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 913.40 10.00 575 101725 25282 56164485
Atrial septal defect 767.59 10.00 326 101974 6180 56183587
Serotonin syndrome 649.96 10.00 470 101830 26020 56163747
Suicidal ideation 475.35 10.00 555 101745 57187 56132580
Drug abuse 458.08 10.00 589 101711 67021 56122746
Ventricular septal defect 428.05 10.00 189 102111 3949 56185818
Patent ductus arteriosus 397.58 10.00 177 102123 3774 56185993
Rheumatoid arthritis 375.03 10.00 115 102185 382489 55807278
Sopor 366.35 10.00 304 101996 20618 56169149
Anxiety 365.74 10.00 967 101333 192205 55997562
Exposure during pregnancy 346.51 10.00 765 101535 135577 56054190
Suicide attempt 344.22 10.00 473 101827 57363 56132404
Depression 285.97 10.00 846 101454 179271 56010496
Contraindicated product administered 271.19 10.00 17 102283 186269 56003498
Agitation 267.55 10.00 413 101887 55623 56134144
Tremor 251.43 10.00 628 101672 120461 56069306
Heart disease congenital 247.28 10.00 91 102209 1157 56188610
Alopecia 242.73 10.00 115 102185 293343 55896424
Congenital anomaly 242.26 10.00 96 102204 1511 56188256
Systemic lupus erythematosus 233.34 10.00 27 102273 180051 56009716
Intentional self-injury 232.33 10.00 256 102044 24736 56165031
Cardiac murmur 227.82 10.00 179 102121 11222 56178545
Mydriasis 223.78 10.00 175 102125 10896 56178871
Drug interaction 222.86 10.00 861 101439 208894 55980873
Nightmare 217.69 10.00 206 102094 16620 56173147
Glossodynia 212.95 10.00 17 102283 152441 56037326
Pulmonary valve stenosis 210.79 10.00 59 102241 280 56189487
Drug ineffective 209.80 10.00 911 101389 918078 55271689
Joint swelling 208.64 10.00 135 102165 289665 55900102
Multiple congenital abnormalities 200.75 10.00 64 102236 508 56189259
Foetal exposure during pregnancy 198.72 10.00 275 102025 33548 56156219
Drug intolerance 198.03 10.00 118 102182 264700 55925067
Synovitis 192.83 10.00 31 102269 161274 56028493
Off label use 189.33 10.00 461 101839 555719 55634048
Persistent foetal circulation 171.07 10.00 46 102254 182 56189585
Treatment failure 168.81 10.00 50 102250 170342 56019425
Somnolence 168.73 10.00 665 101635 162748 56027019
Irritability 168.49 10.00 237 102063 29351 56160416
Depersonalisation/derealisation disorder 167.30 10.00 69 102231 1210 56188557
Pericarditis 161.30 10.00 9 102291 108914 56080853
Abdominal discomfort 158.63 10.00 162 102138 277112 55912655
Anger 156.93 10.00 146 102154 11526 56178241
Mania 156.63 10.00 145 102155 11375 56178392
Hallucinations, mixed 155.14 10.00 98 102202 4326 56185441
Pulmonary artery stenosis congenital 153.81 10.00 43 102257 203 56189564
Hyponatraemia 153.60 10.00 471 101829 101668 56088099
Infusion related reaction 153.47 10.00 95 102205 208836 55980931
Swelling 151.40 10.00 128 102172 239643 55950124
Rash 151.39 10.00 430 101870 492617 55697150
Panic attack 149.22 10.00 185 102115 20262 56169505
Neuroleptic malignant syndrome 147.47 10.00 140 102160 11338 56178429
Hyperhidrosis 145.33 10.00 438 101862 93650 56096117
Disturbance in attention 144.41 10.00 232 102068 32308 56157459
Bradyphrenia 143.30 10.00 109 102191 6511 56183256
Dissociation 140.28 10.00 76 102224 2509 56187258
Disorientation 138.45 10.00 243 102057 36370 56153397
Derealisation 136.94 10.00 57 102243 1024 56188743
Arthropathy 133.83 10.00 101 102199 200174 55989593
Coarctation of the aorta 133.11 10.00 47 102253 526 56189241
Activation syndrome 131.60 10.00 37 102263 179 56189588
Completed suicide 131.18 10.00 536 101764 133297 56056470
Aggression 130.86 10.00 180 102120 21826 56167941
Mood swings 129.46 10.00 156 102144 16591 56173176
Pain 129.46 10.00 694 101606 662490 55527277
Hypersensitivity 126 10.00 169 102131 256239 55933528
Inappropriate antidiuretic hormone secretion 122.82 10.00 138 102162 13618 56176149
Confusional state 122.26 10.00 720 101580 207435 55982332
Feeling of despair 121.59 10.00 65 102235 2088 56187679
Product use issue 120.26 10.00 97 102203 185944 56003823
Overdose 120.10 10.00 444 101856 105386 56084381
Restlessness 115.85 10.00 188 102112 26398 56163369
Fallot's tetralogy 112.58 10.00 27 102273 58 56189709
Therapeutic product effect decreased 112.49 10.00 86 102214 169366 56020401
Withdrawal syndrome 111.26 10.00 152 102148 18310 56171457
Hallucination, auditory 110.48 10.00 120 102180 11404 56178363
Helicobacter infection 108.63 10.00 6 102294 73262 56116505
Developmental delay 108.46 10.00 52 102248 1320 56188447
Peripheral swelling 105.18 10.00 165 102135 234561 55955206
Discomfort 103.29 10.00 65 102235 141696 56048071
Gastric pH decreased 103.01 10.00 41 102259 653 56189114
Dyskinesia 102.12 10.00 187 102113 28921 56160846
Myoglobin urine present 100.19 10.00 38 102262 528 56189239
Toxicity to various agents 97.92 10.00 721 101579 223843 55965924
Hepatic enzyme increased 95.81 10.00 102 102198 171282 56018485
Poisoning deliberate 94.29 10.00 103 102197 9850 56179917
Congenital aortic stenosis 87.55 10.00 17 102283 3 56189764
Wound 85.23 10.00 76 102224 138728 56051039
Arthralgia 84.37 10.00 550 101750 501119 55688648
Nasopharyngitis 82.29 10.00 174 102126 220785 55968982
Blister 82.00 10.00 48 102252 108839 56080928
Insomnia 81.89 10.00 613 101687 191247 55998520
Drug dependence 81.88 10.00 147 102153 22386 56167381
Agoraphobia 81.77 10.00 29 102271 329 56189438
Stomatitis 80.55 10.00 61 102239 120749 56069018
Cogwheel rigidity 79.71 10.00 47 102253 1830 56187937
Transposition of the great vessels 79.71 10.00 25 102275 187 56189580
Flat affect 79.40 10.00 42 102258 1320 56188447
Tearfulness 79.27 10.00 61 102239 3707 56186060
Rheumatoid factor positive 78.70 10.00 15 102285 69045 56120722
Muscle rigidity 76.97 10.00 96 102204 10575 56179192
Crying 76.80 10.00 139 102161 21301 56168466
Lower respiratory tract infection 76.48 10.00 58 102242 114736 56075031
Extrapyramidal disorder 76.38 10.00 103 102197 12253 56177514
Memory impairment 75.71 10.00 335 101965 86222 56103545
Depressed mood 74.73 10.00 188 102112 36171 56153596
Talipes 74.39 10.00 41 102259 1401 56188366
Delirium 72.38 10.00 205 102095 42312 56147455
Febrile neutropenia 72.03 10.00 52 102248 105493 56084274
Emotional disorder 70.74 10.00 99 102201 12196 56177571
Homicidal ideation 70.52 10.00 42 102258 1666 56188101
Folliculitis 69.29 10.00 9 102291 54970 56134797
Hypoplastic left heart syndrome 68.74 10.00 22 102278 177 56189590
Intentional product use issue 68.24 10.00 49 102251 99684 56090083
Muscle injury 67.62 10.00 8 102292 52492 56137275
Bronchial neoplasm 67.21 10.00 27 102273 441 56189326
Cough 66.81 10.00 245 102055 259716 55930051
H1N1 influenza 66.70 10.00 40 102260 1607 56188160
Speech disorder developmental 65.79 10.00 29 102271 603 56189164
Nervousness 64.91 10.00 155 102145 28860 56160907
Dystonia 62.69 10.00 94 102206 12327 56177440
Bronchial haemorrhage 62.68 10.00 27 102273 530 56189237
Abnormal behaviour 62.16 10.00 123 102177 20149 56169618
Intentional overdose 62.12 10.00 267 102033 67850 56121917
Impulsive behaviour 62.07 10.00 37 102263 1470 56188297
Hyperreflexia 61.73 10.00 61 102239 5189 56184578
Altered state of consciousness 61.55 10.00 132 102168 22889 56166878
Libido increased 61.42 10.00 35 102265 1277 56188490
Parkinsonism 61.19 10.00 81 102219 9465 56180302
Infection 60.93 10.00 175 102125 200031 55989736
Congenital cardiovascular anomaly 60.79 10.00 18 102282 108 56189659
Maternal exposure during pregnancy 60.42 10.00 162 102138 189391 56000376
Myoclonus 60.19 10.00 103 102197 15100 56174667
Nasal turbinate hypertrophy 59.35 10.00 28 102272 685 56189082
Cyanosis 58.54 10.00 104 102196 15706 56174061
Bicuspid aortic valve 57.56 10.00 17 102283 101 56189666
Pulmonary valve stenosis congenital 57.23 10.00 18 102282 136 56189631
Clonus 56.82 10.00 53 102247 4196 56185571
Cleft palate 56.36 10.00 30 102270 955 56188812
Homicide 54.62 10.00 22 102278 362 56189405
Mobility decreased 54.09 10.00 60 102240 98931 56090836
Drooling 53.44 10.00 47 102253 3447 56186320
Endometrial ablation 53.02 10.00 28 102272 877 56188890
Anomalous pulmonary venous connection 52.97 10.00 14 102286 51 56189716
Right ventricular hypertrophy 51.98 10.00 25 102275 639 56189128
Feeling of body temperature change 51.52 10.00 52 102248 4537 56185230
General physical health deterioration 51.43 10.00 149 102151 169861 56019906
Affective disorder 51.37 10.00 57 102243 5546 56184221
Psoriatic arthropathy 51.09 10.00 36 102264 73972 56115795
Thermal burn 50.63 10.00 56 102244 5429 56184338
Hallucination 50.60 10.00 200 102100 48949 56140818
Amnesia 50.55 10.00 192 102108 46130 56143637
Hypomania 50.43 10.00 53 102247 4849 56184918
Paraesthesia 49.56 10.00 406 101894 130108 56059659
Feeling jittery 49.53 10.00 83 102217 11963 56177804
Vertigo 49.06 10.00 213 102087 54359 56135408
Renal ischaemia 48.55 10.00 23 102277 568 56189199
Impaired healing 48.14 10.00 52 102248 86789 56102978
Depressed level of consciousness 47.51 10.00 216 102084 56217 56133550
Speech disorder 47.36 10.00 163 102137 37330 56152437
Menstrual disorder 47.13 10.00 50 102250 4625 56185142
Delusion 47.08 10.00 78 102222 11137 56178630
Therapeutic product ineffective 46.73 10.00 30 102270 1362 56188405
Malignant neoplasm progression 46.72 10.00 39 102261 73548 56116219
Pneumonia 46.61 10.00 494 101806 406604 55783163
Self esteem decreased 45.90 10.00 22 102278 558 56189209
Abnormal dreams 45.84 10.00 71 102229 9578 56180189
Hyperprolactinaemia 45.78 10.00 44 102256 3617 56186150
Psychotic disorder 45.49 10.00 119 102181 23439 56166328
Fatigue 45.38 10.00 1090 101210 787462 55402305
Loss of libido 44.89 10.00 28 102272 1208 56188559
Dizziness 44.63 10.00 944 101356 375196 55814571
Dependence 43.48 10.00 33 102267 1964 56187803
Bronchial disorder 43.47 10.00 27 102273 1156 56188611
Parosmia 43.32 10.00 48 102252 4663 56185104
Muscle twitching 43.27 10.00 93 102207 16149 56173618
Depressive symptom 43.23 10.00 42 102258 3499 56186268
Craniosynostosis 43.21 10.00 15 102285 159 56189608
Akathisia 42.99 10.00 65 102235 8587 56181180
Apathy 42.74 10.00 62 102238 7892 56181875
Hip arthroplasty 42.72 10.00 9 102291 38614 56151153
Irritable bowel syndrome 42.58 10.00 37 102263 68421 56121346
Breath sounds abnormal 42.40 10.00 66 102234 8941 56180826
Tinnitus 41.85 10.00 135 102165 29907 56159860
Galactorrhoea 41.66 10.00 43 102257 3852 56185915
Death 41.66 10.00 408 101892 341018 55848749
Paranoia 41.50 10.00 72 102228 10672 56179095
PCO2 increased 41.27 10.00 26 102274 1142 56188625
Accidental poisoning 40.84 10.00 21 102279 622 56189145
Logorrhoea 40.79 10.00 34 102266 2318 56187449
Muscle disorder 40.62 10.00 46 102254 4577 56185190
Fear 40.45 10.00 86 102214 14822 56174945
Knee arthroplasty 40.26 10.00 15 102285 44244 56145523
Hyperacusis 40.09 10.00 31 102269 1897 56187870
Social anxiety disorder 40.07 10.00 18 102282 392 56189375
COVID-19 39.37 10.00 47 102253 75011 56114756
Hostility 39.30 10.00 30 102270 1801 56187966
Chorea 39.11 10.00 27 102273 1385 56188382
Spina bifida 39.02 10.00 22 102278 786 56188981
Incontinence 38.96 10.00 70 102230 10665 56179102
Sinusitis 38.72 10.00 206 102094 197375 55992392
Gastrointestinal disorder 38.45 10.00 93 102207 112609 56077158
Tachycardia 38.39 10.00 326 101974 105550 56084217
Blood creatine phosphokinase increased 38.38 10.00 125 102175 27827 56161940
Hypoaesthesia oral 38.28 10.00 72 102228 11359 56178408
Product complaint 38.06 10.00 73 102227 11687 56178080
Libido decreased 38.05 10.00 33 102267 2375 56187392
Congenital mitral valve stenosis 37.19 10.00 7 102293 0 56189767
Amylase increased 37.03 10.00 49 102251 5722 56184045
Restless legs syndrome 36.26 10.00 89 102211 16858 56172909
Obsessive-compulsive disorder 36.23 10.00 39 102261 3667 56186100
Neutropenia 36.18 10.00 156 102144 158011 56031756
Rhonchi 36.09 10.00 32 102268 2372 56187395
Seizure 35.69 10.00 366 101934 124753 56065014
Psychomotor hyperactivity 35.59 10.00 64 102236 9756 56180011
Dyspnoea 35.42 10.00 814 101486 591763 55598004
Respiratory depression 35.21 10.00 73 102227 12362 56177405
Injection site pain 35.14 10.00 103 102197 117015 56072752
Emotional distress 34.67 10.00 126 102174 29637 56160130
Urinary retention 34.54 10.00 121 102179 27953 56161814
Loss of consciousness 34.17 10.00 326 101974 109023 56080744
Neuropathy peripheral 33.47 10.00 87 102213 102806 56086961
Ventricular hypoplasia 33.38 10.00 12 102288 142 56189625
Electrocardiogram QT prolonged 33.37 10.00 191 102109 54397 56135370
PO2 increased 33.27 10.00 20 102280 807 56188960
Substance abuse 33.10 10.00 41 102259 4484 56185283
Balance disorder 32.87 10.00 245 102055 76275 56113492
Self-injurious ideation 32.76 10.00 30 102270 2320 56187447
Hallucination, visual 32.47 10.00 87 102213 17381 56172386
Maternal drugs affecting foetus 32.31 10.00 43 102257 5050 56184717
Treatment noncompliance 32.17 10.00 131 102169 32492 56157275
Disease progression 31.91 10.00 92 102208 105081 56084686
Congenital aortic valve incompetence 31.87 10.00 6 102294 0 56189767
DiGeorge's syndrome 31.87 10.00 6 102294 0 56189767
Prescription form tampering 31.52 10.00 17 102283 556 56189211
Toxic encephalopathy 31.49 10.00 46 102254 5892 56183875
Fall 31.08 10.00 860 101440 356650 55833117
Neonatal behavioural syndrome 30.83 10.00 9 102291 51 56189716
Pain in extremity 30.81 10.00 369 101931 297062 55892705
Paralysis 30.38 10.00 57 102243 8975 56180792
Cerebral microhaemorrhage 30.36 10.00 10 102290 89 56189678
Diabetes insipidus 29.93 10.00 29 102271 2408 56187359
Hepatocellular injury 29.83 10.00 111 102189 26403 56163364
Product dose omission issue 29.65 10.00 234 102066 204519 55985248
Soft tissue injury 29.58 10.00 24 102276 1575 56188192
Ebstein's anomaly 29.20 10.00 7 102293 15 56189752
Joint hyperextension 28.65 10.00 13 102287 290 56189477
Coma scale 28.57 10.00 8 102292 38 56189729
Neutrophil count decreased 28.54 10.00 29 102271 49793 56139974
Sepsis 28.39 10.00 144 102156 139696 56050071
Encephalopathy 28.10 10.00 133 102167 35192 56154575
Apraxia 28.06 10.00 24 102276 1695 56188072
Injection site erythema 27.95 10.00 62 102238 77386 56112381
Weight increased 27.67 10.00 578 101722 229125 55960642
Cardiomegaly 27.63 10.00 79 102221 16388 56173379
Feelings of worthlessness 27.59 10.00 13 102287 317 56189450
Blood pH decreased 27.52 10.00 28 102272 2466 56187301
Electroencephalogram abnormal 27.40 10.00 33 102267 3506 56186261
Soliloquy 27.25 10.00 11 102289 182 56189585
Sensory disturbance 26.97 10.00 66 102234 12477 56177290
Mental disorder 26.71 10.00 99 102201 23505 56166262
Micrognathia 26.69 10.00 12 102288 262 56189505
Asphyxia 26.67 10.00 42 102258 5747 56184020
Musculoskeletal stiffness 26.63 10.00 170 102130 155837 56033930
Bradykinesia 26.32 10.00 38 102262 4816 56184951
Hot flush 26.31 10.00 160 102140 46566 56143201
Bronchopulmonary dysplasia 26.19 10.00 12 102288 274 56189493
Vesicoureteric reflux 26.01 10.00 11 102289 206 56189561
Cardio-respiratory arrest 25.99 10.00 181 102119 55140 56134627
Personality disorder 25.89 10.00 39 102261 5134 56184633
Therapy non-responder 25.69 10.00 45 102255 61310 56128457
Arthritis 25.67 10.00 94 102206 99758 56090009
Blood sodium decreased 25.55 10.00 94 102206 22240 56167527
Creutzfeldt-Jakob disease 25.43 10.00 10 102290 154 56189613
Post-traumatic neck syndrome 25.16 10.00 24 102276 1954 56187813
Vision blurred 24.79 10.00 245 102055 82698 56107069
Dysmorphism 24.70 10.00 25 102275 2188 56187579
Compartment syndrome 24.70 10.00 24 102276 2000 56187767
Obsessive thoughts 24.69 10.00 14 102286 506 56189261
Tricuspid valve incompetence 24.63 10.00 66 102234 13187 56176580
Congenital heart valve disorder 24.31 10.00 8 102292 71 56189696
Macular degeneration 24.05 10.00 3 102297 18905 56170862
Panic disorder 23.98 10.00 26 102274 2465 56187302
Middle insomnia 23.95 10.00 58 102242 10892 56178875
Congenital tricuspid valve atresia 23.93 10.00 7 102293 40 56189727
Eye movement disorder 23.82 10.00 36 102264 4753 56185014
Panic reaction 23.78 10.00 32 102268 3798 56185969
Blood lactate dehydrogenase increased 23.63 10.00 87 102213 20588 56169179
Anorgasmia 23.60 10.00 14 102286 551 56189216
Aortic valve incompetence 23.51 10.00 39 102261 5573 56184194
Psychiatric symptom 23.51 10.00 36 102264 4808 56184959
Hepatotoxicity 23.06 10.00 14 102286 31139 56158628
Aorta hypoplasia 23.04 10.00 9 102291 136 56189631
Alcoholism 22.93 10.00 24 102276 2185 56187582
Cleft lip and palate 22.66 10.00 12 102288 378 56189389
Oxygen saturation abnormal 22.43 10.00 27 102273 2867 56186900
Cytomegalovirus infection 22.39 10.00 4 102296 19292 56170475
Mood altered 22.34 10.00 64 102236 13291 56176476
Pyrexia 22.29 10.00 585 101715 418188 55771579
Phonophobia 22.25 10.00 11 102289 299 56189468
Poor quality sleep 22.25 10.00 77 102223 17678 56172089
Tension 22.21 10.00 27 102273 2897 56186870
Major depression 22.03 10.00 45 102255 7539 56182228
Altered visual depth perception 21.83 10.00 11 102289 312 56189455
Dilatation ventricular 21.80 10.00 24 102276 2314 56187453
Musculoskeletal pain 21.79 10.00 75 102225 81077 56108690
Generalised anxiety disorder 21.77 10.00 22 102278 1922 56187845
Pulmonary artery stenosis 21.76 10.00 9 102291 159 56189608
Myelosuppression 21.65 10.00 3 102297 17452 56172315
White blood cell count decreased 21.64 10.00 137 102163 125853 56063914
Hypoplastic right heart syndrome 21.59 10.00 7 102293 59 56189708
Ventricular hypertrophy 21.56 10.00 28 102272 3210 56186557
Blood triglycerides increased 21.54 10.00 58 102242 11619 56178148
Anaphylactic reaction 21.47 10.00 47 102253 58948 56130819
Coma 21.25 10.00 183 102117 59472 56130295
Pilonidal cyst congenital 21.25 10.00 4 102296 0 56189767
Congenital aortic atresia 21.25 10.00 4 102296 0 56189767
Sinus tachycardia 21.24 10.00 89 102211 22355 56167412
Hypokinesia 21.07 10.00 61 102239 12742 56177025
Poisoning 21.04 10.00 61 102239 12752 56177015
Somnolence neonatal 21.04 10.00 8 102292 112 56189655
Joint range of motion decreased 20.82 10.00 10 102290 25355 56164412
Euphoric mood 20.61 10.00 32 102268 4326 56185441
Pancytopenia 20.58 10.00 87 102213 88628 56101139
Fibromyalgia 20.47 10.00 49 102251 59554 56130213
Sternal fracture 20.44 10.00 22 102278 2068 56187699
Wolff-Parkinson-White syndrome 20.42 10.00 8 102292 122 56189645
Sleep disorder 20.28 10.00 200 102100 67463 56122304
Sensory loss 20.27 10.00 48 102252 8887 56180880
Mucosal inflammation 20.19 10.00 29 102271 42781 56146986
Metastases to liver 20.17 10.00 7 102293 21579 56168188
Dysarthria 20.13 10.00 132 102168 39418 56150349
Negative thoughts 20.09 10.00 15 102285 871 56188896
Endocrine ophthalmopathy 19.70 10.00 12 102288 496 56189271
Pneumonitis 19.70 10.00 17 102283 31547 56158220
Physical assault 19.64 10.00 15 102285 901 56188866
Aphasia 19.63 10.00 108 102192 30307 56159460
Feeling abnormal 19.41 10.00 346 101954 133256 56056511
Hypertonia 19.28 10.00 30 102270 4062 56185705
Schizophrenia 19.22 10.00 52 102248 10447 56179320
Posterior reversible encephalopathy syndrome 19.20 10.00 3 102297 15957 56173810
Antidepressant discontinuation syndrome 19.18 10.00 5 102295 17 56189750
Troponin increased 19.17 10.00 46 102254 8589 56181178
Failure to thrive 19.11 10.00 39 102261 6531 56183236
Condition aggravated 19.09 10.00 479 101821 344419 55845348
Wrong patient 18.95 10.00 8 102292 149 56189618
Premature baby 18.84 10.00 77 102223 19128 56170639
Increased appetite 18.82 10.00 46 102254 8689 56181078
Plagiocephaly 18.78 10.00 6 102294 48 56189719
Blood bicarbonate decreased 18.69 10.00 24 102276 2722 56187045
Bipolar disorder 18.60 10.00 42 102258 7538 56182229
Right ventricle outflow tract obstruction 18.48 10.00 4 102296 4 56189763
Foetal movement disorder 18.48 10.00 4 102296 4 56189763
Velopharyngeal incompetence 18.36 10.00 5 102295 21 56189746
Psychomotor skills impaired 18.30 10.00 21 102279 2119 56187648
Mitral valve incompetence 17.98 10.00 73 102227 18080 56171687
Hypotonia 17.96 10.00 45 102255 8632 56181135
Plasma cell myeloma 17.95 10.00 36 102264 46610 56143157
Frontotemporal dementia 17.92 10.00 10 102290 350 56189417
Drug abuser 17.92 10.00 24 102276 2835 56186932
Therapeutic product effect incomplete 17.85 10.00 116 102184 105915 56083852
Apnoea 17.63 10.00 40 102260 7202 56182565
Impatience 17.62 10.00 10 102290 362 56189405
Bradycardia 17.61 10.00 194 102106 67310 56122457
Mental impairment 17.56 10.00 57 102243 12665 56177102
Blepharospasm 17.55 10.00 26 102274 3372 56186395
Congenital aortic anomaly 17.42 10.00 6 102294 62 56189705
Toxic shock syndrome 17.41 10.00 12 102288 614 56189153
Injection site reaction 17.33 10.00 45 102255 53202 56136565
Pruritus 17.17 10.00 441 101859 316182 55873585
Pulmonary valve incompetence 17.14 10.00 16 102284 1268 56188499
Hospitalisation 17.12 10.00 74 102226 74926 56114841
Upper respiratory tract infection 17.10 10.00 69 102231 71219 56118548
Back pain 16.99 10.00 316 101984 236854 55952913
Trichotillomania 16.96 10.00 7 102293 123 56189644
Adverse drug reaction 16.94 10.00 61 102239 65071 56124696
Slow response to stimuli 16.85 10.00 14 102286 950 56188817
Leukopenia 16.81 10.00 69 102231 70871 56118896
Otospondylomegaepiphyseal dysplasia 16.77 10.00 6 102294 70 56189697
Disinhibition 16.64 10.00 13 102287 808 56188959
Campylobacter colitis 16.61 10.00 5 102295 32 56189735
Antisocial personality disorder 16.55 10.00 4 102296 9 56189758
Cleft uvula 16.55 10.00 4 102296 9 56189758
Parkinson's disease 16.52 10.00 16 102284 1328 56188439
Illusion 16.48 10.00 14 102286 980 56188787
Social avoidant behaviour 16.46 10.00 23 102277 2829 56186938
Psoriasis 16.33 10.00 100 102200 92592 56097175
Myoglobin blood increased 16.32 10.00 16 102284 1348 56188419
Poriomania 16.18 10.00 6 102294 78 56189689
Congenital tracheomalacia 16.11 10.00 5 102295 36 56189731
Cognitive disorder 16.10 10.00 148 102152 48985 56140782
Feeling guilty 16.08 10.00 11 102289 556 56189211
Oropharyngeal pain 16.04 10.00 88 102212 83700 56106067
Ear infection 15.98 10.00 20 102280 31275 56158492
Lipomeningocele 15.94 10.00 3 102297 0 56189767
Interruption of aortic arch 15.94 10.00 3 102297 0 56189767
Subvalvular aortic stenosis 15.94 10.00 3 102297 0 56189767
Tethered cord syndrome 15.87 10.00 8 102292 227 56189540
Therapy interrupted 15.75 10.00 14 102286 25611 56164156
Delivery 15.72 10.00 13 102287 876 56188891
Product use in unapproved indication 15.61 10.00 172 102128 140650 56049117
Drug resistance 15.53 10.00 9 102291 20533 56169234
Congenital scoliosis 15.49 10.00 4 102296 13 56189754
Autoimmune nephritis 15.39 10.00 9 102291 345 56189422
Premature labour 15.30 10.00 52 102248 11830 56177937
Brugada syndrome 15.30 10.00 9 102291 349 56189418
Granuloma 15.29 10.00 32 102268 5455 56184312
Trismus 15.28 10.00 25 102275 3533 56186234
Generalised tonic-clonic seizure 15.27 10.00 94 102206 27472 56162295
Inflammation 15.25 10.00 69 102231 69002 56120765
Post procedural haematuria 15.23 10.00 5 102295 44 56189723
Foetal death 15.19 10.00 42 102258 8545 56181222
Anhedonia 15.14 10.00 46 102254 9868 56179899
Atrioventricular septal defect 15.08 10.00 8 102292 253 56189514
Thinking abnormal 15.06 10.00 46 102254 9895 56179872
VACTERL syndrome 15.04 10.00 4 102296 15 56189752
Diabetic hyperosmolar coma 15.04 10.00 9 102291 360 56189407
Perseveration 15.02 10.00 8 102292 255 56189512
Arnold-Chiari malformation 14.97 10.00 11 102289 623 56189144
Injection site pruritus 14.77 10.00 34 102266 41897 56147870
Urticaria 14.75 10.00 180 102120 144496 56045271
Diarrhoea 14.63 10.00 982 101318 637525 55552242
Oedema 14.63 10.00 88 102212 81832 56107935
Lactose intolerance 14.61 10.00 21 102279 2651 56187116
Gaze palsy 14.57 10.00 15 102285 1340 56188427
Alcohol abuse 14.55 10.00 18 102282 1966 56187801
Localised infection 14.54 10.00 17 102283 27395 56162372
Anaemia 14.39 10.00 373 101927 267138 55922629
Antipsychotic drug level above therapeutic 14.39 10.00 13 102287 988 56188779
Oesophageal atresia 14.37 10.00 10 102290 520 56189247
Female orgasmic disorder 14.32 10.00 5 102295 54 56189713
Amimia 14.32 10.00 5 102295 54 56189713
Nodule 14.30 10.00 8 102292 18611 56171156
Neonatal asphyxia 14.16 10.00 8 102292 287 56189480
Premature delivery 14.12 10.00 17 102283 27043 56162724
Rhabdomyolysis 14.10 10.00 124 102176 40534 56149233
Tardive dyskinesia 13.93 10.00 39 102261 7992 56181775
Marcus Gunn syndrome 13.86 10.00 3 102297 3 56189764
Leucine aminopeptidase increased 13.86 10.00 3 102297 3 56189764
Dyskinesia neonatal 13.86 10.00 3 102297 3 56189764
Yawning 13.82 10.00 13 102287 1040 56188727
Sacroiliac joint dysfunction 13.80 10.00 4 102296 22 56189745
Muscle contracture 13.79 10.00 14 102286 1230 56188537
Resting tremor 13.65 10.00 11 102289 715 56189052
Tenosynovitis 13.58 10.00 3 102297 12458 56177309
Tri-iodothyronine free decreased 13.58 10.00 8 102292 311 56189456
Intentional device use issue 13.55 10.00 5 102295 64 56189703
Glossoptosis 13.48 10.00 5 102295 65 56189702
Oscillopsia 13.26 10.00 6 102294 133 56189634
Clostridium difficile infection 13.25 10.00 18 102282 27180 56162587
Eyelid disorder 13.14 10.00 15 102285 1506 56188261
Suicidal behaviour 13.12 10.00 19 102281 2414 56187353
Oculogyric crisis 13.11 10.00 15 102285 1509 56188258
Abdominal pain 13.10 10.00 364 101936 258441 55931326
Poor sucking reflex 13.06 10.00 7 102293 226 56189541
Serum sickness-like reaction 13.01 10.00 9 102291 463 56189304
Respiratory tract infection 12.91 10.00 29 102271 36042 56153725
Dairy intolerance 12.90 10.00 5 102295 74 56189693
Dextrocardia 12.86 10.00 4 102296 29 56189738
Genital labial adhesions 12.86 10.00 4 102296 29 56189738
Cholecystitis chronic 12.85 10.00 43 102257 9705 56180062
Right aortic arch 12.76 10.00 7 102293 237 56189530
Aortic stenosis 12.74 10.00 26 102274 4354 56185413
Muscle tightness 12.72 10.00 46 102254 10790 56178977
Asplenia 12.65 10.00 3 102297 6 56189761
Congenital neurological disorder 12.65 10.00 3 102297 6 56189761
Decreased activity 12.63 10.00 30 102270 5566 56184201
Ear pain 12.62 10.00 23 102277 30867 56158900
Ill-defined disorder 12.57 10.00 73 102227 68470 56121297
Apallic syndrome 12.57 10.00 10 102290 638 56189129
Visual impairment 12.54 10.00 197 102103 74005 56115762
Delusion of grandeur 12.49 10.00 6 102294 153 56189614
Aeromonas infection 12.48 10.00 5 102295 81 56189686
Atrial fibrillation 12.47 10.00 132 102168 108765 56081002
Grip strength decreased 12.47 10.00 7 102293 16249 56173518
Laboratory test abnormal 12.38 10.00 16 102284 24679 56165088
Spina bifida occulta 12.34 10.00 3 102297 7 56189760
Coronary artery disease 12.32 10.00 97 102203 30699 56159068
Dermatitis allergic 12.28 10.00 5 102295 13973 56175794
Antiphospholipid antibodies 12.24 10.00 6 102294 160 56189607
Marital problem 12.18 10.00 6 102294 162 56189605
Sexual dysfunction 12.17 10.00 22 102278 3366 56186401
Intestinal infarction 12.16 10.00 12 102288 1019 56188748
Infusion site scar 12.16 10.00 8 102292 379 56189388
Accidental overdose 12.11 10.00 71 102229 20390 56169377
Anal atresia 12.08 10.00 8 102292 383 56189384
Drug-disease interaction 12.02 10.00 8 102292 386 56189381
Dissociative disorder 12 10.00 7 102293 267 56189500
Intra-abdominal haematoma 11.98 10.00 15 102285 1659 56188108
Inferior vena caval occlusion 11.79 10.00 3 102297 9 56189758
Paroxysmal arrhythmia 11.73 10.00 4 102296 40 56189727
Urinary tract infection 11.73 10.00 340 101960 240173 55949594
Pneumocystis jirovecii pneumonia 11.70 10.00 7 102293 15694 56174073
Hypoosmolar state 11.69 10.00 6 102294 177 56189590
Posture abnormal 11.62 10.00 17 102283 2181 56187586
Congenital coronary artery malformation 11.57 10.00 5 102295 99 56189668
Abdominal wall cyst 11.56 10.00 4 102296 42 56189725
Pharyngitis 11.55 10.00 10 102290 18528 56171239
Colitis microscopic 11.52 10.00 36 102264 7839 56181928
Osteoporosis 11.49 10.00 52 102248 52000 56137767
Hypercapnic coma 11.48 10.00 6 102294 184 56189583
Double outlet right ventricle 11.47 10.00 4 102296 43 56189724
Blood pressure systolic increased 11.47 10.00 37 102263 40799 56148968
Cystocele 11.39 10.00 12 102288 1101 56188666
Hyperventilation 11.39 10.00 29 102271 5619 56184148
Platelet count decreased 11.36 10.00 131 102169 106252 56083515
Diet refusal 11.30 10.00 9 102291 575 56189192
Device expulsion 11.29 10.00 24 102276 30425 56159342
Blood aldosterone abnormal 11.23 10.00 4 102296 46 56189721
Diverticulitis 11.13 10.00 31 102269 35821 56153946
Ankle fracture 11.09 10.00 59 102241 16344 56173423
Parkinsonian gait 11.02 10.00 8 102292 445 56189322
Drowning 10.97 10.00 8 102292 448 56189319
Blood cholinesterase decreased 10.96 10.00 5 102295 113 56189654
Persecutory delusion 10.96 10.00 18 102282 2552 56187215
Congenital pulmonary valve disorder 10.93 10.00 4 102296 50 56189717
Obstructive airways disorder 10.91 10.00 61 102239 17221 56172546
Thrombocytopenia 10.87 10.00 178 102122 136046 56053721
Congenital diaphragmatic hernia 10.81 10.00 6 102294 208 56189559
Palpitations 10.76 10.00 247 102053 99425 56090342
Eyelid haematoma 10.76 10.00 3 102297 14 56189753
Dizziness postural 10.73 10.00 31 102269 6467 56183300
Head titubation 10.73 10.00 10 102290 791 56188976
Reversible cerebral vasoconstriction syndrome 10.61 10.00 17 102283 2360 56187407
Congenital eye disorder 10.59 10.00 3 102297 15 56189752
Posturing 10.59 10.00 8 102292 473 56189294
Scratch 10.51 10.00 28 102272 5575 56184192
Mutism 10.51 10.00 13 102287 1420 56188347
Mouth ulceration 10.47 10.00 24 102276 29616 56160151
Hydrocephalus 10.46 10.00 26 102274 4963 56184804
Housebound 10.45 10.00 6 102294 222 56189545
Left ventricular dysfunction 10.44 10.00 44 102256 11079 56178688
Hyperthermia 10.44 10.00 36 102264 8249 56181518
Normetanephrine urine increased 10.43 10.00 3 102297 16 56189751
Electric shock sensation 10.35 10.00 8 102292 489 56189278
Laryngomalacia 10.33 10.00 4 102296 59 56189708
Anxiety disorder 10.32 10.00 22 102278 3798 56185969
Blood pressure diastolic decreased 10.23 10.00 12 102288 19311 56170456
Bundle branch block right 10.23 10.00 25 102275 4722 56185045
Palmar-plantar erythrodysaesthesia syndrome 10.20 10.00 14 102286 21051 56168716
Dyslipidaemia 10.19 10.00 30 102270 6323 56183444
Hypochloraemia 10.17 10.00 14 102286 1698 56188069
Prescription drug used without a prescription 10.01 10.00 15 102285 1965 56187802
Septic shock 10.01 10.00 67 102233 60768 56128999

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 1806.20 11.22 638 51827 7960 31636919
Atrial septal defect 808.02 11.22 335 52130 6592 31638287
Ventricular septal defect 554.33 11.22 214 52251 3463 31641416
Patent ductus arteriosus 485.49 11.22 187 52278 3006 31641873
Drug withdrawal syndrome 398.75 11.22 294 52171 18456 31626423
Foetal exposure during pregnancy 390.26 11.22 406 52059 40470 31604409
Cardiac murmur 351.06 11.22 187 52278 6575 31638304
Congenital anomaly 306.60 11.22 106 52359 1229 31643650
Suicidal ideation 298.95 11.22 334 52131 36072 31608807
Serotonin syndrome 265.87 11.22 232 52233 18541 31626338
Anxiety 264.97 11.22 511 51954 90522 31554357
Heart disease congenital 249.62 11.22 91 52374 1244 31643635
Multiple congenital abnormalities 248.55 11.22 73 52392 473 31644406
Suicide attempt 240.06 11.22 302 52163 36946 31607933
Pulmonary valve stenosis 231.10 11.22 63 52402 298 31644581
Depression 231.00 11.22 482 51983 90333 31554546
Talipes 220.98 11.22 91 52374 1755 31643124
Aggression 220.91 11.22 290 52175 37001 31607878
Irritability 206.96 11.22 221 52244 22668 31622211
Coarctation of the aorta 187.98 11.22 57 52408 418 31644461
Completed suicide 176.14 11.22 435 52030 91079 31553800
Persistent foetal circulation 169.75 11.22 49 52416 296 31644583
Bicuspid aortic valve 162.17 11.22 43 52422 179 31644700
Hypoplastic left heart syndrome 159.38 11.22 43 52422 194 31644685
Pulmonary artery stenosis congenital 157.31 11.22 50 52415 436 31644443
Fallot's tetralogy 149.12 11.22 39 52426 152 31644727
Transposition of the great vessels 126.76 11.22 42 52423 423 31644456
Agitation 126.58 11.22 278 52187 53891 31590988
Intentional self-injury 119.33 11.22 128 52337 13187 31631692
Congenital aortic stenosis 116.97 11.22 28 52437 68 31644811
Panic attack 112.13 11.22 102 52363 8601 31636278
Mania 111.34 11.22 104 52361 9073 31635806
Extrapyramidal disorder 106.91 11.22 114 52351 11664 31633215
Tremor 106.67 11.22 323 52142 76097 31568782
Off label use 106.32 11.22 264 52201 347010 31297869
Insomnia 105.52 11.22 371 52094 94465 31550414
Impulsive behaviour 102.57 11.22 55 52410 1958 31642921
Craniosynostosis 97.23 11.22 32 52433 315 31644564
Febrile neutropenia 97.22 11.22 40 52425 121809 31523070
Developmental delay 97.09 11.22 58 52407 2547 31642332
Disturbance in attention 96.60 11.22 150 52315 22300 31622579
Activation syndrome 95.85 11.22 24 52441 75 31644804
Drug abuse 93.92 11.22 339 52126 87419 31557460
Neuroleptic malignant syndrome 90.38 11.22 125 52340 16744 31628135
Sopor 89.64 11.22 103 52362 11449 31633430
Intentional overdose 85.11 11.22 202 52263 41187 31603692
Coma 84.80 11.22 201 52264 40949 31603930
Congenital cardiovascular anomaly 83.57 11.22 25 52440 174 31644705
Homicide 82.12 11.22 37 52428 895 31643984
Poisoning deliberate 81.06 11.22 79 52386 7265 31637614
Pneumonia 78.10 11.22 289 52176 335023 31309856
Somnolence 76.71 11.22 347 52118 99098 31545781
Anger 75.89 11.22 93 52372 11060 31633819
Withdrawal syndrome 75.40 11.22 95 52370 11622 31633257
Acute kidney injury 74.01 11.22 228 52237 279486 31365393
Death 71.37 11.22 331 52134 360238 31284641
Sleep disorder 69.34 11.22 142 52323 26206 31618673
Double outlet right ventricle 68.82 11.22 19 52446 95 31644784
Cleft lip and palate 65.60 11.22 26 52439 452 31644427
Congenital aortic atresia 65.51 11.22 14 52451 15 31644864
Pulmonary malformation 60.02 11.22 14 52451 29 31644850
Mood swings 58.95 11.22 67 52398 7357 31637522
Confusional state 58.88 11.22 400 52065 132934 31511945
Hypoplastic right heart syndrome 57.61 11.22 12 52453 10 31644869
Tricuspid valve incompetence 57.46 11.22 72 52393 8757 31636122
Sexual dysfunction 56.35 11.22 59 52406 5909 31638970
Cleft palate 55.55 11.22 25 52440 603 31644276
Inappropriate antidiuretic hormone secretion 54.54 11.22 80 52385 11307 31633572
Speech disorder developmental 54.14 11.22 37 52428 2054 31642825
Sepsis 54.10 11.22 106 52359 151823 31493056
Drug ineffective 53.88 11.22 409 52056 395164 31249715
Drug withdrawal syndrome neonatal 51.11 11.22 44 52421 3448 31641431
Hyperhidrosis 51.05 11.22 234 52231 67159 31577720
Nervousness 50.96 11.22 79 52386 11721 31633158
Dyspnoea 48.71 11.22 351 52114 343128 31301751
Cogwheel rigidity 48.59 11.22 29 52436 1271 31643608
Head titubation 48.27 11.22 19 52446 324 31644555
Anticholinergic syndrome 47.91 11.22 27 52438 1061 31643818
Pulmonary valve stenosis congenital 47.89 11.22 15 52450 124 31644755
Plagiocephaly 46.49 11.22 21 52444 511 31644368
Hamartoma 46.46 11.22 12 52453 44 31644835
Erectile dysfunction 46.33 11.22 100 52365 19135 31625744
Congenital aortic valve incompetence 46.00 11.22 15 52450 143 31644736
Overdose 45.41 11.22 267 52198 84397 31560482
Gun shot wound 45.09 11.22 26 52439 1068 31643811
Arnold-Chiari malformation 45.04 11.22 18 52447 320 31644559
Diarrhoea 44.40 11.22 372 52093 352037 31292842
Visceral congestion 43.31 11.22 20 52445 513 31644366
Maternal drugs affecting foetus 43.10 11.22 42 52423 3861 31641018
Depressed mood 43.06 11.22 92 52373 17483 31627396
Nightmare 42.61 11.22 74 52391 12063 31632816
Tremor neonatal 42.42 11.22 18 52447 375 31644504
Thrombocytopenia 42.33 11.22 110 52355 142637 31502242
Ventricular hypoplasia 41.78 11.22 12 52453 71 31644808
Attention deficit hyperactivity disorder 40.87 11.22 33 52432 2365 31642514
Anaemia 40.35 11.22 199 52266 213323 31431556
Right aortic arch 39.85 11.22 9 52456 15 31644864
Disease progression 39.74 11.22 55 52410 90409 31554470
Hangover 39.51 11.22 23 52442 962 31643917
Hyperreflexia 38.84 11.22 35 52430 2914 31641965
Congenital tricuspid valve atresia 38.13 11.22 12 52453 101 31644778
Pyrexia 38.11 11.22 321 52144 303519 31341360
Restlessness 37.61 11.22 104 52361 23257 31621622
Rash 37.37 11.22 189 52276 201297 31443582
Mydriasis 37.28 11.22 50 52415 6502 31638377
Mitral valve stenosis 37.16 11.22 15 52450 274 31644605
Right ventricular hypertrophy 36.53 11.22 24 52441 1247 31643632
Amnesia 36.51 11.22 103 52362 23299 31621580
Akathisia 36.25 11.22 52 52413 7201 31637678
Toxicity to various agents 36.23 11.22 459 52006 181028 31463851
Malignant neoplasm progression 35.73 11.22 47 52418 78951 31565928
Plasma cell myeloma 35.62 11.22 25 52440 56506 31588373
Ejaculation delayed 35.61 11.22 14 52451 238 31644641
Feeling of despair 35.17 11.22 21 52444 921 31643958
Neutropenia 34.51 11.22 118 52347 140246 31504633
Somnolence neonatal 34.48 11.22 8 52457 16 31644863
Abnormal behaviour 34.40 11.22 102 52363 23726 31621153
Abdominal pain 34.35 11.22 125 52340 145827 31499052
Memory impairment 33.92 11.22 139 52326 37991 31606888
Bipolar disorder 33.71 11.22 36 52429 3688 31641191
Atrial fibrillation 33.47 11.22 88 52377 113695 31531184
Parkinsonism 32.80 11.22 51 52414 7585 31637294
Congenital scoliosis 32.66 11.22 10 52455 76 31644803
Hyperthermia 32.54 11.22 59 52406 9945 31634934
Agoraphobia 32.49 11.22 13 52452 232 31644647
DiGeorge's syndrome 32.43 11.22 6 52459 0 31644879
Interruption of aortic arch 32.43 11.22 6 52459 0 31644879
Oral discharge 32.41 11.22 11 52454 120 31644759
Hypomania 32.38 11.22 28 52437 2207 31642672
Congenital aortic anomaly 32.33 11.22 10 52455 79 31644800
COVID-19 32.28 11.22 26 52439 54795 31590084
Choanal atresia 32.07 11.22 7 52458 9 31644870
Infection 31.95 11.22 54 52411 81877 31563002
Libido decreased 31.82 11.22 38 52427 4398 31640481
Anencephaly 31.77 11.22 11 52454 128 31644751
Hypospadias 31.57 11.22 32 52433 3084 31641795
Congenital pulmonary artery anomaly 30.87 11.22 7 52458 12 31644867
Homicidal ideation 30.72 11.22 29 52436 2562 31642317
Cough 30.71 11.22 117 52348 134697 31510182
Pancytopenia 30.12 11.22 62 52403 87254 31557625
Renal impairment 30.05 11.22 61 52404 86288 31558591
Vertigo 29.77 11.22 95 52370 22990 31621889
Product use issue 29.74 11.22 30 52435 56729 31588150
Paraesthesia 29.51 11.22 176 52289 55895 31588984
Dextrocardia 29.31 11.22 10 52455 111 31644768
Muscle rigidity 29.23 11.22 56 52409 9841 31635038
Congenital coronary artery malformation 28.98 11.22 8 52457 40 31644839
Verbal abuse 28.88 11.22 11 52454 171 31644708
Epistaxis 28.58 11.22 28 52437 53679 31591200
Drug dependence 28.28 11.22 92 52373 22487 31622392
General physical health deterioration 28.12 11.22 95 52370 113340 31531539
Disorientation 28.07 11.22 113 52352 30631 31614248
Thinking abnormal 27.92 11.22 40 52425 5533 31639346
Congenital genitourinary abnormality 27.62 11.22 8 52457 49 31644830
Cytomegalovirus infection 27.61 11.22 4 52461 24703 31620176
Physical assault 27.35 11.22 19 52446 1083 31643796
Emotional distress 27.28 11.22 68 52397 14288 31630591
Intentional product use issue 27.11 11.22 25 52440 49322 31595557
Congenital mitral valve stenosis 27.03 11.22 5 52460 0 31644879
Ebstein's anomaly 27.03 11.22 5 52460 0 31644879
Developmental hip dysplasia 26.83 11.22 12 52453 285 31644594
Hyper IgE syndrome 26.83 11.22 8 52457 55 31644824
Paranoia 26.72 11.22 56 52409 10499 31634380
Altered state of consciousness 26.57 11.22 86 52379 20965 31623914
Multiple cardiac defects 26.11 11.22 8 52457 61 31644818
Selective eating disorder 25.84 11.22 22 52443 1698 31643181
Drug abuser 25.82 11.22 32 52433 3848 31641031
Cleft lip 25.76 11.22 12 52453 314 31644565
Pulmonary artery stenosis 25.76 11.22 11 52454 233 31644646
Treatment failure 25.75 11.22 18 52447 40774 31604105
Ejaculation failure 25.74 11.22 16 52449 755 31644124
Tearfulness 25.63 11.22 23 52442 1904 31642975
Vascular stenosis 25.27 11.22 10 52455 173 31644706
C-reactive protein increased 25.16 11.22 26 52439 48624 31596255
Blepharospasm 25.05 11.22 18 52447 1083 31643796
Pulmonary valve incompetence 25.00 11.22 16 52449 795 31644084
Autism spectrum disorder 24.95 11.22 24 52441 2171 31642708
Product use in unapproved indication 24.61 11.22 83 52382 99088 31545791
Bronchopulmonary dysplasia 24.57 11.22 14 52451 562 31644317
Congenital hand malformation 24.26 11.22 14 52451 576 31644303
Myoclonus 24.24 11.22 64 52401 13926 31630953
Depressed level of consciousness 24.18 11.22 127 52338 38474 31606405
Joint swelling 23.94 11.22 32 52433 53399 31591480
Congenital pulmonary hypertension 23.88 11.22 7 52458 45 31644834
Emotional disorder 23.87 11.22 36 52429 5213 31639666
Septic shock 23.65 11.22 46 52419 66112 31578767
Neural tube defect 23.62 11.22 7 52458 47 31644832
Congenital tracheomalacia 23.10 11.22 5 52460 6 31644873
Platelet count decreased 22.54 11.22 100 52365 110335 31534544
Hepatic enzyme increased 22.46 11.22 16 52449 35892 31608987
Truncus arteriosus persistent 22.43 11.22 6 52459 26 31644853
Aortic valve incompetence 22.41 11.22 36 52429 5505 31639374
Gastroschisis 22.17 11.22 8 52457 106 31644773
Rheumatoid arthritis 22.07 11.22 28 52437 47781 31597098
Logorrhoea 22.02 11.22 23 52442 2296 31642583
Neonatal asphyxia 22.02 11.22 11 52454 337 31644542
Cardiomegaly 22.02 11.22 63 52402 14362 31630517
Mood altered 21.97 11.22 45 52420 8301 31636578
Prostate cancer 21.93 11.22 18 52447 37583 31607296
Spina bifida 21.84 11.22 11 52454 343 31644536
Haemoglobin decreased 21.82 11.22 104 52361 112571 31532308
Congenital hydronephrosis 21.70 11.22 14 52451 705 31644174
Noonan syndrome 21.62 11.22 4 52461 0 31644879
Mitral valve atresia 21.62 11.22 4 52461 0 31644879
Idiosyncratic alcohol intoxication 21.62 11.22 4 52461 0 31644879
Abdominal transposition 21.62 11.22 4 52461 0 31644879
Porencephaly 21.62 11.22 4 52461 0 31644879
Reversible cerebral vasoconstriction syndrome 21.61 11.22 11 52454 351 31644528
Congenital diaphragmatic hernia 21.49 11.22 10 52455 261 31644618
Psychotic disorder 21.20 11.22 83 52382 22210 31622669
Erythema 20.84 11.22 66 52399 80339 31564540
Agitation neonatal 20.82 11.22 16 52449 1067 31643812
Sleep apnoea syndrome 20.77 11.22 73 52392 18552 31626327
Chemical submission 20.68 11.22 6 52459 37 31644842
Hallucination, auditory 20.67 11.22 50 52415 10310 31634569
Infantile apnoea 20.63 11.22 15 52450 919 31643960
Affect lability 20.57 11.22 27 52438 3438 31641441
Self esteem decreased 20.55 11.22 12 52453 505 31644374
Blood creatine phosphokinase increased 20.34 11.22 129 52336 41845 31603034
Premature baby 20.32 11.22 71 52394 17995 31626884
Peripheral swelling 20.31 11.22 52 52413 67813 31577066
Flat affect 20.29 11.22 14 52451 789 31644090
Pneumocystis jirovecii pneumonia 20.29 11.22 3 52462 18248 31626631
Wolff-Parkinson-White syndrome 20.23 11.22 9 52456 211 31644668
Ventricular hypertrophy 20.20 11.22 30 52435 4286 31640593
Resting tremor 20.18 11.22 13 52452 653 31644226
Dystonia 20.03 11.22 49 52416 10176 31634703
Ascites 20.01 11.22 23 52442 40990 31603889
Somatic dysfunction 19.88 11.22 5 52460 16 31644863
Obsessive-compulsive disorder 19.86 11.22 32 52433 4905 31639974
Respiratory acidosis 19.83 11.22 31 52434 4631 31640248
Bradykinesia 19.81 11.22 27 52438 3565 31641314
Congenital hydrocephalus 19.73 11.22 7 52458 88 31644791
Seizure 19.72 11.22 252 52213 99516 31545363
Decreased interest 19.56 11.22 21 52444 2164 31642715
Congenital flat feet 19.39 11.22 4 52461 3 31644876
Cardiac failure 19.29 11.22 75 52390 85878 31559001
Tension 19.28 11.22 20 52445 1981 31642898
Delirium 19.27 11.22 126 52339 41295 31603584
Derealisation 19.18 11.22 12 52453 573 31644306
Cerebrovascular stenosis 18.98 11.22 7 52458 99 31644780
Clumsiness 18.97 11.22 18 52447 1601 31643278
Infantile back arching 18.86 11.22 4 52461 4 31644875
Right ventricle outflow tract obstruction 18.86 11.22 4 52461 4 31644875
Asphyxia 18.81 11.22 34 52431 5717 31639162
Transient tachypnoea of the newborn 18.71 11.22 8 52457 170 31644709
Scaphocephaly 18.63 11.22 5 52460 22 31644857
Sedation complication 18.59 11.22 17 52448 1442 31643437
Euphoric mood 18.59 11.22 31 52434 4889 31639990
Tonic convulsion 18.52 11.22 15 52450 1080 31643799
Psychiatric symptom 18.43 11.22 25 52440 3286 31641593
Hospitalisation 18.35 11.22 34 52431 49773 31595106
Dysmorphism 18.33 11.22 24 52441 3048 31641831
Mucosal inflammation 18.26 11.22 18 52447 34409 31610470
Crying 18.19 11.22 33 52432 5564 31639315
Oedema peripheral 18.14 11.22 107 52358 109732 31535147
Obsessive thoughts 18.14 11.22 12 52453 631 31644248
Dissociation 18.13 11.22 16 52449 1296 31643583
Caesarean section 18.03 11.22 19 52446 1917 31642962
Personality disorder 18.02 11.22 15 52450 1122 31643757
Intention tremor 17.98 11.22 10 52455 383 31644496
Aortic stenosis 17.70 11.22 27 52438 3949 31640930
Neutrophil count decreased 17.69 11.22 31 52434 46363 31598516
Ejaculation disorder 17.67 11.22 14 52451 976 31643903
Dyskinesia 17.63 11.22 75 52390 20835 31624044
Abulia 17.54 11.22 11 52454 527 31644352
Infusion related reaction 17.53 11.22 33 52432 48022 31596857
Renal failure 17.40 11.22 126 52339 123204 31521675
Gastrointestinal haemorrhage 17.29 11.22 74 52391 82475 31562404
Ammonia abnormal 17.24 11.22 6 52459 71 31644808
Renal dysplasia 17.19 11.22 8 52457 209 31644670
Tricuspid valve disease 17.19 11.22 8 52457 209 31644670
Abnormal dreams 17.17 11.22 37 52428 7071 31637808
Chordee 17.16 11.22 6 52459 72 31644807
Maternal exposure during pregnancy 17.14 11.22 29 52436 4627 31640252
Panic disorder 17.08 11.22 15 52450 1207 31643672
Alcohol interaction 16.97 11.22 22 52443 2767 31642112
Speech disorder 16.82 11.22 82 52383 24119 31620760
Hypotension 16.82 11.22 238 52227 204380 31440499
Leukopenia 16.78 11.22 45 52420 57783 31587096
White blood cell count decreased 16.72 11.22 81 52384 87317 31557562
Hyperkinesia 16.62 11.22 17 52448 1656 31643223
Pleurothotonus 16.57 11.22 14 52451 1069 31643810
Judgement impaired 16.56 11.22 11 52454 582 31644297
Contraindicated product administered 16.56 11.22 6 52459 19766 31625113
Pulmonary hypoplasia 16.55 11.22 10 52455 448 31644431
Type 2 diabetes mellitus 16.53 11.22 58 52407 14726 31630153
Opisthotonus 16.47 11.22 10 52455 452 31644427
Hypersensitivity 16.46 11.22 43 52422 55700 31589179
Hypertonia 16.35 11.22 26 52439 3942 31640937
Major depression 16.34 11.22 27 52438 4226 31640653
Loss of libido 16.34 11.22 20 52445 2375 31642504
Cyclothymic disorder 16.32 11.22 6 52459 84 31644795
Neurosis 16.32 11.22 7 52458 150 31644729
Vesicoureteric reflux 16.32 11.22 7 52458 150 31644729
Multiple organ dysfunction syndrome 16.29 11.22 58 52407 68145 31576734
Jaundice neonatal 16.28 11.22 15 52450 1285 31643594
Congenital pulmonary valve disorder 16.22 11.22 3 52462 0 31644879
Congenital Eustachian tube anomaly 16.22 11.22 3 52462 0 31644879
Congenital renal disorder 16.07 11.22 6 52459 88 31644791
Delusion 16.04 11.22 50 52415 11947 31632932
Inadequate analgesia 16.01 11.22 21 52444 2672 31642207
Device breakage 15.91 11.22 18 52447 1966 31642913
Subgaleal haematoma 15.89 11.22 5 52460 42 31644837
Cryptorchism 15.89 11.22 18 52447 1969 31642910
Lower respiratory tract infection 15.87 11.22 14 52451 28223 31616656
Neuropathy peripheral 15.73 11.22 68 52397 75581 31569298
Neoplasm progression 15.59 11.22 7 52458 20265 31624614
Arthralgia 15.50 11.22 168 52297 151256 31493623
Psoriasis 15.41 11.22 34 52431 46685 31598194
Legal problem 15.40 11.22 7 52458 173 31644706
Cerebral palsy 15.37 11.22 6 52459 100 31644779
Exomphalos 15.29 11.22 7 52458 176 31644703
Infertility male 15.18 11.22 7 52458 179 31644700
Chronic kidney disease 14.82 11.22 25 52440 37950 31606929
Ankyloglossia congenital 14.81 11.22 8 52457 289 31644590
Congenital mitral valve incompetence 14.80 11.22 6 52459 111 31644768
Mitral valve incompetence 14.79 11.22 54 52411 13979 31630900
Thrombosis 14.78 11.22 33 52432 45118 31599761
Haemoptysis 14.70 11.22 19 52446 32170 31612709
Impulse-control disorder 14.59 11.22 14 52451 1262 31643617
Feeling jittery 14.54 11.22 24 52441 3753 31641126
Phimosis 14.53 11.22 11 52454 717 31644162
Vasoplegia syndrome 14.52 11.22 16 52449 1697 31643182
Colitis 14.47 11.22 21 52444 33866 31611013
Feeling abnormal 14.39 11.22 151 52314 56851 31588028
Hallucination, visual 14.37 11.22 58 52407 15736 31629143
Brachycephaly 14.30 11.22 5 52460 60 31644819
Abdominal distension 14.28 11.22 40 52425 50644 31594235
Mitral valve prolapse 14.27 11.22 10 52455 578 31644301
Feeling guilty 14.23 11.22 8 52457 313 31644566
Oculoauriculovertebral dysplasia 14.14 11.22 3 52462 3 31644876
Cytokine release syndrome 14.02 11.22 5 52460 16637 31628242
Pyloric stenosis 14.01 11.22 11 52454 757 31644122
Drug intolerance 13.98 11.22 42 52423 51991 31592888
Anaphylactic reaction 13.96 11.22 17 52448 29536 31615343
Incoherent 13.76 11.22 25 52440 4219 31640660
Product complaint 13.62 11.22 29 52436 5495 31639384
Poisoning 13.61 11.22 43 52422 10348 31634531
Sexually transmitted disease 13.61 11.22 4 52461 26 31644853
Pruritus 13.56 11.22 137 52328 125030 31519849
Tardive dyskinesia 13.50 11.22 29 52436 5530 31639349
Cytogenetic abnormality 13.33 11.22 11 52454 813 31644066
Congenital tricuspid valve incompetence 13.32 11.22 6 52459 145 31644734
Plasmodium vivax infection 13.28 11.22 3 52462 5 31644874
Apnoea 13.27 11.22 31 52434 6251 31638628
Anomalous pulmonary venous connection 13.23 11.22 5 52460 76 31644803
Asplenia 13.05 11.22 5 52460 79 31644800
Pulmonary aplasia 12.93 11.22 3 52462 6 31644873
Drug screen positive 12.89 11.22 23 52442 3829 31641050
Basal cell carcinoma 12.89 11.22 7 52458 18172 31626707
Administration related reaction 12.88 11.22 5 52460 82 31644797
Mitral valve disease 12.85 11.22 13 52452 1250 31643629
Personality change 12.79 11.22 26 52439 4769 31640110
Therapeutic response decreased 12.79 11.22 15 52450 26494 31618385
Jealous delusion 12.76 11.22 7 52458 261 31644618
Hallucination 12.70 11.22 125 52340 46285 31598594
Periventricular leukomalacia 12.67 11.22 4 52461 34 31644845
Hepatotoxicity 12.66 11.22 8 52457 19118 31625761
Hydrocele 12.63 11.22 16 52449 1967 31642912
Urinary tract infection 12.62 11.22 75 52390 76794 31568085
Otitis media chronic 12.61 11.22 5 52460 87 31644792
Hyperventilation 12.60 11.22 18 52447 2483 31642396
Rebound effect 12.53 11.22 18 52447 2495 31642384
Aorta hypoplasia 12.51 11.22 5 52460 89 31644790
Eating disorder 12.48 11.22 34 52431 7535 31637344
Palmar-plantar erythrodysaesthesia syndrome 12.46 11.22 5 52460 15478 31629401
Limb asymmetry 12.40 11.22 5 52460 91 31644788
Failure to thrive 12.37 11.22 35 52430 7927 31636952
Weight gain poor 12.37 11.22 11 52454 900 31643979
Hyponatraemia 12.36 11.22 181 52284 73618 31571261
Eyelid ptosis congenital 12.35 11.22 5 52460 92 31644787
Renal salt-wasting syndrome 12.35 11.22 7 52458 278 31644601
Thought insertion 12.33 11.22 3 52462 8 31644871
Bone marrow failure 12.31 11.22 17 52448 27991 31616888
Hypocalcaemia 12.23 11.22 11 52454 21967 31622912
Hepatocellular injury 12.22 11.22 69 52396 21475 31623404
Genital paraesthesia 12.19 11.22 4 52461 39 31644840
Acute myeloid leukaemia 12.10 11.22 8 52457 18664 31626215
Depersonalisation/derealisation disorder 12.02 11.22 9 52456 577 31644302
Device related infection 11.96 11.22 6 52459 16293 31628586
Tinnitus 11.93 11.22 56 52409 16219 31628660
Colitis ulcerative 11.92 11.22 8 52457 18521 31626358
Hypertonia neonatal 11.92 11.22 8 52457 431 31644448
Loss of consciousness 11.90 11.22 187 52278 77168 31567711
Patient uncooperative 11.90 11.22 8 52457 432 31644447
Ventricular tachycardia 11.88 11.22 13 52452 23688 31621191
Duodenal atresia 11.83 11.22 3 52462 10 31644869
Persistent depressive disorder 11.79 11.22 7 52458 304 31644575
Feeling of relaxation 11.76 11.22 4 52461 44 31644835
Exhibitionism 11.76 11.22 4 52461 44 31644835
Neutropenic sepsis 11.73 11.22 3 52462 12376 31632503
Epilepsy 11.68 11.22 67 52398 20974 31623905
Swelling 11.66 11.22 28 52437 37330 31607549
Suspiciousness 11.66 11.22 7 52458 310 31644569
Herpes zoster 11.64 11.22 22 52443 31971 31612908
Divorced 11.61 11.22 3 52462 11 31644868
Blood creatinine increased 11.61 11.22 93 52372 88985 31555894
Product administration error 11.57 11.22 53 52412 15194 31629685
Microcephaly 11.54 11.22 10 52455 790 31644089
Neonatal disorder 11.48 11.22 10 52455 796 31644083
Pain in extremity 11.45 11.22 130 52335 116073 31528806
Dehydration 11.45 11.22 134 52331 118977 31525902
Decerebrate posture 11.44 11.22 4 52461 48 31644831
Inflammation 11.42 11.22 15 52450 25226 31619653
Haematochezia 11.35 11.22 32 52433 40432 31604447
Bundle branch block 11.33 11.22 10 52455 810 31644069

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 837.14 10.05 635 117149 41479 70769181
Drug withdrawal syndrome 755.47 10.05 540 117244 32175 70778485
Suicidal ideation 594.59 10.05 653 117131 68943 70741717
Anxiety 524.02 10.05 1140 116644 219190 70591470
Suicide attempt 509.66 10.05 644 117140 78866 70731794
Drug abuse 500.89 10.05 886 116898 146370 70664290
Sopor 465.04 10.05 398 117386 30869 70779791
Depression 449.79 10.05 1009 116775 197965 70612695
Agitation 333.07 10.05 574 117210 92801 70717859
Tremor 323.65 10.05 764 117020 154860 70655800
Intentional self-injury 294.76 10.05 311 117473 31339 70779321
Completed suicide 287.77 10.05 930 116854 226205 70584455
Somnolence 268.77 10.05 878 116906 214728 70595932
Irritability 256.56 10.05 317 117467 37908 70772752
Mydriasis 247.05 10.05 209 117575 15944 70794716
Mania 231.96 10.05 207 117577 16967 70793693
Aggression 230.78 10.05 340 117444 48106 70762554
Rheumatoid arthritis 209.11 10.05 112 117672 291693 70518967
Neuroleptic malignant syndrome 208.14 10.05 236 117548 25771 70784889
Nightmare 201.48 10.05 215 117569 21941 70788719
Drug interaction 199.60 10.05 1197 116587 380244 70430416
Panic attack 196.49 10.05 212 117572 21907 70788753
Confusional state 195.00 10.05 961 116823 283437 70527223
Disturbance in attention 192.82 10.05 293 117491 42601 70768059
Off label use 192.32 10.05 615 117169 742445 70068215
Poisoning deliberate 179.41 10.05 179 117605 16881 70793779
Depersonalisation/derealisation disorder 165.33 10.05 73 117711 1675 70808985
Contraindicated product administered 162.92 10.05 17 117767 134595 70676065
Activation syndrome 161.55 10.05 45 117739 233 70810427
Derealisation 157.82 10.05 68 117716 1468 70809192
Disorientation 157.45 10.05 317 117467 57606 70753054
Hyponatraemia 156.37 10.05 602 117182 159485 70651175
Inappropriate antidiuretic hormone secretion 151.31 10.05 190 117594 23086 70787574
Mood swings 146.42 10.05 166 117618 18120 70792540
Toxicity to various agents 146.16 10.05 1110 116674 381062 70429598
Insomnia 144.92 10.05 730 117054 217076 70593584
Febrile neutropenia 143.99 10.05 80 117704 204238 70606422
Hyperhidrosis 142.84 10.05 512 117272 131074 70679586
Extrapyramidal disorder 142.30 10.05 174 117610 20576 70790084
Withdrawal syndrome 141.16 10.05 190 117594 24714 70785946
Dissociation 140.95 10.05 81 117703 3295 70807365
Feeling of despair 139.25 10.05 74 117710 2577 70808083
Bradyphrenia 138.52 10.05 122 117662 9824 70800836
Joint swelling 138.24 10.05 130 117654 253081 70557579
Anger 136.98 10.05 151 117633 15981 70794679
Overdose 132.56 10.05 596 117188 169149 70641511
Intentional overdose 130.75 10.05 410 117374 98025 70712635
Restlessness 128.42 10.05 242 117542 41886 70768774
Synovitis 125.71 10.05 30 117754 129198 70681462
Drug intolerance 124.20 10.05 115 117669 225572 70585088
Impulsive behaviour 122.85 10.05 69 117715 2685 70807975
Dyskinesia 116.67 10.05 229 117555 40845 70769815
Alopecia 116.66 10.05 95 117689 198395 70612265
Drug ineffective 115.97 10.05 1002 116782 938750 69871910
Cogwheel rigidity 115.41 10.05 68 117716 2900 70807760
Homicide 114.35 10.05 50 117734 1120 70809540
Coma 112.41 10.05 372 117412 91472 70719188
Infusion related reaction 105.93 10.05 103 117681 197431 70613229
Rash 101.76 10.05 469 117315 510093 70300567
Gastric pH decreased 101.55 10.05 41 117743 747 70809913
Systemic lupus erythematosus 100.41 10.05 23 117761 101879 70708781
Treatment failure 99.29 10.05 58 117726 144084 70666576
Hallucinations, mixed 98.68 10.05 83 117701 6279 70804381
Glossodynia 94.80 10.05 15 117769 86472 70724188
Emotional disorder 94.10 10.05 113 117671 13113 70797547
Pericarditis 92.15 10.05 15 117769 84690 70725970
Delirium 91.99 10.05 303 117481 74311 70736349
Memory impairment 90.89 10.05 349 117435 92292 70718368
Myoglobin urine present 90.55 10.05 37 117747 696 70809964
Hyperreflexia 89.37 10.05 84 117700 7358 70803302
Akathisia 87.41 10.05 105 117679 12188 70798472
Hallucination, auditory 86.34 10.05 128 117656 18200 70792460
Agoraphobia 86.29 10.05 33 117751 517 70810143
Pneumonia 85.76 10.05 609 117175 595623 70215037
Muscle rigidity 84.64 10.05 128 117656 18522 70792138
Flat affect 82.59 10.05 47 117737 1876 70808784
Swelling 81.09 10.05 117 117667 188422 70622238
Myoclonus 81.06 10.05 152 117632 26203 70784457
Nervousness 80.62 10.05 167 117617 30953 70779707
Drug dependence 80.46 10.05 186 117598 37135 70773525
Sepsis 78.24 10.05 182 117602 244363 70566297
Altered state of consciousness 78.22 10.05 192 117592 39830 70770830
Vertigo 77.76 10.05 255 117529 62388 70748272
Cough 77.21 10.05 279 117505 325098 70485562
Product use issue 75.10 10.05 114 117670 179823 70630837
Peripheral swelling 73.34 10.05 179 117605 236384 70574276
Helicobacter infection 72.87 10.05 5 117779 55651 70755009
Bronchial neoplasm 72.68 10.05 28 117756 448 70810212
Homicidal ideation 72.43 10.05 53 117731 3270 70807390
Paraesthesia 69.74 10.05 447 117337 145090 70665570
Hypersensitivity 69.59 10.05 176 117608 229636 70581024
Malignant neoplasm progression 69.36 10.05 60 117724 121679 70688981
Parkinsonism 69.29 10.05 105 117679 15220 70795440
Libido increased 67.93 10.05 41 117743 1828 70808832
Depressed level of consciousness 66.69 10.05 305 117479 87126 70723534
Abnormal behaviour 66.23 10.05 165 117619 34544 70776116
Crying 66.12 10.05 123 117661 21076 70789584
Feeling jittery 65.31 10.05 88 117696 11455 70799205
Hepatic enzyme increased 64.03 10.05 101 117683 156889 70653771
Nasal turbinate hypertrophy 62.61 10.05 27 117757 584 70810076
Depressed mood 62.32 10.05 187 117597 43633 70767027
Dystonia 62.29 10.05 115 117669 19591 70791069
Intentional product use issue 61.69 10.05 65 117719 120077 70690583
Therapeutic product effect decreased 61.24 10.05 89 117695 142929 70667731
Tearfulness 60.93 10.05 57 117727 4963 70805697
Speech disorder 60.20 10.05 203 117581 50377 70760283
Blister 59.17 10.05 48 117736 100478 70710182
Clonus 59.06 10.05 62 117722 6206 70804454
Hypomania 58.89 10.05 61 117723 6011 70804649
Libido decreased 58.09 10.05 55 117729 4861 70805799
Endometrial ablation 57.38 10.05 28 117756 812 70809848
Arthropathy 57.07 10.05 101 117683 149956 70660704
Affective disorder 56.68 10.05 66 117718 7413 70803247
H1N1 influenza 56.39 10.05 40 117744 2350 70808310
Stomatitis 54.99 10.05 80 117704 128431 70682229
Paranoia 54.78 10.05 101 117683 17187 70793473
Psychotic disorder 54.67 10.05 162 117622 37539 70773121
Menstrual disorder 54.01 10.05 46 117738 3540 70807120
Sleep disorder 53.47 10.05 244 117540 69628 70741032
Pain 52.60 10.05 732 117052 628084 70182576
Disease progression 52.20 10.05 114 117670 156558 70654102
Delusion 52.19 10.05 105 117679 19060 70791600
Muscle twitching 52.06 10.05 107 117677 19720 70790940
Feeling of body temperature change 51.90 10.05 52 117732 4927 70805733
Nasopharyngitis 51.70 10.05 192 117592 222014 70588646
General physical health deterioration 51.68 10.05 209 117575 235822 70574838
Lower respiratory tract infection 51.58 10.05 66 117718 111847 70698813
Loss of consciousness 51.55 10.05 438 117346 155278 70655382
Amnesia 50.74 10.05 196 117588 51959 70758701
Neutropenia 50.64 10.05 237 117547 256919 70553741
COVID-19 50.17 10.05 61 117723 105696 70704964
Wound 50.03 10.05 54 117730 98678 70711982
Abdominal discomfort 49.60 10.05 186 117598 214472 70596188
Fall 48.96 10.05 1021 116763 443075 70367585
Hallucination 48.80 10.05 253 117531 76007 70734653
Parosmia 48.66 10.05 50 117734 4881 70805779
Dyspnoea 48.41 10.05 945 116839 769115 70041545
Tinnitus 48.29 10.05 151 117633 36025 70774635
Emotional distress 47.60 10.05 153 117631 37035 70773625
Restless legs syndrome 46.69 10.05 98 117686 18330 70792330
Blood creatine phosphokinase increased 46.18 10.05 213 117571 61050 70749610
Self esteem decreased 46.08 10.05 25 117759 908 70809752
Sexual dysfunction 45.76 10.05 56 117728 6625 70804035
Cytomegalovirus infection 45.65 10.05 6 117778 39752 70770908
Personality disorder 45.49 10.05 51 117733 5497 70805163
Infection 44.67 10.05 189 117595 210596 70600064
Drooling 44.62 10.05 50 117734 5386 70805274
Muscle disorder 44.51 10.05 49 117735 5176 70805484
Therapeutic product ineffective 44.43 10.05 30 117754 1627 70809033
Bronchial haemorrhage 44.01 10.05 27 117757 1240 70809420
Rheumatoid factor positive 43.71 10.05 13 117771 48387 70762273
Blepharospasm 43.51 10.05 42 117742 3803 70806857
Pancytopenia 43.22 10.05 119 117665 150988 70659672
Hepatocellular injury 43.04 10.05 171 117613 45920 70764740
Euphoric mood 42.81 10.05 55 117729 6834 70803826
Galactorrhoea 42.24 10.05 39 117745 3339 70807321
Hyperprolactinaemia 42.20 10.05 44 117740 4369 70806291
Neutrophil count decreased 42.00 10.05 46 117738 83510 70727150
Death 41.80 10.05 596 117188 509465 70301195
Cardio-respiratory arrest 41.50 10.05 298 117486 100379 70710281
Abnormal dreams 41.50 10.05 68 117716 10535 70800125
Gun shot wound 41.35 10.05 25 117759 1118 70809542
Folliculitis 41.15 10.05 10 117774 42560 70768100
Logorrhoea 41.11 10.05 42 117742 4072 70806588
Hyperacusis 40.91 10.05 31 117753 2017 70808643
Tachycardia 40.48 10.05 422 117362 158124 70652536
Hostility 40.40 10.05 32 117752 2223 70808437
Hangover 40.26 10.05 30 117754 1903 70808757
Seizure 40.07 10.05 462 117322 177500 70633160
Bipolar disorder 40.02 10.05 56 117728 7552 70803108
Hallucination, visual 39.66 10.05 123 117661 29214 70781446
Apraxia 39.56 10.05 34 117750 2649 70808011
Dizziness 39.10 10.05 1028 116756 463113 70347547
Erectile dysfunction 38.97 10.05 76 117708 13486 70797174
Fear 38.72 10.05 98 117686 20713 70789947
Pyrexia 38.64 10.05 743 117041 606209 70204451
Discomfort 38.27 10.05 73 117711 105363 70705297
Hyperthermia 38.05 10.05 85 117699 16586 70794074
Psoriatic arthropathy 38.02 10.05 31 117753 64740 70745920
Bradykinesia 37.66 10.05 54 117730 7448 70803212
Anaemia 37.56 10.05 459 117325 402964 70407696
Muscle injury 37.29 10.05 9 117775 38485 70772175
Plasma cell myeloma 37.13 10.05 40 117744 73161 70737499
Renal ischaemia 37.03 10.05 23 117761 1080 70809580
Thrombocytopenia 36.85 10.05 239 117545 238871 70571789
Mobility decreased 36.79 10.05 72 117712 102927 70707733
Drug abuser 36.73 10.05 47 117737 5817 70804843
PCO2 increased 36.61 10.05 27 117757 1686 70808974
Arthralgia 36.54 10.05 602 117182 502788 70307872
Neuropathy peripheral 36.24 10.05 100 117684 126796 70683864
Incontinence 36.22 10.05 72 117712 12956 70797704
Myelosuppression 35.96 10.05 4 117780 30141 70780519
Substance abuse 35.71 10.05 61 117723 9776 70800884
Panic disorder 35.68 10.05 33 117751 2831 70807829
Major depression 34.93 10.05 56 117728 8518 70802142
Verbal abuse 34.93 10.05 14 117770 250 70810410
Asphyxia 34.77 10.05 62 117722 10280 70800380
Septic shock 34.71 10.05 85 117699 112173 70698487
Visceral congestion 34.57 10.05 20 117764 824 70809836
Psychomotor hyperactivity 34.46 10.05 78 117706 15355 70795305
Physical assault 34.21 10.05 25 117759 1539 70809121
Rhonchi 34.16 10.05 36 117748 3619 70807041
Atrial fibrillation 33.90 10.05 174 117610 184174 70626486
Loss of libido 33.52 10.05 30 117754 2467 70808193
Acute kidney injury 33.00 10.05 572 117212 474052 70336608
Thinking abnormal 32.78 10.05 66 117718 11985 70798675
Social anxiety disorder 32.32 10.05 16 117768 479 70810181
Product complaint 32.10 10.05 66 117718 12165 70798495
Antidepressant discontinuation syndrome 32.04 10.05 7 117777 9 70810651
Breath sounds abnormal 31.94 10.05 69 117715 13162 70797498
Hypoaesthesia oral 31.84 10.05 66 117718 12234 70798426
Electrocardiogram QT prolonged 31.46 10.05 242 117542 83275 70727385
Joint hyperextension 31.08 10.05 13 117771 260 70810400
Bronchial disorder 31.04 10.05 28 117756 2326 70808334
Apathy 30.95 10.05 64 117720 11844 70798816
Premature labour 30.90 10.05 51 117733 7949 70802711
Obsessive-compulsive disorder 30.47 10.05 41 117743 5329 70805331
Chorea 29.96 10.05 26 117758 2052 70808608
Ejaculation delayed 29.96 10.05 11 117773 153 70810507
Anorgasmia 29.94 10.05 20 117764 1065 70809595
Soft tissue injury 29.92 10.05 24 117760 1698 70808962
Dependence 29.63 10.05 27 117757 2273 70808387
Urinary retention 29.38 10.05 168 117616 52352 70758308
Abdominal pain 29.33 10.05 396 117388 341731 70468929
Mucosal inflammation 29.25 10.05 42 117742 67808 70742852
Sensory loss 29.24 10.05 61 117723 11358 70799302
Mood altered 29.02 10.05 76 117708 16399 70794261
Poisoning 28.88 10.05 93 117691 22529 70788131
Depressive symptom 28.55 10.05 39 117745 5142 70805518
Dysarthria 28.36 10.05 189 117595 62124 70748536
Oral discharge 28.33 10.05 12 117772 248 70810412
Anaphylactic reaction 28.01 10.05 51 117733 74923 70735737
Gastrointestinal disorder 27.97 10.05 86 117698 105341 70705319
Neutropenic sepsis 27.91 10.05 4 117780 24826 70785834
Ejaculation failure 27.56 10.05 13 117771 349 70810311
Hypertonia 27.24 10.05 43 117741 6455 70804205
Anticholinergic syndrome 27.23 10.05 29 117755 2951 70807709
Ascites 27.01 10.05 44 117740 67503 70743157
Coma scale 26.93 10.05 8 117776 54 70810606
Sensory disturbance 26.64 10.05 66 117718 13766 70796894
Cerebral microhaemorrhage 26.63 10.05 11 117773 213 70810447
Head titubation 26.54 10.05 17 117767 843 70809817
Balance disorder 26.45 10.05 247 117537 89881 70720779
Respiratory acidosis 26.42 10.05 55 117729 10226 70800434
Tension 26.39 10.05 33 117751 3991 70806669
Vision blurred 26.24 10.05 257 117527 94727 70715933
PO2 increased 26.18 10.05 21 117763 1486 70809174
Platelet count decreased 26.01 10.05 181 117603 178041 70632619
Hepatotoxicity 25.88 10.05 21 117763 43965 70766695
Obsessive thoughts 25.87 10.05 18 117766 1025 70809635
Sinus tachycardia 25.62 10.05 118 117666 33795 70776865
Weight increased 25.62 10.05 554 117230 241777 70568883
Pneumocystis jirovecii pneumonia 25.54 10.05 9 117775 30073 70780587
Cognitive disorder 25.44 10.05 181 117603 60775 70749885
White blood cell count decreased 25.22 10.05 172 117612 169969 70640691
Injection site pain 25.18 10.05 105 117679 117514 70693146
Chemical submission 25.17 10.05 11 117773 246 70810414
Electroencephalogram abnormal 25.16 10.05 37 117747 5221 70805439
Injection site erythema 25.16 10.05 52 117732 72872 70737788
Post-traumatic neck syndrome 25.10 10.05 23 117761 1950 70808710
Paralysis 24.74 10.05 59 117725 12013 70798647
Creutzfeldt-Jakob disease 24.63 10.05 10 117774 185 70810475
Rhabdomyolysis 24.48 10.05 255 117529 95505 70715155
Hip arthroplasty 24.48 10.05 8 117776 28032 70782628
Eye movement disorder 24.25 10.05 44 117740 7396 70803264
Pain in extremity 24.21 10.05 391 117393 327691 70482969
Treatment noncompliance 24.13 10.05 146 117638 46428 70764232
Cytokine release syndrome 24.10 10.05 7 117777 26460 70784200
Social avoidant behaviour 24.09 10.05 34 117750 4622 70806038
Feeling abnormal 23.83 10.05 350 117434 141969 70668691
Congenital hydrocephalus 23.59 10.05 7 117777 47 70810613
Hypokinesia 23.48 10.05 73 117711 17359 70793301
Cardiac failure 23.37 10.05 141 117643 143400 70667260
Pneumonitis 23.33 10.05 34 117750 54563 70756097
Metastases to liver 23.28 10.05 7 117777 25871 70784789
Impaired healing 23.23 10.05 56 117728 74318 70736342
Rhinitis 23.20 10.05 56 117728 11491 70799169
Accidental poisoning 22.92 10.05 20 117764 1590 70809070
Psoriasis 22.90 10.05 85 117699 98348 70712312
Product use in unapproved indication 22.88 10.05 227 117557 207251 70603409
Diarrhoea 22.84 10.05 1066 116718 782275 70028385
Multiple organ dysfunction syndrome 22.54 10.05 98 117686 108417 70702243
Incoherent 22.29 10.05 42 117742 7264 70803396
Clostridium difficile infection 22.26 10.05 19 117765 38797 70771863
Prostate cancer 22.22 10.05 12 117772 31151 70779509
Negative thoughts 21.74 10.05 18 117766 1332 70809328
Feeling guilty 21.69 10.05 15 117769 846 70809814
Trichotillomania 21.66 10.05 9 117775 177 70810483
C-reactive protein increased 21.64 10.05 102 117682 110415 70700245
Idiosyncratic alcohol intoxication 21.61 10.05 4 117780 0 70810660
Housebound 21.53 10.05 12 117772 460 70810200
Product dose omission issue 21.52 10.05 244 117540 217224 70593436
Frontotemporal dementia 21.35 10.05 13 117771 589 70810071
Self-injurious ideation 21.29 10.05 27 117757 3311 70807349
Affect lability 21.24 10.05 50 117734 10096 70800564
Oedema 21.23 10.05 94 117690 103487 70707173
Oxygen saturation abnormal 21.22 10.05 29 117755 3825 70806835
Inadequate analgesia 21.18 10.05 30 117754 4092 70806568
Mental disorder 21.14 10.05 98 117686 28142 70782518
Musculoskeletal pain 21.01 10.05 78 117706 90249 70720411
Sinusitis 20.86 10.05 180 117604 169015 70641645
Feelings of worthlessness 20.86 10.05 12 117772 489 70810171
Haemoglobin decreased 20.77 10.05 229 117555 204930 70605730
Schizophrenia 20.57 10.05 68 117716 16700 70793960
Irritable bowel syndrome 20.45 10.05 33 117751 50817 70759843
Arthritis 20.04 10.05 89 117695 97891 70712769
Psychiatric symptom 20.03 10.05 38 117746 6606 70804054
Amylase increased 19.97 10.05 49 117735 10159 70800501
Sternal fracture 19.94 10.05 22 117762 2329 70808331
Aspergillus infection 19.80 10.05 3 117781 17865 70792795
Increased appetite 19.77 10.05 50 117734 10563 70800097
Endocrine ophthalmopathy 19.64 10.05 12 117772 547 70810113
Posterior reversible encephalopathy syndrome 19.55 10.05 8 117776 24394 70786266
Blood pH decreased 19.29 10.05 30 117754 4446 70806214
Blood sodium decreased 19.24 10.05 102 117682 30896 70779764
Generalised anxiety disorder 19.19 10.05 20 117764 1985 70808675
Middle insomnia 19.07 10.05 59 117725 13994 70796666
Somatic dysfunction 19.00 10.05 5 117779 20 70810640
Erythema 18.94 10.05 226 117558 199337 70611323
Therapy non-responder 18.84 10.05 65 117719 76850 70733810
Tardive dyskinesia 18.73 10.05 47 117737 9882 70800778
Illusion 18.54 10.05 18 117766 1641 70809019
Maternal exposure during pregnancy 18.41 10.05 114 117670 115231 70695429
Bradycardia 18.39 10.05 300 117484 124315 70686345
Judgement impaired 18.36 10.05 15 117769 1089 70809571
Drug screen positive 18.35 10.05 34 117750 5806 70804854
Diabetes insipidus 18.34 10.05 30 117754 4641 70806019
Leukopenia 18.24 10.05 103 117681 106457 70704203
Brugada syndrome 18.14 10.05 15 117769 1108 70809552
Hyperlipidaemia 18.00 10.05 83 117701 23780 70786880
Foetal death 17.97 10.05 35 117749 6204 70804456
Sedation 17.92 10.05 136 117648 46595 70764065
Ejaculation disorder 17.78 10.05 11 117773 513 70810147
Cyanosis 17.72 10.05 81 117703 23125 70787535
Alcohol abuse 17.67 10.05 31 117753 5076 70805584
Oropharyngeal pain 17.64 10.05 91 117693 96219 70714441
Muscle tightness 17.49 10.05 51 117733 11711 70798949
Poriomania 17.41 10.05 8 117776 202 70810458
Migraine 17.36 10.05 190 117594 72048 70738612
Renal impairment 17.35 10.05 154 117630 143783 70666877
Joint range of motion decreased 17.17 10.05 11 117773 26015 70784645
Drug resistance 17.10 10.05 23 117761 38167 70772493
Resting tremor 16.94 10.05 16 117768 1410 70809250
Myoglobin blood increased 16.89 10.05 23 117761 3024 70807636
Campylobacter colitis 16.80 10.05 5 117779 34 70810626
Hypervolaemia 16.70 10.05 25 117759 39681 70770979
Bronchopulmonary aspergillosis 16.64 10.05 7 117777 20995 70789665
Encephalopathy 16.62 10.05 166 117618 61495 70749165
Clumsiness 16.59 10.05 22 117762 2820 70807840
Soliloquy 16.43 10.05 11 117773 588 70810072
Hyperkinesia 16.39 10.05 21 117763 2602 70808058
Inflammation 16.36 10.05 71 117713 78594 70732066
Poor quality sleep 16.26 10.05 72 117712 20277 70790383
Vasoplegia syndrome 16.26 10.05 23 117761 3133 70807527
Dysacusis 16.21 10.05 3 117781 0 70810660
Phonophobia 16.09 10.05 10 117774 470 70810190
Knee arthroplasty 16.03 10.05 20 117764 34281 70776379
Toxicologic test abnormal 15.97 10.05 15 117769 1312 70809348
Palmar-plantar erythrodysaesthesia syndrome 15.93 10.05 16 117768 30231 70780429
Thermal burn 15.86 10.05 34 117750 6452 70804208
Generalised tonic-clonic seizure 15.84 10.05 121 117663 41540 70769120
Neoplasm progression 15.81 10.05 32 117752 45196 70765464
Dissociative disorder 15.75 10.05 10 117774 488 70810172
Tri-iodothyronine free decreased 15.71 10.05 9 117775 364 70810296
Hospitalisation 15.70 10.05 77 117707 82491 70728169
Cellulitis 15.67 10.05 98 117686 98830 70711830
Parkinson's disease 15.58 10.05 17 117767 1778 70808882
Epistaxis 15.58 10.05 103 117681 102524 70708136
Tumour lysis syndrome 15.56 10.05 8 117776 21352 70789308
Altered visual depth perception 15.53 10.05 9 117775 372 70810288
Intentional device use issue 15.48 10.05 5 117779 46 70810614
Mental impairment 15.29 10.05 63 117721 17192 70793468
Compartment syndrome 15.22 10.05 27 117757 4459 70806201
Vascular stenosis 15.15 10.05 10 117774 522 70810138
Hypoosmolar state 15.15 10.05 8 117776 275 70810385
Hypoaesthesia 15.13 10.05 348 117436 153391 70657269
Persecutory delusion 15.08 10.05 27 117757 4490 70806170
Influenza like illness 14.86 10.05 170 117614 65161 70745499
Dissociative amnesia 14.73 10.05 6 117778 112 70810548
Lactose intolerance 14.64 10.05 18 117766 2140 70808520
Blood chloride decreased 14.64 10.05 37 117747 7813 70802847
Hyperventilation 14.60 10.05 35 117749 7151 70803509
Infusion site scar 14.58 10.05 8 117776 297 70810363
Amimia 14.52 10.05 5 117779 57 70810603
Reversible cerebral vasoconstriction syndrome 14.48 10.05 20 117764 2665 70807995
Cystocele 14.42 10.05 11 117773 723 70809937
Toxic encephalopathy 14.41 10.05 44 117740 10362 70800298
Therapy interrupted 14.39 10.05 12 117772 24790 70785870
Injection site pruritus 14.35 10.05 27 117757 39183 70771477
Colitis microscopic 14.31 10.05 40 117744 8965 70801695
Colitis 14.26 10.05 56 117728 63758 70746902
Antiphospholipid antibodies 14.26 10.05 6 117778 122 70810538
Impatience 14.21 10.05 10 117774 580 70810080
Delivery 14.17 10.05 10 117774 583 70810077
Decreased activity 14.13 10.05 36 117748 7638 70803022
Alcoholism 14.12 10.05 26 117758 4419 70806241
Diabetic hyperosmolar coma 14.09 10.05 11 117773 748 70809912
Wrong patient 14.09 10.05 8 117776 318 70810342
Respiratory tract infection 13.98 10.05 31 117753 42367 70768293
Pleural effusion 13.97 10.05 147 117637 132717 70677943
Fluid retention 13.93 10.05 56 117728 63329 70747331
Marital problem 13.92 10.05 7 117777 217 70810443
Epilepsy 13.84 10.05 111 117673 38673 70771987
Localised infection 13.82 10.05 21 117763 33137 70777523
Anxiety disorder 13.80 10.05 24 117760 3901 70806759
Suspiciousness 13.79 10.05 10 117774 608 70810052
Spinal pain 13.78 10.05 3 117781 13767 70796893
Fatigue 13.68 10.05 1181 116603 823138 69987522
Psychomotor skills impaired 13.54 10.05 25 117759 4259 70806401
Antisocial personality disorder 13.34 10.05 4 117780 28 70810632
Cholecystitis chronic 13.31 10.05 40 117744 9336 70801324
Bladder cancer 13.26 10.05 6 117778 17236 70793424
Laboratory test abnormal 13.21 10.05 14 117770 25809 70784851
Toxic shock syndrome 13.21 10.05 12 117772 1006 70809654
Diet refusal 13.08 10.05 11 117773 832 70809828
Cerebrovascular stenosis 13.04 10.05 6 117778 152 70810508
Dairy intolerance 13.04 10.05 5 117779 79 70810581
Impulse-control disorder 13.03 10.05 15 117769 1664 70808996
Perseveration 12.91 10.05 8 117776 374 70810286
Subdural haematoma 12.81 10.05 88 117696 29210 70781450
Catatonia 12.80 10.05 36 117748 8097 70802563
Urticaria 12.79 10.05 192 117592 162857 70647803
Blood lactate dehydrogenase increased 12.79 10.05 101 117683 35026 70775634
Chronic kidney disease 12.76 10.05 55 117729 61002 70749658
Gaze palsy 12.72 10.05 19 117765 2719 70807941
Antipsychotic drug level increased 12.71 10.05 28 117756 5412 70805248
Hypersomnia 12.67 10.05 68 117716 20696 70789964
Obesity 12.66 10.05 82 117702 26689 70783971
Posture abnormal 12.66 10.05 22 117762 3574 70807086
Thought insertion 12.66 10.05 4 117780 34 70810626
Slow response to stimuli 12.64 10.05 15 117769 1718 70808942
Violence-related symptom 12.53 10.05 10 117774 702 70809958
Stupor 12.47 10.05 31 117753 6478 70804182
Coronary artery disease 12.42 10.05 159 117625 62577 70748083
Blood triglycerides increased 12.41 10.05 65 117719 19599 70791061
Intention tremor 12.39 10.05 10 117774 714 70809946
Injection site reaction 12.29 10.05 42 117742 49810 70760850
Jealous delusion 12.29 10.05 7 117777 280 70810380
Bone marrow failure 12.28 10.05 41 117743 48969 70761691
Ammonia abnormal 12.26 10.05 6 117778 175 70810485
Hypercholesterolaemia 12.21 10.05 61 117723 18056 70792604
Dermatitis allergic 12.20 10.05 6 117778 16425 70794235
Disinhibition 12.20 10.05 17 117767 2284 70808376
Serum sickness-like reaction 12.19 10.05 9 117775 563 70810097
Tenosynovitis 12.18 10.05 4 117780 13972 70796688
Tonic convulsion 12.09 10.05 16 117768 2046 70808614
Plasmodium vivax infection 12.06 10.05 3 117781 9 70810651
Ankle fracture 12.04 10.05 54 117730 15290 70795370
Transaminases increased 12.01 10.05 39 117745 46979 70763681
Therapeutic response decreased 12.01 10.05 53 117731 58400 70752260
Nephropathy toxic 11.98 10.05 8 117776 18506 70792154
Oscillopsia 11.96 10.05 6 117778 185 70810475
Troponin increased 11.95 10.05 57 117727 16557 70794103
Aphasia 11.93 10.05 117 117667 43132 70767528
Device related infection 11.92 10.05 22 117762 32163 70778497
Dyssomnia 11.91 10.05 4 117780 42 70810618
Oedema peripheral 11.90 10.05 288 117496 227803 70582857
Anhedonia 11.90 10.05 51 117733 14162 70796498
Bacteraemia 11.80 10.05 19 117765 29290 70781370
Head injury 11.79 10.05 97 117687 34044 70776616
Fibrocystic breast disease 11.75 10.05 9 117775 595 70810065
Respiratory depression 11.71 10.05 76 117708 24755 70785905
Blood pressure systolic increased 11.71 10.05 52 117732 57207 70753453
Urinary tract infection 11.68 10.05 319 117465 248450 70562210
Trismus 11.67 10.05 26 117758 5065 70805595
Autoimmune nephritis 11.63 10.05 9 117775 604 70810056
Blood aldosterone abnormal 11.58 10.05 4 117780 46 70810614
Dementia 11.51 10.05 70 117714 22295 70788365
Exhibitionism 11.51 10.05 4 117780 47 70810613
Mouth ulceration 11.42 10.05 25 117759 34324 70776336
Hypervigilance 11.41 10.05 8 117776 461 70810199
Hyposmia 11.40 10.05 9 117775 622 70810038
Neurotoxicity 11.40 10.05 20 117764 29806 70780854
Cyclothymic disorder 11.34 10.05 6 117778 207 70810453
Enterococcal infection 11.33 10.05 5 117779 14577 70796083
Paroxysmal arrhythmia 11.28 10.05 4 117780 50 70810610
Mental status changes 11.28 10.05 157 117627 62944 70747716
Convulsions local 11.21 10.05 4 117780 51 70810609
Suicidal behaviour 11.16 10.05 19 117765 3037 70807623
Granuloma 11.09 10.05 33 117751 7662 70802998
Blood pressure diastolic decreased 11.07 10.05 16 117768 25764 70784896
Blood bicarbonate decreased 11.06 10.05 25 117759 4916 70805744
Feeling of relaxation 11.04 10.05 5 117779 122 70810538
Hyper IgE syndrome 11.00 10.05 8 117776 489 70810171
Back pain 10.92 10.05 355 117429 270797 70539863
Delusional perception 10.91 10.05 7 117777 348 70810312
Personality change 10.90 10.05 36 117748 8834 70801826
Administration related reaction 10.89 10.05 5 117779 126 70810534
Injection site swelling 10.89 10.05 36 117748 43121 70767539
Ligament sprain 10.86 10.05 44 117740 11919 70798741
Normetanephrine urine increased 10.86 10.05 3 117781 15 70810645
Metastases to lung 10.83 10.05 7 117777 16477 70794183
Ear infection 10.83 10.05 19 117765 28317 70782343
Decreased interest 10.77 10.05 20 117764 3421 70807239
Hyperbilirubinaemia 10.72 10.05 13 117771 22555 70788105
Fibromyalgia 10.71 10.05 42 117742 47832 70762828
Vasculitis 10.70 10.05 10 117774 19548 70791112
Yawning 10.69 10.05 12 117772 1295 70809365
Visual impairment 10.67 10.05 190 117594 80060 70730600
Energy increased 10.62 10.05 18 117766 2866 70807794
Loss of personal independence in daily activities 10.61 10.05 90 117694 84820 70725840
Accommodation disorder 10.61 10.05 8 117776 517 70810143
Inappropriate schedule of product administration 10.50 10.05 121 117663 107434 70703226
Prescription form tampering 10.48 10.05 7 117777 373 70810287
Hyperphagia 10.43 10.05 16 117768 2343 70808317
Anxiety disorder due to a general medical condition 10.40 10.05 3 117781 18 70810642
Muscle spasms 10.39 10.05 332 117452 153714 70656946
Imprisonment 10.26 10.05 8 117776 543 70810117
Post procedural haematuria 10.24 10.05 6 117778 253 70810407
Sacroiliac joint dysfunction 10.22 10.05 4 117780 67 70810593
Job dissatisfaction 10.22 10.05 4 117780 67 70810593
Abulia 10.18 10.05 10 117774 925 70809735
Tuberculosis 10.18 10.05 6 117778 14842 70795818
Liver function test increased 10.17 10.05 26 117758 33821 70776839
Accidental death 10.15 10.05 21 117763 3887 70806773
Neurosis 10.12 10.05 7 117777 395 70810265
Prescription drug used without a prescription 10.12 10.05 18 117766 2979 70807681
Freezing phenomenon 10.08 10.05 13 117771 1621 70809039
Pruritus 10.07 10.05 470 117314 345090 70465570

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 D018490 Serotonin Agents
MeSH PA D017367 Serotonin Uptake Inhibitors

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)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 10MG BASE/5ML PAROXETINE HYDROCHLORIDE NOVITIUM PHARMA A215003 Sept. 3, 2021 RX SUSPENSION ORAL March 12, 2022 COMPETITIVE GENERIC THERAPY

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
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
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 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
Paroxetine Human Prescription Drug Label 1 13107-154 TABLET, FILM COATED 10 mg ORAL ANDA 34 sections