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

Stem definitionDrug idCAS RN
serotonin and/or norepinephrine reuptake inhibitors, fluoxetine derivatives 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 ยตM/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 4011.27 9.73 1997 208443 23084 50371600
Dysphoria 3455.79 9.73 1129 209311 3645 50391039
Affect lability 2815.82 9.73 1146 209294 7852 50386832
Irritability 2227.33 9.73 1418 209022 27008 50367676
Suicidal ideation 1887.66 9.73 1677 208763 53708 50340976
Agitation 1692.30 9.73 1552 208888 51832 50342852
Paraesthesia 1342.51 9.73 2046 208394 118197 50276487
Sensory disturbance 1308.29 9.73 737 209703 11092 50383592
Hyperhidrosis 1246.07 9.73 1691 208749 87735 50306949
Vertigo 1204.24 9.73 1272 209168 50560 50344124
Insomnia 1135.32 9.73 2346 208094 172519 50222165
Anxiety 1024.11 9.73 2271 208169 175335 50219349
Nightmare 808.13 9.73 611 209829 15475 50379209
Dizziness 743.39 9.73 3126 207314 343243 50051441
Mood swings 729.36 9.73 573 209867 15381 50379303
Tinnitus 615.27 9.73 669 209771 27463 50367221
Hypomania 548.18 9.73 299 210141 4206 50390478
Tremor 528.65 9.73 1347 209093 113556 50281128
Lethargy 526.53 9.73 824 209616 48608 50346076
Serotonin syndrome 502.94 9.73 566 209874 24147 50370537
Pemphigus 481.95 9.73 3 210437 120163 50274521
Confusional state 461.56 9.73 1758 208682 184170 50210514
Glossodynia 331.85 9.73 44 210396 115525 50279159
Headache 321.53 9.73 3365 207075 503170 49891514
Withdrawal syndrome 308.02 9.73 373 210067 17217 50377467
Hand deformity 292.86 9.73 36 210404 100163 50294521
Alopecia 286.52 9.73 359 210081 244688 50149996
Systemic lupus erythematosus 284.91 9.73 114 210326 140508 50254176
Suicide attempt 275.50 9.73 642 209798 51090 50343594
Maternal exposure during pregnancy 270.18 9.73 165 210275 159613 50235071
Nausea 262.18 9.73 4247 206193 701151 49693533
Contraindicated product administered 255.82 9.73 151 210289 148807 50245877
Synovitis 237.21 9.73 109 210331 123756 50270928
Pericarditis 230.60 9.73 28 210412 78661 50316023
Neutropenia 229.69 9.73 168 210272 147797 50246887
Febrile neutropenia 216.89 9.73 68 210372 97599 50297085
Wound 212.23 9.73 87 210353 105707 50288977
Drug intolerance 210.21 9.73 368 210072 218736 50175948
Depression 209.85 9.73 1290 209150 164133 50230551
Crying 205.78 9.73 332 210108 20084 50374600
Sleep disorder 204.96 9.73 613 209827 56670 50338014
Pyrexia 203.57 9.73 852 209588 379351 50015333
Disturbance in attention 199.93 9.73 417 210023 30769 50363915
Anaemia 194.96 9.73 480 209960 251976 50142708
Completed suicide 189.52 9.73 1063 209377 130826 50263858
Treatment failure 186.83 9.73 178 210262 137459 50257225
Abdominal discomfort 184.72 9.73 433 210007 231208 50163476
Infusion related reaction 184.19 9.73 262 210178 169295 50225389
Feeling abnormal 181.33 9.73 1013 209427 124479 50270205
Arthropathy 180.59 9.73 235 210205 157671 50237013
Stubbornness 176.66 9.73 60 210380 225 50394459
Rash 171.64 9.73 1091 209349 436380 49958304
Duodenal ulcer perforation 170.32 9.73 4 210436 45607 50349077
Discomfort 163.09 9.73 127 210313 108253 50286431
Thrombocytopenia 162.01 9.73 175 210265 127498 50267186
Joint swelling 159.22 9.73 507 209933 244779 50149905
Hypersensitivity 155.38 9.73 423 210017 214738 50179946
Anti-cyclic citrullinated peptide antibody positive 151.67 9.73 52 210388 70535 50324149
Mood altered 151.56 9.73 224 210216 12549 50382135
Swelling 143.46 9.73 397 210043 200475 50194209
Pancytopenia 143.03 9.73 86 210354 83944 50310740
Memory impairment 136.17 9.73 672 209768 78688 50315996
Somnolence 133.58 9.73 1101 209339 153884 50240800
Acute kidney injury 132.02 9.73 495 209945 227563 50167121
Thinking abnormal 127.03 9.73 177 210263 9390 50385294
Fibromyalgia 126.17 9.73 443 209997 44535 50350149
Anger 123.46 9.73 191 210249 11142 50383542
Electric shock 121.66 9.73 67 210373 961 50393723
Lower respiratory tract infection 120.18 9.73 131 210309 95070 50299614
Migraine 119.71 9.73 624 209816 74656 50320028
Panic attack 117.43 9.73 253 210187 19089 50375595
Folliculitis 117.29 9.73 13 210427 39212 50355472
Fatigue 113.24 9.73 3789 206651 703812 49690872
Sleep disorder due to general medical condition, insomnia type 112.86 9.73 4 210436 31443 50363241
Off label use 111.25 9.73 1351 209089 473075 49921609
General physical health deterioration 111.23 9.73 269 210171 142165 50252519
Dyspnoea 109.37 9.73 1612 208828 545996 49848688
Malignant neoplasm progression 108.72 9.73 75 210365 68049 50326635
Depressed mood 105.89 9.73 347 210093 33676 50361008
Therapeutic product effect decreased 103.06 9.73 261 210179 135789 50258895
Drug ineffective 100.64 9.73 2619 207821 816714 49577970
Platelet count decreased 100.31 9.73 165 210275 100561 50294123
Disease progression 98.32 9.73 154 210286 95712 50298972
Muscle injury 97.69 9.73 18 210422 37093 50357591
C-reactive protein abnormal 94.97 9.73 5 210435 27804 50366880
Infection 94.52 9.73 384 210056 172570 50222114
Blister 90.69 9.73 134 210306 85284 50309400
Septic shock 89.84 9.73 64 210376 57111 50337573
Rheumatoid factor positive 89.17 9.73 48 210392 49811 50344873
Gastrointestinal tube insertion 88.17 9.73 54 210386 955 50393729
Pneumonia 86.90 9.73 1082 209358 377319 50017365
Product use issue 86.05 9.73 325 210115 149150 50245534
Affective disorder 86.05 9.73 107 210333 5074 50389610
Cardiac failure 84.99 9.73 115 210325 75925 50318759
Coordination abnormal 84.39 9.73 163 210277 11371 50383313
Gastric bypass 83.97 9.73 60 210380 1388 50393296
Intentional product misuse 83.18 9.73 400 210040 46334 50348350
Stomatitis 82.62 9.73 187 210253 101157 50293527
Helicobacter infection 81.61 9.73 53 210387 49649 50345035
Inappropriate antidiuretic hormone secretion 77.60 9.73 170 210270 12973 50381711
Restless legs syndrome 76.74 9.73 190 210250 15707 50378977
Drug reaction with eosinophilia and systemic symptoms 76.53 9.73 13 210427 28411 50366273
Abnormal behaviour 75.67 9.73 216 210224 19442 50375242
Impaired healing 75.53 9.73 108 210332 69678 50325006
Sepsis 75.22 9.73 291 210149 132634 50262050
Peripheral swelling 74.75 9.73 525 209915 205411 50189273
Fall 72.81 9.73 1865 208575 333067 50061617
Aggression 72.69 9.73 223 210217 20893 50373791
Pneumonia aspiration 72.45 9.73 288 210152 30716 50363968
Tardive dyskinesia 71.48 9.73 117 210323 7162 50387522
Erythema 70.93 9.73 340 210100 146074 50248610
Neutrophil count decreased 70.39 9.73 53 210387 45973 50348711
Post-traumatic stress disorder 70.08 9.73 88 210352 4215 50390469
Mucosal inflammation 69.82 9.73 40 210400 40102 50354582
Hallucination 68.87 9.73 379 210061 46278 50348406
Blood creatinine increased 68.39 9.73 133 210307 76027 50318657
White blood cell count abnormal 68.31 9.73 98 210342 5342 50389342
Product substitution issue 67.84 9.73 168 210272 13889 50380795
Renal impairment 67.19 9.73 133 210307 75528 50319156
Abnormal dreams 66.76 9.73 131 210309 9246 50385438
Haemoglobin decreased 66.04 9.73 288 210152 126928 50267756
Somatic symptom disorder 64.38 9.73 58 210382 1886 50392798
Coma 64.23 9.73 431 210009 56448 50338236
Amnesia 64.20 9.73 346 210094 41914 50352770
Multiple sclerosis 63.75 9.73 209 210231 20284 50374400
Ascites 63.43 9.73 35 210405 35826 50358858
Leukopenia 63.21 9.73 115 210325 67413 50327271
Multiple sclerosis relapse 62.74 9.73 348 210092 42616 50352068
Pleural effusion 62.63 9.73 155 210285 81299 50313385
Premature delivery 61.17 9.73 12 210428 23651 50371033
Loss of consciousness 60.88 9.73 683 209757 103670 50291014
Drug interaction 59.87 9.73 1164 209276 198457 50196227
Mania 59.75 9.73 137 210303 10779 50383905
Nasal turbinate hypertrophy 58.91 9.73 36 210404 634 50394050
Interstitial lung disease 58.83 9.73 81 210359 53095 50341589
Bone marrow failure 58.21 9.73 21 210419 27603 50367081
Alanine aminotransferase increased 56.96 9.73 590 209850 87769 50306915
Ill-defined disorder 55.83 9.73 88 210352 54566 50340118
Gastrointestinal disorder 55.22 9.73 204 210236 94252 50300432
Sopor 54.19 9.73 194 210246 19685 50374999
White blood cell count decreased 53.68 9.73 276 210164 116446 50278238
Intentional self-injury 53.45 9.73 214 210226 22898 50371786
Hallucination, visual 53.28 9.73 171 210269 16411 50378273
Renal failure 53.17 9.73 245 210195 106388 50288296
Therapy interrupted 52.68 9.73 194 210246 19958 50374726
Dry mouth 51.52 9.73 405 210035 55773 50338911
Atrial fibrillation 51.19 9.73 233 210207 101512 50293172
Sleep apnoea syndrome 50.47 9.73 215 210225 23653 50371031
Prescribed overdose 50.08 9.73 154 210286 14446 50380238
Red blood cell sedimentation rate abnormal 49.92 9.73 5 210435 16338 50378346
Cytomegalovirus infection 48.83 9.73 8 210432 17954 50376730
Multiple organ dysfunction syndrome 47.76 9.73 85 210355 50252 50344432
Hyperkalaemia 47.64 9.73 79 210361 48010 50346674
Intervertebral discitis 47.59 9.73 57 210383 2599 50392085
Seizure 46.36 9.73 718 209722 117156 50277528
Coma blister 45.93 9.73 19 210421 136 50394548
Device expulsion 45.62 9.73 32 210408 28790 50365894
Neck deformity 44.90 9.73 48 210392 1930 50392754
Extremity contracture 44.85 9.73 39 210401 1209 50393475
Hypocalcaemia 44.84 9.73 28 210412 26788 50367896
Hypotension 44.76 9.73 699 209741 234770 50159914
Death 44.26 9.73 1023 209417 324356 50070328
Pulmonary malformation 43.77 9.73 20 210420 187 50394497
Gastrointestinal haemorrhage 43.75 9.73 157 210283 73164 50321520
Vision blurred 43.28 9.73 509 209931 78138 50316546
Cardiac failure congestive 43.18 9.73 192 210248 84190 50310494
Pulmonary fibrosis 43.00 9.73 24 210416 24413 50370271
Dyskinesia 42.92 9.73 229 210211 27632 50367052
Bronchial neoplasm 42.57 9.73 25 210415 408 50394276
Influenza like illness 42.55 9.73 395 210045 57064 50337620
Muscle twitching 42.41 9.73 151 210289 15280 50379404
Restlessness 42.31 9.73 212 210228 24961 50369723
Irritable bowel syndrome 41.84 9.73 95 210345 51346 50343338
Personality disorder 41.78 9.73 69 210371 4255 50390429
Colitis microscopic 41.55 9.73 87 210353 6433 50388251
Pulmonary oedema 40.93 9.73 89 210351 48849 50345835
Aspartate aminotransferase increased 40.38 9.73 499 209941 77499 50317185
Surgery 39.75 9.73 238 210202 29967 50364717
Nervousness 39.72 9.73 223 210217 27428 50367256
Opsoclonus myoclonus 38.86 9.73 16 210424 113 50394571
Lactic acidosis 38.74 9.73 49 210391 33306 50361378
Rheumatoid nodule 38.63 9.73 4 210436 12731 50381953
Neck mass 38.52 9.73 58 210382 3303 50391381
Bronchial haemorrhage 38.36 9.73 25 210415 495 50394189
Product use in unapproved indication 38.28 9.73 303 210137 115516 50279168
Urinary retention 38.14 9.73 212 210228 25978 50368706
Neoplasm progression 38.03 9.73 39 210401 29118 50365566
Weight increased 37.47 9.73 1102 209338 200789 50193895
Pruritus 37.31 9.73 896 209544 282672 50112012
Paranoia 37.23 9.73 111 210329 10237 50384447
Hyperreflexia 37.04 9.73 72 210368 5046 50389638
Hot flush 37.02 9.73 312 210128 43857 50350827
Respiratory failure 36.80 9.73 225 210215 90956 50303728
Hyperaesthesia 36.65 9.73 95 210345 8078 50386606
Oedema peripheral 36.39 9.73 451 209989 157510 50237174
Temperature intolerance 36.27 9.73 90 210350 7449 50387235
Hip arthroplasty 36.08 9.73 44 210396 30385 50364299
Rubber sensitivity 36.05 9.73 41 210399 1768 50392916
Concussion 35.58 9.73 90 210350 7538 50387146
Condition aggravated 35.49 9.73 952 209488 296106 50098578
Mental disorder 35.42 9.73 183 210257 21808 50372876
Rapid eye movements sleep abnormal 35.39 9.73 15 210425 115 50394569
Tachyphrenia 35.17 9.73 34 210406 1211 50393473
Balance disorder 35.00 9.73 448 209992 70142 50324542
Metabolic surgery 34.96 9.73 31 210409 987 50393697
Hypersomnia 34.77 9.73 141 210299 15173 50379511
Gastrooesophageal reflux disease 34.15 9.73 476 209964 75952 50318732
Live birth 33.69 9.73 13 210427 16395 50378289
Palmar-plantar erythrodysaesthesia syndrome 33.58 9.73 21 210419 20077 50374607
Pre-existing condition improved 33.38 9.73 84 210356 7013 50387671
Blood pressure increased 33.26 9.73 756 209684 132376 50262308
Hostility 33.18 9.73 39 210401 1743 50392941
C-reactive protein increased 32.96 9.73 153 210287 66321 50328363
Impaired driving ability 32.75 9.73 59 210381 3902 50390782
Morbid thoughts 32.68 9.73 23 210417 519 50394165
Product dose omission issue 32.63 9.73 998 209442 182840 50211844
Therapy cessation 32.36 9.73 202 210238 25809 50368875
Dehydration 32.27 9.73 443 209997 152006 50242678
Akathisia 32.23 9.73 91 210349 8138 50386546
Psoriasis 31.75 9.73 432 210008 68568 50326116
Libido decreased 31.60 9.73 44 210396 2332 50392352
Disorientation 31.54 9.73 254 210186 35230 50359454
Sacroiliitis 31.46 9.73 46 210394 2551 50392133
Vomiting 31.32 9.73 2271 208169 458487 49936197
Hypomagnesaemia 31.32 9.73 30 210410 23126 50371558
Epistaxis 31.24 9.73 148 210292 63806 50330878
Lung cyst 31.20 9.73 15 210425 159 50394525
Pulmonary eosinophilia 31.19 9.73 16 210424 197 50394487
Endometrial ablation 31.08 9.73 27 210413 836 50393848
Reversible cerebral vasoconstriction syndrome 30.85 9.73 41 210399 2078 50392606
Melaena 30.64 9.73 40 210400 26824 50367860
Rebound nasal congestion 30.57 9.73 9 210431 18 50394666
Drug resistance 30.16 9.73 21 210419 18968 50375716
Stiff person syndrome 29.97 9.73 16 210424 215 50394469
Anorgasmia 29.91 9.73 22 210418 533 50394151
Bradycardia 29.79 9.73 152 210288 64274 50330410
Psychotic disorder due to a general medical condition 29.77 9.73 16 210424 218 50394466
Bipolar disorder 29.74 9.73 78 210362 6679 50388005
Libido increased 29.70 9.73 31 210409 1212 50393472
Delusion 29.54 9.73 104 210336 10465 50384219
Transplant rejection 29.19 9.73 3 210437 9606 50385078
Thunderclap headache 28.99 9.73 14 210426 150 50394534
Bruxism 28.69 9.73 48 210392 2992 50391692
Formication 28.50 9.73 53 210387 3593 50391091
Dissociation 28.37 9.73 41 210399 2250 50392434
Cough 28.33 9.73 775 209665 240489 50154195
Oesophageal spasm 28.30 9.73 41 210399 2255 50392429
Cognitive disorder 28.12 9.73 294 210146 43829 50350855
Tearfulness 28.07 9.73 53 210387 3634 50391050
Speech disorder 27.65 9.73 247 210193 35301 50359383
Gastric banding 27.55 9.73 11 210429 71 50394613
Nasopharyngitis 27.48 9.73 602 209838 192325 50202359
Haemoptysis 27.24 9.73 40 210400 25533 50369151
Telangiectasia congenital 27.17 9.73 8 210432 16 50394668
Metastases to bone 27.15 9.73 21 210419 17974 50376710
Rash maculo-papular 27.10 9.73 43 210397 26598 50368086
Macular degeneration 26.99 9.73 13 210427 14375 50380309
Blood calcium decreased 26.66 9.73 28 210412 20678 50374006
Complex regional pain syndrome 26.65 9.73 37 210403 1956 50392728
Loss of libido 26.57 9.73 29 210411 1194 50393490
Gastrostomy 26.45 9.73 20 210420 506 50394178
Psychotic disorder 26.27 9.73 168 210272 21644 50373040
Acute myeloid leukaemia 26.24 9.73 15 210425 15059 50379625
Pneumonitis 26.08 9.73 52 210388 29458 50365226
Bone density abnormal 26.01 9.73 46 210394 2999 50391685
Psychomotor hyperactivity 25.54 9.73 91 210349 9210 50385474
Proteinuria 25.52 9.73 19 210421 16578 50378106
Agranulocytosis 25.37 9.73 31 210409 21390 50373294
Head injury 25.32 9.73 179 210261 23841 50370843
Metastases to liver 24.98 9.73 28 210412 20076 50374608
Anovulatory cycle 24.81 9.73 12 210428 129 50394555
Sleep terror 24.79 9.73 22 210418 701 50393983
Mobility decreased 24.66 9.73 213 210227 79735 50314949
Autonomic dysreflexia 24.63 9.73 16 210424 315 50394369
Pregnancy 24.56 9.73 54 210386 29523 50365161
Emotional disorder 24.55 9.73 106 210334 11730 50382954
Acute respiratory distress syndrome 24.50 9.73 31 210409 21068 50373616
Thrombotic microangiopathy 23.71 9.73 4 210436 8787 50385897
Deep vein thrombosis 23.65 9.73 193 210247 73111 50321573
Drug hypersensitivity 23.42 9.73 1272 209168 249738 50144946
Skin necrosis 23.34 9.73 8 210432 10859 50383825
Coronary artery disease 23.28 9.73 56 210384 29670 50365014
Torsade de pointes 23.28 9.73 10 210430 11825 50382859
Neuralgia 23.09 9.73 163 210277 21700 50372984
Major depression 23.04 9.73 72 210368 6812 50387872
Cerebral infarction 22.81 9.73 34 210406 21570 50373114
Ejection fraction decreased 22.79 9.73 26 210414 18494 50376190
Anaphylactic reaction 22.54 9.73 132 210308 53923 50340761
Respiratory tract malformation 22.51 9.73 10 210430 87 50394597
Arthralgia 22.42 9.73 1547 208893 437155 49957529
Disseminated intravascular coagulation 22.25 9.73 23 210417 17112 50377572
Depressive symptom 21.93 9.73 44 210396 3156 50391528
Hypokalaemia 21.87 9.73 247 210193 87745 50306939
Flat affect 21.75 9.73 27 210413 1278 50393406
Decreased interest 21.70 9.73 42 210398 2934 50391750
Circulatory collapse 21.58 9.73 31 210409 19969 50374715
Foetal death 21.46 9.73 4 210436 8176 50386508
Hallucination, auditory 21.43 9.73 95 210345 10633 50384051
Bronchial disorder 21.27 9.73 25 210415 1117 50393567
Hypoglycaemia 21.21 9.73 133 210307 53448 50341236
Myelodysplastic syndrome 21.18 9.73 19 210421 15113 50379571
Mydriasis 21.14 9.73 94 210346 10533 50384151
Liver function test increased 21.05 9.73 47 210393 25559 50369125
Right ventricular failure 21.02 9.73 21 210419 15872 50378812
Ankle fracture 20.76 9.73 124 210316 15598 50379086
Hypoxia 20.70 9.73 126 210314 50997 50343687
Middle insomnia 20.69 9.73 89 210351 9832 50384852
Tenosynovitis 20.67 9.73 9 210431 10556 50384128
Inflammation 20.65 9.73 145 210295 56767 50337917
Therapy non-responder 20.53 9.73 126 210314 50896 50343788
Hypoaesthesia 20.51 9.73 683 209757 126574 50268110
Respiratory distress 20.44 9.73 62 210378 30427 50364257
Granulomatous liver disease 20.44 9.73 20 210420 723 50393961
Haematotoxicity 20.41 9.73 4 210436 7891 50386793
Pulmonary congestion 20.33 9.73 20 210420 15227 50379457
Therapeutic response changed 20.31 9.73 21 210419 812 50393872
Asphyxia 20.27 9.73 59 210381 5368 50389316
Gait disturbance 20.23 9.73 789 209651 149216 50245468
Tension 20.16 9.73 39 210401 2723 50391961
Antinuclear antibody negative 20.01 9.73 12 210428 204 50394480
Basal cell carcinoma 19.92 9.73 42 210398 23314 50371370
Aplastic anaemia 19.71 9.73 4 210436 7699 50386985
Red blood cell sedimentation rate increased 19.59 9.73 60 210380 29356 50365328
Galactorrhoea 19.58 9.73 46 210394 3677 50391007
Coombs positive haemolytic anaemia 19.55 9.73 14 210426 325 50394359
Drug tolerance decreased 19.24 9.73 7 210433 9153 50385531
Premature labour 19.16 9.73 12 210428 11464 50383220
Tubulointerstitial nephritis 19.10 9.73 21 210419 15190 50379494
Hypercalcaemia 19.09 9.73 43 210397 23309 50371375
Homicidal ideation 18.98 9.73 29 210411 1673 50393011
Drug screen positive 18.95 9.73 43 210397 3359 50391325
Conversion disorder 18.95 9.73 28 210412 1568 50393116
Phagophobia 18.85 9.73 7 210433 36 50394648
Exposure via breast milk 18.79 9.73 28 210412 1580 50393104
Hypnopompic hallucination 18.69 9.73 7 210433 37 50394647
Heart rate decreased 18.69 9.73 83 210357 36414 50358270
Pneumocystis jirovecii pneumonia 18.69 9.73 20 210420 14643 50380041
Panic disorder 18.66 9.73 34 210406 2269 50392415
Alcoholism 18.63 9.73 28 210412 1592 50393092
Aspergillus infection 18.63 9.73 3 210437 6818 50387866
Dysphemia 18.63 9.73 34 210406 2272 50392412
Shock 18.58 9.73 36 210404 20614 50374070
Bipolar I disorder 18.55 9.73 27 210413 1491 50393193
Toxic epidermal necrolysis 18.54 9.73 37 210403 20955 50373729
Hyperglycaemia 18.52 9.73 83 210357 36322 50358362
Angioedema 18.51 9.73 87 210353 37589 50357095
Tic 18.42 9.73 24 210416 1193 50393491
Skin haemorrhage 18.42 9.73 67 210373 6851 50387833
Depression suicidal 18.40 9.73 27 210413 1502 50393182
Myoclonus 18.39 9.73 113 210327 14357 50380327
Impulse-control disorder 18.37 9.73 18 210422 652 50394032
Hypoalbuminaemia 18.36 9.73 9 210431 9851 50384833
Demyelination 18.33 9.73 61 210379 5965 50388719
Haemodialysis 18.23 9.73 6 210434 8356 50386328
Clonus 18.18 9.73 48 210392 4127 50390557
Eosinophilia 18.14 9.73 31 210409 18621 50376063
Knee arthroplasty 18.07 9.73 82 210358 35764 50358920
Bacteraemia 18.04 9.73 20 210420 14413 50380271
Cardiogenic shock 18.02 9.73 23 210417 15576 50379108
Intentional dose omission 18.00 9.73 54 210386 4996 50389688
Metastases to lung 17.75 9.73 12 210428 11008 50383676
Feelings of worthlessness 17.75 9.73 13 210427 313 50394371
Tuberculosis 17.60 9.73 10 210430 10073 50384611
Pustular psoriasis 17.57 9.73 46 210394 3935 50390749
Apathy 17.54 9.73 70 210370 7478 50387206
Blood cholesterol increased 17.52 9.73 146 210294 55069 50339615
Cholestasis 17.50 9.73 51 210389 25350 50369334
Drug eruption 17.30 9.73 46 210394 23560 50371124
Metabolic acidosis 17.16 9.73 93 210347 38732 50355952
Toxic skin eruption 17.14 9.73 13 210427 11238 50383446
Arteriosclerosis coronary artery 17.09 9.73 70 210370 7566 50387118
CYP3A4 polymorphism 17.04 9.73 8 210432 80 50394604
Dyspnoea exertional 16.93 9.73 134 210306 51099 50343585
Self-injurious ideation 16.92 9.73 32 210408 2197 50392487
Second primary malignancy 16.86 9.73 4 210436 6910 50387774
Dysphagia 16.86 9.73 432 210008 77086 50317598
Muscle spasms 16.83 9.73 660 209780 124893 50269791
Polyarthritis 16.74 9.73 6 210434 7921 50386763
Hyponatraemic encephalopathy 16.65 9.73 11 210429 223 50394461
Diplopia 16.64 9.73 137 210303 19123 50375561
Myocardial infarction 16.64 9.73 265 210175 88762 50305922
Osteonecrosis of jaw 16.64 9.73 74 210366 32452 50362232
Sleep talking 16.63 9.73 20 210420 916 50393768
Pulseless electrical activity 16.60 9.73 4 210436 6837 50387847
Drug abuse 16.58 9.73 345 210095 59501 50335183
Panic reaction 16.53 9.73 42 210398 3527 50391157
Hyperacusis 16.38 9.73 28 210412 1776 50392908
Abdominal pain 16.36 9.73 809 209631 235419 50159265
Hypervolaemia 16.29 9.73 53 210387 25446 50369238
Spinal operation 16.14 9.73 60 210380 6200 50388484
Accidental exposure to product 16.10 9.73 46 210394 23011 50371673
Cataplexy 16.10 9.73 21 210419 1045 50393639
Oliguria 16.07 9.73 7 210433 8209 50386475
Fear of injection 15.97 9.73 3 210437 6100 50388584
Road traffic accident 15.86 9.73 163 210277 24189 50370495
Poor quality sleep 15.80 9.73 121 210319 16525 50378159
Poisoning 15.76 9.73 97 210343 12332 50382352
Mean cell haemoglobin concentration increased 15.57 9.73 14 210426 454 50394230
Device related infection 15.51 9.73 40 210400 20695 50373989
Intervertebral disc protrusion 15.50 9.73 141 210299 20252 50374432
Metastases to lymph nodes 15.39 9.73 5 210435 7019 50387665
Pulmonary haemorrhage 15.36 9.73 4 210436 6488 50388196
Haemorrhage 15.33 9.73 145 210295 53296 50341388
Lactation disorder 15.27 9.73 12 210428 322 50394362
Gastric ulcer 15.25 9.73 42 210398 21263 50373421
Decreased appetite 15.12 9.73 682 209758 200241 50194443
Neurologic neglect syndrome 15.08 9.73 24 210416 1434 50393250
Ischaemic stroke 15.06 9.73 27 210413 15921 50378763
Sensitivity to weather change 15.04 9.73 57 210383 5944 50388740
Transfusion 14.94 9.73 19 210421 12886 50381798
Congenital tricuspid valve atresia 14.87 9.73 6 210434 40 50394644
Bone erosion 14.83 9.73 16 210424 11671 50383013
Metastases to central nervous system 14.81 9.73 15 210425 11267 50383417
Maternal exposure during breast feeding 14.77 9.73 38 210402 3216 50391468
Acute myocardial infarction 14.73 9.73 67 210373 29206 50365478
Impatience 14.65 9.73 12 210428 342 50394342
Carotid artery thrombosis 14.59 9.73 24 210416 1475 50393209
Spondyloarthropathy 14.55 9.73 17 210423 755 50393929
Red blood cell count decreased 14.44 9.73 82 210358 33753 50360931
Urinary incontinence 14.39 9.73 180 210260 28028 50366656
Caesarean section 14.30 9.73 27 210413 15612 50379072
Creatinine renal clearance decreased 14.27 9.73 17 210423 11864 50382820
Naevus flammeus 14.27 9.73 8 210432 119 50394565
Bradyphrenia 14.25 9.73 57 210383 6095 50388589
Gambling disorder 14.25 9.73 21 210419 1173 50393511
Lung diffusion test decreased 14.22 9.73 15 210425 594 50394090
Feeling of despair 14.13 9.73 28 210412 1990 50392694
Oesophageal pain 14.06 9.73 34 210406 2768 50391916
Intrusive thoughts 14.04 9.73 9 210431 173 50394511
Oesophageal food impaction 14.04 9.73 9 210431 173 50394511
Overdose 14.02 9.73 527 209913 99200 50295484
Post-traumatic neck syndrome 13.98 9.73 27 210413 1883 50392801
Lung disorder 13.97 9.73 119 210321 44680 50350004
Hepatic steatosis 13.93 9.73 159 210281 24225 50370459
Pulmonary arterial hypertension 13.85 9.73 41 210399 20278 50374406
Haemolytic anaemia 13.82 9.73 11 210429 9281 50385403
Intentional overdose 13.79 9.73 349 210091 62155 50332529
Trigeminal neuralgia 13.75 9.73 36 210404 3079 50391605
Scoliosis 13.72 9.73 59 210381 6517 50388167
Uraemic encephalopathy 13.69 9.73 9 210431 181 50394503
Scar 13.60 9.73 90 210350 11728 50382956
Exposure during pregnancy 13.60 9.73 391 210049 120624 50274060
Immunisation reaction 13.58 9.73 5 210435 25 50394659
Tumour lysis syndrome 13.48 9.73 7 210433 7414 50387270
Stillbirth 13.46 9.73 4 210436 5948 50388736
Clitoral engorgement 13.46 9.73 3 210437 0 50394684
Phobia of driving 13.46 9.73 3 210437 0 50394684
Herpes simplex reactivation 13.45 9.73 12 210428 385 50394299
Rales 13.41 9.73 13 210427 9965 50384719
Gun shot wound 13.38 9.73 7 210433 90 50394594
Enterococcal infection 13.30 9.73 6 210434 6892 50387792
Haematuria 13.26 9.73 58 210382 25555 50369129
Pulmonary hypertension 13.20 9.73 83 210357 33334 50361350
Tachyphylaxis 13.19 9.73 10 210430 254 50394430
Hepatobiliary scan abnormal 13.14 9.73 6 210434 56 50394628
Autonomic nervous system imbalance 13.12 9.73 30 210410 2355 50392329
Hepatitis C antibody positive 13.05 9.73 7 210433 95 50394589
Pseudomonas infection 13.01 9.73 12 210428 9418 50385266
Feeling drunk 12.96 9.73 39 210401 3614 50391070
Polyneuropathy 12.90 9.73 19 210421 12112 50382572
Immobilisation prolonged 12.86 9.73 7 210433 98 50394586
Urinary hesitation 12.84 9.73 27 210413 2002 50392682
Leukopenia neonatal 12.83 9.73 5 210435 30 50394654
Holmes-Adie pupil 12.83 9.73 5 210435 30 50394654
Ophthalmic vein thrombosis 12.79 9.73 8 210432 147 50394537
Rhonchi 12.67 9.73 29 210411 2278 50392406
Muscular weakness 12.62 9.73 499 209941 94514 50300170
Pathogen resistance 12.55 9.73 4 210436 5685 50388999
Diffuse large B-cell lymphoma 12.46 9.73 4 210436 5658 50389026
Drug metabolising enzyme decreased 12.45 9.73 4 210436 12 50394672
Cerebral haemorrhage 12.40 9.73 64 210376 26988 50367696
Respiratory tract infection 12.40 9.73 80 210360 31937 50362747
Femur fracture 12.37 9.73 98 210342 37366 50357318
Fear 12.31 9.73 103 210337 14446 50380238
Radiation fibrosis 12.31 9.73 5 210435 34 50394650
Sedation complication 12.28 9.73 11 210429 8755 50385929
Blood lactate dehydrogenase increased 12.26 9.73 41 210399 19521 50375163
Soft tissue injury 12.14 9.73 22 210418 1462 50393222
Intentional product use issue 12.12 9.73 236 210204 76682 50318002
Oedema 12.10 9.73 212 210228 69969 50324715
Lupus-like syndrome 12.03 9.73 13 210427 9478 50385206
Adverse event 12.02 9.73 120 210320 43643 50351041
Blood alkaline phosphatase increased 11.97 9.73 221 210219 37305 50357379
Progressive multifocal leukoencephalopathy 11.85 9.73 85 210355 11372 50383312
Phonophobia 11.80 9.73 10 210430 299 50394385
Adjustment disorder 11.79 9.73 26 210414 1993 50392691
Escherichia infection 11.76 9.73 17 210423 10924 50383760
Liver injury 11.76 9.73 58 210382 24748 50369936
Cataract 11.66 9.73 133 210307 47167 50347517
Electric shock sensation 11.63 9.73 9 210431 236 50394448
Abortion induced 11.62 9.73 13 210427 9331 50385353
Chest discomfort 11.61 9.73 295 210145 92427 50302257
Hepatotoxicity 11.61 9.73 66 210374 27160 50367524
Pulmonary embolism 11.58 9.73 328 210112 101376 50293308
Rotator cuff syndrome 11.57 9.73 85 210355 11459 50383225
Eyelid myoclonus 11.51 9.73 5 210435 41 50394643
Contusion 11.48 9.73 367 210073 111816 50282868
Skin plaque 11.45 9.73 6 210434 6322 50388362
Spasmodic dysphonia 11.41 9.73 6 210434 78 50394606
Visual impairment 11.39 9.73 368 210072 67907 50326777
Chronic idiopathic pain syndrome 11.39 9.73 3 210437 3 50394681
Labelled drug-food interaction issue 11.39 9.73 4 210436 17 50394667
Food craving 11.35 9.73 21 210419 1418 50393266
Neuropsychiatric symptoms 11.33 9.73 13 210427 566 50394118
Rapid eye movement sleep behaviour disorder 11.31 9.73 8 210432 182 50394502
Disturbance in sexual arousal 11.28 9.73 6 210434 80 50394604
Injection site haemorrhage 11.26 9.73 48 210392 21298 50373386
Clostridium difficile colitis 11.25 9.73 37 210403 17705 50376979
Vasculitis 11.24 9.73 26 210414 13965 50380719
Nephrotic syndrome 11.17 9.73 3 210437 4767 50389917
Oxygen saturation decreased 11.16 9.73 226 210214 73022 50321662
Impulsive behaviour 11.15 9.73 21 210419 1437 50393247
Sluggishness 11.13 9.73 42 210398 4371 50390313
Polyglandular autoimmune syndrome type II 11.11 9.73 5 210435 45 50394639
Feeling jittery 11.09 9.73 82 210358 11078 50383606
Cushingoid 11.02 9.73 7 210433 6638 50388046
Supraventricular tachyarrhythmia 11.02 9.73 6 210434 84 50394600
Device difficult to use 10.99 9.73 15 210425 9871 50384813
Infective pulmonary exacerbation of cystic fibrosis 10.99 9.73 10 210430 7899 50386785
Cytomegalovirus viraemia 10.96 9.73 3 210437 4706 50389978
Sciatic nerve injury 10.95 9.73 11 210429 411 50394273
Skin ulcer 10.93 9.73 94 210346 35224 50359460
Carcinoid tumour pulmonary 10.92 9.73 11 210429 412 50394272
Bronchospasm 10.85 9.73 29 210411 14825 50379859
Anaphylactic shock 10.83 9.73 45 210395 20110 50374574
Sternal fracture 10.82 9.73 25 210415 1977 50392707
Epstein-Barr virus infection 10.77 9.73 8 210432 6989 50387695
Haemorrhage intracranial 10.77 9.73 22 210418 12352 50382332
Suspected product quality issue 10.77 9.73 8 210432 197 50394487
Cytokine release syndrome 10.75 9.73 12 210428 8622 50386062
Pain in jaw 10.71 9.73 105 210335 38323 50356361
Status epilepticus 10.70 9.73 25 210415 13381 50381303
Foot amputation 10.68 9.73 9 210431 267 50394417
Chronic obstructive pulmonary disease 10.68 9.73 157 210283 53278 50341406
Pyometra 10.66 9.73 6 210434 90 50394594
Alveolar bone resorption 10.65 9.73 5 210435 50 50394634
Hepatitis A antibody positive 10.65 9.73 5 210435 50 50394634
Blood pressure diastolic decreased 10.64 9.73 35 210405 16746 50377938
Sexual dysfunction 10.62 9.73 34 210406 3258 50391426
Blood pressure diastolic abnormal 10.61 9.73 14 210426 9347 50385337
Ligament injury 10.58 9.73 17 210423 1024 50393660
Mental impairment 10.58 9.73 86 210354 11958 50382726
Purple glove syndrome 10.49 9.73 8 210432 205 50394479
Intestinal cyst 10.49 9.73 6 210434 93 50394591
Psoriatic arthropathy 10.49 9.73 263 210177 46769 50347915
Rectal haemorrhage 10.48 9.73 106 210334 38452 50356232
Pulmonary toxicity 10.47 9.73 5 210435 5557 50389127
Productive cough 10.47 9.73 155 210285 52539 50342145
Hypoventilation 10.46 9.73 38 210402 3883 50390801
Haemolysis 10.45 9.73 6 210434 6010 50388674
Ventricular hypoplasia 10.38 9.73 7 210433 147 50394537
Accommodation disorder 10.37 9.73 10 210430 355 50394329
Trigger finger 10.35 9.73 37 210403 3751 50390933
Acute pulmonary oedema 10.32 9.73 9 210431 7258 50387426
Atelectasis 10.32 9.73 40 210400 18230 50376454
Eye pain 10.31 9.73 171 210269 28278 50366406
Posterior reversible encephalopathy syndrome 10.26 9.73 30 210410 14898 50379786
Central nervous system stimulation 10.26 9.73 4 210436 24 50394660
Parosmia 10.19 9.73 41 210399 4395 50390289
Hypophosphataemia 10.15 9.73 12 210428 8402 50386282
Klebsiella infection 10.11 9.73 9 210431 7185 50387499
Dissociative disorder 10.10 9.73 8 210432 217 50394467
Duodenal ulcer 10.10 9.73 8 210432 6767 50387917
Unintentional medical device removal 10.06 9.73 5 210435 5430 50389254
Unintended pregnancy 10.02 9.73 4 210436 4942 50389742
Suspected suicide attempt 10.00 9.73 6 210434 102 50394582
Lymphadenopathy 9.99 9.73 90 210350 33409 50361275
Haematocrit decreased 9.99 9.73 95 210345 34881 50359803
Drug-induced liver injury 9.98 9.73 72 210368 28023 50366661
Shock haemorrhagic 9.96 9.73 12 210428 8332 50386352
Angina unstable 9.90 9.73 8 210432 6698 50387986
Lung infiltration 9.89 9.73 26 210414 13367 50381317
Lung neoplasm 9.89 9.73 5 210435 5377 50389307
Pericardial effusion 9.88 9.73 64 210376 25525 50369159
Self esteem decreased 9.85 9.73 12 210428 557 50394127
Myocardial ischaemia 9.81 9.73 21 210419 11592 50383092
Enuresis 9.81 9.73 25 210415 2104 50392580
Large intestine perforation 9.80 9.73 10 210430 7484 50387200
Anuria 9.78 9.73 20 210420 11224 50383460
Chronic kidney disease 9.74 9.73 112 210328 39659 50355025

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 1282.70 11.16 684 66993 17300 29489550
Dysphoria 1235.67 11.16 368 67309 1724 29505126
Affect lability 1153.15 11.16 392 67285 3010 29503840
Suicidal ideation 766.64 11.16 635 67042 34081 29472769
Irritability 671.48 11.16 489 67188 21663 29485187
Sensory disturbance 564.59 11.16 269 67408 5300 29501550
Vertigo 499.26 11.16 408 67269 21453 29485397
Paraesthesia 490.68 11.16 610 67067 53235 29453615
Agitation 475.15 11.16 586 67091 50718 29456132
Insomnia 453.59 11.16 764 66913 87997 29418853
Hyperhidrosis 407.32 11.16 612 67065 63928 29442922
Anxiety 382.98 11.16 694 66983 84671 29422179
Nightmare 354.77 11.16 256 67421 11161 29495689
Dizziness 264.30 11.16 992 66685 188692 29318158
Tinnitus 255.06 11.16 241 67436 15373 29491477
Hypomania 235.58 11.16 110 67567 2065 29504785
Completed suicide 234.85 11.16 588 67089 89658 29417192
Confusional state 225.88 11.16 724 66953 127153 29379697
Tremor 225.74 11.16 511 67166 73027 29433823
Lethargy 220.78 11.16 345 67332 37235 29469615
Serotonin syndrome 217.50 11.16 233 67444 17279 29489571
Mood swings 214.81 11.16 158 67519 7093 29499757
Headache 180.70 11.16 832 66845 173175 29333675
Nausea 148.37 11.16 1149 66528 288106 29218744
Sleep disorder 140.55 11.16 222 67455 24164 29482686
Suicide attempt 132.36 11.16 261 67416 33849 29473001
Febrile neutropenia 128.66 11.16 48 67629 112192 29394658
Pyrexia 125.82 11.16 297 67380 287325 29219525
Fatigue 105.97 11.16 1148 66529 315673 29191177
Anger 104.82 11.16 127 67550 10763 29496087
Thrombocytopenia 101.96 11.16 95 67582 134728 29372122
Withdrawal syndrome 95.86 11.16 122 67555 10870 29495980
Acute kidney injury 94.18 11.16 303 67374 264964 29241886
Gastrointestinal tube insertion 89.05 11.16 46 67631 1083 29505767
Anaemia 88.90 11.16 206 67471 200745 29306105
Depression 82.14 11.16 399 67278 84748 29422102
Neutropenia 76.83 11.16 114 67563 131597 29375253
Somnolence 75.88 11.16 419 67258 93536 29413314
Intentional self-injury 72.55 11.16 114 67563 12347 29494503
Pancytopenia 69.70 11.16 53 67624 83115 29423735
Feeling abnormal 68.28 11.16 276 67401 54169 29452681
Fall 65.08 11.16 655 67022 176523 29330327
Memory impairment 61.90 11.16 204 67473 36266 29470584
Disturbance in attention 60.25 11.16 144 67533 21280 29485570
Dyspnoea 58.20 11.16 474 67203 326258 29180592
Sepsis 57.75 11.16 153 67524 142529 29364321
Disease progression 56.97 11.16 62 67615 81854 29424996
Multiple organ dysfunction syndrome 54.45 11.16 39 67638 63077 29443773
Hepatic enzyme increased 52.90 11.16 184 67493 33615 29473235
Platelet count decreased 51.45 11.16 101 67576 104571 29402279
Pleural effusion 50.47 11.16 54 67623 71854 29434996
Sexual dysfunction 49.85 11.16 64 67613 5750 29501100
Mucosal inflammation 48.99 11.16 7 67670 31588 29475262
Haemoglobin decreased 47.91 11.16 111 67566 108264 29398586
Loss of consciousness 47.44 11.16 311 67366 73745 29433105
Malignant neoplasm progression 46.97 11.16 60 67617 73799 29433051
Sedation 45.75 11.16 114 67563 17291 29489559
Intentional overdose 45.68 11.16 192 67485 38336 29468514
Respiratory disorder neonatal 44.35 11.16 32 67645 1393 29505457
Renal failure 42.97 11.16 134 67543 118465 29388385
Blood creatinine increased 42.78 11.16 81 67596 85021 29421829
Leukopenia 42.73 11.16 38 67639 55165 29451685
Myoclonus 41.30 11.16 93 67584 13216 29493634
Migraine 40.99 11.16 89 67588 12341 29494509
Respiratory failure 39.39 11.16 104 67573 97027 29409823
Antidepressant drug level above therapeutic 39.26 11.16 15 67662 166 29506684
Product use in unapproved indication 39.18 11.16 88 67589 86787 29420063
Toxicity to various agents 37.32 11.16 581 67096 173080 29333770
Therapy interrupted 37.24 11.16 68 67609 8318 29498532
Urinary retention 37.06 11.16 158 67519 31740 29475110
Gastric bypass 36.92 11.16 16 67661 250 29506600
Cardiac failure 36.83 11.16 79 67598 79208 29427642
General physical health deterioration 36.69 11.16 117 67560 102740 29404110
Ascites 36.63 11.16 19 67658 36600 29470250
Road traffic accident 34.84 11.16 96 67581 15465 29491385
Pneumonia 34.72 11.16 520 67157 319652 29187198
Analgesic drug level above therapeutic 34.12 11.16 15 67662 243 29506607
Urinary hesitation 33.92 11.16 33 67644 2180 29504670
Haemorrhage 33.73 11.16 32 67645 45040 29461810
Balance disorder 33.05 11.16 167 67510 36003 29470847
Drug resistance 32.86 11.16 5 67672 21535 29485315
Cytomegalovirus infection 31.95 11.16 7 67670 23208 29483642
Abnormal dreams 31.85 11.16 57 67620 6863 29499987
Aggression 31.70 11.16 163 67514 35378 29471472
Septic shock 31.03 11.16 60 67617 62500 29444350
Mania 30.85 11.16 64 67613 8599 29498251
C-reactive protein increased 30.21 11.16 34 67643 44229 29462621
Pain 29.70 11.16 554 67123 170878 29335972
Metabolic acidosis 29.05 11.16 26 67651 37636 29469214
Disorientation 28.90 11.16 139 67538 29376 29477474
Hallucination 28.14 11.16 187 67490 44525 29462325
Overdose 27.74 11.16 292 67385 79527 29427323
Amnesia 27.73 11.16 114 67563 22529 29484321
Surgery 27.71 11.16 74 67603 11705 29495145
Yawning 27.65 11.16 16 67661 474 29506376
Dehydration 27.58 11.16 152 67525 114596 29392254
Self esteem decreased 26.86 11.16 16 67661 501 29506349
Hypokalaemia 26.82 11.16 46 67631 50157 29456693
Cough 26.20 11.16 176 67501 126551 29380299
Disseminated intravascular coagulation 25.60 11.16 7 67670 19973 29486877
Bone marrow failure 24.95 11.16 16 67661 27433 29479417
Atrial fibrillation 24.81 11.16 141 67536 105505 29401345
Renal impairment 24.68 11.16 99 67578 81234 29425616
Initial insomnia 24.51 11.16 31 67646 2744 29504106
Agranulocytosis 24.47 11.16 8 67669 20332 29486518
Toxic epidermal necrolysis 23.94 11.16 6 67671 18147 29488703
White blood cell count decreased 23.73 11.16 104 67573 83258 29423592
Feeling jittery 23.63 11.16 35 67642 3598 29503252
Hallucination, auditory 23.31 11.16 61 67616 9532 29497318
Abnormal behaviour 22.70 11.16 109 67568 23018 29483832
International normalised ratio increased 22.49 11.16 42 67635 44330 29462520
Post concussion syndrome 22.47 11.16 9 67668 114 29506736
Drug hypersensitivity 22.25 11.16 247 67430 68159 29438691
Convulsive threshold lowered 22.13 11.16 14 67663 489 29506361
Homicidal ideation 21.98 11.16 28 67649 2496 29504354
Infusion related reaction 21.84 11.16 42 67635 43844 29463006
Erectile dysfunction 21.53 11.16 90 67587 17919 29488931
Muscle spasticity 20.93 11.16 39 67638 4844 29502006
Acute stress disorder 20.92 11.16 9 67668 138 29506712
Dystonia 20.70 11.16 59 67618 9690 29497160
Agitation neonatal 20.56 11.16 18 67659 1038 29505812
Respiratory distress 20.48 11.16 26 67651 32080 29474770
Interstitial lung disease 20.32 11.16 66 67611 57652 29449198
Hypotension 20.19 11.16 318 67359 194036 29312814
Clonus 20.11 11.16 26 67651 2352 29504498
Growth hormone deficiency 19.97 11.16 10 67667 220 29506630
Complex regional pain syndrome 19.95 11.16 13 67664 478 29506372
Bradyphrenia 19.77 11.16 35 67642 4179 29502671
Somnambulism 19.72 11.16 28 67649 2770 29504080
Haematuria 19.65 11.16 45 67632 44094 29462756
Myocardial infarction 19.53 11.16 160 67517 110136 29396714
Neuralgia 19.50 11.16 62 67615 10812 29496038
Electric shock sensation 19.49 11.16 6 67671 32 29506818
Major depression 19.49 11.16 33 67644 3802 29503048
Pneumocystis jirovecii pneumonia 19.49 11.16 7 67670 16772 29490078
Intentional product misuse 19.46 11.16 141 67536 34520 29472330
Delirium 19.18 11.16 155 67522 39242 29467608
Acute myeloid leukaemia 18.99 11.16 7 67670 16506 29490344
Off label use 18.94 11.16 534 67143 300266 29206584
Hypocalcaemia 18.84 11.16 12 67665 20653 29486197
Pneumonitis 18.64 11.16 22 67655 28022 29478828
Cardiac failure congestive 18.63 11.16 101 67576 76480 29430370
Multiple sclerosis relapse 18.58 11.16 63 67614 11356 29495494
Wrong drug 18.28 11.16 7 67670 78 29506772
Haemoptysis 18.21 11.16 26 67651 30524 29476326
Dysmetropsia 18.10 11.16 4 67673 3 29506847
Sleep-related eating disorder 17.92 11.16 10 67667 276 29506574
Therapy cessation 17.86 11.16 73 67604 14389 29492461
Neuropathy peripheral 17.72 11.16 244 67433 70783 29436067
Liver function test abnormal 17.62 11.16 120 67557 28798 29478052
Sleep sex 17.57 11.16 4 67673 4 29506846
Oedema peripheral 17.53 11.16 152 67525 103405 29403445
Compulsive shopping 17.42 11.16 11 67666 383 29506467
Neutrophil count decreased 17.37 11.16 47 67630 43520 29463330
Affective disorder 17.37 11.16 28 67649 3098 29503752
Acute myocardial infarction 17.32 11.16 55 67622 48383 29458467
Rash maculo-papular 17.30 11.16 18 67659 24271 29482579
Steatohepatitis 17.29 11.16 10 67667 296 29506554
Productive cough 17.28 11.16 28 67649 31231 29475619
Angioedema 17.26 11.16 29 67648 31886 29474964
Hypersomnia 17.21 11.16 59 67618 10695 29496155
Pericardial effusion 17.14 11.16 14 67663 21194 29485656
Prescribed overdose 16.95 11.16 51 67626 8632 29498218
Feeling guilty 16.88 11.16 10 67667 310 29506540
Lymphopenia 16.86 11.16 5 67672 13528 29493322
Gastrointestinal haemorrhage 16.65 11.16 110 67567 79423 29427427
Erythema 16.63 11.16 103 67574 75503 29431347
Fibromyalgia 16.63 11.16 25 67652 2604 29504246
Tardive dyskinesia 16.60 11.16 37 67640 5221 29501629
Delirium tremens 16.60 11.16 12 67665 524 29506326
Forced expiratory flow decreased 16.58 11.16 8 67669 162 29506688
Restless legs syndrome 16.55 11.16 44 67633 6940 29499910
Psychotic disorder 16.54 11.16 91 67586 20263 29486587
Drug reaction with eosinophilia and systemic symptoms 16.51 11.16 24 67653 27968 29478882
Neonatal tachypnoea 16.45 11.16 8 67669 165 29506685
Rash 16.38 11.16 321 67356 189498 29317352
Gait disturbance 16.32 11.16 247 67430 73102 29433748
Paedophilia 16.30 11.16 4 67673 7 29506843
Dry mouth 16.13 11.16 95 67582 21689 29485161
Drug tolerance 15.85 11.16 22 67655 2131 29504719
Apathy 15.77 11.16 40 67637 6131 29500719
Depressed mood 15.76 11.16 77 67600 16371 29490479
Bradycardia 15.72 11.16 87 67590 65542 29441308
Depression suicidal 15.45 11.16 17 67660 1298 29505552
Seizure 15.42 11.16 299 67378 92824 29414026
Neoplasm progression 15.40 11.16 12 67665 18600 29488250
Ventricular hypoplasia 15.34 11.16 6 67671 71 29506779
Nephropathy toxic 15.30 11.16 3 67674 10753 29496097
Hyperlipasaemia 15.30 11.16 11 67666 476 29506374
Orgasm abnormal 15.25 11.16 7 67670 126 29506724
Coronary artery disease 15.23 11.16 51 67626 44139 29462711
Neonatal hyponatraemia 15.19 11.16 6 67671 73 29506777
Blood lactate dehydrogenase increased 15.13 11.16 13 67664 19196 29487654
Cardiogenic shock 15.10 11.16 13 67664 19177 29487673
Mental disorder 15.04 11.16 64 67613 12841 29494009
Epistaxis 15.01 11.16 64 67613 51640 29455210
Alcoholism 15.01 11.16 24 67653 2637 29504213
Bipolar disorder 14.98 11.16 27 67650 3268 29503582
Cerebral infarction 14.70 11.16 21 67656 24654 29482196
Drug screen positive 14.62 11.16 29 67648 3772 29503078
Urethral discharge 14.57 11.16 4 67673 13 29506837
Narcissistic personality disorder 14.57 11.16 4 67673 13 29506837
Thinking abnormal 14.50 11.16 35 67642 5201 29501649
Pulmonary embolism 14.48 11.16 109 67568 76425 29430425
Libido decreased 14.43 11.16 31 67646 4267 29502583
Stiff person syndrome 14.37 11.16 6 67671 85 29506765
Cytokine release syndrome 14.36 11.16 6 67671 13113 29493737
Pulmonary fibrosis 14.27 11.16 9 67668 15573 29491277
Palmar-plantar erythrodysaesthesia syndrome 14.26 11.16 8 67669 14751 29492099
Chills 14.23 11.16 100 67577 71200 29435650
Tumour lysis syndrome 14.19 11.16 7 67670 13877 29492973
Axillary pain 14.18 11.16 9 67668 316 29506534
Retrograde ejaculation 14.16 11.16 9 67668 317 29506533
Stomatitis 14.09 11.16 41 67636 37072 29469778
Anaphylactic reaction 14.06 11.16 26 67651 27547 29479303
Speech sound disorder 13.98 11.16 7 67670 154 29506696
Cholestasis 13.95 11.16 20 67657 23442 29483408
Paranoia 13.94 11.16 52 67625 9825 29497025
Haematochezia 13.93 11.16 41 67636 36942 29469908
Dyskinesia 13.90 11.16 86 67591 19975 29486875
Treatment failure 13.88 11.16 41 67636 36898 29469952
Tubulointerstitial nephritis 13.82 11.16 12 67665 17631 29489219
Rhabdomyolysis 13.81 11.16 82 67595 60726 29446124
Restlessness 13.55 11.16 92 67585 22053 29484797
Angina pectoris 13.55 11.16 27 67650 27823 29479027
Tethered cord syndrome 13.55 11.16 4 67673 18 29506832
Hypoxia 13.54 11.16 59 67618 47320 29459530
Influenza like illness 13.42 11.16 99 67578 24371 29482479
Lymphadenopathy 13.33 11.16 23 67654 25026 29481824
Suicidal behaviour 13.26 11.16 16 67661 1349 29505501
Undifferentiated connective tissue disease 13.21 11.16 4 67673 20 29506830
Psychopathic personality 13.17 11.16 3 67674 3 29506847
Facial spasm 13.10 11.16 7 67670 177 29506673
Loss of employment 13.06 11.16 10 67667 477 29506373
Blood urea increased 13.05 11.16 28 67649 28084 29478766
Ureteric haemorrhage 12.97 11.16 6 67671 110 29506740
Melaena 12.91 11.16 33 67644 31143 29475707
Muscle twitching 12.81 11.16 44 67633 7982 29498868
Homicide 12.68 11.16 13 67664 915 29505935
Brief psychotic disorder with marked stressors 12.65 11.16 7 67670 190 29506660
Chest injury 12.64 11.16 16 67661 1417 29505433
Concussion 12.30 11.16 19 67658 2027 29504823
Ileus 12.28 11.16 9 67668 14393 29492457
Acute respiratory distress syndrome 12.26 11.16 21 67656 22914 29483936
Disease recurrence 12.25 11.16 11 67666 15903 29490947
Selective eating disorder 12.25 11.16 17 67660 1646 29505204
Psychomotor hyperactivity 12.23 11.16 44 67633 8169 29498681
Hyperglycaemia 12.21 11.16 39 67638 34248 29472602
Autonomic dysreflexia 12.10 11.16 5 67672 69 29506781
Drug screen false positive 12.07 11.16 11 67666 669 29506181
Helplessness 12.03 11.16 5 67672 70 29506780
Central nervous system stimulation 11.97 11.16 3 67674 6 29506844
Lung disorder 11.92 11.16 33 67644 30329 29476521
Abdominal compartment syndrome 11.91 11.16 12 67665 827 29506023
Pseudomonas infection 11.82 11.16 5 67672 10847 29496003
Product prescribing error 11.80 11.16 76 67601 17900 29488950
Myelodysplastic syndrome 11.78 11.16 14 67663 17780 29489070
Posterior reversible encephalopathy syndrome 11.77 11.16 3 67674 8973 29497877
Peritonitis 11.71 11.16 10 67667 14814 29492036
Hyperreflexia 11.71 11.16 22 67655 2750 29504100
Blue toe syndrome 11.70 11.16 6 67671 139 29506711
Deep vein thrombosis 11.70 11.16 80 67597 57319 29449531
Mood altered 11.69 11.16 43 67634 8068 29498782
Panic disorder 11.65 11.16 14 67663 1176 29505674
Snoring 11.64 11.16 22 67655 2762 29504088
Hepatitis E antibody positive 11.62 11.16 6 67671 141 29506709
Lymphoma 11.59 11.16 4 67673 9824 29497026
Gout 11.52 11.16 13 67664 16898 29489952
Reflexes abnormal 11.51 11.16 8 67669 328 29506522
Abdominal pain 11.33 11.16 230 67447 135127 29371723
Graft versus host disease 11.21 11.16 4 67673 9624 29497226
Multiple sclerosis 11.20 11.16 33 67644 5521 29501329

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 974.97 9.84 782 191569 30509 64275872
Suicidal ideation 762.82 9.84 966 191385 65576 64240805
Serotonin syndrome 672.96 9.84 702 191649 38580 64267801
Completed suicide 486.39 9.84 1623 190728 222791 64083590
Dysphoria 477.23 9.84 242 192109 4146 64302235
Hyperhidrosis 439.10 9.84 1076 191275 123844 64182537
Affect lability 380.57 9.84 270 192081 8720 64297661
Irritability 367.42 9.84 499 191852 36247 64270134
Anxiety 333.57 9.84 1341 191010 201308 64105073
Tremor 302.25 9.84 1051 191300 147179 64159202
Nightmare 293.05 9.84 337 192014 20656 64285725
Insomnia 283.39 9.84 1255 191096 196581 64109800
Febrile neutropenia 277.81 9.84 106 192245 187551 64118830
Agitation 267.73 9.84 720 191631 87647 64218734
Dizziness 241.93 9.84 2144 190207 428019 63878362
Depression 222.31 9.84 1108 191243 182183 64124198
Thrombocytopenia 221 9.84 205 192146 223596 64082785
Paraesthesia 220.97 9.84 890 191461 133632 64172749
Suicide attempt 220.56 9.84 584 191767 70423 64235958
Neutropenia 217.75 9.84 236 192115 239388 64066993
Somnolence 212.62 9.84 1181 191170 202464 64103917
Feeling abnormal 203.76 9.84 864 191487 132738 64173643
Pyrexia 203.56 9.84 916 191435 557728 63748653
Vertigo 201.51 9.84 503 191848 58508 64247873
Withdrawal syndrome 197.86 9.84 294 192057 23198 64283183
Mood swings 192.73 9.84 249 192102 17219 64289162
Stubbornness 191.11 9.84 60 192291 251 64306130
Sensory disturbance 191.06 9.84 216 192135 12992 64293389
Anaemia 182.34 9.84 553 191798 378127 63928254
Acute kidney injury 175.52 9.84 717 191634 448523 63857858
Fall 168.74 9.84 1942 190409 414884 63891497
Pancytopenia 168.35 9.84 110 192241 143199 64163182
Pemphigus 161.86 9.84 4 192347 60697 64245684
Fibromyalgia 148.59 9.84 329 192022 35402 64270979
Headache 148.49 9.84 2308 190043 527159 63779222
Crying 144.80 9.84 234 192117 19856 64286525
Mood altered 144.75 9.84 207 192144 15772 64290609
Migraine 141.37 9.84 460 191891 62217 64244164
Nausea 138.81 9.84 3189 189162 782611 63523770
Intentional self-injury 134.07 9.84 279 192072 28765 64277616
Memory impairment 129.69 9.84 553 191798 85129 64221252
Anger 128.27 9.84 194 192157 15547 64290834
Disturbance in attention 122.64 9.84 333 192018 40741 64265640
Confusional state 122.24 9.84 1253 191098 259891 64046490
Tinnitus 120.78 9.84 295 192056 33838 64272543
Platelet count decreased 116.15 9.84 201 192150 167510 64138871
Thinking abnormal 115.57 9.84 157 192194 11399 64294982
Pericarditis 111.28 9.84 25 192326 62491 64243890
Malignant neoplasm progression 110.60 9.84 104 192247 112767 64193614
Sepsis 106.72 9.84 342 192009 229999 64076382
Loss of consciousness 102.15 9.84 775 191576 147590 64158791
Therapy interrupted 100.22 9.84 199 192152 19837 64286544
Cardiac failure 99.78 9.84 150 192201 132223 64174158
Depressed mood 97.93 9.84 307 192044 40705 64265676
Synovitis 95.10 9.84 93 192258 98997 64207384
Glossodynia 94.90 9.84 37 192314 64659 64241722
Hypomania 94.89 9.84 100 192251 5554 64300827
Electric shock 93.71 9.84 52 192299 1077 64305304
Product substitution issue 93.71 9.84 181 192170 17680 64288701
Hand deformity 93.57 9.84 35 192316 62736 64243645
Septic shock 93.29 9.84 106 192245 105331 64201050
Inappropriate antidiuretic hormone secretion 92.40 9.84 205 192146 22084 64284297
Disease progression 91.67 9.84 177 192174 141503 64164878
Affective disorder 90.75 9.84 105 192246 6475 64299906
Mucosal inflammation 89.82 9.84 37 192314 62547 64243834
Renal failure 87.50 9.84 265 192086 181423 64124958
Multiple sclerosis relapse 85.72 9.84 294 192057 40841 64265540
Contraindicated product administered 84.38 9.84 119 192232 107710 64198671
Duodenal ulcer perforation 83.15 9.84 5 192346 34620 64271761
Drug hypersensitivity 82.93 9.84 1078 191273 236737 64069644
Multiple organ dysfunction syndrome 82.30 9.84 109 192242 101304 64205077
Restless legs syndrome 82.03 9.84 167 192184 16949 64289432
Blood creatinine increased 81.59 9.84 177 192174 135605 64170776
Pain 80.29 9.84 2189 190162 551322 63755059
Ascites 79.23 9.84 43 192308 61958 64244423
Abnormal behaviour 78.73 9.84 250 192101 33372 64273009
Dry mouth 78.68 9.84 373 191978 60045 64246336
Somatic symptom disorder 76.52 9.84 55 192296 1813 64304568
General physical health deterioration 76.08 9.84 332 192019 204093 64102288
Leukopenia 76.02 9.84 115 192236 101127 64205254
Drug reaction with eosinophilia and systemic symptoms 74.71 9.84 34 192317 54183 64252198
Weight increased 73.91 9.84 966 191385 212382 64093999
Multiple sclerosis 72.73 9.84 169 192182 18772 64287609
Toxicity to various agents 72.62 9.84 1503 190848 362010 63944371
Tardive dyskinesia 70.40 9.84 110 192241 9068 64297313
Amnesia 70.30 9.84 308 192043 47961 64258420
Pleural effusion 69.58 9.84 173 192178 126386 64179995
Renal impairment 68.58 9.84 192 192159 134825 64171556
Post-traumatic stress disorder 68.14 9.84 73 192278 4132 64302249
Therapy cessation 67.51 9.84 232 192119 32257 64274124
C-reactive protein abnormal 67.38 9.84 5 192346 29042 64277339
Coordination abnormal 67.02 9.84 142 192209 14822 64291559
Bone marrow failure 66.19 9.84 30 192321 47922 64258459
Cytomegalovirus infection 65.95 9.84 15 192336 37184 64269197
Mania 65.50 9.84 148 192203 16138 64290243
Surgery 65.34 9.84 209 192142 28004 64278377
Sopor 65.34 9.84 216 192135 29445 64276936
Drug interaction 65.23 9.84 1475 190876 360608 63945773
Off label use 64.73 9.84 1417 190934 631389 63674992
Balance disorder 63.21 9.84 448 191903 83478 64222903
Infusion related reaction 63.08 9.84 264 192087 164203 64142178
Dyspnoea 62.87 9.84 1648 190703 717026 63589355
Panic attack 62.66 9.84 170 192181 20783 64285598
Urinary retention 62.07 9.84 301 192050 48900 64257481
Pneumonia 61.61 9.84 1238 191113 558338 63748043
Sleep disorder 61.32 9.84 345 192006 59364 64247017
Haemoglobin decreased 60.91 9.84 337 192014 194726 64111655
Neutrophil count decreased 60.58 9.84 85 192266 77111 64229270
Maternal exposure during pregnancy 60.10 9.84 122 192229 95762 64210619
Gastric bypass 59.99 9.84 38 192313 1012 64305369
Atrial fibrillation 59.97 9.84 284 192067 170805 64135576
Sleep disorder due to general medical condition, insomnia type 59.60 9.84 5 192346 26265 64280116
Systemic lupus erythematosus 59.38 9.84 87 192264 77525 64228856
Pneumonia aspiration 58.59 9.84 339 192012 58932 64247449
Neck deformity 58.04 9.84 45 192306 1667 64304714
Coma blister 57.90 9.84 23 192328 213 64306168
Folliculitis 57.78 9.84 10 192341 30067 64276314
Nasal turbinate hypertrophy 57.57 9.84 30 192321 545 64305836
Hallucination 57.43 9.84 393 191958 72395 64233986
Gastrointestinal tube insertion 57.19 9.84 42 192309 1432 64304949
Abnormal dreams 56.86 9.84 107 192244 10249 64296132
Coma 56.56 9.84 451 191900 87164 64219217
Intentional overdose 55.90 9.84 459 191892 89485 64216896
Fatigue 54.96 9.84 2743 189608 745987 63560394
Lethargy 54.95 9.84 388 191963 72206 64234175
Hypocalcaemia 54.76 9.84 28 192323 41725 64264656
Rubber sensitivity 54.06 9.84 39 192312 1293 64305088
Prescribed overdose 53.99 9.84 158 192193 20173 64286208
Disorientation 53.04 9.84 316 192035 55512 64250869
Treatment failure 52.97 9.84 175 192176 116641 64189740
Interstitial lung disease 52.62 9.84 135 192216 97597 64208784
Hyperreflexia 52.52 9.84 84 192267 7064 64299317
Stiff person syndrome 52.21 9.84 22 192329 240 64306141
Rash 51.77 9.84 1010 191341 457539 63848842
Alopecia 50.77 9.84 288 192063 165402 64140979
Respiratory failure 50.56 9.84 278 192073 160905 64145476
Hypersensitivity 50.20 9.84 361 191990 196091 64110290
Bronchial neoplasm 49.83 9.84 25 192326 418 64305963
Erythema 49.64 9.84 340 192011 186730 64119651
Product dose omission issue 49.47 9.84 836 191515 193911 64112470
Extremity contracture 49.28 9.84 40 192311 1585 64304796
Mental disorder 49.09 9.84 182 192169 26263 64280118
Hallucination, visual 48.73 9.84 188 192163 27646 64278735
Drug resistance 48.38 9.84 22 192329 35080 64271301
Clonus 48.33 9.84 74 192277 5993 64300388
Psoriasis 47.87 9.84 372 191979 71331 64235050
Product use in unapproved indication 47.86 9.84 319 192032 176299 64130082
Intentional product misuse 47.68 9.84 374 191977 71921 64234460
Colitis microscopic 47.45 9.84 82 192269 7350 64299031
Personality disorder 47.10 9.84 64 192287 4647 64301734
Dyskinesia 46.16 9.84 236 192115 39152 64267229
Libido increased 45.90 9.84 40 192311 1750 64304631
Bronchopulmonary aspergillosis 45.10 9.84 3 192348 19082 64287299
Cardiac failure congestive 45.02 9.84 218 192133 130362 64176019
Wound 44.85 9.84 101 192250 76376 64230005
Oesophageal spasm 44.78 9.84 46 192305 2479 64303902
Anti-cyclic citrullinated peptide antibody positive 44.73 9.84 49 192302 49513 64256868
Lower respiratory tract infection 44.10 9.84 140 192211 94474 64211907
Blood pressure increased 43.91 9.84 741 191610 171811 64134570
Coronary artery disease 43.12 9.84 71 192280 60362 64246019
Hyperaesthesia 42.52 9.84 93 192258 9921 64296460
White blood cell count decreased 42.30 9.84 286 192065 157551 64148830
Vision blurred 41.98 9.84 433 191918 89883 64216498
Stomatitis 41.97 9.84 176 192175 109429 64196952
Oedema peripheral 41.77 9.84 413 191938 209904 64096477
Drug intolerance 41.72 9.84 359 191992 187633 64118748
Muscle twitching 41.53 9.84 138 192213 18860 64287521
Hyperkalaemia 41.50 9.84 158 192193 100971 64205410
Intervertebral discitis 41.01 9.84 54 192297 3803 64302578
Hot flush 40.95 9.84 257 192094 45978 64260403
Endometrial ablation 40.87 9.84 27 192324 774 64305607
Gastrointestinal haemorrhage 40.51 9.84 230 192121 132082 64174299
Blister 40.46 9.84 116 192235 80851 64225530
Reversible cerebral vasoconstriction syndrome 40.34 9.84 42 192309 2300 64304081
Pneumocystis jirovecii pneumonia 40.20 9.84 16 192335 27618 64278763
Temperature intolerance 40.09 9.84 81 192270 8174 64298207
Self esteem decreased 39.87 9.84 28 192323 889 64305492
Autonomic dysreflexia 39.79 9.84 21 192330 392 64305989
Myoclonus 39.44 9.84 164 192187 24954 64281427
Akathisia 39.15 9.84 98 192253 11412 64294969
Alanine aminotransferase increased 39.08 9.84 607 191744 138424 64167957
Muscle injury 38.96 9.84 15 192336 26422 64279959
Influenza like illness 38.93 9.84 316 192035 61386 64244995
Morbid thoughts 38.33 9.84 25 192326 701 64305680
Discomfort 38.16 9.84 119 192232 80759 64225622
Arthropathy 37.73 9.84 209 192142 120758 64185623
Haemoptysis 37.50 9.84 55 192296 48993 64257388
Restlessness 37.03 9.84 224 192127 39561 64266820
Acute myeloid leukaemia 36.64 9.84 18 192333 27445 64278936
Overdose 36.58 9.84 674 191677 158892 64147489
Bone density abnormal 36.52 9.84 43 192308 2702 64303679
Rapid eye movements sleep abnormal 36.45 9.84 17 192334 240 64306141
Concussion 36.33 9.84 76 192275 7862 64298519
Neck mass 36.05 9.84 52 192299 3992 64302389
Cognitive disorder 35.78 9.84 284 192067 54803 64251578
Gastrooesophageal reflux disease 35.55 9.84 392 191959 82751 64223630
Dehydration 35.38 9.84 445 191906 216318 64090063
Hostility 35.21 9.84 38 192313 2169 64304212
Head injury 35.20 9.84 192 192159 32650 64273731
Hypersomnia 35.19 9.84 134 192217 19583 64286798
Angioedema 35.15 9.84 83 192268 61738 64244643
Disseminated intravascular coagulation 35.10 9.84 27 192324 32321 64274060
Sacroiliitis 34.90 9.84 44 192307 2968 64303413
Aspergillus infection 34.84 9.84 4 192347 16375 64290006
Pulmonary malformation 34.84 9.84 14 192337 134 64306247
Bipolar disorder 34.83 9.84 68 192283 6693 64299688
Rash maculo-papular 34.73 9.84 54 192297 46972 64259409
Red blood cell sedimentation rate abnormal 34.64 9.84 4 192347 16302 64290079
Opsoclonus myoclonus 34.41 9.84 15 192336 179 64306202
Epistaxis 34.30 9.84 163 192188 97968 64208413
Agranulocytosis 34.27 9.84 38 192313 38191 64268190
Hypoaesthesia 34.16 9.84 594 191757 138514 64167867
Sedation 33.97 9.84 226 192125 41236 64265145
Hypotension 33.86 9.84 871 191480 380103 63926278
Lactic acidosis 33.69 9.84 84 192267 61326 64245055
Pulmonary fibrosis 33.63 9.84 24 192327 29854 64276527
Libido decreased 33.49 9.84 55 192296 4729 64301652
Rebound nasal congestion 33.21 9.84 9 192342 19 64306362
C-reactive protein increased 32.97 9.84 158 192193 94751 64211630
Bradyphrenia 32.95 9.84 81 192270 9325 64297056
Melaena 32.81 9.84 69 192282 53479 64252902
Muscle spasms 32.79 9.84 597 191754 140426 64165955
Major depression 32.52 9.84 72 192279 7744 64298637
Joint swelling 32.29 9.84 450 191901 214932 64091449
Toxic epidermal necrolysis 32.17 9.84 38 192313 37128 64269253
Aspartate aminotransferase increased 32.15 9.84 519 191832 119269 64187112
Psychotic disorder due to a general medical condition 32.03 9.84 16 192335 265 64306116
Impaired driving ability 31.90 9.84 53 192298 4601 64301780
Nervousness 31.82 9.84 173 192178 29383 64276998
Sleep apnoea syndrome 31.70 9.84 174 192177 29658 64276723
Pneumonitis 31.62 9.84 64 192287 50301 64256080
Cardiogenic shock 31.60 9.84 30 192321 32397 64273984
Hypomagnesaemia 31.52 9.84 39 192312 37337 64269044
Haematuria 31.43 9.84 85 192266 60386 64245995
Ankle fracture 31.40 9.84 106 192245 14604 64291777
Metabolic acidosis 31.00 9.84 108 192243 70850 64235531
Respiratory distress 30.77 9.84 69 192282 52262 64254119
Infection 30.75 9.84 378 191973 184502 64121879
Road traffic accident 30.47 9.84 176 192175 30569 64275812
Cerebral infarction 30.43 9.84 47 192304 40997 64265384
Acute respiratory distress syndrome 30.41 9.84 43 192308 38892 64267489
Neoplasm progression 30.28 9.84 47 192304 40917 64265464
Palmar-plantar erythrodysaesthesia syndrome 30.08 9.84 25 192326 28794 64277587
Sleep-related eating disorder 30.06 9.84 21 192330 661 64305720
Aggression 29.83 9.84 238 192113 45994 64260387
Tubulointerstitial nephritis 29.65 9.84 29 192322 30880 64275501
Myocardial infarction 29.51 9.84 334 192017 165487 64140894
Neuralgia 29.37 9.84 155 192196 26029 64280352
Thunderclap headache 29.15 9.84 14 192337 212 64306169
Metabolic surgery 29.12 9.84 23 192328 876 64305505
Swelling 28.79 9.84 322 192029 159896 64146485
Bacteraemia 28.52 9.84 23 192328 26888 64279493
Hallucination, auditory 28.50 9.84 113 192238 16826 64289555
Anovulatory cycle 28.06 9.84 11 192340 98 64306283
Poor quality sleep 27.64 9.84 121 192230 18830 64287551
Bradycardia 27.46 9.84 223 192128 117996 64188385
Dissociation 27.26 9.84 39 192312 2972 64303409
Rheumatoid nodule 27.14 9.84 3 192348 12648 64293733
Anaphylactic reaction 27.07 9.84 109 192242 68555 64237826
Speech disorder 26.83 9.84 241 192110 48200 64258181
Bronchial haemorrhage 26.79 9.84 25 192326 1197 64305184
Lung cyst 26.68 9.84 12 192339 155 64306226
Premature delivery 26.65 9.84 11 192340 18578 64287803
Paranoia 26.65 9.84 108 192243 16244 64290137
Formication 26.42 9.84 47 192304 4310 64302071
Cataplexy 26.36 9.84 21 192330 810 64305571
Alcoholism 26.27 9.84 41 192310 3376 64303005
Drug eruption 26.20 9.84 42 192309 36094 64270287
Emotional disorder 26.16 9.84 90 192261 12517 64293864
Hypokalaemia 26.05 9.84 235 192116 121668 64184713
Anorgasmia 25.95 9.84 22 192329 927 64305454
Enterococcal infection 25.79 9.84 5 192346 13861 64292520
Graft versus host disease 25.65 9.84 5 192346 13808 64292573
Analgesic drug level above therapeutic 25.53 9.84 16 192335 418 64305963
Acute myocardial infarction 25.43 9.84 114 192237 69604 64236777
Gait disturbance 25.43 9.84 683 191668 171472 64134909
Haemorrhage 25.34 9.84 136 192215 79215 64227166
Galactorrhoea 25.27 9.84 39 192312 3180 64303201
Myelodysplastic syndrome 25.18 9.84 27 192324 27552 64278829
Hyperglycaemia 25.17 9.84 95 192256 60873 64245508
Eosinophilia 25.10 9.84 47 192304 38029 64268352
Pseudomonas infection 24.97 9.84 11 192340 17872 64288509
Blood lactate dehydrogenase increased 24.41 9.84 38 192313 33040 64273341
Maternal exposure during breast feeding 24.24 9.84 30 192321 1986 64304395
Cholestasis 24.13 9.84 62 192289 44810 64261571
Depressive symptom 24.12 9.84 46 192305 4450 64301931
Tumour lysis syndrome 24.09 9.84 14 192337 19426 64286955
Delusion 24.01 9.84 112 192239 17902 64288479
Psychomotor hyperactivity 23.99 9.84 96 192255 14355 64292026
Psychotic disorder 23.97 9.84 181 192170 34397 64271984
Therapeutic product effect incomplete 23.32 9.84 436 191915 103046 64203335
Haematotoxicity 23.26 9.84 5 192346 12891 64293490
Cytokine release syndrome 23.09 9.84 17 192334 20812 64285569
Skin haemorrhage 23.06 9.84 67 192284 8518 64297863
Demyelination 23.04 9.84 58 192293 6776 64299605
Cystitis 22.96 9.84 211 192140 42464 64263917
Hypoalbuminaemia 22.95 9.84 12 192339 17662 64288719
Abdominal discomfort 22.88 9.84 394 191957 181928 64124453
Pulseless electrical activity 22.85 9.84 5 192346 12734 64293647
Speech sound disorder 22.45 9.84 8 192343 53 64306328
International normalised ratio increased 22.44 9.84 141 192210 79026 64227355
Post-traumatic neck syndrome 22.38 9.84 28 192323 1874 64304507
Toxic skin eruption 22.36 9.84 15 192336 19269 64287112
Pathogen resistance 22.35 9.84 5 192346 12538 64293843
Feeling guilty 22.34 9.84 19 192332 804 64305577
Depression suicidal 22.32 9.84 32 192319 2443 64303938
Apathy 22.28 9.84 79 192272 11153 64295228
Lactation disorder 22.14 9.84 11 192340 180 64306201
Aplastic anaemia 22.06 9.84 7 192344 13913 64292468
Antidepressant drug level above therapeutic 22.03 9.84 16 192335 536 64305845
Drug screen positive 21.86 9.84 51 192300 5678 64300703
Prescribed underdose 21.85 9.84 109 192242 17906 64288475
Device related infection 21.83 9.84 36 192315 30590 64275791
Spinal operation 21.68 9.84 53 192298 6080 64300301
Sensitivity to weather change 21.62 9.84 56 192295 6658 64299723
Hypoxia 21.53 9.84 164 192187 87985 64218396
Hypnopompic hallucination 21.49 9.84 8 192343 61 64306320
Pustular psoriasis 21.46 9.84 42 192309 4141 64302240
Rheumatoid factor positive 21.42 9.84 45 192306 34893 64271488
Irritable bowel syndrome 21.38 9.84 50 192301 37319 64269062
Pulmonary eosinophilia 21.28 9.84 16 192335 566 64305815
Proteinuria 21.27 9.84 31 192320 27692 64278689
Metastases to liver 21.24 9.84 24 192327 23917 64282464
Acute pulmonary oedema 21.10 9.84 6 192345 12803 64293578
Metastases to bone 21.00 9.84 18 192333 20417 64285964
Phagophobia 20.97 9.84 7 192344 37 64306344
Gambling disorder 20.89 9.84 27 192324 1867 64304514
Sexual dysfunction 20.87 9.84 54 192297 6417 64299964
Product prescribing error 20.84 9.84 178 192173 35091 64271290
Pulmonary oedema 20.84 9.84 143 192208 78531 64227850
Impaired healing 20.81 9.84 101 192250 60372 64246009
Thrombotic microangiopathy 20.63 9.84 12 192339 16643 64289738
Epstein-Barr virus infection 20.29 9.84 6 192345 12482 64293899
Poisoning 20.24 9.84 123 192228 21756 64284625
Pain in extremity 20.19 9.84 1101 191250 301984 64004397
Pulmonary haemorrhage 20.06 9.84 7 192344 13102 64293279
Second primary malignancy 19.91 9.84 6 192345 12331 64294050
Helicobacter infection 19.87 9.84 54 192297 38308 64268073
Deep vein thrombosis 19.85 9.84 209 192142 104973 64201408
Feeling jittery 19.58 9.84 73 192278 10562 64295819
Tearfulness 19.39 9.84 43 192308 4630 64301751
Neurologic neglect syndrome 19.33 9.84 24 192327 1594 64304787
Ejection fraction decreased 19.31 9.84 35 192316 28672 64277709
Initial insomnia 19.30 9.84 49 192302 5755 64300626
Diarrhoea 19.28 9.84 1875 190476 720829 63585552
Phobia of driving 19.27 9.84 4 192347 0 64306381
Blood calcium decreased 19.20 9.84 29 192322 25525 64280856
Peritonitis 19.18 9.84 28 192323 24995 64281386
Ischaemic stroke 19 9.84 36 192315 28999 64277382
Psoriatic arthropathy 18.93 9.84 205 192146 43076 64263305
Muscle spasticity 18.92 9.84 99 192252 16570 64289811
Carotid artery thrombosis 18.88 9.84 25 192326 1770 64304611
Somnambulism 18.79 9.84 45 192306 5096 64301285
Delirium 18.63 9.84 300 192051 68894 64237487
Hypertonia 18.59 9.84 51 192300 6274 64300107
Respiratory tract congestion 18.34 9.84 96 192255 16069 64290312
Oesophageal pain 18.27 9.84 34 192317 3229 64303152
Snoring 18.22 9.84 42 192309 4640 64301741
Skin necrosis 18.21 9.84 10 192341 14319 64292062
Arteriosclerosis coronary artery 18.16 9.84 93 192258 15436 64290945
Increased appetite 18.14 9.84 69 192282 10077 64296304
Bruxism 18.13 9.84 36 192315 3588 64302793
Hepatic steatosis 18.06 9.84 156 192195 30851 64275530
Sleep terror 18.04 9.84 20 192331 1177 64305204
Haemolytic anaemia 17.93 9.84 13 192338 16040 64290341
Middle insomnia 17.86 9.84 81 192270 12796 64293585
Tension 17.85 9.84 37 192314 3803 64302578
Scar 17.64 9.84 83 192268 13315 64293066
Haemodialysis 17.60 9.84 15 192336 17062 64289319
Neck pain 17.41 9.84 269 192082 61264 64245117
Hyponatraemic encephalopathy 17.36 9.84 11 192340 293 64306088
Nephropathy toxic 17.31 9.84 16 192335 17498 64288883
Compulsive shopping 17.23 9.84 16 192335 761 64305620
CYP3A4 polymorphism 17.15 9.84 7 192344 70 64306311
Bronchial disorder 17.13 9.84 26 192325 2089 64304292
Sleep talking 17.12 9.84 18 192333 997 64305384
Spondyloarthropathy 17.08 9.84 16 192335 770 64305611
Creatinine renal clearance decreased 17.01 9.84 11 192340 14410 64291971
Feelings of worthlessness 16.97 9.84 13 192338 473 64305908
Tenosynovitis 16.97 9.84 7 192344 11826 64294555
Shoulder operation 16.92 9.84 26 192325 2112 64304269
Pneumothorax 16.91 9.84 29 192322 24269 64282112
Angina pectoris 16.87 9.84 73 192278 45008 64261373
Diplopia 16.84 9.84 137 192214 26628 64279753
Acute stress disorder 16.82 9.84 12 192339 391 64305990
Flat affect 16.73 9.84 24 192327 1833 64304548
Dyspnoea exertional 16.70 9.84 140 192211 73590 64232791
Pre-existing condition improved 16.67 9.84 41 192310 4721 64301660
Angina unstable 16.67 9.84 13 192338 15454 64290927
Visual impairment 16.65 9.84 312 192039 73765 64232616
Urinary incontinence 16.64 9.84 173 192178 35978 64270403
Soft tissue injury 16.62 9.84 22 192329 1557 64304824
Carcinoid tumour pulmonary 16.45 9.84 11 192340 322 64306059
Hyperuricaemia 16.37 9.84 5 192346 10186 64296195
Electric shock sensation 16.36 9.84 11 192340 325 64306056
Peripheral swelling 16.27 9.84 487 191864 208666 64097715
Sinus disorder 16.24 9.84 96 192255 16812 64289569
Rapid eye movement sleep behaviour disorder 16.21 9.84 11 192340 330 64306051
Cytomegalovirus viraemia 16.20 9.84 6 192345 10822 64295559
Intentional dose omission 16.05 9.84 45 192306 5607 64300774
Granulomatous liver disease 16.02 9.84 19 192332 1203 64305178
Hypoglycaemia 16.01 9.84 181 192170 89711 64216670
Rheumatic fever 15.98 9.84 4 192347 9290 64297091
Clostridium difficile colitis 15.92 9.84 36 192315 27187 64279194
Therapy non-responder 15.90 9.84 123 192228 65776 64240605
Homicidal ideation 15.87 9.84 32 192319 3225 64303156
Gastrointestinal disorder 15.83 9.84 181 192170 89528 64216853
Feeling drunk 15.80 9.84 37 192314 4130 64302251
Sinus congestion 15.70 9.84 89 192262 15350 64291031
Basal cell carcinoma 15.53 9.84 44 192307 30794 64275587
Ill-defined disorder 15.49 9.84 73 192278 43979 64262402
Mydriasis 15.40 9.84 88 192263 15224 64291157
Urinary hesitation 15.36 9.84 33 192318 3477 64302904
Urinary tract infection 15.35 9.84 841 191510 230755 64075626
Intervertebral disc protrusion 15.32 9.84 108 192243 20083 64286298
Convulsive threshold lowered 15.26 9.84 16 192335 883 64305498
Joint stiffness 15.20 9.84 148 192203 30256 64276125
Decreased interest 15.18 9.84 32 192319 3328 64303053
Intestinal perforation 15.12 9.84 14 192337 15299 64291082
Haemolysis 15.09 9.84 7 192344 11032 64295349
Diffuse large B-cell lymphoma 15.07 9.84 6 192345 10355 64296026
Myocardial ischaemia 15.06 9.84 29 192322 23222 64283159
Hyperbilirubinaemia 15.04 9.84 25 192326 21180 64285201
Metastases to lung 15.02 9.84 14 192337 15250 64291131
Poverty of speech 14.97 9.84 13 192338 566 64305815
Scoliosis 14.95 9.84 46 192305 6036 64300345
Hysterectomy 14.95 9.84 41 192310 5044 64301337
Open reduction of fracture 14.85 9.84 9 192342 221 64306160
Renal tubular necrosis 14.83 9.84 27 192324 22083 64284298
Hepatotoxicity 14.78 9.84 65 192286 39897 64266484
Oliguria 14.78 9.84 13 192338 14563 64291818
Immobilisation prolonged 14.75 9.84 7 192344 103 64306278
Rhonchi 14.52 9.84 32 192319 3431 64302950
Klebsiella infection 14.52 9.84 11 192340 13270 64293111
Blood urea increased 14.47 9.84 75 192276 44078 64262303
Rectocele repair 14.45 9.84 3 192348 0 64306381
Clitoral engorgement 14.45 9.84 3 192348 0 64306381
Eye pain 14.39 9.84 151 192200 31474 64274907
Dystonia 14.36 9.84 101 192250 18764 64287617
Hyperventilation 14.34 9.84 49 192302 6791 64299590
Lung disorder 14.32 9.84 114 192237 60586 64245795
Circulatory collapse 14.29 9.84 52 192299 33680 64272701
Illness anxiety disorder 14.23 9.84 9 192342 239 64306142
Therapeutic product effect decreased 14.23 9.84 250 192101 115101 64191280
Renal injury 14.20 9.84 15 192336 15414 64290967
Dissociative disorder 14.13 9.84 11 192340 410 64305971
Musculoskeletal discomfort 14.11 9.84 90 192261 16187 64290194
Acute hepatic failure 14.10 9.84 36 192315 26076 64280305
Therapeutic response changed 14.07 9.84 16 192335 968 64305413
Tuberculosis 14.00 9.84 11 192340 13027 64293354
Hospitalisation 14.00 9.84 308 192043 74899 64231482
Live birth 13.98 9.84 8 192343 11196 64295185
Asphyxia 13.89 9.84 61 192290 9505 64296876
Joint noise 13.84 9.84 30 192321 3181 64303200
Drug metabolising enzyme decreased 13.76 9.84 4 192347 12 64306369
Torsade de pointes 13.74 9.84 19 192332 17344 64289037
Hypervolaemia 13.72 9.84 63 192288 38222 64268159
Hepatocellular carcinoma 13.72 9.84 4 192347 8399 64297982
Right ventricular failure 13.72 9.84 27 192324 21444 64284937
Drug screen false positive 13.71 9.84 16 192335 996 64305385
Atelectasis 13.66 9.84 39 192312 27227 64279154
Heart rate decreased 13.66 9.84 102 192249 54965 64251416
Obsessive-compulsive personality disorder 13.64 9.84 7 192344 123 64306258
Growth hormone deficiency 13.62 9.84 10 192341 341 64306040
Radiation fibrosis 13.56 9.84 5 192346 37 64306344
Impulse-control disorder 13.55 9.84 20 192331 1568 64304813
Polyarthritis 13.53 9.84 6 192345 9709 64296672
Pyometra 13.52 9.84 6 192345 75 64306306
Lymphoma 13.46 9.84 13 192338 13928 64292453
Bladder cancer 13.46 9.84 8 192343 10966 64295415
Mean cell haemoglobin concentration increased 13.35 9.84 14 192337 773 64305608
Respiratory tract malformation 13.33 9.84 5 192346 39 64306342
Panic disorder 13.33 9.84 27 192324 2730 64303651
Atrioventricular block complete 13.29 9.84 14 192337 14404 64291977
Exposure via breast milk 13.25 9.84 14 192337 780 64305601
Parosmia 13.23 9.84 37 192314 4603 64301778
Immunisation reaction 13.22 9.84 5 192346 40 64306341
Haemophagocytic lymphohistiocytosis 13.21 9.84 20 192331 17589 64288792
Status epilepticus 13.20 9.84 28 192323 21635 64284746
Oesophagitis 13.14 9.84 28 192323 21602 64284779
Pneumonia fungal 13.14 9.84 5 192346 8872 64297509
Eyelid myoclonus 13.12 9.84 5 192346 41 64306340
Shock 13.08 9.84 64 192287 38176 64268205
Coagulopathy 13.00 9.84 50 192301 31870 64274511
Accidental death 12.97 9.84 32 192319 3693 64302688
Ophthalmic vein thrombosis 12.90 9.84 8 192343 205 64306176
Respiratory arrest 12.90 9.84 226 192125 52759 64253622
Burning sensation 12.88 9.84 214 192137 49450 64256931
Hyponatraemia 12.83 9.84 553 191798 147786 64158595
Metastases to lymph nodes 12.76 9.84 5 192346 8712 64297669
Febrile bone marrow aplasia 12.72 9.84 9 192342 11246 64295135
Anaphylactic shock 12.68 9.84 47 192304 30281 64276100
Pericardial effusion 12.68 9.84 67 192284 39187 64267194
Gastric ulcer 12.55 9.84 47 192304 30187 64276194
Retrograde ejaculation 12.53 9.84 8 192343 216 64306165
Gastric haemorrhage 12.53 9.84 13 192338 13468 64292913
Skin lesion 12.51 9.84 61 192290 36421 64269960
Muscular weakness 12.46 9.84 481 191870 126857 64179524
Movement disorder 12.46 9.84 110 192241 21890 64284491
Suspected suicide 12.43 9.84 55 192296 8599 64297782
Psychopathic personality 12.38 9.84 3 192348 3 64306378
Floating patella 12.38 9.84 3 192348 3 64306378
Tachyphrenia 12.37 9.84 21 192330 1855 64304526
Panic reaction 12.37 9.84 33 192318 3994 64302387
Labelled drug-food interaction issue 12.33 9.84 4 192347 19 64306362
Hypercalcaemia 12.30 9.84 50 192301 31366 64275015
Illusion 12.30 9.84 19 192332 1551 64304830
Haemoglobin urine present 12.29 9.84 14 192337 849 64305532
Metastases to central nervous system 12.28 9.84 14 192337 13898 64292483
Axillary pain 12.24 9.84 20 192331 1712 64304669
Adjustment disorder 12.23 9.84 26 192325 2719 64303662
Chronic kidney disease 12.22 9.84 112 192239 57807 64248574
Loose tooth 12.17 9.84 27 192324 2907 64303474
Acute respiratory failure 12.14 9.84 93 192258 49841 64256540
Posterior reversible encephalopathy syndrome 12.11 9.84 32 192319 22914 64283467
Sinus tachycardia 12.08 9.84 148 192203 32040 64274341
Sternal fracture 12.07 9.84 23 192328 2224 64304157
Transfusion 12.05 9.84 22 192329 17972 64288409
Forced expiratory flow decreased 12.03 9.84 8 192343 232 64306149
Palpitations 12.02 9.84 402 191949 104086 64202295
Anal incontinence 11.95 9.84 82 192269 15114 64291267
Night sweats 11.95 9.84 162 192189 35884 64270497
Feeling hot 11.93 9.84 197 192154 45466 64260915
Abulia 11.92 9.84 14 192337 877 64305504
Bipolar I disorder 11.91 9.84 20 192331 1751 64304630
Trigger finger 11.86 9.84 30 192321 3515 64302866
Blood bilirubin increased 11.84 9.84 112 192239 57441 64248940
Ocular vascular disorder 11.82 9.84 10 192341 420 64305961
Red blood cell count decreased 11.82 9.84 90 192261 48296 64258085
Supraventricular tachyarrhythmia 11.82 9.84 6 192345 103 64306278
Pancreatitis acute 11.80 9.84 77 192274 42778 64263603
Cholangitis 11.74 9.84 9 192342 10793 64295588
Prostate cancer 11.72 9.84 26 192325 19769 64286612
Social avoidant behaviour 11.70 9.84 35 192316 4522 64301859
Nephrotic syndrome 11.70 9.84 7 192344 9560 64296821
Acute graft versus host disease in skin 11.69 9.84 3 192348 6852 64299529
Post concussion syndrome 11.63 9.84 11 192340 536 64305845
Impulsive behaviour 11.61 9.84 25 192326 2638 64303743
Escherichia infection 11.60 9.84 17 192334 15151 64291230
Drug abuse 11.57 9.84 494 191857 131880 64174501
Facial spasm 11.48 9.84 12 192339 660 64305721
Infective pulmonary exacerbation of cystic fibrosis 11.39 9.84 11 192340 11785 64294596
Ligament injury 11.33 9.84 15 192336 1062 64305319
Progressive multifocal leukoencephalopathy 11.29 9.84 93 192258 18139 64288242
Economic problem 11.27 9.84 22 192329 2165 64304216
Sciatic nerve injury 11.22 9.84 10 192341 451 64305930
Somatic delusion 11.22 9.84 12 192339 678 64305703
Complex regional pain syndrome 11.21 9.84 19 192332 1677 64304704
Purple glove syndrome 11.17 9.84 8 192343 262 64306119
Holmes-Adie pupil 11.16 9.84 4 192347 27 64306354
Embolism 11.14 9.84 12 192339 12223 64294158
Lung infiltration 11.13 9.84 29 192322 20860 64285521
Haemodynamic instability 11.13 9.84 17 192334 14895 64291486
Cerebral haemorrhage 11.12 9.84 98 192253 50992 64255389
Liver function test increased 11.08 9.84 51 192300 30919 64275462
Dysphemia 11.08 9.84 27 192324 3092 64303289
Trismus 11.07 9.84 36 192315 4865 64301516
Exposure via ingestion 11.06 9.84 36 192315 4866 64301515
Rib fracture 11.04 9.84 115 192236 23923 64282458
Bone erosion 10.98 9.84 11 192340 11584 64294797
Serum serotonin increased 10.96 9.84 8 192343 270 64306111
Adiposis dolorosa 10.94 9.84 8 192343 271 64306110
Rhabdomyolysis 10.93 9.84 200 192151 91526 64214855
Cardiac failure acute 10.93 9.84 20 192331 16324 64290057
Blood bilirubin 10.92 9.84 4 192347 29 64306352
Lymphadenopathy 10.86 9.84 88 192263 46598 64259783
Tethered cord syndrome 10.86 9.84 3 192348 7 64306374
Drug level decreased 10.80 9.84 11 192340 11492 64294889
Multiple-drug resistance 10.79 9.84 3 192348 6499 64299882
Large intestine perforation 10.79 9.84 13 192338 12591 64293790
Device expulsion 10.76 9.84 30 192321 21106 64285275
Rales 10.76 9.84 18 192333 15211 64291170
Cholecystectomy 10.75 9.84 50 192301 7982 64298399
Tachyphylaxis 10.74 9.84 8 192343 279 64306102
Impaired work ability 10.73 9.84 80 192271 15139 64291242
Pulmonary alveolar haemorrhage 10.73 9.84 8 192343 9730 64296651
Allodynia 10.72 9.84 16 192335 1267 64305114
Gambling 10.69 9.84 8 192343 281 64306100
Hypogammaglobulinaemia 10.67 9.84 9 192342 10290 64296091
Stress 10.66 9.84 246 192105 60288 64246093
Product use issue 10.65 9.84 358 191993 151357 64155024
Dysstasia 10.64 9.84 111 192240 23104 64283277
Alveolar bone resorption 10.63 9.84 5 192346 72 64306309
Delirium tremens 10.61 9.84 11 192340 599 64305782
Regurgitation 10.61 9.84 21 192330 2088 64304293
Dysphagia 10.58 9.84 404 191947 106408 64199973
Relapsing multiple sclerosis 10.57 9.84 5 192346 73 64306308
Intervertebral disc operation 10.55 9.84 12 192339 726 64305655
Vasculitis 10.52 9.84 24 192327 18071 64288310
Arthroscopy 10.51 9.84 10 192341 491 64305890
Ventricular hypokinesia 10.50 9.84 5 192346 7764 64298617
Hepatic cytolysis 10.50 9.84 16 192335 14033 64292348
Central nervous system stimulation 10.47 9.84 4 192347 33 64306348
Rectal haemorrhage 10.41 9.84 126 192225 61691 64244690
Osteonecrosis 10.39 9.84 46 192305 28183 64278198
Cycloplegia 10.32 9.84 3 192348 9 64306372
Skin plaque 10.30 9.84 7 192344 8933 64297448
Osteonecrosis of jaw 10.24 9.84 73 192278 39752 64266629
Productive cough 10.23 9.84 155 192196 73048 64233333
Bacterial infection 10.22 9.84 39 192312 24911 64281470
Intestinal cyst 10.21 9.84 6 192345 139 64306242
Leukoencephalopathy 10.19 9.84 4 192347 6963 64299418
Cushingoid 10.12 9.84 5 192346 7598 64298783
Hepatitis E antibody positive 10.10 9.84 6 192345 142 64306239
Narcissistic personality disorder 10.09 9.84 3 192348 10 64306371
Hepatic enzyme increased 10.06 9.84 479 191872 129464 64176917
Blood pressure systolic decreased 10.04 9.84 7 192344 8813 64297568
Communication disorder 10.03 9.84 29 192322 3677 64302704
Eating disorder 10.03 9.84 85 192266 16720 64289661
Bone density decreased 9.94 9.84 9 192342 9943 64296438
Inflammation 9.92 9.84 136 192215 65164 64241217
Cephalo-pelvic disproportion 9.92 9.84 6 192345 147 64306234
Breakthrough pain 9.89 9.84 15 192336 1205 64305176
Knee operation 9.87 9.84 33 192318 4524 64301857

FDA Adverse Event Reporting System (Pediatric)

None

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 (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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ 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 0615-8204 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 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 0904-7044 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 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 13668-111 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
Cymbalta HUMAN PRESCRIPTION DRUG LABEL 1 21695-145 CAPSULE, DELAYED RELEASE 30 mg ORAL NDA 34 sections
Cymbalta HUMAN PRESCRIPTION DRUG LABEL 1 21695-146 CAPSULE, DELAYED RELEASE 60 mg ORAL NDA 34 sections
Cymbalta HUMAN PRESCRIPTION DRUG LABEL 1 21695-657 CAPSULE, DELAYED RELEASE 20 mg ORAL NDA 34 sections
Duloxetine Human Prescription Drug Label 1 25000-608 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 35 sections
Duloxetine Human Prescription Drug Label 1 25000-609 CAPSULE, DELAYED RELEASE 30 mg ORAL ANDA 35 sections
Duloxetine Human Prescription Drug Label 1 25000-610 CAPSULE, DELAYED RELEASE 60 mg ORAL ANDA 35 sections
Duloxetine Human Prescription Drug Label 1 27241-097 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 31 sections
Duloxetine Human Prescription Drug Label 1 27241-098 CAPSULE, DELAYED RELEASE 30 mg ORAL ANDA 31 sections
Duloxetine Human Prescription Drug Label 1 27241-099 CAPSULE, DELAYED RELEASE 60 mg ORAL ANDA 31 sections