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

Stem definitionDrug idCAS RN
serotonin and/or norepinephrine reuptake inhibitors, fluoxetine derivatives 1209 54910-89-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • prozac
  • fluoxetine
  • fluoxetine hydrochloride
  • fluoxetin
  • fluoxetine HCl
The first highly specific serotonin uptake inhibitor. It is used as an antidepressant and often has a more acceptable side-effects profile than traditional antidepressants.
  • Molecular weight: 309.33
  • Formula: C17H18F3NO
  • CLOGP: 4.57
  • LIPINSKI: 0
  • HAC: 2
  • HDO: 1
  • TPSA: 21.26
  • ALOGS: -5.26
  • ROTB: 7

  • 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) 15.20 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 1.25 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 4.30 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 60 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
Dec. 29, 1987 FDA ELI LILLY AND CO

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
Completed suicide 1502.04 9.86 1760 139140 132073 56019094
Intentional overdose 873.53 9.86 961 139939 67156 56084011
Toxicity to various agents 804.63 9.86 1750 139150 222814 55928353
Suicidal ideation 786.35 9.86 841 140059 56901 56094266
Serotonin syndrome 599.52 9.86 511 140389 25979 56125188
Drug abuse 599.36 9.86 791 140109 66819 56084348
Depression 548.35 9.86 1317 139583 178800 55972367
Suicide attempt 534.88 9.86 691 140209 57145 56094022
Intentional self-injury 503.00 9.86 451 140449 24541 56126626
Drug interaction 480.29 9.86 1379 139521 208376 55942791
Anxiety 422.89 9.86 1250 139650 191922 55959245
Rheumatoid arthritis 369.67 9.86 253 140647 382351 55768816
Electrocardiogram QT prolonged 351.78 9.86 549 140351 54039 56097128
Systemic lupus erythematosus 340.08 9.86 30 140870 180048 55971119
Tremor 327.59 9.86 847 140053 120242 56030925
Synovitis 321.19 9.86 21 140879 161284 55989883
Hand deformity 306.86 9.86 6 140894 134486 56016681
Agitation 287.82 9.86 509 140391 55527 56095640
Contraindicated product administered 285.90 9.86 59 140841 186227 55964940
Drug intolerance 270.68 9.86 164 140736 264654 55886513
Glossodynia 256.37 9.86 38 140862 152420 55998747
Joint swelling 256.01 9.86 210 140690 289590 55861577
Cardio-respiratory arrest 251.86 9.86 477 140423 54844 56096323
Overdose 248.72 9.86 703 140197 105127 56046040
Treatment failure 243.48 9.86 63 140837 170329 55980838
Drug withdrawal syndrome 242.12 9.86 311 140589 25546 56125621
Infusion related reaction 228.37 9.86 119 140781 208812 55942355
Wound 227.91 9.86 37 140863 138767 56012400
Alopecia 220.28 9.86 246 140654 293212 55857955
Withdrawal syndrome 216.73 9.86 249 140651 18213 56132954
Cardiac arrest 209.29 9.86 580 140320 85734 56065433
Pericarditis 208.70 9.86 17 140883 108906 56042261
Poisoning 201.92 9.86 202 140698 12611 56138556
Respiratory arrest 201.40 9.86 311 140589 30314 56120853
Arthropathy 199.05 9.86 128 140772 200147 55951020
Swelling 195.70 9.86 187 140713 239584 55911583
Irritability 192.52 9.86 299 140601 29289 56121878
Rash 188.66 9.86 620 140280 492427 55658740
Abdominal discomfort 187.42 9.86 252 140648 277022 55874145
Somnolence 187.37 9.86 858 140042 162555 55988612
Peripheral swelling 171.46 9.86 201 140699 234525 55916642
Reversible cerebral vasoconstriction syndrome 160.46 9.86 90 140810 2287 56148880
Rheumatoid factor positive 153.90 9.86 4 140896 69056 56082111
Drug ineffective 151.86 9.86 1522 139378 917467 55233700
Akathisia 150.52 9.86 144 140756 8508 56142659
Torsade de pointes 149.76 9.86 170 140730 12270 56138897
Hepatic enzyme increased 147.72 9.86 127 140773 171257 55979910
Sopor 146.81 9.86 219 140681 20703 56130464
Therapeutic product effect decreased 146.74 9.86 125 140775 169327 55981840
Nightmare 146.05 9.86 195 140705 16631 56134536
Aggression 142.62 9.86 222 140678 21784 56129383
Helicobacter infection 141.55 9.86 11 140889 73257 56077910
Disturbance in attention 141.20 9.86 275 140625 32265 56118902
Duodenal ulcer perforation 138.66 9.86 8 140892 68334 56082833
Discomfort 137.54 9.86 93 140807 141668 56009499
Arthralgia 134.58 9.86 723 140177 500946 55650221
Depressed mood 133.78 9.86 287 140613 36072 56115095
Product use issue 132.94 9.86 162 140738 185879 55965288
Infection 128.17 9.86 189 140711 200017 55951150
Panic attack 122.49 9.86 199 140701 20248 56130919
Suicidal behaviour 119.42 9.86 75 140825 2358 56148809
Mania 116.47 9.86 144 140756 11376 56139791
Poisoning deliberate 116.41 9.86 134 140766 9819 56141348
Febrile neutropenia 115.39 9.86 60 140840 105485 56045682
Crying 111.63 9.86 196 140704 21244 56129923
White blood cell count abnormal 110.40 9.86 102 140798 5765 56145402
Hypersensitivity 110.29 9.86 305 140595 256103 55895064
Folliculitis 109.82 9.86 7 140893 54972 56096195
Product complaint 109.37 9.86 141 140759 11619 56139548
Mydriasis 104.94 9.86 134 140766 10937 56140230
Coma 104.53 9.86 358 140542 59297 56091870
Foetal exposure during pregnancy 104.38 9.86 249 140651 33574 56117593
Seizure 103.57 9.86 600 140300 124519 56026648
Blister 103.52 9.86 73 140827 108814 56042353
Product substitution issue 99.83 9.86 151 140749 14448 56136719
Lower respiratory tract infection 98.95 9.86 85 140815 114709 56036458
Muscle injury 98.33 9.86 9 140891 52491 56098676
Nasopharyngitis 94.87 9.86 263 140637 220696 55930471
Respiratory depression 91.32 9.86 133 140767 12302 56138865
Sleep disorder due to general medical condition, insomnia type 91.31 9.86 4 140896 43334 56107833
Obsessive-compulsive disorder 88.96 9.86 74 140826 3632 56147535
Stomatitis 88.60 9.86 103 140797 120707 56030460
Muscle rigidity 88.54 9.86 121 140779 10550 56140617
Impaired healing 88.26 9.86 54 140846 86787 56064380
Suspected suicide 87.64 9.86 87 140813 5379 56145788
Coma scale abnormal 86.61 9.86 82 140818 4781 56146386
Galactorrhoea 85.75 9.86 74 140826 3821 56147346
Self-injurious ideation 85.24 9.86 60 140840 2290 56148877
Dystonia 82.85 9.86 127 140773 12294 56138873
Insomnia 82.81 9.86 788 140112 191072 55960095
Tardive dyskinesia 82.17 9.86 101 140799 7930 56143237
Neutropenia 81.52 9.86 171 140729 157996 55993171
Muscle twitching 80.08 9.86 145 140755 16097 56135070
Pneumonia 79.98 9.86 644 140256 406454 55744713
Depressed level of consciousness 79.80 9.86 316 140584 56117 56095050
Anger 77.37 9.86 119 140781 11553 56139614
Mood swings 75.67 9.86 144 140756 16603 56134564
General physical health deterioration 73.96 9.86 201 140699 169809 55981358
Restlessness 73.85 9.86 188 140712 26398 56124769
Miosis 72.50 9.86 86 140814 6506 56144661
Off label use 72.31 9.86 970 139930 555210 55595957
Abnormal behaviour 72.25 9.86 158 140742 20114 56131053
Hyperhidrosis 71.93 9.86 442 140458 93646 56057521
Bezoar 71.78 9.86 44 140856 1324 56149843
Gastrointestinal disorder 70.51 9.86 108 140792 112594 56038573
Tearfulness 69.92 9.86 65 140835 3703 56147464
Electrocardiogram QRS complex prolonged 69.72 9.86 77 140823 5390 56145777
Extrapyramidal disorder 69.63 9.86 117 140783 12239 56138928
Hyperprolactinaemia 69.57 9.86 64 140836 3597 56147570
Hypertonia neonatal 68.41 9.86 25 140875 219 56150948
Generalised tonic-clonic seizure 67.50 9.86 186 140714 27380 56123787
Drug dependence 66.43 9.86 163 140737 22370 56128797
Pyrexia 65.60 9.86 701 140199 418072 55733095
Parkinsonism 64.23 9.86 98 140802 9448 56141719
Myoclonus 64.14 9.86 127 140773 15076 56136091
Hallucination, auditory 63.45 9.86 108 140792 11416 56139751
Restless legs syndrome 62.58 9.86 134 140766 16813 56134354
Emotional distress 62.43 9.86 190 140710 29573 56121594
Therapeutic product effect incomplete 62.20 9.86 106 140794 105925 56045242
Pain 62.20 9.86 1229 139671 661955 55489212
Memory impairment 62.04 9.86 400 140500 86157 56065010
Mood altered 61.78 9.86 116 140784 13239 56137928
Intentional product misuse 61.58 9.86 274 140626 51230 56099937
Intentional product use issue 59.15 9.86 99 140801 99634 56051533
Therapeutic response unexpected 58.66 9.86 131 140769 16913 56134254
Dyskinesia 58.44 9.86 183 140717 28925 56122242
Mobility decreased 57.12 9.86 100 140800 98891 56052276
Ill-defined disorder 56.36 9.86 53 140847 68490 56082677
Drug withdrawal syndrome neonatal 56.34 9.86 44 140856 1972 56149195
Malignant neoplasm progression 55.83 9.86 61 140839 73526 56077641
Sedation 55.73 9.86 203 140697 34651 56116516
C-reactive protein increased 55.64 9.86 69 140831 78615 56072552
Disease progression 55.62 9.86 112 140788 105061 56046106
Cholecystitis chronic 54.52 9.86 92 140808 9656 56141511
Confusional state 53.99 9.86 775 140125 207380 55943787
Exposure during pregnancy 53.91 9.86 550 140350 135792 56015375
Paranoia 53.07 9.86 96 140804 10648 56140519
Abnormal dreams 52.56 9.86 90 140810 9559 56141608
Stress cardiomyopathy 52.48 9.86 83 140817 8253 56142914
Tic 52.12 9.86 35 140865 1236 56149931
Hyperreflexia 52.06 9.86 65 140835 5185 56145982
Hip arthroplasty 51.92 9.86 16 140884 38607 56112560
Pancytopenia 51.75 9.86 89 140811 88626 56062541
Myocardial depression 51.65 9.86 25 140875 464 56150703
Cerebral vasoconstriction 51.39 9.86 33 140867 1079 56150088
Libido increased 51.11 9.86 35 140865 1277 56149890
Anaemia 50.70 9.86 427 140473 267084 55884083
Pulseless electrical activity 49.95 9.86 74 140826 6950 56144217
Atrial septal defect 49.84 9.86 71 140829 6435 56144732
Sinus bradycardia 49.68 9.86 107 140793 13479 56137688
Decorticate posture 49.50 9.86 21 140879 282 56150885
Clonus 49.34 9.86 57 140843 4192 56146975
Hostility 49.09 9.86 39 140861 1792 56149375
Renal impairment 48.90 9.86 79 140821 80634 56070533
Bradyphrenia 48.89 9.86 71 140829 6549 56144618
Mucosal inflammation 48.79 9.86 23 140877 42787 56108380
Platelet count decreased 48.35 9.86 123 140777 106260 56044907
Sinusitis 47.79 9.86 294 140606 197287 55953880
Thrombocytopenia 47.36 9.86 178 140722 136046 56015121
Impulsive behaviour 46.75 9.86 35 140865 1472 56149695
Maternal exposure during breast feeding 45.88 9.86 51 140849 3596 56147571
Atrial fibrillation 44.93 9.86 132 140768 108765 56042402
Accidental death 44.85 9.86 37 140863 1795 56149372
Persistent genital arousal disorder 44.80 9.86 20 140880 306 56150861
Major depression 44.32 9.86 73 140827 7511 56143656
Tachycardia 43.72 9.86 431 140469 105445 56045722
Depressive symptom 43.66 9.86 49 140851 3492 56147675
Feeling abnormal 43.65 9.86 519 140381 133083 56018084
Irritable bowel syndrome 43.39 9.86 65 140835 68393 56082774
Knee arthroplasty 42.94 9.86 29 140871 44230 56106937
Amnesia 42.85 9.86 229 140671 46093 56105074
Alcohol interaction 42.81 9.86 40 140860 2293 56148874
Blood pressure fluctuation 42.55 9.86 24 140876 40336 56110831
Long QT syndrome 42.15 9.86 45 140855 3031 56148136
Mental disorder 41.63 9.86 142 140758 23462 56127705
Speech disorder 41.50 9.86 195 140705 37298 56113869
Dyspnoea 41.00 9.86 1150 139750 591427 55559740
Pre-eclampsia 40.87 9.86 75 140825 8411 56142756
Dependence 40.08 9.86 36 140864 1961 56149206
Blood hyposmosis 40.04 9.86 10 140890 17 56151150
Ventricular fibrillation 39.75 9.86 86 140814 10866 56140301
Agitation neonatal 39.36 9.86 21 140879 482 56150685
Hyponatraemia 38.92 9.86 409 140491 101730 56049437
Fear 38.91 9.86 103 140797 14805 56136362
Euphoric mood 38.57 9.86 51 140849 4307 56146860
Maternal drugs affecting foetus 38.16 9.86 55 140845 5038 56146129
Dysarthria 37.59 9.86 197 140703 39353 56111814
Unresponsive to stimuli 37.33 9.86 168 140732 31557 56119610
Diarrhoea 37.13 9.86 1268 139632 637239 55513928
Anorgasmia 37.07 9.86 21 140879 544 56150623
Arthritis 37.01 9.86 127 140773 99725 56051442
Cough 35.62 9.86 448 140452 259513 55891654
Apathy 35.44 9.86 68 140832 7886 56143281
Atrioventricular block first degree 35.41 9.86 62 140838 6703 56144464
Sinus tachycardia 35.27 9.86 130 140770 22314 56128853
Hallucination, visual 35.23 9.86 110 140790 17358 56133809
Accidental overdose 35.13 9.86 122 140778 20339 56130828
Traumatic coma 34.41 9.86 11 140889 61 56151106
Red blood cell sedimentation rate increased 34.20 9.86 25 140875 36598 56114569
Cogwheel rigidity 34.10 9.86 32 140868 1845 56149322
Morbid thoughts 34.04 9.86 20 140880 556 56150611
Respiration abnormal 33.91 9.86 55 140845 5586 56145581
Ventricular hypokinesia 33.89 9.86 47 140853 4154 56147013
Inappropriate antidiuretic hormone secretion 33.85 9.86 93 140807 13663 56137504
Oculogyric crisis 33.64 9.86 29 140871 1495 56149672
Mental impairment 33.31 9.86 88 140812 12634 56138533
Hallucination 33.30 9.86 224 140676 48925 56102242
Inflammation 32.84 9.86 78 140822 68993 56082174
Stress 32.72 9.86 256 140644 58654 56092513
Delusion of grandeur 32.72 9.86 13 140887 146 56151021
Hypotonia neonatal 32.43 9.86 25 140875 1099 56150068
Physical assault 32.33 9.86 23 140877 893 56150274
Lethargy 32.23 9.86 230 140670 51211 56099956
Cytomegalovirus infection 31.97 9.86 5 140895 19291 56131876
Antipsychotic drug level increased 31.93 9.86 40 140860 3202 56147965
Hypertonia 31.85 9.86 45 140855 4047 56147120
Catatonia 31.46 9.86 44 140856 3920 56147247
Binge eating 31.33 9.86 17 140883 404 56150763
Blood prolactin increased 31.28 9.86 40 140860 3269 56147898
Panic reaction 31.13 9.86 43 140857 3787 56147380
Blood creatinine increased 31.08 9.86 100 140800 80091 56071076
Cardiac failure 30.70 9.86 104 140796 81989 56069178
Heart sounds 30.57 9.86 21 140879 770 56150397
Herpes zoster 30.57 9.86 93 140807 75796 56075371
Soft tissue injury 30.47 9.86 28 140872 1571 56149596
Loss of libido 30.33 9.86 25 140875 1211 56149956
Psychotic disorder 30.19 9.86 128 140772 23430 56127737
Abortion missed 30.10 9.86 28 140872 1596 56149571
Breech presentation 29.95 9.86 24 140876 1117 56150050
Joint range of motion decreased 29.88 9.86 13 140887 25352 56125815
Multiple sclerosis relapse 29.44 9.86 203 140697 44700 56106467
Sternal fracture 29.39 9.86 31 140869 2059 56149108
Neuropathy peripheral 29.29 9.86 145 140755 102748 56048419
Migraine 29.14 9.86 339 140561 86458 56064709
Talipes 28.95 9.86 26 140874 1416 56149751
Urinary incontinence 28.55 9.86 148 140752 29437 56121730
Prolonged expiration 28.51 9.86 21 140879 861 56150306
Bulimia nervosa 28.47 9.86 16 140884 408 56150759
Myelosuppression 27.86 9.86 5 140895 17450 56133717
Fatigue 27.79 9.86 1654 139246 786898 55364269
Burning mouth syndrome 27.65 9.86 16 140884 432 56150735
Cystostomy 27.42 9.86 9 140891 55 56151112
Drug level increased 26.86 9.86 113 140787 20612 56130555
Concussion 26.84 9.86 62 140838 8184 56142983
Maternal exposure during pregnancy 26.57 9.86 325 140575 189228 55961939
Flat affect 26.25 9.86 24 140876 1338 56149829
Drug abuser 26.14 9.86 34 140866 2825 56148342
Pulmonary valve stenosis 26.10 9.86 14 140886 325 56150842
Heart disease congenital 26.04 9.86 23 140877 1225 56149942
Neoplasm progression 26.03 9.86 25 140875 31991 56119176
Depression suicidal 25.86 9.86 26 140874 1632 56149535
Musculoskeletal pain 25.69 9.86 110 140790 81042 56070125
Poor quality sleep 25.55 9.86 100 140800 17655 56133512
Attention-seeking behaviour 25.45 9.86 9 140891 71 56151096
Protein C increased 25.44 9.86 10 140890 109 56151058
Agoraphobia 25.38 9.86 14 140886 344 56150823
Marital problem 25.33 9.86 11 140889 157 56151010
Blood lactate dehydrogenase increased 25.32 9.86 10 140890 20665 56130502
Disinhibition 25.32 9.86 19 140881 802 56150365
Breast discomfort 25.28 9.86 15 140885 425 56150742
Thinking abnormal 25.25 9.86 68 140832 9873 56141294
Persistent foetal circulation 25.12 9.86 12 140888 216 56150951
Septic shock 24.90 9.86 74 140826 60761 56090406
Dysphoria 24.86 9.86 44 140856 4798 56146369
Metabolic acidosis 24.83 9.86 180 140720 40274 56110893
Erythema 24.75 9.86 260 140640 155679 55995488
Posture abnormal 24.71 9.86 29 140871 2169 56148998
Hypothermia 24.66 9.86 78 140822 12392 56138775
Pleural effusion 24.60 9.86 120 140780 85360 56065807
Trichotillomania 24.58 9.86 10 140890 120 56151047
Affect lability 24.47 9.86 68 140832 10057 56141110
Bone marrow failure 24.29 9.86 21 140879 28265 56122902
Reduced facial expression 24.13 9.86 26 140874 1770 56149397
Dissociation 24.04 9.86 31 140869 2554 56148613
Dizziness 23.98 9.86 1161 139739 374979 55776188
Self esteem decreased 23.85 9.86 16 140884 564 56150603
Psychomotor hyperactivity 23.78 9.86 66 140834 9754 56141413
Gallbladder disorder 23.64 9.86 96 140804 17238 56133929
Multiple sclerosis 23.41 9.86 134 140766 27668 56123499
Ventricular tachycardia 23.37 9.86 94 140806 16807 56134360
White blood cell count decreased 22.98 9.86 203 140697 125787 56025380
Respiratory disorder neonatal 22.97 9.86 19 140881 925 56150242
Breast enlargement 22.95 9.86 23 140877 1438 56149729
Pulmonary valve stenosis congenital 22.95 9.86 10 140890 144 56151023
Emotional poverty 22.94 9.86 13 140887 337 56150830
Heart rate 22.86 9.86 8 140892 61 56151106
Borderline personality disorder 22.77 9.86 17 140883 712 56150455
Disorientation 22.53 9.86 163 140737 36450 56114717
Haemoglobin decreased 22.37 9.86 221 140679 133916 56017251
Developmental delay 22.30 9.86 22 140878 1350 56149817
Diet failure 22.17 9.86 7 140893 37 56151130
Hypomania 21.96 9.86 42 140858 4860 56146307
Food interaction 21.90 9.86 17 140883 755 56150412
Acute kidney injury 21.88 9.86 448 140452 240315 55910852
Loss of consciousness 21.85 9.86 390 140510 108959 56042208
Infantile apnoea 21.82 9.86 18 140882 873 56150294
Formication 21.58 9.86 37 140863 3933 56147234
Induced abortion failed 21.54 9.86 11 140889 230 56150937
Neonatal complications of substance abuse 21.51 9.86 5 140895 5 56151162
Eye movement disorder 21.41 9.86 41 140859 4748 56146419
Hyperthermia 21.38 9.86 57 140843 8228 56142939
Narcolepsy 21.29 9.86 21 140879 1288 56149879
Sleep-related eating disorder 21.29 9.86 17 140883 787 56150380
Yawning 21.17 9.86 19 140881 1034 56150133
Weight increased 21.04 9.86 737 140163 228966 55922201
Psychomotor retardation 21.01 9.86 35 140865 3634 56147533
CYP3A4 polymorphism 20.96 9.86 8 140892 80 56151087
Leukocytosis 20.91 9.86 116 140784 23675 56127492
Tongue biting 20.69 9.86 21 140879 1333 56149834
Myasthenic syndrome 20.67 9.86 11 140889 251 56150916
Neonatal hypoxia 20.66 9.86 14 140886 502 56150665
Small for dates baby 20.66 9.86 34 140866 3496 56147671
Dysphemia 20.57 9.86 28 140872 2432 56148735
Eating disorder symptom 20.44 9.86 9 140891 133 56151034
Post-traumatic neck syndrome 20.44 9.86 25 140875 1953 56149214
Patent ductus arteriosus 20.41 9.86 36 140864 3915 56147252
Aortic bruit 20.36 9.86 6 140894 24 56151143
Affective disorder 20.34 9.86 44 140856 5559 56145608
Gestational diabetes 20.32 9.86 55 140845 8009 56143158
IIIrd nerve paresis 20.32 9.86 9 140891 135 56151032
Blood pressure systolic increased 20.31 9.86 45 140855 40791 56110376
Bipolar I disorder 20.18 9.86 23 140877 1667 56149500
Psoriatic arthropathy 20.09 9.86 106 140794 73902 56077265
Brugada syndrome 20.03 9.86 12 140888 346 56150821
Gastric bypass 20.01 9.86 22 140878 1532 56149635
Homicidal ideation 19.98 9.86 23 140877 1685 56149482
Posterior segment of eye anomaly congenital 19.97 9.86 4 140896 0 56151167
Feeling jittery 19.97 9.86 71 140829 11975 56139192
Alcoholism 19.78 9.86 26 140874 2183 56148984
Procedural hypertension 19.77 9.86 11 140889 275 56150892
Plasma cell myeloma 19.62 9.86 56 140844 46590 56104577
Nervousness 19.51 9.86 132 140768 28883 56122284
Feeling guilty 19.47 9.86 14 140886 553 56150614
Ideas of reference 19.23 9.86 8 140892 102 56151065
Personality change 19.22 9.86 44 140856 5773 56145394
Bruxism 19.21 9.86 31 140869 3135 56148032
Cataplexy 19.18 9.86 20 140880 1311 56149856
Primitive reflex test positive 19.18 9.86 5 140895 11 56151156
Optic ischaemic neuropathy 19.06 9.86 18 140882 1046 56150121
Drug tolerance decreased 19.05 9.86 5 140895 13406 56137761
Electrolyte depletion 18.89 9.86 9 140891 161 56151006
Gaze palsy 18.88 9.86 20 140880 1335 56149832
Bone erosion 18.74 9.86 7 140893 14967 56136200
Acute respiratory distress syndrome 18.67 9.86 106 140794 21820 56129347
Bradykinesia 18.64 9.86 39 140861 4815 56146352
Cholecystectomy 18.63 9.86 60 140840 9624 56141543
Slow response to stimuli 18.60 9.86 17 140883 947 56150220
Spinal shock 18.59 9.86 5 140895 13 56151154
Somnambulism 18.50 9.86 40 140860 5052 56146115
Neuroleptic malignant syndrome 18.47 9.86 67 140833 11411 56139756
Drug screen positive 18.46 9.86 32 140868 3432 56147735
Balance disorder 18.27 9.86 281 140619 76239 56074928
Libido decreased 18.04 9.86 26 140874 2382 56148785
Intrusive thoughts 17.99 9.86 9 140891 180 56150987
Atrioventricular block second degree 17.97 9.86 33 140867 3703 56147464
Drug hypersensitivity 17.96 9.86 538 140362 274667 55876500
Oppositional defiant disorder 17.84 9.86 6 140894 40 56151127
Atelectasis neonatal 17.83 9.86 5 140895 16 56151151
Influenza like illness 17.78 9.86 232 140668 60756 56090411
Drug eruption 17.78 9.86 23 140877 25740 56125427
pH body fluid increased 17.74 9.86 4 140896 3 56151164
Regurgitation 17.72 9.86 20 140880 1434 56149733
Anterograde amnesia 17.69 9.86 13 140887 531 56150636
Constipation 17.68 9.86 378 140522 201565 55949602
Sepsis 17.66 9.86 245 140655 139595 56011572
Pruritus 17.57 9.86 632 140268 315991 55835176
Blood pressure measurement 17.55 9.86 10 140890 262 56150905
Posterior reversible encephalopathy syndrome 17.54 9.86 9 140891 15951 56135216
Hallucinations, mixed 17.52 9.86 36 140864 4388 56146779
Sudden onset of sleep 17.50 9.86 13 140887 540 56150627
Emotional disorder 17.49 9.86 69 140831 12226 56138941
Prolonged labour 17.46 9.86 13 140887 542 56150625
Hypercalcaemia 17.22 9.86 23 140877 25388 56125779
Supraventricular tachyarrhythmia 17.21 9.86 7 140893 84 56151083
Pre-existing condition improved 17.20 9.86 49 140851 7349 56143818
Chronic fatigue syndrome 17.16 9.86 17 140883 1048 56150119
Energy increased 17.06 9.86 25 140875 2325 56148842
Incubator therapy 17.00 9.86 6 140894 47 56151120
Serum sickness-like reaction 17 9.86 12 140888 460 56150707
Road traffic accident 16.99 9.86 124 140776 27803 56123364
Neonatal asphyxia 16.80 9.86 10 140890 285 56150882
Congenital brain damage 16.74 9.86 4 140896 5 56151162
Acute myeloid leukaemia 16.62 9.86 11 140889 16961 56134206
Liver function test increased 16.60 9.86 28 140872 28105 56123062
Pulmonary haemosiderosis 16.59 9.86 5 140895 22 56151145
Prolonged rupture of membranes 16.58 9.86 6 140894 51 56151116
Bipolar disorder 16.47 9.86 49 140851 7531 56143636
Placenta praevia 16.46 9.86 16 140884 964 56150203
Osteonecrosis of jaw 16.39 9.86 37 140863 33321 56117846
Fibromyalgia 16.39 9.86 85 140815 59518 56091649
Withdrawal catatonia 16.38 9.86 6 140894 53 56151114
Disturbance in sexual arousal 16.37 9.86 7 140893 96 56151071
Injury 16.35 9.86 225 140675 59626 56091541
Polydactyly 16.31 9.86 10 140890 301 56150866
Agonal rhythm 16.24 9.86 5 140895 24 56151143
Tachyphrenia 16.23 9.86 18 140882 1266 56149901
Foetal arrhythmia 16.22 9.86 8 140892 155 56151012
Foetal alcohol syndrome 16.07 9.86 5 140895 25 56151142
Anhedonia 16.06 9.86 58 140842 9856 56141311
Decreased interest 16.05 9.86 28 140872 3018 56148149
Paraesthesia 16.01 9.86 434 140466 130080 56021087
Nystagmus 15.97 9.86 41 140859 5784 56145383
Cholelithiasis 15.96 9.86 160 140740 39304 56111863
Obsessive thoughts 15.96 9.86 12 140888 508 56150659
Hypersomnia 15.94 9.86 82 140818 16259 56134908
Blunted affect 15.89 9.86 9 140891 233 56150934
Alcohol withdrawal syndrome 15.78 9.86 14 140886 750 56150417
Phobia 15.71 9.86 10 140890 322 56150845
Gait disturbance 15.70 9.86 527 140373 162794 55988373
Appetite disorder 15.66 9.86 44 140856 6549 56144618
Eosinophilic pneumonia acute 15.65 9.86 10 140890 324 56150843
Analgesic drug level increased 15.63 9.86 21 140879 1801 56149366
Osteoporosis 15.60 9.86 72 140828 51980 56099187
Anorexia nervosa 15.59 9.86 9 140891 242 56150925
Staring 15.58 9.86 19 140881 1479 56149688
Tension 15.57 9.86 27 140873 2897 56148270
Alcohol use 15.37 9.86 22 140878 2003 56149164
Tooth hypoplasia 15.29 9.86 6 140894 65 56151102
Parkinsonian gait 15.13 9.86 11 140889 442 56150725
Sluggishness 15.09 9.86 35 140865 4633 56146534
Skin ulcer 15.06 9.86 48 140852 38560 56112607
Sleep paralysis 14.96 9.86 12 140888 559 56150608
Oesophageal food impaction 14.94 9.86 8 140892 185 56150982
Polyneuropathy 14.88 9.86 7 140893 13043 56138124
Toxic epidermal necrolysis 14.88 9.86 20 140880 22022 56129145
Creatinine renal clearance decreased 14.86 9.86 9 140891 14550 56136617
Liver disorder 14.75 9.86 59 140841 44311 56106856
Microcephaly 14.72 9.86 14 140886 821 56150346
Umbilical cord around neck 14.67 9.86 8 140892 192 56150975
Theft 14.60 9.86 6 140894 74 56151093
Cleft palate 14.55 9.86 15 140885 970 56150197
Chemical burn 14.50 9.86 10 140890 369 56150798
Psychotic behaviour 14.48 9.86 12 140888 586 56150581
Hypoprolactinaemia 14.46 9.86 4 140896 12 56151155
Hyporesponsive to stimuli 14.39 9.86 15 140885 983 56150184
Muscle enzyme increased 14.36 9.86 7 140893 132 56151035
Hypoxic-ischaemic encephalopathy 14.34 9.86 31 140869 3914 56147253
Feeling of despair 14.34 9.86 22 140878 2131 56149036
Jaundice neonatal 14.33 9.86 14 140886 849 56150318
Mononucleosis syndrome 14.31 9.86 7 140893 133 56151034
Cold agglutinins positive 14.30 9.86 5 140895 38 56151129
Abortion spontaneous 14.28 9.86 170 140730 43583 56107584
Heavy menstrual bleeding 14.22 9.86 79 140821 16130 56135037
Purple glove syndrome 14.20 9.86 8 140892 205 56150962
Transient aphasia 14.19 9.86 5 140895 39 56151128
Hypnopompic hallucination 14.19 9.86 5 140895 39 56151128
Plasma cell mastitis 14.19 9.86 5 140895 39 56151128
Fall 14.14 9.86 1058 139842 356452 55794715
Biliary dyskinesia 14.08 9.86 24 140876 2539 56148628
Increased appetite 14.06 9.86 51 140849 8684 56142483
Grip strength decreased 14.04 9.86 12 140888 16244 56134923
Feeling drunk 14.02 9.86 30 140870 3762 56147405
Negative thoughts 14.02 9.86 14 140886 872 56150295
Confabulation 14.00 9.86 9 140891 295 56150872
Basilar migraine 13.97 9.86 5 140895 41 56151126
Social anxiety disorder 13.79 9.86 10 140890 400 56150767
Sudden cardiac death 13.69 9.86 21 140879 2033 56149134
Hypouricaemia 13.68 9.86 7 140893 147 56151020
Anal incontinence 13.63 9.86 64 140836 12234 56138933
Foetal monitoring abnormal 13.63 9.86 8 140892 222 56150945
Dermatillomania 13.60 9.86 7 140893 149 56151018
Post-traumatic stress disorder 13.56 9.86 33 140867 4505 56146662
Ventricular arrhythmia 13.55 9.86 28 140872 3426 56147741
Therapeutic response decreased 13.53 9.86 77 140823 52681 56098486
Coordination abnormal 13.49 9.86 65 140835 12556 56138611
Floppy infant 13.49 9.86 6 140894 91 56151076
Pericardial effusion 13.47 9.86 30 140870 27145 56124022
Panniculitis 13.37 9.86 4 140896 9838 56141329
Palmar-plantar erythrodysaesthesia syndrome 13.34 9.86 20 140880 21045 56130122
Fluid retention 13.30 9.86 80 140820 53998 56097169
Electrocardiogram repolarisation abnormality 13.27 9.86 16 140884 1231 56149936
Panic disorder 13.26 9.86 23 140877 2468 56148699
Amenorrhoea 13.25 9.86 51 140849 8935 56142232
Amaurosis 13.17 9.86 11 140889 543 56150624
Device placement issue 13.14 9.86 14 140886 941 56150226
Osteoarthritis 13.09 9.86 133 140767 80163 56071004
Pulmonary vasculitis 13.09 9.86 6 140894 98 56151069
Neonatal disorder 13.03 9.86 11 140889 551 56150616
Oesophageal adenocarcinoma 13.03 9.86 7 140893 163 56151004
Jaw clicking 13.02 9.86 4 140896 19 56151148
Depersonalisation/derealisation disorder 12.95 9.86 16 140884 1263 56149904
Drug use disorder 12.94 9.86 33 140867 4636 56146531
Pregnancy with advanced maternal age 12.91 9.86 3 140897 3 56151164
Craniosynostosis 12.88 9.86 7 140893 167 56151000
Platelet dysfunction 12.87 9.86 6 140894 102 56151065
Metastases to bone 12.87 9.86 18 140882 19490 56131677
Single umbilical artery 12.78 9.86 8 140892 250 56150917
Peritonitis 12.77 9.86 13 140887 16189 56134978
Loss of bladder sensation 12.76 9.86 5 140895 54 56151113
Fear of weight gain 12.69 9.86 4 140896 21 56151146
General physical condition abnormal 12.62 9.86 29 140871 3814 56147353
Leukopenia 12.62 9.86 115 140785 70825 56080342
Potentiating drug interaction 12.61 9.86 30 140870 4036 56147131
Duodenal ulcer repair 12.60 9.86 5 140895 56 56151111
Blood pressure diastolic decreased 12.58 9.86 18 140882 19305 56131862
Bradycardia neonatal 12.57 9.86 13 140887 844 56150323
Substance abuse 12.56 9.86 32 140868 4493 56146674
Adverse event 12.55 9.86 84 140816 55292 56095875
Pleurothotonus 12.53 9.86 16 140884 1305 56149862
Sensation of blood flow 12.52 9.86 5 140895 57 56151110
Vertigo 12.49 9.86 199 140701 54373 56096794
Thrombotic microangiopathy 12.47 9.86 4 140896 9407 56141760
Bursitis 12.44 9.86 32 140868 27550 56123617
Accidental exposure to product 12.39 9.86 27 140873 24620 56126547
Hospitalisation 12.32 9.86 124 140776 74876 56076291
Tenosynovitis 12.31 9.86 8 140892 12453 56138714
Ventricular septal defect 12.26 9.86 30 140870 4108 56147059
Social avoidant behaviour 12.24 9.86 24 140876 2828 56148339
Infantile vomiting 12.22 9.86 6 140894 115 56151052
Unmasking of previously unidentified disease 12.16 9.86 13 140887 877 56150290
Haematotoxicity 12.15 9.86 3 140897 8380 56142787
Brucellosis 12.14 9.86 5 140895 62 56151105
Hyperkalaemia 12.11 9.86 76 140824 50789 56100378
Areflexia 12.11 9.86 24 140876 2851 56148316
Hepatic function abnormal 12.10 9.86 45 140855 34513 56116654
Gambling disorder 12.02 9.86 15 140885 1196 56149971
Economic problem 11.99 9.86 19 140881 1892 56149275
Musculoskeletal stiffness 11.97 9.86 298 140602 155709 55995458
Product use in unapproved indication 11.91 9.86 265 140635 140557 56010610
Blood magnesium decreased 11.87 9.86 60 140840 11814 56139353
Premature labour 11.85 9.86 60 140840 11822 56139345
Medical diet 11.85 9.86 4 140896 27 56151140
Transplant rejection 11.85 9.86 5 140895 9929 56141238
Device related infection 11.82 9.86 23 140877 21857 56129310
Swollen tongue 11.81 9.86 122 140778 30202 56120965
Condition aggravated 11.79 9.86 725 140175 344173 55806994
Menstruation irregular 11.74 9.86 39 140861 6357 56144810
Prescribed underdose 11.73 9.86 21 140879 20596 56130571
Renal adenoma 11.70 9.86 3 140897 6 56151161
Carotid arterial embolus 11.70 9.86 3 140897 6 56151161
Hyperinsulinism 11.70 9.86 3 140897 6 56151161
Vision blurred 11.69 9.86 281 140619 82662 56068505
Joint hyperextension 11.61 9.86 8 140892 295 56150872
Pulmonary fibrosis 11.60 9.86 37 140863 29721 56121446
Antidepressant drug level above therapeutic 11.51 9.86 9 140891 404 56150763
Ketonuria 11.49 9.86 10 140890 522 56150645
Cytopenia 11.49 9.86 5 140895 9750 56141417
Lip dry 11.46 9.86 5 140895 9735 56141432
Multiple allergies 11.41 9.86 6 140894 10490 56140677
Spina bifida occulta 11.38 9.86 3 140897 7 56151160
Autonomic nervous system imbalance 11.35 9.86 22 140878 2571 56148596
Pulmonary valve incompetence 11.32 9.86 15 140885 1269 56149898
Hypertonic bladder 11.30 9.86 25 140875 3207 56147960
Acute stress disorder 11.29 9.86 7 140893 215 56150952
Hypometabolism 11.26 9.86 4 140896 32 56151135
Periodic limb movement disorder 11.26 9.86 7 140893 216 56150951
Dysmorphism 11.22 9.86 20 140880 2193 56148974
Status migrainosus 11.20 9.86 6 140894 139 56151028
Hypnagogic hallucination 11.16 9.86 6 140894 140 56151027
Death of relative 11.12 9.86 7 140893 221 56150946
Dissociative identity disorder 11.11 9.86 5 140895 78 56151089
Diverticulitis 11.10 9.86 49 140851 35803 56115364
Apgar score low 11.09 9.86 11 140889 679 56150488
Spasmodic dysphonia 11.06 9.86 5 140895 79 56151088
Congenital multiplex arthrogryposis 11.05 9.86 4 140896 34 56151133
Pregnancy on oral contraceptive 11.04 9.86 13 140887 976 56150191
Pleural disorder 11.02 9.86 10 140890 552 56150615
Pulmonary arterial hypertension 11.01 9.86 32 140868 26471 56124696
Macular degeneration 10.99 9.86 19 140881 18889 56132278
Blood triglycerides increased 10.98 9.86 58 140842 11619 56139548
Lymphocytic hypophysitis 10.98 9.86 7 140893 226 56150941
Postural tremor 10.98 9.86 7 140893 226 56150941
Sleep attacks 10.89 9.86 5 140895 82 56151085
Oedema peripheral 10.86 9.86 336 140564 170918 55980249
Thought insertion 10.84 9.86 3 140897 9 56151158
Tooth demineralisation 10.84 9.86 3 140897 9 56151158
Irregular breathing 10.84 9.86 8 140892 329 56150838
Personality disorder 10.82 9.86 33 140867 5140 56146027
Proteinuria 10.82 9.86 17 140883 17553 56133614
Gingival discomfort 10.82 9.86 7 140893 232 56150935
Trismus 10.76 9.86 26 140874 3532 56147635
Complication of device insertion 10.76 9.86 38 140862 6386 56144781
Respiratory disorder 10.76 9.86 46 140854 33911 56117256
Treatment noncompliance 10.76 9.86 127 140773 32496 56118671
Muscle neoplasm 10.76 9.86 4 140896 37 56151130
Extensor plantar response 10.74 9.86 14 140886 1166 56150001
Bacteraemia 10.74 9.86 14 140886 15617 56135550
Blood pressure diastolic abnormal 10.72 9.86 8 140892 11590 56139577
Cytokine release syndrome 10.72 9.86 7 140893 10868 56140299
Blood bilirubin increased 10.68 9.86 45 140855 33309 56117858
Neonatal respiratory distress 10.67 9.86 8 140892 337 56150830
Superior mesenteric artery syndrome 10.67 9.86 5 140895 86 56151081
Back pain 10.65 9.86 485 140415 236685 55914482
Pulmonary artery stenosis congenital 10.63 9.86 7 140893 239 56150928
Aspiration 10.61 9.86 50 140850 9571 56141596
Peripheral venous disease 10.61 9.86 6 140894 10073 56141094
Antisocial personality disorder 10.60 9.86 3 140897 10 56151157
Joint effusion 10.59 9.86 13 140887 14885 56136282
Apnoea 10.59 9.86 41 140859 7201 56143966
Gallbladder neoplasm 10.57 9.86 4 140896 39 56151128
Dermatitis atopic 10.56 9.86 45 140855 8254 56142913
Premature rupture of membranes 10.54 9.86 31 140869 4734 56146433
Oedema 10.52 9.86 143 140757 81777 56069390
Pelvic pain 10.52 9.86 58 140842 11809 56139358
Lymphatic system neoplasm 10.48 9.86 4 140896 40 56151127
Job dissatisfaction 10.39 9.86 4 140896 41 56151126
Lactation disorder 10.35 9.86 8 140892 353 56150814
Blood parathyroid hormone decreased 10.32 9.86 4 140896 8360 56142807
Pyloric stenosis 10.27 9.86 8 140892 357 56150810
Brain injury 10.14 9.86 37 140863 6318 56144849
Pulmonary embolism 10.12 9.86 345 140555 106779 56044388
Derealisation 10.11 9.86 13 140887 1068 56150099
Basal cell carcinoma 10.09 9.86 31 140869 25190 56125977
Verbal abuse 10.08 9.86 5 140895 98 56151069
Skin disorder 10.06 9.86 33 140867 26276 56124891
Middle insomnia 10.03 9.86 54 140846 10896 56140271
Neutropenic sepsis 10.03 9.86 14 140886 15171 56135996
Embolism 9.99 9.86 3 140897 7361 56143806
Rhabdomyolysis 9.97 9.86 150 140750 40508 56110659
Ataxia 9.97 9.86 66 140834 14337 56136830
Micturition urgency 9.96 9.86 46 140854 8735 56142432
Menstruation normal 9.95 9.86 6 140894 175 56150992
Skin infection 9.94 9.86 11 140889 13184 56137983

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
Serotonin syndrome 945.80 10.99 533 59727 18240 31618844
Suicidal ideation 449.76 10.99 443 59817 35963 31601121
Completed suicide 394.59 10.99 659 59601 90855 31546229
Toxicity to various agents 369.54 10.99 959 59301 180528 31456556
Suicide attempt 348.76 10.99 391 59869 36857 31600227
Obsessive-compulsive disorder 334.93 10.99 171 60089 4766 31632318
Intentional overdose 316.98 10.99 392 59868 40997 31596087
Drug interaction 289.00 10.99 961 59299 207582 31429502
Depression 230.32 10.99 523 59737 90292 31546792
Akathisia 229.16 10.99 153 60107 7100 31629984
Anxiety 218.46 10.99 513 59747 90520 31546564
Aggression 182.80 10.99 285 59975 37006 31600078
Agitation 170.75 10.99 341 59919 53828 31583256
Euphoric mood 165.64 10.99 108 60152 4812 31632272
Drug abuse 162.02 10.99 448 59812 87310 31549774
Overdose 147.25 10.99 423 59837 84241 31552843
Antipsychotic drug level below therapeutic 146.03 10.99 73 60187 1942 31635142
Therapeutic product effect variable 136.89 10.99 69 60191 1869 31635215
Drug withdrawal syndrome 132.93 10.99 171 60089 18579 31618505
Disinhibition 128.81 10.99 74 60186 2619 31634465
Homicide 125.51 10.99 52 60208 880 31636204
Febrile neutropenia 116.53 10.99 43 60217 121806 31515278
Increased appetite 113.19 10.99 95 60165 6249 31630835
Irritability 93.27 10.99 161 60099 22728 31614356
Depressed mood 92.66 10.99 139 60121 17436 31619648
Psychotic disorder 92.40 10.99 158 60102 22135 31614949
Electrocardiogram QT prolonged 91.94 10.99 215 60045 37772 31599312
Pneumonia 89.66 10.99 332 59928 334980 31302104
Drug dependence 89.63 10.99 157 60103 22422 31614662
Tardive dyskinesia 84.54 10.99 76 60184 5483 31631601
Obesity 83.04 10.99 104 60156 10996 31626088
Pyrexia 80.42 10.99 302 59958 303538 31333546
Anaemia 79.97 10.99 180 60080 213342 31423742
Paranoia 77.54 10.99 98 60162 10457 31626627
Malignant neoplasm progression 76.98 10.99 27 60233 78971 31558113
Sepsis 76.86 10.99 106 60154 151823 31485261
Mania 76.80 10.99 91 60169 9086 31627998
Exposure during pregnancy 76.53 10.99 88 60172 8510 31628574
Sedation 72.85 10.99 130 60130 18835 31618249
Poisoning 70.88 10.99 93 60167 10298 31626786
Intentional self-injury 69.74 10.99 105 60155 13210 31623874
Suicidal behaviour 67.55 10.99 39 60221 1393 31635691
Intentional product misuse 63.35 10.99 187 60073 37764 31599320
Hyperreflexia 62.85 10.99 49 60211 2900 31634184
Tremor 62.29 10.99 299 59961 76121 31560963
Thrombocytopenia 62.26 10.99 110 60150 142637 31494447
Victim of child abuse 60.14 10.99 31 60229 881 31636203
Platelet count decreased 59.99 10.99 73 60187 110362 31526722
Anger 58.48 10.99 88 60172 11065 31626019
Drug withdrawal syndrome neonatal 57.61 10.99 50 60210 3442 31633642
Muscle twitching 56.66 10.99 74 60186 8156 31628928
Weight increased 56.07 10.99 308 59952 82639 31554445
Abnormal behaviour 55.61 10.99 133 60127 23695 31613389
Disease progression 55.54 10.99 54 60206 90410 31546674
Homicidal ideation 55.11 10.99 43 60217 2548 31634536
Extrapyramidal disorder 54.87 10.99 88 60172 11690 31625394
Tic 54.67 10.99 38 60222 1883 31635201
Sexual dysfunction 54.66 10.99 62 60198 5906 31631178
General physical health deterioration 53.55 10.99 83 60177 113352 31523732
Social avoidant behaviour 53.50 10.99 45 60215 2968 31634116
Affective disorder 52.75 10.99 49 60211 3687 31633397
Dyskinesia 51.28 10.99 119 60141 20791 31616293
Diarrhoea 50.22 10.99 429 59831 351980 31285104
Disturbance in attention 49.92 10.99 123 60137 22327 31614757
Rheumatoid arthritis 48.91 10.99 15 60245 47794 31589290
Insomnia 47.56 10.99 326 59934 94510 31542574
Parasomnia 47.55 10.99 20 60240 352 31636732
Synaesthesia 47.41 10.99 9 60251 0 31637084
Hallucination, auditory 46.35 10.99 76 60184 10284 31626800
Mental disorder 45.83 10.99 89 60171 13745 31623339
Obsessive-compulsive symptom 45.64 10.99 15 60245 126 31636958
Asphyxia 44.80 10.99 55 60205 5696 31631388
Haemoglobin decreased 44.58 10.99 92 60168 112583 31524501
Antipsychotic drug level increased 44.34 10.99 43 60217 3415 31633669
Torsade de pointes 43.18 10.99 59 60201 6791 31630293
Pancytopenia 43.03 10.99 62 60198 87254 31549830
Renal impairment 42.86 10.99 61 60199 86288 31550796
Myoclonus 42.73 10.99 87 60173 13903 31623181
Withdrawal syndrome 42.05 10.99 78 60182 11639 31625445
Bipolar disorder 41.66 10.99 43 60217 3681 31633403
Nightmare 41.33 10.99 79 60181 12058 31625026
Visceral congestion 40.67 10.99 20 60240 513 31636571
Panic attack 40.50 10.99 65 60195 8638 31628446
Major depression 40.34 10.99 45 60215 4208 31632876
Drug abuser 40.19 10.99 43 60217 3837 31633247
Rash 40.17 10.99 222 60038 201264 31435820
Atrial fibrillation 40.05 10.99 99 60161 113684 31523400
Tremor neonatal 40.02 10.99 18 60242 375 31636709
Generalised tonic-clonic seizure 39.95 10.99 105 60155 19826 31617258
Infection 39.56 10.99 59 60201 81872 31555212
Depersonalisation/derealisation disorder 38.87 10.99 20 60240 566 31636518
Hepatic function abnormal 38.60 10.99 15 60245 41207 31595877
Respiratory depression 38.27 10.99 85 60175 14425 31622659
Neutropenia 36.68 10.99 140 60120 140224 31496860
Prescribed overdose 36.57 10.99 64 60196 9128 31627956
Maternal drugs affecting foetus 36.51 10.99 41 60219 3862 31633222
Chorea 36.25 10.99 23 60237 977 31636107
Acute kidney injury 36.07 10.99 349 59911 279365 31357719
Clonus 35.49 10.99 33 60227 2486 31634598
Apathy 35.21 10.99 52 60208 6430 31630654
Hyperhidrosis 35.16 10.99 234 60026 67159 31569925
Thinking abnormal 35.13 10.99 48 60212 5525 31631559
Somnolence 35.01 10.99 315 59945 99130 31537954
Neuroleptic malignant syndrome 34.97 10.99 90 60170 16779 31620305
Mucosal inflammation 34.86 10.99 11 60249 34416 31602668
Blood prolactin increased 34.64 10.99 27 60233 1597 31635487
Mast cell activation syndrome 33.88 10.99 13 60247 178 31636906
Abnormal sleep-related event 33.87 10.99 17 60243 456 31636628
Delusion 33.60 10.99 72 60188 11925 31625159
Rhabdomyolysis 33.31 10.99 221 60039 63360 31573724
Seizure 33.08 10.99 312 59948 99456 31537628
Dyslipidaemia 32.81 10.99 50 60210 6356 31630728
Stomatitis 32.78 10.99 17 60243 39421 31597663
Mood swings 32.59 10.99 54 60206 7370 31629714
Priapism 32.52 10.99 42 60218 4578 31632506
Product complaint 32.46 10.99 46 60214 5478 31631606
Hallucination 32.46 10.99 174 60086 46236 31590848
Drug level increased 32.28 10.99 98 60162 20088 31616996
Poisoning deliberate 31.68 10.99 53 60207 7291 31629793
Nervousness 30.98 10.99 69 60191 11731 31625353
Oral discharge 30.92 10.99 11 60249 120 31636964
Cytomegalovirus infection 30.79 10.99 5 60255 24702 31612382
Choreoathetosis 30.73 10.99 21 60239 1012 31636072
Sleep disorder 30.70 10.99 115 60145 26233 31610851
Abnormal dreams 30.26 10.99 51 60209 7057 31630027
Memory impairment 30.18 10.99 148 60112 37982 31599102
Septic shock 29.70 10.99 50 60210 66108 31570976
Restless legs syndrome 29.57 10.99 53 60207 7703 31629381
Persistent foetal circulation 29.51 10.99 14 60246 331 31636753
Social anxiety disorder 29.12 10.99 13 60247 266 31636818
Tearfulness 28.62 10.99 26 60234 1901 31635183
Psychomotor hyperactivity 28.46 10.99 56 60204 8731 31628353
Child abuse 28.40 10.99 14 60246 361 31636723
Dissociation 28.39 10.99 22 60238 1290 31635794
Epidural lipomatosis 28.34 10.99 18 60242 766 31636318
Bruxism 28.23 10.99 24 60236 1606 31635478
Serum ferritin abnormal 28.08 10.99 12 60248 220 31636864
Interstitial lung disease 27.94 10.99 46 60214 61357 31575727
Huntington's disease 27.88 10.99 8 60252 40 31637044
Derealisation 27.78 10.99 16 60244 569 31636515
Impulsive behaviour 27.65 10.99 26 60234 1987 31635097
Libido decreased 27.65 10.99 38 60222 4398 31632686
Muscle rigidity 27.26 10.99 59 60201 9838 31627246
Antidepressant drug level increased 27.18 10.99 10 60250 121 31636963
Congenital aortic valve stenosis 27.18 10.99 10 60250 121 31636963
Off label use 26.83 10.99 482 59778 346792 31290292
Coma 26.58 10.99 151 60109 40999 31596085
Cardiac failure 26.33 10.99 80 60180 85873 31551211
Prostate cancer 26.03 10.99 20 60240 37581 31599503
Accidental death 25.53 10.99 26 60234 2191 31634893
Cyanosis neonatal 25.48 10.99 12 60248 279 31636805
Neonatal disorder 25.44 10.99 17 60243 789 31636295
Cardiac arrest 25.40 10.99 270 59990 88792 31548292
Accommodation disorder 25.29 10.99 11 60249 211 31636873
Renal failure 25.02 10.99 135 60125 123195 31513889
Initial insomnia 24.59 10.99 29 60231 2880 31634204
Product substitution issue 24.59 10.99 55 60205 9377 31627707
Gambling disorder 24.55 10.99 22 60238 1580 31635504
Foetal exposure during pregnancy 24.46 10.99 147 60113 40729 31596355
Oculogyric crisis 24.34 10.99 21 60239 1434 31635650
Pulmonary embolism 24.29 10.99 77 60183 81569 31555515
Alcohol poisoning 24.18 10.99 30 60230 3141 31633943
Dreamy state 24.12 10.99 6 60254 15 31637069
Violence-related symptom 24.05 10.99 14 60246 508 31636576
Antisocial behaviour 24.04 10.99 12 60248 318 31636766
Obsessive thoughts 23.83 10.99 15 60245 628 31636456
Herpes zoster 23.47 10.99 16 60244 31977 31605107
Hyperkalaemia 23.41 10.99 55 60205 64296 31572788
Plasma cell myeloma 23.33 10.99 45 60215 56486 31580598
Mood altered 23.27 10.99 50 60210 8296 31628788
Restlessness 23.21 10.99 97 60163 23264 31613820
Compulsions 23.17 10.99 10 60250 188 31636896
Lethargy 23.14 10.99 139 60121 38502 31598582
Tourette's disorder 23.11 10.99 8 60252 80 31637004
Electrocardiogram QRS complex prolonged 23.07 10.99 34 60226 4195 31632889
Juvenile idiopathic arthritis 23.07 10.99 22 60238 1711 31635373
Feeling jittery 23.01 10.99 32 60228 3745 31633339
Hostility 22.87 10.99 16 60244 801 31636283
Pleural effusion 22.75 10.99 70 60190 74850 31562234
Neuropathy peripheral 22.75 10.99 71 60189 75578 31561506
Parkinsonism 22.74 10.99 47 60213 7589 31629495
Schizoaffective disorder 22.55 10.99 19 60241 1256 31635828
Eye movement disorder 22.46 10.99 32 60228 3829 31633255
Neonatal respiratory distress syndrome 22.31 10.99 32 60228 3853 31633231
Bone marrow failure 21.93 10.99 13 60247 27995 31609089
Disseminated intravascular coagulation 21.82 10.99 6 60254 20531 31616553
Emotional disorder 21.47 10.99 37 60223 5212 31631872
Vasoplegia syndrome 21.40 10.99 21 60239 1692 31635392
Serum serotonin decreased 21.07 10.99 4 60256 0 31637084
Treatment failure 21.05 10.99 28 60232 40764 31596320
Hyperdynamic left ventricle 21.01 10.99 9 60251 166 31636918
Alcoholism 21.01 10.99 29 60231 3370 31633714
Blunted affect 20.95 10.99 11 60249 325 31636759
Respiratory arrest 20.83 10.99 102 60158 26155 31610929
Porphyria acute 20.82 10.99 11 60249 329 31636755
Flat affect 20.80 10.99 15 60245 788 31636296
Vascular stenosis 20.63 10.99 9 60251 174 31636910
Mydriasis 20.31 10.99 41 60219 6511 31630573
Ascites 20.31 10.99 29 60231 40984 31596100
Poor quality sleep 20.27 10.99 45 60215 7633 31629451
Selective mutism 20.22 10.99 7 60253 70 31637014
Infusion related reaction 20.05 10.99 38 60222 48017 31589067
Leukaemia 20.03 10.99 31 60229 3994 31633090
Myocardial infarction 19.93 10.99 130 60130 113324 31523760
Erythema 19.83 10.99 82 60178 80323 31556761
White blood cell count decreased 19.82 10.99 92 60168 87306 31549778
Hypersomnia 19.71 10.99 56 60204 11063 31626021
Loss of employment 19.65 10.99 12 60248 476 31636608
Dystonia 19.61 10.99 53 60207 10172 31626912
Premature baby 19.53 10.99 77 60183 17989 31619095
Peripheral swelling 19.49 10.99 65 60195 67800 31569284
Cholinergic syndrome 19.38 10.99 12 60248 488 31636596
Pain 19.26 10.99 245 60015 186514 31450570
Tachyphrenia 19.22 10.99 17 60243 1200 31635884
Yawning 19.20 10.99 12 60248 496 31636588
Compulsive shopping 19.13 10.99 11 60249 390 31636694
Negative thoughts 19.03 10.99 13 60247 626 31636458
Arthralgia 19.01 10.99 190 60070 151234 31485850
Self-injurious ideation 18.98 10.99 19 60241 1568 31635516
Hypoglycaemia neonatal 18.90 10.99 20 60240 1762 31635322
Agitation neonatal 18.87 10.99 16 60244 1067 31636017
Loss of libido 18.81 10.99 23 60237 2372 31634712
Somnambulism 18.64 10.99 25 60235 2827 31634257
Congenital aortic valve incompetence 18.56 10.99 8 60252 150 31636934
Compulsive hoarding 18.53 10.99 5 60255 19 31637065
Renal ischaemia 18.51 10.99 12 60248 529 31636555
Hypomania 18.43 10.99 22 60238 2213 31634871
Retinal phototoxicity 18.30 10.99 4 60256 4 31637080
COVID-19 18.27 10.99 49 60211 54772 31582312
Pneumocystis jirovecii pneumonia 18.18 10.99 6 60254 18245 31618839
Pituitary tumour benign 18.13 10.99 14 60246 817 31636267
Small for dates baby 17.98 10.99 28 60232 3627 31633457
Neoplasm progression 17.97 10.99 8 60252 20264 31616820
Condition aggravated 17.92 10.99 423 59837 163586 31473498
Haematochezia 17.77 10.99 31 60229 40433 31596651
Colitis 17.75 10.99 23 60237 33864 31603220
Anaphylactic reaction 17.71 10.99 18 60242 29535 31607549
Dyspnoea 17.62 10.99 508 59752 342971 31294113
Gastrointestinal haemorrhage 17.49 10.99 89 60171 82460 31554624
Chronic actinic dermatitis 17.43 10.99 5 60255 25 31637059
C-reactive protein increased 17.35 10.99 42 60218 48608 31588476
Tumour lysis syndrome 17.30 10.99 4 60256 15381 31621703
Urinary tract discomfort 17.25 10.99 7 60253 112 31636972
Cognitive disorder 17.12 10.99 93 60167 24830 31612254
Lymphocyte count decreased 17.01 10.99 9 60251 20640 31616444
Hypersexuality 17.00 10.99 17 60243 1401 31635683
Cough 16.98 10.99 169 60091 134645 31502439
Coagulation factor VII level decreased 16.92 10.99 7 60253 118 31636966
Liver disorder 16.79 10.99 19 60241 29688 31607396
Physical deconditioning 16.65 10.99 14 60246 923 31636161
Alcohol use 16.62 10.99 25 60235 3142 31633942
Secondary hypogonadism 16.60 10.99 9 60251 284 31636800
Neutrophil count decreased 16.59 10.99 40 60220 46354 31590730
Hyperprolactinaemia 16.29 10.99 17 60243 1474 31635610
Joint swelling 16.16 10.99 50 60210 53381 31583703
Pupil fixed 16.09 10.99 18 60242 1689 31635395
Renal artery thrombosis 16.07 10.99 9 60251 303 31636781
Miosis 16.01 10.99 44 60216 8526 31628558
Multiple organ dysfunction syndrome 15.93 10.99 71 60189 68132 31568952
Feeling abnormal 15.86 10.99 172 60088 56830 31580254
Feeling guilty 15.83 10.99 9 60251 312 31636772
Basilar migraine 15.80 10.99 4 60256 11 31637073
Dysphoria 15.68 10.99 20 60240 2152 31634932
Decreased interest 15.59 10.99 20 60240 2165 31634919
Palmar-plantar erythrodysaesthesia syndrome 15.58 10.99 5 60255 15478 31621606
Muscle necrosis 15.55 10.99 13 60247 850 31636234
Erectile dysfunction 15.45 10.99 75 60185 19160 31617924
Tension 15.37 10.99 19 60241 1982 31635102
Phobia 15.34 10.99 7 60253 151 31636933
Dissociative disorder 15.25 10.99 8 60252 236 31636848
Congenital hand malformation 15.24 10.99 11 60249 579 31636505
Coma uraemic 15.21 10.99 5 60255 42 31637042
Exposure via ingestion 15.18 10.99 19 60241 2006 31635078
Autonomic nervous system imbalance 15.17 10.99 21 60239 2446 31634638
Transposition of the great vessels 15.14 10.99 10 60250 455 31636629
Blood cholesterol increased 15.14 10.99 68 60192 16825 31620259
Hyperbilirubinaemia neonatal 15.10 10.99 12 60248 730 31636354
Spina bifida 15.01 10.99 9 60251 345 31636739
Cataplexy 14.90 10.99 9 60251 350 31636734
Creatinine urine decreased 14.81 10.99 5 60255 46 31637038
Pyloric stenosis 14.74 10.99 12 60248 756 31636328
Mutism 14.66 10.99 12 60248 762 31636322
Respiratory failure 14.58 10.99 123 60137 101326 31535758
Cerebrovascular stenosis 14.56 10.99 6 60254 100 31636984
Salivary hypersecretion 14.55 10.99 40 60220 7752 31629332
Eye colour change 14.54 10.99 8 60252 260 31636824
Dysphemia 14.50 10.99 16 60244 1478 31635606
Ear discomfort 14.49 10.99 20 60240 2324 31634760
Bronchopulmonary aspergillosis 14.45 10.99 4 60256 13630 31623454
Post 5-alpha-reductase inhibitor syndrome 14.40 10.99 6 60254 103 31636981
Intentional product use issue 14.35 10.99 47 60213 49300 31587784
Blood glucose fluctuation 14.16 10.99 26 60234 3849 31633235
Bipolar I disorder 14.13 10.99 12 60248 802 31636282
Feeling drunk 14.05 10.99 17 60243 1734 31635350
Tongue injury 14.04 10.99 6 60254 110 31636974
Blood luteinising hormone decreased 13.94 10.99 6 60254 112 31636972
Otosalpingitis 13.94 10.99 4 60256 20 31637064
Alpha 2 globulin decreased 13.94 10.99 4 60256 20 31637064
Crying 13.88 10.99 32 60228 5565 31631519
Disorientation 13.82 10.99 103 60157 30641 31606443
Sex hormone binding globulin decreased 13.78 10.99 4 60256 21 31637063
Free androgen index decreased 13.78 10.99 4 60256 21 31637063
Delayed sleep phase 13.73 10.99 3 60257 3 31637081
Blood creatine phosphokinase MB 13.73 10.99 3 60257 3 31637081
Blood creatinine increased 13.72 10.99 106 60154 88972 31548112
Hypogonadism male 13.70 10.99 8 60252 292 31636792
Myelodysplastic syndrome 13.63 10.99 10 60250 19241 31617843
Viral acanthoma 13.62 10.99 4 60256 22 31637062
Androgen insensitivity syndrome 13.62 10.99 4 60256 22 31637062
Bone marrow oedema 13.48 10.99 10 60250 549 31636535
Self-medication 13.47 10.99 19 60241 2252 31634832
Panic disorder 13.47 10.99 14 60246 1208 31635876
Tinnitus 13.47 10.99 64 60196 16211 31620873
Marital problem 13.34 10.99 5 60255 64 31637020
Pruritus 13.33 10.99 163 60097 125004 31512080
Testicular microlithiasis 13.33 10.99 4 60256 24 31637060
Treatment noncompliance 13.27 10.99 89 60171 25595 31611489
Hypertonia neonatal 13.24 10.99 9 60251 430 31636654
Urine calcium/creatinine ratio increased 13.19 10.99 4 60256 25 31637059
Dehydroepiandrosterone decreased 13.19 10.99 4 60256 25 31637059
Logorrhoea 13.17 10.99 19 60241 2300 31634784
Confusional state 13.09 10.99 339 59921 132995 31504089
Suspected suicide 13.09 10.99 26 60234 4081 31633003
Economic problem 13.01 10.99 14 60246 1257 31635827
Faecal calprotectin 12.93 10.99 4 60256 27 31637057
Fear 12.86 10.99 45 60215 9929 31627155
Blood triglycerides increased 12.82 10.99 55 60205 13342 31623742
Arnold-Chiari malformation 12.82 10.99 8 60252 330 31636754
Hypothalamic pituitary adrenal axis suppression 12.80 10.99 6 60254 138 31636946
Hospitalisation 12.78 10.99 50 60210 49757 31587327
Oedema 12.75 10.99 40 60220 42521 31594563
Hepatic failure 12.66 10.99 27 60233 32675 31604409
Cytokine release syndrome 12.64 10.99 8 60252 16634 31620450
Blood lactate dehydrogenase increased 12.63 10.99 12 60248 20327 31616757
Product prescribing error 12.62 10.99 72 60188 19570 31617514
Testis cancer 12.62 10.99 14 60246 1301 31635783
Heart rate abnormal 12.54 10.99 16 60244 1722 31635362
Atrial conduction time prolongation 12.52 10.99 3 60257 6 31637078
Alpha globulin increased 12.52 10.99 3 60257 6 31637078
Thrombosis 12.45 10.99 44 60216 45107 31591977
Atrial septal defect 12.39 10.99 35 60225 6892 31630192
Retrograde ejaculation 12.37 10.99 8 60252 351 31636733
Wrong drug 12.32 10.99 5 60255 80 31637004
Cerebral infarction 12.24 10.99 19 60241 25958 31611126
Full blood count abnormal 12.23 10.99 8 60252 16339 31620745
Dry mouth 12.19 10.99 84 60176 24374 31612710
Death 12.19 10.99 561 59699 360008 31277076
Panic reaction 12.13 10.99 14 60246 1358 31635726
Candida infection 12.10 10.99 8 60252 16250 31620834
Cyclothymic disorder 12.05 10.99 5 60255 85 31636999
Blood urea increased 12.05 10.99 23 60237 28989 31608095
Blood bilirubin increased 12.01 10.99 31 60229 35105 31601979
Speech disorder 11.99 10.99 83 60177 24118 31612966
Dyspnoea exertional 11.99 10.99 36 60224 38801 31598283
Cardiac failure congestive 11.97 10.99 95 60165 79292 31557792
Locked-in syndrome 11.95 10.99 7 60253 257 31636827
Urinary retention 11.93 10.99 107 60153 33618 31603466
Thought insertion 11.92 10.99 3 60257 8 31637076
Self esteem decreased 11.91 10.99 9 60251 508 31636576
Arthropathy 11.91 10.99 17 60243 24034 31613050
Staring 11.89 10.99 14 60246 1388 31635696
Nausea 11.89 10.99 472 59788 307475 31329609
Therapeutic response unexpected 11.88 10.99 41 60219 8983 31628101
Chronic kidney disease 11.87 10.99 35 60225 37940 31599144
Inflammatory bowel disease 11.84 10.99 19 60241 2524 31634560
Psychiatric symptom 11.83 10.99 22 60238 3289 31633795
Sleep apnoea syndrome 11.79 10.99 68 60192 18557 31618527
Abdominal distension 11.69 10.99 53 60207 50631 31586453
Cortisol increased 11.69 10.99 6 60254 169 31636915
Mental status changes 11.66 10.99 112 60148 35856 31601228
Drooling 11.60 10.99 21 60239 3074 31634010
Sinus tachycardia 11.47 10.99 60 60200 15789 31621295
Mixed delusion 11.47 10.99 4 60256 41 31637043
Coordination abnormal 11.40 10.99 35 60225 7216 31629868
Haemophagocytic lymphohistiocytosis 11.35 10.99 4 60256 11674 31625410
Carbon monoxide poisoning 11.30 10.99 5 60255 100 31636984
Gastric hypomotility 11.26 10.99 5 60255 101 31636983
Water intoxication 11.22 10.99 8 60252 413 31636671
Galactorrhoea 11.22 10.99 8 60252 413 31636671
COVID-19 pneumonia 11.21 10.99 5 60255 12650 31624434
Genital anaesthesia 11.20 10.99 3 60257 11 31637073
Thyroxine free abnormal 11.20 10.99 3 60257 11 31637073
Ankyloglossia congenital 11.19 10.99 7 60253 290 31636794
Productive cough 11.15 10.99 30 60230 33510 31603574
Peripheral venous disease 11.07 10.99 18 60242 2418 31634666

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
Completed suicide 1913.89 9.82 2458 158087 224677 70543222
Serotonin syndrome 1399.10 9.82 979 159566 41135 70726764
Intentional overdose 1112.86 9.82 1239 159306 97196 70670703
Toxicity to various agents 1093.83 9.82 2562 157983 379610 70388289
Suicidal ideation 980.20 9.82 985 159560 68611 70699288
Suicide attempt 714.15 9.82 890 159655 78620 70689279
Drug abuse 678.01 9.82 1204 159341 146052 70621847
Drug interaction 674.65 9.82 2144 158401 379297 70388602
Depression 607.13 9.82 1370 159175 197604 70570295
Anxiety 490.36 9.82 1345 159200 218985 70548914
Intentional self-injury 480.61 9.82 467 160078 31183 70736716
Electrocardiogram QT prolonged 419.44 9.82 710 159835 82807 70685092
Overdose 394.25 9.82 1053 159492 168692 70599207
Rheumatoid arthritis 343.65 9.82 116 160429 291689 70476210
Agitation 333.72 9.82 686 159859 92689 70675210
Tremor 317.45 9.82 921 159624 154703 70613196
Poisoning 299.65 9.82 310 160235 22312 70745587
Drug withdrawal syndrome 286.77 9.82 362 160183 32353 70735546
Respiratory arrest 260.79 9.82 451 160094 53482 70714417
Cardiac arrest 249.84 9.82 863 159682 158971 70608928
Obsessive-compulsive disorder 236.64 9.82 149 160396 5221 70762678
Synovitis 233.19 9.82 15 160530 129213 70638686
Febrile neutropenia 227.24 9.82 89 160456 204229 70563670
Akathisia 226.35 9.82 202 160343 12091 70755808
Cardio-respiratory arrest 223.92 9.82 615 159930 100062 70667837
Aggression 214.73 9.82 390 160155 48056 70719843
Contraindicated product administered 203.08 9.82 31 160514 134581 70633318
Irritability 201.16 9.82 332 160213 37893 70730006
Torsade de pointes 199.15 9.82 225 160320 17891 70750008
Withdrawal syndrome 192.45 9.82 259 160286 24645 70743254
Somnolence 183.01 9.82 967 159578 214639 70553260
Suicidal behaviour 182.12 9.82 103 160442 2953 70764946
Depressed mood 181.94 9.82 343 160202 43477 70724422
Joint swelling 180.55 9.82 184 160361 253027 70514872
Hand deformity 172.53 9.82 5 160540 86477 70681422
Infusion related reaction 170.93 9.82 119 160426 197415 70570484
Drug intolerance 166.65 9.82 159 160386 225528 70542371
Pneumonia 157.74 9.82 754 159791 595478 70172421
Reversible cerebral vasoconstriction syndrome 155.98 9.82 89 160456 2596 70765303
Poisoning deliberate 153.03 9.82 191 160354 16869 70751030
Systemic lupus erythematosus 152.48 9.82 24 160521 101878 70666021
Tardive dyskinesia 147.86 9.82 145 160400 9784 70758115
Mania 145.68 9.82 187 160358 16987 70750912
Treatment failure 141.19 9.82 75 160470 144067 70623832
Pericarditis 138.61 9.82 15 160530 84690 70683209
Rash 138.27 9.82 640 159905 509922 70257977
Peripheral swelling 135.91 9.82 203 160342 236360 70531539
Nightmare 135.28 9.82 206 160339 21950 70745949
Disturbance in attention 134.54 9.82 299 160246 42595 70725304
Anaemia 132.94 9.82 468 160077 402955 70364944
Coma 130.62 9.82 481 160064 91363 70676536
Respiratory depression 129.74 9.82 215 160330 24616 70743283
Panic attack 128.52 9.82 201 160344 21918 70745981
Drug dependence 128.31 9.82 270 160275 37051 70730848
Infection 127.88 9.82 174 160371 210611 70557288
Intentional product misuse 126.17 9.82 432 160113 79163 70688736
Sopor 125.17 9.82 241 160304 31026 70736873
Mydriasis 124.81 9.82 168 160377 15985 70751914
Pyrexia 123.97 9.82 835 159710 606117 70161782
Muscle twitching 123.40 9.82 186 160359 19641 70748258
Seizure 118.77 9.82 749 159796 177213 70590686
Wound 114.77 9.82 40 160505 98692 70669207
General physical health deterioration 112.40 9.82 228 160317 235803 70532096
Malignant neoplasm progression 111.14 9.82 69 160476 121670 70646229
Homicide 108.47 9.82 53 160492 1117 70766782
Thrombocytopenia 106.34 9.82 240 160305 238870 70529029
Swelling 106.13 9.82 164 160381 188375 70579524
Neutropenia 104.97 9.82 270 160275 256886 70511013
Arthropathy 104.67 9.82 111 160434 149946 70617953
Abnormal behaviour 102.22 9.82 236 160309 34473 70733426
Crying 102.07 9.82 177 160368 21022 70746877
Arthralgia 101.95 9.82 694 159851 502696 70265203
Platelet count decreased 101.30 9.82 154 160391 178068 70589831
Pancytopenia 100.76 9.82 116 160429 150991 70616908
Off label use 100.27 9.82 1138 159407 741922 70025977
Generalised tonic-clonic seizure 99.10 9.82 261 160284 41400 70726499
Extrapyramidal disorder 96.98 9.82 171 160374 20579 70747320
Muscle rigidity 96.78 9.82 161 160384 18489 70749410
Paranoia 96.16 9.82 154 160391 17134 70750765
Dystonia 94.18 9.82 164 160381 19542 70748357
Therapeutic product effect decreased 94.05 9.82 111 160434 142907 70624992
Myoclonus 93.32 9.82 193 160352 26162 70741737
Helicobacter infection 93.27 9.82 9 160536 55647 70712252
Hyperreflexia 93.20 9.82 99 160446 7343 70760556
Restless legs syndrome 92.85 9.82 157 160388 18271 70749628
Rheumatoid factor positive 92.35 9.82 4 160541 48396 70719503
Hepatic enzyme increased 91.79 9.82 133 160412 156857 70611042
Alopecia 90.89 9.82 196 160349 198294 70569605
Euphoric mood 90.48 9.82 94 160451 6795 70761104
Sedation 89.82 9.82 271 160274 46460 70721439
Self-injurious ideation 88.98 9.82 68 160477 3270 70764629
Disease progression 88.43 9.82 136 160409 156536 70611363
Stomatitis 87.47 9.82 97 160448 128414 70639485
Tic 87.10 9.82 62 160483 2671 70765228
Coma scale abnormal 86.14 9.82 99 160446 8017 70759882
Dyskinesia 85.44 9.82 245 160300 40829 70727070
Electrocardiogram QRS complex prolonged 85.10 9.82 108 160437 9698 70758201
Hyperhidrosis 84.77 9.82 549 159996 131037 70636862
Anger 84.70 9.82 140 160405 15992 70751907
Psychotic disorder 84.44 9.82 231 160314 37470 70730429
Galactorrhoea 83.92 9.82 66 160479 3312 70764587
Clonus 83.17 9.82 86 160459 6182 70761717
Nasopharyngitis 82.67 9.82 244 160301 221962 70545937
Glossodynia 81.77 9.82 47 160498 86440 70681459
Restlessness 81.62 9.82 245 160300 41883 70726016
Renal impairment 81.18 9.82 125 160420 143812 70624087
Sepsis 80.90 9.82 283 160262 244262 70523637
Tearfulness 79.81 9.82 76 160469 4944 70762955
Miosis 78.96 9.82 126 160419 13975 70753924
Hallucination, auditory 77.97 9.82 145 160400 18183 70749716
Mucosal inflammation 77.97 9.82 28 160517 67822 70700077
Atrial fibrillation 77.17 9.82 191 160354 184157 70583742
Drug ineffective 76.46 9.82 1586 158959 938166 69829733
Diarrhoea 75.76 9.82 1283 159262 782058 69985841
Mental disorder 75.57 9.82 185 160360 28055 70739844
Mood swings 74.48 9.82 142 160403 18144 70749755
Acute kidney injury 72.76 9.82 705 159840 473919 70293980
Duodenal ulcer perforation 72.16 9.82 14 160531 51098 70716801
C-reactive protein increased 71.35 9.82 87 160458 110430 70657469
Parkinsonism 71.24 9.82 126 160419 15199 70752700
Depressed level of consciousness 70.56 9.82 387 160158 87044 70680855
Abdominal discomfort 69.93 9.82 250 160295 214408 70553491
Abnormal dreams 69.61 9.82 102 160443 10501 70757398
Accidental death 69.54 9.82 63 160482 3845 70764054
Insomnia 67.47 9.82 772 159773 217034 70550865
Lower respiratory tract infection 67.20 9.82 93 160452 111820 70656079
Discomfort 67.02 9.82 84 160461 105352 70662547
Impulsive behaviour 66.68 9.82 53 160492 2701 70765198
Product substitution issue 66.04 9.82 136 160409 18377 70749522
Confusional state 63.75 9.82 950 159595 283448 70484451
Bezoar 63.73 9.82 48 160497 2258 70765641
Cytomegalovirus infection 62.65 9.82 8 160537 39750 70728149
Memory impairment 62.42 9.82 391 160154 92250 70675649
Antipsychotic drug level increased 62.24 9.82 69 160476 5371 70762528
Hypersensitivity 62.08 9.82 288 160257 229524 70538375
Sleep disorder due to general medical condition, insomnia type 61.98 9.82 5 160540 35727 70732172
Folliculitis 61.51 9.82 11 160534 42559 70725340
Hallucination 61.16 9.82 337 160208 75923 70691976
Intentional product use issue 60.67 9.82 112 160433 120030 70647869
Cardiac failure 60.63 9.82 148 160397 143393 70624506
Mood altered 59.92 9.82 122 160423 16353 70751546
Drug abuser 59.68 9.82 70 160475 5794 70762105
Disinhibition 59.42 9.82 46 160499 2255 70765644
Product complaint 58.72 9.82 102 160443 12129 70755770
Hostility 58.06 9.82 45 160500 2210 70765689
Blister 57.93 9.82 86 160459 100440 70667459
Emotional distress 57.30 9.82 200 160345 36988 70730911
Homicidal ideation 56.07 9.82 52 160493 3271 70764628
C-reactive protein abnormal 55.67 9.82 10 160535 38569 70729330
Muscle injury 55.50 9.82 10 160535 38484 70729415
Impaired healing 55.30 9.82 52 160493 74322 70693577
Affective disorder 55.07 9.82 76 160469 7403 70760496
Social avoidant behaviour 54.90 9.82 60 160485 4596 70763303
Victim of child abuse 54.24 9.82 31 160514 907 70766992
Cholecystitis chronic 54.18 9.82 85 160460 9291 70758608
Myocardial depression 52.76 9.82 25 160520 491 70767408
Major depression 52.73 9.82 80 160465 8494 70759405
Septic shock 52.06 9.82 110 160435 112148 70655751
Pain 51.92 9.82 1058 159487 627758 70140141
Libido increased 51.86 9.82 39 160506 1830 70766069
Drug level increased 51.82 9.82 191 160354 36278 70731621
Apathy 51.65 9.82 95 160450 11813 70756086
Dissociation 51.57 9.82 50 160495 3326 70764573
Stress cardiomyopathy 50.99 9.82 85 160460 9777 70758122
Decorticate posture 50.63 9.82 21 160524 296 70767603
Haemoglobin decreased 50.28 9.82 266 160279 204893 70563006
Mobility decreased 50.26 9.82 98 160447 102901 70664998
Myelosuppression 50.18 9.82 5 160540 30140 70737759
Gastrointestinal disorder 50.00 9.82 102 160443 105325 70662574
Feeling abnormal 49.83 9.82 517 160028 141802 70626097
Blood creatinine increased 49.63 9.82 162 160383 142839 70625060
Neuroleptic malignant syndrome 49.20 9.82 150 160395 25857 70742042
Herpes zoster 49.03 9.82 73 160472 85162 70682737
Blood prolactin increased 48.90 9.82 51 160494 3703 70764196
Hyperprolactinaemia 48.82 9.82 55 160490 4358 70763541
Nervousness 48.50 9.82 168 160377 30952 70736947
Thinking abnormal 48.36 9.82 93 160452 11958 70755941
Obsessive-compulsive symptom 47.89 9.82 18 160527 192 70767707
Hepatic function abnormal 47.73 9.82 50 160495 67946 70699953
Product use issue 47.69 9.82 227 160318 179710 70588189
Oculogyric crisis 47.04 9.82 43 160502 2655 70765244
Speech disorder 46.39 9.82 232 160313 50348 70717551
Migraine 46.25 9.82 301 160244 71937 70695962
Dyspnoea 46.02 9.82 1360 159185 768700 69999199
Fear 45.10 9.82 126 160419 20685 70747214
Cough 44.59 9.82 496 160049 324881 70443018
Erythema 44.43 9.82 267 160278 199296 70568603
Psychomotor hyperactivity 44.41 9.82 104 160441 15329 70752570
Persistent genital arousal disorder 43.74 9.82 19 160526 302 70767597
Pleural effusion 43.73 9.82 154 160391 132710 70635189
Long QT syndrome 43.61 9.82 57 160488 5270 70762629
Parasomnia 43.24 9.82 22 160523 507 70767392
Neuropathy peripheral 43.18 9.82 145 160400 126751 70641148
Bone marrow failure 43.05 9.82 29 160516 48981 70718918
Sinus bradycardia 42.60 9.82 134 160411 23489 70744410
Blood pressure fluctuation 41.86 9.82 43 160502 58969 70708930
Cerebral vasoconstriction 41.78 9.82 30 160515 1310 70766589
Poor quality sleep 40.98 9.82 120 160425 20229 70747670
Plasma cell myeloma 40.84 9.82 64 160481 73137 70694762
Dependence 40.77 9.82 37 160508 2263 70765636
Synaesthesia 40.75 9.82 8 160537 0 70767899
Blood hyposmosis 40.68 9.82 10 160535 18 70767881
Arthritis 40.60 9.82 102 160443 97878 70670021
Physical assault 39.81 9.82 31 160514 1533 70766366
Hyperkalaemia 38.92 9.82 118 160427 106473 70661426
Morbid thoughts 38.47 9.82 23 160522 733 70767166
Atrioventricular block first degree 38.44 9.82 83 160462 11590 70756309
Neoplasm progression 38.09 9.82 28 160517 45200 70722699
Increased appetite 37.89 9.82 78 160467 10535 70757364
Anorgasmia 37.81 9.82 26 160519 1059 70766840
Bradyphrenia 37.78 9.82 75 160470 9871 70758028
Libido decreased 37.78 9.82 51 160494 4865 70763034
Alcohol poisoning 37.76 9.82 48 160497 4317 70763582
Bruxism 37.10 9.82 44 160501 3685 70764214
Eye movement disorder 36.97 9.82 63 160482 7377 70760522
Sinus tachycardia 36.53 9.82 163 160382 33750 70734149
Reduced facial expression 36.24 9.82 35 160510 2317 70765582
Tachycardia 35.62 9.82 530 160015 158016 70609883
White blood cell count decreased 35.61 9.82 232 160313 169909 70597990
Prostate cancer 35.56 9.82 13 160532 31150 70736749
Amnesia 35.04 9.82 220 160325 51935 70715964
Blood lactate dehydrogenase increased 34.78 9.82 18 160527 35109 70732790
Cogwheel rigidity 34.57 9.82 38 160507 2930 70764969
Ill-defined disorder 34.37 9.82 44 160501 54697 70713202
Bipolar I disorder 34.30 9.82 31 160514 1886 70766013
Flat affect 34.21 9.82 31 160514 1892 70766007
Suspected suicide 34.02 9.82 67 160478 8767 70759132
Inappropriate antidiuretic hormone secretion 33.99 9.82 123 160422 23153 70744746
Derealisation 33.89 9.82 28 160517 1508 70766391
Panic reaction 33.88 9.82 45 160500 4226 70763673
Yawning 33.47 9.82 26 160519 1281 70766618
Asphyxia 33.44 9.82 73 160472 10269 70757630
Huntington's disease 33.44 9.82 8 160537 12 70767887
Binge eating 33.38 9.82 18 160527 469 70767430
Feeling guilty 33.27 9.82 22 160523 839 70767060
Drug hypersensitivity 33.26 9.82 407 160138 262052 70505847
Traumatic coma 33.13 9.82 10 160535 50 70767849
Mental impairment 33.08 9.82 100 160445 17155 70750744
Therapeutic product effect incomplete 33.08 9.82 149 160396 119733 70648166
Marital problem 32.96 9.82 14 160531 210 70767689
Alcoholism 32.47 9.82 45 160500 4400 70763499
Unresponsive to stimuli 32.40 9.82 215 160330 51716 70716183
Foetal exposure during pregnancy 32.37 9.82 51 160494 5594 70762305
Ascites 32.32 9.82 65 160480 67482 70700417
Bipolar disorder 32.12 9.82 60 160485 7548 70760351
Violence-related symptom 31.98 9.82 20 160525 692 70767207
Obsessive thoughts 31.72 9.82 23 160522 1020 70766879
Hallucination, visual 31.60 9.82 141 160404 29196 70738703
Borderline personality disorder 31.21 9.82 21 160524 825 70767074
Soft tissue injury 31.11 9.82 28 160517 1694 70766205
Lethargy 31.05 9.82 283 160262 74967 70692932
Hypomania 30.94 9.82 52 160493 6020 70761879
Heart sounds 30.91 9.82 20 160525 735 70767164
Abnormal sleep-related event 30.72 9.82 21 160524 847 70767052
Pulseless electrical activity 30.61 9.82 82 160463 13133 70754766
Social anxiety disorder 30.35 9.82 17 160528 478 70767421
Multiple sclerosis relapse 29.86 9.82 183 160362 42834 70725065
Tension 29.79 9.82 41 160504 3983 70763916
Dysarthria 29.72 9.82 242 160303 62071 70705828
Staring 29.57 9.82 32 160513 2424 70765475
Emotional disorder 29.57 9.82 81 160464 13145 70754754
Dysphoria 29.13 9.82 43 160502 4455 70763444
Rhabdomyolysis 28.97 9.82 338 160207 95422 70672477
Visceral congestion 28.88 9.82 20 160525 824 70767075
Inflammation 28.77 9.82 87 160458 78578 70689321
Red blood cell sedimentation rate increased 28.74 9.82 27 160518 38615 70729284
Delusion 28.60 9.82 102 160443 19063 70748836
Negative thoughts 28.52 9.82 24 160521 1326 70766573
Dysphemia 28.41 9.82 36 160509 3227 70764672
Basilar migraine 28.31 9.82 9 160536 55 70767844
Initial insomnia 28.21 9.82 51 160494 6258 70761641
Weight increased 28.14 9.82 733 159812 241598 70526301
Tachyphrenia 28.13 9.82 28 160517 1923 70765976
Multiple organ dysfunction syndrome 28.10 9.82 138 160407 108377 70659522
Hypersomnia 28.04 9.82 107 160438 20657 70747242
Accidental overdose 28.01 9.82 155 160390 34966 70732933
Hyponatraemia 27.77 9.82 513 160032 159574 70608325
Cataplexy 27.69 9.82 21 160524 998 70766901
Respiration abnormal 27.58 9.82 53 160492 6811 70761088
Loss of libido 27.42 9.82 31 160514 2466 70765433
Depressive symptom 27.25 9.82 45 160500 5136 70762763
Aspergillus infection 27.19 9.82 4 160541 17864 70750035
Influenza like illness 27.11 9.82 246 160299 65085 70702814
Carbon monoxide poisoning 27.04 9.82 13 160532 264 70767635
Catatonia 26.98 9.82 58 160487 8075 70759824
Depersonalisation/derealisation disorder 26.91 9.82 26 160519 1722 70766177
Sinusitis 26.40 9.82 250 160295 168945 70598954
Liver disorder 26.36 9.82 63 160482 61505 70706394
Oxygen saturation decreased 26.30 9.82 155 160390 116274 70651625
Blunted affect 26.18 9.82 15 160530 441 70767458
Obesity 26.12 9.82 125 160420 26646 70741253
Antipsychotic drug level below therapeutic 26.11 9.82 20 160525 965 70766934
Multiple sclerosis 26.09 9.82 120 160425 25165 70742734
Prolonged expiration 25.97 9.82 20 160525 973 70766926
Blood bilirubin increased 25.88 9.82 61 160484 59840 70708059
Transplant rejection 25.60 9.82 5 160540 18166 70749733
Sternal fracture 25.49 9.82 29 160516 2322 70765577
Ventricular hypokinesia 25.46 9.82 57 160488 8155 70759744
Somnambulism 25.42 9.82 44 160501 5216 70762683
Musculoskeletal stiffness 25.39 9.82 213 160332 147547 70620352
Decreased interest 25.39 9.82 35 160510 3406 70764493
Antidepressant drug level increased 25.15 9.82 14 160531 389 70767510
Treatment noncompliance 25.05 9.82 186 160359 46388 70721511
Thrombotic microangiopathy 24.96 9.82 5 160540 17843 70750056
Self esteem decreased 24.85 9.82 19 160526 914 70766985
Bulimia nervosa 24.60 9.82 12 160533 252 70767647
Burning mouth syndrome 24.60 9.82 15 160530 496 70767403
Disorientation 24.49 9.82 219 160326 57704 70710195
Epidural lipomatosis 24.43 9.82 19 160526 938 70766961
Coordination abnormal 24.40 9.82 86 160459 15980 70751919
Tumour lysis syndrome 24.22 9.82 9 160536 21351 70746548
Posture abnormal 24.19 9.82 35 160510 3561 70764338
Cytokine release syndrome 24.14 9.82 15 160530 26452 70741447
Heart rate 24.00 9.82 8 160537 58 70767841
Serum serotonin decreased 23.99 9.82 6 160539 12 70767887
Palmar-plantar erythrodysaesthesia syndrome 23.86 9.82 20 160525 30227 70737672
Breast discomfort 23.72 9.82 13 160532 350 70767549
Bacteraemia 23.59 9.82 19 160526 29290 70738609
Sleep disorder 23.58 9.82 252 160293 69620 70698279
Neutrophil count decreased 23.56 9.82 103 160442 83453 70684446
Cystostomy 23.53 9.82 8 160537 62 70767837
Protein C increased 23.46 9.82 9 160536 102 70767797
Priapism 23.39 9.82 37 160508 4073 70763826
Drug screen positive 23.35 9.82 45 160500 5795 70762104
Gastrointestinal haemorrhage 23.20 9.82 199 160346 137209 70630690
Compulsive shopping 23.11 9.82 17 160528 771 70767128
Therapeutic response unexpected 23.04 9.82 92 160453 18139 70749760
Anterograde amnesia 22.96 9.82 16 160529 666 70767233
Diet failure 22.87 9.82 7 160538 37 70767862
Hip arthroplasty 22.79 9.82 18 160527 28022 70739877
Polyneuropathy 22.69 9.82 10 160535 21405 70746494
Haemophagocytic lymphohistiocytosis 22.69 9.82 8 160537 19604 70748295
Irritable bowel syndrome 22.60 9.82 51 160494 50799 70717100
Formication 22.57 9.82 39 160506 4618 70763281
Sleep-related eating disorder 22.40 9.82 16 160529 693 70767206
Pneumocystis jirovecii pneumonia 22.39 9.82 21 160524 30061 70737838
Hypertonia 22.31 9.82 47 160498 6451 70761448
Choreoathetosis 22.31 9.82 22 160523 1494 70766405
Musculoskeletal pain 22.17 9.82 117 160428 90210 70677689
Disseminated intravascular coagulation 22.15 9.82 26 160519 33572 70734327
Trichotillomania 22.10 9.82 10 160535 176 70767723
Hyporesponsive to stimuli 21.93 9.82 24 160521 1841 70766058
Autonomic nervous system imbalance 21.90 9.82 37 160508 4302 70763597
Oral discharge 21.80 9.82 11 160534 249 70767650
Heart rate decreased 21.68 9.82 70 160475 61945 70705954
Blood pressure diastolic decreased 21.66 9.82 16 160529 25764 70742135
Sluggishness 21.60 9.82 44 160501 5899 70762000
Product use in unapproved indication 21.52 9.82 335 160210 207143 70560756
Chorea 21.47 9.82 25 160520 2053 70765846
Graft versus host disease 21.45 9.82 4 160541 15019 70752880
Urinary incontinence 21.43 9.82 153 160392 37689 70730210
Foetal arrhythmia 21.21 9.82 7 160538 49 70767850
Blood pressure systolic increased 21.17 9.82 63 160482 57196 70710703
Tourette's disorder 21.15 9.82 8 160537 87 70767812
Jaundice neonatal 21.07 9.82 9 160536 137 70767762
Exposure via ingestion 21.05 9.82 39 160506 4876 70763023
Stress 21.05 9.82 241 160304 67725 70700174
Haematotoxicity 20.95 9.82 3 160542 13671 70754228
Panic disorder 20.93 9.82 29 160516 2835 70765064
Osteonecrosis of jaw 20.89 9.82 38 160507 40964 70726935
Post-traumatic neck syndrome 20.83 9.82 24 160521 1949 70765950
Myelodysplastic syndrome 20.79 9.82 22 160523 29763 70738136
Single umbilical artery 20.71 9.82 5 160540 8 70767891
Child abuse 20.70 9.82 12 160533 361 70767538
Hallucinations, mixed 20.68 9.82 45 160500 6317 70761582
Dreamy state 20.40 9.82 7 160538 56 70767843
Agitation neonatal 20.37 9.82 4 160541 0 70767899
Phobia 20.34 9.82 12 160533 373 70767526
Economic problem 20.28 9.82 25 160520 2179 70765720
Ideas of reference 20.23 9.82 9 160536 152 70767747
Alcohol use 20.17 9.82 37 160508 4590 70763309
Pathogen resistance 20.15 9.82 3 160542 13276 70754623
Patent ductus arteriosus 20.08 9.82 8 160537 101 70767798
Personality disorder 20.07 9.82 41 160504 5507 70762392
Alcohol interaction 20.03 9.82 37 160508 4616 70763283
Analgesic drug level increased 19.78 9.82 26 160519 2417 70765482
Thought insertion 19.56 9.82 6 160539 32 70767867
IIIrd nerve paresis 19.41 9.82 9 160536 168 70767731
Genital anaesthesia 19.37 9.82 5 160540 12 70767887
Oedema 19.33 9.82 146 160399 103435 70664464
Accommodation disorder 19.29 9.82 13 160532 512 70767387
Acute myeloid leukaemia 19.29 9.82 25 160520 30915 70736984
Depression suicidal 19.28 9.82 28 160517 2859 70765040
Respiratory disorder 19.27 9.82 37 160508 39086 70728813
Feeling drunk 19.14 9.82 35 160510 4332 70763567
Hospitalisation 19.14 9.82 109 160436 82459 70685440
CYP3A4 polymorphism 19.03 9.82 7 160538 70 70767829
Bronchopulmonary aspergillosis 19.02 9.82 12 160533 20990 70746909
Oedema peripheral 18.97 9.82 383 160162 227708 70540191
Concussion 18.91 9.82 52 160493 8457 70759442
Drug eruption 18.90 9.82 38 160507 39458 70728441
Metabolic acidosis 18.88 9.82 254 160291 74092 70693807
Vision blurred 18.84 9.82 311 160234 94673 70673226
Agoraphobia 18.74 9.82 13 160532 537 70767362
Loss of consciousness 18.64 9.82 473 160072 155243 70612656
Hypoalbuminaemia 18.63 9.82 10 160535 19112 70748787
Induced abortion failed 18.49 9.82 9 160536 188 70767711
Mental status changes 18.32 9.82 221 160324 62880 70705019
Injury 18.29 9.82 227 160318 65018 70702881
Serum sickness-like reaction 18.28 9.82 13 160532 559 70767340
Gallbladder disorder 18.23 9.82 84 160461 17628 70750271
Knee arthroplasty 18.19 9.82 31 160514 34270 70733629
Feeling of despair 18.12 9.82 26 160519 2625 70765274
Sexual dysfunction 18.12 9.82 44 160501 6637 70761262
Blood urea increased 18.09 9.82 49 160496 45860 70722039
Diffuse large B-cell lymphoma 18.04 9.82 4 160541 13298 70754601
Myocardial infarction 17.84 9.82 277 160268 171368 70596531
Colitis 17.78 9.82 79 160466 63735 70704164
Retinal phototoxicity 17.61 9.82 4 160541 4 70767895
Enterocolitis 17.57 9.82 4 160541 13062 70754837
Psoriatic arthropathy 17.56 9.82 81 160464 64690 70703209
Cardiac failure congestive 17.54 9.82 209 160336 135248 70632651
Peritonitis 17.51 9.82 20 160525 26139 70741760
Tenosynovitis 17.41 9.82 5 160540 13971 70753928
Hypercalcaemia 17.40 9.82 32 160513 34353 70733546
Anaphylactic reaction 17.36 9.82 99 160446 74875 70693024
Serum ferritin abnormal 17.35 9.82 11 160534 390 70767509
Pupil fixed 17.33 9.82 29 160516 3345 70764554
Joint range of motion decreased 17.31 9.82 20 160525 26006 70741893
Chronic actinic dermatitis 17.27 9.82 5 160540 21 70767878
Drooling 17.16 9.82 38 160507 5398 70762501
Neonatal seizure 17.14 9.82 4 160541 5 70767894
Amenorrhoea 17.07 9.82 44 160501 6886 70761013
Posterior reversible encephalopathy syndrome 17.06 9.82 18 160527 24384 70743515
Proteinuria 17.04 9.82 25 160520 29349 70738550
Pseudomonas infection 17.00 9.82 11 160534 18983 70748916
Cytopenia 16.97 9.82 9 160536 17314 70750585
Bladder cancer 16.83 9.82 9 160536 17233 70750666
Pruritus 16.82 9.82 626 159919 344934 70422965
Narcolepsy 16.72 9.82 17 160528 1198 70766701
Liver function test increased 16.68 9.82 32 160513 33815 70734084
Breast enlargement 16.61 9.82 18 160527 1366 70766533
Supraventricular tachyarrhythmia 16.60 9.82 7 160538 103 70767796
Neutropenic sepsis 16.60 9.82 19 160526 24811 70743088
Anhedonia 16.60 9.82 70 160475 14143 70753756
Dehydroepiandrosterone decreased 16.56 9.82 5 160540 25 70767874
Complication of device insertion 16.52 9.82 37 160508 5295 70762604
Pituitary tumour benign 16.49 9.82 24 160521 2455 70765444
Psychomotor retardation 16.41 9.82 38 160507 5560 70762339
Gambling disorder 16.27 9.82 21 160524 1917 70765982
Antisocial personality disorder 16.25 9.82 5 160540 27 70767872
Ventricular fibrillation 16.16 9.82 111 160434 27000 70740899
Cerebral infarction 16.13 9.82 47 160498 42962 70724937
Diverticulitis 16.10 9.82 45 160500 41689 70726210
Oesophageal food impaction 16.07 9.82 10 160535 343 70767556
Cholecystectomy 16.06 9.82 49 160496 8448 70759451
Hypnopompic hallucination 16.05 9.82 6 160539 63 70767836
Breath sounds abnormal 16 9.82 5 160540 13226 70754673
Tinnitus 15.92 9.82 138 160407 36038 70731861
Secondary hypogonadism 15.89 9.82 10 160535 350 70767549
Agranulocytosis 15.89 9.82 43 160502 40255 70727644
Appetite disorder 15.80 9.82 43 160502 6952 70760947
Disturbance in sexual arousal 15.78 9.82 8 160537 183 70767716
Interstitial lung disease 15.76 9.82 156 160389 104529 70663370
Confabulation 15.76 9.82 11 160534 459 70767440
Antisocial behaviour 15.70 9.82 12 160533 577 70767322
Constipation 15.70 9.82 443 160102 251995 70515904
Device placement issue 15.70 9.82 14 160531 837 70767062
Rash maculo-papular 15.69 9.82 60 160485 50485 70717414
Swollen tongue 15.62 9.82 140 160405 36906 70730993
Renal failure 15.56 9.82 318 160227 188752 70579147
Parkinsonian gait 15.51 9.82 14 160531 850 70767049
Gastric bypass 15.50 9.82 16 160529 1148 70766751
Spinal shock 15.40 9.82 5 160540 33 70767866
Respiratory failure 15.35 9.82 279 160266 168456 70599443
Drug-induced liver injury 15.32 9.82 70 160475 56043 70711856
Sleep paralysis 15.31 9.82 12 160533 599 70767300
Feeling jittery 15.19 9.82 59 160486 11484 70756415
Selective mutism 15.19 9.82 6 160539 74 70767825
Transaminases increased 15.13 9.82 55 160490 46963 70720936
Hypoplastic left heart syndrome 15.11 9.82 4 160541 11 70767888
Therapeutic product effect variable 15.10 9.82 19 160526 1691 70766208
Energy increased 15.10 9.82 25 160520 2859 70765040
Self-medication 15.10 9.82 32 160513 4411 70763488
Cellulitis 15.07 9.82 147 160398 98781 70669118
Sudden onset of sleep 15.04 9.82 12 160533 615 70767284
Micturition urgency 15.03 9.82 58 160487 11256 70756643
Nystagmus 15.01 9.82 51 160494 9304 70758595
Mast cell activation syndrome 15.00 9.82 12 160533 617 70767282
Blood magnesium decreased 14.99 9.82 70 160475 14771 70753128
Fatigue 14.94 9.82 1636 158909 822683 69945216
Dizziness 14.94 9.82 1232 159313 462909 70304990
Delusion of grandeur 14.93 9.82 14 160531 893 70767006
Slow response to stimuli 14.90 9.82 19 160526 1714 70766185
Cytomegalovirus viraemia 14.90 9.82 4 160541 11681 70756218
Dermatillomania 14.85 9.82 8 160537 208 70767691
Tubulointerstitial nephritis 14.84 9.82 33 160512 33043 70734856
Hypersexuality 14.82 9.82 18 160527 1545 70766354
Death of relative 14.82 9.82 8 160537 209 70767690
Personality change 14.80 9.82 49 160496 8821 70759078
Autism spectrum disorder 14.78 9.82 15 160530 1055 70766844
Asthenia 14.68 9.82 867 159678 456799 70311100
Atrioventricular block second degree 14.65 9.82 41 160504 6737 70761162
Haematochezia 14.60 9.82 101 160444 72980 70694919
Blood pressure measurement 14.59 9.82 10 160535 405 70767494
Locked-in syndrome 14.58 9.82 12 160533 643 70767256
Pregnancy on oral contraceptive 14.51 9.82 13 160532 782 70767117
COVID-19 pneumonia 14.48 9.82 17 160528 21952 70745947
Resting tremor 14.47 9.82 17 160528 1409 70766490
Bradycardia 14.46 9.82 377 160168 124238 70643661
Incubator therapy 14.46 9.82 5 160540 41 70767858
Attention deficit hyperactivity disorder 14.46 9.82 25 160520 2962 70764937
Logorrhoea 14.41 9.82 30 160515 4084 70763815
Skin ulcer 14.40 9.82 58 160487 48087 70719812
Hypoprolactinaemia 14.39 9.82 4 160541 14 70767885
Atrial septal defect 14.39 9.82 19 160526 1774 70766125
Hyperthermia 14.26 9.82 75 160470 16596 70751303
Coma uraemic 14.25 9.82 5 160540 43 70767856
Large intestine perforation 14.24 9.82 6 160539 13189 70754710
Body temperature decreased 14.22 9.82 27 160518 28645 70739254
Eating disorder 14.18 9.82 81 160464 18484 70749415
Jaw clicking 14.17 9.82 4 160541 15 70767884
Grip strength decreased 14.15 9.82 9 160536 15676 70752223
Metastases to lung 14.15 9.82 10 160535 16474 70751425
Exposure during pregnancy 14.14 9.82 278 160267 87439 70680460
Post 5-alpha-reductase inhibitor syndrome 14.13 9.82 6 160539 90 70767809
Pulmonary haemosiderosis 14.06 9.82 5 160540 45 70767854
Pneumothorax 14.03 9.82 23 160522 25823 70742076
Creatinine renal clearance decreased 14.03 9.82 11 160534 17189 70750710
Anorexia nervosa 14.03 9.82 8 160537 233 70767666
Pericardial effusion 14.02 9.82 48 160497 41728 70726171
Basal cell carcinoma 14.02 9.82 35 160510 33663 70734236
Alcohol withdrawal syndrome 14.00 9.82 19 160526 1822 70766077
Fluid retention 13.99 9.82 85 160460 63300 70704599
Balance disorder 13.98 9.82 284 160261 89844 70678055
Osteoporosis 13.96 9.82 60 160485 48847 70719052
Bradykinesia 13.94 9.82 43 160502 7459 70760440
Tongue biting 13.93 9.82 19 160526 1830 70766069
Therapy change 13.93 9.82 40 160505 6669 70761230
Foetal monitoring abnormal 13.89 9.82 7 160538 158 70767741
Productive cough 13.87 9.82 112 160433 78225 70689674
Salivary hypersecretion 13.83 9.82 62 160483 12863 70755036
Impulse-control disorder 13.80 9.82 18 160527 1661 70766238
Pulmonary arterial hypertension 13.76 9.82 34 160511 32821 70735078
Vaginal haemorrhage 13.76 9.82 86 160459 20266 70747633
Blood test abnormal 13.68 9.82 8 160537 14582 70753317
Cold agglutinins positive 13.68 9.82 5 160540 49 70767850
Hypoxic-ischaemic encephalopathy 13.68 9.82 42 160503 7266 70760633
Gestational diabetes 13.66 9.82 37 160508 5964 70761935
Myasthenic syndrome 13.62 9.82 12 160533 706 70767193
Chemical burn 13.61 9.82 10 160535 453 70767446
Prolonged rupture of membranes 13.59 9.82 5 160540 50 70767849
Road traffic accident 13.58 9.82 129 160416 34553 70733346
Enuresis 13.58 9.82 24 160521 2893 70765006
Asthma 13.56 9.82 192 160353 120601 70647298
Haemorrhage intracranial 13.50 9.82 22 160523 24755 70743144
Loss of personal independence in daily activities 13.43 9.82 125 160420 84785 70683114
Compulsions 13.43 9.82 9 160536 351 70767548
Candida infection 13.43 9.82 37 160508 34436 70733463
Ventricular hypertrophy 13.42 9.82 39 160506 6545 70761354
Heart disease congenital 13.42 9.82 11 160534 586 70767313
Mutism 13.38 9.82 20 160525 2096 70765803
Skin cancer 13.31 9.82 7 160538 13529 70754370
Appendicitis 13.28 9.82 11 160534 16722 70751177
Thrombosis 13.26 9.82 108 160437 75297 70692602
Abortion spontaneous 13.26 9.82 104 160441 26375 70741524
Umbilical cord around neck 13.25 9.82 4 160541 20 70767879
Renal disorder 13.22 9.82 43 160502 37966 70729933
Purple glove syndrome 13.19 9.82 8 160537 262 70767637
Klebsiella infection 13.17 9.82 8 160537 14284 70753615
Hyperdynamic left ventricle 13.14 9.82 9 160536 364 70767535
Premature baby 13.14 9.82 26 160519 3413 70764486
Decreased appetite 13.12 9.82 560 159985 304220 70463679
Electrolyte depletion 13.12 9.82 9 160536 365 70767534
Joint hyperextension 13.11 9.82 8 160537 265 70767634
Pain in extremity 13.07 9.82 608 159937 327474 70440425
Blood pressure increased 12.98 9.82 326 160219 188191 70579708
Venoocclusive liver disease 12.98 9.82 4 160541 10674 70757225
Panniculitis 12.97 9.82 4 160541 10672 70757227
Dissociative disorder 12.96 9.82 10 160535 488 70767411
Antidepressant drug level above therapeutic 12.95 9.82 11 160534 616 70767283
Blood creatine phosphokinase MB 12.94 9.82 4 160541 22 70767877
Haemolysis 12.88 9.82 5 160540 11546 70756353
Cholangitis 12.87 9.82 5 160540 11544 70756355
Ventricular arrhythmia 12.84 9.82 43 160502 7787 70760112
Gastric disorder 12.80 9.82 36 160509 33286 70734613
Status migrainosus 12.78 9.82 5 160540 60 70767839
Dissociative identity disorder 12.63 9.82 5 160540 62 70767837
Blood triglycerides increased 12.62 9.82 82 160463 19582 70748317
Multiple system atrophy 12.62 9.82 9 160536 389 70767510
Cataract 12.60 9.82 74 160471 55571 70712328
Ventricular tachycardia 12.58 9.82 132 160413 36291 70731608
Faecal calprotectin 12.51 9.82 4 160541 25 70767874
Blood potassium decreased 12.50 9.82 149 160396 42272 70725627
Second primary malignancy 12.46 9.82 7 160538 13044 70754855
Procedural hypertension 12.44 9.82 8 160537 291 70767608
Brugada syndrome 12.43 9.82 14 160531 1109 70766790
Vascular stenosis 12.37 9.82 10 160535 522 70767377
Back pain 12.35 9.82 495 160050 270657 70497242
Urinary retention 12.34 9.82 177 160368 52343 70715556
Enterococcal infection 12.31 9.82 9 160536 14573 70753326
Intrusive thoughts 12.24 9.82 9 160536 408 70767491
Blood pressure systolic abnormal 12.22 9.82 7 160538 12902 70754997
Compulsive hoarding 12.21 9.82 5 160540 68 70767831
Device related infection 12.20 9.82 35 160510 32150 70735749
Haemorrhage 12.16 9.82 126 160419 83689 70684210
End stage renal disease 12.11 9.82 5 160540 11128 70756771
Hypothermia 12.09 9.82 84 160461 20510 70747389
Metastases to bone 12.07 9.82 20 160525 22356 70745543
Red blood cell count decreased 12.01 9.82 69 160476 52092 70715807
Tremor neonatal 12.00 9.82 3 160542 6 70767893
Apgar score low 12.00 9.82 3 160542 6 70767893
Right aortic arch 12.00 9.82 3 160542 6 70767893
Acquired cardiac septal defect 12.00 9.82 3 160542 6 70767893
Lumbar radiculopathy 11.88 9.82 18 160527 1908 70765991
Coagulation factor VII level decreased 11.88 9.82 7 160538 217 70767682
Plasma cell mastitis 11.88 9.82 4 160541 30 70767869
Electrocardiogram repolarisation abnormality 11.86 9.82 18 160527 1911 70765988
Toxic skin eruption 11.85 9.82 17 160528 20145 70747754
Appendicitis perforated 11.84 9.82 23 160522 2980 70764919
Agonal rhythm 11.83 9.82 5 160540 74 70767825
Duodenal ulcer repair 11.77 9.82 5 160540 75 70767824
Muscle necrosis 11.76 9.82 15 160530 1353 70766546
Intervertebral disc displacement 11.74 9.82 9 160536 435 70767464
Disability 11.70 9.82 10 160535 14973 70752926
Bursitis 11.65 9.82 27 160518 26646 70741253
Enthesopathy 11.64 9.82 5 160540 10864 70757035
Grandiosity 11.62 9.82 10 160535 570 70767329
Cardiomegaly 11.53 9.82 95 160450 24450 70743449
Cholinergic syndrome 11.47 9.82 12 160533 874 70767025
Chronic fatigue syndrome 11.47 9.82 14 160531 1208 70766691
Persecutory delusion 11.46 9.82 29 160516 4488 70763411
Placenta praevia 11.45 9.82 11 160534 723 70767176
Food interaction 11.45 9.82 16 160529 1577 70766322
Premature labour 11.45 9.82 42 160503 7958 70759941
Stereotypy 11.34 9.82 12 160533 886 70767013
Accidental poisoning 11.32 9.82 16 160529 1594 70766305
Hypogammaglobulinaemia 11.29 9.82 6 160539 11532 70756367
Renal artery thrombosis 11.28 9.82 9 160536 461 70767438
Hypnagogic hallucination 11.28 9.82 6 160539 152 70767747
Cerebrovascular stenosis 11.28 9.82 6 160539 152 70767747
Theft 11.23 9.82 7 160538 241 70767658
Epistaxis 11.21 9.82 164 160381 102463 70665436
Rabbit syndrome 11.19 9.82 8 160537 347 70767552
Psychotic behaviour 11.15 9.82 13 160532 1069 70766830
Pulmonary valve stenosis 11.15 9.82 4 160541 37 70767862
Medical diet 11.14 9.82 3 160542 9 70767890
Neonatal respiratory distress syndrome 11.12 9.82 7 160538 245 70767654
Gout 11.12 9.82 22 160523 22984 70744915
Oral candidiasis 11.11 9.82 25 160520 24927 70742972
Exposure via inhalation 11.10 9.82 5 160540 87 70767812
Regurgitation 11.07 9.82 19 160526 2237 70765662
Maternal drugs affecting foetus 11.06 9.82 16 160529 1628 70766271
Vasoplegia syndrome 11.04 9.82 23 160522 3133 70764766
Accidental exposure to product 11.00 9.82 30 160515 28021 70739878
Developmental delay 11.00 9.82 13 160532 1085 70766814
Pre-eclampsia 10.98 9.82 36 160509 6449 70761450
Alpha 1 globulin increased 10.95 9.82 5 160540 90 70767809
Chronic kidney disease 10.95 9.82 87 160458 60970 70706929
Dyspnoea exertional 10.94 9.82 119 160426 78311 70689588
Hyperinsulinism 10.90 9.82 3 160542 10 70767889
Peripheral sensory neuropathy 10.86 9.82 7 160538 12103 70755796
Heavy menstrual bleeding 10.85 9.82 57 160488 12608 70755291
Acute psychosis 10.84 9.82 26 160519 3890 70764009
Osteonecrosis 10.84 9.82 32 160513 29128 70738771
Gaze palsy 10.83 9.82 21 160524 2717 70765182
Transient aphasia 10.77 9.82 6 160539 167 70767732
Legal problem 10.74 9.82 6 160539 168 70767731
Withdrawal catatonia 10.74 9.82 6 160539 168 70767731
Anal incontinence 10.73 9.82 69 160476 16421 70751478
Prostatic specific antigen increased 10.71 9.82 4 160541 9462 70758437
Colitis ulcerative 10.70 9.82 40 160505 33883 70734016
Loss of bladder sensation 10.70 9.82 5 160540 95 70767804
Head deformity 10.70 9.82 4 160541 42 70767857
Febrile bone marrow aplasia 10.66 9.82 7 160538 11984 70755915
Full blood count abnormal 10.66 9.82 40 160505 33838 70734061
Full blood count decreased 10.62 9.82 24 160521 23894 70744005
Colorectal cancer 10.61 9.82 3 160542 8467 70759432
Metastases to central nervous system 10.61 9.82 11 160534 15023 70752876
Hypervolaemia 10.56 9.82 50 160495 39656 70728243
Squamous cell carcinoma of skin 10.54 9.82 8 160537 12704 70755195
Lymphatic system neoplasm 10.53 9.82 4 160541 44 70767855
Melanocytic hyperplasia 10.48 9.82 3 160542 12 70767887
Cushingoid 10.45 9.82 3 160542 8385 70759514
Sleep attacks 10.42 9.82 6 160539 178 70767721
Toxic epidermal necrolysis 10.41 9.82 50 160495 39507 70728392
Eye colour change 10.41 9.82 8 160537 388 70767511
Drug withdrawal syndrome neonatal 10.40 9.82 7 160538 275 70767624
Maternal exposure during pregnancy 10.40 9.82 191 160354 115154 70652745
Device expulsion 10.39 9.82 86 160459 22160 70745739
Hypertriglyceridaemia 10.36 9.82 7 160538 11804 70756095
Affect lability 10.35 9.82 48 160497 10098 70757801
Gastric hypomotility 10.33 9.82 6 160539 181 70767718
Skin necrosis 10.32 9.82 13 160532 16278 70751621
Uterine hypertonus 10.31 9.82 7 160538 279 70767620
Haematuria 10.31 9.82 93 160452 63480 70704419
Trismus 10.23 9.82 30 160515 5061 70762838
Biliary dyskinesia 10.23 9.82 19 160526 2380 70765519
Drug resistance 10.21 9.82 48 160497 38142 70729757
Gastrointestinal hypermotility 10.18 9.82 7 160538 285 70767614
Menstruation irregular 10.16 9.82 28 160517 4560 70763339
Osteoarthritis 10.14 9.82 113 160432 74034 70693865
Platelet count increased 10.14 9.82 19 160526 20254 70747645
Blood uric acid increased 10.10 9.82 4 160541 9125 70758774
Blood pressure decreased 10.08 9.82 146 160399 91369 70676530
Skin infection 10.06 9.82 13 160532 16099 70751800
Imprisonment 10.03 9.82 9 160536 542 70767357
Clostridium difficile colitis 9.95 9.82 33 160512 28963 70738936
Alpha 2 globulin decreased 9.94 9.82 3 160542 15 70767884
Sex hormone binding globulin decreased 9.94 9.82 3 160542 15 70767884
Pregnancy with contraceptive patch 9.94 9.82 3 160542 15 70767884
Testicular microlithiasis 9.94 9.82 3 160542 15 70767884
Otosalpingitis 9.94 9.82 3 160542 15 70767884
Internal haemorrhage 9.94 9.82 3 160542 8113 70759786
Metastases to liver 9.91 9.82 28 160517 25850 70742049
Blood glucose fluctuation 9.91 9.82 34 160511 6233 70761666
Blood parathyroid hormone decreased 9.90 9.82 4 160541 9020 70758879
Localised infection 9.88 9.82 40 160505 33118 70734781
Bradypnoea 9.87 9.82 31 160514 5428 70762471
Hypoglycaemia neonatal 9.87 9.82 4 160541 53 70767846
Optic ischaemic neuropathy 9.87 9.82 20 160525 2672 70765227
Foetal alcohol syndrome 9.87 9.82 4 160541 53 70767846
Lung disorder 9.86 9.82 105 160440 69379 70698520
Alanine aminotransferase abnormal 9.83 9.82 3 160542 8056 70759843

FDA Adverse Event Reporting System (Pediatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Feeling jittery 45.63 22.91 18 774 44 88956
Exposure during pregnancy 32.11 22.91 48 744 1286 87714
Hypertonia neonatal 27.90 22.91 23 769 304 88696
Tremor neonatal 22.95 22.91 13 779 87 88913

Pharmacologic Action:

SourceCodeDescription
ATC N06AB03 NERVOUS SYSTEM
PSYCHOANALEPTICS
ANTIDEPRESSANTS
Selective serotonin reuptake inhibitors
ATC N06CA03 NERVOUS SYSTEM
PSYCHOANALEPTICS
PSYCHOLEPTICS AND PSYCHOANALEPTICS IN COMBINATION
Antidepressants in combination with psycholeptics
FDA MoA N0000000109 Serotonin Uptake Inhibitors
CHEBI has role CHEBI:35469 antidepressants
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:50949 SSRI
CHEBI has role CHEBI:78298 environmental contaminants
CHEBI has role CHEBI:88188 allergenic drug
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
FDA EPC N0000175696 Serotonin Reuptake Inhibitor

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

DiseaseRelationSNOMED_IDDOID
Premenstrual dysphoric disorder indication 596004
Depressive disorder indication 35489007
Bulimia nervosa indication 78004001
Bipolar affective disorder, current episode depression indication 191627008 DOID:3312
Obsessive-compulsive disorder indication 191736004 DOID:10933
Major depressive disorder indication 370143000
Panic disorder indication 371631005 DOID:594
Posttraumatic stress disorder off-label use 47505003 DOID:2055
Postpartum depression off-label use 58703003 DOID:9478
Cataplexy and narcolepsy off-label use 193042000
Menopausal flushing off-label use 198436008
Fibromyalgia off-label use 203082005 DOID:631
Seasonal affective disorder off-label use 247803002
Suicidal thoughts contraindication 6471006
Weight gain finding contraindication 8943002
Sinus tachycardia contraindication 11092001
Hypercholesterolemia contraindication 13644009
Bipolar disorder contraindication 13746004 DOID:3312
Neuroleptic malignant syndrome contraindication 15244003 DOID:14464
Senile dementia contraindication 15662003
Agranulocytosis contraindication 17182001 DOID:12987
Lowered convulsive threshold contraindication 19260006
Cirrhosis of liver contraindication 19943007 DOID:5082
Myocardial infarction contraindication 22298006 DOID:5844
Hypovolemia contraindication 28560003
Orthostatic hypotension contraindication 28651003
Dehydration contraindication 34095006
Upper gastrointestinal hemorrhage contraindication 37372002
Conduction disorder of the heart contraindication 44808001
Low blood pressure contraindication 45007003
Bradycardia contraindication 48867003
Syndrome of inappropriate vasopressin secretion contraindication 55004003 DOID:3401
Paralytic ileus contraindication 55525008 DOID:8442
Hyperlipidemia contraindication 55822004 DOID:1168
Anorexia nervosa contraindication 56882008 DOID:8689
Abnormal sexual function contraindication 56925008
Hepatic failure contraindication 59927004
Cerebrovascular disease contraindication 62914000 DOID:6713
Blood coagulation disorder contraindication 64779008 DOID:1247
Diabetes mellitus contraindication 73211009 DOID:9351
Hyperglycemia contraindication 80394007 DOID:4195
Heart failure contraindication 84114007 DOID:6000
Epilepsy contraindication 84757009 DOID:1826
Leukopenia contraindication 84828003 DOID:615
Hyponatremia contraindication 89627008
Tardive dyskinesia contraindication 102449007
Seizure disorder contraindication 128613002
Liver function tests abnormal contraindication 166603001
Cerebrovascular accident contraindication 230690007
Mania contraindication 231494001
Hypomania contraindication 231496004
Disease of liver contraindication 235856003 DOID:409
Metabolic syndrome X contraindication 237602007 DOID:14221
Hyperprolactinemia contraindication 237662005 DOID:12700
Transient ischemic attack contraindication 266257000 DOID:224
Esophageal dysmotility contraindication 266434009 DOID:9192
Benign prostatic hyperplasia contraindication 266569009
Hypertriglyceridemia contraindication 302870006
Neutropenic disorder contraindication 303011007 DOID:1227
Serotonin syndrome contraindication 371089000
At risk for aspiration contraindication 371736008
Angle-closure glaucoma contraindication 392291006 DOID:13550
Myocardial ischemia contraindication 414795007 DOID:3393
Obesity contraindication 414916001 DOID:9970
Carcinoma of female breast contraindication 447782002
Smokes tobacco daily contraindication 449868002




๐Ÿถ Veterinary Drug Use

SpeciesUseRelation
Dogs Separation anxiety Indication

๐Ÿถ Veterinary products

ProductApplicantIngredients
Reconcile Pegasus Laboratories Inc. 1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.32 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Sodium-dependent serotonin transporter Transporter INHIBITOR Kd 9.09 WOMBAT-PK CHEMBL
Alpha-2A adrenergic receptor GPCR Ki 8.20 CHEMBL
Sigma non-opioid intracellular receptor 1 Membrane receptor IC50 6.07 CHEMBL
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 6.16 WOMBAT-PK
Sodium-dependent noradrenaline transporter Transporter Kd 6.62 WOMBAT-PK
5-hydroxytryptamine receptor 2A GPCR Ki 6.61 WOMBAT-PK
5-hydroxytryptamine receptor 2B GPCR ANTAGONIST Ki 5.30 IUPHAR
5-hydroxytryptamine receptor 2C GPCR Ki 6.40 WOMBAT-PK
5-hydroxytryptamine receptor 6 GPCR Ki 6.11 CHEMBL
Alpha-1A adrenergic receptor GPCR Ki 5.70 PDSP
Alpha-2B adrenergic receptor GPCR Ki 6.16 DRUG MATRIX
D(3) dopamine receptor GPCR Ki 5.70 WOMBAT-PK
Histamine H1 receptor GPCR Ki 5.96 WOMBAT-PK
Muscarinic acetylcholine receptor M1 GPCR Ki 6.05 WOMBAT-PK
Muscarinic acetylcholine receptor M2 GPCR Ki 5.57 PDSP
Muscarinic acetylcholine receptor M3 GPCR Ki 6 WOMBAT-PK
Muscarinic acetylcholine receptor M4 GPCR Ki 5.54 PDSP
Muscarinic acetylcholine receptor M5 GPCR Ki 5.57 PDSP
Sodium-dependent dopamine transporter Transporter Kd 5.44 WOMBAT-PK
Cytochrome P450 2D6 Enzyme IC50 6.16 DRUG MATRIX
Acetylcholinesterase Enzyme IC50 6.89 CHEMBL
Potassium channel subfamily K member 2 Ion channel IC50 4.85 CHEMBL
Histamine H3 receptor GPCR Ki 5.14 CHEMBL
Equilibrative nucleoside transporter 4 Transporter INHIBITOR Ki 4.64 IUPHAR
Beta-1 adrenergic receptor GPCR Ki 5.36 WOMBAT-PK
Sodium-dependent serotonin transporter Transporter Ki 8.70 CHEMBL
Sodium-dependent dopamine transporter Transporter Ki 6.11 CHEMBL
5-hydroxytryptamine receptor 2A GPCR ANTAGONIST Ki 6.50 IUPHAR
Sigma non-opioid intracellular receptor 1 Membrane receptor Ki 6.62 CHEMBL
Transporter Transporter Ki 6.84 CHEMBL
Sodium-dependent dopamine transporter Transporter Ki 7.97 CHEMBL
Sodium-dependent noradrenaline transporter Transporter Ki 7.07 CHEMBL
5-hydroxytryptamine receptor 2C GPCR Ki 6.96 CHEMBL
5-hydroxytryptamine receptor 6 GPCR ANTAGONIST Ki 5.80 IUPHAR
Transporter Transporter Ki 6.80 CHEMBL
Serotonin 1 (5-HT1) receptor GPCR IC50 7.82 CHEMBL
Adrenergic receptor alpha-2 GPCR Ki 5.72 CHEMBL
Adrenergic receptor alpha-1 GPCR Ki 6.22 CHEMBL
Potassium voltage-gated channel subfamily C member 1 Ion channel IC50 4.88 CHEMBL
G protein-activated inward rectifier potassium channel 2 Ion channel GATING INHIBITOR IC50 4.80 IUPHAR
Sigma intracellular receptor 2 Unclassified Ki 4.79 CHEMBL

External reference:

IDSource
D00326 KEGG_DRUG
56296-78-7 SECONDARY_CAS_RN
4019389 VANDF
4019761 VANDF
C0016365 UMLSCUI
CHEBI:5118 CHEBI
RFX PDB_CHEM_ID
CHEMBL1201082 ChEMBL_ID
CHEMBL153036 ChEMBL_ID
CHEMBL41 ChEMBL_ID
DB00472 DRUGBANK_ID
D005473 MESH_DESCRIPTOR_UI
3386 PUBCHEM_CID
203 IUPHAR_LIGAND_ID
3883 INN_ID
01K63SUP8D UNII
227224 RXNORM
17711 MMSL
28237 MMSL
37675 MMSL
4091 MMSL
41730 MMSL
4746 MMSL
d00236 MMSL
001514 NDDF
004613 NDDF
372767007 SNOMEDCT_US
53640004 SNOMEDCT_US
75115009 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Symbyax HUMAN PRESCRIPTION DRUG LABEL 2 0002-3230 CAPSULE 25 mg ORAL NDA 34 sections
Symbyax HUMAN PRESCRIPTION DRUG LABEL 2 0002-3231 CAPSULE 25 mg ORAL NDA 34 sections
Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0093-0807 TABLET, FILM COATED 20 mg ORAL ANDA 32 sections
Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0093-0807 TABLET, FILM COATED 20 mg ORAL ANDA 32 sections
Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0093-5262 TABLET, FILM COATED 60 mg ORAL ANDA 32 sections
Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0093-5262 TABLET, FILM COATED 60 mg ORAL ANDA 32 sections
Olanzapine and Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 2 0093-5503 CAPSULE 25 mg ORAL ANDA 32 sections
Olanzapine and Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 2 0093-5504 CAPSULE 25 mg ORAL ANDA 32 sections
Olanzapine and Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 2 0093-5505 CAPSULE 50 mg ORAL ANDA 32 sections
Olanzapine and Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 2 0093-5506 CAPSULE 25 mg ORAL ANDA 32 sections
Olanzapine and Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 2 0093-5507 CAPSULE 50 mg ORAL ANDA 32 sections
Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0093-7188 TABLET, FILM COATED 10 mg ORAL ANDA 32 sections
Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0093-7188 TABLET, FILM COATED 10 mg ORAL ANDA 32 sections
Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0093-7198 CAPSULE 40 mg ORAL ANDA 31 sections
Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0093-7198 CAPSULE 40 mg ORAL ANDA 31 sections
Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0121-0721 SOLUTION 20 mg ORAL ANDA 33 sections
Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0121-0721 SOLUTION 20 mg ORAL ANDA 33 sections
Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0121-4721 SOLUTION 20 mg ORAL ANDA 33 sections
Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0121-4721 SOLUTION 20 mg ORAL ANDA 33 sections
Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0615-1384 CAPSULE 10 mg ORAL ANDA 33 sections
Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0615-7625 CAPSULE 20 mg ORAL ANDA 32 sections
Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0615-7625 CAPSULE 20 mg ORAL ANDA 32 sections
Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0615-7638 CAPSULE 10 mg ORAL ANDA 32 sections
Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8093 CAPSULE 10 mg ORAL ANDA 32 sections
Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8093 CAPSULE 10 mg ORAL ANDA 32 sections
Fluoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8183 CAPSULE 40 mg ORAL ANDA 33 sections
Prozac HUMAN PRESCRIPTION DRUG LABEL 1 0777-3104 CAPSULE 10 mg ORAL NDA 35 sections
Prozac HUMAN PRESCRIPTION DRUG LABEL 1 0777-3105 CAPSULE 20 mg ORAL NDA 35 sections
Prozac HUMAN PRESCRIPTION DRUG LABEL 1 0777-3107 CAPSULE 40 mg ORAL NDA 35 sections
Fluoxetine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0781-2822 CAPSULE 20 mg ORAL ANDA 31 sections