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

Stem definitionDrug idCAS RN
serotonin and/or norepinephrine reuptake inhibitors, fluoxetine derivatives 972 116539-59-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • yentreve
  • cymbalta
  • duloxetine
  • (S)-Duloxetine
  • duloxetine hydrochloride
  • duloxetine HCl
A thiophene derivative and selective NEUROTRANSMITTER UPTAKE INHIBITOR for SEROTONIN and NORADRENALINE (SNRI). It is an ANTIDEPRESSIVE AGENT and ANXIOLYTIC, and is also used for the treatment of pain in patients with DIABETES MELLITUS and FIBROMYALGIA.
  • Molecular weight: 297.42
  • Formula: C18H19NOS
  • CLOGP: 4.26
  • LIPINSKI: 0
  • HAC: 2
  • HDO: 1
  • TPSA: 21.26
  • ALOGS: -5
  • ROTB: 6
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
60 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 2.88 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 50 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
CL (Clearance) 8.57 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.04 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 12 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Aug. 3, 2004 FDA LILLY

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug withdrawal syndrome 4058.24 9.95 2001 220845 23856 56045365
Dysphoria 3494.55 9.95 1129 221717 3713 56065508
Affect lability 2803.44 9.95 1165 221681 8960 56060261
Irritability 2259.03 9.95 1426 221420 28162 56041059
Suicidal ideation 1986.87 9.95 1721 221125 56021 56013200
Agitation 1742.03 9.95 1577 221269 54459 56014762
Hyperhidrosis 1321.96 9.95 1742 221104 92346 55976875
Paraesthesia 1318.09 9.95 2065 220781 128449 55940772
Sensory disturbance 1318 9.95 743 222103 11800 56057421
Anxiety 1296.62 9.95 2553 220293 190619 55878602
Vertigo 1228.42 9.95 1287 221559 53285 56015936
Insomnia 1108.40 9.95 2384 220462 189476 55879745
Nightmare 830.44 9.95 620 222226 16206 56053015
Dizziness 753.02 9.95 3212 219634 372928 55696293
Mood swings 736.17 9.95 576 222270 16171 56053050
Tinnitus 632.26 9.95 684 222162 29358 56039863
Serotonin syndrome 608.69 9.95 632 222214 25858 56043363
Pemphigus 604.22 9.95 3 222843 157209 55912012
Tremor 569.96 9.95 1389 221457 119700 55949521
Hypomania 538.31 9.95 299 222547 4603 56064618
Lethargy 536.51 9.95 827 222019 50614 56018607
Depression 516.96 9.95 1728 221118 178389 55890832
Glossodynia 445.03 9.95 44 222802 152414 55916807
Confusional state 439.67 9.95 1809 221037 206346 55862875
Hand deformity 397.31 9.95 37 222809 134455 55934766
Systemic lupus erythematosus 378.07 9.95 121 222725 179957 55889264
Alopecia 353.99 9.95 384 222462 293074 55776147
Headache 342.33 9.95 3545 219301 555499 55513722
Withdrawal syndrome 338.05 9.95 391 222455 18071 56051150
Contraindicated product administered 326.15 9.95 165 222681 186121 55883100
Pericarditis 318.95 9.95 31 222815 108892 55960329
Synovitis 316.89 9.95 121 222725 161184 55908037
Suicide attempt 299.51 9.95 689 222157 57147 56012074
Wound 298.96 9.95 89 222757 138715 55930506
Nausea 285.15 9.95 4419 218427 759759 55309462
Maternal exposure during pregnancy 282.67 9.95 203 222643 189350 55879871
Arthropathy 257.28 9.95 248 222598 200027 55869194
Drug intolerance 251.54 9.95 413 222433 264405 55804816
Duodenal ulcer perforation 249.85 9.95 4 222842 68338 56000883
Abdominal discomfort 244.67 9.95 453 222393 276821 55792400
Treatment failure 240.55 9.95 193 222653 170199 55899022
Anti-cyclic citrullinated peptide antibody positive 233.77 9.95 52 222794 98548 55970673
Infusion related reaction 231.73 9.95 292 222554 208639 55860582
Discomfort 230.01 9.95 138 222708 141623 55927598
Febrile neutropenia 223.04 9.95 70 222776 105475 55963746
Neutropenia 220.95 9.95 181 222665 157986 55911235
Rheumatoid arthritis 220.89 9.95 776 222070 381828 55687393
Crying 214.09 9.95 338 222508 21102 56048119
Completed suicide 211.16 9.95 1068 221778 132765 55936456
Stubbornness 211.05 9.95 70 222776 255 56068966
Feeling abnormal 209.98 9.95 1065 221781 132537 55936684
Joint swelling 208.04 9.95 531 222315 289269 55779952
Disturbance in attention 207.76 9.95 422 222424 32118 56037103
Pyrexia 203.25 9.95 910 221936 417863 55651358
Hypersensitivity 195.67 9.95 455 222391 255953 55813268
Swelling 193.16 9.95 413 222433 239358 55829863
Rash 190.18 9.95 1159 221687 491888 55577333
Anaemia 182.97 9.95 502 222344 267009 55802212
Sleep disorder 175.25 9.95 628 222218 67035 56002186
Mood altered 171.50 9.95 237 222609 13118 56056103
Folliculitis 165.33 9.95 14 222832 54965 56014256
Thrombocytopenia 159.87 9.95 182 222664 136042 55933179
Somnolence 156.78 9.95 1146 221700 162267 55906954
Therapeutic product effect decreased 153.64 9.95 272 222574 169180 55900041
Sleep disorder due to general medical condition, insomnia type 152.59 9.95 4 222842 43334 56025887
Lower respiratory tract infection 152.20 9.95 138 222708 114656 55954565
Muscle injury 145.88 9.95 18 222828 52482 56016739
Thinking abnormal 143.85 9.95 187 222659 9754 56059467
Helicobacter infection 143.72 9.95 55 222791 73213 55996008
Memory impairment 143.71 9.95 701 222145 85856 55983365
Rheumatoid factor positive 142.00 9.95 48 222798 69012 56000209
Pancytopenia 141.56 9.95 88 222758 88627 55980594
General physical health deterioration 140.90 9.95 288 222558 169722 55899499
Panic attack 130.30 9.95 265 222581 20182 56049039
Anger 129.16 9.95 193 222653 11479 56057742
Off label use 127.58 9.95 1499 221347 554681 55514540
Electric shock 126.30 9.95 69 222777 1026 56068195
Blister 123.95 9.95 149 222697 108738 55960483
C-reactive protein abnormal 123.90 9.95 5 222841 36804 56032417
Fibromyalgia 123.89 9.95 516 222330 59087 56010134
Product use issue 123.48 9.95 354 222492 185687 55883534
Migraine 121.93 9.95 671 222175 86126 55983095
Acute kidney injury 119.69 9.95 518 222328 240245 55828976
Depressed mood 114.99 9.95 361 222485 35998 56033223
Fatigue 114.13 9.95 3996 218850 784556 55284665
Infection 112.66 9.95 410 222436 199796 55869425
Impaired healing 110.86 9.95 108 222738 86733 55982488
Coordination abnormal 108.49 9.95 186 222660 12435 56056786
Malignant neoplasm progression 108.02 9.95 80 222766 73507 55995714
Drug ineffective 105.21 9.95 2805 220041 916184 55153037
Disease progression 102.53 9.95 161 222685 105012 55964209
Stomatitis 102.33 9.95 202 222644 120608 55948613
Inappropriate antidiuretic hormone secretion 98.20 9.95 187 222659 13569 56055652
Affective disorder 98.11 9.95 116 222730 5487 56063734
Abnormal behaviour 95.65 9.95 233 222613 20039 56049182
Dyspnoea 95.19 9.95 1713 221133 590864 55478357
Platelet count decreased 93.48 9.95 174 222672 106209 55963012
Drug interaction 93.29 9.95 1253 221593 208502 55860719
Tardive dyskinesia 92.03 9.95 135 222711 7896 56061325
Fall 90.58 9.95 1949 220897 355561 55713660
Hallucination 90.28 9.95 410 222436 48739 56020482
Gastrointestinal tube insertion 89.50 9.95 54 222792 978 56068243
Septic shock 88.18 9.95 67 222779 60768 56008453
Peripheral swelling 87.47 9.95 557 222289 234169 55835052
Cardiac failure 85.53 9.95 120 222726 81973 55987248
Gastric bypass 82.81 9.95 60 222786 1494 56067727
Intentional product misuse 79.70 9.95 409 222437 51095 56018126
Pneumonia aspiration 78.97 9.95 295 222551 32116 56037105
Ill-defined disorder 78.83 9.95 93 222753 68450 56000771
Drug reaction with eosinophilia and systemic symptoms 78.10 9.95 13 222833 30291 56038930
Restless legs syndrome 78.06 9.95 193 222653 16754 56052467
Post-traumatic stress disorder 76.25 9.95 92 222754 4446 56064775
Aggression 75.65 9.95 225 222621 21781 56047440
Product substitution issue 74.50 9.95 173 222673 14426 56054795
Abnormal dreams 73.66 9.95 135 222711 9514 56059707
White blood cell count abnormal 73.65 9.95 103 222743 5764 56063457
Multiple sclerosis relapse 73.30 9.95 362 222484 44541 56024680
Loss of consciousness 72.39 9.95 706 222140 108643 55960578
Coma 71.93 9.95 443 222403 59212 56010009
Premature delivery 68.88 9.95 12 222834 27048 56042173
Gastrointestinal disorder 68.62 9.95 223 222623 112479 55956742
Irritable bowel syndrome 68.43 9.95 103 222743 68355 56000866
Neutrophil count decreased 67.07 9.95 59 222787 49763 56019458
Blood creatinine increased 66.25 9.95 136 222710 80055 55989166
Nasal turbinate hypertrophy 66.24 9.95 39 222807 674 56068547
Sepsis 65.73 9.95 307 222539 139533 55929688
Somatic symptom disorder 65.06 9.95 59 222787 2036 56067185
Renal impairment 64.90 9.95 139 222707 80574 55988647
Intentional self-injury 64.70 9.95 232 222614 24760 56044461
Erythema 64.42 9.95 358 222488 155581 55913640
Leukopenia 63.22 9.95 115 222731 70825 55998396
Pneumonia 62.95 9.95 1184 221662 405914 55663307
Amnesia 62.29 9.95 354 222492 45968 56023253
Personality disorder 62.25 9.95 89 222757 5084 56064137
Mucosal inflammation 62.23 9.95 47 222799 42763 56026458
Influenza like illness 62.03 9.95 434 222412 60554 56008667
Interstitial lung disease 61.87 9.95 81 222765 56982 56012239
Mania 61.54 9.95 139 222707 11381 56057840
Sleep apnoea syndrome 60.84 9.95 234 222612 25827 56043394
Reversible cerebral vasoconstriction syndrome 60.57 9.95 60 222786 2317 56066904
Haemoglobin decreased 59.26 9.95 301 222545 133836 55935385
Ascites 57.48 9.95 39 222807 37505 56031716
Vision blurred 57.10 9.95 540 222306 82403 55986818
Pleural effusion 56.40 9.95 163 222683 85317 55983904
Red blood cell sedimentation rate abnormal 55.46 9.95 5 222841 18668 56050553
Alanine aminotransferase increased 55.42 9.95 591 222255 93071 55976150
Sopor 54.83 9.95 195 222651 20727 56048494
Hallucination, visual 54.82 9.95 173 222673 17295 56051926
Pulmonary fibrosis 54.07 9.95 25 222821 29733 56039488
Hip arthroplasty 52.89 9.95 45 222801 38578 56030643
Bone marrow failure 52.59 9.95 23 222823 28263 56040958
White blood cell count decreased 51.61 9.95 290 222556 125700 55943521
Colitis microscopic 51.28 9.95 103 222743 7772 56061449
Dyskinesia 50.62 9.95 239 222607 28869 56040352
Intervertebral discitis 50.62 9.95 59 222787 2748 56066473
Pulmonary malformation 50.43 9.95 23 222823 226 56068995
Cytomegalovirus infection 50.35 9.95 8 222838 19288 56049933
Therapy interrupted 50.24 9.95 218 222628 25407 56043814
Seizure 50.14 9.95 734 222112 124385 55944836
Lymphocytic oesophagitis 50.01 9.95 13 222833 13 56069208
Mental disorder 49.53 9.95 205 222641 23399 56045822
Urinary retention 49.18 9.95 231 222615 27843 56041378
Renal failure 48.78 9.95 248 222598 110252 55958969
Hyperkalaemia 48.48 9.95 79 222767 50786 56018435
Muscle twitching 48.37 9.95 158 222688 16084 56053137
Neutropenic sepsis 48.13 9.95 3 222843 15182 56054039
Hot flush 47.80 9.95 333 222513 46393 56022828
Surgery 47.51 9.95 254 222592 32232 56036989
Restlessness 47.49 9.95 220 222626 26366 56042855
Bronchial neoplasm 47.19 9.95 27 222819 441 56068780
Atrial fibrillation 47.17 9.95 246 222600 108651 55960570
Coma blister 46.84 9.95 19 222827 136 56069085
Multiple sclerosis 46.70 9.95 226 222620 27576 56041645
Hyperaesthesia 45.73 9.95 104 222742 8553 56060668
Neck deformity 45.73 9.95 48 222798 1987 56067234
Extremity contracture 45.69 9.95 39 222807 1240 56067981
Device expulsion 44.81 9.95 33 222813 30416 56038805
Product dose omission issue 44.50 9.95 1093 221753 203660 55865561
Hypocalcaemia 43.86 9.95 30 222816 28730 56040491
Lung cyst 43.69 9.95 22 222824 274 56068947
Mobility decreased 43.22 9.95 223 222623 98768 55970453
Multiple organ dysfunction syndrome 43.15 9.95 90 222756 52680 56016541
Bronchial haemorrhage 42.84 9.95 27 222819 530 56068691
Liver injury 42.75 9.95 62 222784 41786 56027435
Nervousness 42.53 9.95 227 222619 28788 56040433
Blood pressure increased 42.11 9.95 808 222038 144368 55924853
Hyperreflexia 42.04 9.95 75 222771 5175 56064046
Condition aggravated 41.97 9.95 1042 221804 343856 55725365
Rheumatoid nodule 41.50 9.95 5 222841 14852 56054369
Rubber sensitivity 41.49 9.95 45 222801 1935 56067286
Live birth 41.39 9.95 13 222833 19592 56049629
Neck mass 41.39 9.95 59 222787 3361 56065860
Balance disorder 41.21 9.95 474 222372 76046 55993175
Paranoia 40.94 9.95 114 222732 10630 56058591
Vomiting 40.82 9.95 2385 220461 495843 55573378
Dry mouth 40.75 9.95 411 222435 63794 56005427
Neoplasm progression 40.63 9.95 40 222806 31976 56037245
C-reactive protein increased 40.43 9.95 167 222679 78517 55990704
Gastrointestinal haemorrhage 40.42 9.95 159 222687 75792 55993429
Pruritus 40.32 9.95 950 221896 315673 55753548
Aspartate aminotransferase increased 39.82 9.95 501 222345 82101 55987120
Product use in unapproved indication 39.69 9.95 361 222485 140461 55928760
Temperature intolerance 39.63 9.95 94 222752 7946 56061275
Oesophageal spasm 39.44 9.95 52 222794 2750 56066471
Macular degeneration 39.10 9.95 13 222833 18895 56050326
Oedema peripheral 38.49 9.95 463 222383 170791 55898430
Lactic acidosis 38.49 9.95 50 222796 35296 56033925
Hypersomnia 38.37 9.95 147 222699 16194 56053027
Cardiac failure congestive 38.07 9.95 198 222648 87522 55981699
Therapy cessation 37.73 9.95 210 222636 27054 56042167
Endometrial ablation 37.34 9.95 30 222816 875 56068346
Concussion 37.02 9.95 93 222753 8153 56061068
Metabolic surgery 36.24 9.95 33 222813 1145 56068076
Opsoclonus myoclonus 36.11 9.95 16 222830 146 56069075
Pre-existing condition improved 35.93 9.95 86 222760 7312 56061909
Rapid eye movements sleep abnormal 35.77 9.95 15 222831 118 56069103
Disorientation 35.74 9.95 258 222588 36355 56032866
Tachyphrenia 35.70 9.95 34 222812 1250 56067971
Pulmonary oedema 35.60 9.95 95 222751 51048 56018173
Major depression 35.59 9.95 87 222759 7497 56061724
Hostility 35.57 9.95 40 222806 1791 56067430
Respiratory tract malformation 35.55 9.95 16 222830 152 56069069
Hypotension 35.49 9.95 739 222107 249769 55819452
Gastrooesophageal reflux disease 34.76 9.95 492 222354 82765 55986456
Impaired driving ability 34.72 9.95 60 222786 4036 56065185
Death 34.69 9.95 1058 221788 340368 55728853
Rebound nasal congestion 34.45 9.95 10 222836 20 56069201
Neurologic neglect syndrome 34.41 9.95 43 222803 2155 56067066
Respiratory failure 34.12 9.95 228 222618 94834 55974387
Neuralgia 33.79 9.95 184 222662 23511 56045710
Carotid artery thrombosis 33.70 9.95 43 222803 2201 56067020
Palmar-plantar erythrodysaesthesia syndrome 33.44 9.95 21 222825 21044 56048177
Libido increased 33.21 9.95 33 222813 1279 56067942
Bruxism 33.11 9.95 51 222795 3115 56066106
Blood cholesterol increased 33.11 9.95 161 222685 72418 55996803
Libido decreased 32.83 9.95 44 222802 2364 56066857
Bipolar disorder 32.48 9.95 84 222762 7496 56061725
Morbid thoughts 32.44 9.95 23 222823 553 56068668
Anovulatory cycle 32.40 9.95 15 222831 153 56069068
Sacroiliitis 32.35 9.95 47 222799 2725 56066496
Akathisia 32.18 9.95 91 222755 8561 56060660
Blood calcium decreased 32.17 9.95 28 222818 23741 56045480
Drug tolerance decreased 31.91 9.95 7 222839 13404 56055817
Dissociation 31.88 9.95 45 222801 2540 56066681
Speech disorder 31.45 9.95 255 222591 37238 56031983
Hypomagnesaemia 30.89 9.95 32 222814 24983 56044238
Thunderclap headache 30.87 9.95 15 222831 172 56069049
Melaena 30.82 9.95 40 222806 28250 56040971
Anorgasmia 30.53 9.95 22 222824 543 56068678
Tearfulness 30.39 9.95 54 222792 3714 56065507
Depressive symptom 30.19 9.95 52 222794 3489 56065732
Psychotic disorder due to a general medical condition 29.94 9.95 16 222830 227 56068994
Delusion 29.79 9.95 105 222741 11110 56058111
Acute myeloid leukaemia 29.70 9.95 15 222831 16957 56052264
Red blood cell sedimentation rate increased 29.49 9.95 63 222783 36560 56032661
Head injury 29.49 9.95 185 222661 24881 56044340
Rash maculo-papular 29.36 9.95 43 222803 28864 56040357
Complex regional pain syndrome 29.26 9.95 39 222807 2084 56067137
Therapy non-responder 29.22 9.95 134 222712 61221 56008000
Weight increased 29.02 9.95 1148 221698 228555 55840666
Epistaxis 28.68 9.95 152 222694 66871 56002350
Transplant rejection 28.61 9.95 3 222843 9931 56059290
Bradycardia 28.38 9.95 154 222692 67350 56001871
Formication 28.37 9.95 54 222792 3916 56065305
Pulmonary eosinophilia 28.31 9.95 16 222830 255 56068966
Hypoventilation 28.07 9.95 57 222789 4335 56064886
Drug resistance 28.04 9.95 24 222822 20518 56048703
Bone density abnormal 27.97 9.95 48 222798 3211 56066010
Skin haemorrhage 27.95 9.95 85 222761 8328 56060893
Psychotic disorder 27.79 9.95 174 222672 23384 56045837
Gastric banding 27.70 9.95 11 222835 74 56069147
Metastases to bone 27.61 9.95 22 222824 19486 56049735
Telangiectasia congenital 27.56 9.95 8 222838 16 56069205
Emotional disorder 27.56 9.95 109 222737 12186 56057035
Loss of libido 27.50 9.95 29 222817 1207 56068014
Stiff person syndrome 27.01 9.95 17 222829 333 56068888
Arthralgia 26.99 9.95 1669 221177 500000 55569221
Inflammation 26.66 9.95 162 222684 68909 56000312
Knee arthroplasty 26.63 9.95 88 222758 44171 56025050
Skin necrosis 26.45 9.95 8 222838 12353 56056868
Pregnancy 26.45 9.95 57 222789 32976 56036245
Psychomotor hyperactivity 26.13 9.95 92 222754 9728 56059493
Middle insomnia 26.12 9.95 99 222747 10851 56058370
Gait disturbance 25.98 9.95 838 222008 162483 55906738
Proteinuria 25.91 9.95 19 222827 17551 56051670
Agranulocytosis 25.77 9.95 31 222815 22628 56046593
Intentional product use issue 25.42 9.95 262 222584 99471 55969750
Dehydration 25.38 9.95 459 222387 158366 55910855
Autonomic dysreflexia 25.26 9.95 16 222830 317 56068904
Ankle fracture 25.18 9.95 130 222716 16273 56052948
Gastrostomy 25.08 9.95 20 222826 577 56068644
Bronchial disorder 24.98 9.95 27 222819 1156 56068065
Cognitive disorder 24.96 9.95 301 222545 48832 56020389
Sleep terror 24.88 9.95 22 222824 734 56068487
Sensitivity to weather change 24.79 9.95 70 222776 6579 56062642
Pulmonary arterial hypertension 24.48 9.95 42 222804 26461 56042760
Dysphagia 24.40 9.95 458 222388 81489 55987732
Nasopharyngitis 24.34 9.95 677 222169 220282 55848939
Thrombotic microangiopathy 24.33 9.95 4 222842 9407 56059814
Metastases to liver 24.06 9.95 30 222816 21556 56047665
Adverse event 24.02 9.95 125 222721 55251 56013970
Oesophageal pain 23.97 9.95 45 222801 3230 56065991
Acute respiratory distress syndrome 23.89 9.95 31 222815 21895 56047326
Therapeutic response changed 23.83 9.95 23 222823 860 56068361
Ejection fraction decreased 23.81 9.95 26 222820 19815 56049406
Decreased interest 23.73 9.95 43 222803 3003 56066218
Flat affect 23.52 9.95 28 222818 1334 56067887
Tenosynovitis 23.37 9.95 10 222836 12451 56056770
Intentional overdose 22.86 9.95 388 222458 67729 56001492
Prescribed overdose 22.86 9.95 159 222687 22137 56047084
Haemoptysis 22.82 9.95 44 222802 26516 56042705
Drug abuse 22.65 9.95 385 222461 67225 56001996
Aplastic anaemia 22.63 9.95 4 222842 8924 56060297
Type 2 diabetes mellitus 22.52 9.95 102 222744 46760 56022461
Tension 22.43 9.95 41 222805 2883 56066338
Cerebral infarction 22.35 9.95 34 222812 22471 56046750
Spinal operation 22.30 9.95 72 222774 7284 56061937
Deep vein thrombosis 22.26 9.95 196 222650 76781 55992440
Depression suicidal 22.16 9.95 30 222816 1628 56067593
Plasma cell myeloma 22.13 9.95 102 222744 46544 56022677
Phagophobia 21.95 9.95 8 222838 41 56069180
Galactorrhoea 21.93 9.95 48 222798 3847 56065374
Mydriasis 21.56 9.95 94 222752 10977 56058244
Exposure via breast milk 21.55 9.95 31 222815 1781 56067440
Demyelination 21.49 9.95 64 222782 6198 56063023
Foetal death 21.44 9.95 4 222842 8583 56060638
Lip dry 21.40 9.95 6 222840 9734 56059487
Myelodysplastic syndrome 21.40 9.95 20 222826 16386 56052835
Muscular weakness 21.30 9.95 553 222293 103899 55965322
Granulomatous liver disease 21.26 9.95 20 222826 724 56068497
Circulatory collapse 21.07 9.95 31 222815 20772 56048449
Hallucination, auditory 21.05 9.95 96 222750 11428 56057793
Bone erosion 21.05 9.95 17 222829 14957 56054264
Lung disorder 21.02 9.95 122 222724 52475 56016746
Disseminated intravascular coagulation 20.84 9.95 24 222822 17861 56051360
Coronary artery disease 20.84 9.95 58 222788 30738 56038483
Diplopia 20.73 9.95 145 222701 20224 56048997
Haematotoxicity 20.73 9.95 4 222842 8379 56060842
Antinuclear antibody negative 20.55 9.95 12 222834 204 56069017
Clonus 20.21 9.95 49 222797 4200 56065021
Homicidal ideation 19.99 9.95 29 222817 1679 56067542
Coombs positive haemolytic anaemia 19.99 9.95 14 222832 330 56068891
Creatinine renal clearance decreased 19.88 9.95 17 222829 14542 56054679
Apathy 19.87 9.95 73 222773 7881 56061340
Drug screen positive 19.86 9.95 43 222803 3421 56065800
Tubulointerstitial nephritis 19.82 9.95 22 222824 16643 56052578
Basal cell carcinoma 19.80 9.95 44 222802 25177 56044044
Liver function test increased 19.78 9.95 52 222794 28081 56041140
Asphyxia 19.71 9.95 59 222787 5730 56063491
Aspergillus infection 19.69 9.95 3 222843 7462 56061759
Adjustment disorder 19.66 9.95 34 222812 2289 56066932
Exposure during pregnancy 19.64 9.95 401 222445 135941 55933280
Drug hypersensitivity 19.60 9.95 1302 221544 273903 55795318
Dysphemia 19.51 9.95 35 222811 2425 56066796
Pneumonitis 19.51 9.95 62 222784 31502 56037719
Pulmonary congestion 19.47 9.95 21 222825 16094 56053127
Conversion disorder 19.44 9.95 28 222818 1610 56067611
Sedation complication 19.42 9.95 11 222835 11661 56057560
Hypercalcaemia 19.40 9.95 45 222801 25366 56043855
Drug eruption 19.37 9.95 46 222800 25717 56043504
Bacteraemia 19.29 9.95 20 222826 15611 56053610
Hypokalaemia 19.09 9.95 261 222585 94176 55975045
Hypnopompic hallucination 19.03 9.95 7 222839 37 56069184
Arteriosclerosis coronary artery 18.97 9.95 71 222775 7734 56061487
Oedema 18.96 9.95 220 222626 81700 55987521
Hypoaesthesia 18.76 9.95 711 222135 140780 55928441
Hyperacusis 18.70 9.95 30 222816 1898 56067323
Shock 18.67 9.95 36 222810 21692 56047529
Premature labour 18.65 9.95 12 222834 11870 56057351
Muscle spasms 18.62 9.95 692 222154 136679 55932542
Tic 18.53 9.95 24 222822 1247 56067974
Anaphylactic reaction 18.51 9.95 147 222699 58848 56010373
Myoclonus 18.38 9.95 113 222733 15090 56054131
Pneumocystis jirovecii pneumonia 18.37 9.95 21 222825 15680 56053541
Respiratory distress 18.34 9.95 64 222782 31603 56037618
Feelings of worthlessness 18.18 9.95 13 222833 317 56068904
Panic reaction 18.04 9.95 44 222802 3786 56065435
Right ventricular failure 18.01 9.95 23 222823 16356 56052865
Impulse-control disorder 17.96 9.95 18 222828 705 56068516
Panic disorder 17.95 9.95 34 222812 2457 56066764
Poor quality sleep 17.84 9.95 126 222720 17629 56051592
Breast cancer metastatic 17.77 9.95 21 222825 15448 56053773
Toxic epidermal necrolysis 17.68 9.95 38 222808 22004 56047217
Torsade de pointes 17.64 9.95 14 222832 12426 56056795
Hypoalbuminaemia 17.62 9.95 10 222836 10589 56058632
Lupus-like syndrome 17.60 9.95 14 222832 12413 56056808
Haemodialysis 17.60 9.95 6 222840 8585 56060636
Decompression sickness 17.51 9.95 7 222839 48 56069173
Tuberculosis 17.50 9.95 11 222835 11018 56058203
Ophthalmic vein thrombosis 17.50 9.95 11 222835 215 56069006
Eosinophilia 17.48 9.95 33 222813 20044 56049177
CYP3A4 polymorphism 17.42 9.95 8 222838 80 56069141
Bipolar I disorder 17.36 9.95 27 222819 1663 56067558
Second primary malignancy 17.34 9.95 4 222842 7398 56061823
Poisoning 17.27 9.95 98 222748 12715 56056506
Sleep talking 17.24 9.95 20 222826 927 56068294
Cough 17.23 9.95 847 221999 259114 55810107
Lactation disorder 17.13 9.95 13 222833 348 56068873
Heart rate decreased 17.12 9.95 92 222754 40335 56028886
Hypoglycaemia 17.09 9.95 140 222706 55675 56013546
Overdose 17.08 9.95 544 222302 105286 55963935
Pulmonary toxicity 17.05 9.95 5 222841 7878 56061343
Hypoxia 17.05 9.95 134 222712 53763 56015458
Autonomic nervous system imbalance 16.99 9.95 34 222812 2559 56066662
Toxic skin eruption 16.91 9.95 13 222833 11726 56057495
Hyponatraemic encephalopathy 16.89 9.95 11 222835 229 56068992
Cardiogenic shock 16.86 9.95 24 222822 16301 56052920
Metastases to lung 16.85 9.95 13 222833 11705 56057516
Self-injurious ideation 16.84 9.95 32 222814 2318 56066903
Urinary incontinence 16.71 9.95 185 222661 29400 56039821
Pustular psoriasis 16.56 9.95 47 222799 4431 56064790
Cholestasis 16.54 9.95 53 222793 26860 56042361
Toxicity to various agents 16.45 9.95 1065 221781 223499 55845722
Polyarthritis 16.38 9.95 7 222839 8721 56060500
Pulseless electrical activity 16.05 9.95 4 222842 7020 56062201
Sinus congestion 16.04 9.95 112 222734 15612 56053609
Decreased appetite 15.99 9.95 707 222139 218524 55850697
Bradyphrenia 15.91 9.95 60 222786 6560 56062661
Intervertebral disc protrusion 15.80 9.95 143 222703 21551 56047670
Sinus disorder 15.79 9.95 138 222708 20596 56048625
Alcoholism 15.73 9.95 30 222816 2179 56067042
Device related infection 15.72 9.95 40 222806 21840 56047381
Cystitis 15.62 9.95 277 222569 48761 56020460
Metastases to central nervous system 15.59 9.95 15 222831 12121 56057100
Mean cell haemoglobin concentration increased 15.51 9.95 14 222832 480 56068741
Post-traumatic neck syndrome 15.51 9.95 28 222818 1950 56067271
Dyspnoea exertional 15.48 9.95 140 222706 54549 56014672
Oliguria 15.47 9.95 7 222839 8433 56060788
Hepatotoxicity 15.45 9.95 67 222779 31086 56038135
Hepatic steatosis 15.30 9.95 165 222681 26049 56043172
Ischaemic stroke 15.27 9.95 27 222819 16815 56052406
Feeling drunk 15.21 9.95 41 222805 3751 56065470
Scoliosis 15.17 9.95 61 222785 6872 56062349
Rhonchi 15.13 9.95 31 222815 2373 56066848
Metabolic acidosis 15.03 9.95 96 222750 40358 56028863
Congenital tricuspid valve atresia 15.03 9.95 6 222840 41 56069180
Blood alkaline phosphatase increased 15.01 9.95 227 222619 38718 56030503
Hypervolaemia 14.97 9.95 54 222792 26404 56042817
Trigeminal neuralgia 14.85 9.95 38 222808 3369 56065852
Transfusion 14.85 9.95 19 222827 13501 56055720
Accidental exposure to product 14.83 9.95 49 222797 24598 56044623
Drug-induced liver injury 14.83 9.95 78 222768 34384 56034837
Gambling disorder 14.82 9.95 21 222825 1190 56068031
Scar 14.77 9.95 92 222754 12341 56056880
Eating disorder 14.70 9.95 117 222729 16988 56052233
Hyperglycaemia 14.66 9.95 90 222756 38191 56031030
Impatience 14.65 9.95 12 222834 360 56068861
Naevus flammeus 14.64 9.95 8 222838 119 56069102
Fear 14.52 9.95 105 222741 14803 56054418
Contusion 14.51 9.95 392 222454 128038 55941183
Intentional dose omission 14.37 9.95 55 222791 6055 56063166
Genital pain 14.37 9.95 12 222834 370 56068851
Maternal exposure during breast feeding 14.19 9.95 39 222807 3608 56065613
Gastric ulcer 14.17 9.95 44 222802 22519 56046702
Intrusive thoughts 14.13 9.95 9 222837 180 56069041
Red blood cell count decreased 14.07 9.95 86 222760 36531 56032690
Pulmonary hypertension 14.03 9.95 84 222762 35860 56033361
Oesophageal food impaction 13.96 9.95 9 222837 184 56069037
Spondyloarthropathy 13.93 9.95 17 222829 831 56068390
Breast cancer female 13.90 9.95 17 222829 12321 56056900
Tumour lysis syndrome 13.87 9.95 7 222839 7916 56061305
Metastases to lymph nodes 13.85 9.95 6 222840 7417 56061804
Feeling of despair 13.83 9.95 28 222818 2125 56067096
Lung diffusion test decreased 13.73 9.95 15 222831 650 56068571
Urinary hesitation 13.65 9.95 27 222819 2015 56067206
Clitoral engorgement 13.61 9.95 3 222843 0 56069221
Phobia of driving 13.61 9.95 3 222843 0 56069221
Psoriasis 13.55 9.95 471 222375 92221 55977000
Caesarean section 13.53 9.95 27 222819 16064 56053157
Osteonecrosis of jaw 13.53 9.95 77 222769 33281 56035940
Pseudomonas infection 13.46 9.95 12 222834 10059 56059162
Hepatobiliary scan abnormal 13.42 9.95 6 222840 56 56069165
Stillbirth 13.34 9.95 4 222842 6210 56063011
Cytokine release syndrome 13.33 9.95 14 222832 10861 56058360
Cataplexy 13.31 9.95 21 222825 1310 56067911
Rotator cuff syndrome 13.28 9.95 88 222758 12055 56057166
Tachyphylaxis 13.23 9.95 10 222836 266 56068955
Immobilisation prolonged 13.18 9.95 7 222839 98 56069123
Neuropathy peripheral 13.15 9.95 515 222331 102378 55966843
Progressive multifocal leukoencephalopathy 13.11 9.95 87 222759 11926 56057295
Enterococcal infection 13.11 9.95 6 222840 7178 56062043
Leukopenia neonatal 13.07 9.95 5 222841 30 56069191
Holmes-Adie pupil 13.07 9.95 5 222841 30 56069191
Hepatitis C antibody positive 13.06 9.95 7 222839 100 56069121
Respiratory tract congestion 13.05 9.95 106 222740 15485 56053736
Cardiotoxicity 13.03 9.95 7 222839 7643 56061578
Soft tissue injury 13.01 9.95 23 222823 1576 56067645
Dystonia 12.98 9.95 89 222757 12332 56056889
Somnambulism 12.95 9.95 47 222799 5045 56064176
Road traffic accident 12.86 9.95 168 222678 27759 56041462
Deformity 12.80 9.95 13 222833 10242 56058979
Heat exhaustion 12.70 9.95 7 222839 106 56069115
Angioedema 12.68 9.95 104 222742 41349 56027872
Abdominal pain 12.68 9.95 868 221978 257937 55811284
Skin plaque 12.65 9.95 6 222840 7032 56062189
Drug metabolising enzyme decreased 12.65 9.95 4 222842 12 56069209
Pathogen resistance 12.63 9.95 4 222842 5996 56063225
Blood pressure diastolic decreased 12.63 9.95 37 222809 19286 56049935
Diffuse large B-cell lymphoma 12.58 9.95 6 222840 7010 56062211
Sciatic nerve injury 12.56 9.95 12 222834 443 56068778
Radiation fibrosis 12.54 9.95 5 222841 34 56069187
Blood lactate dehydrogenase increased 12.51 9.95 41 222805 20634 56048587
Gun shot wound 12.47 9.95 7 222839 110 56069111
Acute myocardial infarction 12.41 9.95 70 222776 30323 56038898
Haemolytic anaemia 12.40 9.95 12 222834 9673 56059548
Peripheral venous disease 12.32 9.95 13 222833 10066 56059155
Cushingoid 12.23 9.95 7 222839 7377 56061844
Status epilepticus 12.23 9.95 26 222820 15115 56054106
Haematuria 12.22 9.95 60 222786 26927 56042294
Phonophobia 12.21 9.95 10 222836 300 56068921
Cerebral haemorrhage 12.16 9.95 65 222781 28541 56040680
Rales 12.15 9.95 15 222831 10825 56058396
Nephrotic syndrome 12.15 9.95 3 222843 5297 56063924
Sternal fracture 12.05 9.95 26 222820 2064 56067157
Mental impairment 12.04 9.95 89 222757 12633 56056588
Anaphylactic shock 11.89 9.95 45 222801 21695 56047526
Pulmonary haemorrhage 11.86 9.95 6 222840 6777 56062444
Feeling jittery 11.82 9.95 85 222761 11961 56057260
Respiratory tract infection 11.73 9.95 89 222757 35982 56033239
Spasmodic dysphonia 11.69 9.95 6 222840 78 56069143
Breast cancer stage I 11.69 9.95 5 222841 6225 56062996
Electric shock sensation 11.67 9.95 12 222834 485 56068736
Herpes simplex reactivation 11.61 9.95 12 222834 488 56068733
Visual impairment 11.60 9.95 380 222466 73822 55995399
Eye pain 11.58 9.95 179 222667 30668 56038553
Parosmia 11.57 9.95 43 222803 4668 56064553
Chronic idiopathic pain syndrome 11.54 9.95 3 222843 3 56069218
Cytomegalovirus viraemia 11.54 9.95 3 222843 5117 56064104
Uraemic encephalopathy 11.51 9.95 9 222837 252 56068969
Sleep-related eating disorder 11.44 9.95 15 222831 789 56068432
Impulsive behaviour 11.39 9.95 21 222825 1486 56067735
Polyglandular autoimmune syndrome type II 11.34 9.95 5 222841 45 56069176
Retching 11.33 9.95 92 222754 13438 56055783
Escherichia infection 11.30 9.95 18 222828 11681 56057540
Food craving 11.28 9.95 21 222825 1498 56067723
Economic problem 11.27 9.95 24 222822 1887 56067334
Motor dysfunction 11.25 9.95 70 222776 9387 56059834
Supraventricular tachyarrhythmia 11.24 9.95 6 222840 85 56069136
Rapid eye movement sleep behaviour disorder 11.22 9.95 8 222838 194 56069027
Labelled drug-food interaction issue 11.22 9.95 4 222842 19 56069202
Carcinoid tumour pulmonary 11.21 9.95 11 222835 420 56068801
Abortion induced 11.18 9.95 13 222833 9632 56059589
Ligament injury 11.16 9.95 17 222829 1028 56068193
Antidepressant drug level increased 11.16 9.95 9 222837 264 56068957
Liver disorder 11.12 9.95 117 222729 44253 56024968
Epstein-Barr virus infection 11.09 9.95 8 222838 7455 56061766
Blood pressure diastolic abnormal 11.06 9.95 18 222828 11580 56057641
Fear of injection 11.04 9.95 6 222840 6509 56062712
Sexual dysfunction 11.04 9.95 34 222812 3354 56065867
Generalised anxiety disorder 10.99 9.95 24 222822 1920 56067301
Foot amputation 10.99 9.95 9 222837 270 56068951
Sluggishness 10.96 9.95 42 222804 4626 56064595
Rectal haemorrhage 10.95 9.95 108 222738 41359 56027862
Vasculitis 10.94 9.95 27 222819 14896 56054325
Alveolar bone resorption 10.89 9.95 5 222841 50 56069171
Polyneuropathy 10.88 9.95 22 222824 13028 56056193
Suspected product quality issue 10.88 9.95 8 222838 204 56069017
Aphasia 10.85 9.95 175 222671 30240 56038981
Purple glove syndrome 10.84 9.95 8 222838 205 56069016
Posterior reversible encephalopathy syndrome 10.84 9.95 30 222816 15930 56053291
Ventricular hypoplasia 10.70 9.95 7 222839 147 56069074
Alcohol abuse 10.66 9.95 24 222822 1960 56067261
Shock haemorrhagic 10.66 9.95 12 222834 9021 56060200
Pyometra 10.65 9.95 6 222840 95 56069126
Hepatitis A antibody positive 10.63 9.95 5 222841 53 56069168
Accommodation disorder 10.63 9.95 10 222836 362 56068859
Neuropsychiatric symptoms 10.62 9.95 13 222833 638 56068583
Myocardial infarction 10.61 9.95 283 222563 92587 55976634
Infective pulmonary exacerbation of cystic fibrosis 10.57 9.95 10 222836 8147 56061074
Disturbance in sexual arousal 10.54 9.95 6 222840 97 56069124
Trigger finger 10.49 9.95 37 222809 3916 56065305
Drug withdrawal syndrome neonatal 10.41 9.95 24 222822 1992 56067229
Stress 10.35 9.95 306 222540 58604 56010617
Pericardial effusion 10.35 9.95 64 222782 27111 56042110
Tongue movement disturbance 10.29 9.95 9 222837 296 56068925
Hyperventilation 10.28 9.95 47 222799 5601 56063620
Central nervous system lesion 10.26 9.95 71 222775 9867 56059354
Bone density decreased 10.23 9.95 22 222824 12738 56056483
Enuresis 10.22 9.95 26 222820 2297 56066924
Haemorrhage intracranial 10.22 9.95 22 222824 12733 56056488
Acute pulmonary oedema 10.22 9.95 9 222837 7588 56061633
Breast cancer stage II 10.21 9.95 5 222841 5753 56063468
Poor sucking reflex 10.20 9.95 8 222838 225 56068996
Intervertebral disc operation 10.17 9.95 14 222832 772 56068449
Self esteem decreased 10.14 9.95 12 222834 568 56068653
Adiposis dolorosa 10.09 9.95 9 222837 304 56068917
Violence-related symptom 10.01 9.95 10 222836 390 56068831
Unintentional medical device removal 10.01 9.95 5 222841 5689 56063532
Oesophageal obstruction 10.01 9.95 11 222835 480 56068741
Serum serotonin increased 9.99 9.95 7 222839 165 56069056
Device difficult to use 9.99 9.95 17 222829 10744 56058477
Increased appetite 9.98 9.95 64 222782 8671 56060550

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
Drug withdrawal syndrome 1278.75 11.26 688 70525 18062 31608069
Dysphoria 1228.67 11.26 368 70845 1804 31624327
Affect lability 1153.11 11.26 392 70821 3073 31623058
Suicidal ideation 766.86 11.26 643 70570 35763 31590368
Irritability 665.13 11.26 489 70724 22400 31603731
Sensory disturbance 564.26 11.26 270 70943 5477 31620654
Paraesthesia 489.37 11.26 616 70597 55455 31570676
Vertigo 486.31 11.26 408 70805 22677 31603454
Agitation 472.55 11.26 595 70618 53574 31572557
Anxiety 457.59 11.26 770 70443 90263 31535868
Insomnia 443.63 11.26 777 70436 94059 31532072
Hyperhidrosis 431.30 11.26 637 70576 66756 31559375
Nightmare 383.62 11.26 273 70940 11864 31614267
Dizziness 264.49 11.26 1013 70200 198134 31427997
Serotonin syndrome 255.40 11.26 260 70953 18513 31607618
Tinnitus 250.32 11.26 241 70972 16034 31610097
Completed suicide 243.93 11.26 595 70618 90919 31535212
Hypomania 234.65 11.26 110 71103 2125 31624006
Tremor 233.25 11.26 524 70689 75896 31550235
Confusional state 227.42 11.26 737 70476 132597 31493534
Lethargy 221.08 11.26 347 70866 38294 31587837
Mood swings 214.07 11.26 158 71055 7266 31618865
Headache 180.49 11.26 853 70360 182799 31443332
Depression 178.81 11.26 528 70685 90287 31535844
Nausea 154.53 11.26 1200 70013 306747 31319384
Suicide attempt 140.92 11.26 279 70934 36969 31589162
Febrile neutropenia 140.81 11.26 49 71164 121800 31504331
Sleep disorder 137.51 11.26 227 70986 26121 31600010
Pyrexia 126.53 11.26 313 70900 303527 31322604
Fatigue 106.59 11.26 1185 70028 334021 31292110
Thrombocytopenia 104.51 11.26 100 71113 142647 31483484
Anger 104.26 11.26 127 71086 11026 31615105
Acute kidney injury 100.08 11.26 310 70903 279404 31346727
Withdrawal syndrome 97.69 11.26 126 71087 11591 31614540
Anaemia 88.68 11.26 220 70993 213302 31412829
Gastrointestinal tube insertion 88.04 11.26 46 71167 1131 31625000
Somnolence 78.57 11.26 435 70778 99010 31527121
Pancytopenia 73.95 11.26 53 71160 87263 31538868
Fall 71.80 11.26 685 70528 185404 31440727
Feeling abnormal 71.23 11.26 285 70928 56717 31569414
Intentional self-injury 71.18 11.26 116 71097 13199 31612932
Neutropenia 69.51 11.26 131 71082 140233 31485898
Disturbance in attention 65.09 11.26 151 71062 22299 31603832
Memory impairment 63.18 11.26 209 71004 37921 31588210
Sepsis 62.64 11.26 157 71056 151772 31474359
Sedation 62.20 11.26 134 71079 18831 31607300
Multiple organ dysfunction syndrome 59.60 11.26 40 71173 68163 31557968
Dyspnoea 55.66 11.26 499 70714 342980 31283151
Disease progression 52.60 11.26 76 71137 90388 31535743
Hepatic enzyme increased 51.81 11.26 188 71025 35720 31590411
Intentional overdose 50.93 11.26 206 71007 41183 31584948
Pleural effusion 50.78 11.26 56 71157 74864 31551267
Antidepressant drug level above therapeutic 50.25 11.26 19 71194 208 31625923
Haemoglobin decreased 49.95 11.26 112 71101 112563 31513568
Sexual dysfunction 49.46 11.26 64 71149 5904 31620227
Loss of consciousness 47.47 11.26 317 70896 77038 31549093
Urinary retention 46.50 11.26 174 71039 33551 31592580
Malignant neoplasm progression 46.28 11.26 66 71147 78932 31547199
Analgesic drug level above therapeutic 45.24 11.26 19 71194 279 31625852
Blood creatinine increased 45.06 11.26 82 71131 88996 31537135
Platelet count decreased 44.81 11.26 115 71098 110320 31515811
Respiratory disorder neonatal 43.50 11.26 32 71181 1463 31624668
Toxicity to various agents 42.95 11.26 608 70605 180879 31445252
Ascites 41.63 11.26 20 71193 40993 31585138
Myoclonus 41.54 11.26 95 71118 13895 31612236
Migraine 38.52 11.26 93 71120 14087 31612044
Cardiac failure 38.44 11.26 85 71128 85868 31540263
Therapy interrupted 38.40 11.26 78 71135 10518 31615613
General physical health deterioration 38.13 11.26 129 71084 113306 31512825
Renal failure 37.66 11.26 146 71067 123184 31502947
Balance disorder 37.42 11.26 175 71038 37247 31588884
Gastric bypass 37.14 11.26 16 71197 251 31625880
Pneumonia 36.27 11.26 533 70680 334779 31291352
Mucosal inflammation 36.16 11.26 16 71197 34411 31591720
Haemorrhage 35.95 11.26 32 71181 47302 31578829
Road traffic accident 35.80 11.26 99 71114 16282 31609849
Respiratory failure 35.03 11.26 114 71099 101335 31524796
Cytomegalovirus infection 34.03 11.26 7 71206 24700 31601431
Urinary hesitation 33.76 11.26 34 71179 2387 31623744
Hallucination, auditory 33.74 11.26 73 71140 10287 31615844
Drug resistance 33.67 11.26 6 71207 23447 31602684
Pain 33.34 11.26 597 70616 186162 31439969
Product use in unapproved indication 33.17 11.26 113 71100 99058 31527073
Abnormal dreams 32.79 11.26 58 71155 7050 31619081
Aggression 32.72 11.26 168 71045 37123 31589008
Reversible airways obstruction 32.61 11.26 16 71197 343 31625788
C-reactive protein increased 32.26 11.26 37 71176 48613 31577518
Major depression 31.24 11.26 43 71170 4210 31621921
Feeling jittery 30.51 11.26 40 71173 3737 31622394
Overdose 30.27 11.26 307 70906 84357 31541774
Metabolic acidosis 29.76 11.26 27 71186 39550 31586581
Hallucination 29.55 11.26 192 71021 46218 31579913
Mania 29.13 11.26 64 71149 9113 31617018
Neuropathy peripheral 28.84 11.26 278 70935 75371 31550760
Hypokalaemia 28.27 11.26 48 71165 53526 31572605
Renal impairment 27.79 11.26 100 71113 86249 31539882
Affective disorder 27.79 11.26 38 71175 3698 31622433
Yawning 27.39 11.26 16 71197 492 31625639
Surgery 27.39 11.26 76 71137 12523 31613608
Disorientation 27.31 11.26 139 71074 30605 31595526
Self esteem decreased 27.13 11.26 16 71197 501 31625630
Growth hormone deficiency 26.96 11.26 13 71200 268 31625863
Amnesia 26.83 11.26 114 71099 23288 31602843
Septic shock 26.73 11.26 69 71144 66089 31560042
Dehydration 26.44 11.26 158 71055 118953 31507178
Cough 26.29 11.26 186 71027 134628 31491503
Leukopenia 26.00 11.26 57 71156 57771 31568360
Disseminated intravascular coagulation 25.95 11.26 7 71206 20530 31605601
Bradyphrenia 25.78 11.26 40 71173 4364 31621767
Agranulocytosis 25.46 11.26 8 71205 21239 31604892
White blood cell count decreased 25.06 11.26 106 71107 87292 31538839
Bone marrow failure 25.03 11.26 16 71197 27992 31598139
Off label use 24.76 11.26 593 70620 346681 31279450
Electric shock sensation 24.71 11.26 9 71204 88 31626043
Atrial fibrillation 24.69 11.26 152 71061 113631 31512500
Fibromyalgia 24.51 11.26 31 71182 2795 31623336
Initial insomnia 23.80 11.26 31 71182 2878 31623253
Drug hypersensitivity 23.02 11.26 257 70956 72342 31553789
Abnormal behaviour 22.78 11.26 110 71103 23718 31602413
International normalised ratio increased 22.52 11.26 42 71171 45181 31580950
Acute myeloid leukaemia 22.42 11.26 7 71206 18665 31607466
Neuralgia 22.35 11.26 68 71145 11798 31614333
Post concussion syndrome 22.15 11.26 9 71204 121 31626010
Psychotic disorder 22.10 11.26 104 71109 22189 31603942
Convulsive threshold lowered 22.06 11.26 14 71199 501 31625630
Hypertensive emergency 22.06 11.26 18 71195 960 31625171
Homicidal ideation 21.81 11.26 28 71185 2563 31623568
Hepatitis E antibody positive 21.60 11.26 11 71202 256 31625875
Depressed mood 21.23 11.26 87 71126 17488 31608643
Dystonia 20.59 11.26 60 71153 10165 31615966
Hepatitis E virus test positive 20.57 11.26 11 71202 284 31625847
Interstitial lung disease 20.50 11.26 70 71143 61333 31564798
Agitation neonatal 20.46 11.26 18 71195 1065 31625066
Colitis ulcerative 20.44 11.26 8 71205 18521 31607610
Hypocalcaemia 20.41 11.26 12 71201 21966 31604165
Delirium 20.35 11.26 161 71052 41260 31584871
Gastrointestinal adenocarcinoma 20.34 11.26 7 71206 57 31626074
Liver function test abnormal 20.23 11.26 125 71088 29567 31596564
Erectile dysfunction 20.00 11.26 91 71122 19144 31606987
Pneumocystis jirovecii pneumonia 19.94 11.26 8 71205 18243 31607888
Muscle spasticity 19.85 11.26 41 71172 5594 31620537
Acute stress disorder 19.77 11.26 9 71204 162 31625969
Cardiogenic shock 19.75 11.26 13 71200 22395 31603736
Haemoptysis 19.74 11.26 26 71187 32163 31593968
Somnambulism 19.70 11.26 28 71185 2824 31623307
Complex regional pain syndrome 19.61 11.26 13 71200 502 31625629
Undifferentiated connective tissue disease 19.60 11.26 6 71207 32 31626099
Pneumonitis 19.58 11.26 24 71189 30628 31595503
Prostate cancer 19.55 11.26 34 71179 37567 31588564
Infusion related reaction 19.50 11.26 50 71163 48005 31578126
Cardiac failure congestive 19.40 11.26 102 71111 79285 31546846
Clonus 19.31 11.26 26 71187 2493 31623638
Oedema peripheral 19.29 11.26 156 71057 109683 31516448
Toxic epidermal necrolysis 19.09 11.26 10 71203 19514 31606617
Myocardial infarction 19.08 11.26 163 71050 113291 31512840
Neutrophil count decreased 19.03 11.26 48 71165 46346 31579785
Multiple sclerosis relapse 19.02 11.26 65 71148 11982 31614149
Rash maculo-papular 18.80 11.26 18 71195 25701 31600430
Rash 18.79 11.26 329 70884 201157 31424974
Erythema 18.71 11.26 105 71108 80300 31545831
Respiratory distress 18.69 11.26 29 71184 33524 31592607
Lacunar stroke 18.69 11.26 9 71204 185 31625946
Productive cough 18.68 11.26 29 71184 33511 31592620
Drug reaction with eosinophilia and systemic symptoms 18.66 11.26 24 71189 29994 31596137
Pericardial effusion 18.46 11.26 14 71199 22409 31603722
Hypersomnia 18.45 11.26 61 71152 11058 31615073
Wrong drug 18.40 11.26 7 71206 78 31626053
Dysmetropsia 18.17 11.26 4 71209 3 31626128
Neutropenic sepsis 18.14 11.26 3 71210 12376 31613755
Apathy 18.13 11.26 43 71170 6439 31619692
Lymphopenia 17.89 11.26 5 71208 14324 31611807
Sleep sex 17.64 11.26 4 71209 4 31626127
Gait disturbance 17.63 11.26 258 70955 77237 31548894
Acute myocardial infarction 17.61 11.26 57 71156 50766 31575365
Sleep-related eating disorder 17.55 11.26 10 71203 293 31625838
Compulsive shopping 17.43 11.26 11 71202 390 31625741
Haematochezia 17.28 11.26 41 71172 40423 31585708
Steatohepatitis 17.25 11.26 10 71203 303 31625828
Cytokine release syndrome 17.06 11.26 8 71205 16634 31609497
Drug interaction 17.05 11.26 600 70613 207943 31418188
Feeling guilty 17.02 11.26 10 71203 311 31625820
Gastrointestinal haemorrhage 17.01 11.26 112 71101 82437 31543694
Therapy cessation 16.99 11.26 73 71140 14982 31611149
Treatment failure 16.89 11.26 42 71171 40750 31585381
Tardive dyskinesia 16.78 11.26 38 71175 5521 31620610
Thinking abnormal 16.71 11.26 38 71175 5535 31620596
Pulmonary embolism 16.71 11.26 111 71102 81535 31544596
Haematuria 16.71 11.26 51 71162 46263 31579868
Neonatal tachypnoea 16.59 11.26 8 71205 165 31625966
Forced expiratory flow decreased 16.54 11.26 8 71205 166 31625965
Coronary artery disease 16.45 11.26 51 71162 46036 31580095
Tumour lysis syndrome 16.39 11.26 7 71206 15378 31610753
Seizure 16.39 11.26 315 70898 99453 31526678
Paedophilia 16.37 11.26 4 71209 7 31626124
Blood lactate dehydrogenase increased 16.36 11.26 13 71200 20326 31605805
Mental disorder 16.33 11.26 68 71145 13766 31612365
Restlessness 16.33 11.26 99 71114 23262 31602869
Intentional product misuse 16.23 11.26 143 71070 37808 31588323
Product used for unknown indication 16.13 11.26 14 71199 813 31625318
Nephropathy toxic 16.09 11.26 3 71210 11350 31614781
Angioedema 16.06 11.26 32 71181 33586 31592545
Stomatitis 16.03 11.26 41 71172 39397 31586734
Prescribed overdose 15.76 11.26 51 71162 9141 31616990
Adenocarcinoma of appendix 15.74 11.26 7 71206 119 31626012
Cholestasis 15.63 11.26 20 71193 25055 31601076
Pulmonary fibrosis 15.61 11.26 9 71204 16651 31609480
Orgasm abnormal 15.38 11.26 7 71206 126 31626005
Neonatal hyponatraemia 15.30 11.26 6 71207 73 31626058
Libido decreased 15.30 11.26 32 71181 4404 31621727
Psychomotor hyperactivity 15.29 11.26 49 71164 8738 31617393
Delirium tremens 15.25 11.26 12 71201 607 31625524
Hyperlipasaemia 15.14 11.26 11 71202 493 31625638
Palmar-plantar erythrodysaesthesia syndrome 15.03 11.26 8 71205 15475 31610656
Ventricular hypoplasia 15.01 11.26 6 71207 77 31626054
Nephrolithiasis 14.96 11.26 109 71104 27230 31598901
Cerebral infarction 14.91 11.26 22 71191 25955 31600176
Drug screen positive 14.73 11.26 29 71184 3823 31622308
Tubulointerstitial nephritis 14.66 11.26 12 71201 18484 31607647
Urethral discharge 14.64 11.26 4 71209 13 31626118
Hypotension 14.64 11.26 349 70864 204269 31421862
Angina pectoris 14.34 11.26 28 71185 29613 31596518
Rhabdomyolysis 14.27 11.26 84 71129 63497 31562634
Inappropriate antidiuretic hormone secretion 14.25 11.26 57 71156 11330 31614801
Dyskinesia 14.22 11.26 88 71125 20822 31605309
Bipolar disorder 14.19 11.26 28 71185 3696 31622435
Restless legs syndrome 14.19 11.26 44 71169 7712 31618419
Speech sound disorder 14.10 11.26 7 71206 154 31625977
Abdominal pain 14.02 11.26 237 70976 145715 31480416
Drug screen false positive 13.92 11.26 12 71201 691 31625440
Hypoxia 13.82 11.26 62 71151 50251 31575880
Bladder cancer 13.73 11.26 8 71205 14717 31611414
Epistaxis 13.68 11.26 68 71145 53639 31572492
Influenza like illness 13.68 11.26 101 71112 25336 31600795
Tethered cord syndrome 13.62 11.26 4 71209 18 31626113
Chills 13.62 11.26 104 71109 74046 31552085
Blood urea increased 13.53 11.26 28 71185 28984 31597147
Muscle twitching 13.52 11.26 45 71168 8185 31617946
Retrograde ejaculation 13.52 11.26 9 71204 350 31625781
Stiff person syndrome 13.49 11.26 6 71207 102 31626029
Drug tolerance 13.48 11.26 22 71191 2505 31623626
Narcissistic personality disorder 13.45 11.26 4 71209 19 31626112
Axillary pain 13.40 11.26 9 71204 355 31625776
Psychopathic personality 13.23 11.26 3 71210 3 31626128
Melaena 13.23 11.26 34 71179 32620 31593511
Loss of employment 13.20 11.26 10 71203 478 31625653
Ileus 13.10 11.26 9 71204 15160 31610971
Ureteric haemorrhage 13.08 11.26 6 71207 110 31626021
Suicidal behaviour 12.88 11.26 16 71197 1416 31624715
Ventricular fibrillation 12.86 11.26 14 71199 18834 31607297
Intentional product use issue 12.85 11.26 62 71151 49285 31576846
Homicide 12.83 11.26 13 71200 919 31625212
Depression suicidal 12.68 11.26 17 71196 1623 31624508
Hyperglycaemia 12.57 11.26 41 71172 36435 31589696
Paranoia 12.55 11.26 52 71161 10503 31615628
Pseudomonas infection 12.45 11.26 5 71208 11396 31614735
Chest injury 12.45 11.26 16 71197 1466 31624665
Graft versus host disease 12.40 11.26 4 71209 10443 31615688
Lymphadenopathy 12.36 11.26 25 71188 26096 31600035
Dissociation 12.35 11.26 15 71198 1297 31624834
Facial spasm 12.35 11.26 7 71206 203 31625928
Brief psychotic disorder with marked stressors 12.29 11.26 7 71206 205 31625926
Alcoholism 12.29 11.26 25 71188 3374 31622757
Mood altered 12.29 11.26 44 71169 8302 31617829
Hyperreflexia 12.25 11.26 23 71190 2926 31623205
Deep vein thrombosis 12.21 11.26 83 71130 60653 31565478
Autonomic dysreflexia 12.19 11.26 5 71208 69 31626062
Helplessness 12.12 11.26 5 71208 70 31626061
Inflammation 12.08 11.26 24 71189 25217 31600914
Peritonitis 12.07 11.26 10 71203 15317 31610814
Snoring 12.07 11.26 23 71190 2960 31623171
Selective eating disorder 12.05 11.26 17 71196 1703 31624428
Central nervous system stimulation 12.02 11.26 3 71210 6 31626125
Plasma cell myeloma 12.00 11.26 76 71137 56455 31569676
Dry mouth 11.97 11.26 95 71118 24363 31601768
Aplastic anaemia 11.89 11.26 3 71210 9200 31616931
Drug eruption 11.87 11.26 14 71199 18173 31607958
Abdominal compartment syndrome 11.86 11.26 12 71201 847 31625284
Concussion 11.82 11.26 19 71194 2136 31623995
Blue toe syndrome 11.81 11.26 6 71207 139 31625992
Neoplasm progression 11.80 11.26 17 71196 20255 31605876
Hypoalbuminaemia 11.78 11.26 5 71208 11023 31615108
Pre-existing condition improved 11.75 11.26 20 71193 2357 31623774
Reflexes abnormal 11.64 11.26 8 71205 328 31625803
Lymphoma 11.62 11.26 5 71208 10938 31615193
Depersonalisation/derealisation disorder 11.59 11.26 10 71203 576 31625555
Panic disorder 11.55 11.26 14 71199 1208 31624923
Disease recurrence 11.51 11.26 15 71198 18646 31607485
Slow speech 11.51 11.26 13 71200 1041 31625090
Cyanosis 11.49 11.26 6 71207 11729 31614402
Bradycardia 11.47 11.26 100 71113 69227 31556904
Asthma 11.41 11.26 53 71160 42558 31583573
Lung disorder 11.35 11.26 36 71177 32276 31593855
Myelodysplastic syndrome 11.35 11.26 16 71197 19235 31606896

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
Drug withdrawal syndrome 980.77 9.71 790 204808 31925 70690921
Suicidal ideation 815.34 9.71 1007 204591 68589 70654257
Serotonin syndrome 795.35 9.71 783 204815 41331 70681515
Completed suicide 511.09 9.71 1633 203965 225502 70497344
Depression 494.41 9.71 1481 204117 197493 70525353
Hyperhidrosis 490.98 9.71 1140 204458 130446 70592400
Dysphoria 478.06 9.71 242 205356 4256 70718590
Anxiety 471.23 9.71 1557 204041 218773 70504073
Affect lability 400.97 9.71 289 205309 9857 70712989
Irritability 373.69 9.71 506 205092 37719 70685127
Tremor 328.18 9.71 1095 204503 154529 70568317
Nightmare 326.71 9.71 361 205237 21795 70701051
Febrile neutropenia 299.33 9.71 109 205489 204209 70518637
Agitation 285.62 9.71 750 204848 92625 70630221
Insomnia 263.45 9.71 1289 204309 216517 70506329
Suicide attempt 249.67 9.71 645 204953 78865 70643981
Dizziness 244.68 9.71 2231 203367 461910 70260936
Feeling abnormal 231.05 9.71 920 204678 141399 70581447
Somnolence 228.66 9.71 1230 204368 214376 70508470
Thrombocytopenia 228.17 9.71 214 205384 238896 70483950
Stubbornness 227.02 9.71 70 205528 282 70722564
Pemphigus 220.44 9.71 4 205594 83032 70639814
Withdrawal syndrome 214.09 9.71 310 205288 24594 70698252
Paraesthesia 209.71 9.71 907 204691 144630 70578216
Neutropenia 206.91 9.71 265 205333 256891 70465955
Pyrexia 205.05 9.71 984 204614 605968 70116878
Vertigo 204.77 9.71 516 205082 62127 70660719
Sensory disturbance 199.83 9.71 223 205375 13609 70709237
Mood swings 193.98 9.71 252 205346 18034 70704812
Fall 187.92 9.71 2040 203558 442056 70280790
Anaemia 180.04 9.71 585 205013 402838 70320008
Acute kidney injury 174.16 9.71 746 204852 473878 70248968
Pancytopenia 173.53 9.71 112 205486 150995 70571851
Headache 163.95 9.71 2474 203124 577931 70144915
Mood altered 162.36 9.71 219 205379 16256 70706590
Pericarditis 156.85 9.71 28 205570 84677 70638169
Nausea 151.28 9.71 3377 202221 848711 69874135
Fibromyalgia 147.80 9.71 386 205212 47488 70675358
Crying 147.15 9.71 239 205359 20960 70701886
Intentional self-injury 146.10 9.71 299 205299 31351 70691495
Migraine 145.67 9.71 501 205097 71737 70651109
Hand deformity 144.93 9.71 36 205562 86446 70636400
Glossodynia 143.02 9.71 37 205561 86450 70636396
Synovitis 140.08 9.71 102 205496 129126 70593720
Anger 131.70 9.71 196 205402 15936 70706910
Tinnitus 130.98 9.71 310 205288 35866 70686980
Memory impairment 130.80 9.71 574 205024 92067 70630779
Thinking abnormal 129.26 9.71 167 205431 11884 70710962
Disturbance in attention 126.48 9.71 340 205258 42554 70680292
Duodenal ulcer perforation 126.26 9.71 5 205593 51107 70671739
Confusional state 123.56 9.71 1314 204284 283084 70439762
Inappropriate antidiuretic hormone secretion 117.16 9.71 228 205370 23048 70699798
Contraindicated product administered 114.21 9.71 133 205465 134479 70588367
Affective disorder 112.21 9.71 123 205475 7356 70715490
Malignant neoplasm progression 111.34 9.71 113 205485 121626 70601220
Loss of consciousness 110.68 9.71 802 204796 154914 70567932
Platelet count decreased 109.02 9.71 220 205378 178002 70544844
Depressed mood 107.45 9.71 325 205273 43495 70679351
Sepsis 107.29 9.71 357 205241 244188 70478658
Cardiac failure 105.25 9.71 158 205440 143383 70579463
Drug interaction 100.17 9.71 1607 203991 379834 70343012
Electric shock 97.79 9.71 54 205544 1141 70721705
Product substitution issue 97.67 9.71 185 205413 18328 70704518
Disease progression 95.30 9.71 194 205404 156478 70566368
Systemic lupus erythematosus 95.00 9.71 93 205505 101809 70621037
Therapy interrupted 94.67 9.71 217 205381 24585 70698261
Abnormal behaviour 93.29 9.71 266 205332 34443 70688403
General physical health deterioration 93.27 9.71 360 205238 235671 70487175
Toxicity to various agents 92.93 9.71 1590 204008 380582 70342264
Multiple sclerosis relapse 92.58 9.71 305 205293 42712 70680134
Pain 92.11 9.71 2429 203169 626387 70096459
Hypomania 91.34 9.71 100 205498 5972 70716874
Coordination abnormal 90.33 9.71 165 205433 15901 70706945
Septic shock 88.83 9.71 117 205481 112141 70610705
C-reactive protein abnormal 88.30 9.71 6 205592 38573 70684273
Folliculitis 88.30 9.71 10 205588 42560 70680286
Anti-cyclic citrullinated peptide antibody positive 84.75 9.71 49 205549 70136 70652710
Blood creatinine increased 84.50 9.71 180 205418 142821 70580025
Tardive dyskinesia 84.46 9.71 123 205475 9806 70713040
Multiple organ dysfunction syndrome 83.93 9.71 115 205483 108400 70614446
Sleep disorder due to general medical condition, insomnia type 83.45 9.71 5 205593 35727 70687119
Urinary retention 81.53 9.71 335 205263 52185 70670661
Off label use 81.12 9.71 1593 204005 741467 69981379
Ascites 80.37 9.71 48 205550 67499 70655347
Renal failure 80.18 9.71 280 205318 188790 70534056
Infusion related reaction 80.16 9.71 298 205300 197236 70525610
Drug reaction with eosinophilia and systemic symptoms 79.85 9.71 34 205564 57979 70664867
Restless legs syndrome 79.10 9.71 169 205429 18259 70704587
Wound 78.01 9.71 103 205495 98629 70624217
Treatment failure 77.44 9.71 191 205407 143951 70578895
Somatic symptom disorder 76.06 9.71 56 205542 1974 70720872
Hallucination 74.63 9.71 426 205172 75834 70647012
Mucosal inflammation 74.23 9.71 53 205545 67797 70655049
Post-traumatic stress disorder 74.10 9.71 77 205521 4330 70718516
Reversible cerebral vasoconstriction syndrome 72.39 9.71 61 205537 2624 70720222
Intentional overdose 72.23 9.71 511 205087 97924 70624922
Renal impairment 71.02 9.71 199 205399 143738 70579108
Panic attack 70.99 9.71 181 205417 21938 70700908
Personality disorder 70.96 9.71 84 205514 5464 70717382
Balance disorder 70.33 9.71 475 205123 89653 70633193
Surgery 70.32 9.71 219 205379 29770 70693076
Cytomegalovirus infection 69.69 9.71 15 205583 39743 70683103
Drug hypersensitivity 69.65 9.71 1108 204490 261351 70461495
Alopecia 69.56 9.71 317 205281 198173 70524673
Therapy cessation 69.12 9.71 235 205363 33441 70689405
Pleural effusion 67.56 9.71 181 205417 132683 70590163
Amnesia 66.75 9.71 314 205284 51841 70671005
Muscle injury 66.50 9.71 15 205583 38479 70684367
Discomfort 66.30 9.71 128 205470 105308 70617538
Hypersensitivity 65.94 9.71 393 205205 229419 70493427
Nasal turbinate hypertrophy 65.30 9.71 33 205565 578 70722268
Mania 65.25 9.71 150 205448 17024 70705822
Sopor 63.13 9.71 217 205381 31050 70691796
Arthropathy 63.09 9.71 223 205375 149834 70573012
Leukopenia 63.05 9.71 134 205464 106426 70616420
Coma 62.90 9.71 469 205129 91375 70631471
Bone marrow failure 62.40 9.71 32 205566 48978 70673868
Neutrophil count decreased 62.18 9.71 91 205507 83465 70639381
Fatigue 62.13 9.71 2951 202647 821368 69901478
Rash 62.01 9.71 1074 204524 509488 70213358
Mental disorder 61.45 9.71 201 205397 28039 70694807
Lower respiratory tract infection 61.12 9.71 147 205451 111766 70611080
Maternal exposure during pregnancy 61.04 9.71 154 205444 115191 70607655
Pneumonia aspiration 60.31 9.71 347 205251 61942 70660904
Rubber sensitivity 60.02 9.71 43 205555 1452 70721394
Haemoglobin decreased 59.83 9.71 349 205249 204810 70518036
Abnormal dreams 59.74 9.71 109 205489 10494 70712352
Atrial fibrillation 59.59 9.71 303 205295 184045 70538801
Neutropenic sepsis 59.45 9.71 3 205595 24827 70698019
Weight increased 58.72 9.71 1008 204590 241323 70481523
Oesophageal spasm 58.66 9.71 58 205540 3073 70719773
Coma blister 58.53 9.71 23 205575 213 70722633
Dry mouth 58.40 9.71 377 205221 70080 70652766
Neck deformity 58.05 9.71 45 205553 1716 70721130
Multiple sclerosis 57.77 9.71 183 205415 25102 70697744
Colitis microscopic 57.76 9.71 98 205500 8907 70713939
Hypocalcaemia 57.54 9.71 29 205569 44830 70678016
Gastric bypass 57.39 9.71 38 205560 1126 70721720
Gastrointestinal tube insertion 57.26 9.71 42 205556 1472 70721374
Drug intolerance 57.08 9.71 401 205197 225286 70497560
Interstitial lung disease 55.99 9.71 139 205459 104546 70618300
Hyperreflexia 55.91 9.71 87 205511 7355 70715491
Influenza like illness 55.65 9.71 352 205246 64979 70657867
Lethargy 55.40 9.71 391 205207 74859 70647987
Dyspnoea 55.15 9.71 1757 203841 768303 69954543
Bronchial neoplasm 54.68 9.71 27 205571 449 70722397
Hallucination, visual 54.41 9.71 198 205400 29139 70693707
Disorientation 54.34 9.71 320 205278 57603 70665243
Blister 54.14 9.71 133 205465 100393 70622453
Vision blurred 54.11 9.71 465 205133 94519 70628327
Stomatitis 54.00 9.71 191 205407 128320 70594526
Product dose omission issue 53.56 9.71 907 204691 216561 70506285
Joint swelling 52.00 9.71 476 205122 252735 70470111
Dyskinesia 51.62 9.71 246 205352 40828 70682018
Sleep disorder 51.40 9.71 363 205235 69509 70653337
Lymphocytic oesophagitis 51.35 9.71 13 205585 19 70722827
Extremity contracture 49.53 9.71 40 205558 1620 70721226
Clonus 49.51 9.71 75 205523 6193 70716653
Pneumonia 49.49 9.71 1333 204265 594899 70127947
Libido increased 49.44 9.71 42 205556 1827 70721019
Bronchopulmonary aspergillosis 48.86 9.71 3 205595 20999 70701847
Erythema 48.80 9.71 358 205240 199205 70523641
Drug resistance 48.52 9.71 25 205573 38165 70684681
Hot flush 48.51 9.71 277 205321 49307 70673539
Oedema peripheral 48.49 9.71 425 205173 227666 70495180
Swelling 48.16 9.71 334 205264 188205 70534641
Blood pressure increased 48.15 9.71 791 204807 187726 70535120
Major depression 48.13 9.71 88 205510 8486 70714360
Endometrial ablation 47.78 9.71 30 205568 810 70722036
Hyperaesthesia 47.71 9.71 101 205497 10841 70712005
Respiratory failure 47.62 9.71 290 205308 168445 70554401
Helicobacter infection 47.17 9.71 55 205543 55601 70667245
Stiff person syndrome 46.29 9.71 22 205576 335 70722511
Hyperkalaemia 45.06 9.71 158 205440 106433 70616413
Muscle twitching 44.84 9.71 143 205455 19684 70703162
Rheumatoid factor positive 44.15 9.71 45 205553 48355 70674491
Cardiac failure congestive 43.56 9.71 223 205375 135234 70587612
White blood cell count decreased 43.16 9.71 302 205296 169839 70553007
Product use in unapproved indication 43.03 9.71 389 205209 207089 70515757
Intentional product misuse 42.91 9.71 385 205213 79210 70643636
Acute myeloid leukaemia 42.79 9.71 18 205580 30922 70691924
Neurologic neglect syndrome 42.57 9.71 43 205555 2338 70720508
Restlessness 42.30 9.71 237 205361 41891 70680955
Coronary artery disease 42.25 9.71 73 205525 62663 70660183
Temperature intolerance 42.14 9.71 84 205514 8639 70714207
Intervertebral discitis 42.05 9.71 56 205542 4105 70718741
Pulmonary malformation 42.03 9.71 17 205581 171 70722675
Carotid artery thrombosis 41.94 9.71 44 205554 2502 70720344
Lung cyst 41.46 9.71 19 205579 265 70722581
Red blood cell sedimentation rate abnormal 41.41 9.71 4 205594 19299 70703547
Neuralgia 40.93 9.71 178 205420 28425 70694421
C-reactive protein increased 40.82 9.71 173 205425 110344 70612502
Pneumocystis jirovecii pneumonia 40.81 9.71 18 205580 30064 70692782
Sleep apnoea syndrome 40.44 9.71 195 205403 32518 70690328
Bradyphrenia 40.16 9.71 89 205509 9857 70712989
Self esteem decreased 40.15 9.71 28 205570 905 70721941
Overdose 39.98 9.71 703 204895 169042 70553804
Pulmonary fibrosis 39.95 9.71 25 205573 34285 70688561
Gastrointestinal haemorrhage 39.91 9.71 234 205364 137174 70585672
Autonomic dysreflexia 39.79 9.71 21 205577 404 70722442
Infection 39.15 9.71 406 205192 210379 70512467
Bone density abnormal 38.87 9.71 45 205553 2858 70719988
Akathisia 38.83 9.71 100 205498 12193 70710653
Sedation 38.69 9.71 250 205348 46481 70676365
Rash maculo-papular 38.64 9.71 54 205544 50491 70672355
Myoclonus 38.47 9.71 165 205433 26190 70696656
Hypersomnia 38.39 9.71 140 205458 20624 70702222
Morbid thoughts 38.05 9.71 25 205573 731 70722115
Abdominal discomfort 38.04 9.71 418 205180 214240 70508606
Impaired healing 38.04 9.71 101 205497 74273 70648573
Concussion 37.63 9.71 79 205519 8430 70714416
Head injury 37.61 9.71 197 205401 33944 70688902
Rheumatoid arthritis 37.58 9.71 607 204991 291198 70431648
Aspergillus infection 37.56 9.71 4 205594 17864 70704982
Neck mass 37.28 9.71 53 205545 4133 70718713
Irritable bowel syndrome 37.22 9.71 56 205542 50794 70672052
Rebound nasal congestion 37.21 9.71 10 205588 21 70722825
Hostility 37.20 9.71 39 205559 2216 70720630
Rheumatic fever 37.00 9.71 4 205594 17656 70705190
Rapid eye movements sleep abnormal 36.79 9.71 17 205581 242 70722604
Anovulatory cycle 36.37 9.71 14 205584 122 70722724
Cystitis 36.37 9.71 247 205351 46694 70676152
Cardiogenic shock 36.37 9.71 31 205567 36276 70686570
Agranulocytosis 36.15 9.71 38 205560 40260 70682586
Hallucination, auditory 35.95 9.71 126 205472 18202 70704644
Alanine aminotransferase increased 35.88 9.71 614 204984 146866 70575980
Haemoptysis 35.45 9.71 59 205539 51393 70671453
Ankle fracture 35.00 9.71 111 205487 15233 70707613
Analgesic drug level above therapeutic 34.94 9.71 20 205578 454 70722392
Libido decreased 34.90 9.71 56 205542 4860 70717986
Muscle spasms 34.86 9.71 634 204964 153412 70569434
Hypomagnesaemia 34.85 9.71 40 205558 40724 70682122
Sleep-related eating disorder 34.61 9.71 23 205575 686 70722160
Sacroiliitis 34.54 9.71 45 205553 3228 70719618
Disseminated intravascular coagulation 34.50 9.71 28 205570 33570 70689276
Gastrooesophageal reflux disease 34.48 9.71 409 205189 90430 70632416
Skin haemorrhage 34.44 9.71 85 205513 10095 70712751
Prescribed overdose 34.30 9.71 163 205435 27018 70695828
Bipolar disorder 34.07 9.71 71 205527 7537 70715309
Melaena 34.06 9.71 70 205528 56285 70666561
Hypoaesthesia 33.84 9.71 630 204968 153109 70569737
Dissociation 33.45 9.71 45 205553 3331 70719515
Impaired driving ability 32.68 9.71 54 205544 4803 70718043
Opsoclonus myoclonus 32.56 9.71 15 205583 212 70722634
Cognitive disorder 32.42 9.71 294 205304 60662 70662184
Epistaxis 32.40 9.71 170 205428 102457 70620389
Psychotic disorder due to a general medical condition 31.98 9.71 16 205582 274 70722572
Bacteraemia 31.91 9.71 23 205575 29286 70693560
Nervousness 31.86 9.71 176 205422 30944 70691902
Premature delivery 31.78 9.71 11 205587 21293 70701553
Dehydration 31.62 9.71 463 205135 225679 70497167
Palmar-plantar erythrodysaesthesia syndrome 31.32 9.71 25 205573 30222 70692624
Lactic acidosis 31.25 9.71 91 205507 64933 70657913
Thunderclap headache 31.06 9.71 15 205583 237 70722609
Tubulointerstitial nephritis 31.03 9.71 30 205568 33046 70689800
Cerebral infarction 30.87 9.71 48 205550 42961 70679885
Gait disturbance 30.78 9.71 728 204870 184378 70538468
Oesophageal pain 30.75 9.71 46 205552 3756 70719090
Sensitivity to weather change 30.74 9.71 67 205531 7338 70715508
Therapeutic product effect decreased 30.58 9.71 266 205332 142752 70580094
Bronchial haemorrhage 30.54 9.71 27 205571 1240 70721606
Metabolic surgery 30.50 9.71 25 205573 1034 70721812
Drug eruption 30.38 9.71 42 205556 39454 70683392
Metabolic acidosis 30.23 9.71 112 205486 74234 70648612
Depressive symptom 30.13 9.71 54 205544 5127 70717719
Rheumatoid nodule 30.12 9.71 4 205594 15063 70707783
Neoplasm progression 30.12 9.71 53 205545 45175 70677671
Aspartate aminotransferase increased 29.93 9.71 526 205072 126452 70596394
Antidepressant drug level above therapeutic 29.78 9.71 20 205578 607 70722239
Aggression 29.62 9.71 241 205357 48205 70674641
Prostate cancer 29.55 9.71 28 205570 31135 70691711
Toxic epidermal necrolysis 29.50 9.71 43 205555 39514 70683332
Respiratory tract congestion 29.30 9.71 115 205483 17538 70705308
Emotional disorder 28.65 9.71 94 205504 13132 70709714
Cytokine release syndrome 28.52 9.71 21 205577 26446 70696400
Spinal operation 28.50 9.71 63 205535 6965 70715881
Speech disorder 28.47 9.71 247 205351 50333 70672513
Haematuria 28.39 9.71 92 205506 63481 70659365
Psychotic disorder 28.39 9.71 197 205401 37504 70685342
Respiratory distress 28.11 9.71 74 205524 54576 70668270
Aplastic anaemia 27.92 9.71 7 205591 16709 70706137
Sinus congestion 27.89 9.71 112 205486 17261 70705585
Poor quality sleep 27.87 9.71 125 205473 20224 70702622
Muscle spasticity 27.77 9.71 122 205476 19567 70703279
Graft versus host disease 27.73 9.71 5 205593 15018 70707828
Sinus disorder 27.14 9.71 118 205480 18841 70704005
Tumour lysis syndrome 27.11 9.71 14 205584 21346 70701500
Hypotension 26.85 9.71 931 204667 403450 70319396
Psychomotor hyperactivity 26.81 9.71 102 205496 15331 70707515
Enterococcal infection 26.60 9.71 5 205593 14577 70708269
Road traffic accident 26.57 9.71 182 205416 34500 70688346
Pneumonitis 26.53 9.71 76 205522 54521 70668325
Formication 26.39 9.71 48 205550 4609 70718237
Blood lactate dehydrogenase increased 26.38 9.71 38 205560 35089 70687757
Pseudomonas infection 26.35 9.71 11 205587 18983 70703863
Apathy 26.13 9.71 85 205513 11823 70711023
Galactorrhoea 26.09 9.71 40 205558 3338 70719508
Ill-defined disorder 26.02 9.71 77 205521 54664 70668182
Psoriasis 25.85 9.71 415 205183 98018 70624828
Paranoia 25.82 9.71 109 205489 17179 70705667
Bladder cancer 25.55 9.71 9 205589 17233 70705613
Respiratory tract malformation 25.51 9.71 10 205588 92 70722754
Angioedema 25.38 9.71 103 205495 66507 70656339
Cholestasis 25.25 9.71 64 205534 47808 70675038
Hypokalaemia 25.04 9.71 251 205347 130937 70591909
Plasma cell myeloma 24.97 9.71 118 205480 73083 70649763
Dystonia 24.74 9.71 118 205480 19588 70703258
Myelodysplastic syndrome 24.63 9.71 30 205568 29755 70693091
Acute myocardial infarction 24.56 9.71 118 205480 72769 70650077
Eosinophilia 24.43 9.71 50 205548 40269 70682577
Haematotoxicity 24.29 9.71 5 205593 13669 70709177
Phagophobia 24.23 9.71 8 205590 42 70722804
Demyelination 24.04 9.71 60 205538 7176 70715670
Lactation disorder 23.96 9.71 12 205586 206 70722640
Bradycardia 23.96 9.71 238 205360 124377 70598469
Anorgasmia 23.94 9.71 22 205576 1063 70721783
Blood calcium decreased 23.91 9.71 29 205569 28817 70694029
Post-traumatic neck syndrome 23.80 9.71 29 205569 1944 70720902
Maternal exposure during breast feeding 23.59 9.71 31 205567 2243 70720603
Hypoalbuminaemia 23.58 9.71 13 205585 19109 70703737
Electric shock sensation 23.52 9.71 17 205581 582 70722264
Depression suicidal 23.45 9.71 35 205563 2852 70719994
Myocardial infarction 23.44 9.71 353 205245 171292 70551554
Pathogen resistance 23.29 9.71 5 205593 13274 70709572
Cataplexy 23.15 9.71 21 205577 998 70721848
Pulseless electrical activity 23.13 9.71 5 205593 13210 70709636
Toxic skin eruption 23.05 9.71 15 205583 20147 70702699
Device related infection 23.02 9.71 36 205562 32149 70690697
Pain in extremity 22.97 9.71 1167 204431 326915 70395931
Middle insomnia 22.88 9.71 91 205507 13962 70708884
Product prescribing error 22.86 9.71 192 205406 38760 70684086
Hyperglycaemia 22.80 9.71 103 205495 64569 70658277
Delusion 22.80 9.71 113 205485 19052 70703794
Peripheral swelling 22.77 9.71 517 205081 236046 70486800
Speech sound disorder 22.67 9.71 8 205590 53 70722793
Acute respiratory distress syndrome 22.66 9.71 54 205544 41200 70681646
Metastases to bone 22.54 9.71 19 205579 22357 70700489
Eating disorder 22.47 9.71 110 205488 18455 70704391
Feeling jittery 22.34 9.71 79 205519 11464 70711382
Creatinine renal clearance decreased 22.24 9.71 11 205587 17189 70705657
Thrombotic microangiopathy 22.20 9.71 12 205586 17836 70705010
Drug screen positive 22.18 9.71 51 205547 5789 70717057
Feeling guilty 22.06 9.71 19 205579 842 70722004
Bruxism 21.86 9.71 39 205559 3690 70719156
Therapy non-responder 21.78 9.71 132 205466 76783 70646063
Hypnopompic hallucination 21.71 9.71 8 205590 61 70722785
Alcoholism 21.71 9.71 43 205555 4402 70718444
Skin necrosis 21.70 9.71 10 205588 16281 70706565
Acute pulmonary oedema 21.67 9.71 6 205592 13406 70709440
Metastases to liver 21.47 9.71 26 205572 25852 70696994
Gastrointestinal disorder 21.26 9.71 199 205399 105228 70617618
Poisoning 21.23 9.71 125 205473 22497 70700349
Tenosynovitis 21.23 9.71 7 205591 13969 70708877
Somnambulism 21.16 9.71 47 205551 5213 70717633
Epstein-Barr virus infection 21.14 9.71 6 205592 13192 70709654
Anaphylactic reaction 21.06 9.71 129 205469 74845 70648001
Gambling disorder 21.01 9.71 27 205571 1911 70720935
Lung disorder 20.88 9.71 117 205481 69367 70653479
Proteinuria 20.87 9.71 33 205565 29341 70693505
Second primary malignancy 20.79 9.71 6 205592 13045 70709801
Sexual dysfunction 20.74 9.71 54 205544 6627 70716219
International normalised ratio increased 20.60 9.71 143 205455 80583 70642263
Deep vein thrombosis 20.55 9.71 214 205384 110828 70612018
Ejection fraction decreased 20.52 9.71 36 205562 30726 70692120
Pulmonary eosinophilia 20.46 9.71 16 205582 618 70722228
Pustular psoriasis 20.36 9.71 43 205555 4607 70718239
Hypoventilation 20.23 9.71 53 205545 6529 70716317
Hypoxia 20.22 9.71 173 205425 93171 70629675
Product use issue 20.04 9.71 384 205214 179553 70543293
Muscular weakness 20.00 9.71 534 205064 137802 70585044
Adjustment disorder 19.88 9.71 34 205564 3110 70719736
Hypertonia 19.64 9.71 52 205546 6446 70716400
Diplopia 19.41 9.71 144 205454 28003 70694843
Phobia of driving 19.39 9.71 4 205594 0 70722846
Decompression sickness 19.15 9.71 7 205591 52 70722794
Growth hormone deficiency 19.09 9.71 13 205585 404 70722442
Live birth 19.08 9.71 8 205590 13771 70709075
Peritonitis 18.96 9.71 29 205569 26130 70696716
Hepatitis E antibody positive 18.93 9.71 11 205587 257 70722589
Pulmonary arterial hypertension 18.86 9.71 42 205556 32813 70690033
Snoring 18.81 9.71 43 205555 4861 70717985
Initial insomnia 18.58 9.71 50 205548 6259 70716587
Tension 18.55 9.71 38 205560 3986 70718860
Pulmonary oedema 18.50 9.71 151 205447 82127 70640719
Scar 18.49 9.71 85 205513 13896 70708950
Hepatic steatosis 18.45 9.71 164 205434 33649 70689197
Urinary incontinence 18.36 9.71 179 205419 37663 70685183
Bronchial disorder 18.36 9.71 28 205570 2326 70720520
Increased appetite 18.32 9.71 70 205528 10543 70712303
Delirium 18.26 9.71 311 205287 74303 70648543
Sleep terror 18.26 9.71 20 205578 1195 70721651
Pre-existing condition improved 18.25 9.71 43 205555 4959 70717887
Arteriosclerosis coronary artery 18.16 9.71 94 205504 16121 70706725
Tearfulness 18.15 9.71 43 205555 4977 70717869
Neuropathy peripheral 18.11 9.71 489 205109 126407 70596439
Flat affect 18.09 9.71 25 205573 1898 70720948
Hepatitis E virus test positive 18.09 9.71 11 205587 280 70722566
Prescribed underdose 18.06 9.71 115 205483 21270 70701576
Hepatotoxicity 18.05 9.71 66 205532 43920 70678926
Palpitations 17.91 9.71 434 205164 110319 70612527
Motor dysfunction 17.69 9.71 80 205518 12990 70709856
Hepatocellular carcinoma 17.59 9.71 4 205594 10204 70712642
Feeling drunk 17.54 9.71 39 205559 4328 70718518
Hyperuricaemia 17.54 9.71 5 205593 10961 70711885
Cytomegalovirus viraemia 17.49 9.71 6 205592 11679 70711167
Pneumothorax 17.47 9.71 30 205568 25816 70697030
Compulsive shopping 17.43 9.71 16 205582 772 70722074
Haemorrhage 17.42 9.71 157 205441 83658 70639188
Therapeutic product effect incomplete 17.40 9.71 463 205135 119419 70603427
Hyponatraemic encephalopathy 17.39 9.71 11 205587 301 70722545
Exposure via breast milk 17.36 9.71 17 205581 890 70721956
CYP3A4 polymorphism 17.34 9.71 7 205591 70 70722776
Haemolytic anaemia 17.24 9.71 14 205584 16780 70706066
Haemodialysis 17.18 9.71 15 205583 17351 70705495
Sleep talking 17.17 9.71 18 205580 1023 70721823
Dyspnoea exertional 17.15 9.71 145 205453 78285 70644561
Soft tissue injury 17.13 9.71 23 205575 1699 70721147
Intentional product use issue 17.12 9.71 245 205353 119897 70602949
Neck pain 17.11 9.71 280 205318 66377 70656469
Mydriasis 16.97 9.71 92 205506 16061 70706785
Feelings of worthlessness 16.95 9.71 13 205585 488 70722358
Therapeutic response changed 16.77 9.71 18 205580 1051 70721795
Colitis ulcerative 16.64 9.71 47 205551 33876 70688970
Acute stress disorder 16.52 9.71 12 205586 414 70722432
Diffuse large B-cell lymphoma 16.47 9.71 9 205589 13293 70709553
Decreased interest 16.46 9.71 33 205565 3408 70719438
Shoulder operation 16.41 9.71 27 205571 2393 70720453
Hyperbilirubinaemia 16.37 9.71 25 205573 22543 70700303
Granulomatous liver disease 16.33 9.71 19 205579 1213 70721633
Basal cell carcinoma 16.30 9.71 47 205551 33651 70689195
Rhonchi 16.24 9.71 34 205564 3621 70719225
Carcinoid tumour pulmonary 16.20 9.71 11 205587 340 70722506
Status epilepticus 16.09 9.71 29 205569 24497 70698349
Homicidal ideation 16.05 9.71 32 205566 3291 70719555
Visual impairment 15.99 9.71 324 205274 79926 70642920
Urinary hesitation 15.96 9.71 34 205564 3665 70719181
Haemophagocytic lymphohistiocytosis 15.96 9.71 20 205578 19592 70703254
Pulmonary haemorrhage 15.87 9.71 10 205588 13663 70709183
Feeling hot 15.84 9.71 213 205385 48457 70674389
Rapid eye movement sleep behaviour disorder 15.82 9.71 11 205587 354 70722492
Hyponatraemia 15.77 9.71 590 205008 159497 70563349
Sinus tachycardia 15.77 9.71 159 205439 33754 70689092
Tuberculosis 15.72 9.71 12 205586 14836 70708010
Intestinal perforation 15.70 9.71 14 205584 16030 70706816
Scoliosis 15.68 9.71 48 205550 6463 70716383
Ischaemic stroke 15.64 9.71 42 205556 30778 70692068
Urinary tract infection 15.62 9.71 876 204722 247893 70474953
Renal tubular necrosis 15.56 9.71 27 205571 23144 70699702
Drug screen false positive 15.52 9.71 17 205581 1016 70721830
Diarrhoea 15.49 9.71 2012 203586 781329 69941517
Eye pain 15.43 9.71 159 205439 33943 70688903
Metastases to lung 15.41 9.71 15 205583 16469 70706377
Angina unstable 15.40 9.71 14 205584 15879 70706967
Circulatory collapse 15.38 9.71 52 205546 35422 70687424
Poverty of speech 15.29 9.71 13 205585 566 70722280
Convulsive threshold lowered 15.28 9.71 16 205582 908 70721938
Bone erosion 15.14 9.71 13 205585 15160 70707686
Spondyloarthropathy 15.12 9.71 16 205582 919 70721927
Clostridium difficile colitis 15.11 9.71 39 205559 28957 70693889
Hysterectomy 15.07 9.71 43 205555 5569 70717277
Immobilisation prolonged 14.94 9.71 7 205591 103 70722743
Dissociative disorder 14.86 9.71 12 205586 486 70722360
Intervertebral disc protrusion 14.82 9.71 110 205488 21393 70701453
Inflammation 14.80 9.71 151 205447 78514 70644332
Dysphagia 14.75 9.71 430 205168 112404 70610442
Ophthalmic vein thrombosis 14.74 9.71 9 205589 231 70722615
Myocardial ischaemia 14.67 9.71 30 205568 24170 70698676
Open reduction of fracture 14.67 9.71 9 205589 233 70722613
Burning sensation 14.67 9.71 225 205373 52645 70670201
Renal injury 14.63 9.71 15 205583 16079 70706767
Hyperventilation 14.61 9.71 50 205548 7136 70715710
Acute hepatic failure 14.59 9.71 37 205561 27635 70695211
Drug abuse 14.57 9.71 543 205055 146713 70576133
Red blood cell sedimentation rate increased 14.56 9.71 60 205538 38582 70684264
Klebsiella infection 14.56 9.71 12 205586 14280 70708566
Rectocele repair 14.54 9.71 3 205595 0 70722846
Clitoral engorgement 14.54 9.71 3 205595 0 70722846
Lymphoma 14.53 9.71 14 205584 15448 70707398
Anaphylactic shock 14.52 9.71 47 205551 32443 70690403
Shock 14.48 9.71 64 205534 40361 70682485
Illness anxiety disorder 14.47 9.71 9 205589 239 70722607
Lacunar stroke 14.45 9.71 10 205588 319 70722527
Pericardial effusion 14.45 9.71 67 205531 41709 70681137
Hypoglycaemia 14.31 9.71 190 205408 94174 70628672
Atelectasis 14.30 9.71 40 205558 28922 70693924
Suspected suicide 14.22 9.71 57 205541 8777 70714069
Joint noise 14.19 9.71 31 205567 3400 70719446
Oedema 14.14 9.71 213 205385 103368 70619478
Haemolysis 14.03 9.71 8 205590 11543 70711303
Respiratory arrest 14.01 9.71 227 205371 53706 70669140
Blood urea increased 13.96 9.71 77 205521 45832 70677014
Atrioventricular block complete 13.94 9.71 14 205584 15149 70707697
Nephropathy toxic 13.93 9.71 20 205578 18494 70704352
Drug metabolising enzyme decreased 13.88 9.71 4 205594 12 70722834
Hypercalcaemia 13.84 9.71 52 205546 34333 70688513
Obsessive-compulsive personality disorder 13.83 9.71 7 205591 123 70722723
Oesophagitis 13.80 9.71 28 205570 22624 70700222
Hospitalisation 13.79 9.71 325 205273 82243 70640603
Polyarthritis 13.72 9.71 7 205591 10749 70712097
Oliguria 13.72 9.71 14 205584 15037 70707809
Radiation fibrosis 13.70 9.71 5 205593 37 70722809
Aphasia 13.56 9.71 188 205410 43061 70679785
Hypervolaemia 13.54 9.71 64 205534 39642 70683204
Anal incontinence 13.51 9.71 88 205510 16402 70706444
Undifferentiated connective tissue disease 13.47 9.71 5 205593 39 70722807
Nephrotic syndrome 13.46 9.71 7 205591 10633 70712213
Parosmia 13.45 9.71 38 205560 4893 70717953
Pneumonia fungal 13.43 9.71 6 205592 9947 70712899
Rib fracture 13.33 9.71 122 205476 25234 70697612
Illusion 13.32 9.71 20 205578 1639 70721207
Mean cell haemoglobin concentration increased 13.23 9.71 14 205584 804 70722042
Pyometra 13.20 9.71 6 205592 82 70722764
Gastric haemorrhage 13.15 9.71 13 205585 14172 70708674
Panic disorder 13.15 9.71 27 205571 2837 70720009
Movement disorder 13.15 9.71 117 205481 24012 70698834
Impulse-control disorder 13.13 9.71 20 205578 1659 70721187
Skin lesion 13.11 9.71 62 205536 38398 70684448
Sternal fracture 13.03 9.71 24 205574 2327 70720519
Tongue movement disturbance 13.00 9.71 10 205588 377 70722469
Heart rate decreased 12.96 9.71 116 205482 61899 70660947
Gambling 12.96 9.71 9 205589 289 70722557
Coagulopathy 12.92 9.71 51 205547 33198 70689648
Economic problem 12.85 9.71 23 205575 2181 70720665
Chronic kidney disease 12.85 9.71 114 205484 60943 70661903
Social avoidant behaviour 12.82 9.71 36 205562 4620 70718226
Musculoskeletal discomfort 12.74 9.71 92 205506 17740 70705106
Panic reaction 12.73 9.71 34 205564 4237 70718609
Trismus 12.70 9.71 38 205560 5053 70717793
Sciatic nerve injury 12.67 9.71 11 205587 493 70722353
Dysstasia 12.66 9.71 120 205478 25059 70697787
Sensory loss 12.65 9.71 66 205532 11353 70711493
Metastases to central nervous system 12.58 9.71 15 205583 15019 70707827
Posterior reversible encephalopathy syndrome 12.58 9.71 33 205565 24369 70698477
Accidental death 12.56 9.71 32 205566 3876 70718970
Haemoglobin urine present 12.56 9.71 14 205584 853 70721993
Adiposis dolorosa 12.56 9.71 9 205589 304 70722542
Red blood cell count decreased 12.53 9.71 94 205504 52067 70670779
Liver disorder 12.50 9.71 116 205482 61452 70661394
Bone density decreased 12.50 9.71 9 205589 11465 70711381
Bipolar I disorder 12.48 9.71 21 205577 1896 70720950
Floating patella 12.47 9.71 3 205595 3 70722843
Psychopathic personality 12.47 9.71 3 205595 3 70722843
Loose tooth 12.45 9.71 27 205571 2947 70719899
Multiple-drug resistance 12.44 9.71 3 205595 7352 70715494
Rales 12.41 9.71 19 205579 17116 70705730
Pulmonary toxicity 12.39 9.71 8 205590 10790 70712056
Right ventricular failure 12.36 9.71 29 205569 22245 70700601
Asphyxia 12.32 9.71 61 205537 10281 70712565
Respiratory depression 12.31 9.71 118 205480 24713 70698133
Febrile bone marrow aplasia 12.30 9.71 10 205588 11981 70710865
Application site perspiration 12.28 9.71 4 205594 20 70722826
Intervertebral disc operation 12.27 9.71 14 205584 875 70721971
Hip arthroplasty 12.23 9.71 41 205557 27999 70694847
Gastric ulcer 12.21 9.71 49 205549 31741 70691105
Tachyphrenia 12.21 9.71 21 205577 1930 70720916
Complex regional pain syndrome 12.09 9.71 20 205578 1780 70721066
Retrograde ejaculation 12.08 9.71 8 205590 237 70722609
Lymphoedema 11.99 9.71 64 205534 11105 70711741
Escherichia infection 11.94 9.71 18 205580 16313 70706533
Embolism 11.93 9.71 12 205586 12976 70709870
Supraventricular tachyarrhythmia 11.93 9.71 6 205592 104 70722742
Acute graft versus host disease in skin 11.90 9.71 3 205595 7134 70715712
Dysphemia 11.85 9.71 28 205570 3235 70719611
Metastases to lymph nodes 11.80 9.71 6 205592 9232 70713614
Post concussion syndrome 11.74 9.71 11 205587 545 70722301
Transfusion 11.72 9.71 23 205575 18813 70704033
Ocular vascular disorder 11.71 9.71 10 205588 438 70722408
Abulia 11.70 9.71 14 205584 921 70721925
Exposure via ingestion 11.62 9.71 36 205562 4879 70717967
Forced expiratory volume decreased 11.62 9.71 47 205551 7267 70715579
Ligament injury 11.60 9.71 15 205583 1068 70721778
Pulmonary hypertension 11.59 9.71 83 205515 46453 70676393
Dysarthria 11.57 9.71 249 205349 62064 70660782
Lip dry 11.57 9.71 7 205591 9778 70713068
Skin plaque 11.57 9.71 7 205591 9776 70713070
Impulsive behaviour 11.52 9.71 25 205573 2729 70720117
Trigger finger 11.45 9.71 30 205568 3697 70719149
Infective pulmonary exacerbation of cystic fibrosis 11.44 9.71 11 205587 12147 70710699
Progressive multifocal leukoencephalopathy 11.43 9.71 95 205503 19119 70703727
Cushingoid 11.41 9.71 5 205593 8383 70714463
Colitis 11.39 9.71 124 205474 63690 70659156
Purple glove syndrome 11.38 9.71 8 205590 262 70722584
Facial spasm 11.37 9.71 12 205586 687 70722159
Somatic delusion 11.36 9.71 12 205586 688 70722158
Intentional dose omission 11.35 9.71 45 205553 6896 70715950
Lung infiltration 11.33 9.71 29 205569 21595 70701251
Rectal haemorrhage 11.32 9.71 129 205469 65702 70657144
Forced expiratory flow decreased 11.30 9.71 8 205590 265 70722581
Holmes-Adie pupil 11.27 9.71 4 205594 27 70722819
Blood bilirubin increased 11.26 9.71 115 205483 59786 70663060
Regurgitation 11.23 9.71 22 205576 2234 70720612
Vasculitis 11.23 9.71 25 205573 19533 70703313
Large intestine perforation 11.22 9.71 13 205585 13182 70709664
Drug level decreased 11.22 9.71 12 205586 12612 70710234
Axillary pain 11.19 9.71 20 205578 1895 70720951
Cardiac failure acute 11.19 9.71 21 205577 17466 70705380
Withdrawal hypertension 11.15 9.71 9 205589 364 70722482
Serum serotonin increased 11.12 9.71 8 205590 272 70722574
Rhabdomyolysis 11.07 9.71 203 205395 95557 70627289
Blood pressure diastolic decreased 11.03 9.71 38 205560 25742 70697104
Blood bilirubin 11.03 9.71 4 205594 29 70722817
Ventricular hypokinesia 11.00 9.71 5 205593 8207 70714639
Tethered cord syndrome 10.95 9.71 3 205595 7 70722839
Acute respiratory failure 10.94 9.71 101 205497 53564 70669282
Pregnancy 10.91 9.71 34 205564 23747 70699099
Eye allergy 10.89 9.71 11 205587 598 70722248
Genital pain 10.87 9.71 10 205588 484 70722362
Poor sucking reflex 10.83 9.71 5 205593 71 70722775
Device expulsion 10.78 9.71 31 205567 22215 70700631
Alveolar bone resorption 10.77 9.71 5 205593 72 70722774
Cholecystectomy 10.75 9.71 51 205547 8446 70714400
Cerebral haemorrhage 10.72 9.71 102 205496 53762 70669084
Paralogism 10.69 9.71 4 205594 32 70722814
Loss of control of legs 10.67 9.71 19 205579 1795 70721051
Joint stiffness 10.66 9.71 152 205446 35024 70687822
Arthroscopy 10.58 9.71 10 205588 501 70722345
Torsade de pointes 10.53 9.71 23 205575 18093 70704753
Hyperthyroidism 10.49 9.71 27 205571 20064 70702782
Leukoencephalopathy 10.48 9.71 4 205594 7290 70715556
Cachexia 10.48 9.71 8 205590 9892 70712954
Throat irritation 10.48 9.71 152 205446 35152 70687694
Delusion of grandeur 10.41 9.71 13 205585 894 70721952
Cycloplegia 10.41 9.71 3 205595 9 70722837
Blood prolactin increased 10.31 9.71 29 205569 3725 70719121
Atrioventricular block 10.26 9.71 13 205585 12675 70710171
Therapeutic response unexpected 10.24 9.71 89 205509 18142 70704704
Cholangitis 10.24 9.71 11 205587 11538 70711308
Hypogammaglobulinaemia 10.21 9.71 11 205587 11527 70711319
Lupus-like syndrome 10.17 9.71 11 205587 11504 70711342
Knee operation 10.16 9.71 35 205563 5012 70717834
Liver function test increased 10.16 9.71 57 205541 33790 70689056
Persistent genital arousal disorder 10.14 9.71 8 205590 313 70722533
Communication disorder 10.12 9.71 29 205569 3765 70719081
Nephrolithiasis 10.08 9.71 193 205405 47130 70675716
Cephalo-pelvic disproportion 10.07 9.71 6 205592 147 70722699
Haematochezia 10.07 9.71 150 205448 72931 70649915
Allodynia 10.07 9.71 16 205582 1377 70721469
Bacterial infection 10.07 9.71 41 205557 26451 70696395
Hepatic cancer 10.03 9.71 8 205590 9675 70713171
Physical assault 10.00 9.71 17 205581 1547 70721299
Blood pressure systolic decreased 10.00 9.71 8 205590 9663 70713183
Muscle rigidity 9.94 9.71 90 205508 18560 70704286
Tachyphylaxis 9.93 9.71 8 205590 323 70722523
Hepatic encephalopathy 9.88 9.71 32 205566 22086 70700760
Tachypnoea 9.86 9.71 46 205552 28592 70694254
Hepatic cytolysis 9.86 9.71 26 205572 19166 70703680
Labelled drug-food interaction issue 9.82 9.71 4 205594 41 70722805
Dermatitis acneiform 9.76 9.71 7 205591 8938 70713908
Activated partial thromboplastin time prolonged 9.76 9.71 15 205583 13490 70709356
Ceruloplasmin increased 9.75 9.71 3 205595 12 70722834
Thyroid adenoma 9.72 9.71 6 205592 157 70722689
Deformity 9.72 9.71 6 205592 8291 70714555
Shock haemorrhagic 9.71 9.71 24 205574 18082 70704764

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
Telangiectasia congenital 30.47 28.20 9 373 18 89392
Liver disorder 29.80 28.20 8 374 9 89401

Pharmacologic Action:

SourceCodeDescription
ATC N06AX21 NERVOUS SYSTEM
PSYCHOANALEPTICS
ANTIDEPRESSANTS
Other antidepressants
FDA MoA N0000000102 Norepinephrine Uptake Inhibitors
FDA MoA N0000000109 Serotonin Uptake Inhibitors
MeSH PA D000700 Analgesics
MeSH PA D000928 Antidepressive Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D015259 Dopamine Agents
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D014179 Neurotransmitter Uptake Inhibitors
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D011619 Psychotropic Drugs
MeSH PA D018689 Sensory System Agents
MeSH PA D000068760 Serotonin and Noradrenaline Reuptake Inhibitors
FDA EPC N0000175749 Serotonin and Norepinephrine Reuptake Inhibitor
CHEBI has role CHEBI:35469 antidepressants

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

DiseaseRelationSNOMED_IDDOID
Generalized anxiety disorder indication 21897009 DOID:14320
Female stress incontinence indication 60241006 DOID:724
Fibromyalgia indication 203082005 DOID:631
Major depressive disorder indication 370143000
Diabetic peripheral neuropathy indication 424736006
Chronic Musculoskeletal Pain indication
Osteoarthritis off-label use 396275006
Suicidal thoughts contraindication 6471006
Alcoholism contraindication 7200002
Bipolar disorder contraindication 13746004 DOID:3312
Neuroleptic malignant syndrome contraindication 15244003 DOID:14464
Jaundice contraindication 18165001
Cirrhosis of liver contraindication 19943007 DOID:5082
Orthostatic hypotension contraindication 28651003
Hypertensive disorder contraindication 38341003 DOID:10763
Alcoholic liver damage contraindication 41309000
Syndrome of inappropriate vasopressin secretion contraindication 55004003 DOID:3401
Acute nephropathy contraindication 58574008
Blood coagulation disorder contraindication 64779008 DOID:1247
Chronic hepatitis contraindication 76783007 DOID:2237
Hyperglycemia contraindication 80394007 DOID:4195
Epilepsy contraindication 84757009 DOID:1826
Hyponatremia contraindication 89627008
Inflammatory disease of liver contraindication 128241005
Liver function tests abnormal contraindication 166603001
Mania contraindication 231494001
Hypomania contraindication 231496004
Disease of liver contraindication 235856003 DOID:409
Retention of urine contraindication 267064002
Serotonin syndrome contraindication 371089000
Angle-closure glaucoma contraindication 392291006 DOID:13550
Gastrointestinal hypomotility contraindication 421807004




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.7 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 20MG BASE CYMBALTA LILLY N021427 Aug. 3, 2004 RX CAPSULE, DELAYED REL PELLETS ORAL April 20, 2023 NEW PATIENT POPULATION
EQ 30MG BASE CYMBALTA LILLY N021427 Aug. 3, 2004 RX CAPSULE, DELAYED REL PELLETS ORAL April 20, 2023 NEW PATIENT POPULATION
EQ 60MG BASE CYMBALTA LILLY N021427 Aug. 3, 2004 RX CAPSULE, DELAYED REL PELLETS ORAL April 20, 2023 NEW PATIENT POPULATION

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Sodium-dependent serotonin transporter Transporter INHIBITOR Ki 9.62 CHEMBL CHEMBL
Sodium-dependent noradrenaline transporter Transporter INHIBITOR Ki 8.22 CHEMBL CHEMBL
5-hydroxytryptamine receptor 1A GPCR Ki 5.30 PDSP
5-hydroxytryptamine receptor 2A GPCR ANTAGONIST Ki 6.30 IUPHAR
5-hydroxytryptamine receptor 2B GPCR Ki 5.68 PDSP
5-hydroxytryptamine receptor 2C GPCR ANTAGONIST Ki 6 IUPHAR
5-hydroxytryptamine receptor 6 GPCR ANTAGONIST Ki 6.40 IUPHAR
5-hydroxytryptamine receptor 7 GPCR Ki 5.65 PDSP
Histamine H1 receptor GPCR Ki 5.64 PDSP
5-hydroxytryptamine receptor 1B GPCR Ki 5.40 PDSP
5-hydroxytryptamine receptor 1D GPCR Ki 5.52 PDSP
Sodium-dependent dopamine transporter Transporter Ki 6.62 CHEMBL
5-hydroxytryptamine receptor 1F GPCR Ki 5.35 PDSP
5-hydroxytryptamine receptor 1E GPCR Ki 5.43 PDSP
Serine hydroxymethyltransferase, mitochondrial Enzyme IC50 5.16 CHEMBL
Sodium-dependent serotonin transporter Transporter Ki 10.09 CHEMBL
Sodium-dependent dopamine transporter Transporter IC50 6.43 CHEMBL
Transporter Transporter Ki 8.52 CHEMBL

External reference:

IDSource
D01179 KEGG_DRUG
136434-34-9 SECONDARY_CAS_RN
4021477 VANDF
C0245561 UMLSCUI
CHEBI:31526 CHEBI
29E PDB_CHEM_ID
CHEMBL1175 ChEMBL_ID
CHEMBL1200328 ChEMBL_ID
DB00476 DRUGBANK_ID
D000068736 MESH_DESCRIPTOR_UI
60835 PUBCHEM_CID
202 IUPHAR_LIGAND_ID
7012 INN_ID
O5TNM5N07U UNII
476250 RXNORM
18760 MMSL
208014 MMSL
33554 MMSL
59319 MMSL
d05355 MMSL
008705 NDDF
008707 NDDF
407032004 SNOMEDCT_US
407033009 SNOMEDCT_US
426892003 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Cymbalta HUMAN PRESCRIPTION DRUG LABEL 1 0002-3235 CAPSULE, DELAYED RELEASE 20 mg ORAL NDA 36 sections
Cymbalta HUMAN PRESCRIPTION DRUG LABEL 1 0002-3240 CAPSULE, DELAYED RELEASE 30 mg ORAL NDA 36 sections
Cymbalta HUMAN PRESCRIPTION DRUG LABEL 1 0002-3270 CAPSULE, DELAYED RELEASE 60 mg ORAL NDA 36 sections
Duloxetine HUMAN PRESCRIPTION DRUG LABEL 1 0228-2890 CAPSULE, DELAYED RELEASE PELLETS 20 mg ORAL ANDA 29 sections
Duloxetine HUMAN PRESCRIPTION DRUG LABEL 1 0228-2891 CAPSULE, DELAYED RELEASE PELLETS 30 mg ORAL ANDA 29 sections
Duloxetine HUMAN PRESCRIPTION DRUG LABEL 1 0228-2892 CAPSULE, DELAYED RELEASE PELLETS 60 mg ORAL ANDA 29 sections
Duloxetine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8203 CAPSULE, DELAYED RELEASE 30 mg ORAL ANDA 31 sections
Duloxetine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8203 CAPSULE, DELAYED RELEASE 30 mg ORAL ANDA 31 sections
Duloxetine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8204 CAPSULE, DELAYED RELEASE 60 mg ORAL ANDA 31 sections
Duloxetine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8204 CAPSULE, DELAYED RELEASE 60 mg ORAL ANDA 31 sections
Duloxetine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8290 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 30 sections
Duloxetine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8290 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 30 sections
Duloxetine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6452 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 30 sections
Duloxetine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6453 CAPSULE, DELAYED RELEASE 30 mg ORAL ANDA 30 sections
Duloxetine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6454 CAPSULE, DELAYED RELEASE 60 mg ORAL ANDA 30 sections
Duloxetine HUMAN PRESCRIPTION DRUG LABEL 1 0904-7043 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 31 sections
Duloxetine HUMAN PRESCRIPTION DRUG LABEL 1 0904-7043 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 31 sections
Duloxetine HUMAN PRESCRIPTION DRUG LABEL 1 0904-7044 CAPSULE, DELAYED RELEASE 30 mg ORAL ANDA 31 sections
Duloxetine HUMAN PRESCRIPTION DRUG LABEL 1 0904-7044 CAPSULE, DELAYED RELEASE 30 mg ORAL ANDA 31 sections
Duloxetine HUMAN PRESCRIPTION DRUG LABEL 1 0904-7045 CAPSULE, DELAYED RELEASE 60 mg ORAL ANDA 31 sections
Duloxetine HUMAN PRESCRIPTION DRUG LABEL 1 0904-7045 CAPSULE, DELAYED RELEASE 60 mg ORAL ANDA 31 sections
Duloxetine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-109 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 30 sections
Duloxetine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-109 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 30 sections
Duloxetine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-109 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 30 sections
Duloxetine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-110 CAPSULE, DELAYED RELEASE 30 mg ORAL ANDA 30 sections
Duloxetine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-110 CAPSULE, DELAYED RELEASE 30 mg ORAL ANDA 30 sections
Duloxetine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-110 CAPSULE, DELAYED RELEASE 30 mg ORAL ANDA 30 sections
Duloxetine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-111 CAPSULE, DELAYED RELEASE 60 mg ORAL ANDA 30 sections
Duloxetine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-111 CAPSULE, DELAYED RELEASE 60 mg ORAL ANDA 30 sections
Duloxetine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-111 CAPSULE, DELAYED RELEASE 60 mg ORAL ANDA 30 sections