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

Stem definitionDrug idCAS RN
serotonin and/or norepinephrine reuptake inhibitors, fluoxetine derivatives 2068 61869-08-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • BRL 29060A
  • BRL-29060A
  • paroxetine hydrochloride hydrate
  • brisdelle
  • paroxetine
  • paxetil
  • paxil
  • paroxetine hydrochloride
  • paroxetine mesylate
  • paroxetine hydrochloride hemihydrate
  • paroxetine hydrochloride anhydrous
  • paroxetine mesilate
  • paroxetine HCl
A serotonin uptake inhibitor that is effective in the treatment of depression.
  • Molecular weight: 329.37
  • Formula: C19H20FNO3
  • CLOGP: 4.24
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 1
  • TPSA: 39.72
  • ALOGS: -4.59
  • ROTB: 4
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
20 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 5.40 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) 2.53 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) 18 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 18 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.06 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 13 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Dec. 29, 1992 FDA APOTEX TECHNOLOGIES

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
Drug withdrawal syndrome 939.65 10.27 585 108886 26609 63352942
Serotonin syndrome 770.45 10.27 527 108944 28155 63351396
Atrial septal defect 763.87 10.27 326 109145 6612 63372939
Suicidal ideation 498.82 10.27 576 108895 61845 63317706
Ventricular septal defect 427.35 10.27 189 109282 4189 63375362
Sopor 396.47 10.27 319 109152 21845 63357706
Patent ductus arteriosus 394.11 10.27 177 109294 4073 63375478
Drug abuse 380.23 10.27 543 108928 71975 63307576
Suicide attempt 356.55 10.27 481 108990 60437 63319114
Exposure during pregnancy 317.82 10.27 776 108695 154771 63224780
Agitation 292.18 10.27 433 109038 59324 63320227
Drug interaction 287.09 10.27 958 108513 228173 63151378
Anxiety 277.38 10.27 915 108556 216626 63162925
Alopecia 276.68 10.27 118 109353 337418 63042133
Contraindicated product administered 272.58 10.27 29 109442 217619 63161932
Systemic lupus erythematosus 263.78 10.27 27 109444 208891 63170660
Tremor 261.86 10.27 652 108819 131587 63247964
Heart disease congenital 248.38 10.27 91 109380 1208 63378343
Congenital anomaly 241.29 10.27 97 109374 1679 63377872
Glossodynia 239.67 10.27 18 109453 178858 63200693
Mydriasis 226.45 10.27 178 109293 11778 63367773
Intentional self-injury 223.70 10.27 248 109223 25439 63354112
Foetal exposure during pregnancy 222.38 10.27 275 109196 31687 63347864
Nightmare 216.83 10.27 213 109258 18981 63360570
Pulmonary valve stenosis 215.24 10.27 60 109411 298 63379253
Off label use 209.70 10.27 541 108930 673921 62705630
Multiple congenital abnormalities 203.18 10.27 64 109407 516 63379035
Drug ineffective 201.81 10.27 1024 108447 1043741 62335810
Cardiac murmur 199.88 10.27 180 109291 14372 63365179
Drug intolerance 190.39 10.27 152 109319 308509 63071042
Hallucinations, mixed 187.47 10.27 112 109359 4717 63374834
Abdominal discomfort 184.53 10.27 169 109302 320716 63058835
Pericarditis 182.80 10.27 11 109460 131568 63247983
Hyponatraemia 182.06 10.27 513 108958 111387 63268164
Somnolence 179.16 10.27 695 108776 177990 63201561
Joint swelling 174.10 10.27 185 109286 327481 63052070
Persistent foetal circulation 173.47 10.27 46 109425 182 63379369
Depersonalisation/derealisation disorder 172.90 10.27 71 109400 1301 63378250
Irritability 169.94 10.27 240 109231 31454 63348097
Synovitis 166.87 10.27 57 109414 186861 63192690
Neuroleptic malignant syndrome 163.36 10.27 148 109323 11908 63367643
Anger 163.10 10.27 150 109321 12306 63367245
Mania 162.07 10.27 149 109322 12218 63367333
Swelling 159.51 10.27 144 109327 275234 63104317
Pulmonary artery stenosis congenital 154.85 10.27 43 109428 210 63379341
Disorientation 152.79 10.27 257 109214 39195 63340356
Bradyphrenia 147.69 10.27 111 109360 6869 63372682
Rash 145.68 10.27 489 108982 560382 62819169
Treatment failure 144.12 10.27 82 109389 198961 63180590
Myoglobin urine present 143.61 10.27 53 109418 719 63378832
Dissociation 140.83 10.27 78 109393 2841 63376710
Rheumatoid arthritis 140.79 10.27 138 109333 253681 63125870
Derealisation 140.38 10.27 59 109412 1149 63378402
Infusion related reaction 140.25 10.27 130 109341 245391 63134160
Hallucination, auditory 136.87 10.27 138 109333 12686 63366865
Panic attack 136.19 10.27 180 109291 22151 63357400
Coarctation of the aorta 135.04 10.27 47 109424 532 63379019
Helicobacter infection 134.39 10.27 6 109465 92779 63286772
Completed suicide 132.66 10.27 550 108921 145123 63234428
Activation syndrome 132.52 10.27 37 109434 185 63379366
Hyperhidrosis 131.34 10.27 447 109024 107389 63272162
Disturbance in attention 131.23 10.27 236 109235 37953 63341598
Mood swings 130.13 10.27 159 109312 18089 63361462
Overdose 129.76 10.27 465 109006 114613 63264938
Arthropathy 128.65 10.27 129 109342 234663 63144888
Aggression 127.54 10.27 179 109292 23319 63356232
Depression 127.53 10.27 672 108799 195820 63183731
Discomfort 125.45 10.27 66 109405 167308 63212243
Feeling of despair 125.33 10.27 67 109404 2272 63377279
Restlessness 123.66 10.27 199 109272 29254 63350297
Confusional state 123.58 10.27 763 108708 235617 63143934
Product use issue 121.00 10.27 121 109350 220399 63159152
Hypersensitivity 119.97 10.27 200 109271 292485 63087066
Inappropriate antidiuretic hormone secretion 117.25 10.27 139 109332 15323 63364228
Withdrawal syndrome 112.52 10.27 155 109316 19842 63359709
Fallot's tetralogy 112.16 10.27 27 109444 64 63379487
Pain 111.65 10.27 784 108687 739844 62639707
Gastric pH decreased 107.66 10.27 43 109428 731 63378820
Dyskinesia 105.18 10.27 194 109277 31808 63347743
Developmental delay 101.23 10.27 50 109421 1433 63378118
Toxicity to various agents 101.03 10.27 751 108720 246499 63133052
Blister 99.03 10.27 50 109421 129764 63249787
Hepatic enzyme increased 97.87 10.27 123 109348 202205 63177346
Insomnia 96.72 10.27 669 108802 214583 63164968
Therapeutic product effect decreased 96.02 10.27 115 109356 193072 63186479
Stomatitis 93.63 10.27 62 109409 138663 63240888
Wound 91.35 10.27 88 109383 163175 63216376
Poisoning deliberate 90.31 10.27 104 109367 11114 63368437
Extrapyramidal disorder 90.29 10.27 113 109358 13171 63366380
Folliculitis 88.90 10.27 9 109462 70308 63309243
Peripheral swelling 87.20 10.27 207 109264 265735 63113816
Nasopharyngitis 86.51 10.27 194 109277 254063 63125488
Drug dependence 86.28 10.27 153 109318 24330 63355221
Tearfulness 85.75 10.27 65 109406 4074 63375477
Cogwheel rigidity 85.19 10.27 49 109422 1921 63377630
Intentional product use issue 85.18 10.27 58 109413 127834 63251717
Flat affect 84.69 10.27 44 109427 1406 63378145
Agoraphobia 84.17 10.27 30 109441 366 63379185
Arthralgia 83.28 10.27 608 108863 569102 62810449
Muscle rigidity 81.66 10.27 100 109371 11400 63368151
Muscle injury 80.98 10.27 9 109462 65336 63314215
Transposition of the great vessels 77.84 10.27 25 109446 216 63379335
Crying 77.32 10.27 142 109329 23201 63356350
Homicidal ideation 76.89 10.27 44 109427 1708 63377843
Congenital aortic stenosis 76.28 10.27 17 109454 24 63379527
Emotional disorder 74.21 10.27 103 109368 13276 63366275
Talipes 73.88 10.27 41 109430 1499 63378052
Bronchial neoplasm 73.82 10.27 29 109442 471 63379080
Febrile neutropenia 73.32 10.27 58 109413 118391 63261160
Lower respiratory tract infection 72.06 10.27 73 109398 132234 63247317
Memory impairment 72.02 10.27 363 109108 103895 63275656
H1N1 influenza 71.87 10.27 42 109429 1697 63377854
Abnormal behaviour 71.80 10.27 131 109340 21295 63358256
Dystonia 71.64 10.27 103 109368 13716 63365835
Hyperreflexia 71.04 10.27 68 109403 5866 63373685
Depressed mood 71.00 10.27 190 109281 40001 63339550
Delirium 70.96 10.27 220 109251 50321 63329230
Impulsive behaviour 70.13 10.27 40 109431 1543 63378008
Thermal burn 69.96 10.27 68 109403 5978 63373573
Hypoplastic left heart syndrome 69.88 10.27 22 109449 177 63379374
Bronchial haemorrhage 69.08 10.27 29 109442 563 63378988
Nervousness 69.00 10.27 160 109311 30819 63348732
Maternal exposure during pregnancy 68.43 10.27 176 109295 219886 63159665
Mobility decreased 68.12 10.27 65 109406 121094 63258457
Intentional overdose 67.45 10.27 280 109191 73872 63305679
Psoriatic arthropathy 67.20 10.27 37 109434 91483 63288068
Parkinsonism 66.53 10.27 86 109385 10353 63369198
Blood creatine phosphokinase increased 66.50 10.27 156 109315 30274 63349277
Altered state of consciousness 66.01 10.27 139 109332 25091 63354460
Speech disorder developmental 65.21 10.27 29 109442 651 63378900
Nasal turbinate hypertrophy 65.13 10.27 30 109441 733 63378818
Breath sounds abnormal 64.68 10.27 87 109384 10886 63368665
Cough 62.39 10.27 276 109195 292467 63087084
Libido increased 62.32 10.27 35 109436 1310 63378241
Congenital cardiovascular anomaly 61.73 10.27 18 109453 108 63379443
Cyanosis 61.18 10.27 107 109364 16828 63362723
General physical health deterioration 61.14 10.27 163 109308 201239 63178312
Myoclonus 60.93 10.27 103 109368 15765 63363786
Psychotic disorder 60.82 10.27 136 109335 25576 63353975
Rheumatoid factor positive 60.72 10.27 35 109436 84371 63295180
Apathy 60.08 10.27 75 109396 8719 63370832
Amylase increased 60.00 10.27 64 109407 6281 63373270
Infection 59.14 10.27 200 109271 228973 63150578
Clonus 59.08 10.27 55 109416 4581 63374970
Delusion 58.57 10.27 87 109384 11930 63367621
Endometrial ablation 58.46 10.27 30 109441 934 63378617
Bicuspid aortic valve 58.02 10.27 17 109454 104 63379447
Cleft palate 57.08 10.27 30 109441 982 63378569
Feeling of body temperature change 56.52 10.27 55 109416 4842 63374709
Affective disorder 56.38 10.27 61 109410 6085 63373466
Homicide 55.68 10.27 22 109449 363 63379188
Drooling 55.40 10.27 49 109422 3819 63375732
Pulmonary valve stenosis congenital 55.20 10.27 18 109453 164 63379387
Renal ischaemia 54.38 10.27 25 109446 608 63378943
Impaired healing 54.23 10.27 58 109413 102484 63277067
Irritable bowel syndrome 54.03 10.27 38 109433 82374 63297177
Abnormal dreams 53.95 10.27 78 109393 10438 63369113
Anomalous pulmonary venous connection 53.70 10.27 14 109457 51 63379500
Hyperprolactinaemia 53.07 10.27 48 109423 3852 63375699
Toxic encephalopathy 52.97 10.27 61 109410 6518 63373033
Right ventricular hypertrophy 51.88 10.27 25 109446 678 63378873
Hallucination 51.43 10.27 209 109262 54608 63324943
Hallucination, visual 51.28 10.27 107 109364 19191 63360360
Malignant neoplasm progression 51.08 10.27 40 109431 82081 63297470
Therapeutic product ineffective 50.98 10.27 34 109437 1738 63377813
Feeling jittery 50.14 10.27 86 109385 13317 63366234
Knee arthroplasty 49.25 10.27 16 109455 54190 63325361
Hip arthroplasty 49.06 10.27 11 109460 47635 63331916
Fatigue 48.39 10.27 1165 108306 886863 62492688
Speech disorder 48.17 10.27 167 109304 40462 63339089
Depressed level of consciousness 47.78 10.27 223 109248 61855 63317696
Bronchial disorder 47.70 10.27 29 109442 1261 63378290
Vertigo 47.47 10.27 217 109254 59670 63319881
Menstrual disorder 47.46 10.27 52 109419 5261 63374290
COVID-19 46.53 10.27 77 109394 113026 63266525
PCO2 increased 46.19 10.27 28 109443 1211 63378340
Death 46.11 10.27 418 109053 373963 63005588
Troponin increased 46.10 10.27 71 109400 10050 63369501
Pneumonia 45.99 10.27 535 108936 456232 62923319
Galactorrhoea 44.86 10.27 45 109426 4110 63375441
Emotional distress 44.13 10.27 140 109331 32409 63347142
Loss of libido 43.99 10.27 28 109443 1321 63378230
Self esteem decreased 43.89 10.27 22 109449 651 63378900
Dependence 43.87 10.27 33 109438 2044 63377507
Craniosynostosis 43.73 10.27 15 109456 162 63379389
Social anxiety disorder 43.33 10.27 19 109452 412 63379139
Muscle disorder 43.29 10.27 48 109423 4921 63374630
Hypomania 43.26 10.27 54 109417 6276 63373275
Akathisia 42.84 10.27 65 109406 9081 63370470
Logorrhoea 42.49 10.27 35 109436 2475 63377076
Accidental poisoning 42.35 10.27 21 109450 607 63378944
Gastrointestinal disorder 42.29 10.27 103 109368 131136 63248415
Seizure 42.27 10.27 381 109090 132253 63247298
Obsessive-compulsive disorder 42.06 10.27 43 109428 4017 63375534
Depressive symptom 41.69 10.27 43 109428 4059 63375492
Dyspnoea 41.54 10.27 848 108623 660465 62719086
Fear 41.40 10.27 87 109384 15679 63363872
Paranoia 41.17 10.27 73 109398 11606 63367945
Encephalopathy 40.90 10.27 153 109318 38467 63341084
Electrocardiogram QT prolonged 40.89 10.27 207 109264 59323 63320228
Disease progression 40.62 10.27 95 109376 122663 63256888
Hostility 40.11 10.27 30 109441 1842 63377709
Incontinence 40.09 10.27 72 109399 11560 63367991
Rhonchi 39.65 10.27 34 109437 2542 63377009
Hyperacusis 39.02 10.27 31 109440 2082 63377469
Spina bifida 38.84 10.27 22 109449 837 63378714
Fibromyalgia 38.73 10.27 49 109422 80371 63299180
Restless legs syndrome 38.33 10.27 93 109378 18438 63361113
Fall 38.09 10.27 915 108556 391419 62988132
Amnesia 37.98 10.27 193 109278 55392 63324159
Hypoaesthesia oral 37.88 10.27 75 109396 12958 63366593
Parosmia 37.79 10.27 50 109421 6156 63373395
Substance abuse 37.75 10.27 44 109427 4763 63374788
Congenital mitral valve stenosis 37.55 10.27 7 109464 0 63379551
Paraesthesia 37.10 10.27 424 109047 156542 63223009
Diabetes insipidus 37.09 10.27 33 109438 2592 63376959
Chorea 36.99 10.27 27 109444 1597 63377954
Sinusitis 36.90 10.27 234 109237 226419 63153132
Libido decreased 36.58 10.27 33 109438 2639 63376912
Loss of consciousness 36.46 10.27 337 109134 117784 63261767
Product complaint 36.37 10.27 73 109398 12736 63366815
Tinnitus 35.96 10.27 139 109332 35489 63344062
Muscle twitching 35.76 10.27 94 109377 19574 63359977
PO2 increased 35.72 10.27 21 109450 858 63378693
Blood lactate dehydrogenase increased 35.62 10.27 104 109367 23012 63356539
Psychomotor hyperactivity 35.48 10.27 65 109406 10598 63368953
Treatment noncompliance 34.76 10.27 142 109329 37183 63342368
Urinary retention 34.58 10.27 123 109348 30178 63349373
Dizziness 34.57 10.27 978 108493 428947 62950604
Ventricular hypoplasia 34.00 10.27 12 109459 142 63379409
Therapy non-responder 33.77 10.27 49 109422 75852 63303699
Hepatocellular injury 33.73 10.27 114 109357 27267 63352284
Tachycardia 33.45 10.27 331 109140 117825 63261726
Generalised anxiety disorder 33.20 10.27 28 109443 2046 63377505
Maternal drugs affecting foetus 33.11 10.27 43 109428 5199 63374352
Respiratory depression 32.94 10.27 73 109398 13642 63365909
Product dose omission issue 32.70 10.27 253 109218 234060 63145491
Endocrine ophthalmopathy 32.56 10.27 18 109453 653 63378898
Paralysis 32.50 10.27 60 109411 9840 63369711
Prescription form tampering 32.22 10.27 17 109454 561 63378990
DiGeorge's syndrome 32.19 10.27 6 109465 0 63379551
Congenital aortic valve incompetence 32.19 10.27 6 109465 0 63379551
Balance disorder 31.92 10.27 252 109219 84170 63295381
Bradykinesia 31.91 10.27 42 109429 5146 63374405
Blood pH decreased 31.64 10.27 30 109441 2557 63376994
Weight increased 31.58 10.27 628 108843 260164 63119387
Neonatal behavioural syndrome 31.30 10.27 9 109462 51 63379500
Electroencephalogram abnormal 31.18 10.27 35 109436 3637 63375914
Increased appetite 31.16 10.27 58 109413 9572 63369979
Macular degeneration 31.12 10.27 3 109468 24373 63355178
Self-injurious ideation 30.94 10.27 30 109441 2629 63376922
Neutrophil count decreased 30.83 10.27 31 109440 56375 63323176
Neuropathy peripheral 30.81 10.27 97 109374 113570 63265981
Myelosuppression 30.04 10.27 3 109468 23700 63355851
Soft tissue injury 30.00 10.27 24 109447 1628 63377923
Injection site pain 29.69 10.27 119 109352 129681 63249870
Ebstein's anomaly 29.56 10.27 7 109464 15 63379536
Coma 29.40 10.27 201 109270 64163 63315388
Asphyxia 29.05 10.27 44 109427 6137 63373414
Toxic shock syndrome 28.77 10.27 18 109453 824 63378727
Joint range of motion decreased 28.71 10.27 10 109461 32418 63347133
Schizophrenia 28.60 10.27 57 109414 9895 63369656
Pain in extremity 28.58 10.27 401 109070 331085 63048466
Coma scale 28.33 10.27 8 109463 42 63379509
Blood sodium decreased 28.15 10.27 99 109372 24153 63355398
Alcoholism 27.99 10.27 24 109447 1794 63377757
Apraxia 27.96 10.27 24 109447 1797 63377754
Feelings of worthlessness 27.73 10.27 13 109458 331 63379220
Hypertonia 27.69 10.27 37 109434 4600 63374951
Rhabdomyolysis 27.54 10.27 149 109322 43802 63335749
Sinus tachycardia 27.26 10.27 98 109373 24170 63355381
Cardio-respiratory arrest 27.24 10.27 187 109284 59772 63319779
Cerebral microhaemorrhage 27.21 10.27 10 109461 134 63379417
Hepatotoxicity 27.15 10.27 15 109456 37026 63342525
Injection site erythema 27.00 10.27 65 109406 83109 63296442
Joint hyperextension 26.93 10.27 13 109458 354 63379197
Cardiomegaly 26.90 10.27 79 109392 17535 63362016
Sensory disturbance 26.57 10.27 67 109404 13605 63365946
Micrognathia 26.56 10.27 12 109459 280 63379271
Vesicoureteric reflux 26.23 10.27 11 109460 213 63379338
Mental disorder 26.06 10.27 101 109370 25818 63353733
Neutropenia 25.82 10.27 186 109285 174819 63204732
Eye movement disorder 25.69 10.27 38 109433 5190 63374361
Pyrexia 25.54 10.27 617 108854 469861 62909690
Adverse drug reaction 25.33 10.27 63 109408 79651 63299900
Post-traumatic neck syndrome 25.27 10.27 24 109447 2050 63377501
Soliloquy 25.19 10.27 11 109460 236 63379315
Dysmorphism 25.03 10.27 25 109446 2271 63377280
Creutzfeldt-Jakob disease 24.88 10.27 10 109461 173 63379378
Vision blurred 24.80 10.27 255 109216 91669 63287882
Negative thoughts 24.79 10.27 17 109454 910 63378641
Sepsis 24.44 10.27 159 109312 152964 63226587
Congenital heart valve disorder 24.33 10.27 8 109463 75 63379476
Personality disorder 24.03 10.27 39 109432 5772 63373779
Obsessive thoughts 23.70 10.27 14 109457 577 63378974
Anaphylactic reaction 23.63 10.27 49 109422 66051 63313500
Anorgasmia 23.44 10.27 14 109457 589 63378962
Cytomegalovirus infection 23.33 10.27 4 109467 20948 63358603
Compartment syndrome 23.32 10.27 24 109447 2260 63377291
Aorta hypoplasia 23.26 10.27 9 109462 140 63379411
Aortic valve incompetence 23.16 10.27 39 109432 5949 63373602
Disinhibition 23.16 10.27 16 109455 867 63378684
Vulvovaginal burning sensation 23.06 10.27 23 109448 2086 63377465
Panic reaction 22.95 10.27 32 109439 4142 63375409
Psychiatric symptom 22.89 10.27 36 109435 5187 63374364
Tricuspid valve incompetence 22.74 10.27 66 109405 14555 63364996
Alcohol abuse 22.73 10.27 23 109448 2123 63377428
Oedema 22.64 10.27 89 109382 97533 63282018
Rhinalgia 22.39 10.27 20 109451 1579 63377972
Liver injury 22.37 10.27 44 109427 60476 63319075
Oxygen saturation abnormal 22.37 10.27 29 109442 3500 63376051
Mucosal inflammation 22.17 10.27 29 109442 46899 63332652
Bronchopulmonary dysplasia 22.07 10.27 12 109459 421 63379130
Dilatation ventricular 21.96 10.27 24 109447 2421 63377130
Hypoplastic right heart syndrome 21.95 10.27 7 109464 59 63379492
Urticaria thermal 21.92 10.27 12 109459 427 63379124
Eyelid disorder 21.78 10.27 21 109450 1828 63377723
Blood bicarbonate decreased 21.57 10.27 26 109445 2915 63376636
Altered visual depth perception 21.57 10.27 11 109460 338 63379213
Tension 21.56 10.27 27 109444 3148 63376403
Middle insomnia 21.55 10.27 59 109412 12584 63366967
Congenital aortic atresia 21.46 10.27 4 109467 0 63379551
Pilonidal cyst congenital 21.46 10.27 4 109467 0 63379551
Mood altered 21.45 10.27 65 109406 14678 63364873
Somnolence neonatal 21.45 10.27 8 109463 112 63379439
Musculoskeletal stiffness 21.45 10.27 209 109262 184409 63195142
Metastases to liver 21.43 10.27 7 109464 23632 63355919
Ventricular hypertrophy 21.41 10.27 28 109443 3408 63376143
Phonophobia 21.02 10.27 11 109460 357 63379194
Blood triglycerides increased 21.01 10.27 58 109413 12430 63367121
Upper respiratory tract infection 20.86 10.27 72 109399 81975 63297576
Musculoskeletal pain 20.84 10.27 85 109386 92192 63287359
Hypokinesia 20.80 10.27 62 109409 13874 63365677
Sensory loss 20.77 10.27 51 109420 10187 63369364
Wolff-Parkinson-White syndrome 20.76 10.27 8 109463 123 63379428
Pulmonary artery stenosis 20.75 10.27 9 109462 190 63379361
Chemical submission 20.72 10.27 10 109461 272 63379279
Clinodactyly 20.65 10.27 8 109463 125 63379426
Hot flush 20.60 10.27 155 109316 51004 63328547
Poisoning 20.50 10.27 61 109410 13639 63365912
Euphoric mood 20.48 10.27 33 109438 4854 63374697
Condition aggravated 20.32 10.27 533 108938 401684 62977867
Poor quality sleep 20.30 10.27 78 109393 19857 63359694
Physical assault 20.24 10.27 15 109456 908 63378643
Aphasia 20.09 10.27 111 109360 32889 63346662
Sternal fracture 20.03 10.27 22 109449 2232 63377319
Posterior reversible encephalopathy syndrome 20.01 10.27 3 109468 17342 63362209
Sluggishness 19.96 10.27 34 109437 5235 63374316
Dysarthria 19.87 10.27 134 109337 42577 63336974
Catatonia 19.82 10.27 31 109440 4446 63375105
Dizziness postural 19.71 10.27 41 109430 7335 63372216
Pneumonitis 19.66 10.27 19 109452 35203 63344348
Major depression 19.62 10.27 43 109428 7975 63371576
Grip strength decreased 19.51 10.27 7 109464 22280 63357271
Premature baby 19.40 10.27 79 109392 20656 63358895
Antidepressant discontinuation syndrome 18.77 10.27 6 109465 51 63379500
Therapy interrupted 18.71 10.27 17 109454 32438 63347113
Foetal movement disorder 18.69 10.27 4 109467 4 63379547
Right ventricle outflow tract obstruction 18.69 10.27 4 109467 4 63379547
Arthritis 18.68 10.27 120 109351 115801 63263750
Velopharyngeal incompetence 18.62 10.27 5 109466 21 63379530
Drug abuser 18.50 10.27 24 109447 2899 63376652
Thinking abnormal 18.47 10.27 50 109421 10593 63368958
Congenital tricuspid valve atresia 18.45 10.27 7 109464 103 63379448
Mental impairment 18.39 10.27 60 109411 14091 63365460
Illusion 18.28 10.27 15 109456 1055 63378496
Bradycardia 18.28 10.27 200 109271 73027 63306524
Plagiocephaly 18.18 10.27 6 109465 57 63379494
Blood potassium increased 18.12 10.27 71 109400 18238 63361313
Frontotemporal dementia 18.08 10.27 10 109461 363 63379188
Failure to thrive 18.07 10.27 39 109432 7159 63372392
Cleft lip and palate 17.83 10.27 12 109459 623 63378928
Anaemia 17.82 10.27 378 109093 293052 63086499
Granuloma 17.77 10.27 34 109437 5727 63373824
Congenital aortic anomaly 17.73 10.27 6 109465 62 63379489
Ear infection 17.66 10.27 24 109447 38189 63341362
White blood cell count decreased 17.65 10.27 154 109317 138950 63240601
Impatience 17.64 10.27 10 109461 381 63379170
Leukopenia 17.58 10.27 71 109400 77219 63302332
Hypotonia 17.52 10.27 45 109426 9240 63370311
Psychomotor skills impaired 17.48 10.27 21 109450 2347 63377204
Therapeutic product effect incomplete 17.44 10.27 135 109336 124921 63254630
Trismus 17.34 10.27 27 109444 3858 63375693
Panic disorder 17.26 10.27 22 109449 2611 63376940
Drug resistance 17.23 10.27 9 109462 22924 63356627
Premature labour 17.15 10.27 54 109417 12450 63367101
Mitral valve incompetence 17.03 10.27 73 109398 19521 63360030
Hospitalisation 17.02 10.27 82 109389 84999 63294552
Scratch 16.97 10.27 36 109435 6529 63373022
Sleep disorder 16.92 10.27 215 109256 81351 63298200
Trichotillomania 16.91 10.27 7 109464 131 63379420
Campylobacter colitis 16.87 10.27 5 109466 32 63379519
Tardive dyskinesia 16.87 10.27 42 109429 8460 63371091
Pulmonary valve incompetence 16.84 10.27 16 109455 1367 63378184
Cleft uvula 16.76 10.27 4 109467 9 63379542
Antisocial personality disorder 16.76 10.27 4 109467 9 63379542
Slow response to stimuli 16.66 10.27 14 109457 1018 63378533
Myoglobin blood increased 16.63 10.27 16 109455 1389 63378162
Parkinson's disease 16.58 10.27 15 109456 1204 63378347
Social avoidant behaviour 16.56 10.27 23 109448 2965 63376586
Congenital tracheomalacia 16.37 10.27 5 109466 36 63379515
Feeling guilty 16.34 10.27 11 109460 571 63378980
Wrong patient 16.33 10.27 8 109463 225 63379326
Apnoea 16.31 10.27 40 109431 7982 63371569
Ill-defined disorder 16.24 10.27 79 109392 81676 63297875
Nodule 16.17 10.27 8 109463 21018 63358533
Subvalvular aortic stenosis 16.09 10.27 3 109468 0 63379551
Lipomeningocele 16.09 10.27 3 109468 0 63379551
Interruption of aortic arch 16.09 10.27 3 109468 0 63379551
Localised infection 16.06 10.27 17 109454 30193 63349358
Product use in unapproved indication 15.99 10.27 215 109256 178865 63200686
Generalised tonic-clonic seizure 15.96 10.27 95 109376 28921 63350630
Poriomania 15.96 10.27 6 109465 86 63379465
Blepharospasm 15.64 10.27 33 109438 5963 63373588
Skin laceration 15.62 10.27 79 109392 22629 63356922
Feeling abnormal 15.56 10.27 350 109121 148042 63231509
Post procedural haematuria 15.49 10.27 5 109466 44 63379507
Otospondylomegaepiphyseal dysplasia 15.47 10.27 6 109465 94 63379457
Respiratory tract infection 15.47 10.27 30 109441 41453 63338098
Diabetic hyperosmolar coma 15.46 10.27 9 109462 361 63379190
Bipolar disorder 15.46 10.27 39 109432 7921 63371630
Pancytopenia 15.28 10.27 101 109370 96832 63282719
Chronic spontaneous urticaria 15.27 10.27 14 109457 1143 63378408
VACTERL syndrome 15.25 10.27 4 109467 15 63379536
Back pain 15.25 10.27 343 109128 263802 63115749
Urticaria 15.19 10.27 198 109273 165604 63213947
Dyslipidaemia 15.18 10.27 37 109434 7356 63372195
Lactose intolerance 15.15 10.27 22 109449 2956 63376595
Perseveration 15.08 10.27 8 109463 267 63379284
Brugada syndrome 15.06 10.27 9 109462 379 63379172
Arnold-Chiari malformation 15.02 10.27 11 109460 654 63378897
Alanine aminotransferase increased 15.02 10.27 257 109214 103513 63276038
Diarrhoea 14.86 10.27 1048 108423 714318 62665233
Tethered cord syndrome 14.84 10.27 8 109463 276 63379275
Anhedonia 14.69 10.27 47 109424 10927 63368624
Gaze palsy 14.64 10.27 15 109456 1405 63378146
Amimia 14.58 10.27 5 109466 54 63379497
Antipsychotic drug level above therapeutic 14.51 10.27 13 109458 1030 63378521
Ear pain 14.47 10.27 25 109446 36093 63343458
Oesophageal atresia 14.42 10.27 10 109461 545 63379006
Staphylococcal infection 14.42 10.27 121 109350 41135 63338416
Female orgasmic disorder 14.41 10.27 5 109466 56 63379495
Autoimmune nephritis 14.37 10.27 9 109462 413 63379138
Yawning 14.12 10.27 13 109458 1067 63378484
Autoimmune disorder 14.04 10.27 6 109465 17171 63362380
Atrioventricular septal defect 14.04 10.27 8 109463 308 63379243
Marcus Gunn syndrome 14.02 10.27 3 109468 3 63379548
Leucine aminopeptidase increased 14.02 10.27 3 109468 3 63379548
Dyskinesia neonatal 14.02 10.27 3 109468 3 63379548
Neonatal asphyxia 14.02 10.27 8 109463 309 63379242
Premature delivery 14.01 10.27 19 109452 30262 63349289
Oculogyric crisis 13.93 10.27 16 109455 1705 63377846
Mean cell haemoglobin increased 13.90 10.27 21 109450 2922 63376629
Wheezing 13.89 10.27 102 109369 95493 63284058
Wound infection 13.86 10.27 10 109461 21400 63358151
Tri-iodothyronine free decreased 13.85 10.27 8 109463 316 63379235
Foetal death 13.77 10.27 46 109425 10934 63368617
Thrombocytopenia 13.67 10.27 181 109290 150976 63228575
Oscillopsia 13.40 10.27 6 109465 137 63379414
Persecutory delusion 13.31 10.27 20 109451 2770 63376781
Intra-abdominal haematoma 13.31 10.27 16 109455 1789 63377762
Injection site pruritus 13.30 10.27 37 109434 45079 63334472
Intentional device use issue 13.28 10.27 5 109466 72 63379479
Device expulsion 13.24 10.27 25 109446 34897 63344654
Nasal ulcer 13.17 10.27 18 109453 2286 63377265
Left ventricular dysfunction 13.11 10.27 48 109423 11940 63367611
Palpitations 13.11 10.27 270 109201 112500 63267051
Right aortic arch 13.10 10.27 7 109464 237 63379314
Drowning 13.09 10.27 9 109462 484 63379067
Dextrocardia 13.07 10.27 4 109467 29 63379522
Genital labial adhesions 13.07 10.27 4 109467 29 63379522
Dairy intolerance 12.97 10.27 5 109466 77 63379474
Aeromonas infection 12.97 10.27 5 109466 77 63379474
Glossoptosis 12.97 10.27 5 109466 77 63379474
Resting tremor 12.95 10.27 11 109460 812 63378739
Muscle contracture 12.93 10.27 14 109457 1397 63378154
Hypocoagulable state 12.90 10.27 13 109458 1194 63378357
Dermatitis allergic 12.86 10.27 5 109466 15143 63364408
Heterophoria 12.84 10.27 4 109467 31 63379520
Serum sickness-like reaction 12.81 10.27 9 109462 501 63379050
Congenital neurological disorder 12.81 10.27 3 109468 6 63379545
Asplenia 12.81 10.27 3 109468 6 63379545
Bursitis 12.79 10.27 28 109443 37013 63342538
Pruritus 12.71 10.27 502 108969 360951 63018600
Suicidal behaviour 12.71 10.27 19 109452 2620 63376931
Tenosynovitis 12.66 10.27 4 109467 13791 63365760
Clostridium difficile infection 12.65 10.27 20 109451 29902 63349649
Cholecystitis chronic 12.64 10.27 43 109428 10318 63369233
Reversible cerebral vasoconstriction syndrome 12.60 10.27 19 109452 2639 63376912
Dissociative disorder 12.54 10.27 8 109463 379 63379172
Drug-disease interaction 12.53 10.27 9 109462 519 63379032
Intestinal infarction 12.51 10.27 12 109459 1038 63378513
Spina bifida occulta 12.49 10.27 3 109468 7 63379544
Muscle tightness 12.48 10.27 47 109424 11853 63367698
Marital problem 12.47 10.27 6 109465 162 63379389
Coronary artery disease 12.42 10.27 97 109374 32280 63347271
Antiphospholipid antibodies 12.41 10.27 6 109465 164 63379387
Cognitive disorder 12.38 10.27 149 109322 55666 63323885
Haemorrhagic diathesis 12.34 10.27 25 109446 4390 63375161
Laboratory test abnormal 12.34 10.27 17 109454 26895 63352656
Anal atresia 12.33 10.27 8 109463 390 63379161
Atrial fibrillation 12.32 10.27 135 109336 116501 63263050
Ankle fracture 12.20 10.27 62 109409 17793 63361758
Sacroiliac joint dysfunction 12.12 10.27 4 109467 38 63379513
Apallic syndrome 12.09 10.27 10 109461 711 63378840
Epilepsy 12.05 10.27 84 109387 26981 63352570
Platelet count decreased 12.03 10.27 135 109336 115987 63263564
Diverticulitis 12.00 10.27 32 109439 39525 63340026
Electrocardiogram repolarisation abnormality 11.95 10.27 13 109458 1304 63378247
Inferior vena caval occlusion 11.95 10.27 3 109468 9 63379542
Paroxysmal arrhythmia 11.94 10.27 4 109467 40 63379511
Abdominal pain 11.79 10.27 401 109070 293055 63086496
Abdominal wall cyst 11.76 10.27 4 109467 42 63379509
Hypoosmolar state 11.72 10.27 6 109465 186 63379365
Double outlet right ventricle 11.68 10.27 4 109467 43 63379508
Fluid retention 11.66 10.27 58 109413 59628 63319923
Affect lability 11.66 10.27 44 109427 11107 63368444
Vascular access site pain 11.64 10.27 5 109466 103 63379448
Administration site erythema 11.58 10.27 10 109461 755 63378796
Sudden death 11.57 10.27 42 109429 10407 63369144
Posture abnormal 11.53 10.27 17 109454 2315 63377236
Hypercapnic coma 11.51 10.27 6 109465 193 63379358
Poor sucking reflex 11.50 10.27 7 109464 305 63379246
Lupus-like syndrome 11.49 10.27 6 109465 15289 63364262
Blood aldosterone abnormal 11.44 10.27 4 109467 46 63379505
Wound complication 11.42 10.27 22 109449 3725 63375826
Subdural haematoma 11.41 10.27 52 109419 14276 63365275
Vitamin B12 deficiency 11.38 10.27 27 109444 5276 63374275
Hepatitis fulminant 11.38 10.27 21 109450 3443 63376108
Mutism 11.29 10.27 14 109457 1616 63377935
Delivery 11.28 10.27 13 109458 1390 63378161
Decreased activity 11.28 10.27 30 109441 6290 63373261
Aortic stenosis 11.25 10.27 26 109445 4994 63374557
Diet refusal 11.24 10.27 9 109462 611 63378940
Cystocele 11.21 10.27 12 109459 1182 63378369
Vasculitis 11.15 10.27 9 109462 18200 63361351
Palmar-plantar erythrodysaesthesia syndrome 11.10 10.27 14 109457 23001 63356550
Pharyngitis 11.09 10.27 11 109460 20132 63359419
Vulvovaginal pruritus 11.08 10.27 20 109451 3223 63376328
Congenital diaphragmatic hernia 11.00 10.27 6 109465 212 63379339
Blood cholinesterase decreased 10.90 10.27 5 109466 121 63379430
Hyperventilation 10.88 10.27 29 109442 6087 63373464
Congenital pulmonary valve disorder 10.79 10.27 4 109467 55 63379496
Congenital eye disorder 10.75 10.27 3 109468 15 63379536
Mental status changes 10.74 10.27 110 109361 39489 63340062
Postural tremor 10.74 10.27 7 109464 344 63379207
Ventricular tachycardia 10.72 10.27 65 109406 19914 63359637
Posturing 10.66 10.27 8 109463 494 63379057
Neoplasm progression 10.65 10.27 30 109441 36398 63343153
Disorganised speech 10.64 10.27 12 109459 1253 63378298
Communication disorder 10.64 10.27 17 109454 2483 63377068
Housebound 10.60 10.27 6 109465 228 63379323
Economic problem 10.58 10.27 15 109456 1971 63377580
Laryngomalacia 10.53 10.27 4 109467 59 63379492
Head titubation 10.49 10.27 10 109461 858 63378693
Osteoporosis 10.48 10.27 57 109414 57281 63322270
Cerebral haematoma 10.47 10.27 21 109450 3662 63375889
Hypochloraemia 10.45 10.27 15 109456 1994 63377557
Normetanephrine urine increased 10.43 10.27 3 109468 17 63379534
Parkinsonian gait 10.42 10.27 8 109463 511 63379040
Congenital scoliosis 10.35 10.27 4 109467 62 63379489
Infusion site scar 10.35 10.27 8 109463 516 63379035
Hydrocephalus 10.33 10.27 26 109445 5274 63374277
Hyperthermia 10.30 10.27 37 109434 9119 63370432
Granuloma skin 10.28 10.27 35 109436 8402 63371149

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
Exposure during pregnancy 1837.68 11.53 641 53284 8293 34894713
Atrial septal defect 826.73 11.53 340 53585 7052 34895954
Ventricular septal defect 554.96 11.53 215 53710 3786 34899220
Patent ductus arteriosus 496.53 11.53 189 53736 3165 34899841
Foetal exposure during pregnancy 446.32 11.53 410 53515 37691 34865315
Drug withdrawal syndrome 411.57 11.53 298 53627 19536 34883470
Cardiac murmur 345.78 11.53 190 53735 7647 34895359
Congenital anomaly 309.49 11.53 106 53819 1287 34901719
Suicidal ideation 305.10 11.53 343 53582 40045 34862961
Serotonin syndrome 300.91 11.53 248 53677 19685 34883321
Heart disease congenital 252.29 11.53 91 53834 1299 34901707
Multiple congenital abnormalities 251.29 11.53 73 53852 491 34902515
Suicide attempt 240.40 11.53 299 53626 38817 34864189
Pulmonary valve stenosis 238.84 11.53 64 53861 305 34902701
Anxiety 228.91 11.53 486 53439 98942 34804064
Aggression 225.41 11.53 289 53636 38675 34864331
Talipes 223.58 11.53 91 53834 1832 34901174
Irritability 213.06 11.53 225 53700 24465 34878541
Coarctation of the aorta 191.94 11.53 57 53868 418 34902588
Completed suicide 188.00 11.53 446 53479 97722 34805284
Persistent foetal circulation 174.91 11.53 50 53875 315 34902691
Bicuspid aortic valve 164.22 11.53 43 53882 184 34902822
Pulmonary artery stenosis congenital 163.46 11.53 51 53874 450 34902556
Hypoplastic left heart syndrome 162.02 11.53 43 53882 196 34902810
Fallot's tetralogy 151.85 11.53 39 53886 152 34902854
Transposition of the great vessels 133.39 11.53 43 53882 426 34902580
Agitation 132.40 11.53 281 53644 57118 34845888
Poisoning deliberate 121.26 11.53 99 53826 7745 34895261
Off label use 120.78 11.53 296 53629 419228 34483778
Congenital aortic stenosis 118.94 11.53 28 53897 68 34902938
Tremor 117.65 11.53 336 53589 82251 34820755
Extrapyramidal disorder 117.57 11.53 121 53804 12759 34890247
Mania 114.43 11.53 104 53821 9407 34893599
Insomnia 106.16 11.53 377 53548 103530 34799476
Coma 105.75 11.53 224 53701 45454 34857552
Sopor 105.37 11.53 111 53814 12025 34890981
Febrile neutropenia 104.84 11.53 40 53885 136809 34766197
Intentional self-injury 103.95 11.53 117 53808 13654 34889352
Impulsive behaviour 102.52 11.53 55 53870 2107 34900899
Panic attack 101.63 11.53 97 53828 9335 34893671
Drug abuse 100.76 11.53 359 53566 98737 34804269
Depression 98.93 11.53 352 53573 96746 34806260
Activation syndrome 97.53 11.53 24 53901 75 34902931
Developmental delay 97.47 11.53 58 53867 2717 34900289
Craniosynostosis 96.59 11.53 32 53893 348 34902658
Intentional overdose 95.17 11.53 209 53716 43465 34859541
Neuroleptic malignant syndrome 94.31 11.53 127 53798 17807 34885199
Disturbance in attention 89.64 11.53 151 53774 25794 34877212
Congenital cardiovascular anomaly 85.19 11.53 25 53900 175 34902831
Homicide 83.98 11.53 37 53888 912 34902094
Somnolence 82.64 11.53 365 53560 110751 34792255
Withdrawal syndrome 79.32 11.53 97 53828 12358 34890648
Anger 78.04 11.53 94 53831 11790 34891216
Pneumonia 76.28 11.53 295 53630 362332 34540674
Sexual dysfunction 72.08 11.53 67 53858 6236 34896770
Acute kidney injury 70.11 11.53 239 53686 304749 34598257
Double outlet right ventricle 68.57 11.53 19 53906 105 34902901
Confusional state 67.27 11.53 416 53509 143744 34759262
Congenital aortic atresia 66.49 11.53 14 53911 15 34902991
Mood swings 61.11 11.53 68 53857 7833 34895173
Pulmonary malformation 61.00 11.53 14 53911 29 34902977
Cogwheel rigidity 60.22 11.53 33 53892 1319 34901687
Death 59.76 11.53 365 53560 397684 34505322
Hypoplastic right heart syndrome 58.45 11.53 12 53913 10 34902996
Sleep disorder 58.39 11.53 142 53783 31546 34871460
Head titubation 56.67 11.53 22 53903 389 34902617
Cleft palate 56.60 11.53 25 53900 620 34902386
Tricuspid valve incompetence 55.76 11.53 72 53853 9688 34893318
Sepsis 55.54 11.53 108 53817 166453 34736553
Drug ineffective 54.80 11.53 447 53478 456304 34446702
Speech disorder developmental 54.80 11.53 37 53888 2163 34900843
Erectile dysfunction 53.39 11.53 106 53819 20531 34882475
Inappropriate antidiuretic hormone secretion 53.34 11.53 81 53844 12672 34890334
Drug withdrawal syndrome neonatal 52.44 11.53 44 53881 3575 34899431
Ventricular hypoplasia 51.52 11.53 14 53911 71 34902935
Cleft lip and palate 51.25 11.53 26 53899 886 34902120
Nervousness 51.22 11.53 79 53846 12527 34890479
Visceral congestion 50.75 11.53 23 53902 607 34902399
Disease progression 49.74 11.53 56 53869 108021 34794985
Overdose 49.71 11.53 274 53651 90785 34812221
Hyperhidrosis 49.10 11.53 239 53686 75453 34827553
Arnold-Chiari malformation 48.99 11.53 19 53906 335 34902671
Pulmonary valve stenosis congenital 48.62 11.53 15 53910 127 34902879
Anticholinergic syndrome 48.46 11.53 28 53897 1241 34901765
Diarrhoea 47.44 11.53 380 53545 389532 34513474
Plagiocephaly 47.31 11.53 21 53904 527 34902479
Hamartoma 47.29 11.53 12 53913 44 34902962
Congenital aortic valve incompetence 46.14 11.53 15 53910 153 34902853
Gun shot wound 46.05 11.53 26 53899 1102 34901904
Maternal drugs affecting foetus 45.05 11.53 42 53883 3923 34899083
Dyspnoea 43.63 11.53 372 53553 376410 34526596
Tremor neonatal 43.25 11.53 18 53907 384 34902622
Congenital tricuspid valve atresia 43.12 11.53 13 53912 101 34902905
Libido decreased 42.63 11.53 44 53881 4652 34898354
Ejaculation delayed 42.12 11.53 16 53909 266 34902740
Drug dependence 41.95 11.53 106 53819 24111 34878895
Thinking abnormal 41.04 11.53 49 53876 6088 34896918
Attention deficit hyperactivity disorder 41.03 11.53 33 53892 2526 34900480
Toxicity to various agents 40.64 11.53 480 53445 199882 34703124
Restlessness 40.51 11.53 108 53817 25374 34877632
Right aortic arch 40.48 11.53 9 53916 15 34902991
COVID-19 40.46 11.53 36 53889 77514 34825492
Depressed mood 40.43 11.53 91 53834 19226 34883780
Hangover 39.63 11.53 23 53902 1028 34901978
Hyperreflexia 38.44 11.53 35 53890 3171 34899835
Abdominal pain 38.32 11.53 127 53798 163491 34739515
Abnormal behaviour 37.86 11.53 104 53821 24865 34878141
Mitral valve stenosis 37.69 11.53 15 53910 284 34902722
Nightmare 37.32 11.53 74 53851 14317 34888689
Rash 37.22 11.53 197 53728 222555 34680451
Pyrexia 37.09 11.53 332 53593 332681 34570325
Anaemia 37.00 11.53 210 53715 233125 34669881
Thrombocytopenia 36.78 11.53 121 53804 156126 34746880
Bipolar disorder 36.27 11.53 36 53889 3633 34899373
Affect lability 36.16 11.53 36 53889 3647 34899359
Mydriasis 36.15 11.53 50 53875 7187 34895819
Malignant neoplasm progression 35.92 11.53 50 53875 87996 34815010
Feeling of despair 35.83 11.53 21 53904 956 34902050
Somnolence neonatal 35.04 11.53 8 53917 16 34902990
Infection 34.78 11.53 54 53871 90861 34812145
Intentional product use issue 34.67 11.53 25 53900 59791 34843215
Akathisia 34.61 11.53 52 53873 8057 34894949
Parkinsonism 34.47 11.53 52 53873 8086 34894920
Memory impairment 34.21 11.53 145 53780 43173 34859833
Right ventricular hypertrophy 33.97 11.53 24 53901 1510 34901496
Dextrocardia 33.94 11.53 11 53914 111 34902895
Disorientation 33.46 11.53 120 53805 33068 34869938
Altered state of consciousness 33.37 11.53 94 53831 22799 34880207
General physical health deterioration 33.26 11.53 95 53830 128174 34774832
Hyperthermia 33.17 11.53 59 53866 10518 34892488
Neutropenia 33.17 11.53 127 53798 156651 34746355
Agoraphobia 33.02 11.53 13 53912 239 34902767
Amnesia 32.95 11.53 103 53822 26460 34876546
DiGeorge's syndrome 32.86 11.53 6 53919 0 34903006
Interruption of aortic arch 32.86 11.53 6 53919 0 34903006
Hypomania 32.78 11.53 28 53897 2331 34900675
Hypospadias 32.75 11.53 32 53893 3169 34899837
Congenital aortic anomaly 32.69 11.53 10 53915 82 34902924
Choanal atresia 32.56 11.53 7 53918 9 34902997
Anencephaly 32.53 11.53 11 53914 128 34902878
Oral discharge 32.45 11.53 11 53914 129 34902877
Renal impairment 31.71 11.53 61 53864 94452 34808554
Homicidal ideation 31.61 11.53 29 53896 2653 34900353
Cough 31.52 11.53 122 53803 150018 34752988
Congenital scoliosis 31.49 11.53 10 53915 94 34902912
Congenital pulmonary artery anomaly 31.36 11.53 7 53918 12 34902994
Muscle rigidity 30.86 11.53 57 53868 10461 34892545
Product use issue 29.90 11.53 32 53893 63184 34839822
Depressed level of consciousness 29.74 11.53 138 53787 42703 34860303
Pancytopenia 29.73 11.53 64 53861 95093 34807913
Emotional distress 29.47 11.53 69 53856 14957 34888049
Treatment failure 29.10 11.53 18 53907 46679 34856327
Vertigo 28.94 11.53 96 53829 25440 34877566
Drug abuser 28.82 11.53 33 53892 3921 34899085
Verbal abuse 28.20 11.53 11 53914 197 34902809
Congenital genitourinary abnormality 28.17 11.53 8 53917 49 34902957
Epistaxis 28.10 11.53 29 53896 58222 34844784
Atrial fibrillation 27.95 11.53 96 53829 122297 34780709
Physical assault 27.91 11.53 19 53906 1126 34901880
Hyper IgE syndrome 27.38 11.53 8 53917 55 34902951
Ebstein's anomaly 27.38 11.53 5 53920 0 34903006
Abdominal transposition 27.38 11.53 5 53920 0 34903006
Congenital mitral valve stenosis 27.38 11.53 5 53920 0 34903006
Developmental hip dysplasia 27.34 11.53 12 53913 293 34902713
Congenital coronary artery malformation 27.14 11.53 8 53917 57 34902949
Cytomegalovirus infection 27.09 11.53 4 53921 26131 34876875
Product use in unapproved indication 26.94 11.53 92 53833 117407 34785599
Multiple cardiac defects 26.66 11.53 8 53917 61 34902945
Asphyxia 26.60 11.53 42 53883 6793 34896213
Selective eating disorder 26.55 11.53 22 53903 1756 34901250
Cleft lip 26.19 11.53 12 53913 325 34902681
Myoclonus 26.07 11.53 65 53860 14660 34888346
Ejaculation failure 26.07 11.53 16 53909 793 34902213
C-reactive protein increased 26.01 11.53 27 53898 54071 34848935
Blepharospasm 25.66 11.53 18 53907 1120 34901886
Vascular stenosis 25.49 11.53 10 53915 182 34902824
Paraesthesia 25.49 11.53 178 53747 63994 34839012
Autism spectrum disorder 25.47 11.53 24 53901 2272 34900734
Joint swelling 25.45 11.53 33 53892 59857 34843149
Respiratory acidosis 25.38 11.53 35 53890 5015 34897991
Congenital hand malformation 25.07 11.53 14 53911 581 34902425
Bronchopulmonary dysplasia 25 11.53 14 53911 584 34902422
Delirium 24.39 11.53 133 53792 43858 34859148
Paranoia 24.30 11.53 56 53869 12012 34890994
Pulmonary valve incompetence 24.20 11.53 16 53909 903 34902103
Neural tube defect 24.10 11.53 7 53918 47 34902959
Pulmonary artery stenosis 24.01 11.53 11 53914 298 34902708
Subgaleal haematoma 23.82 11.53 8 53917 91 34902915
Blood creatine phosphokinase increased 23.79 11.53 134 53791 44723 34858283
Septic shock 23.54 11.53 47 53878 71787 34831219
Emotional disorder 23.47 11.53 36 53889 5680 34897326
Resting tremor 23.29 11.53 14 53911 668 34902338
Hepatic enzyme increased 23.08 11.53 16 53909 39064 34863942
Seizure 22.91 11.53 255 53670 104602 34798404
Truncus arteriosus persistent 22.85 11.53 6 53919 26 34902980
Ascites 22.67 11.53 23 53902 46548 34856458
Peripheral swelling 22.66 11.53 53 53872 76488 34826518
Aortic valve incompetence 22.59 11.53 36 53889 5868 34897138
Neonatal asphyxia 22.55 11.53 11 53914 344 34902662
Logorrhoea 22.51 11.53 23 53902 2403 34900603
Sedation complication 22.49 11.53 20 53905 1757 34901249
Congenital hydronephrosis 22.36 11.53 14 53911 719 34902287
Congenital tracheomalacia 22.25 11.53 5 53920 9 34902997
Platelet count decreased 22.19 11.53 102 53823 119615 34783391
Congenital diaphragmatic hernia 22.17 11.53 10 53915 261 34902745
Spina bifida 22.15 11.53 11 53914 358 34902648
Cardiomegaly 22.12 11.53 63 53862 15375 34887631
Erythema 22.10 11.53 67 53858 88713 34814293
Judgement impaired 22.04 11.53 13 53912 599 34902407
Mood altered 21.98 11.53 45 53880 8907 34894099
Mitral valve atresia 21.90 11.53 4 53921 0 34903006
Idiosyncratic alcohol intoxication 21.90 11.53 4 53921 0 34903006
Porencephaly 21.90 11.53 4 53921 0 34903006
Noonan syndrome 21.90 11.53 4 53921 0 34903006
Sleep apnoea syndrome 21.79 11.53 75 53850 20246 34882760
Agitation neonatal 21.65 11.53 16 53909 1080 34901926
Dystonia 21.48 11.53 50 53875 10795 34892211
Hyperarousal 21.24 11.53 6 53919 36 34902970
Infantile apnoea 21.20 11.53 15 53910 946 34902060
Prostate cancer 21.16 11.53 18 53907 39631 34863375
Bradykinesia 21.12 11.53 28 53897 3865 34899141
Chemical submission 21.10 11.53 6 53919 37 34902969
Dyskinesia 20.87 11.53 79 53846 22334 34880672
Self esteem decreased 20.87 11.53 12 53913 527 34902479
Illusion 20.82 11.53 14 53911 813 34902193
Tearfulness 20.70 11.53 23 53902 2644 34900362
Wolff-Parkinson-White syndrome 20.61 11.53 9 53916 217 34902789
Ejaculation disorder 20.54 11.53 15 53910 994 34902012
Intention tremor 20.49 11.53 11 53914 422 34902584
Pneumocystis jirovecii pneumonia 20.46 11.53 3 53922 19707 34883299
Congenital pulmonary hypertension 20.36 11.53 7 53918 86 34902920
Ventricular hypertrophy 20.32 11.53 30 53895 4577 34898429
Flat affect 20.26 11.53 14 53911 850 34902156
Somatic dysfunction 20.23 11.53 5 53920 16 34902990
Haemoglobin decreased 20.03 11.53 107 53818 120665 34782341
Congenital hydrocephalus 20.00 11.53 7 53918 91 34902915
Reversible cerebral vasoconstriction syndrome 19.93 11.53 11 53914 446 34902560
Premature baby 19.79 11.53 71 53854 19562 34883444
Derealisation 19.73 11.53 12 53913 585 34902421
Congenital flat feet 19.67 11.53 4 53921 3 34903003
Gastroschisis 19.47 11.53 8 53917 165 34902841
Decreased interest 19.44 11.53 21 53904 2339 34900667
Psychotic disorder 19.41 11.53 82 53843 24370 34878636
Cerebrovascular stenosis 19.27 11.53 7 53918 102 34902904
Dysmorphism 19.16 11.53 24 53901 3132 34899874
Infantile back arching 19.14 11.53 4 53921 4 34903002
Tension 19.06 11.53 20 53905 2155 34900851
Clumsiness 19.01 11.53 18 53907 1714 34901292
Mitral valve prolapse 19.00 11.53 12 53913 626 34902380
Scaphocephaly 18.98 11.53 5 53920 22 34902984
Mucosal inflammation 18.88 11.53 19 53906 38603 34864403
Transient tachypnoea of the newborn 18.83 11.53 8 53917 180 34902826
Crying 18.77 11.53 33 53892 5829 34897177
Cytokine release syndrome 18.67 11.53 6 53919 22871 34880135
Psychiatric symptom 18.65 11.53 25 53900 3488 34899518
Delusion 18.53 11.53 52 53873 12583 34890423
Abnormal dreams 18.49 11.53 38 53887 7540 34895466
Hallucination, auditory 18.42 11.53 50 53875 11867 34891139
Tonic convulsion 18.23 11.53 15 53910 1186 34901820
Arthralgia 18.22 11.53 171 53754 169870 34733136
Speech disorder 18.01 11.53 83 53842 25603 34877403
Infusion related reaction 18.00 11.53 34 53891 53023 34849983
Hospitalisation 17.99 11.53 38 53887 56864 34846142
Oedema peripheral 17.79 11.53 110 53815 119702 34783304
Tricuspid valve disease 17.73 11.53 8 53917 209 34902797
Ammonia abnormal 17.65 11.53 6 53919 71 34902935
Plasmodium vivax infection 17.52 11.53 4 53921 8 34902998
Neoplasm progression 17.50 11.53 7 53918 23293 34879713
Renal dysplasia 17.48 11.53 8 53917 216 34902790
Maternal exposure during pregnancy 17.48 11.53 29 53896 4889 34898117
Hypersensitivity 17.48 11.53 43 53882 60992 34842014
Alcohol interaction 17.44 11.53 22 53903 2891 34900115
Caesarean section 17.38 11.53 19 53906 2145 34900861
Cardiac failure 17.35 11.53 77 53848 91171 34811835
Lower respiratory tract infection 17.33 11.53 14 53911 31623 34871383
Aortic stenosis 17.27 11.53 27 53898 4331 34898675
Gastrointestinal haemorrhage 17.22 11.53 74 53851 88403 34814603
Right ventricle outflow tract obstruction 17.20 11.53 4 53921 9 34902997
Obsessive thoughts 17.16 11.53 12 53913 743 34902263
Abulia 17.15 11.53 11 53914 589 34902417
Neutrophil count decreased 17.12 11.53 33 53892 51071 34851935
Euphoric mood 17.09 11.53 31 53894 5610 34897396
Chordee 17.07 11.53 6 53919 79 34902927
Type 2 diabetes mellitus 17.04 11.53 59 53866 15973 34887033
Opisthotonus 17.03 11.53 10 53915 457 34902549
Pruritus 16.88 11.53 139 53786 141842 34761164
Hyperkinesia 16.84 11.53 17 53908 1751 34901255
Multiple organ dysfunction syndrome 16.84 11.53 61 53864 76505 34826501
Jaundice neonatal 16.74 11.53 15 53910 1331 34901675
Neuropathy peripheral 16.60 11.53 69 53856 83194 34819812
Cyclothymic disorder 16.54 11.53 6 53919 87 34902919
Neurosis 16.54 11.53 7 53918 156 34902850
Cryptorchism 16.53 11.53 18 53907 2023 34900983
Personality disorder 16.51 11.53 14 53911 1154 34901852
Pulmonary hypoplasia 16.45 11.53 10 53915 487 34902519
Loss of libido 16.45 11.53 20 53905 2532 34900474
Congenital Eustachian tube anomaly 16.43 11.53 3 53922 0 34903006
Congenital pulmonary valve disorder 16.43 11.53 3 53922 0 34903006
Hypertonia 16.40 11.53 26 53899 4220 34898786
Abdominal distension 16.14 11.53 42 53883 58450 34844556
White blood cell count decreased 16.13 11.53 84 53841 95361 34807645
Pleurothotonus 16.13 11.53 14 53911 1191 34901815
Plasma cell myeloma 16.03 11.53 25 53900 42012 34860994
Leukopenia 15.95 11.53 47 53878 62809 34840197
Dissociation 15.90 11.53 16 53909 1642 34901364
Renal failure 15.89 11.53 127 53798 130430 34772576
Colitis 15.83 11.53 21 53904 37729 34865277
Legal problem 15.79 11.53 7 53918 175 34902831
Thrombosis 15.69 11.53 34 53891 50424 34852582
Panic disorder 15.65 11.53 14 53911 1240 34901766
Inadequate analgesia 15.53 11.53 21 53904 2954 34900052
Infertility male 15.51 11.53 7 53918 183 34902823
Epilepsy 15.48 11.53 70 53855 21425 34881581
Hypotension 15.34 11.53 245 53680 221404 34681602
Ankyloglossia congenital 15.34 11.53 8 53917 289 34902717
Vesicoureteric reflux 15.30 11.53 7 53918 189 34902817
Congenital renal disorder 15.25 11.53 6 53919 110 34902896
Haemoptysis 15.17 11.53 19 53906 34987 34868019
Mitral valve incompetence 15.03 11.53 54 53871 14889 34888117
Drug intolerance 14.79 11.53 45 53880 59525 34843481
Poisoning 14.78 11.53 47 53878 12179 34890827
Device breakage 14.78 11.53 18 53907 2282 34900724
Feeling jittery 14.76 11.53 24 53901 3979 34899027
Product administration error 14.72 11.53 57 53868 16287 34886719
Feeling guilty 14.71 11.53 8 53917 315 34902691
Exomphalos 14.65 11.53 7 53918 209 34902797
Anaphylactic reaction 14.56 11.53 17 53908 32284 34870722
Vasoplegia syndrome 14.40 11.53 16 53909 1840 34901166
Oculoauriculovertebral dysplasia 14.35 11.53 3 53922 3 34903003
Chronic kidney disease 14.34 11.53 26 53899 41184 34861822
Hepatocellular injury 14.29 11.53 70 53855 22141 34880865
Incoherent 14.17 11.53 25 53900 4427 34898579
Tardive dyskinesia 14.09 11.53 29 53896 5761 34897245
Sexually transmitted disease 13.88 11.53 4 53921 26 34902980
Congenital mitral valve incompetence 13.80 11.53 6 53919 143 34902863
Hepatotoxicity 13.78 11.53 8 53917 21477 34881529
Contraindicated product administered 13.77 11.53 8 53917 21473 34881533
Product complaint 13.75 11.53 29 53896 5861 34897145
Clonus 13.73 11.53 19 53906 2731 34900275
Loss of consciousness 13.72 11.53 191 53734 82476 34820530
Obsessive-compulsive disorder 13.69 11.53 28 53897 5536 34897470
Cerebral palsy 13.69 11.53 6 53919 146 34902860
Drug screen positive 13.68 11.53 23 53902 3920 34899086
Therapeutic response decreased 13.68 11.53 15 53910 29298 34873708
Congenital tricuspid valve incompetence 13.61 11.53 6 53919 148 34902858
Hallucination, visual 13.61 11.53 59 53866 17732 34885274
Anomalous pulmonary venous connection 13.51 11.53 5 53920 77 34902929
Phimosis 13.51 11.53 11 53914 857 34902149
Apnoea 13.50 11.53 31 53894 6633 34896373
Pyloric stenosis 13.44 11.53 11 53914 863 34902143
Asplenia 13.39 11.53 5 53920 79 34902927
Loss of personal independence in daily activities 13.36 11.53 19 53906 33160 34869846
Drug interaction 13.35 11.53 449 53476 225497 34677509
Impulse-control disorder 13.30 11.53 13 53912 1288 34901718
Cytogenetic abnormality 13.21 11.53 11 53914 884 34902122
Failure to thrive 13.21 11.53 36 53889 8565 34894441
Ventricular tachycardia 13.08 11.53 13 53912 26566 34876440
Basal cell carcinoma 13.07 11.53 7 53918 19651 34883355
Hypocalcaemia 12.99 11.53 11 53914 24278 34878728
Hyponatraemia 12.90 11.53 189 53736 82502 34820504
Brachycephaly 12.90 11.53 5 53920 88 34902918
Otitis media chronic 12.90 11.53 5 53920 88 34902918
Hydrocele 12.88 11.53 16 53909 2071 34900935
Aorta hypoplasia 12.85 11.53 5 53920 89 34902917
Cognitive disorder 12.84 11.53 82 53843 28611 34874395
Personality change 12.81 11.53 26 53899 5113 34897893
Swelling 12.80 11.53 29 53896 42337 34860669
Eyelid ptosis congenital 12.70 11.53 5 53920 92 34902914
Palmar-plantar erythrodysaesthesia syndrome 12.69 11.53 5 53920 16790 34886216
Urinary tract infection 12.58 11.53 77 53848 84004 34819002
Feeling abnormal 12.55 11.53 151 53774 63084 34839922
Thought insertion 12.54 11.53 3 53922 8 34902998
Depersonalisation/derealisation disorder 12.48 11.53 9 53916 585 34902421
Genital paraesthesia 12.46 11.53 4 53921 39 34902967
Major depression 12.45 11.53 24 53901 4548 34898458
Administration related reaction 12.40 11.53 5 53920 98 34902908
Neutropenic sepsis 12.37 11.53 3 53922 13764 34889242
Mitral valve disease 12.35 11.53 13 53912 1406 34901600
Cardio-respiratory arrest 12.32 11.53 135 53790 55138 34847868
Jealous delusion 12.20 11.53 7 53918 306 34902700
Eating disorder 12.17 11.53 34 53891 8206 34894800
Dehydration 12.14 11.53 135 53790 129834 34773172
Duodenal atresia 12.04 11.53 3 53922 10 34902996
Microcephaly 12.04 11.53 10 53915 801 34902205
Exhibitionism 12.03 11.53 4 53921 44 34902962
Affective disorder 12.01 11.53 23 53902 4337 34898669
Hypertonia neonatal 11.98 11.53 8 53917 459 34902547
Nystagmus 11.93 11.53 24 53901 4691 34898315
Incorrect route of product administration 11.92 11.53 4 53921 14841 34888165
Hyperventilation 11.90 11.53 18 53907 2806 34900200
Patient uncooperative 11.86 11.53 8 53917 467 34902539
Neonatal disorder 11.84 11.53 10 53915 820 34902186
Limb asymmetry 11.83 11.53 5 53920 111 34902895
Divorced 11.82 11.53 3 53922 11 34902995
Cellulitis 11.76 11.53 42 53883 52909 34850097
Decerebrate posture 11.72 11.53 4 53921 48 34902958
Herpes zoster 11.70 11.53 22 53903 34377 34868629
Suspiciousness 11.68 11.53 7 53918 332 34902674
Device related infection 11.66 11.53 6 53919 17231 34885775
Persistent depressive disorder 11.65 11.53 7 53918 334 34902672
Apathy 11.64 11.53 30 53895 6902 34896104
Psychomotor hyperactivity 11.64 11.53 37 53888 9585 34893421
Feeling of relaxation 11.57 11.53 4 53921 50 34902956
Renal salt-wasting syndrome 11.57 11.53 7 53918 338 34902668
Ventricular fibrillation 11.56 11.53 11 53914 22943 34880063
Bone marrow failure 11.54 11.53 17 53908 29236 34873770

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
Serotonin syndrome 976.89 10.33 701 125014 44326 79574347
Drug withdrawal syndrome 779.44 10.33 552 125163 34166 79584507
Suicidal ideation 615.69 10.33 678 125037 75662 79543011
Suicide attempt 532.32 10.33 655 125060 82277 79536396
Sopor 511.74 10.33 421 125294 32589 79586084
Drug abuse 436.01 10.33 858 124857 161833 79456840
Anxiety 428.36 10.33 1099 124616 247413 79371260
Agitation 357.61 10.33 597 125118 99118 79519555
Tremor 339.39 10.33 796 124919 169287 79449386
Completed suicide 296.18 10.33 956 124759 244811 79373862
Somnolence 283.80 10.33 925 124790 238056 79380617
Intentional self-injury 268.24 10.33 292 125423 32127 79586546
Irritability 260.67 10.33 323 125392 40821 79577852
Drug interaction 252.43 10.33 1306 124409 413877 79204796
Mydriasis 246.53 10.33 212 125503 17431 79601242
Mania 240.22 10.33 212 125503 18048 79600625
Aggression 225.38 10.33 336 125379 50622 79568051
Neuroleptic malignant syndrome 222.39 10.33 245 125470 27314 79591359
Off label use 219.46 10.33 718 124997 906497 78712176
Poisoning deliberate 213.27 10.33 201 125514 18627 79600046
Confusional state 204.78 10.33 1017 124698 316980 79301693
Depression 202.86 10.33 776 124939 216014 79402659
Nightmare 195.14 10.33 222 125493 25639 79593034
Hyponatraemia 178.32 10.33 651 125064 177197 79441476
Panic attack 176.17 10.33 204 125511 24012 79594661
Disorientation 175.12 10.33 337 125378 62439 79556234
Disturbance in attention 173.84 10.33 298 125417 50503 79568170
Depersonalisation/derealisation disorder 171.00 10.33 75 125640 1787 79616886
Derealisation 163.14 10.33 70 125645 1579 79617094
Activation syndrome 162.76 10.33 45 125670 240 79618433
Extrapyramidal disorder 161.55 10.33 189 125526 22490 79596183
Insomnia 159.06 10.33 786 124929 244384 79374289
Febrile neutropenia 154.35 10.33 86 125629 230913 79387760
Contraindicated product administered 153.04 10.33 31 125684 157507 79461166
Mood swings 148.87 10.33 170 125545 19710 79598963
Toxicity to various agents 147.27 10.33 1152 124563 420388 79198285
Feeling of despair 144.19 10.33 76 125639 2745 79615928
Inappropriate antidiuretic hormone secretion 143.76 10.33 192 125523 26121 79592552
Withdrawal syndrome 143.74 10.33 194 125521 26660 79592013
Overdose 143.37 10.33 623 125092 183583 79435090
Intentional overdose 141.07 10.33 427 125288 105533 79513140
Coma 141.01 10.33 413 125302 100236 79518437
Bradyphrenia 140.88 10.33 124 125591 10516 79608157
Anger 139.20 10.33 153 125562 17009 79601664
Alopecia 138.22 10.33 98 125617 231257 79387416
Dissociation 136.85 10.33 83 125632 3938 79614735
Restlessness 136.36 10.33 255 125460 46237 79572436
Myoglobin urine present 134.13 10.33 52 125663 895 79617778
Hyperhidrosis 128.47 10.33 526 125189 150966 79467707
Impulsive behaviour 128.33 10.33 71 125644 2829 79615844
Cogwheel rigidity 126.85 10.33 72 125643 3016 79615657
Dyskinesia 124.42 10.33 240 125475 44533 79574140
Systemic lupus erythematosus 119.42 10.33 23 125692 121126 79497547
Homicide 116.19 10.33 50 125665 1136 79617537
Hallucinations, mixed 113.21 10.33 91 125624 6808 79611865
Drug intolerance 112.50 10.33 151 125564 263968 79354705
Drug ineffective 111.18 10.33 1130 124585 1079783 78538890
Glossodynia 109.87 10.33 16 125699 103321 79515352
Joint swelling 109.34 10.33 179 125536 288467 79330206
Pericarditis 106.60 10.33 18 125697 104218 79514455
Gastric pH decreased 105.77 10.33 43 125672 843 79617830
Synovitis 100.82 10.33 56 125659 150678 79467995
Hyperreflexia 97.80 10.33 91 125624 8294 79610379
Delirium 97.04 10.33 324 125391 84303 79534370
Emotional disorder 96.04 10.33 116 125599 14271 79604402
Rash 95.37 10.33 529 125186 577829 79040844
Hallucination, auditory 95.15 10.33 139 125576 20554 79598119
Drug dependence 93.67 10.33 202 125513 40567 79578106
Infusion related reaction 90.75 10.33 139 125576 230098 79388575
Agoraphobia 89.97 10.33 34 125681 544 79618129
Helicobacter infection 89.48 10.33 5 125710 69699 79548974
Altered state of consciousness 89.32 10.33 207 125508 43615 79575058
Muscle rigidity 89.17 10.33 132 125583 19750 79598923
Nervousness 86.64 10.33 174 125541 33241 79585432
Memory impairment 85.42 10.33 376 125339 111358 79507315
Akathisia 85.41 10.33 105 125610 13154 79605519
Flat affect 84.95 10.33 48 125667 1993 79616680
Pneumonia 83.55 10.33 654 125061 659592 78959081
Swelling 83.34 10.33 133 125582 216578 79402095
Myoclonus 82.71 10.33 153 125562 27507 79591166
Treatment failure 82.64 10.33 88 125627 170398 79448275
Bronchial neoplasm 79.50 10.33 30 125685 478 79618195
Intentional product use issue 78.91 10.33 74 125641 152038 79466635
Homicidal ideation 77.61 10.33 55 125660 3402 79615271
Sepsis 75.83 10.33 198 125517 269230 79349443
Parkinsonism 75.67 10.33 111 125604 16473 79602200
Abnormal behaviour 75.28 10.33 173 125542 36248 79582425
Rheumatoid arthritis 74.58 10.33 134 125581 208336 79410337
Vertigo 74.38 10.33 259 125456 68823 79549850
Malignant neoplasm progression 73.11 10.33 64 125651 135926 79482747
Dystonia 72.49 10.33 125 125590 21274 79597399
Cough 72.18 10.33 315 125400 366474 79252199
Depressed level of consciousness 72.17 10.33 323 125392 96329 79522344
Blister 72.11 10.33 50 125665 119426 79499247
Blood creatine phosphokinase increased 71.34 10.33 248 125467 65842 79552831
Product use issue 69.69 10.33 141 125574 209681 79408992
Disease progression 68.22 10.33 116 125599 184246 79434427
Libido increased 67.31 10.33 41 125674 1960 79616713
Crying 67.07 10.33 126 125589 22917 79595756
Libido decreased 66.45 10.33 60 125655 5261 79613412
Nasal turbinate hypertrophy 66.31 10.33 29 125686 686 79617987
Feeling jittery 66.04 10.33 91 125624 12750 79605923
Abdominal discomfort 65.52 10.33 191 125524 250536 79368137
Stomatitis 65.44 10.33 81 125634 146676 79471997
COVID-19 65.23 10.33 92 125623 157582 79461091
Delusion 64.91 10.33 116 125599 20307 79598366
Psychotic disorder 64.90 10.33 177 125538 41225 79577448
Hypersensitivity 63.40 10.33 207 125508 262032 79356641
Endometrial ablation 63.19 10.33 30 125685 863 79617810
General physical health deterioration 62.64 10.33 223 125492 275015 79343658
Clonus 62.56 10.33 65 125650 6775 79611898
Affective disorder 62.04 10.33 71 125644 8248 79610425
Speech disorder 62.00 10.33 208 125507 54237 79564436
Hepatic enzyme increased 61.25 10.33 122 125593 182488 79436185
H1N1 influenza 61.04 10.33 42 125673 2477 79616196
Peripheral swelling 60.33 10.33 220 125495 269397 79349276
Tearfulness 59.94 10.33 60 125655 5985 79612688
Emotional distress 57.86 10.33 166 125549 39803 79578870
Fall 57.67 10.33 1084 124631 486545 79132128
Drooling 57.19 10.33 58 125657 5876 79612797
Depressed mood 56.80 10.33 187 125528 48293 79570380
Feeling of body temperature change 56.78 10.33 55 125660 5271 79613402
Wound 56.26 10.33 60 125655 116119 79502554
Folliculitis 55.66 10.33 10 125705 55370 79563303
Loss of consciousness 55.20 10.33 453 125262 167490 79451183
Menstrual disorder 55.05 10.33 48 125667 4019 79614654
Hallucination, visual 54.40 10.33 143 125572 32586 79586087
Sexual dysfunction 54.13 10.33 64 125651 7699 79610974
Nasopharyngitis 53.66 10.33 212 125503 253669 79365004
Dyspnoea 53.45 10.33 991 124724 856034 78762639
Paraesthesia 52.36 10.33 465 125250 175858 79442815
Congenital hydrocephalus 51.72 10.33 14 125701 68 79618605
Abnormal dreams 51.51 10.33 76 125639 11336 79607337
Paranoia 51.35 10.33 102 125613 19330 79599343
Discomfort 51.25 10.33 74 125641 125543 79493130
Therapeutic product ineffective 51.24 10.33 34 125681 1888 79616785
Hypomania 50.63 10.33 61 125654 7483 79611190
Breath sounds abnormal 49.79 10.33 90 125625 15894 79602779
Bronchial haemorrhage 49.48 10.33 29 125686 1291 79617382
Psoriatic arthropathy 49.28 10.33 31 125684 77968 79540705
Arthropathy 49.16 10.33 131 125584 176980 79441693
Restless legs syndrome 48.98 10.33 102 125613 19990 79598683
Myelosuppression 48.48 10.33 4 125711 40292 79578381
Hepatocellular injury 48.28 10.33 175 125540 47418 79571255
Therapeutic product effect decreased 47.95 10.33 118 125597 163745 79454928
Lower respiratory tract infection 47.15 10.33 82 125633 129138 79489535
Cytomegalovirus infection 46.74 10.33 6 125709 42638 79576035
Infection 46.65 10.33 209 125506 241503 79377170
Hallucination 46.62 10.33 262 125453 85483 79533190
Muscle disorder 46.49 10.33 51 125664 5656 79613017
Muscle injury 46.22 10.33 10 125705 48551 79570122
Thinking abnormal 46.05 10.33 78 125637 13083 79605590
Mobility decreased 45.99 10.33 76 125639 122099 79496574
Self esteem decreased 45.62 10.33 25 125690 977 79617696
Apathy 45.53 10.33 77 125638 12900 79605773
Cardio-respiratory arrest 45.45 10.33 310 125405 108200 79510473
Galactorrhoea 45.31 10.33 41 125674 3605 79615068
Seizure 45.23 10.33 476 125239 188358 79430315
Asphyxia 44.42 10.33 72 125643 11648 79607025
Bradykinesia 44.40 10.33 59 125656 7984 79610689
Sleep disorder 44.10 10.33 258 125457 85419 79533254
Neutrophil count decreased 43.86 10.33 50 125665 93909 79524764
Hyperprolactinaemia 43.78 10.33 45 125670 4631 79614042
Erectile dysfunction 43.69 10.33 81 125634 14583 79604090
Pyrexia 43.44 10.33 781 124934 677928 78940745
Pain 43.14 10.33 816 124899 702986 78915687
Logorrhoea 42.68 10.33 43 125672 4322 79614351
Renal ischaemia 42.17 10.33 25 125690 1137 79617536
Neutropenia 42.10 10.33 273 125442 287437 79331236
Blepharospasm 42.06 10.33 49 125666 5802 79612871
Gun shot wound 42.01 10.33 25 125690 1145 79617528
Anaemia 41.91 10.33 474 125241 444541 79174132
Personality disorder 41.75 10.33 50 125665 6096 79612577
Bipolar disorder 41.73 10.33 56 125659 7651 79611022
Euphoric mood 41.62 10.33 56 125659 7670 79611003
Visceral congestion 41.19 10.33 23 125692 933 79617740
Hostility 41.19 10.33 32 125683 2278 79616395
Death 41.10 10.33 637 125078 565877 79052796
Muscle twitching 40.95 10.33 108 125607 24656 79594017
PCO2 increased 40.67 10.33 29 125686 1811 79616862
Substance abuse 40.35 10.33 65 125650 10461 79608212
Hyperacusis 40.09 10.33 31 125684 2192 79616481
Fear 39.58 10.33 99 125616 21887 79596786
Parosmia 39.57 10.33 52 125663 6962 79611711
Drug abuser 39.35 10.33 48 125667 5965 79612708
Hangover 39.28 10.33 30 125685 2082 79616591
Apraxia 39.13 10.33 34 125681 2833 79615840
Chemical submission 39.01 10.33 16 125699 321 79618352
Thrombocytopenia 38.65 10.33 252 125463 265007 79353666
Tinnitus 38.38 10.33 155 125560 44178 79574495
Pancytopenia 37.87 10.33 134 125581 165611 79453062
Electrocardiogram QT prolonged 37.71 10.33 258 125457 90128 79528545
Hyperthermia 37.63 10.33 86 125629 17951 79600722
Arthralgia 37.50 10.33 655 125060 571148 79047525
Amnesia 37.19 10.33 197 125518 62860 79555813
Incontinence 37.00 10.33 74 125641 14090 79604583
Neuropathy peripheral 36.63 10.33 108 125607 141197 79477476
Ejaculation delayed 36.59 10.33 13 125702 173 79618500
Rhabdomyolysis 36.50 10.33 283 125432 102848 79515825
Rhonchi 36.28 10.33 38 125677 3998 79614675
Amylase increased 36.05 10.33 64 125651 11145 79607528
Psychomotor hyperactivity 35.89 10.33 81 125634 16768 79601905
Affect lability 35.84 10.33 64 125651 11195 79607478
Hypertonia 35.32 10.33 50 125665 7182 79611491
Bronchial disorder 34.95 10.33 30 125685 2459 79616214
Physical assault 34.71 10.33 25 125690 1586 79617087
Verbal abuse 34.55 10.33 14 125701 272 79618401
Premature labour 33.80 10.33 53 125662 8337 79610336
Septic shock 33.19 10.33 92 125623 122709 79495964
Tachycardia 33.15 10.33 427 125288 177341 79441332
Loss of libido 32.99 10.33 30 125685 2655 79616018
Endocrine ophthalmopathy 32.70 10.33 18 125697 710 79617963
Mucosal inflammation 32.35 10.33 43 125672 75537 79543136
Ascites 31.32 10.33 44 125671 75518 79543155
Hypoaesthesia oral 31.32 10.33 69 125646 14055 79604618
Respiratory acidosis 31.06 10.33 60 125655 11140 79607533
Social anxiety disorder 30.95 10.33 16 125699 555 79618118
Atrial fibrillation 30.89 10.33 184 125531 197702 79420971
Anaphylactic reaction 30.67 10.33 53 125662 83690 79534983
Increased appetite 30.60 10.33 62 125653 11916 79606757
Product complaint 30.49 10.33 66 125649 13283 79605390
Obsessive-compulsive disorder 30.47 10.33 42 125673 5885 79612788
Sinus tachycardia 30.34 10.33 127 125588 36781 79581892
Soft tissue injury 30.31 10.33 24 125691 1757 79616916
Hepatotoxicity 30.31 10.33 22 125693 51330 79567343
Dizziness 30.00 10.33 1062 124653 525379 79093294
Generalised anxiety disorder 29.88 10.33 26 125689 2171 79616502
Troponin increased 29.85 10.33 82 125633 19173 79599500
Major depression 29.82 10.33 52 125663 8928 79609745
Antidepressant discontinuation syndrome 29.70 10.33 8 125707 38 79618635
Dependence 29.63 10.33 27 125688 2395 79616278
Abdominal pain 29.60 10.33 434 125281 389135 79229538
Sensory loss 29.41 10.33 64 125651 12927 79605746
Dysarthria 29.39 10.33 195 125520 67427 79551246
Joint hyperextension 29.32 10.33 13 125702 318 79618355
Neutropenic sepsis 29.20 10.33 4 125711 27060 79591613
Poisoning 29.17 10.33 97 125618 25175 79593498
Hip arthroplasty 29.08 10.33 10 125705 35746 79582927
Toxic encephalopathy 28.97 10.33 59 125656 11381 79607292
Urinary retention 28.79 10.33 170 125545 56460 79562213
Electroencephalogram abnormal 28.68 10.33 39 125676 5395 79613278
Illusion 28.64 10.33 23 125692 1718 79616955
Oral discharge 28.58 10.33 12 125703 256 79618417
Head titubation 28.47 10.33 18 125697 920 79617753
Gastrointestinal disorder 28.45 10.33 98 125617 122107 79496566
Panic disorder 28.39 10.33 29 125686 2963 79615710
PO2 increased 28.32 10.33 22 125693 1566 79617107
Schizophrenia 28.29 10.33 70 125645 15370 79603303
Anorgasmia 28.26 10.33 20 125695 1234 79617439
Impaired healing 28.16 10.33 60 125655 87595 79531078
Ejaculation failure 28.11 10.33 13 125702 352 79618321
Irritable bowel syndrome 28.10 10.33 34 125681 62207 79556466
Vulvovaginal burning sensation 27.97 10.33 22 125693 1595 79617078
Chorea 27.74 10.33 26 125689 2391 79616282
Mood altered 27.67 10.33 76 125639 17771 79600902
Platelet count decreased 27.31 10.33 187 125528 194477 79424196
Sensory disturbance 27.25 10.33 68 125647 15009 79603664
Anticholinergic syndrome 27.23 10.33 31 125684 3580 79615093
Balance disorder 26.94 10.33 256 125459 98601 79520072
Coma scale 26.84 10.33 8 125707 58 79618615
Rheumatoid factor positive 26.69 10.33 33 125682 59806 79558867
Paralysis 26.58 10.33 62 125653 13115 79605558
Diarrhoea 26.53 10.33 1127 124588 879362 78739311
Negative thoughts 26.30 10.33 20 125695 1379 79617294
Encephalopathy 26.13 10.33 189 125526 67208 79551465
Cerebral microhaemorrhage 26.10 10.33 11 125704 237 79618436
Weight increased 25.94 10.33 596 125119 276790 79341883
Oedema 25.79 10.33 99 125616 119481 79499192
Catatonia 25.63 10.33 48 125667 8708 79609965
Obsessive thoughts 25.39 10.33 18 125697 1114 79617559
Tension 25.39 10.33 33 125682 4371 79614302
Cardiac failure 25.22 10.33 142 125573 154700 79463973
Therapy non-responder 25.05 10.33 69 125646 92236 79526437
Post-traumatic neck syndrome 24.95 10.33 23 125692 2071 79616602
Vision blurred 24.90 10.33 266 125449 105632 79513041
Eye movement disorder 24.81 10.33 45 125670 7966 79610707
Metastases to liver 24.67 10.33 7 125708 28307 79590366
Alcohol abuse 24.62 10.33 36 125679 5327 79613346
Hypokinesia 24.58 10.33 76 125639 18984 79599689
Social avoidant behaviour 24.58 10.33 34 125681 4780 79613893
Epilepsy 24.33 10.33 128 125587 40732 79577941
Product dose omission issue 24.32 10.33 261 125454 247276 79371397
Joint range of motion decreased 24.29 10.33 11 125704 33271 79585402
Creutzfeldt-Jakob disease 24.18 10.33 10 125705 205 79618468
Injection site erythema 23.90 10.33 55 125660 78142 79540531
Toxic shock syndrome 23.80 10.33 18 125697 1231 79617442
Multiple organ dysfunction syndrome 23.76 10.33 103 125612 120143 79498530
Depressive symptom 23.72 10.33 39 125676 6384 79612289
Incoherent 23.56 10.33 43 125672 7649 79611024
Treatment noncompliance 23.49 10.33 152 125563 52116 79566557
Pneumocystis jirovecii pneumonia 23.33 10.33 11 125704 32497 79586176
Accidental poisoning 23.32 10.33 20 125695 1637 79617036
Fibromyalgia 23.31 10.33 41 125674 64299 79554374
Urticaria thermal 22.78 10.33 12 125703 433 79618240
Prostate cancer 22.75 10.33 12 125703 33256 79585417
Pain in extremity 22.46 10.33 422 125293 364116 79254557
Diabetes insipidus 22.38 10.33 34 125681 5203 79613470
Feeling guilty 22.29 10.33 15 125700 853 79617820
Blood pH decreased 22.17 10.33 32 125683 4679 79613994
White blood cell count decreased 22.11 10.33 190 125525 188098 79430575
Cognitive disorder 22.09 10.33 187 125528 69739 79548934
Housebound 22.02 10.33 12 125703 464 79618209
Trichotillomania 21.93 10.33 9 125706 181 79618492
Thermal burn 21.90 10.33 40 125675 7120 79611553
Product use in unapproved indication 21.86 10.33 271 125444 250088 79368585
Idiosyncratic alcohol intoxication 21.82 10.33 4 125711 0 79618673
Acute kidney injury 21.76 10.33 638 125077 518766 79099907
Frontotemporal dementia 21.72 10.33 13 125702 602 79618071
Tardive dyskinesia 21.61 10.33 50 125665 10521 79608152
Oxygen saturation abnormal 21.38 10.33 31 125684 4551 79614122
Knee arthroplasty 21.30 10.33 22 125693 43226 79575447
Blood sodium decreased 21.07 10.33 106 125609 33149 79585524
Judgement impaired 21.02 10.33 17 125698 1283 79617390
Pneumonitis 20.96 10.33 40 125675 60820 79557853
Maternal exposure during pregnancy 20.75 10.33 128 125587 136410 79482263
Clostridium difficile infection 20.70 10.33 22 125693 42663 79576010
Mental disorder 20.70 10.33 101 125614 31201 79587472
Injection site pain 20.64 10.33 120 125595 129718 79488955
Self-injurious ideation 20.57 10.33 27 125688 3611 79615062
Feelings of worthlessness 20.36 10.33 12 125703 540 79618133
Aspergillus infection 20.28 10.33 3 125712 19158 79599515
Posterior reversible encephalopathy syndrome 20.28 10.33 8 125707 26273 79592400
Blood lactate dehydrogenase increased 20.18 10.33 118 125597 39052 79579621
Alcoholism 20.08 10.33 27 125688 3696 79614977
Psychiatric symptom 19.89 10.33 38 125677 6997 79611676
Inadequate analgesia 19.71 10.33 30 125685 4599 79614074
Sternal fracture 19.56 10.33 22 125693 2508 79616165
Skin laceration 19.55 10.33 94 125621 28868 79589805
Accommodation disorder 19.47 10.33 12 125703 586 79618087
Bradycardia 19.43 10.33 311 125404 135246 79483427
Cytokine release syndrome 19.26 10.33 17 125698 35981 79582692
Disinhibition 19.08 10.33 22 125693 2576 79616097
Rhinitis 19.06 10.33 59 125656 14748 79603925
Rhinalgia 19.02 10.33 21 125694 2346 79616327
Administration site erythema 18.98 10.33 10 125705 361 79618312
Leukopenia 18.88 10.33 107 125608 116406 79502267
Cellulitis 18.86 10.33 98 125617 108962 79509711
Sinusitis 18.85 10.33 207 125508 195294 79423379
Musculoskeletal pain 18.84 10.33 90 125625 102264 79516409
Drug screen positive 18.71 10.33 34 125681 6029 79612644
Somatic dysfunction 18.69 10.33 5 125710 23 79618650
Cyanosis 18.66 10.33 84 125631 25098 79593575
Neoplasm progression 18.66 10.33 33 125682 51649 79567024
Hyperlipidaemia 18.57 10.33 86 125629 26007 79592666
Haemoglobin decreased 18.43 10.33 243 125472 221876 79396797
Feeling abnormal 18.43 10.33 353 125362 158846 79459827
Colitis 18.29 10.33 57 125658 73250 79545423
Dissociative disorder 18.29 10.33 13 125702 808 79617865
Ejaculation disorder 18.02 10.33 11 125704 528 79618145
Respiratory tract infection 17.66 10.33 31 125684 48658 79570015
Mental impairment 17.64 10.33 68 125647 18968 79599705
Hyperarousal 17.59 10.33 5 125710 30 79618643
Brugada syndrome 17.54 10.33 15 125700 1223 79617450
Foetal death 17.50 10.33 39 125676 8005 79610668
Poriomania 17.39 10.33 8 125707 214 79618459
Parkinson's disease 17.33 10.33 17 125698 1654 79617019
Palmar-plantar erythrodysaesthesia syndrome 17.31 10.33 16 125699 33118 79585555
Renal impairment 17.30 10.33 162 125553 157621 79461052
Myoglobin blood increased 17.22 10.33 23 125692 3128 79615545
Muscle tightness 17.13 10.33 52 125663 12862 79605811
Middle insomnia 17.07 10.33 60 125655 16009 79602664
Campylobacter colitis 17.05 10.33 5 125710 34 79618639
Bronchopulmonary aspergillosis 16.85 10.33 7 125708 22287 79596386
Plasmodium vivax infection 16.82 10.33 4 125711 10 79618663
Resting tremor 16.77 10.33 16 125699 1505 79617168
Sluggishness 16.77 10.33 34 125681 6538 79612135
Eyelid disorder 16.68 10.33 18 125697 1960 79616713
Hyperkinesia 16.60 10.33 21 125694 2708 79615965
Therapy interrupted 16.53 10.33 15 125700 31326 79587347
Localised infection 16.47 10.33 21 125694 37554 79581119
Dysacusis 16.36 10.33 3 125712 0 79618673
Toxicologic test abnormal 16.33 10.33 15 125700 1345 79617328
Grip strength decreased 16.32 10.33 7 125708 21862 79596811
Haemophagocytic lymphohistiocytosis 16.28 10.33 7 125708 21830 79596843
Reversible cerebral vasoconstriction syndrome 16.23 10.33 22 125693 3035 79615638
Oedema peripheral 16.17 10.33 290 125425 251998 79366675
Drug resistance 16.12 10.33 26 125689 42187 79576486
Hospitalisation 16.12 10.33 85 125630 94151 79524522
Tri-iodothyronine free decreased 15.99 10.33 9 125706 371 79618302
Phonophobia 15.90 10.33 10 125705 506 79618167
Lactose intolerance 15.90 10.33 19 125696 2311 79616362
Clumsiness 15.84 10.33 22 125693 3105 79615568
Vasculitis 15.82 10.33 10 125705 25092 79593581
Generalised tonic-clonic seizure 15.81 10.33 121 125594 43789 79574884
Persecutory delusion 15.75 10.33 28 125687 4881 79613792
Soliloquy 15.68 10.33 11 125704 669 79618004
Altered visual depth perception 15.62 10.33 9 125706 388 79618285
Vulvovaginal pruritus 15.60 10.33 20 125695 2613 79616060
Fluid retention 15.56 10.33 57 125658 69752 79548921
C-reactive protein increased 15.23 10.33 130 125585 128897 79489776
Epistaxis 15.20 10.33 108 125607 111407 79507266
Fatigue 15.18 10.33 1261 124454 928466 78690207
Spinal pain 15.00 10.33 3 125712 15389 79603284
Migraine 14.99 10.33 207 125508 87286 79531387
Bladder cancer 14.97 10.33 6 125709 19520 79599153
Sedation 14.94 10.33 136 125579 51759 79566914
Hypersomnia 14.91 10.33 74 125641 23012 79595661
Blood chloride decreased 14.91 10.33 37 125678 8140 79610533
Intentional device use issue 14.85 10.33 5 125710 56 79618617
Dissociative amnesia 14.83 10.33 6 125709 116 79618557
Poor quality sleep 14.80 10.33 73 125642 22649 79596024
Amimia 14.77 10.33 5 125710 57 79618616
Pleural effusion 14.73 10.33 152 125563 145110 79473563
Vasoplegia syndrome 14.72 10.33 23 125692 3607 79615066
Subdural haematoma 14.48 10.33 92 125623 31342 79587331
Tumour lysis syndrome 14.46 10.33 10 125705 23929 79594744
Vascular stenosis 14.44 10.33 10 125705 596 79618077
Antiphospholipid antibodies 14.42 10.33 6 125709 125 79618548
Cystocele 14.38 10.33 11 125704 765 79617908
Mental status changes 14.27 10.33 165 125550 66794 79551879
Marital problem 14.26 10.33 7 125708 217 79618456
Diabetic hyperosmolar coma 14.12 10.33 11 125704 786 79617887
Respiratory depression 14.08 10.33 83 125632 27547 79591126
Impatience 14.06 10.33 10 125705 622 79618051
Hypoosmolar state 14.01 10.33 8 125707 339 79618334
Dizziness postural 13.93 10.33 45 125670 11504 79607169
Hypervolaemia 13.89 10.33 29 125686 42661 79576012
Nasal ulcer 13.87 10.33 17 125698 2123 79616550
Suspiciousness 13.85 10.33 10 125705 637 79618036
Compartment syndrome 13.82 10.33 27 125688 5055 79613618
Chronic spontaneous urticaria 13.73 10.33 13 125702 1211 79617462
Bacteraemia 13.71 10.33 19 125696 32805 79585868
Infusion site scar 13.67 10.33 8 125707 355 79618318
Influenza like illness 13.67 10.33 173 125542 71534 79547139
Hyperventilation 13.62 10.33 35 125680 7864 79610809
Trismus 13.61 10.33 28 125687 5439 79613234
Plasma cell myeloma 13.58 10.33 41 125674 53218 79565455
Wrong patient 13.57 10.33 8 125707 360 79618313
Wheezing 13.57 10.33 118 125597 116546 79502127
Gaze palsy 13.54 10.33 20 125695 2985 79615688
Cerebral haematoma 13.50 10.33 35 125680 7907 79610766
Stupor 13.49 10.33 32 125683 6840 79611833
Chronic kidney disease 13.48 10.33 56 125659 66098 79552575
Sleep disorder due to a general medical condition 13.46 10.33 3 125712 14274 79604399
Decreased activity 13.45 10.33 37 125678 8657 79610016
Blood bicarbonate decreased 13.42 10.33 27 125688 5164 79613509
Coronary artery disease 13.36 10.33 160 125555 65314 79553359
Immunodeficiency 13.27 10.33 9 125706 21759 79596914
Diet refusal 13.26 10.33 11 125704 860 79617813
Cholecystitis chronic 13.24 10.33 40 125675 9866 79608807
Dermatitis allergic 13.22 10.33 6 125709 18124 79600549
Accidental death 13.16 10.33 24 125691 4267 79614406
Cerebrovascular stenosis 13.13 10.33 6 125709 158 79618515
Dairy intolerance 13.12 10.33 5 125710 82 79618591
Upper respiratory tract infection 13.06 10.33 87 125628 91081 79527592
Nephropathy toxic 13.06 10.33 8 125707 20411 79598262
Perseveration 13.01 10.33 8 125707 389 79618284
Laboratory test abnormal 13.00 10.33 15 125700 28033 79590640
Thought insertion 12.87 10.33 4 125711 34 79618639
Productive cough 12.81 10.33 84 125631 88247 79530426
Urticaria 12.79 10.33 210 125505 184991 79433682
Violence-related symptom 12.76 10.33 10 125705 721 79617952
Injection site pruritus 12.71 10.33 30 125685 42253 79576420
Slow response to stimuli 12.65 10.33 15 125700 1810 79616863
Delivery 12.63 10.33 10 125705 732 79617941
Blood triglycerides increased 12.58 10.33 66 125649 20974 79597699
Intention tremor 12.58 10.33 10 125705 736 79617937
Arthritis 12.57 10.33 118 125597 114762 79503911
Granuloma 12.53 10.33 35 125680 8262 79610411
Neurotoxicity 12.44 10.33 20 125695 32498 79586175
Posture abnormal 12.34 10.33 22 125693 3844 79614829
Hypoaesthesia 12.29 10.33 370 125345 178982 79439691
Device related infection 12.29 10.33 22 125693 34272 79584401
Aphasia 12.23 10.33 120 125595 46612 79572061
Product administration error 12.17 10.33 89 125626 31757 79586916
Colitis microscopic 12.13 10.33 41 125674 10727 79607946
Ankle fracture 12.13 10.33 56 125659 16913 79601760
Dyssomnia 12.11 10.33 4 125711 42 79618631
Erythema 12.09 10.33 264 125451 223026 79395647
Ammonia abnormal 12.05 10.33 6 125709 192 79618481
Anhedonia 12.04 10.33 51 125664 14847 79603826
Antipsychotic drug level increased 11.98 10.33 28 125687 5929 79612744
Bone marrow failure 11.88 10.33 41 125674 51066 79567607
Head injury 11.83 10.33 100 125615 37269 79581404
Tonic convulsion 11.82 10.33 16 125699 2204 79616469
Blood aldosterone abnormal 11.79 10.33 4 125711 46 79618627
Metastases to lung 11.78 10.33 7 125708 18156 79600517
Oscillopsia 11.77 10.33 6 125709 202 79618471
Serum sickness-like reaction 11.77 10.33 9 125706 626 79618047
Impaired quality of life 11.74 10.33 4 125711 14382 79604291
Jealous delusion 11.72 10.33 7 125708 323 79618350
Exhibitionism 11.71 10.33 4 125711 47 79618626
Enterococcal infection 11.71 10.33 5 125710 15655 79603018
Cytopenia 11.68 10.33 9 125706 20374 79598299
Sinus congestion 11.62 10.33 62 125653 19834 79598839
Tenosynovitis 11.57 10.33 5 125710 15549 79603124
Ear infection 11.54 10.33 23 125692 34409 79584264
Cyclothymic disorder 11.50 10.33 6 125709 212 79618461
Hyperbilirubinaemia 11.49 10.33 13 125702 24505 79594168
Paroxysmal arrhythmia 11.49 10.33 4 125711 50 79618623
Liver injury 11.49 10.33 48 125667 56566 79562107
Thrombotic microangiopathy 11.44 10.33 9 125706 20160 79598513
Scratch 11.40 10.33 34 125681 8329 79610344
Impulse-control disorder 11.35 10.33 14 125701 1760 79616913
Liver function test increased 11.34 10.33 29 125686 39744 79578929
Hypervigilance 11.34 10.33 8 125707 491 79618182
Fibrocystic breast disease 11.34 10.33 9 125706 661 79618012
Oropharyngeal pain 11.26 10.33 114 125601 109239 79509434
Suicidal behaviour 11.04 10.33 19 125696 3228 79615445
Vascular access site pain 11.00 10.33 5 125710 130 79618543
Psychomotor skills impaired 10.96 10.33 25 125690 5212 79613461
Hypercholesterolaemia 10.89 10.33 68 125647 23027 79595646
Energy increased 10.89 10.33 19 125696 3263 79615410
Haemodynamic instability 10.85 10.33 7 125708 17375 79601298
Normetanephrine urine increased 10.85 10.33 3 125712 16 79618657
Rash macular 10.85 10.33 18 125697 28881 79589792
Injection site swelling 10.83 10.33 38 125677 47094 79571579
Inflammation 10.82 10.33 95 125620 93658 79525015
Delusional perception 10.81 10.33 7 125708 373 79618300
Yawning 10.77 10.33 12 125703 1354 79617319
Antisocial behaviour 10.76 10.33 9 125706 712 79617961
Cardiotoxicity 10.71 10.33 3 125712 12236 79606437
Back pain 10.71 10.33 382 125333 303798 79314875
Prescription form tampering 10.61 10.33 7 125708 385 79618288
Autoimmune nephritis 10.57 10.33 9 125706 730 79617943
Rash erythematous 10.51 10.33 51 125664 57718 79560955
Decreased interest 10.49 10.33 20 125695 3677 79614996
Imprisonment 10.48 10.33 8 125707 555 79618118
Anaphylactic shock 10.46 10.33 26 125689 35970 79582703
Herpes zoster 10.45 10.33 95 125620 92988 79525685
Feeling of relaxation 10.43 10.33 5 125710 147 79618526
Transaminases increased 10.42 10.33 44 125671 51699 79566974
Hyper IgE syndrome 10.38 10.33 8 125707 563 79618110
Gastrointestinal haemorrhage 10.36 10.33 167 125548 147552 79471121
Metastases to bone 10.35 10.33 14 125701 24413 79594260

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N06AB05 NERVOUS SYSTEM
PSYCHOANALEPTICS
ANTIDEPRESSANTS
Selective serotonin reuptake inhibitors
FDA MoA N0000000109 Serotonin Uptake Inhibitors
CHEBI has role CHEBI:35469 antidepressants
CHEBI has role CHEBI:35474 anti-anxiety agents
CHEBI has role CHEBI:50183 P450 inhibitors
CHEBI has role CHEBI:50908 agente hepatotoxico
CHEBI has role CHEBI:50949 SSRI
FDA EPC N0000175696 Serotonin Reuptake Inhibitor
MeSH PA D000928 Antidepressive Agents
MeSH PA D018687 Antidepressive Agents, Second-Generation
MeSH PA D002491 Central Nervous System Agents
MeSH PA D065690 Cytochrome P-450 CYP2D6 Inhibitors
MeSH PA D065607 Cytochrome P-450 Enzyme Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D065606 Metabolic Side Effects of Drugs and Substances
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D014179 Neurotransmitter Uptake Inhibitors
MeSH PA D011619 Psychotropic Drugs
MeSH PA D017367 Selective Serotonin Reuptake Inhibitors
MeSH PA D018490 Serotonin Agents

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

DiseaseRelationSNOMED_IDDOID
Premenstrual dysphoric disorder indication 596004
Generalized anxiety disorder indication 21897009 DOID:14320
Social phobia indication 25501002 DOID:11257
Depressive disorder indication 35489007
Posttraumatic stress disorder indication 47505003 DOID:2055
Obsessive-compulsive disorder indication 191736004 DOID:10933
Menopausal flushing indication 198436008
Major depressive disorder indication 370143000
Panic disorder indication 371631005 DOID:594
Bipolar affective disorder, current episode depression off-label use 191627008 DOID:3312
Fibromyalgia off-label use 203082005 DOID:631
Suicidal thoughts contraindication 6471006
Bipolar disorder contraindication 13746004 DOID:3312
Neuroleptic malignant syndrome contraindication 15244003 DOID:14464
Upper gastrointestinal hemorrhage contraindication 37372002
Syndrome of inappropriate vasopressin secretion contraindication 55004003 DOID:3401
Acute nephropathy contraindication 58574008
Blood coagulation disorder contraindication 64779008 DOID:1247
Hyponatremia contraindication 89627008
Seizure disorder contraindication 128613002
Mania contraindication 231494001
Disease of liver contraindication 235856003 DOID:409
Pathological fracture contraindication 268029009
Akathisia contraindication 285145004
Pregnancy, function contraindication 289908002
Serotonin syndrome contraindication 371089000




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.51 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 7.5MG BASE BRISDELLE SEBELA IRELAND LTD N204516 June 28, 2013 RX CAPSULE ORAL 8946251 Aug. 4, 2026 TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE
EQ 7.5MG BASE BRISDELLE SEBELA IRELAND LTD N204516 June 28, 2013 RX CAPSULE ORAL 9393237 Aug. 4, 2026 TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE
EQ 7.5MG BASE BRISDELLE SEBELA IRELAND LTD N204516 June 28, 2013 RX CAPSULE ORAL 8658663 April 6, 2029 TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Sodium-dependent serotonin transporter Transporter INHIBITOR Ki 10.40 CHEMBL CHEMBL
Sigma non-opioid intracellular receptor 1 Membrane receptor Ki 5.65 DRUG MATRIX
Potassium voltage-gated channel subfamily H member 2 Ion channel Ki 5.07 DRUG MATRIX
Sodium-dependent noradrenaline transporter Transporter Kd 7.40 WOMBAT-PK
5-hydroxytryptamine receptor 1A GPCR Kd 4.52 CHEMBL
D(3) dopamine receptor GPCR Ki 5.42 WOMBAT-PK
Muscarinic acetylcholine receptor M1 GPCR Ki 7.46 DRUG MATRIX
Muscarinic acetylcholine receptor M2 GPCR Ki 6.72 DRUG MATRIX
Muscarinic acetylcholine receptor M3 GPCR Ki 7.42 DRUG MATRIX
Muscarinic acetylcholine receptor M4 GPCR Ki 7.47 DRUG MATRIX
Muscarinic acetylcholine receptor M5 GPCR Ki 7.05 DRUG MATRIX
Sodium-dependent dopamine transporter Transporter Kd 6.31 WOMBAT-PK
Cytochrome P450 2D6 Enzyme IC50 6 DRUG MATRIX
Cytochrome P450 1A2 Enzyme IC50 4.96 WOMBAT-PK
Substance-P receptor GPCR IC50 6.05 CHEMBL
Potassium voltage-gated channel subfamily A member 3 Ion channel IC50 4.50 CHEMBL
Myeloperoxidase Enzyme IC50 7.70 CHEMBL
Beta-adrenergic receptor kinase 1 Kinase IC50 5.86 CHEMBL
P2X purinoceptor 4 Ion channel IC50 5.33 CHEMBL
Beta-1 adrenergic receptor GPCR Ki 5 WOMBAT-PK
Sodium-dependent serotonin transporter Transporter Ki 10.30 CHEMBL
Sodium-dependent dopamine transporter Transporter Ki 7.01 CHEMBL
Transporter Transporter Ki 7.48 CHEMBL
Sodium-dependent dopamine transporter Transporter Ki 9.36 CHEMBL
Sodium-dependent noradrenaline transporter Transporter Ki 7.70 CHEMBL
Transporter Transporter Ki 7.23 CHEMBL
Quinolone resistance protein NorA Transporter IC50 5.15 CHEMBL
Adrenergic receptor alpha-2 GPCR Ki 5.20 CHEMBL
Adrenergic receptor alpha-1 GPCR Ki 5.27 CHEMBL
P2X purinoceptor 4 Ion channel IC50 5.61 CHEMBL
Beta-adrenergic receptor kinase 1 Kinase IC50 5.89 CHEMBL

External reference:

IDSource
D02260 KEGG_DRUG
110429-35-1 SECONDARY_CAS_RN
217797-14-3 SECONDARY_CAS_RN
78246-49-8 SECONDARY_CAS_RN
4020738 VANDF
4020815 VANDF
C0070122 UMLSCUI
CHEBI:7936 CHEBI
8PR PDB_CHEM_ID
CHEMBL490 ChEMBL_ID
CHEMBL4297919 ChEMBL_ID
CHEMBL1200609 ChEMBL_ID
DB00715 DRUGBANK_ID
CHEMBL1708 ChEMBL_ID
CHEMBL1256912 ChEMBL_ID
D017374 MESH_DESCRIPTOR_UI
43815 PUBCHEM_CID
4790 IUPHAR_LIGAND_ID
4327 INN_ID
41VRH5220H UNII
114228 RXNORM
18339 MMSL
205288 MMSL
262886 MMSL
29631 MMSL
4517 MMSL
47422 MMSL
5236 MMSL
d03157 MMSL
004016 NDDF
004017 NDDF
008361 NDDF
1269153001 SNOMEDCT_US
321963000 SNOMEDCT_US
372595009 SNOMEDCT_US
411000220105 SNOMEDCT_US
420495003 SNOMEDCT_US
96214003 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Paroxetine HUMAN PRESCRIPTION DRUG LABEL 1 0378-7001 TABLET, FILM COATED 10 mg ORAL ANDA 28 sections
Paroxetine HUMAN PRESCRIPTION DRUG LABEL 1 0378-7001 TABLET, FILM COATED 10 mg ORAL ANDA 28 sections
Paroxetine HUMAN PRESCRIPTION DRUG LABEL 1 0378-7002 TABLET, FILM COATED 20 mg ORAL ANDA 28 sections
Paroxetine HUMAN PRESCRIPTION DRUG LABEL 1 0378-7002 TABLET, FILM COATED 20 mg ORAL ANDA 28 sections
Paroxetine HUMAN PRESCRIPTION DRUG LABEL 1 0378-7003 TABLET, FILM COATED 30 mg ORAL ANDA 28 sections
Paroxetine HUMAN PRESCRIPTION DRUG LABEL 1 0378-7003 TABLET, FILM COATED 30 mg ORAL ANDA 28 sections
Paroxetine HUMAN PRESCRIPTION DRUG LABEL 1 0378-7004 TABLET, FILM COATED 40 mg ORAL ANDA 28 sections
Paroxetine HUMAN PRESCRIPTION DRUG LABEL 1 0378-7004 TABLET, FILM COATED 40 mg ORAL ANDA 28 sections
Paroxetine HUMAN PRESCRIPTION DRUG LABEL 1 0574-0279 CAPSULE 7.50 mg ORAL NDA 28 sections
Paroxetine HUMAN PRESCRIPTION DRUG LABEL 1 0574-0279 CAPSULE 7.50 mg ORAL NDA 28 sections
Paroxetine HUMAN PRESCRIPTION DRUG LABEL 1 0615-7985 TABLET, FILM COATED 20 mg ORAL ANDA 24 sections
Paroxetine HUMAN PRESCRIPTION DRUG LABEL 1 0615-7985 TABLET, FILM COATED 20 mg ORAL ANDA 24 sections
Paroxetine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8173 TABLET, FILM COATED 30 mg ORAL ANDA 24 sections
Paroxetine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8173 TABLET, FILM COATED 30 mg ORAL ANDA 24 sections
Paroxetine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8174 TABLET, FILM COATED 40 mg ORAL ANDA 24 sections
Paroxetine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8174 TABLET, FILM COATED 40 mg ORAL ANDA 24 sections
Paroxetine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8359 TABLET, FILM COATED 10 mg ORAL ANDA 25 sections
Paroxetine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8359 TABLET, FILM COATED 10 mg ORAL ANDA 25 sections
PAROXETINE HUMAN PRESCRIPTION DRUG LABEL 1 0904-5676 TABLET, FILM COATED 10 mg ORAL ANDA 37 sections
PAROXETINE HUMAN PRESCRIPTION DRUG LABEL 1 0904-5676 TABLET, FILM COATED 10 mg ORAL ANDA 37 sections
PAROXETINE HUMAN PRESCRIPTION DRUG LABEL 1 0904-5677 TABLET, FILM COATED 20 mg ORAL ANDA 37 sections
PAROXETINE HUMAN PRESCRIPTION DRUG LABEL 1 0904-5677 TABLET, FILM COATED 20 mg ORAL ANDA 37 sections
PAROXETINE HUMAN PRESCRIPTION DRUG LABEL 1 0904-5678 TABLET, FILM COATED 30 mg ORAL ANDA 37 sections
PAROXETINE HUMAN PRESCRIPTION DRUG LABEL 1 0904-5678 TABLET, FILM COATED 30 mg ORAL ANDA 37 sections
PAROXETINE HUMAN PRESCRIPTION DRUG LABEL 1 0904-5679 TABLET, FILM COATED 40 mg ORAL ANDA 37 sections
PAROXETINE HUMAN PRESCRIPTION DRUG LABEL 1 0904-5679 TABLET, FILM COATED 40 mg ORAL ANDA 37 sections
PAROXETINE HUMAN PRESCRIPTION DRUG LABEL 1 10544-433 TABLET, FILM COATED 20 mg ORAL ANDA 32 sections
PAROXETINE HUMAN PRESCRIPTION DRUG LABEL 1 10544-809 TABLET, FILM COATED 40 mg ORAL ANDA 32 sections
PAROXETINE HUMAN PRESCRIPTION DRUG LABEL 1 12634-248 TABLET, FILM COATED 20 mg ORAL ANDA 31 sections
Paroxetine Human Prescription Drug Label 1 13107-154 TABLET, FILM COATED 10 mg ORAL ANDA 34 sections