 163327 32476 79548553
Alcohol abuse 11.12 9.84 30 163329 5333 79575696
Drug use disorder 11.11 9.84 41 163318 8610 79572419
Deformity 11.04 9.84 3 163356 9602 79571427
Extensor plantar response 11.03 9.84 16 163343 1805 79579224
Perforated ulcer 11.02 9.84 10 163349 677 79580352
Shared psychotic disorder 11.00 9.84 4 163355 43 79580986
Cerebral atrophy 10.99 9.84 39 163320 8036 79572993
Carbon monoxide poisoning 10.97 9.84 7 163352 278 79580751
Lymphadenopathy 10.96 9.84 64 163295 53183 79527846
Blood creatinine increased 10.96 9.84 238 163121 154819 79426210
Verbal abuse 10.95 9.84 7 163352 279 79580750
Bronchopulmonary aspergillosis 10.91 9.84 18 163341 22276 79558753
Chronic kidney disease 10.88 9.84 85 163274 66069 79514960
Throat irritation 10.86 9.84 45 163314 40901 79540128
Basophil count decreased 10.84 9.84 7 163352 284 79580745
Peritonitis 10.83 9.84 26 163333 28010 79553019
Incorrect route of product administration 10.83 9.84 36 163323 34893 79546136
Blood uric acid increased 10.83 9.84 7 163352 13353 79567676
Hot flush 10.75 9.84 67 163292 54810 79526219
Breast cancer female 10.75 9.84 5 163354 11456 79569573
Pulmonary alveolar haemorrhage 10.74 9.84 5 163354 11452 79569577
Mood disorder due to a general medical condition 10.69 9.84 4 163355 47 79580982
Labelled drug-disease interaction issue 10.69 9.84 4 163355 47 79580982
Peripheral T-cell lymphoma unspecified recurrent 10.69 9.84 4 163355 47 79580982
Accidental poisoning 10.68 9.84 15 163344 1642 79579387
Hypertriglyceridaemia 10.65 9.84 53 163306 12687 79568342
Gambling 10.64 9.84 7 163352 293 79580736
Amnesia 10.64 9.84 185 163174 62872 79518157
Thyroxine free decreased 10.62 9.84 12 163347 1055 79579974
Drug eruption 10.62 9.84 50 163309 43885 79537144
Unemployment 10.61 9.84 4 163355 48 79580981
Facial paresis 10.56 9.84 30 163329 5496 79575533
Adverse event 10.55 9.84 76 163283 60138 79520891
Ballismus 10.52 9.84 7 163352 299 79580730
Product quality issue 10.51 9.84 35 163324 33905 79547124
Polyarthritis 10.44 9.84 6 163353 12196 79568833
Skin fissures 10.39 9.84 7 163352 13066 79567963
Viral infection 10.37 9.84 49 163310 42967 79538062
Acute abdomen 10.29 9.84 21 163338 3116 79577913
Pregnancy 10.29 9.84 25 163334 26826 79554203
Nephrotic syndrome 10.29 9.84 5 163354 11169 79569860
Chemical burns of eye 10.19 9.84 5 163354 118 79580911
COVID-19 pneumonia 10.19 9.84 28 163331 28821 79552208
Stress 10.18 9.84 109 163250 79503 79501526
Aspartate aminotransferase decreased 10.17 9.84 12 163347 1105 79579924
Resting tremor 10.15 9.84 14 163345 1507 79579522
Bronchiectasis 10.12 9.84 19 163340 22367 79558662
Gamma-glutamyltransferase abnormal 10.07 9.84 9 163350 597 79580432
Synovial cyst 10.06 9.84 4 163355 10061 79570968
Jealous delusion 10.04 9.84 7 163352 323 79580706
Alcohol poisoning 10.03 9.84 27 163332 4794 79576235
Alcohol problem 9.99 9.84 4 163355 57 79580972
Swelling face 9.97 9.84 203 163156 71009 79510020
Rapid eye movement sleep behaviour disorder 9.96 9.84 8 163351 458 79580571
Aspergillus test positive 9.96 9.84 10 163349 768 79580261
Cholelithiasis 9.96 9.84 65 163294 52599 79528430
Hyperacusis 9.95 9.84 17 163342 2206 79578823
Transferrin saturation decreased 9.93 9.84 12 163347 1134 79579895
Marital problem 9.88 9.84 6 163353 218 79580811
Dreamy state 9.86 9.84 4 163355 59 79580970
Skull fracture 9.86 9.84 15 163344 1765 79579264
Intervertebral disc protrusion 9.86 9.84 21 163338 23600 79557429
Partner stress 9.85 9.84 7 163352 333 79580696
Coordination abnormal 9.85 9.84 65 163294 17247 79563782

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
Neonatal seizure 36.23 30.88 28 595 437 88732

Pharmacologic Action:

SourceCodeDescription
ATC N06AX11 NERVOUS SYSTEM
PSYCHOANALEPTICS
ANTIDEPRESSANTS
Other antidepressants
MeSH PA D018663 Adrenergic Agents
MeSH PA D058669 Adrenergic alpha-2 Receptor Antagonists
MeSH PA D000317 Adrenergic alpha-Antagonists
MeSH PA D018674 Adrenergic Antagonists
MeSH PA D014151 Anti-Anxiety Agents
MeSH PA D000928 Antidepressive Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D018494 Histamine Agents
MeSH PA D006633 Histamine Antagonists
MeSH PA D006634 Histamine H1 Antagonists
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D011619 Psychotropic Drugs
MeSH PA D058830 Serotonin 5-HT2 Receptor Antagonists
MeSH PA D058831 Serotonin 5-HT3 Receptor Antagonists
MeSH PA D018490 Serotonin Agents
MeSH PA D012702 Serotonin Antagonists
MeSH PA D014149 Tranquilizing Agents
CHEBI has role CHEBI:35474 anti-anxiety agents
CHEBI has role CHEBI:37890 alpha-adrenergic receptor blockaders
CHEBI has role CHEBI:37955 H1 receptor antagonists
CHEBI has role CHEBI:37956 antihistamines
CHEBI has role CHEBI:48279 serotonin antagonists
CHEBI has role CHEBI:146270 oneirogens

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

DiseaseRelationSNOMED_IDDOID
Major depressive disorder indication 370143000
Excessive vomiting in pregnancy off-label use 14094001
Posttraumatic stress disorder off-label use 47505003 DOID:2055
Suicidal thoughts contraindication 6471006
Weight gain finding contraindication 8943002
Hypercholesterolemia contraindication 13644009
Myocardial infarction contraindication 22298006 DOID:5844
Hypovolemia contraindication 28560003
Orthostatic hypotension contraindication 28651003
Dehydration contraindication 34095006
Low blood pressure contraindication 45007003
Cerebrovascular disease contraindication 62914000 DOID:6713
Hyponatremia contraindication 89627008
Seizure disorder contraindication 128613002
Liver function tests abnormal contraindication 166603001
Bipolar affective disorder, current episode manic contraindication 191618007
Angina pectoris contraindication 194828000
Impaired renal function disorder contraindication 197663003
Cerebrovascular accident contraindication 230690007
Disease of liver contraindication 235856003 DOID:409
Akathisia contraindication 285145004
Hypertriglyceridemia contraindication 302870006
Neutropenic disorder contraindication 303011007 DOID:1227
Serotonin syndrome contraindication 371089000
Obesity contraindication 414916001 DOID:9970
Acute Thromboembolic Stroke contraindication




🐶 Veterinary Drug Use

SpeciesUseRelation
Cats Management of weight loss in cats Indication

🐶 Veterinary products

ProductApplicantIngredients
Mirataz Dechra, Ltd. 1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.67 Basic
pKa2 2.91 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
5-hydroxytryptamine receptor 2C GPCR ANTAGONIST Ki 7.41 CHEMBL CHEMBL
5-hydroxytryptamine receptor 2A GPCR ANTAGONIST Ki 7.16 CHEMBL CHEMBL
Alpha-2A adrenergic receptor GPCR ANTAGONIST Ki 7.70 CHEMBL
Sodium-dependent noradrenaline transporter Transporter Ki 5.34 PDSP
5-hydroxytryptamine receptor 1A GPCR Kd 5.30 CHEMBL
5-hydroxytryptamine receptor 7 GPCR Ki 6.58 CHEMBL
Alpha-1A adrenergic receptor GPCR IC50 5.50 CHEMBL
Alpha-2B adrenergic receptor GPCR ANTAGONIST IC50 6.65 CHEMBL
D(3) dopamine receptor GPCR Ki 5.24 CHEMBL
Histamine H1 receptor GPCR Ki 8.80 WOMBAT-PK
Muscarinic acetylcholine receptor M1 GPCR WOMBAT-PK
Muscarinic acetylcholine receptor M2 GPCR WOMBAT-PK
Alpha-2C adrenergic receptor GPCR ANTAGONIST Ki 7.74 CHEMBL
5-hydroxytryptamine receptor 3A Ion channel Ki 5.54 CHEMBL
D(1A) dopamine receptor GPCR Ki 5.38 PDSP
D(2) dopamine receptor GPCR Ki 5.26 PDSP
D(2) dopamine receptor GPCR Ki 5.84 CHEMBL
5-hydroxytryptamine receptor 2A GPCR Ki 8.70 CHEMBL
Transporter Transporter Ki 5.79 CHEMBL
D(1A) dopamine receptor GPCR Ki 5.38 CHEMBL
5-hydroxytryptamine receptor 2C GPCR Ki 8.26 CHEMBL
Adrenergic receptor alpha-1 GPCR Ki 6.22 CHEMBL

External reference:

IDSource
4020978 VUID
N0000148449 NUI
D00563 KEGG_DRUG
4020978 VANDF
C0049506 UMLSCUI
CHEBI:6950 CHEBI
CHEMBL654 ChEMBL_ID
DB00370 DRUGBANK_ID
D000078785 MESH_DESCRIPTOR_UI
4205 PUBCHEM_CID
7241 IUPHAR_LIGAND_ID
6481 INN_ID
A051Q2099Q UNII
15996 RXNORM
46110 MMSL
5120 MMSL
d04025 MMSL
006054 NDDF
108430001 SNOMEDCT_US
386847004 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
REMERON HUMAN PRESCRIPTION DRUG LABEL 1 0052-0105 TABLET, FILM COATED 15 mg ORAL NDA 31 sections
REMERONSOLTAB HUMAN PRESCRIPTION DRUG LABEL 1 0052-0106 TABLET, ORALLY DISINTEGRATING 15 mg ORAL NDA 31 sections
REMERON HUMAN PRESCRIPTION DRUG LABEL 1 0052-0107 TABLET, FILM COATED 30 mg ORAL NDA 31 sections
REMERONSOLTAB HUMAN PRESCRIPTION DRUG LABEL 1 0052-0108 TABLET, ORALLY DISINTEGRATING 30 mg ORAL NDA 31 sections
REMERON HUMAN PRESCRIPTION DRUG LABEL 1 0052-0109 TABLET, FILM COATED 45 mg ORAL NDA 31 sections
REMERONSOLTAB HUMAN PRESCRIPTION DRUG LABEL 1 0052-0110 TABLET, ORALLY DISINTEGRATING 45 mg ORAL NDA 31 sections
REMERON HUMAN PRESCRIPTION DRUG LABEL 1 0052-4364 TABLET, FILM COATED 15 mg ORAL NDA 31 sections
REMERON HUMAN PRESCRIPTION DRUG LABEL 1 0052-4365 TABLET, FILM COATED 30 mg ORAL NDA 31 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0378-3515 TABLET, FILM COATED 15 mg ORAL ANDA 29 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0378-3515 TABLET, FILM COATED 15 mg ORAL ANDA 29 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0378-3530 TABLET, FILM COATED 30 mg ORAL ANDA 29 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0378-3530 TABLET, FILM COATED 30 mg ORAL ANDA 29 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0378-3545 TABLET, FILM COATED 45 mg ORAL ANDA 29 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0378-3545 TABLET, FILM COATED 45 mg ORAL ANDA 29 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8078 TABLET 7.50 mg ORAL ANDA 25 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8078 TABLET 7.50 mg ORAL ANDA 25 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8268 TABLET, FILM COATED 15 mg ORAL ANDA 25 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8269 TABLET, FILM COATED 30 mg ORAL ANDA 25 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0904-6519 TABLET, FILM COATED 15 mg ORAL ANDA 25 sections
Mirtazapine HUMAN PRESCRIPTION DRUG LABEL 1 0904-6519 TABLET, FILM COATED 15 mg ORAL ANDA 25 sections
Mirtazapine Human Prescription Drug Label 1 13107-001 TABLET, FILM COATED 7.50 mg ORAL ANDA 28 sections
Mirtazapine Human Prescription Drug Label 1 13107-001 TABLET, FILM COATED 7.50 mg ORAL ANDA 28 sections
Mirtazapine Human Prescription Drug Label 1 13107-003 TABLET, FILM COATED 30 mg ORAL ANDA 28 sections
Mirtazapine Human Prescription Drug Label 1 13107-003 TABLET, FILM COATED 30 mg ORAL ANDA 28 sections
Mirtazapine Human Prescription Drug Label 1 13107-031 TABLET, FILM COATED 15 mg ORAL ANDA 28 sections
Mirtazapine Human Prescription Drug Label 1 13107-031 TABLET, FILM COATED 15 mg ORAL ANDA 28 sections
Mirtazapine Human Prescription Drug Label 1 13107-032 TABLET, FILM COATED 45 mg ORAL ANDA 28 sections
Mirtazapine Human Prescription Drug Label 1 13107-032 TABLET, FILM COATED 45 mg ORAL ANDA 28 sections
MIRTAZAPINE HUMAN PRESCRIPTION DRUG LABEL 1 16590-153 TABLET, FILM COATED 15 mg ORAL ANDA 26 sections
MIRTAZAPINE HUMAN PRESCRIPTION DRUG LABEL 1 16590-154 TABLET, FILM COATED 30 mg ORAL ANDA 26 sections