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 883.23 10.18 568 96588 24513 50483455
Atrial septal defect 758.44 10.18 326 96830 6015 50501953
Serotonin syndrome 588.20 10.18 440 96716 24273 50483695
Suicidal ideation 446.43 10.18 541 96615 54844 50453124
Ventricular septal defect 422.40 10.18 189 96967 3852 50504116
Patent ductus arteriosus 393.99 10.18 177 96979 3643 50504325
Exposure during pregnancy 368.54 10.18 755 96401 120260 50387708
Sopor 334.57 10.18 289 96867 19590 50488378
Drug abuse 326.17 10.18 483 96673 59363 50448605
Suicide attempt 305.92 10.18 434 96722 51298 50456670
Anxiety 255.97 10.18 836 96320 176770 50331198
Heart disease congenital 243.98 10.18 91 97065 1135 50506833
Congenital anomaly 242.27 10.18 96 97060 1425 50506543
Agitation 242.18 10.18 396 96760 52988 50454980
Contraindicated product administered 236.32 10.18 12 97144 148946 50359022
Tremor 232.84 10.18 611 96545 114292 50393676
Cardiac murmur 227.95 10.18 179 96977 10605 50497363
Foetal exposure during pregnancy 224.79 10.18 270 96886 27089 50480879
Mydriasis 213.07 10.18 171 96985 10456 50497512
Nightmare 212.17 10.18 204 96952 15882 50492086
Pulmonary valve stenosis 211.13 10.18 59 97097 260 50507708
Drug ineffective 210.12 10.18 838 96318 818495 49689473
Joint swelling 209.04 10.18 105 97051 245181 50262787
Intentional self-injury 201.30 10.18 235 96921 22877 50485091
Multiple congenital abnormalities 200.57 10.18 64 97092 479 50507489
Alopecia 198.38 10.18 112 97044 244935 50263033
Drug intolerance 189.37 10.18 92 97064 219012 50288956
Off label use 187.21 10.18 395 96761 474031 50033937
Synovitis 184.41 10.18 14 97142 123851 50384117
Systemic lupus erythematosus 181.12 10.18 27 97129 140595 50367373
Drug interaction 178.85 10.18 808 96348 198813 50309155
Treatment failure 169.26 10.18 30 97126 137607 50370361
Persistent foetal circulation 168.97 10.18 46 97110 180 50507788
Irritability 164.31 10.18 236 96920 28190 50479778
Glossodynia 164.03 10.18 16 97140 115553 50392415
Depersonalisation/derealisation disorder 161.23 10.18 67 97089 1131 50506837
Rheumatoid arthritis 156.24 10.18 98 97058 202452 50305516
Anger 153.77 10.18 146 97010 11187 50496781
Mania 152.64 10.18 143 97013 10773 50497195
Somnolence 152.19 10.18 645 96511 154340 50353628
Pulmonary artery stenosis congenital 151.47 10.18 43 97113 203 50507765
Rash 149.46 10.18 393 96763 437078 50070890
Infusion related reaction 145.23 10.18 72 97084 169485 50338483
Hyponatraemia 144.11 10.18 459 96697 95680 50412288
Dissociation 142.14 10.18 75 97081 2216 50505752
Panic attack 136.64 10.18 177 96979 19165 50488803
Disturbance in attention 134.21 10.18 226 96930 30960 50477008
Derealisation 132.40 10.18 56 97100 990 50506978
Disorientation 131.77 10.18 241 96915 35243 50472725
Neuroleptic malignant syndrome 131.62 10.18 133 97023 10997 50496971
Coarctation of the aorta 130.58 10.18 47 97109 526 50507442
Hyperhidrosis 130.43 10.18 423 96733 89003 50418965
Swelling 127.10 10.18 119 97037 200753 50307215
Mood swings 127.03 10.18 155 97001 15799 50492169
Confusional state 125.62 10.18 695 96461 185233 50322735
Abdominal discomfort 124.68 10.18 157 96999 231484 50276484
Hallucinations, mixed 122.72 10.18 84 97072 4019 50503949
Activation syndrome 121.81 10.18 35 97121 174 50507794
Depression 121.69 10.18 633 96523 164790 50343178
Aggression 121.57 10.18 175 96981 20941 50487027
Feeling of despair 119.38 10.18 64 97092 1954 50506014
Pericarditis 116.79 10.18 9 97147 78680 50429288
Hypersensitivity 114.57 10.18 147 97009 215014 50292954
Pain 114.40 10.18 649 96507 578254 49929714
Completed suicide 113.61 10.18 528 96628 131361 50376607
Inappropriate antidiuretic hormone secretion 113.37 10.18 133 97023 13010 50494958
Arthropathy 112.89 10.18 83 97073 157823 50350145
Fallot's tetralogy 111.10 10.18 27 97129 58 50507910
Overdose 110.48 10.18 431 96725 99296 50408672
Peripheral swelling 109.33 10.18 141 97015 205795 50302173
Restlessness 109.08 10.18 183 96973 24990 50482978
Bradyphrenia 108.70 10.18 92 97064 6060 50501908
Developmental delay 102.60 10.18 50 97106 1244 50506724
Product use issue 102.47 10.18 82 97074 149393 50358575
Therapeutic product effect decreased 101.88 10.18 68 97088 135982 50371986
Hallucination, auditory 100.00 10.18 113 97043 10615 50497353
Gastric pH decreased 99.24 10.18 40 97116 622 50507346
Withdrawal syndrome 97.22 10.18 143 97013 17447 50490521
Dyskinesia 92.00 10.18 180 96976 27681 50480287
Congenital aortic stenosis 86.62 10.18 17 97139 3 50507965
Transposition of the great vessels 83.79 10.18 25 97131 145 50507823
Drug dependence 80.80 10.18 140 97016 19619 50488349
Agoraphobia 80.30 10.18 29 97127 328 50507640
Hepatic enzyme increased 79.32 10.18 88 97068 137292 50370676
Delirium 77.13 10.18 203 96953 37989 50469979
Cogwheel rigidity 77.09 10.18 46 97110 1731 50506237
Arthralgia 76.98 10.18 510 96646 438192 50069776
Crying 76.21 10.18 139 97017 20277 50487691
Febrile neutropenia 75.58 10.18 47 97109 97620 50410348
Tearfulness 75.33 10.18 60 97096 3627 50504341
Cough 73.88 10.18 228 96928 241036 50266932
Insomnia 73.14 10.18 580 96576 174285 50333683
Talipes 73.03 10.18 41 97115 1373 50506595
Helicobacter infection 72.86 10.18 6 97150 49696 50458272
Nasopharyngitis 72.19 10.18 165 96991 192762 50315206
Discomfort 69.92 10.18 63 97093 108317 50399651
Toxicity to various agents 69.21 10.18 667 96489 211832 50296136
Depressed mood 68.86 10.18 181 96975 33842 50474126
Wound 68.84 10.18 61 97095 105733 50402235
Homicidal ideation 68.53 10.18 42 97114 1660 50506308
Lower respiratory tract infection 68.05 10.18 50 97106 95151 50412817
Emotional disorder 67.99 10.18 98 97058 11738 50496230
Muscle rigidity 67.94 10.18 89 97067 9740 50498228
Flat affect 67.84 10.18 38 97118 1267 50506701
Hypoplastic left heart syndrome 67.56 10.18 22 97134 177 50507791
Extrapyramidal disorder 65.49 10.18 96 97060 11674 50496294
Stomatitis 65.26 10.18 59 97097 101285 50406683
Myoglobin urine present 63.46 10.18 25 97131 365 50507603
H1N1 influenza 63.26 10.18 39 97117 1558 50506410
Speech disorder developmental 62.27 10.18 28 97128 577 50507391
Memory impairment 61.27 10.18 308 96848 79052 50428916
Bronchial neoplasm 60.93 10.18 25 97131 408 50507560
Congenital cardiovascular anomaly 59.82 10.18 18 97138 108 50507860
Abnormal behaviour 58.92 10.18 122 97034 19536 50488432
Impulsive behaviour 58.76 10.18 36 97120 1422 50506546
Libido increased 58.72 10.18 34 97122 1209 50506759
Infection 58.36 10.18 156 97000 172798 50335170
Blister 58.33 10.18 47 97109 85371 50422597
Parkinsonism 57.91 10.18 78 97078 8769 50499199
Altered state of consciousness 57.66 10.18 129 97027 21781 50486187
Bicuspid aortic valve 57.07 10.18 17 97139 98 50507870
Hyperreflexia 56.60 10.18 59 97097 5059 50502909
Bronchial haemorrhage 56.52 10.18 25 97131 495 50507473
Pulmonary valve stenosis congenital 56.37 10.18 18 97138 135 50507833
Cleft palate 55.45 10.18 30 97126 933 50507035
Poisoning deliberate 55.24 10.18 72 97084 7840 50500128
Dystonia 54.75 10.18 89 97067 11837 50496131
Intentional product use issue 54.19 10.18 41 97115 76877 50431091
Homicide 54.13 10.18 22 97134 350 50507618
Nervousness 53.83 10.18 145 97011 27506 50480462
Nasal turbinate hypertrophy 53.45 10.18 26 97130 644 50507324
Myoclonus 53.35 10.18 98 97058 14372 50493596
Anomalous pulmonary venous connection 52.21 10.18 14 97142 51 50507917
Pneumonia 52.15 10.18 470 96686 377931 50130037
Amnesia 52.02 10.18 189 96967 42071 50465897
Hypomania 51.74 10.18 53 97103 4452 50503516
Clonus 51.40 10.18 51 97105 4124 50503844
Intentional overdose 51.39 10.18 247 96909 62257 50445711
Right ventricular hypertrophy 50.75 10.18 25 97131 637 50507331
Drooling 50.54 10.18 46 97110 3338 50504630
Cyanosis 50.00 10.18 98 97058 15086 50492882
Feeling jittery 49.50 10.18 82 97074 11078 50496890
Feeling of body temperature change 49.47 10.18 51 97105 4316 50503652
Death 49.37 10.18 394 96762 324985 50182983
Affective disorder 49.01 10.18 55 97101 5126 50502842
Maternal exposure during pregnancy 48.86 10.18 151 97005 159627 50348341
Paraesthesia 48.15 10.18 395 96761 119848 50388120
Vertigo 47.92 10.18 212 96944 51620 50456348
Renal ischaemia 47.68 10.18 23 97133 559 50507409
Endometrial ablation 47.24 10.18 26 97130 837 50507131
Folliculitis 47.21 10.18 9 97147 39216 50468752
Depressed level of consciousness 46.90 10.18 211 96945 51742 50456226
Delusion 46.00 10.18 77 97079 10492 50497476
Menstrual disorder 45.87 10.18 49 97107 4321 50503647
Malignant neoplasm progression 45.87 10.18 38 97118 68086 50439882
Muscle injury 45.78 10.18 8 97148 37103 50470865
Speech disorder 45.47 10.18 161 96995 35387 50472581
Self esteem decreased 45.15 10.18 22 97134 547 50507421
Psychotic disorder 45.12 10.18 117 97039 21695 50486273
Loss of libido 43.75 10.18 28 97128 1195 50506773
Dependence 43.72 10.18 33 97123 1842 50506126
Hallucination 43.25 10.18 191 96965 46466 50461502
Abnormal dreams 43.08 10.18 70 97086 9307 50498661
Therapeutic product ineffective 42.79 10.18 28 97128 1242 50506726
Craniosynostosis 42.66 10.18 15 97141 156 50507812
Apathy 42.63 10.18 62 97094 7486 50500482
Dizziness 42.34 10.18 915 96241 345454 50162514
Parosmia 41.81 10.18 47 97109 4389 50503579
Tinnitus 41.81 10.18 134 97022 27998 50479970
Neutropenia 41.66 10.18 145 97011 147820 50360148
Akathisia 41.34 10.18 64 97092 8165 50499803
Hyperprolactinaemia 41.23 10.18 41 97115 3324 50504644
Mobility decreased 41.08 10.18 56 97100 79892 50428076
Accidental poisoning 41.05 10.18 21 97135 581 50507387
Spina bifida 40.94 10.18 22 97134 675 50507293
PCO2 increased 40.47 10.18 26 97130 1117 50506851
Hyperacusis 40.41 10.18 31 97125 1773 50506195
Fatigue 40.11 10.18 1044 96112 706557 49801411
Galactorrhoea 39.53 10.18 42 97114 3681 50504287
Logorrhoea 39.51 10.18 34 97122 2290 50505678
Social anxiety disorder 39.51 10.18 18 97138 383 50507585
Chorea 39.05 10.18 27 97129 1313 50506655
Incontinence 38.56 10.18 69 97087 9916 50498052
Muscle twitching 38.54 10.18 89 97067 15342 50492626
Bronchial disorder 38.04 10.18 25 97131 1117 50506851
Muscle disorder 37.48 10.18 44 97112 4306 50503662
Libido decreased 36.87 10.18 33 97123 2343 50505625
Congenital mitral valve stenosis 36.80 10.18 7 97149 0 50507968
Paranoia 36.79 10.18 69 97087 10279 50497689
Injection site pain 36.78 10.18 101 97055 110923 50397045
Product complaint 36.54 10.18 73 97083 11393 50496575
Hostility 36.41 10.18 29 97127 1753 50506215
Hypoaesthesia oral 36.25 10.18 70 97086 10658 50497310
Restless legs syndrome 35.72 10.18 88 97068 15809 50492159
Psychomotor hyperactivity 35.56 10.18 64 97092 9237 50498731
Impaired healing 34.73 10.18 50 97106 69736 50438232
Sinusitis 34.68 10.18 189 96967 170369 50337599
Seizure 34.45 10.18 362 96794 117512 50390456
Neuropathy peripheral 34.36 10.18 85 97071 96672 50411296
Gastrointestinal disorder 34.31 10.18 82 97074 94374 50413594
Obsessive-compulsive disorder 34.27 10.18 37 97119 3303 50504665
General physical health deterioration 34.06 10.18 149 97007 142285 50365683
Urinary retention 33.82 10.18 119 97037 26071 50481897
Dyspnoea 33.38 10.18 799 96357 546809 49961159
Tachycardia 33.33 10.18 315 96841 99448 50408520
Ventricular hypoplasia 32.74 10.18 12 97144 142 50507826
Self-injurious ideation 32.70 10.18 30 97126 2199 50505769
Hip arthroplasty 32.60 10.18 9 97147 30420 50477548
Knee arthroplasty 32.54 10.18 14 97142 35832 50472136
PO2 increased 32.37 10.18 20 97136 802 50507166
Neonatal behavioural syndrome 32.14 10.18 9 97147 40 50507928
Fear 32.13 10.18 80 97076 14469 50493499
Rhonchi 31.82 10.18 30 97126 2277 50505691
Pain in extremity 31.67 10.18 353 96803 272512 50235456
Congenital aortic valve incompetence 31.55 10.18 6 97150 0 50507968
DiGeorge's syndrome 31.55 10.18 6 97150 0 50507968
Hallucination, visual 31.31 10.18 86 97070 16496 50491472
Disease progression 31.17 10.18 88 97068 95778 50412190
Balance disorder 31.04 10.18 237 96919 70353 50437615
Emotional distress 30.98 10.18 123 97033 28540 50479428
Arthritis 30.94 10.18 76 97080 86645 50421323
Thermal burn 30.65 10.18 42 97114 4799 50503169
Sepsis 30.61 10.18 141 97015 132784 50375184
Maternal drugs affecting foetus 30.57 10.18 43 97113 5034 50502934
Injection site erythema 30.56 10.18 61 97095 74875 50433093
Depressive symptom 30.32 10.18 34 97122 3166 50504802
Cerebral microhaemorrhage 30.12 10.18 10 97146 86 50507882
Diabetes insipidus 29.33 10.18 29 97127 2335 50505633
Apraxia 29.15 10.18 24 97132 1521 50506447
Product dose omission issue 29.05 10.18 220 96936 183618 50324350
Ebstein's anomaly 28.82 10.18 7 97149 15 50507953
Paralysis 28.62 10.18 56 97100 8608 50499360
Coma scale 28.14 10.18 8 97148 38 50507930
Personality disorder 28.11 10.18 38 97118 4286 50503682
Prescription form tampering 28.07 10.18 16 97140 552 50507416
COVID-19 27.90 10.18 29 97127 46633 50461335
Soft tissue injury 27.89 10.18 23 97133 1461 50506507
Hepatocellular injury 27.77 10.18 111 97045 25836 50482132
Respiratory depression 27.54 10.18 67 97089 11943 50496025
Micrognathia 27.53 10.18 12 97144 229 50507739
Loss of consciousness 27.51 10.18 314 96842 104039 50403929
Schizophrenia 27.14 10.18 50 97106 7347 50500621
Sensory disturbance 27.13 10.18 66 97090 11763 50496205
Neutrophil count decreased 27.07 10.18 29 97127 45997 50461971
Feelings of worthlessness 27.06 10.18 13 97143 313 50507655
Encephalopathy 26.82 10.18 132 97024 33579 50474389
Soliloquy 26.72 10.18 11 97145 181 50507787
Blood pH decreased 26.61 10.18 28 97128 2427 50505541
Cardiomegaly 26.52 10.18 79 97077 15866 50492102
Breath sounds abnormal 26.52 10.18 51 97105 7741 50500227
Vesicoureteric reflux 26.29 10.18 11 97145 189 50507779
Electroencephalogram abnormal 26.25 10.18 33 97123 3466 50504502
Alcoholism 26.13 10.18 23 97133 1597 50506371
Sleep disorder 26.13 10.18 194 96962 57089 50450879
Weight increased 26.12 10.18 538 96618 201353 50306615
Creutzfeldt-Jakob disease 26.09 10.18 10 97146 135 50507833
Blood creatine phosphokinase increased 26.01 10.18 110 97046 26257 50481711
Fall 25.83 10.18 833 96323 334099 50173869
Bronchopulmonary dysplasia 25.72 10.18 12 97144 270 50507698
Irritable bowel syndrome 25.45 10.18 37 97119 51404 50456564
Joint hyperextension 25.21 10.18 12 97144 283 50507685
Blood sodium decreased 24.70 10.18 93 97063 21054 50486914
Musculoskeletal stiffness 24.68 10.18 145 97011 128336 50379632
Electrocardiogram QT prolonged 24.39 10.18 177 96979 51709 50456259
Obsessive thoughts 24.25 10.18 14 97142 495 50507473
Cytomegalovirus infection 24.16 10.18 3 97153 17959 50490009
Compartment syndrome 24.01 10.18 24 97132 1958 50506010
Dysmorphism 23.99 10.18 25 97131 2142 50505826
Treatment noncompliance 23.95 10.18 118 97038 30032 50477936
White blood cell count decreased 23.90 10.18 129 97027 116593 50391375
Congenital heart valve disorder 23.88 10.18 8 97148 71 50507897
Congenital tricuspid valve atresia 23.70 10.18 7 97149 39 50507929
Mental disorder 23.47 10.18 94 97062 21897 50486071
Cardio-respiratory arrest 23.16 10.18 180 96976 53712 50454256
Tricuspid valve incompetence 22.90 10.18 65 97091 12705 50495263
Post-traumatic neck syndrome 22.90 10.18 23 97133 1887 50506081
Cleft lip and palate 22.85 10.18 12 97144 351 50507617
Oxygen saturation abnormal 22.73 10.18 27 97129 2675 50505293
Panic reaction 22.65 10.18 31 97125 3538 50504430
Aortic valve incompetence 22.64 10.18 39 97117 5437 50502531
Aorta hypoplasia 22.56 10.18 9 97147 136 50507832
Eye movement disorder 22.35 10.18 35 97121 4510 50503458
Vision blurred 22.25 10.18 240 96916 78407 50429561
Tension 22.25 10.18 27 97129 2735 50505233
Substance abuse 22.03 10.18 33 97123 4091 50503877
Sensory loss 21.99 10.18 47 97109 7691 50500277
Mood altered 21.93 10.18 64 97092 12709 50495259
Poor quality sleep 21.81 10.18 76 97080 16570 50491398
Mucosal inflammation 21.76 10.18 27 97129 40115 50467853
Phonophobia 21.71 10.18 11 97145 298 50507670
Wolff-Parkinson-White syndrome 21.50 10.18 8 97148 99 50507869
Altered visual depth perception 21.48 10.18 11 97145 305 50507663
Pulmonary artery stenosis 21.33 10.18 9 97147 158 50507810
Middle insomnia 21.33 10.18 54 97102 9867 50498101
Hypoplastic right heart syndrome 21.31 10.18 7 97149 58 50507910
Pancytopenia 21.26 10.18 86 97070 83944 50424024
Psoriatic arthropathy 21.21 10.18 36 97120 46996 50460972
Anaphylactic reaction 21.20 10.18 45 97111 54010 50453958
Hepatotoxicity 21.19 10.18 13 97143 27213 50480755
Congenital aortic atresia 21.03 10.18 4 97152 0 50507968
Pilonidal cyst congenital 21.03 10.18 4 97152 0 50507968
Euphoric mood 21.02 10.18 32 97124 4023 50503945
Dilatation ventricular 20.84 10.18 24 97132 2301 50505667
Psychiatric symptom 20.83 10.18 34 97122 4536 50503432
Musculoskeletal pain 20.79 10.18 70 97086 72107 50435861
Somnolence neonatal 20.74 10.18 8 97148 110 50507858
Oropharyngeal pain 20.72 10.18 78 97078 77723 50430245
Blood triglycerides increased 20.70 10.18 58 97098 11254 50496714
Anorgasmia 20.59 10.18 13 97143 542 50507426
Ventricular hypertrophy 20.51 10.18 28 97128 3187 50504781
Leukopenia 20.49 10.18 64 97092 67464 50440504
Asphyxia 20.31 10.18 37 97119 5390 50502578
Generalised anxiety disorder 20.16 10.18 21 97135 1799 50506169
Pruritus 20.01 10.18 404 96752 283164 50224804
Hypokinesia 19.82 10.18 60 97096 12157 50495811
Negative thoughts 19.66 10.18 15 97141 851 50507117
Metastases to liver 19.65 10.18 7 97149 20097 50487871
Dysarthria 19.58 10.18 131 97025 37272 50470696
Feeling abnormal 19.50 10.18 344 96812 125148 50382820
Back pain 19.49 10.18 301 96855 219729 50288239
Sinus tachycardia 19.47 10.18 87 97069 21267 50486701
Pneumonitis 19.20 10.18 17 97139 29493 50478475
Poisoning 19.19 10.18 60 97096 12369 50495599
Amylase increased 19.04 10.18 36 97120 5394 50502574
Physical assault 19.03 10.18 15 97141 893 50507075
Antidepressant discontinuation syndrome 18.91 10.18 5 97151 17 50507951
Posterior reversible encephalopathy syndrome 18.89 10.18 3 97153 14925 50493043
Aphasia 18.84 10.18 106 97050 28388 50479580
Therapy non-responder 18.76 10.18 44 97112 50978 50456990
Delivery 18.62 10.18 13 97143 642 50507326
Pyrexia 18.60 10.18 572 96584 379631 50128337
Failure to thrive 18.51 10.18 39 97117 6319 50501649
Injection site reaction 18.51 10.18 43 97113 49989 50457979
Sternal fracture 18.51 10.18 21 97135 1981 50505987
Premature baby 18.48 10.18 77 97079 18260 50489708
Plagiocephaly 18.45 10.18 6 97150 48 50507920
Foetal movement disorder 18.27 10.18 4 97152 4 50507964
Right ventricle outflow tract obstruction 18.27 10.18 4 97152 4 50507964
Hypotonia 18.25 10.18 45 97111 8089 50499879
Hot flush 18.14 10.18 146 97010 44023 50463945
Velopharyngeal incompetence 18.08 10.18 5 97151 21 50507947
Macular degeneration 17.97 10.18 3 97153 14385 50493583
Red blood cell sedimentation rate increased 17.90 10.18 18 97138 29398 50478570
Blood bicarbonate decreased 17.79 10.18 24 97132 2701 50505267
Upper respiratory tract infection 17.59 10.18 66 97090 65832 50442136
Slow response to stimuli 17.45 10.18 14 97142 855 50507113
Hypertonia 17.36 10.18 29 97127 3944 50504024
Injection site pruritus 17.26 10.18 32 97124 40379 50467589
Coma 17.23 10.18 176 96980 56703 50451265
Inflammation 17.22 10.18 54 97102 56858 50451110
Apnoea 17.20 10.18 40 97116 6926 50501042
Pulmonary valve incompetence 17.17 10.18 16 97140 1197 50506771
Drug abuser 17.10 10.18 24 97132 2804 50505164
Congenital aortic anomaly 17.10 10.18 6 97150 62 50507906
Arnold-Chiari malformation 16.97 10.18 11 97145 480 50507488
Hospitalisation 16.89 10.18 70 97086 67867 50440101
Urticaria 16.89 10.18 163 96993 129398 50378570
Anaemia 16.82 10.18 363 96793 252093 50255875
Trichotillomania 16.80 10.18 7 97149 119 50507849
Mitral valve incompetence 16.55 10.18 72 97084 17399 50490569
Myelosuppression 16.48 10.18 3 97153 13514 50494454
Otospondylomegaepiphyseal dysplasia 16.45 10.18 6 97150 70 50507898
Therapeutic response decreased 16.37 10.18 42 97114 47189 50460779
Campylobacter colitis 16.34 10.18 5 97151 32 50507936
Psychomotor skills impaired 16.34 10.18 20 97136 2044 50505924
Antisocial personality disorder 16.33 10.18 4 97152 9 50507959
Cleft uvula 16.33 10.18 4 97152 9 50507959
Myoglobin blood increased 16.30 10.18 16 97140 1277 50506691
Illusion 16.24 10.18 14 97142 945 50507023
Intentional device use issue 16.21 10.18 5 97151 33 50507935
Disinhibition 16.16 10.18 13 97143 797 50507171
Poriomania 16.07 10.18 6 97150 75 50507893
Neonatal asphyxia 15.95 10.18 8 97148 212 50507756
Congenital tracheomalacia 15.84 10.18 5 97151 36 50507932
Diarrhoea 15.83 10.18 947 96209 587529 49920439
Bipolar disorder 15.82 10.18 38 97118 6719 50501249
Mental impairment 15.79 10.18 55 97101 11989 50495979
Lipomeningocele 15.77 10.18 3 97153 0 50507968
Interruption of aortic arch 15.77 10.18 3 97153 0 50507968
Subvalvular aortic stenosis 15.77 10.18 3 97153 0 50507968
Bradycardia 15.70 10.18 191 96965 64235 50443733
Post procedural haematuria 15.60 10.18 5 97151 38 50507930
Autoimmune nephritis 15.57 10.18 9 97147 319 50507649
Parkinson's disease 15.46 10.18 15 97141 1180 50506788
Tethered cord syndrome 15.45 10.18 8 97148 227 50507741
Congenital scoliosis 15.27 10.18 4 97152 13 50507955
Toxic encephalopathy 15.10 10.18 33 97123 5482 50502486
Cognitive disorder 15.06 10.18 140 97016 43983 50463985
Localised infection 15.05 10.18 16 97140 25469 50482499
Dextrocardia 15.04 10.18 4 97152 14 50507954
Foetal death 15.02 10.18 42 97114 8138 50499830
Tardive dyskinesia 15.00 10.18 39 97117 7240 50500728
Urinary tract infection 14.95 10.18 322 96834 223698 50284270
Drug resistance 14.87 10.18 9 97147 18980 50488988
VACTERL syndrome 14.83 10.18 4 97152 15 50507953
Atrioventricular septal defect 14.67 10.18 8 97148 253 50507715
Perseveration 14.61 10.18 8 97148 255 50507713
Thinking abnormal 14.60 10.18 46 97110 9521 50498447
Diabetic hyperosmolar coma 14.59 10.18 9 97147 360 50507608
Ear infection 14.57 10.18 17 97139 25953 50482015
Blood pressure diastolic decreased 14.54 10.18 7 97149 16774 50491194
Abdominal pain 14.50 10.18 344 96812 235884 50272084
Endocrine ophthalmopathy 14.50 10.18 9 97147 364 50507604
Thrombocytopenia 14.45 10.18 166 96990 127507 50380461
C-reactive protein increased 14.43 10.18 72 97084 66402 50441566
Social avoidant behaviour 14.40 10.18 22 97134 2775 50505193
Amimia 14.39 10.18 5 97151 50 50507918
Granuloma 14.38 10.18 30 97126 4828 50503140
Alcohol abuse 14.37 10.18 18 97138 1883 50506085
Lactose intolerance 14.35 10.18 21 97135 2549 50505419
Blood pressure systolic increased 14.33 10.18 29 97127 35420 50472548
Major depression 14.31 10.18 37 97119 6847 50501121
Female orgasmic disorder 14.31 10.18 5 97151 51 50507917
Dairy intolerance 14.31 10.18 5 97151 51 50507917
Condition aggravated 14.25 10.18 448 96708 296610 50211358
Gaze palsy 14.09 10.18 15 97141 1318 50506650
Oesophageal atresia 13.92 10.18 10 97146 517 50507451
Feeling guilty 13.87 10.18 10 97146 520 50507448
Premature labour 13.84 10.18 51 97105 11425 50496543
Anhedonia 13.82 10.18 45 97111 9479 50498489
Blood lactate dehydrogenase increased 13.75 10.18 74 97082 19488 50488480
Erythema 13.75 10.18 198 96958 146216 50361752
Leucine aminopeptidase increased 13.70 10.18 3 97153 3 50507965
Dyskinesia neonatal 13.70 10.18 3 97153 3 50507965
Marcus Gunn syndrome 13.70 10.18 3 97153 3 50507965
Generalised tonic-clonic seizure 13.68 10.18 92 97064 26218 50481750
Increased appetite 13.50 10.18 41 97115 8320 50499648
Muscle contracture 13.50 10.18 14 97142 1193 50506775
Nodule 13.40 10.18 8 97148 16995 50490973
Tri-iodothyronine free decreased 13.38 10.18 8 97148 302 50507666
Product use in unapproved indication 13.34 10.18 150 97006 115669 50392299
Therapeutic product effect incomplete 13.29 10.18 112 97044 91403 50416565
Glossoptosis 13.29 10.18 5 97151 64 50507904
Oculogyric crisis 13.16 10.18 15 97141 1422 50506546
Panic disorder 13.12 10.18 19 97137 2284 50505684
Resting tremor 13.12 10.18 11 97145 715 50507253
Device expulsion 13.05 10.18 22 97134 28800 50479168
Adverse drug reaction 13.05 10.18 58 97098 55164 50452804
Decreased activity 13.04 10.18 30 97126 5157 50502811
Poor sucking reflex 13.02 10.18 7 97149 215 50507753
Oscillopsia 12.94 10.18 6 97150 133 50507835
Dissociative disorder 12.93 10.18 7 97149 218 50507750
Suicidal behaviour 12.93 10.18 19 97137 2315 50505653
Brugada syndrome 12.92 10.18 8 97148 322 50507646
Rhabdomyolysis 12.91 10.18 123 97033 38904 50469064
Clostridium difficile infection 12.88 10.18 18 97138 25421 50482547
Joint range of motion decreased 12.86 10.18 10 97146 18502 50489466
Infusion site scar 12.79 10.18 8 97148 328 50507640
Therapy interrupted 12.65 10.18 12 97144 20140 50487828
Genital labial adhesions 12.65 10.18 4 97152 29 50507939
Yawning 12.62 10.18 12 97144 921 50507047
Serum sickness-like reaction 12.59 10.18 9 97147 462 50507506
Regressive behaviour 12.57 10.18 5 97151 75 50507893
Aortic stenosis 12.53 10.18 26 97130 4168 50503800
Colitis microscopic 12.49 10.18 34 97122 6486 50501482
Congenital neurological disorder 12.49 10.18 3 97153 6 50507962
Asplenia 12.49 10.18 3 97153 6 50507962
Aeromonas infection 12.45 10.18 5 97151 77 50507891
Right aortic arch 12.40 10.18 7 97149 237 50507731
Delusion of grandeur 12.40 10.18 6 97150 147 50507821
Blood pressure fluctuation 12.30 10.18 32 97124 35791 50472177
Apallic syndrome 12.29 10.18 10 97146 623 50507345
Toxic shock syndrome 12.23 10.18 9 97147 483 50507485
Spina bifida occulta 12.17 10.18 3 97153 7 50507961
Laboratory test abnormal 12.17 10.18 16 97140 23192 50484776
Mouth ulceration 12.13 10.18 22 97134 28002 50479966
Atrial fibrillation 12.02 10.18 131 97025 101614 50406354
Haemoglobin decreased 11.95 10.18 172 96984 127044 50380924
Antiphospholipid antibodies 11.93 10.18 6 97150 160 50507808
Marital problem 11.90 10.18 6 97150 161 50507807
Muscle tightness 11.83 10.18 45 97111 10235 50497733
Septic shock 11.80 10.18 63 97093 57112 50450856
Intestinal infarction 11.79 10.18 12 97144 1000 50506968
Skin ulcer 11.78 10.18 32 97124 35286 50472682
Sexual dysfunction 11.76 10.18 22 97134 3270 50504698
Premature delivery 11.72 10.18 17 97139 23646 50484322
Paroxysmal arrhythmia 11.70 10.18 4 97152 38 50507930
Cholecystitis chronic 11.69 10.18 43 97113 9626 50498342
Anal atresia 11.68 10.18 8 97148 383 50507585
Inferior vena caval occlusion 11.63 10.18 3 97153 9 50507959
Abdominal wall cyst 11.63 10.18 3 97153 9 50507959
Visual impairment 11.63 10.18 190 96966 68085 50439883
Hypercapnic coma 11.57 10.18 6 97150 171 50507797
Posture abnormal 11.56 10.18 17 97139 2072 50505896
Tenosynovitis 11.55 10.18 3 97153 10562 50497406
Ear pain 11.55 10.18 23 97133 28260 50479708
Coronary artery disease 11.53 10.18 97 97059 29629 50478339
Dermatitis allergic 11.49 10.18 5 97151 12715 50495253
Pharyngitis 11.49 10.18 10 97146 17493 50490475
Pneumocystis jirovecii pneumonia 11.41 10.18 7 97149 14656 50493312
Platelet count decreased 11.38 10.18 131 97025 100595 50407373
Reversible cerebral vasoconstriction syndrome 11.38 10.18 17 97139 2102 50505866
Hypoosmolar state 11.38 10.18 6 97150 177 50507791
Blood aldosterone abnormal 11.34 10.18 4 97152 42 50507926
Congenital coronary artery malformation 11.30 10.18 5 97151 99 50507869
Bradykinesia 11.26 10.18 24 97132 3919 50504049
Double outlet right ventricle 11.26 10.18 4 97152 43 50507925
Persecutory delusion 11.21 10.18 18 97138 2369 50505599
Accidental overdose 11.20 10.18 70 97086 19463 50488505
Liver function test increased 11.18 10.18 20 97136 25586 50482382
Hyperventilation 11.17 10.18 29 97127 5380 50502588
Prescription drug used without a prescription 11.14 10.18 15 97141 1685 50506283
Cystocele 11.06 10.18 12 97144 1077 50506891
Cataract 10.98 10.18 50 97106 47250 50460718
Diet refusal 10.96 10.18 9 97147 568 50507400
Blood cholinesterase decreased 10.91 10.18 5 97151 108 50507860
Obstructive airways disorder 10.86 10.18 59 97097 15593 50492375
Hyperthermia 10.84 10.18 36 97120 7660 50500308
Obesity 10.82 10.18 62 97094 16713 50491255
Parkinsonian gait 10.80 10.18 8 97148 434 50507534
Congenital pulmonary valve disorder 10.72 10.18 4 97152 50 50507918
Respiratory tract infection 10.69 10.18 29 97127 31988 50475980
Congenital diaphragmatic hernia 10.50 10.18 6 97150 208 50507760
Anencephaly 10.50 10.18 6 97150 208 50507760
Left ventricular dysfunction 10.49 10.18 44 97112 10462 50497506
Stupor 10.46 10.18 22 97134 3561 50504407
Congenital eye disorder 10.43 10.18 3 97153 15 50507953
Palmar-plantar erythrodysaesthesia syndrome 10.40 10.18 14 97142 20084 50487884
Diverticulitis 10.38 10.18 31 97125 33151 50474817
Mutism 10.32 10.18 13 97143 1368 50506600
Influenza 10.29 10.18 116 97040 89422 50418546
Normetanephrine urine increased 10.27 10.18 3 97153 16 50507952
Hydrocephalus 10.23 10.18 26 97130 4762 50503206
Transaminases increased 10.22 10.18 24 97132 27800 50480168
Posturing 10.20 10.18 8 97148 473 50507495
Housebound 10.19 10.18 6 97150 220 50507748

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 1786.34 11.01 638 50167 7916 29515806
Atrial septal defect 802.54 11.01 335 50470 6454 29517268
Ventricular septal defect 555.16 11.01 214 50591 3315 29520407
Patent ductus arteriosus 482.31 11.01 187 50618 2944 29520778
Foetal exposure during pregnancy 432.45 11.01 401 50404 33466 29490256
Drug withdrawal syndrome 397.71 11.01 293 50512 17691 29506031
Cardiac murmur 348.45 11.01 187 50618 6426 29517296
Congenital anomaly 303.29 11.01 106 50699 1222 29522500
Suicidal ideation 288.09 11.01 326 50479 34390 29489332
Heart disease congenital 250.06 11.01 91 50714 1189 29522533
Multiple congenital abnormalities 248.83 11.01 73 50732 451 29523271
Serotonin syndrome 246.17 11.01 219 50586 17293 29506429
Pulmonary valve stenosis 228.78 11.01 63 50742 298 29523424
Anxiety 221.59 11.01 467 50338 84898 29438824
Talipes 220.32 11.01 91 50714 1701 29522021
Suicide attempt 218.60 11.01 281 50524 33829 29489893
Irritability 206.16 11.01 221 50584 21931 29501791
Aggression 204.93 11.01 278 50527 35263 29488459
Coarctation of the aorta 186.61 11.01 57 50748 412 29523310
Persistent foetal circulation 168.23 11.01 49 50756 294 29523428
Completed suicide 165.48 11.01 431 50374 89815 29433907
Bicuspid aortic valve 161.16 11.01 43 50762 176 29523546
Hypoplastic left heart syndrome 159.26 11.01 43 50762 186 29523536
Pulmonary artery stenosis congenital 155.48 11.01 50 50755 436 29523286
Fallot's tetralogy 147.68 11.01 39 50766 152 29523570
Transposition of the great vessels 125.68 11.01 42 50763 418 29523304
Congenital aortic stenosis 115.94 11.01 28 50777 68 29523654
Mania 111.22 11.01 103 50702 8560 29515162
Agitation 106.46 11.01 257 50548 51047 29472675
Insomnia 103.90 11.01 362 50443 88399 29435323
Intentional self-injury 101.52 11.01 116 50689 12345 29511377
Impulsive behaviour 99.68 11.01 54 50751 1889 29521833
Craniosynostosis 99.31 11.01 32 50773 281 29523441
Panic attack 99.24 11.01 95 50710 8231 29515491
Disturbance in attention 97.69 11.01 150 50655 21274 29502448
Developmental delay 96.92 11.01 58 50747 2460 29521262
Activation syndrome 94.97 11.01 24 50781 75 29523647
Tremor 94.05 11.01 309 50496 73229 29450493
Extrapyramidal disorder 91.93 11.01 103 50702 10728 29512994
Depression 90.90 11.01 337 50468 84810 29438912
Febrile neutropenia 90.13 11.01 40 50765 112200 29411522
Off label use 89.63 11.01 245 50560 300555 29223167
Congenital cardiovascular anomaly 82.65 11.01 25 50780 174 29523548
Homicide 80.96 11.01 37 50768 891 29522831
Neuroleptic malignant syndrome 79.22 11.01 117 50688 16031 29507691
Sopor 77.83 11.01 95 50710 10839 29512883
Death 76.97 11.01 315 50490 341769 29181953
Pneumonia 76.36 11.01 288 50517 319884 29203838
Intentional overdose 74.60 11.01 188 50617 38340 29485382
Cleft lip and palate 74.59 11.01 26 50779 297 29523425
Acute kidney injury 73.86 11.01 223 50582 265044 29258678
Anger 73.30 11.01 92 50713 10798 29512924
Sleep disorder 72.12 11.01 141 50664 24245 29499477
Coma 69.70 11.01 186 50619 39264 29484458
Withdrawal syndrome 69.47 11.01 90 50715 10902 29512820
Somnolence 69.14 11.01 332 50473 93623 29430099
Double outlet right ventricle 68.12 11.01 19 50786 95 29523627
Drug abuse 67.48 11.01 294 50511 79589 29444133
Congenital aortic atresia 64.99 11.01 14 50791 15 29523707
Pulmonary malformation 59.50 11.01 14 50791 29 29523693
Tricuspid valve incompetence 58.23 11.01 72 50733 8322 29515400
Hypoplastic right heart syndrome 57.17 11.01 12 50793 10 29523712
Mood swings 56.54 11.01 66 50739 7185 29516537
Cleft palate 56.40 11.01 25 50780 559 29523163
Speech disorder developmental 55.99 11.01 37 50768 1870 29521852
Inappropriate antidiuretic hormone secretion 54.76 11.01 80 50725 10852 29512870
Drug ineffective 52.63 11.01 387 50418 362783 29160939
Sexual dysfunction 52.29 11.01 57 50748 5757 29517965
Confusional state 52.10 11.01 387 50418 127490 29396232
Hyperhidrosis 51.81 11.01 234 50571 64306 29459416
Poisoning deliberate 51.22 11.01 56 50749 5675 29518047
Drug withdrawal syndrome neonatal 50.76 11.01 44 50761 3351 29520371
Sepsis 50.44 11.01 106 50699 142576 29381146
Nervousness 49.90 11.01 78 50727 11228 29512494
Pulmonary valve stenosis congenital 47.35 11.01 15 50790 124 29523598
Plagiocephaly 46.91 11.01 21 50784 481 29523241
Dyspnoea 46.90 11.01 349 50456 326383 29197339
Hamartoma 46.01 11.01 12 50793 44 29523678
Diarrhoea 45.58 11.01 360 50445 332338 29191384
Congenital aortic valve incompetence 45.46 11.01 15 50790 143 29523579
Arnold-Chiari malformation 45.35 11.01 18 50787 302 29523420
Thrombocytopenia 44.50 11.01 104 50701 134719 29389003
Gun shot wound 44.39 11.01 26 50779 1059 29522663
Nightmare 43.91 11.01 74 50731 11343 29512379
Depressed mood 43.73 11.01 91 50714 16357 29507365
Visceral congestion 43.52 11.01 20 50785 488 29523234
Erectile dysfunction 42.56 11.01 95 50710 17914 29505808
Overdose 42.35 11.01 258 50547 79561 29444161
Ventricular hypoplasia 42.23 11.01 12 50793 65 29523657
Attention deficit hyperactivity disorder 42.07 11.01 33 50772 2184 29521538
Anaemia 41.99 11.01 190 50615 200761 29322961
Maternal drugs affecting foetus 41.87 11.01 42 50763 3851 29519871
Anticholinergic syndrome 40.79 11.01 23 50782 871 29522851
Hyperreflexia 39.59 11.01 35 50770 2737 29520985
Right aortic arch 39.52 11.01 9 50796 15 29523707
Tremor neonatal 39.51 11.01 17 50788 353 29523369
Hangover 38.89 11.01 23 50782 954 29522768
Pyrexia 38.53 11.01 313 50492 287309 29236413
Right ventricular hypertrophy 37.70 11.01 24 50781 1137 29522585
Akathisia 37.69 11.01 52 50753 6690 29517032
Congenital tricuspid valve atresia 37.69 11.01 12 50793 101 29523621
Restlessness 37.68 11.01 103 50702 22042 29501680
Mitral valve stenosis 36.62 11.01 15 50790 274 29523448
Rash 36.42 11.01 185 50620 189634 29334088
Cogwheel rigidity 36.21 11.01 24 50781 1219 29522503
Malignant neoplasm progression 35.30 11.01 45 50760 73814 29449908
Disease progression 35.07 11.01 54 50751 81862 29441860
Feeling of despair 34.87 11.01 21 50784 901 29522821
Memory impairment 34.48 11.01 139 50666 36331 29487391
Bipolar disorder 34.43 11.01 35 50770 3260 29520462
Amnesia 34.31 11.01 101 50704 22542 29501180
Somnolence neonatal 34.19 11.01 8 50797 16 29523706
Head titubation 33.16 11.01 14 50791 277 29523445
Abnormal behaviour 33.00 11.01 101 50704 23026 29500696
Congenital scoliosis 32.30 11.01 10 50795 76 29523646
Neutropenia 32.22 11.01 117 50688 131594 29392128
DiGeorge's syndrome 32.21 11.01 6 50799 0 29523722
Interruption of aortic arch 32.21 11.01 6 50799 0 29523722
Agoraphobia 32.17 11.01 13 50792 229 29523493
Hypomania 32.14 11.01 28 50777 2147 29521575
Oral discharge 32.01 11.01 11 50794 120 29523602
Congenital aortic anomaly 31.96 11.01 10 50795 79 29523643
Parkinsonism 31.82 11.01 50 50755 7228 29516494
Choanal atresia 31.81 11.01 7 50798 9 29523713
Hypospadias 31.58 11.01 32 50773 2970 29520752
Anencephaly 31.37 11.01 11 50794 128 29523594
Atrial fibrillation 31.35 11.01 86 50719 105560 29418162
Hyperthermia 30.93 11.01 57 50748 9373 29514349
Abdominal pain 30.68 11.01 124 50681 135233 29388489
Congenital pulmonary artery anomaly 30.61 11.01 7 50798 12 29523710
Homicidal ideation 30.45 11.01 29 50776 2495 29521227
Libido decreased 30.02 11.01 37 50768 4261 29519461
Paraesthesia 29.79 11.01 176 50629 53669 29470053
Infection 29.70 11.01 54 50751 76697 29447025
Drug dependence 29.35 11.01 91 50714 20890 29502832
Pancytopenia 29.18 11.01 62 50743 83106 29440616
Ejaculation delayed 29.01 11.01 12 50793 225 29523497
Dextrocardia 28.94 11.01 10 50795 111 29523611
Vertigo 28.92 11.01 93 50712 21768 29501954
Thinking abnormal 28.69 11.01 40 50765 5196 29518526
Congenital coronary artery malformation 28.68 11.01 8 50797 40 29523682
Epistaxis 28.53 11.01 28 50777 51676 29472046
Verbal abuse 28.48 11.01 11 50794 171 29523551
Mydriasis 28.28 11.01 43 50762 6042 29517680
Renal impairment 28.23 11.01 61 50744 81272 29442450
Tearfulness 28.16 11.01 23 50782 1613 29522109
Cough 28.15 11.01 117 50688 126610 29397112
Altered state of consciousness 27.58 11.01 86 50719 19803 29503919
Congenital genitourinary abnormality 27.32 11.01 8 50797 49 29523673
Intentional product use issue 27.14 11.01 20 50785 42478 29481244
Emotional distress 27.08 11.01 68 50737 13827 29509895
Physical assault 27.00 11.01 19 50786 1065 29522657
Congenital mitral valve stenosis 26.84 11.01 5 50800 0 29523722
Ebstein's anomaly 26.84 11.01 5 50800 0 29523722
Cytomegalovirus infection 26.70 11.01 4 50801 23211 29500511
Paranoia 26.66 11.01 55 50750 9822 29513900
Developmental hip dysplasia 26.64 11.01 12 50793 279 29523443
Hyper IgE syndrome 26.53 11.01 8 50797 55 29523667
Muscle rigidity 26.11 11.01 53 50752 9358 29514364
Pulmonary valve incompetence 26.06 11.01 16 50789 711 29523011
Product use issue 26.00 11.01 30 50775 51414 29472308
Multiple cardiac defects 25.82 11.01 8 50797 61 29523661
Selective eating disorder 25.77 11.01 22 50783 1641 29522081
Autism spectrum disorder 25.77 11.01 24 50781 2008 29521714
Pulmonary artery stenosis 25.76 11.01 11 50794 224 29523498
Cleft lip 25.34 11.01 12 50793 314 29523408
Bronchopulmonary dysplasia 25.32 11.01 14 50791 510 29523212
Ejaculation failure 25.27 11.01 16 50789 751 29522971
Drug abuser 25.22 11.01 32 50773 3795 29519927
Blepharospasm 25.14 11.01 18 50787 1037 29522685
Vascular stenosis 24.97 11.01 10 50795 172 29523550
Emotional disorder 24.57 11.01 36 50769 4895 29518827
Reversible cerebral vasoconstriction syndrome 24.33 11.01 11 50794 258 29523464
Aortic valve incompetence 24.11 11.01 36 50769 4977 29518745
Treatment failure 24.09 11.01 17 50788 36922 29486800
Congenital hand malformation 23.97 11.01 14 50791 567 29523155
Neural tube defect 23.75 11.01 7 50798 44 29523678
Congenital pulmonary hypertension 23.62 11.01 7 50798 45 29523677
Neonatal asphyxia 23.47 11.01 11 50794 281 29523441
General physical health deterioration 23.44 11.01 94 50711 102763 29420959
Septic shock 23.33 11.01 45 50760 62515 29461207
C-reactive protein increased 23.26 11.01 25 50780 44238 29479484
Congenital tracheomalacia 22.91 11.01 5 50800 6 29523716
Psychotic disorder 22.88 11.01 82 50723 20272 29503450
Seizure 22.57 11.01 252 50553 92871 29430851
Cardiomegaly 22.37 11.01 63 50742 13713 29510009
Truncus arteriosus persistent 22.21 11.01 6 50799 26 29523696
Hallucination, auditory 21.99 11.01 50 50755 9543 29514179
Hospitalisation 21.98 11.01 28 50777 45960 29477762
Joint swelling 21.93 11.01 32 50773 49598 29474124
Depressed level of consciousness 21.89 11.01 123 50682 36819 29486903
Gastroschisis 21.88 11.01 8 50797 106 29523616
Mood altered 21.70 11.01 45 50760 8066 29515656
Haemoglobin decreased 21.68 11.01 104 50701 108271 29415451
Logorrhoea 21.57 11.01 23 50782 2265 29521457
Congenital hydronephrosis 21.52 11.01 14 50791 689 29523033
Mitral valve atresia 21.47 11.01 4 50801 0 29523722
Noonan syndrome 21.47 11.01 4 50801 0 29523722
Porencephaly 21.47 11.01 4 50801 0 29523722
Abdominal transposition 21.47 11.01 4 50801 0 29523722
Idiosyncratic alcohol intoxication 21.47 11.01 4 50801 0 29523722
Hepatic enzyme increased 21.46 11.01 16 50789 33783 29489939
Spina bifida 21.46 11.01 11 50794 343 29523379
Erythema 21.35 11.01 63 50742 75543 29448179
Platelet count decreased 21.20 11.01 100 50705 104572 29419150
Chemical submission 21.19 11.01 6 50799 32 29523690
Congenital diaphragmatic hernia 21.17 11.01 10 50795 260 29523462
Infantile apnoea 20.86 11.01 15 50790 870 29522852
Respiratory acidosis 20.70 11.01 31 50774 4297 29519425
Product use in unapproved indication 20.68 11.01 78 50727 86797 29436925
Agitation neonatal 20.65 11.01 16 50789 1040 29522682
Wolff-Parkinson-White syndrome 20.52 11.01 9 50796 196 29523526
Self esteem decreased 20.13 11.01 12 50793 505 29523217
Toxicity to various agents 20.12 11.01 414 50391 173247 29350475
Tonic convulsion 20.11 11.01 15 50790 921 29522801
Blood creatine phosphokinase increased 20.05 11.01 129 50676 40515 29483207
Flat affect 20.00 11.01 14 50791 778 29522944
Bradykinesia 19.89 11.01 27 50778 3420 29520302
Sleep apnoea syndrome 19.87 11.01 71 50734 17528 29506194
Premature baby 19.75 11.01 70 50735 17210 29506512
Somatic dysfunction 19.69 11.01 5 50800 16 29523706
Ventricular hypertrophy 19.63 11.01 30 50775 4234 29519488
Congenital hydrocephalus 19.48 11.01 7 50798 88 29523634
Tension 19.41 11.01 20 50785 1893 29521829
Decreased interest 19.29 11.01 21 50784 2117 29521605
Congenital flat feet 19.24 11.01 4 50801 3 29523719
Pneumocystis jirovecii pneumonia 19.04 11.01 3 50802 16776 29506946
Cardiac failure 18.99 11.01 71 50734 79216 29444506
Derealisation 18.88 11.01 12 50793 567 29523155
Peripheral swelling 18.81 11.01 52 50753 63687 29460035
Cerebrovascular stenosis 18.73 11.01 7 50798 99 29523623
Right ventricle outflow tract obstruction 18.71 11.01 4 50801 4 29523718
Infantile back arching 18.71 11.01 4 50801 4 29523718
Affect lability 18.66 11.01 26 50779 3376 29520346
Disorientation 18.65 11.01 100 50705 29415 29494307
Gastrointestinal haemorrhage 18.55 11.01 72 50733 79461 29444261
Psychiatric symptom 18.47 11.01 25 50780 3159 29520563
Scaphocephaly 18.45 11.01 5 50800 22 29523700
Transient tachypnoea of the newborn 18.42 11.01 8 50797 170 29523552
Crying 18.38 11.01 33 50772 5318 29518404
Hypotension 18.26 11.01 230 50575 194124 29329598
Dysmorphism 18.26 11.01 24 50781 2947 29520775
COVID-19 18.19 11.01 21 50784 35993 29487729
Euphoric mood 18.19 11.01 31 50774 4794 29518928
Type 2 diabetes mellitus 18.16 11.01 58 50747 13523 29510199
Renal dysplasia 18.12 11.01 8 50797 177 29523545
Drug reaction with eosinophilia and systemic symptoms 18.09 11.01 13 50792 27979 29495743
Obsessive thoughts 18.09 11.01 12 50793 610 29523112
Ascites 17.81 11.01 22 50783 36597 29487125
Chordee 17.75 11.01 6 50799 62 29523660
Renal failure 17.73 11.01 125 50680 118474 29405248
Abulia 17.69 11.01 11 50794 500 29523222
Oedema peripheral 17.59 11.01 105 50700 103452 29420270
Maternal exposure during pregnancy 17.57 11.01 28 50777 4095 29519627
Caesarean section 17.55 11.01 19 50786 1904 29521818
Ejaculation disorder 17.49 11.01 14 50791 954 29522768
Neutrophil count decreased 17.44 11.01 30 50775 43537 29480185
Congenital renal disorder 17.42 11.01 6 50799 66 29523656
Aortic stenosis 17.37 11.01 27 50778 3867 29519855
Hypersensitivity 17.27 11.01 41 50764 52862 29470860
Ammonia abnormal 17.25 11.01 6 50799 68 29523654
Myoclonus 17.04 11.01 56 50749 13253 29510469
Dyskinesia 17.03 11.01 74 50731 19987 29503735
Abnormal dreams 16.90 11.01 37 50768 6883 29516839
Tricuspid valve disease 16.90 11.01 8 50797 209 29523513
Pulmonary hypoplasia 16.88 11.01 10 50795 416 29523306
Alcohol interaction 16.87 11.01 22 50783 2681 29521041
Infusion related reaction 16.86 11.01 31 50774 43855 29479867
Hyperkinesia 16.74 11.01 17 50788 1582 29522140
White blood cell count decreased 16.66 11.01 80 50725 83282 29440440
Pleurothotonus 16.63 11.01 14 50791 1024 29522698
Urinary tract infection 16.55 11.01 66 50739 72288 29451434
Speech disorder 16.47 11.01 82 50723 23434 29500288
Neurosis 16.46 11.01 7 50798 141 29523581
Mucosal inflammation 16.42 11.01 18 50787 31577 29492145
Hypertonia 16.32 11.01 26 50779 3803 29519919
Leukopenia 16.31 11.01 45 50760 55158 29468564
Opisthotonus 16.29 11.01 10 50795 444 29523278
Jaundice neonatal 16.25 11.01 15 50790 1241 29522481
Dystonia 16.23 11.01 45 50760 9704 29514018
Judgement impaired 16.21 11.01 11 50794 581 29523141
Cyclothymic disorder 16.11 11.01 6 50799 84 29523638
Congenital pulmonary valve disorder 16.11 11.01 3 50802 0 29523722
Congenital Eustachian tube anomaly 16.11 11.01 3 50802 0 29523722
Vesicoureteric reflux 16.07 11.01 7 50798 150 29523572
Asphyxia 16.03 11.01 31 50774 5284 29518438
Clumsiness 15.74 11.01 16 50789 1490 29522232
Exomphalos 15.73 11.01 7 50798 158 29523564
Vasoplegia syndrome 15.72 11.01 16 50789 1492 29522230
Cryptorchism 15.68 11.01 18 50787 1924 29521798
Personality disorder 15.68 11.01 14 50791 1109 29522613
Inadequate analgesia 15.64 11.01 21 50784 2633 29521089
Dissociation 15.61 11.01 14 50791 1115 29522607
Contraindicated product administered 15.46 11.01 6 50799 18260 29505462
Obsessive-compulsive disorder 15.43 11.01 28 50777 4548 29519174
Drug intolerance 15.39 11.01 38 50767 48341 29475381
Plasma cell myeloma 15.37 11.01 25 50780 37090 29486632
Mitral valve incompetence 15.32 11.01 54 50751 13239 29510483
Renal salt-wasting syndrome 15.22 11.01 7 50798 171 29523551
Cerebral palsy 15.15 11.01 6 50799 100 29523622
Legal problem 15.15 11.01 7 50798 173 29523549
Lower respiratory tract infection 15.03 11.01 14 50791 26488 29497234
Rebound effect 15.03 11.01 18 50787 2013 29521709
Panic disorder 14.98 11.01 14 50791 1176 29522546
Infertility male 14.93 11.01 7 50798 179 29523543
Epilepsy 14.89 11.01 67 50738 18365 29505357
Phimosis 14.74 11.01 11 50794 676 29523046
Chronic kidney disease 14.64 11.01 25 50780 36391 29487331
Congenital mitral valve incompetence 14.58 11.01 6 50799 111 29523611
Feeling jittery 14.57 11.01 24 50781 3609 29520113
Ankyloglossia congenital 14.53 11.01 8 50797 289 29523433
Feeling abnormal 14.42 11.01 150 50655 54295 29469427
Neoplasm progression 14.35 11.01 7 50798 18605 29505117
Thrombosis 14.34 11.01 33 50772 43012 29480710
Arthralgia 14.34 11.01 162 50643 139455 29384267
Neuropathy peripheral 14.29 11.01 68 50737 70959 29452763
Haemoptysis 14.19 11.01 19 50786 30531 29493191
Delusion 14.19 11.01 47 50758 11169 29512553
Mitral valve prolapse 14.19 11.01 10 50795 562 29523160
Multiple organ dysfunction syndrome 14.16 11.01 58 50747 63058 29460664
Brachycephaly 14.12 11.01 5 50800 60 29523662
Jealous delusion 14.12 11.01 7 50798 203 29523519
Plasmodium vivax infection 14.03 11.01 3 50802 3 29523719
Oculoauriculovertebral dysplasia 14.03 11.01 3 50802 3 29523719
Feeling guilty 13.97 11.01 8 50797 312 29523410
Pyloric stenosis 13.88 11.01 11 50794 739 29522983
Device breakage 13.88 11.01 16 50789 1718 29522004
Hyponatraemia 13.73 11.01 177 50628 67456 29456266
Poisoning 13.66 11.01 43 50762 9950 29513772
Major depression 13.62 11.01 24 50781 3811 29519911
VACTERL syndrome 13.57 11.01 3 50802 4 29523718
Resting tremor 13.51 11.01 10 50795 607 29523115
Sexually transmitted disease 13.46 11.01 4 50801 26 29523696
Pruritus 13.45 11.01 132 50673 116717 29407005
Otitis media chronic 13.42 11.01 5 50800 70 29523652
Product complaint 13.32 11.01 29 50776 5376 29518346
Congenital tricuspid valve incompetence 13.11 11.01 6 50799 145 29523577
Apnoea 13.10 11.01 31 50774 6071 29517651
Anomalous pulmonary venous connection 13.05 11.01 5 50800 76 29523646
Cytogenetic abnormality 13.03 11.01 11 50794 808 29522914
Affective disorder 13.01 11.01 21 50784 3105 29520617
Colitis 12.98 11.01 21 50784 31227 29492495
Anaphylactic reaction 12.96 11.01 17 50788 27556 29496166
Mitral valve disease 12.91 11.01 13 50792 1197 29522525
Hyperventilation 12.88 11.01 18 50787 2344 29521378
Asplenia 12.87 11.01 5 50800 79 29523643
Pulmonary aplasia 12.82 11.01 3 50802 6 29523716
Thought insertion 12.82 11.01 3 50802 6 29523716
Bone marrow failure 12.82 11.01 17 50788 27432 29496290
Drug-induced liver injury 12.80 11.01 11 50794 21644 29502078
Patient uncooperative 12.78 11.01 8 50797 368 29523354
Impulse-control disorder 12.78 11.01 13 50792 1212 29522510
Personality change 12.72 11.01 26 50779 4612 29519110
Tardive dyskinesia 12.71 11.01 28 50777 5230 29518492
Administration related reaction 12.70 11.01 5 50800 82 29523640
Eating disorder 12.61 11.01 34 50771 7213 29516509
Weight gain poor 12.57 11.01 11 50794 848 29522874
Atrioventricular septal defect 12.53 11.01 6 50799 161 29523561
Periventricular leukomalacia 12.53 11.01 4 50801 34 29523688
Incoherent 12.50 11.01 24 50781 4068 29519654
Drug screen positive 12.49 11.01 23 50782 3778 29519944
Aorta hypoplasia 12.48 11.01 5 50800 86 29523636
Abdominal distension 12.42 11.01 39 50766 45872 29477850
Hydrocele 12.35 11.01 16 50789 1937 29521785
Failure to thrive 12.33 11.01 35 50770 7649 29516073
Hypertonia neonatal 12.33 11.01 8 50797 392 29523330
Subgaleal haematoma 12.33 11.01 4 50801 36 29523686
Product administration error 12.31 11.01 53 50752 14257 29509465
Loss of consciousness 12.29 11.01 187 50618 73869 29449853
Sedation complication 12.28 11.01 13 50792 1269 29522453
Palmar-plantar erythrodysaesthesia syndrome 12.24 11.01 5 50800 14754 29508968
Feeling of relaxation 12.23 11.01 4 50801 37 29523685
Limb asymmetry 12.22 11.01 5 50800 91 29523631
Eyelid ptosis congenital 12.17 11.01 5 50800 92 29523630
Basal cell carcinoma 12.09 11.01 7 50798 16903 29506819
Blood creatinine increased 12.08 11.01 91 50714 85011 29438711
Tinnitus 12.05 11.01 56 50749 15558 29508164
Hepatotoxicity 11.94 11.01 8 50797 17859 29505863
Device related infection 11.87 11.01 6 50799 15630 29508092
Persistent depressive disorder 11.86 11.01 7 50798 289 29523433
Therapeutic response decreased 11.85 11.01 15 50790 24696 29499026
Dehydration 11.83 11.01 133 50672 114615 29409107
Haematochezia 11.80 11.01 29 50776 36954 29486768
Depersonalisation/derealisation disorder 11.79 11.01 9 50796 572 29523150
Microcephaly 11.78 11.01 10 50795 740 29522982
Herpes zoster 11.75 11.01 21 50784 30031 29493691
Duodenal atresia 11.72 11.01 3 50802 10 29523712
Circulatory collapse 11.64 11.01 9 50796 18664 29505058
Suspiciousness 11.63 11.01 7 50798 300 29523422
Hypocalcaemia 11.62 11.01 11 50794 20654 29503068
Exhibitionism 11.61 11.01 4 50801 44 29523678
Decerebrate posture 11.61 11.01 4 50801 44 29523678
Ventricular tachycardia 11.58 11.01 13 50792 22561 29501161
Divorced 11.50 11.01 3 50802 11 29523711
Syndactyly 11.50 11.01 10 50795 765 29522957
Hepatocellular injury 11.46 11.01 69 50736 21174 29502548
Anorgasmia 11.44 11.01 9 50796 598 29523124
Hemivertebra 11.44 11.01 5 50800 108 29523614
Neutropenic sepsis 11.44 11.01 3 50802 11724 29511998
Cognitive disorder 11.23 11.01 74 50731 23425 29500297
Intention tremor 11.22 11.01 7 50798 320 29523402
Neonatal disorder 11.19 11.01 10 50795 793 29522929

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 779.33 10.09 602 111208 38680 64348242
Drug withdrawal syndrome 737.91 10.09 532 111278 30759 64356163
Suicidal ideation 559.52 10.09 632 111178 65910 64321012
Suicide attempt 454.00 10.09 587 111223 70420 64316502
Sopor 421.99 10.09 375 111435 29286 64357636
Anxiety 413.07 10.09 1013 110797 201636 64185286
Drug abuse 351.22 10.09 735 111075 131639 64255283
Tremor 297.55 10.09 737 111073 147493 64239429
Agitation 292.95 10.09 539 111271 87828 64299094
Completed suicide 261.30 10.09 919 110891 223495 64163427
Irritability 254.08 10.09 316 111494 36430 64350492
Intentional self-injury 247.59 10.09 278 111532 28766 64358156
Somnolence 247.51 10.09 846 110964 202799 64184123
Mania 227.81 10.09 204 111606 16082 64370840
Mydriasis 226.55 10.09 198 111612 15114 64371808
Aggression 209.01 10.09 324 111486 45908 64341014
Nightmare 199.89 10.09 213 111597 20780 64366142
Depression 194.06 10.09 728 111082 182563 64204359
Confusional state 191.84 10.09 928 110882 260216 64126706
Disturbance in attention 187.27 10.09 289 111521 40785 64346137
Neuroleptic malignant syndrome 182.55 10.09 221 111589 24775 64362147
Panic attack 175.91 10.09 199 111611 20754 64366168
Off label use 173.52 10.09 543 111267 632263 63754659
Depersonalisation/derealisation disorder 160.33 10.09 71 111739 1569 64385353
Drug interaction 159.07 10.09 1123 110687 360960 64025962
Hyponatraemia 154.30 10.09 586 111224 147753 64239169
Derealisation 153.52 10.09 67 111743 1428 64385494
Activation syndrome 151.70 10.09 43 111767 228 64386694
Mood swings 145.11 10.09 165 111645 17303 64369619
Inappropriate antidiuretic hormone secretion 143.46 10.09 185 111625 22104 64364818
Disorientation 142.08 10.09 305 111505 55523 64331399
Joint swelling 140.65 10.09 101 111709 215281 64171641
Febrile neutropenia 140.54 10.09 75 111735 187582 64199340
Contraindicated product administered 139.41 10.09 13 111797 107816 64279106
Dissociation 138.18 10.09 78 111732 2933 64383989
Insomnia 137.99 10.09 693 111117 197143 64189779
Feeling of despair 135.67 10.09 73 111737 2495 64384427
Anger 132.99 10.09 150 111660 15591 64371331
Hyperhidrosis 132.79 10.09 497 111313 124423 64262499
Extrapyramidal disorder 125.39 10.09 162 111648 19390 64367532
Withdrawal syndrome 125.35 10.09 178 111632 23314 64363608
Restlessness 124.65 10.09 237 111573 39548 64347374
Drug intolerance 122.93 10.09 88 111722 187904 64199018
Overdose 122.04 10.09 574 111236 158992 64227930
Synovitis 120.31 10.09 15 111795 99075 64287847
Impulsive behaviour 116.86 10.09 67 111743 2596 64384326
Drug ineffective 115.17 10.09 920 110890 839327 63547595
Homicide 113.07 10.09 50 111760 1101 64385821
Intentional overdose 111.99 10.09 377 111433 89567 64297355
Cogwheel rigidity 109.98 10.09 66 111744 2787 64384135
Poisoning deliberate 109.88 10.09 126 111684 13332 64373590
Dyskinesia 106.96 10.09 221 111589 39167 64347755
Bradyphrenia 106.90 10.09 105 111705 9301 64377621
Infusion related reaction 103.63 10.09 80 111730 164387 64222535
Toxicity to various agents 101.58 10.09 1019 110791 362494 64024428
Rash 100.07 10.09 432 111378 458117 63928805
Treatment failure 99.38 10.09 39 111771 116777 64270145
Gastric pH decreased 99.15 10.09 40 111770 695 64386227
Coma 94.25 10.09 350 111460 87265 64299657
Emotional disorder 92.91 10.09 112 111698 12495 64374427
Pneumonia 89.86 10.09 585 111225 558991 63827931
Alopecia 89.52 10.09 93 111717 165597 64221325
Akathisia 87.69 10.09 104 111706 11406 64375516
Rheumatoid arthritis 86.77 10.09 94 111716 164200 64222722
Hallucination, auditory 85.47 10.09 125 111685 16814 64370108
Hyperreflexia 85.37 10.09 82 111728 7066 64379856
Agoraphobia 85.09 10.09 33 111777 514 64386408
Hallucinations, mixed 85.01 10.09 76 111734 5976 64380946
Memory impairment 83.72 10.09 332 111478 85350 64301572
Drug dependence 80.19 10.09 178 111632 33134 64353788
Cough 79.21 10.09 264 111546 301884 64085038
Vertigo 77.59 10.09 252 111558 58759 64328163
Muscle rigidity 76.91 10.09 121 111689 17352 64369570
Sepsis 76.90 10.09 179 111631 230162 64156760
Delirium 76.58 10.09 279 111531 68915 64318007
Altered state of consciousness 76.47 10.09 189 111621 37713 64349209
Peripheral swelling 74.36 10.09 157 111653 208996 64177926
Flat affect 71.69 10.09 43 111767 1814 64385108
Homicidal ideation 71.34 10.09 53 111757 3204 64383718
Nervousness 71.22 10.09 158 111652 29398 64357524
Systemic lupus erythematosus 70.97 10.09 23 111787 77589 64309333
Paraesthesia 70.21 10.09 436 111374 134086 64252836
Glossodynia 69.06 10.09 14 111796 64682 64322240
Malignant neoplasm progression 68.45 10.09 57 111753 112814 64274108
Product use issue 67.40 10.09 99 111711 151616 64235306
Crying 67.06 10.09 123 111687 19967 64366955
Swelling 66.92 10.09 109 111701 160109 64226813
Feeling jittery 66.45 10.09 87 111723 10548 64376374
Bronchial neoplasm 66.35 10.09 26 111784 417 64386505
Myoclonus 65.93 10.09 139 111671 24979 64361943
Libido increased 65.37 10.09 40 111770 1750 64385172
Depressed level of consciousness 64.43 10.09 296 111514 81140 64305782
Parkinsonism 63.91 10.09 100 111710 14273 64372649
Sleep disorder 63.75 10.09 238 111572 59471 64327451
Pericarditis 63.75 10.09 15 111795 62501 64324421
Hypersensitivity 63.70 10.09 155 111655 196297 64190625
Abnormal behaviour 62.97 10.09 163 111647 33459 64353463
Myoglobin urine present 62.41 10.09 27 111783 563 64386359
Tearfulness 60.38 10.09 56 111754 4617 64382305
Hypomania 60.34 10.09 61 111749 5593 64381329
Speech disorder 58.47 10.09 201 111609 48240 64338682
Depressed mood 58.36 10.09 180 111630 40832 64346090
Affective disorder 57.80 10.09 64 111746 6516 64380406
Nasal turbinate hypertrophy 56.55 10.09 25 111785 550 64386372
Psychotic disorder 56.10 10.09 159 111651 34419 64352503
Libido decreased 55.47 10.09 54 111756 4730 64382192
Hepatic enzyme increased 54.63 10.09 88 111722 129855 64257067
H1N1 influenza 54.45 10.09 39 111771 2227 64384695
Therapeutic product effect decreased 53.48 10.09 73 111737 115278 64271644
Clonus 53.27 10.09 59 111751 6008 64380914
Menstrual disorder 52.78 10.09 45 111765 3320 64383602
Neutropenia 52.60 10.09 225 111585 239399 64147523
Intentional product use issue 52.08 10.09 53 111757 95311 64291611
Endometrial ablation 51.57 10.09 26 111784 775 64386147
Dystonia 51.38 10.09 106 111704 18759 64368163
Paranoia 50.70 10.09 97 111713 16255 64370667
Feeling of body temperature change 49.67 10.09 51 111759 4763 64382159
Amnesia 49.54 10.09 190 111620 48079 64338843
Arthropathy 48.92 10.09 84 111726 120883 64266039
Delusion 48.81 10.09 101 111709 17913 64369009
Tinnitus 48.74 10.09 150 111660 33983 64352939
Helicobacter infection 48.58 10.09 5 111805 38357 64348565
Muscle twitching 48.55 10.09 104 111706 18894 64368028
Death 48.26 10.09 570 111240 482135 63904787
Parosmia 47.59 10.09 49 111761 4591 64382331
Disease progression 47.33 10.09 110 111700 141570 64245352
Personality disorder 46.97 10.09 49 111761 4662 64382260
Cytomegalovirus infection 46.72 10.09 5 111805 37194 64349728
Restless legs syndrome 46.41 10.09 96 111714 17020 64369902
Loss of consciousness 46.29 10.09 426 111384 147939 64238983
Lower respiratory tract infection 45.77 10.09 58 111752 94556 64292366
Self esteem decreased 45.48 10.09 25 111785 892 64386030
Pain 45.03 10.09 682 111128 552829 63834093
Dyspnoea 44.38 10.09 930 110880 717744 63669178
Nasopharyngitis 44.33 10.09 182 111628 195891 64191031
Emotional distress 43.89 10.09 150 111660 35888 64351034
Stomatitis 43.51 10.09 77 111733 109528 64277394
Muscle disorder 43.22 10.09 48 111762 4903 64382019
Euphoric mood 42.87 10.09 55 111755 6536 64380386
Pancytopenia 42.66 10.09 118 111692 143191 64243731
Fall 42.44 10.09 983 110827 415843 63971079
Seizure 42.29 10.09 459 111351 166433 64220489
Sexual dysfunction 42.09 10.09 54 111756 6417 64380505
Drooling 42.08 10.09 49 111761 5270 64381652
Gun shot wound 42.01 10.09 25 111785 1039 64385883
Blister 41.98 10.09 47 111763 80920 64306002
Hyperacusis 41.15 10.09 31 111779 1914 64385008
Therapeutic product ineffective 40.93 10.09 28 111782 1485 64385437
Infection 40.92 10.09 173 111637 184707 64202215
Hepatocellular injury 40.77 10.09 171 111639 45064 64341858
Galactorrhoea 40.48 10.09 38 111772 3181 64383741
Bipolar disorder 40.22 10.09 54 111756 6707 64380215
Logorrhoea 40.08 10.09 42 111768 4017 64382905
Thrombocytopenia 39.96 10.09 226 111584 223575 64163347
Anaemia 39.83 10.09 442 111368 378238 64008684
Neutrophil count decreased 39.81 10.09 45 111765 77151 64309771
Hangover 39.56 10.09 30 111780 1871 64385051
Hallucination 39.26 10.09 238 111572 72550 64314372
Abnormal dreams 39.20 10.09 67 111743 10289 64376633
Tachycardia 39.11 10.09 414 111396 149165 64237757
Bronchial haemorrhage 38.83 10.09 25 111785 1197 64385725
Hyperprolactinaemia 38.25 10.09 41 111769 4024 64382898
Dizziness 38.25 10.09 996 110814 429167 63957755
Acute kidney injury 38.07 10.09 549 111261 448691 63938231
Erectile dysfunction 38.04 10.09 74 111736 12553 64374369
Wound 37.92 10.09 46 111764 76431 64310491
Blood creatine phosphokinase increased 37.87 10.09 201 111609 58357 64328565
Cardio-respiratory arrest 37.80 10.09 296 111514 98097 64288825
Hostility 37.69 10.09 31 111779 2176 64384746
Hyperthermia 37.31 10.09 83 111727 15467 64371455
Septic shock 36.73 10.09 80 111730 105357 64281565
Incontinence 36.64 10.09 71 111739 12010 64374912
Renal ischaemia 36.51 10.09 23 111787 1060 64385862
PCO2 increased 36.23 10.09 27 111783 1640 64385282
Hallucination, visual 35.80 10.09 118 111692 27716 64359206
Psychomotor hyperactivity 35.66 10.09 78 111732 14373 64372549
General physical health deterioration 35.65 10.09 208 111602 204217 64182705
Drug abuser 35.49 10.09 47 111763 5761 64381161
Pyrexia 34.69 10.09 722 111088 557922 63829000
Verbal abuse 34.35 10.09 14 111796 250 64386672
Visceral congestion 34.26 10.09 20 111790 802 64386120
Abdominal discomfort 34.25 10.09 181 111629 182141 64204781
Neuropathy peripheral 34.06 10.09 98 111712 117427 64269495
COVID-19 33.56 10.09 38 111772 65102 64321820
Physical assault 33.51 10.09 25 111785 1521 64385401
Social anxiety disorder 33.12 10.09 16 111794 434 64386488
Thinking abnormal 32.73 10.09 66 111744 11490 64375432
Fear 31.98 10.09 92 111718 20079 64366843
Blepharospasm 31.69 10.09 34 111776 3341 64383581
Apathy 31.64 10.09 64 111746 11168 64375754
Arthralgia 31.59 10.09 558 111252 441702 63945220
Loss of libido 31.43 10.09 29 111781 2375 64384547
Product complaint 31.19 10.09 66 111744 11888 64375034
Rhonchi 30.97 10.09 34 111776 3429 64383493
Atrial fibrillation 30.94 10.09 172 111638 170917 64216005
Joint hyperextension 30.87 10.09 13 111797 253 64386669
Mobility decreased 30.84 10.09 64 111746 85776 64301146
Schizophrenia 30.70 10.09 63 111747 11105 64375817
Hypoaesthesia oral 30.29 10.09 64 111746 11516 64375406
Dependence 30.14 10.09 27 111783 2128 64384794
Sensory loss 29.91 10.09 59 111751 10110 64376812
Urinary retention 29.86 10.09 166 111644 49035 64337887
Chorea 29.85 10.09 26 111784 1974 64384948
Premature labour 29.77 10.09 50 111760 7570 64379352
Anorgasmia 29.13 10.09 19 111791 930 64385992
C-reactive protein increased 29.10 10.09 77 111733 94832 64292090
Soft tissue injury 28.70 10.09 23 111787 1556 64385366
Apraxia 28.63 10.09 28 111782 2467 64384455
Bronchial disorder 28.60 10.09 26 111784 2089 64384833
Mucosal inflammation 28.60 10.09 40 111770 62544 64324378
Abdominal pain 28.48 10.09 376 111434 311999 64074923
Mood altered 28.42 10.09 76 111734 15903 64371019
Poisoning 28.36 10.09 93 111717 21786 64365136
Myelosuppression 27.98 10.09 4 111806 23826 64363096
Injection site erythema 27.86 10.09 50 111760 70750 64316172
Oral discharge 27.83 10.09 12 111798 248 64386674
Cerebral microhaemorrhage 27.65 10.09 11 111799 184 64386738
Injection site pain 27.35 10.09 100 111710 111308 64275614
Neutropenic sepsis 27.10 10.09 4 111806 23268 64363654
Ejaculation failure 27.06 10.09 13 111797 348 64386574
Sensory disturbance 26.78 10.09 66 111744 13142 64373780
Hypertonia 26.73 10.09 43 111767 6282 64380640
Coma scale 26.59 10.09 8 111802 54 64386868
Tension 26.49 10.09 33 111777 3807 64383115
Obsessive-compulsive disorder 26.43 10.09 37 111773 4781 64382141
Respiratory acidosis 26.40 10.09 55 111755 9800 64377122
Asphyxia 26.34 10.09 54 111756 9512 64377410
Balance disorder 26.16 10.09 241 111569 83685 64303237
Weight increased 26.12 10.09 517 111293 212831 64174091
Ascites 26.04 10.09 42 111768 61959 64324963
Chemical submission 25.98 10.09 11 111799 217 64386705
Erythema 25.80 10.09 204 111606 186866 64200056
Feeling abnormal 25.77 10.09 349 111461 133253 64253669
White blood cell count decreased 25.72 10.09 164 111646 157673 64229249
Anaphylactic reaction 25.68 10.09 50 111760 68614 64318308
Folliculitis 25.63 10.09 10 111800 30067 64356855
Obsessive thoughts 25.59 10.09 18 111792 999 64385923
PO2 increased 25.57 10.09 21 111789 1471 64385451
Congenital hydrocephalus 25.37 10.09 7 111803 33 64386889
Cognitive disorder 25.32 10.09 173 111637 54914 64332008
Dysarthria 25.22 10.09 183 111627 59223 64327699
Gastrointestinal disorder 25.13 10.09 76 111734 89633 64297289
Creutzfeldt-Jakob disease 24.88 10.09 10 111800 172 64386750
Sinus tachycardia 24.71 10.09 116 111694 32072 64354850
Eye movement disorder 24.46 10.09 44 111766 7035 64379887
Hepatotoxicity 24.44 10.09 20 111790 39942 64346980
Pain in extremity 24.38 10.09 374 111436 302711 64084211
Electroencephalogram abnormal 24.25 10.09 37 111773 5166 64381756
Electrocardiogram QT prolonged 24.19 10.09 227 111583 79221 64307701
Platelet count decreased 24.01 10.09 181 111629 167530 64219392
Accidental poisoning 23.96 10.09 20 111790 1433 64385489
Substance abuse 23.89 10.09 51 111759 9241 64377681
Pneumocystis jirovecii pneumonia 23.86 10.09 9 111801 27625 64359297
Major depression 23.78 10.09 46 111764 7770 64379152
Head titubation 23.72 10.09 16 111794 829 64386093
Vision blurred 23.60 10.09 250 111560 90066 64296856
Paralysis 23.57 10.09 58 111752 11537 64375385
Rhabdomyolysis 23.55 10.09 253 111557 91473 64295449
Arthritis 23.48 10.09 71 111739 83743 64303179
Antidepressant discontinuation syndrome 23.34 10.09 5 111805 5 64386917
Ejaculation delayed 23.22 10.09 9 111801 140 64386782
Haemoglobin decreased 23.21 10.09 221 111589 194842 64192080
Post-traumatic neck syndrome 23.05 10.09 22 111788 1880 64385042
Diarrhoea 22.95 10.09 1022 110788 721682 63665240
Hypokinesia 22.83 10.09 72 111738 16524 64370398
Panic disorder 22.82 10.09 26 111784 2731 64384191
Affect lability 22.72 10.09 49 111761 8941 64377981
Depressive symptom 22.42 10.09 33 111777 4463 64382459
Muscle injury 22.19 10.09 9 111801 26428 64360494
Social avoidant behaviour 22.08 10.09 33 111777 4524 64382398
Metastases to liver 22.05 10.09 7 111803 23934 64362988
Oxygen saturation abnormal 21.98 10.09 29 111781 3542 64383380
Cardiac failure 21.85 10.09 137 111673 132236 64254686
Bradykinesia 21.69 10.09 40 111770 6520 64380402
Trichotillomania 21.52 10.09 9 111801 172 64386750
Negative thoughts 21.44 10.09 18 111792 1300 64385622
Idiosyncratic alcohol intoxication 21.44 10.09 4 111806 0 64386922
Self-injurious ideation 21.30 10.09 27 111783 3170 64383752
Pneumonitis 21.26 10.09 34 111776 50331 64336591
Clostridium difficile infection 21.02 10.09 19 111791 36144 64350778
Oropharyngeal pain 21.01 10.09 81 111729 88786 64298136
Inadequate analgesia 21.01 10.09 30 111780 3948 64382974
Discomfort 20.92 10.09 71 111739 80807 64306115
Mental disorder 20.81 10.09 96 111714 26349 64360573
Feelings of worthlessness 20.72 10.09 12 111798 474 64386448
Incoherent 20.58 10.09 41 111769 7077 64379845
Multiple organ dysfunction syndrome 20.56 10.09 98 111712 101315 64285607
Psychiatric symptom 20.42 10.09 38 111772 6235 64380687
Treatment noncompliance 20.25 10.09 137 111673 43345 64343577
Breath sounds abnormal 20.25 10.09 55 111755 11614 64375308
Product use in unapproved indication 20.21 10.09 202 111608 176416 64210506
Musculoskeletal pain 19.93 10.09 73 111737 81221 64305701
Leukopenia 19.85 10.09 99 111711 101143 64285779
Product dose omission issue 19.77 10.09 229 111581 194518 64192404
Feeling guilty 19.40 10.09 14 111796 809 64386113
Posterior reversible encephalopathy syndrome 18.95 10.09 8 111802 22938 64363984
Rhinitis 18.94 10.09 51 111759 10714 64376208
Blood sodium decreased 18.92 10.09 101 111709 29381 64357541
Somatic dysfunction 18.78 10.09 5 111805 20 64386902
Tardive dyskinesia 18.75 10.09 46 111764 9132 64377790
Illusion 18.73 10.09 18 111792 1552 64385370
Renal impairment 18.72 10.09 147 111663 134870 64252052
Blood pH decreased 18.70 10.09 30 111780 4372 64382550
Aspergillus infection 18.65 10.09 3 111807 16376 64370546
Housebound 18.56 10.09 11 111799 454 64386468
Intentional device use issue 18.40 10.09 5 111805 22 64386900
Alcoholism 18.38 10.09 26 111784 3391 64383531
Sinusitis 18.36 10.09 163 111647 145765 64241157
Hip arthroplasty 18.36 10.09 7 111803 21344 64365578
Sternal fracture 18.28 10.09 21 111789 2226 64384696
Foetal death 18.16 10.09 35 111775 5895 64381027
Diabetes insipidus 18.11 10.09 30 111780 4491 64382431
Epistaxis 18.09 10.09 98 111712 98033 64288889
Myoglobin blood increased 17.99 10.09 23 111787 2724 64384198
Vasoplegia syndrome 17.85 10.09 23 111787 2744 64384178
Alcohol abuse 17.85 10.09 31 111779 4821 64382101
Middle insomnia 17.83 10.09 56 111754 12821 64374101
Hyperlipidaemia 17.78 10.09 83 111727 22893 64364029
Drug screen positive 17.78 10.09 34 111776 5695 64381227
Ejaculation disorder 17.66 10.09 11 111799 497 64386425
Cytokine release syndrome 17.63 10.09 7 111803 20822 64366100
Migraine 17.56 10.09 176 111634 62501 64324421
Hospitalisation 17.49 10.09 69 111741 75138 64311784
Generalised anxiety disorder 17.47 10.09 19 111791 1896 64385026
Red blood cell sedimentation rate increased 17.46 10.09 17 111793 31218 64355704
Poriomania 17.34 10.09 8 111802 195 64386727
Hypoaesthesia 17.31 10.09 338 111472 138770 64248152
Obesity 17.19 10.09 76 111734 20486 64366436
Inflammation 17.11 10.09 57 111753 65243 64321679
Therapeutic response decreased 17.03 10.09 41 111769 52147 64334775
Hypervolaemia 16.97 10.09 25 111785 38260 64348662
Muscle tightness 16.95 10.09 50 111760 11065 64375857
Psoriatic arthropathy 16.64 10.09 31 111779 43250 64343672
Drug reaction with eosinophilia and systemic symptoms 16.60 10.09 44 111766 54173 64332749
Parkinson's disease 16.59 10.09 17 111793 1584 64385338
Campylobacter colitis 16.59 10.09 5 111805 34 64386888
Poor quality sleep 16.58 10.09 71 111739 18880 64368042
Injection site pruritus 16.47 10.09 25 111785 37801 64349121
Resting tremor 16.47 10.09 16 111794 1398 64385524
Cellulitis 16.47 10.09 95 111715 93562 64293360
Encephalopathy 16.40 10.09 165 111645 58654 64328268
Hyperkinesia 16.17 10.09 21 111789 2525 64384397
Soliloquy 16.15 10.09 11 111799 579 64386343
Judgement impaired 16.12 10.09 14 111796 1059 64385863
Dysacusis 16.08 10.09 3 111807 0 64386922
Brugada syndrome 16.06 10.09 14 111796 1064 64385858
Liver function test increased 16.02 10.09 18 111792 30952 64355970
Colitis microscopic 15.99 10.09 38 111772 7394 64379528
Reversible cerebral vasoconstriction syndrome 15.95 10.09 20 111790 2322 64384600
Urinary tract infection 15.93 10.09 294 111516 231302 64155620
Persecutory delusion 15.87 10.09 27 111783 4131 64382791
Urticaria 15.83 10.09 171 111639 147146 64239776
Oedema 15.76 10.09 94 111716 91841 64295081
Palmar-plantar erythrodysaesthesia syndrome 15.75 10.09 16 111794 28803 64358119
Phonophobia 15.70 10.09 10 111800 470 64386452
Impaired healing 15.69 10.09 53 111757 60420 64326502
Tri-iodothyronine free decreased 15.62 10.09 9 111801 352 64386570
Compartment syndrome 15.52 10.09 27 111783 4205 64382717
Vascular stenosis 15.51 10.09 10 111800 480 64386442
Drug resistance 15.48 10.09 23 111787 35079 64351843
Anticholinergic syndrome 15.39 10.09 21 111789 2648 64384274
Altered visual depth perception 15.32 10.09 9 111801 365 64386557
Infusion site scar 15.32 10.09 8 111802 257 64386665
Bronchopulmonary aspergillosis 15.22 10.09 7 111803 19078 64367844
Neoplasm progression 15.17 10.09 30 111780 40934 64345988
Blood pressure diastolic decreased 15.14 10.09 10 111800 22291 64364631
Lactose intolerance 15 10.09 18 111792 1998 64384924
Blood chloride decreased 14.97 10.09 37 111773 7379 64379543
Increased appetite 14.87 10.09 45 111765 10101 64376821
Hyperventilation 14.74 10.09 35 111775 6805 64380117
Delivery 14.74 10.09 10 111800 523 64386399
Psychomotor skills impaired 14.72 10.09 25 111785 3820 64383102
Decreased activity 14.68 10.09 36 111774 7144 64379778
Bone marrow failure 14.62 10.09 39 111771 47913 64339009
Amimia 14.55 10.09 5 111805 54 64386868
Dissociative amnesia 14.48 10.09 6 111804 112 64386810
Sedation 14.44 10.09 122 111688 41340 64345582
Dairy intolerance 14.39 10.09 5 111805 56 64386866
Endocrine ophthalmopathy 14.38 10.09 9 111801 410 64386512
Cystocele 14.34 10.09 11 111799 698 64386224
Diabetic hyperosmolar coma 14.24 10.09 11 111799 705 64386217
Tumour lysis syndrome 14.20 10.09 8 111802 19432 64367490
Epilepsy 14.06 10.09 103 111707 33428 64353494
Antiphospholipid antibodies 14.01 10.09 6 111804 122 64386800
Pleural effusion 13.96 10.09 146 111664 126413 64260509
Maternal exposure during pregnancy 13.94 10.09 103 111707 95781 64291141
Suspiciousness 13.81 10.09 10 111800 581 64386341
Basal cell carcinoma 13.80 10.09 20 111790 30818 64356104
Clumsiness 13.78 10.09 20 111790 2671 64384251
Therapy non-responder 13.76 10.09 63 111747 65836 64321086
Generalised tonic-clonic seizure 13.73 10.09 117 111693 39740 64347182
Marital problem 13.72 10.09 7 111803 214 64386708
Cyanosis 13.61 10.09 75 111735 22080 64364842
Jealous delusion 13.54 10.09 7 111803 220 64386702
Plasmodium vivax infection 13.54 10.09 3 111807 4 64386918
Injection site reaction 13.45 10.09 39 111771 46625 64340297
Slow response to stimuli 13.36 10.09 15 111795 1550 64385372
Mental impairment 13.36 10.09 60 111750 16283 64370639
Catatonia 13.31 10.09 36 111774 7584 64379338
Gastrointestinal haemorrhage 13.26 10.09 156 111654 132156 64254766
Antisocial personality disorder 13.17 10.09 4 111806 28 64386894
Stupor 13.14 10.09 31 111779 6004 64380918
Gaze palsy 13.13 10.09 19 111791 2531 64384391
Localised infection 13.07 10.09 20 111790 30141 64356781
Influenza like illness 13.07 10.09 164 111646 61538 64325384
Blood pressure systolic increased 13.07 10.09 43 111767 49410 64337512
Transaminases increased 13.05 10.09 37 111773 44557 64342365
Fluid retention 13.04 10.09 56 111754 59550 64327372
Inappropriate schedule of product administration 13.01 10.09 100 111710 92186 64294736
Loss of personal independence in daily activities 13 10.09 73 111737 72381 64314541
Bradycardia 12.98 10.09 282 111528 117937 64268985
Hypersomnia 12.96 10.09 68 111742 19649 64367273
Spinal pain 12.92 10.09 3 111807 12618 64374304
Posture abnormal 12.84 10.09 22 111788 3384 64383538
Cerebrovascular stenosis 12.80 10.09 6 111804 152 64386770
Diet refusal 12.78 10.09 11 111799 822 64386100
Tonic convulsion 12.71 10.09 16 111794 1865 64385057
Thought insertion 12.70 10.09 4 111806 32 64386890
Toxicologic test abnormal 12.68 10.09 13 111797 1212 64385710
Device related infection 12.62 10.09 21 111789 30605 64356317
Perseveration 12.60 10.09 8 111802 374 64386548
Ammonia abnormal 12.55 10.09 6 111804 159 64386763
Cholecystitis chronic 12.51 10.09 40 111770 9247 64377675
Hyperbilirubinaemia 12.49 10.09 11 111799 21194 64365728
Laboratory test abnormal 12.43 10.09 14 111796 24049 64362873
Acute respiratory distress syndrome 12.38 10.09 31 111779 38904 64348018
Violence-related symptom 12.37 10.09 10 111800 685 64386237
Blood triglycerides increased 12.36 10.09 65 111745 18801 64368121
Intention tremor 12.36 10.09 10 111800 686 64386236
Chronic kidney disease 12.31 10.09 55 111755 57864 64329058
Colitis 12.30 10.09 56 111754 58618 64328304
Therapy interrupted 12.29 10.09 10 111800 20026 64366896
Hypercholesterolaemia 12.24 10.09 56 111754 15317 64371605
Plasma cell myeloma 12.22 10.09 40 111770 46035 64340887
Autoimmune nephritis 12.20 10.09 9 111801 538 64386384
Serum sickness-like reaction 12.16 10.09 9 111801 541 64386381
Aphasia 12.01 10.09 116 111694 40790 64346132
Disinhibition 11.97 10.09 17 111793 2226 64384696
Oscillopsia 11.93 10.09 6 111804 178 64386744
Hyposmia 11.84 10.09 9 111801 563 64386359
Skin necrosis 11.83 10.09 5 111805 14324 64372598
Mouth ulceration 11.81 10.09 24 111786 32420 64354502
Fatigue 11.78 10.09 1128 110682 747602 63639320
Pruritus 11.74 10.09 433 111377 311967 64074955
Blood aldosterone abnormal 11.74 10.09 4 111806 42 64386880
Dyssomnia 11.74 10.09 4 111806 42 64386880
Coronary artery disease 11.70 10.09 158 111652 60275 64326647
Nephropathy toxic 11.69 10.09 8 111802 17506 64369416
Subdural haematoma 11.66 10.09 86 111724 27968 64358954
Injection site swelling 11.60 10.09 35 111775 41318 64345604
Impulse-control disorder 11.52 10.09 14 111796 1574 64385348
Toxic epidermal necrolysis 11.50 10.09 30 111780 37136 64349786
Back pain 11.47 10.09 338 111472 249833 64137089
Fibrocystic breast disease 11.44 10.09 9 111801 593 64386329
Prescription drug used without a prescription 11.43 10.09 18 111792 2582 64384340
Suicidal behaviour 11.35 10.09 19 111791 2868 64384054
Dermatitis allergic 11.35 10.09 6 111804 15103 64371819
Exhibitionism 11.34 10.09 4 111806 47 64386875
Convulsions local 11.26 10.09 4 111806 48 64386874
Granuloma 11.22 10.09 31 111779 6610 64380312
Hypervigilance 11.21 10.09 8 111802 454 64386468
Enterococcal infection 11.19 10.09 5 111805 13861 64373061
Paroxysmal arrhythmia 11.19 10.09 4 111806 49 64386873
Head injury 11.10 10.09 96 111714 32746 64354176
Cyclothymic disorder 11.10 10.09 6 111804 207 64386715
Feeling of relaxation 10.99 10.09 5 111805 118 64386804
Respiratory tract infection 10.97 10.09 31 111779 37376 64349546
Anhedonia 10.96 10.09 50 111760 13656 64373266
Job dissatisfaction 10.90 10.09 4 111806 53 64386869
Normetanephrine urine increased 10.73 10.09 3 111807 15 64386907
Blood bicarbonate decreased 10.72 10.09 25 111785 4804 64382118
Hyper IgE syndrome 10.72 10.09 8 111802 487 64386435
Administration related reaction 10.69 10.09 5 111805 126 64386796
Knee arthroplasty 10.68 10.09 19 111791 26980 64359942
Mental status changes 10.67 10.09 157 111653 61005 64325917
Personality change 10.67 10.09 36 111774 8557 64378365
Amylase increased 10.66 10.09 39 111771 9646 64377276
Muscle spasms 10.65 10.09 320 111490 140703 64246219
Energy increased 10.65 10.09 18 111792 2740 64384182
Hyperphagia 10.59 10.09 16 111794 2215 64384707
Bacteraemia 10.59 10.09 19 111791 26892 64360030
Ankle fracture 10.56 10.09 52 111758 14658 64372264
Ligament sprain 10.55 10.09 42 111768 10810 64376112
Influenza 10.52 10.09 126 111684 106405 64280517
Decreased interest 10.50 10.09 20 111790 3340 64383582
Skin ulcer 10.44 10.09 40 111770 43934 64342988
Rebound effect 10.43 10.09 25 111785 4892 64382030
Accommodation disorder 10.42 10.09 8 111802 508 64386414
Respiratory distress 10.35 10.09 51 111759 52280 64334642
Joint range of motion decreased 10.27 10.09 11 111799 19332 64367590
Visual impairment 10.25 10.09 183 111627 73894 64313028
Abulia 10.22 10.09 10 111800 881 64386041
Rash pruritic 10.21 10.09 58 111752 57346 64329576
Freezing phenomenon 10.21 10.09 13 111797 1533 64385389
Neurotoxicity 10.21 10.09 20 111790 27384 64359538
Metastases to lung 10.15 10.09 7 111803 15257 64371665

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
CHEMBL1708 ChEMBL_ID
DB00715 DRUGBANK_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 0378-7002 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 0378-7004 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 0615-8173 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 0615-8359 TABLET, FILM COATED 10 mg ORAL ANDA 25 sections
PAROXETINE HUMAN PRESCRIPTION DRUG LABEL 1 0904-5676 TABLET, FILM COATED 10 mg ORAL ANDA 31 sections
PAROXETINE HUMAN PRESCRIPTION DRUG LABEL 1 0904-5677 TABLET, FILM COATED 20 mg ORAL ANDA 31 sections
PAROXETINE HUMAN PRESCRIPTION DRUG LABEL 1 0904-5678 TABLET, FILM COATED 30 mg ORAL ANDA 31 sections
PAROXETINE HUMAN PRESCRIPTION DRUG LABEL 1 0904-5679 TABLET, FILM COATED 40 mg ORAL ANDA 31 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 25 sections
Paroxetine Human Prescription Drug Label 1 13107-155 TABLET, FILM COATED 20 mg ORAL ANDA 25 sections
Paroxetine Human Prescription Drug Label 1 13107-156 TABLET, FILM COATED 30 mg ORAL ANDA 25 sections
Paroxetine Human Prescription Drug Label 1 13107-157 TABLET, FILM COATED 40 mg ORAL ANDA 25 sections
PAROXETINE Human Prescription Drug Label 1 16590-181 TABLET, FILM COATED 20 mg ORAL ANDA 25 sections
PAROXETINE Human Prescription Drug Label 1 16590-322 TABLET, FILM COATED 10 mg ORAL ANDA 30 sections
PAXILCR HUMAN PRESCRIPTION DRUG LABEL 1 16590-514 TABLET, FILM COATED, EXTENDED RELEASE 12.50 mg ORAL NDA 15 sections
Paroxetine Human Prescription Drug Label 1 16714-181 TABLET, FILM COATED 10 mg ORAL ANDA 28 sections
Paroxetine Human Prescription Drug Label 1 16714-182 TABLET, FILM COATED 20 mg ORAL ANDA 28 sections
Paroxetine Human Prescription Drug Label 1 16714-183 TABLET, FILM COATED 30 mg ORAL ANDA 28 sections
Paroxetine Human Prescription Drug Label 1 16714-184 TABLET, FILM COATED 40 mg ORAL ANDA 28 sections
Paroxetine HUMAN PRESCRIPTION DRUG LABEL 1 21695-101 TABLET, FILM COATED 10 mg ORAL ANDA 22 sections
Paroxetine HUMAN PRESCRIPTION DRUG LABEL 1 21695-102 TABLET, FILM COATED 20 mg ORAL ANDA 22 sections
Paroxetine HUMAN PRESCRIPTION DRUG LABEL 1 21695-103 TABLET, FILM COATED 30 mg ORAL ANDA 22 sections