duloxetine 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 ┬ÁM/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 3864.21 10.10 1993 189127 25391 46469551
Dysphoria 3521.47 10.10 1130 189990 3459 46491483
Affect lability 2862.11 10.10 1118 190002 6902 46488040
Irritability 2179.88 10.10 1400 189720 27546 46467396
Suicidal ideation 1753.05 10.10 1610 189510 54772 46440170
Agitation 1621.65 10.10 1530 189590 53885 46441057
Paraesthesia 1359.47 10.10 2015 189105 115422 46379520
Sensory disturbance 1288.82 10.10 735 190385 11532 46483410
Vertigo 1172.17 10.10 1247 189873 50801 46444141
Insomnia 1162.00 10.10 2268 188852 162656 46332286
Hyperhidrosis 1125.62 10.10 1596 189524 87712 46407230
Anxiety 1061.44 10.10 2315 188805 179642 46315300
Nightmare 760.38 10.10 593 190527 16005 46478937
Mood swings 702.25 10.10 561 190559 15691 46479251
Dizziness 675.23 10.10 2967 188153 337447 46157495
Tinnitus 594.39 10.10 647 190473 27026 46467916
Hypomania 559.99 10.10 299 190821 4089 46490853
Confusional state 543.91 10.10 1662 189458 158230 46336712
Lethargy 501.31 10.10 814 190306 50357 46444585
Tremor 460.34 10.10 1272 189848 114367 46380575
Serotonin syndrome 424.86 10.10 510 190610 23710 46471232
Depression 359.96 10.10 1514 189606 168590 46326352
Headache 293.65 10.10 3117 188003 475235 46019707
Withdrawal syndrome 284.42 10.10 361 190759 17773 46477169
Sleep disorder 257.82 10.10 583 190537 46212 46448730
Neutropenia 235.02 10.10 148 190972 143056 46351886
Anaemia 224.84 10.10 442 190678 255337 46239605
Suicide attempt 222.26 10.10 609 190511 54427 46440515
Febrile neutropenia 221.43 10.10 57 191063 94570 46400372
Nausea 202.01 10.10 3936 187184 683518 45811424
Pyrexia 193.62 10.10 754 190366 348048 46146894
Acute kidney injury 190.09 10.10 428 190692 235427 46259515
Crying 189.08 10.10 323 190797 20818 46474124
Disturbance in attention 187.13 10.10 405 190715 31155 46463787
Fibromyalgia 176.55 10.10 432 190688 36031 46458911
Pemphigus 170.06 10.10 3 191117 45271 46449671
Fatigue 164.77 10.10 3444 187676 605253 45889689
Thrombocytopenia 163.55 10.10 166 190954 126415 46368527
Pancytopenia 143.52 10.10 85 191035 84973 46409969
Feeling abnormal 140.58 10.10 935 190185 124125 46370817
Pneumonia 134.65 10.10 945 190175 375375 46119567
Maternal exposure during pregnancy 133.00 10.10 134 190986 102415 46392527
Stubbornness 121.72 10.10 43 191077 190 46494752
Mood altered 120.64 10.10 202 190918 12805 46482137
Dyspnoea 118.90 10.10 1446 189674 514102 45980840
Anger 115.21 10.10 188 190932 11664 46483278
Alopecia 114.89 10.10 315 190805 162099 46332843
Memory impairment 113.53 10.10 620 190500 76717 46418225
Platelet count decreased 112.06 10.10 147 190973 99877 46395065
Panic attack 107.90 10.10 249 190871 19993 46474949
Electric shock 107.90 10.10 59 191061 848 46494094
Disease progression 103.49 10.10 133 190987 91167 46403775
Malignant neoplasm progression 102.50 10.10 70 191050 64856 46430086
Thinking abnormal 98.57 10.10 158 190962 9656 46485286
Completed suicide 98.45 10.10 971 190149 144949 46349993
Migraine 97.85 10.10 554 190566 69472 46425470
Cardiac failure 97.47 10.10 110 191010 79838 46415104
Rash 95.48 10.10 966 190154 355546 46139396
Septic shock 94.66 10.10 60 191060 57833 46437109
Death 94.12 10.10 899 190221 334649 46160293
Sepsis 91.60 10.10 270 190850 135744 46359198
Contraindicated product administered 89.02 10.10 118 191002 79829 46415113
Erythema 85.37 10.10 299 190821 142521 46352421
Haemoglobin decreased 84.65 10.10 259 190861 128690 46366252
Depressed mood 84.30 10.10 314 190806 33005 46461937
Drug reaction with eosinophilia and systemic symptoms 83.62 10.10 11 191109 29537 46465405
Treatment failure 83.22 10.10 159 190961 92928 46402014
Gastrointestinal tube insertion 81.18 10.10 53 191067 1070 46493872
Somnolence 79.18 10.10 984 190136 155537 46339405
Gastric bypass 78.88 10.10 56 191064 1303 46493639
Glossodynia 78.20 10.10 42 191078 44331 46450611
Drug intolerance 76.85 10.10 325 190795 146724 46348218
Hand deformity 76.78 10.10 23 191097 34551 46460391
Pleural effusion 75.64 10.10 140 190980 82812 46412130
Blood creatinine increased 73.22 10.10 125 190995 76278 46418664
Renal impairment 72.82 10.10 120 191000 74252 46420690
Neutrophil count decreased 72.38 10.10 44 191076 43382 46451560
Intentional product misuse 71.97 10.10 382 190738 46746 46448196
Interstitial lung disease 70.48 10.10 70 191050 53879 46441063
Renal failure 70.46 10.10 234 190886 113360 46381582
Mucosal inflammation 70.00 10.10 36 191084 38940 46456002
Atrial fibrillation 68.74 10.10 207 190913 103383 46391559
Synovitis 68.13 10.10 90 191030 60985 46433957
Rheumatoid arthritis 67.08 10.10 644 190476 239571 46255371
Systemic lupus erythematosus 65.86 10.10 103 191017 65077 46429865
Restless legs syndrome 65.59 10.10 177 190943 15666 46479276
Ascites 65.39 10.10 34 191086 36550 46458392
Tardive dyskinesia 64.49 10.10 113 191007 7430 46487512
Prescribed overdose 64.11 10.10 136 190984 10313 46484629
Bone marrow failure 63.63 10.10 21 191099 29648 46465294
General physical health deterioration 63.52 10.10 251 190869 115518 46379424
Multiple organ dysfunction syndrome 63.18 10.10 71 191049 51639 46443303
Off label use 63.11 10.10 1135 189985 378706 46116236
Cardiac failure congestive 62.56 10.10 181 190939 91569 46403373
Leukopenia 61.72 10.10 116 191004 68227 46426715
Amnesia 60.55 10.10 333 190787 41298 46453644
White blood cell count decreased 59.27 10.10 247 190873 111984 46382958
Aggression 58.92 10.10 216 190904 22528 46472414
Abnormal dreams 57.61 10.10 129 190991 10150 46484792
Hyperkalaemia 57.31 10.10 74 191046 50635 46444307
Hypotension 56.58 10.10 644 190476 231945 46262997
Infusion related reaction 56.43 10.10 218 190902 100990 46393952
Post-traumatic stress disorder 56.33 10.10 76 191044 3972 46490970
Somatic symptom disorder 56.21 10.10 53 191067 1859 46493083
Premature delivery 56.20 10.10 11 191109 22058 46472884
Affective disorder 56.05 10.10 83 191037 4732 46490210
Weight increased 55.50 10.10 964 190156 163509 46331433
Gastrointestinal haemorrhage 55.45 10.10 149 190971 77224 46417718
Multiple sclerosis relapse 54.11 10.10 326 190794 41799 46453143
Mania 54.08 10.10 130 190990 10716 46484226
Coordination abnormal 53.27 10.10 130 190990 10819 46484123
Alanine aminotransferase increased 53.13 10.10 575 190545 87876 46407066
Hypersensitivity 52.34 10.10 380 190740 149941 46345001
Cough 51.98 10.10 648 190472 229601 46265341
Product substitution issue 51.62 10.10 157 190963 14874 46480068
Infection 50.82 10.10 329 190791 133263 46361679
Cytomegalovirus infection 50.76 10.10 7 191113 18137 46476805
White blood cell count abnormal 50.68 10.10 82 191038 5050 46489892
Hepatic enzyme increased 50.20 10.10 534 190586 81253 46413689
Pneumonia aspiration 50.19 10.10 259 190861 31346 46463596
Sopor 49.43 10.10 186 190934 19642 46475300
Abdominal discomfort 49.37 10.10 389 190731 150776 46344166
Dehydration 48.27 10.10 419 190701 159121 46335821
Therapy interrupted 48.17 10.10 124 190996 10667 46484275
Neck deformity 48.13 10.10 48 191072 1806 46493136
Respiratory failure 47.41 10.10 213 190907 94603 46400339
Inappropriate antidiuretic hormone secretion 47.21 10.10 146 190974 13956 46480986
Extremity contracture 47.03 10.10 39 191081 1150 46493792
Lactic acidosis 46.63 10.10 42 191078 33867 46461075
Joint swelling 46.41 10.10 445 190675 165628 46329314
Abnormal behaviour 46.39 10.10 190 190930 20868 46474074
Coma blister 46.22 10.10 19 191101 136 46494806
Pulmonary oedema 45.91 10.10 87 191033 51018 46443924
Device expulsion 45.77 10.10 28 191092 27514 46467428
Oedema peripheral 44.60 10.10 428 190692 159278 46335664
Bradycardia 44.31 10.10 132 190988 66166 46428776
Intentional self-injury 43.32 10.10 205 190915 23961 46470981
Loss of consciousness 43.05 10.10 652 190468 107586 46387356
Palmar-plantar erythrodysaesthesia syndrome 42.94 10.10 15 191105 20436 46474506
Hypocalcaemia 42.10 10.10 29 191091 26756 46468186
Fall 41.77 10.10 1695 189425 327402 46167540
Hallucination 41.57 10.10 348 190772 49603 46445339
Dry mouth 41.21 10.10 374 190746 54552 46440390
Coma 40.12 10.10 390 190730 57959 46436983
Drug ineffective 39.88 10.10 2321 188799 675517 45819425
Cognitive disorder 39.72 10.10 273 190847 36610 46458332
Wound 39.21 10.10 72 191048 42730 46452212
Lower respiratory tract infection 38.78 10.10 107 191013 54982 46439960
Epistaxis 38.14 10.10 135 190985 64170 46430772
Rapid eye movements sleep abnormal 37.91 10.10 15 191105 96 46494846
Deep vein thrombosis 37.64 10.10 183 190937 79590 46415352
Pericarditis 37.48 10.10 26 191094 23901 46471041
Neoplasm progression 36.75 10.10 33 191087 26650 46468292
Myocardial infarction 36.66 10.10 241 190879 97287 46397655
Balance disorder 36.25 10.10 414 190706 64107 46430835
Product use in unapproved indication 36.03 10.10 219 190901 90054 46404888
Intervertebral discitis 35.84 10.10 48 191072 2491 46492451
Urinary retention 35.60 10.10 205 190915 25856 46469086
Pulmonary fibrosis 35.42 10.10 19 191101 20073 46474869
Colitis microscopic 35.32 10.10 81 191039 6475 46488467
Aspartate aminotransferase increased 35.23 10.10 484 190636 78216 46416726
Muscle twitching 35.23 10.10 136 190984 14536 46480406
Metabolic surgery 34.64 10.10 30 191090 940 46494002
Tachyphrenia 34.51 10.10 34 191086 1260 46493682
Neck mass 34.42 10.10 54 191066 3239 46491703
Sacroiliitis 33.71 10.10 43 191077 2126 46492816
Coronary artery disease 33.46 10.10 54 191066 33698 46461244
Sleep apnoea syndrome 33.23 10.10 179 190941 22022 46472920
Restlessness 33.07 10.10 198 190922 25326 46469616
Peripheral swelling 33.01 10.10 452 190668 157619 46337323
Melaena 32.98 10.10 39 191081 27733 46467209
Psychotic disorder due to a general medical condition 32.31 10.10 16 191104 185 46494757
Rash maculo-papular 32.19 10.10 40 191080 27834 46467108
Akathisia 31.75 10.10 86 191034 7628 46487314
Dyskinesia 31.68 10.10 215 190905 28710 46466232
Abdominal pain 31.60 10.10 709 190411 229322 46265620
Hallucination, visual 31.59 10.10 151 190969 17722 46477220
Seizure 31.56 10.10 692 190428 122362 46372580
Eosinophilia 31.29 10.10 20 191100 19197 46475745
Paranoia 31.20 10.10 105 191015 10492 46484450
Anaphylactic reaction 31.16 10.10 112 191008 53000 46441942
Arthropathy 30.98 10.10 211 190909 84489 46410453
Stomatitis 30.89 10.10 159 190961 68138 46426804
Acute myeloid leukaemia 30.76 10.10 13 191107 15765 46479177
Impaired driving ability 30.71 10.10 59 191061 4165 46490777
Hypersomnia 30.67 10.10 135 190985 15304 46479638
Stiff person syndrome 30.55 10.10 15 191105 170 46494772
Bipolar disorder 30.53 10.10 81 191039 7096 46487846
Hypokalaemia 30.38 10.10 223 190897 87801 46407141
Surgery 30.36 10.10 212 190908 28573 46466369
Hypomagnesaemia 29.95 10.10 28 191092 22182 46472760
Libido decreased 29.03 10.10 44 191076 2561 46492381
Pulmonary eosinophilia 28.96 10.10 16 191104 235 46494707
Dissociation 28.84 10.10 37 191083 1840 46493102
Haemoptysis 28.79 10.10 39 191081 26150 46468792
Anorgasmia 28.76 10.10 22 191098 576 46494366
Proteinuria 28.68 10.10 16 191104 16537 46478405
Cerebral infarction 28.63 10.10 32 191088 23334 46471608
Nervousness 28.46 10.10 207 190913 28268 46466674
Hyperreflexia 28.40 10.10 65 191055 5189 46489753
Disseminated intravascular coagulation 28.02 10.10 22 191098 18983 46475959
Acute respiratory distress syndrome 27.99 10.10 29 191091 21893 46473049
Autonomic dysreflexia 27.96 10.10 15 191105 207 46494735
Drug interaction 27.81 10.10 1055 190065 202039 46292903
Agranulocytosis 27.60 10.10 30 191090 22155 46472787
Complex regional pain syndrome 27.56 10.10 38 191082 2028 46492914
Therapy cessation 27.43 10.10 195 190925 26434 46468508
Hypoxia 27.40 10.10 114 191006 51724 46443218
Hypoglycaemia 27.21 10.10 122 190998 54227 46440715
Rubber sensitivity 26.96 10.10 34 191086 1662 46493280
Dyspnoea exertional 26.95 10.10 110 191010 50179 46444763
Gastric banding 26.73 10.10 11 191109 79 46494863
Cholestasis 26.68 10.10 43 191077 26850 46468092
Temperature intolerance 26.63 10.10 80 191040 7527 46487415
Rheumatoid nodule 26.40 10.10 3 191117 9017 46485925
Hot flush 26.16 10.10 283 190837 43234 46451708
Pulmonary arterial hypertension 26.15 10.10 41 191079 25887 46469055
Bone density abnormal 26.10 10.10 46 191074 3038 46491904
Metastases to bone 26.06 10.10 20 191100 17456 46477486
Pruritus 25.34 10.10 777 190343 241575 46253367
Plasma cell myeloma 25.30 10.10 95 191025 44383 46450559
Gastrostomy 25.15 10.10 20 191100 555 46494387
Pulmonary malformation 25.10 10.10 11 191109 94 46494848
Hyperaesthesia 25.07 10.10 80 191040 7776 46487166
Vision blurred 25.01 10.10 462 190658 79246 46415696
Mental disorder 24.74 10.10 167 190953 22258 46472684
Myelodysplastic syndrome 24.70 10.10 17 191103 15694 46479248
Anovulatory cycle 24.67 10.10 12 191108 133 46494809
Pain 24.63 10.10 2269 188851 474679 46020263
Loss of libido 24.62 10.10 29 191091 1320 46493622
Disorientation 24.52 10.10 245 190875 36673 46458269
Drug resistance 24.50 10.10 21 191099 17347 46477595
Duodenal ulcer perforation 24.45 10.10 3 191117 8499 46486443
Bruxism 24.25 10.10 44 191076 2973 46491969
Product use issue 24.18 10.10 259 190861 94385 46400557
Pneumonitis 24.13 10.10 50 191070 28370 46466572
Multiple sclerosis 24.08 10.10 179 190941 24612 46470330
Oxygen saturation decreased 23.97 10.10 175 190945 68989 46425953
Pulmonary embolism 23.93 10.10 307 190813 108278 46386664
Concussion 23.90 10.10 73 191047 6930 46488012
Torsade de pointes 23.71 10.10 10 191110 12144 46482798
Formication 23.70 10.10 51 191069 3905 46491037
Sleep terror 23.56 10.10 22 191098 762 46494180
Nasal turbinate hypertrophy 23.35 10.10 17 191103 412 46494530
Tearfulness 23.29 10.10 52 191068 4083 46490859
Respiratory distress 23.21 10.10 61 191059 31855 46463087
Angioedema 23.05 10.10 83 191037 39259 46455683
Foetal death 23.03 10.10 4 191116 8739 46486203
Psychotic disorder 22.92 10.10 165 190955 22456 46472486
Metastases to liver 22.73 10.10 28 191092 19557 46475385
Toxic epidermal necrolysis 22.69 10.10 35 191085 22243 46472699
Peritonitis 22.61 10.10 31 191089 20683 46474259
Metabolic acidosis 22.60 10.10 82 191038 38698 46456244
Ejection fraction decreased 22.60 10.10 24 191096 17913 46477029
Speech disorder 22.58 10.10 237 190883 35930 46459012
Shock 22.56 10.10 34 191086 21811 46473131
Decreased appetite 22.38 10.10 613 190507 193223 46301719
Drug hypersensitivity 22.14 10.10 1215 189905 242610 46252332
C-reactive protein increased 21.90 10.10 145 190975 58445 46436497
Delusion 21.60 10.10 97 191023 11091 46483851
Thrombotic microangiopathy 21.44 10.10 4 191116 8302 46486640
Haemorrhage 21.42 10.10 134 190986 54735 46440207
Fluid overload 21.29 10.10 50 191070 27135 46467807
Osteonecrosis of jaw 21.22 10.10 71 191049 34331 46460611
Hostility 21.17 10.10 27 191093 1335 46493607
Neuralgia 21.11 10.10 155 190965 21228 46473714
Depressive symptom 21.09 10.10 40 191080 2796 46492146
Circulatory collapse 21.05 10.10 35 191085 21589 46473353
Angina unstable 20.91 10.10 3 191117 7545 46487397
Right ventricular failure 20.88 10.10 21 191099 16072 46478870
Pneumocystis jirovecii pneumonia 20.83 10.10 19 191101 15229 46479713
Mydriasis 20.75 10.10 92 191028 10461 46484481
Haemodialysis 20.70 10.10 6 191114 9211 46485731
Influenza like illness 20.68 10.10 341 190779 57229 46437713
Peritonitis bacterial 20.64 10.10 5 191115 8648 46486294
Blood pressure increased 20.55 10.10 671 190449 125995 46368947
Cardiogenic shock 20.55 10.10 22 191098 16362 46478580
Pregnancy 20.40 10.10 51 191069 27086 46467856
Chronic obstructive pulmonary disease 20.37 10.10 145 190975 57488 46437454
Discomfort 20.34 10.10 110 191010 46560 46448382
Hypoalbuminaemia 20.30 10.10 8 191112 10119 46484823
Cardiac arrest 20.14 10.10 255 190865 90144 46404798
Toxic skin eruption 20.02 10.10 13 191107 12374 46482568
Morbid thoughts 19.84 10.10 17 191103 525 46494417
Psychomotor hyperactivity 19.82 10.10 85 191035 9528 46485414
Acute myocardial infarction 19.61 10.10 66 191054 31858 46463084
Emotional disorder 19.56 10.10 101 191019 12223 46482719
Infective pulmonary exacerbation of cystic fibrosis 19.37 10.10 10 191110 10797 46484145
Decreased interest 19.31 10.10 41 191079 3111 46491831
Hyperglycaemia 19.24 10.10 76 191044 34995 46459947
Tuberculosis 19.16 10.10 9 191111 10256 46484686
Antinuclear antibody negative 19.01 10.10 12 191108 228 46494714
Granulomatous liver disease 18.93 10.10 20 191100 806 46494136
Lung disorder 18.91 10.10 102 191018 43202 46451740
Accidental exposure to product 18.83 10.10 36 191084 21045 46473897
Swelling 18.75 10.10 378 190742 124133 46370809
Device related infection 18.74 10.10 36 191084 21005 46473937
Haematotoxicity 18.64 10.10 3 191117 6930 46488012
Aspergillus infection 18.49 10.10 3 191117 6887 46488055
Pulmonary congestion 18.42 10.10 20 191100 14779 46480163
Haemorrhage intracranial 18.42 10.10 15 191105 12709 46482233
Tubulointerstitial nephritis 18.39 10.10 20 191100 14768 46480174
Gastrooesophageal reflux disease 18.39 10.10 416 190704 73928 46421014
Hallucination, auditory 18.38 10.10 90 191030 10666 46484276
Ischaemic stroke 18.28 10.10 25 191095 16697 46478245
Libido increased 18.24 10.10 19 191101 753 46494189
Tension 18.16 10.10 38 191082 2854 46492088
Homicidal ideation 18.08 10.10 29 191091 1773 46493169
Premature labour 18.07 10.10 12 191108 11287 46483655
Sexual dysfunction 18.01 10.10 34 191086 2369 46492573
Coombs positive haemolytic anaemia 17.99 10.10 14 191106 376 46494566
Respiratory tract malformation 17.99 10.10 8 191112 71 46494871
Caesarean section 17.97 10.10 25 191095 16578 46478364
Conversion disorder 17.97 10.10 28 191092 1670 46493272
Pulmonary hypertension 17.89 10.10 81 191039 35912 46459030
Pustular psoriasis 17.77 10.10 46 191074 3971 46490971
Hepatitis C antibody positive 17.70 10.10 8 191112 74 46494868
Metastases to lung 17.59 10.10 11 191109 10685 46484257
Pseudomonas infection 17.54 10.10 9 191111 9749 46485193
Vomiting 17.53 10.10 2113 189007 450681 46044261
Flat affect 17.50 10.10 24 191096 1274 46493668
Oliguria 17.42 10.10 7 191113 8752 46486190
Graft versus host disease 17.38 10.10 3 191117 6585 46488357
Pulseless electrical activity 17.37 10.10 4 191116 7163 46487779
Second primary malignancy 17.37 10.10 3 191117 6581 46488361
Galactorrhoea 17.33 10.10 44 191076 3753 46491189
Aplastic anaemia 17.32 10.10 4 191116 7149 46487793
Disability 17.32 10.10 85 191035 10082 46484860
Gastric ulcer 17.29 10.10 40 191080 21823 46473119
Pre-existing condition improved 17.29 10.10 63 191057 6549 46488393
Heart rate decreased 17.24 10.10 69 191051 31654 46463288
CYP3A4 polymorphism 17.16 10.10 8 191112 80 46494862
Apathy 17.14 10.10 67 191053 7201 46487741
Acute hepatic failure 17.13 10.10 21 191099 14700 46480242
Liver function test increased 17.08 10.10 43 191077 22783 46472159
Lymphadenopathy 16.86 10.10 75 191045 33413 46461529
Haematuria 16.86 10.10 55 191065 26803 46468139
Chest discomfort 16.78 10.10 264 190856 90005 46404937
Bacteraemia 16.74 10.10 20 191100 14159 46480783
Hypnopompic hallucination 16.72 10.10 6 191114 28 46494914
Cerebrovascular accident 16.67 10.10 302 190818 100737 46394205
Inflammation 16.62 10.10 124 190996 48657 46446285
Live birth 16.48 10.10 11 191109 10319 46484623
Reversible cerebral vasoconstriction syndrome 16.37 10.10 27 191093 1690 46493252
Transfusion 16.34 10.10 18 191102 13213 46481729
Therapy non-responder 16.32 10.10 100 191020 41052 46453890
Clonus 16.30 10.10 45 191075 4035 46490907
Abdominal distension 16.30 10.10 207 190913 73144 46421798
Hepatic function abnormal 16.21 10.10 79 191041 34342 46460600
Bronchial neoplasm 16.19 10.10 11 191109 238 46494704
Product dose omission issue 16.12 10.10 844 190276 167676 46327266
Head injury 16.12 10.10 163 190957 24473 46470469
Major depression 16.05 10.10 62 191058 6628 46488314
Foetal exposure during pregnancy 16.01 10.10 68 191052 30679 46464263
Dysphemia 16.01 10.10 32 191088 2326 46492616
Asthma 15.94 10.10 271 190849 91271 46403671
Asphyxia 15.88 10.10 53 191067 5273 46489669
Cerebral haemorrhage 15.87 10.10 61 191059 28310 46466632
Red blood cell count decreased 15.87 10.10 74 191046 32549 46462393
Opsoclonus myoclonus 15.72 10.10 9 191111 142 46494800
Bipolar I disorder 15.67 10.10 25 191095 1521 46493421
Drug screen positive 15.63 10.10 43 191077 3848 46491094
Pathogen resistance 15.47 10.10 3 191117 6057 46488885
Hypercalcaemia 15.47 10.10 40 191080 21006 46473936
Breast cancer metastatic 15.41 10.10 20 191100 13658 46481284
Condition aggravated 15.40 10.10 833 190287 244219 46250723
Productive cough 15.40 10.10 133 190987 50582 46444360
Skin necrosis 15.37 10.10 8 191112 8596 46486346
Panic disorder 15.33 10.10 33 191087 2528 46492414
Anaphylactic shock 15.32 10.10 38 191082 20236 46474706
Metastases to central nervous system 15.30 10.10 14 191106 11207 46483735
Respiratory tract infection 15.17 10.10 67 191053 29905 46465037
Pulmonary haemorrhage 15.05 10.10 4 191116 6501 46488441
Diffuse large B-cell lymphoma 15.03 10.10 3 191117 5935 46489007
Haemolytic anaemia 15.01 10.10 11 191109 9831 46485111
Oedema 15.01 10.10 189 190931 66882 46428060
Lung cyst 15.00 10.10 8 191112 109 46494833
Stillbirth 15.00 10.10 4 191116 6487 46488455
Hypoaesthesia 14.96 10.10 612 190508 118257 46376685
Cataplexy 14.93 10.10 21 191099 1142 46493800
Abortion spontaneous 14.85 10.10 111 191009 43535 46451407
Chest pain 14.78 10.10 581 190539 175743 46319199
Bronchospasm 14.76 10.10 26 191094 15681 46479261
Sleep talking 14.76 10.10 19 191101 948 46493994
Immunisation reaction 14.75 10.10 5 191115 19 46494923
Cataract 14.74 10.10 117 191003 45298 46449644
Herpes simplex reactivation 14.64 10.10 12 191108 348 46494594
Eyelid myoclonus 14.47 10.10 6 191114 44 46494898
Congenital tricuspid valve atresia 14.47 10.10 6 191114 44 46494898
Hypophosphataemia 14.47 10.10 6 191114 7361 46487581
Feelings of worthlessness 14.35 10.10 11 191109 289 46494653
Impulse-control disorder 14.31 10.10 16 191104 688 46494254
Blood lactate dehydrogenase increased 14.29 10.10 40 191080 20460 46474482
Basal cell carcinoma 14.26 10.10 40 191080 20447 46474495
Feeling of despair 14.10 10.10 26 191094 1779 46493163
Gait disturbance 13.99 10.10 728 190392 144535 46350407
Tic 13.95 10.10 21 191099 1215 46493727
Drug eruption 13.86 10.10 43 191077 21286 46473656
Clostridium difficile colitis 13.84 10.10 35 191085 18518 46476424
Abortion induced 13.76 10.10 13 191107 10247 46484695
Metastases to lymph nodes 13.69 10.10 5 191115 6626 46488316
Rectal haemorrhage 13.63 10.10 96 191024 38159 46456783
Femur fracture 13.60 10.10 92 191028 36905 46458037
Phobia of driving 13.51 10.10 3 191117 0 46494942
Hyperacusis 13.51 10.10 26 191094 1838 46493104
Ophthalmic vein thrombosis 13.51 10.10 8 191112 135 46494807
Hyponatraemic encephalopathy 13.50 10.10 10 191110 249 46494693
Phagophobia 13.50 10.10 5 191115 26 46494916
Chronic kidney disease 13.40 10.10 105 191015 40766 46454176
Ankle fracture 13.40 10.10 109 191011 15402 46479540
Polyarthritis 13.39 10.10 5 191115 6537 46488405
Pain in jaw 13.33 10.10 97 191023 38275 46456667
Road traffic accident 13.29 10.10 152 190968 23539 46471403
Depression suicidal 13.18 10.10 23 191097 1507 46493435
Food craving 13.16 10.10 20 191100 1167 46493775
Demyelination 13.11 10.10 52 191068 5628 46489314
Impatience 13.10 10.10 11 191109 330 46494612
Autonomic nervous system imbalance 13.10 10.10 30 191090 2396 46492546
Escherichia infection 13.05 10.10 15 191105 10802 46484140
Self-injurious ideation 13.04 10.10 29 191091 2271 46492671
Uraemic encephalopathy 13.03 10.10 9 191111 200 46494742
Spinal operation 13.01 10.10 51 191069 5489 46489453
Myocardial ischaemia 13.01 10.10 20 191100 12729 46482213
Bronchial haemorrhage 12.99 10.10 11 191109 334 46494608
Diplopia 12.99 10.10 129 190991 19276 46475666
Therapeutic product effect decreased 12.97 10.10 249 190871 82352 46412590
Blood calcium decreased 12.95 10.10 28 191092 15645 46479297
Holmes-Adie pupil 12.91 10.10 5 191115 30 46494912
Renal injury 12.90 10.10 12 191108 9529 46485413
Herpes zoster 12.78 10.10 198 190922 67674 46427268
Renal disorder 12.71 10.10 61 191059 26625 46468317
Blood pressure diastolic abnormal 12.57 10.10 5 191115 6289 46488653
Gun shot wound 12.54 10.10 7 191113 105 46494837
Tumour lysis syndrome 12.53 10.10 7 191113 7229 46487713
Rapid eye movement sleep behaviour disorder 12.45 10.10 8 191112 157 46494785
Pericardial effusion 12.39 10.10 58 191062 25485 46469457
Leukopenia neonatal 12.38 10.10 5 191115 34 46494908
Status epilepticus 12.37 10.10 24 191096 13955 46480987
Mean cell haemoglobin concentration increased 12.26 10.10 12 191108 441 46494501
Hepatobiliary scan abnormal 12.22 10.10 6 191114 68 46494874
Panic reaction 12.17 10.10 38 191082 3651 46491291
Unintended pregnancy 12.15 10.10 4 191116 5656 46489286
Nasal congestion 12.15 10.10 132 190988 47981 46446961
Hepatic steatosis 12.06 10.10 151 190969 23891 46471051
Rales 12.01 10.10 13 191107 9618 46485324
Therapeutic response changed 11.99 10.10 15 191105 727 46494215
Tenosynovitis 11.99 10.10 8 191112 7507 46487435
Myoclonus 11.94 10.10 100 191020 14252 46480690
Suspected product quality issue 11.86 10.10 8 191112 171 46494771
Neuropsychiatric symptoms 11.81 10.10 12 191108 462 46494480
Acute pulmonary oedema 11.80 10.10 9 191111 7882 46487060
Haemolysis 11.80 10.10 5 191115 6054 46488888
Enterococcal infection 11.75 10.10 7 191113 6980 46487962
Vasculitis 11.74 10.10 24 191096 13687 46481255
Radiation fibrosis 11.69 10.10 5 191115 40 46494902
Staphylococcal infection 11.68 10.10 92 191028 35679 46459263
Lung infiltration 11.67 10.10 25 191095 14018 46480924
Rebound nasal congestion 11.64 10.10 4 191116 16 46494926
Anuria 11.60 10.10 18 191102 11413 46483529
Osteonecrosis 11.60 10.10 60 191060 25684 46469258
Alcoholism 11.51 10.10 27 191093 2191 46492751
Bone erosion 11.49 10.10 13 191107 9430 46485512
Disease recurrence 11.47 10.10 38 191082 18433 46476509
Hypoaesthesia teeth 11.44 10.10 3 191117 3 46494939
Atelectasis 11.44 10.10 39 191081 18751 46476191
Phonophobia 11.40 10.10 10 191110 319 46494623
Dry skin 11.39 10.10 110 191010 40906 46454036
Low birth weight baby 11.38 10.10 4 191116 5430 46489512
Pneumothorax 11.38 10.10 27 191093 14602 46480340
Eczema 11.32 10.10 44 191076 20356 46474586
Swelling face 11.32 10.10 151 190969 52908 46442034
Bradyphrenia 11.27 10.10 53 191067 6177 46488765
Scar 11.23 10.10 86 191034 11933 46483009
Polyneuropathy 11.19 10.10 19 191101 11625 46483317
Middle insomnia 11.19 10.10 72 191048 9443 46485499
Urinary hesitation 11.19 10.10 24 191096 1834 46493108
Polyglandular autoimmune syndrome type II 11.18 10.10 5 191115 45 46494897
Skin discolouration 11.17 10.10 83 191037 32597 46462345
Osteopenia 11.16 10.10 34 191086 16927 46478015
Duodenal ulcer 11.10 10.10 8 191112 7210 46487732
Poor quality sleep 11.00 10.10 103 191017 15150 46479792
Feeling drunk 10.99 10.10 38 191082 3849 46491093
Feeling jittery 10.98 10.10 80 191040 10928 46484014
Posterior reversible encephalopathy syndrome 10.96 10.10 29 191091 15112 46479830
Tricuspid valve incompetence 10.93 10.10 25 191095 13692 46481250
Blood urea increased 10.91 10.10 60 191060 25292 46469650
Sluggishness 10.87 10.10 43 191077 4648 46490294
Spasmodic dysphonia 10.87 10.10 6 191114 88 46494854
Embolism 10.86 10.10 8 191112 7130 46487812
Coagulopathy 10.85 10.10 39 191081 18460 46476482
Osteoporosis 10.82 10.10 110 191010 40498 46454444
Impulsive behaviour 10.82 10.10 21 191099 1494 46493448
Purple glove syndrome 10.81 10.10 8 191112 199 46494743
Sleep disorder due to general medical condition, insomnia type 10.76 10.10 4 191116 5245 46489697
Lung neoplasm 10.76 10.10 5 191115 5735 46489207
Daydreaming 10.74 10.10 10 191110 345 46494597
Accommodation disorder 10.74 10.10 10 191110 345 46494597
Alveolar bone resorption 10.73 10.10 5 191115 50 46494892
Blood pressure decreased 10.68 10.10 167 190953 56992 46437950
Injection site haemorrhage 10.66 10.10 46 191074 20663 46474279
Blister 10.65 10.10 124 190996 44507 46450435
Angina pectoris 10.65 10.10 65 191055 26710 46468232
Haematocrit decreased 10.61 10.10 92 191028 34965 46459977
Skin lesion 10.55 10.10 65 191055 26648 46468294
Gambling disorder 10.54 10.10 19 191101 1277 46493665
International normalised ratio increased 10.53 10.10 132 190988 46751 46448191
Nasopharyngitis 10.52 10.10 519 190601 153479 46341463
Clostridium difficile infection 10.48 10.10 60 191060 25043 46469899
Rash erythematous 10.46 10.10 90 191030 34260 46460682
Acute respiratory failure 10.44 10.10 73 191047 29065 46465877
Maternal exposure during breast feeding 10.40 10.10 30 191090 2759 46492183
Ventricular hypoplasia 10.40 10.10 7 191113 149 46494793
Drug-induced liver injury 10.40 10.10 61 191059 25307 46469635
Flushing 10.38 10.10 194 190926 64420 46430522
Skin ulcer 10.36 10.10 84 191036 32374 46462568
Shock haemorrhagic 10.36 10.10 12 191108 8612 46486330
Dialysis 10.20 10.10 16 191104 10100 46484842
Intestinal cyst 10.19 10.10 6 191114 100 46494842
Intervertebral disc protrusion 10.17 10.10 128 190992 20277 46474665
Hepatitis A antibody positive 10.16 10.10 5 191115 57 46494885

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 1283.72 10.91 684 61471 19125 29871198
Dysphoria 1257.28 10.91 367 61788 1781 29888542
Affect lability 1165.00 10.91 386 61769 3032 29887291
Suicidal ideation 748.38 10.91 611 61544 35503 29854820
Irritability 673.96 10.91 479 61676 22571 29867752
Sensory disturbance 575.71 10.91 268 61887 5543 29884780
Paraesthesia 516.11 10.91 599 61556 53728 29836595
Vertigo 515.52 10.91 405 61750 22230 29868093
Agitation 476.86 10.91 574 61581 53499 29836824
Anxiety 456.45 10.91 731 61424 89140 29801183
Insomnia 446.67 10.91 739 61416 92597 29797726
Hyperhidrosis 365.71 10.91 564 61591 66526 29823797
Nightmare 292.03 10.91 224 61931 11852 29878471
Dizziness 268.95 10.91 951 61204 193958 29696365
Tinnitus 243.74 10.91 228 61927 15860 29874463
Confusional state 224.99 10.91 702 61453 134132 29756191
Lethargy 224.65 10.91 339 61816 39180 29851143
Tremor 224.61 10.91 488 61667 74875 29815448
Hypomania 217.06 10.91 102 62053 2154 29888169
Mood swings 216.95 10.91 156 61999 7470 29882853
Serotonin syndrome 191.25 10.91 210 61945 17681 29872642
Completed suicide 174.14 10.91 527 61628 98965 29791358
Headache 164.75 10.91 781 61374 181525 29708798
Depression 161.97 10.91 483 61672 89954 29800369
Nausea 141.14 10.91 1075 61080 295882 29594441
Sleep disorder 129.21 10.91 203 61952 24276 29866047
Pyrexia 125.66 10.91 265 61890 294224 29596099
Suicide attempt 122.39 10.91 249 61906 36448 29853875
Febrile neutropenia 108.19 10.91 43 62112 106650 29783673
Fatigue 101.64 10.91 1063 61092 319610 29570713
Thrombocytopenia 99.50 10.91 83 62072 136961 29753362
Anger 97.71 10.91 118 62037 11002 29879321
Acute kidney injury 95.09 10.91 274 61881 273568 29616755
Gastrointestinal tube insertion 87.82 10.91 46 62109 1235 29889088
Anaemia 82.13 10.91 195 61960 207797 29682526
Withdrawal syndrome 80.83 10.91 108 62047 11142 29879181
Intentional self-injury 72.47 10.91 113 62042 13419 29876904
Somnolence 72.00 10.91 393 61762 96370 29793953
Pancytopenia 70.14 10.91 45 62110 85007 29805316
Feeling abnormal 68.67 10.91 266 61889 56490 29833833
Neutropenia 65.95 10.91 103 62052 128437 29761886
Dyspnoea 65.28 10.91 415 61740 332880 29557443
Disturbance in attention 62.05 10.91 140 62015 21989 29868334
Memory impairment 57.61 10.91 189 61966 36985 29853338
Fall 57.38 10.91 603 61552 181269 29709054
Sepsis 54.77 10.91 141 62014 146254 29744069
Hepatic enzyme increased 52.54 10.91 171 61984 33323 29857000
Sexual dysfunction 49.99 10.91 62 62093 5939 29884384
Platelet count decreased 49.83 10.91 90 62065 106039 29784284
Disease progression 48.00 10.91 57 62098 79817 29810506
Blood creatinine increased 47.04 10.91 73 62082 91302 29799021
Renal failure 46.12 10.91 127 62028 128839 29761484
Leukopenia 45.89 10.91 30 62125 56129 29834194
Multiple organ dysfunction syndrome 45.34 10.91 39 62116 63448 29826875
Haemoglobin decreased 44.92 10.91 107 62048 113991 29776332
Pleural effusion 44.35 10.91 53 62102 74013 29816310
Loss of consciousness 42.94 10.91 297 61858 79078 29811245
Respiratory failure 42.36 10.91 91 62064 100551 29789772
Cardiac failure 41.65 10.91 68 62087 83350 29806973
Mucosal inflammation 40.89 10.91 7 62148 30487 29859836
Malignant neoplasm progression 37.92 10.91 57 62098 72230 29818093
Gastric bypass 37.63 10.91 16 62139 264 29890059
Urinary retention 37.15 10.91 151 62004 32766 29857557
Migraine 36.70 10.91 82 62073 12792 29877531
Urinary hesitation 35.78 10.91 33 62122 2251 29888072
Intentional overdose 35.31 10.91 175 61980 41306 29849017
Cytomegalovirus infection 35.11 10.91 4 62151 23670 29866653
Antidepressant drug level above therapeutic 34.55 10.91 13 62142 153 29890170
Septic shock 34.49 10.91 49 62106 63558 29826765
Cough 34.41 10.91 139 62016 125503 29764820
Pneumonia 34.06 10.91 489 61666 333817 29556506
Balance disorder 33.98 10.91 158 61997 36335 29853988
Respiratory disorder neonatal 33.09 10.91 24 62131 1164 29889159
Metabolic acidosis 32.00 10.91 19 62136 37442 29852881
Therapy interrupted 31.80 10.91 43 62112 4486 29885837
Myoclonus 31.66 10.91 79 62076 13233 29877090
Mania 31.54 10.91 63 62092 9091 29881232
Toxicity to various agents 31.33 10.91 529 61626 176654 29713669
Road traffic accident 31.25 10.91 92 62063 16979 29873344
Major depression 31.04 10.91 40 62115 3982 29886341
General physical health deterioration 31.01 10.91 105 62050 99839 29790484
Aggression 30.91 10.91 155 62000 36752 29853571
Haemorrhage 30.88 10.91 30 62125 46049 29844274
Atrial fibrillation 29.99 10.91 119 62036 108005 29782318
Dehydration 29.99 10.91 143 62012 123396 29766927
Analgesic drug level above therapeutic 29.65 10.91 13 62142 232 29890091
Ascites 29.59 10.91 19 62136 35902 29854421
Pain 29.27 10.91 512 61643 172129 29718194
Disorientation 29.23 10.91 136 62019 31282 29859041
Drug hypersensitivity 28.96 10.91 242 61913 68277 29822046
Amnesia 28.58 10.91 113 62042 24208 29866115
Drug resistance 28.41 10.91 4 62151 20129 29870194
Renal impairment 27.81 10.91 86 62069 84098 29806225
Self esteem decreased 27.50 10.91 16 62139 530 29889793
C-reactive protein increased 27.21 10.91 30 62125 43443 29846880
Yawning 27.20 10.91 16 62139 541 29889782
Abnormal dreams 26.95 10.91 55 62100 8060 29882263
Myocardial infarction 26.79 10.91 152 62003 125473 29764850
Interstitial lung disease 26.52 10.91 53 62102 60144 29830179
Product use in unapproved indication 25.99 10.91 73 62082 73620 29816703
Disseminated intravascular coagulation 25.84 10.91 7 62148 22164 29868159
Initial insomnia 25.27 10.91 29 62126 2560 29887763
Sedation 25.13 10.91 83 62072 16290 29874033
Homicidal ideation 24.74 10.91 28 62127 2435 29887888
Bone marrow failure 24.20 10.91 16 62139 29769 29860554
Erectile dysfunction 23.65 10.91 87 62068 18015 29872308
Agranulocytosis 23.63 10.91 8 62147 21934 29868389
Fibromyalgia 23.35 10.91 28 62127 2590 29887733
Feeling jittery 23.25 10.91 34 62121 3814 29886509
Acute respiratory distress syndrome 22.89 10.91 10 62145 23462 29866861
Surgery 22.84 10.91 64 62091 11487 29878836
Convulsive threshold lowered 22.74 10.91 14 62141 515 29889808
Rash 22.65 10.91 272 61883 191617 29698706
Multiple sclerosis relapse 22.28 10.91 61 62094 10801 29879522
Hypokalaemia 22.27 10.91 44 62111 50148 29840175
Overdose 22.15 10.91 270 61885 84067 29806256
Hallucination, auditory 22.14 10.91 57 62098 9732 29880591
Cardiac failure congestive 22.09 10.91 95 62060 84312 29806011
White blood cell count decreased 21.65 10.91 95 62060 83852 29806471
Hallucination 21.11 10.91 174 61981 48885 29841438
International normalised ratio increased 21.05 10.91 42 62113 47697 29842626
Somnambulism 20.30 10.91 29 62126 3185 29887138
Toxic epidermal necrolysis 20.28 10.91 6 62149 17934 29872389
Wrong drug 19.98 10.91 7 62148 66 29890257
Erythema 19.76 10.91 88 62067 77363 29812960
Bradyphrenia 19.74 10.91 32 62123 3925 29886398
Neonatal tachypnoea 19.69 10.91 8 62147 117 29890206
Abnormal behaviour 19.64 10.91 105 62050 25518 29864805
Delirium 19.62 10.91 148 62007 40483 29849840
Prescribed overdose 19.51 10.91 50 62105 8511 29881812
Peritonitis 19.47 10.91 10 62145 21365 29868958
Depression suicidal 19.15 10.91 18 62137 1258 29889065
Hypotension 19.10 10.91 297 61858 200268 29690055
Growth hormone deficiency 19.02 10.91 9 62146 193 29890130
Gastrointestinal haemorrhage 18.85 10.91 99 62056 83347 29806976
Neuralgia 18.77 10.91 56 62099 10410 29879913
Acute myeloid leukaemia 18.65 10.91 7 62148 17999 29872324
Dysmetropsia 18.49 10.91 4 62151 3 29890320
Psychotic disorder 18.46 10.91 91 62064 21424 29868899
Dystonia 18.36 10.91 53 62102 9674 29880649
Intentional product misuse 18.30 10.91 129 62026 34538 29855785
Feeling guilty 18.26 10.91 10 62145 294 29890029
Acute myocardial infarction 18.25 10.91 53 62102 52886 29837437
Blood lactate dehydrogenase increased 18.23 10.91 10 62145 20591 29869732
Muscle spasticity 18.23 10.91 36 62119 5152 29885171
Affective disorder 18.11 10.91 27 62128 3081 29887242
Acute stress disorder 17.98 10.91 8 62147 148 29890175
Haemoptysis 17.79 10.91 23 62132 31055 29859268
Death 17.76 10.91 586 61569 356697 29533626
Coronary artery disease 17.70 10.91 49 62106 49663 29840660
Infusion related reaction 17.62 10.91 36 62119 40528 29849795
Treatment failure 17.55 10.91 28 62127 34651 29855672
Therapy cessation 17.52 10.91 70 62085 15067 29875256
Respiratory distress 17.28 10.91 26 62129 32946 29857377
Angioedema 17.18 10.91 28 62127 34356 29855967
Pneumocystis jirovecii pneumonia 17.16 10.91 7 62148 17113 29873210
Steatohepatitis 17.08 10.91 10 62145 335 29889988
Speech sound disorder 17.00 10.91 6 62149 58 29890265
Haematuria 16.87 10.91 43 62112 44791 29845532
Hypocalcaemia 16.68 10.91 12 62143 21364 29868959
Ventricular hypoplasia 16.56 10.91 6 62149 63 29890260
Thinking abnormal 16.47 10.91 35 62120 5276 29885047
Tardive dyskinesia 16.47 10.91 34 62121 5023 29885300
Chills 16.24 10.91 86 62069 72252 29818071
Oedema peripheral 16.19 10.91 141 62014 105691 29784632
Orgasm abnormal 16.17 10.91 7 62148 121 29890202
Drug tolerance 15.90 10.91 21 62134 2141 29888182
Hyperlipasaemia 15.87 10.91 11 62144 496 29889827
Dry mouth 15.75 10.91 91 62064 22759 29867564
Sleep-related eating disorder 15.66 10.91 9 62146 291 29890032
Melaena 15.66 10.91 27 62128 32410 29857913
Restless legs syndrome 15.52 10.91 40 62115 6832 29883491
Delirium tremens 15.45 10.91 11 62144 518 29889805
Mental disorder 15.41 10.91 62 62093 13387 29876936
Rash maculo-papular 15.40 10.91 18 62137 25400 29864923
Depressed mood 15.31 10.91 73 62082 16956 29873367
Hypersomnia 15.30 10.91 55 62100 11261 29879062
Retrograde ejaculation 15.15 10.91 9 62146 310 29890013
Liver function test abnormal 15.09 10.91 113 62042 30837 29859486
Pericardial effusion 15.07 10.91 13 62142 21131 29869192
Muscle twitching 14.97 10.91 44 62111 8111 29882212
Urethral discharge 14.96 10.91 4 62151 13 29890310
Gait disturbance 14.95 10.91 228 61927 74549 29815774
Neonatal hyponatraemia 14.69 10.91 6 62149 89 29890234
Compulsive shopping 14.69 10.91 10 62145 438 29889885
Blood urea increased 14.36 10.91 27 62128 31354 29858969
Epistaxis 14.24 10.91 59 62096 52922 29837401
Neoplasm progression 14.22 10.91 10 62145 18013 29872310
Seizure 14.21 10.91 285 61870 98190 29792133
Eosinophilia 14.19 10.91 15 62140 22145 29868178
Paranoia 14.19 10.91 50 62105 10138 29880185
Lower respiratory tract infection 14.06 10.91 21 62134 26693 29863630
Libido decreased 14.06 10.91 30 62125 4536 29885787
Pneumonitis 14.05 10.91 22 62133 27432 29862891
Gastric ulcer 13.88 10.91 7 62148 15114 29875209
Stomatitis 13.84 10.91 36 62119 37243 29853080
Lymphopenia 13.83 10.91 5 62150 13158 29877165
Dyskinesia 13.80 10.91 85 62070 21749 29868574
Apathy 13.79 10.91 36 62119 6196 29884127
Complex regional pain syndrome 13.79 10.91 10 62145 485 29889838
Cholestasis 13.74 10.91 19 62136 24931 29865392
Concussion 13.66 10.91 19 62136 2035 29888288
Limb reduction defect 13.64 10.91 7 62148 180 29890143
Cerebral infarction 13.62 10.91 21 62134 26352 29863971
Drug screen positive 13.62 10.91 29 62126 4378 29885945
Drug reaction with eosinophilia and systemic symptoms 13.49 10.91 24 62131 28464 29861859
Sleep sex 13.47 10.91 3 62152 3 29890320
Helplessness 13.35 10.91 5 62150 58 29890265
Nephropathy toxic 13.09 10.91 3 62152 10636 29879687
Bipolar disorder 13.02 10.91 26 62129 3750 29886573
Angina pectoris 12.98 10.91 26 62129 29492 29860831
Akathisia 12.96 10.91 34 62121 5870 29884453
Facial spasm 12.90 10.91 7 62148 202 29890121
Psychomotor hyperactivity 12.90 10.91 42 62113 8182 29882141
Neutrophil count decreased 12.88 10.91 45 62110 42409 29847914
Suicidal behaviour 12.86 10.91 15 62140 1347 29888976
Myelodysplastic syndrome 12.84 10.91 12 62143 18766 29871557
Colitis ulcerative 12.78 10.91 7 62148 14427 29875896
Lung disorder 12.77 10.91 29 62126 31440 29858883
Productive cough 12.65 10.91 27 62128 29926 29860397
Reflexes abnormal 12.58 10.91 8 62147 312 29890011
Deep vein thrombosis 12.45 10.91 74 62081 60427 29829896
Rhabdomyolysis 12.44 10.91 79 62076 63501 29826822
Homicide 12.44 10.91 13 62142 1033 29889290
Autonomic dysreflexia 12.44 10.91 5 62150 71 29890252
Pulmonary embolism 12.43 10.91 103 62052 78032 29812291
Stiff person syndrome 12.30 10.91 6 62149 138 29890185
Pulmonary fibrosis 12.29 10.91 9 62146 15881 29874442
Clonus 12.29 10.91 20 62135 2461 29887862
Paedophilia 12.26 10.91 3 62152 6 29890317
Graft versus host disease 12.22 10.91 3 62152 10147 29880176
Drug screen false positive 12.21 10.91 11 62144 728 29889595
Lymphoma 12.17 10.91 3 62152 10118 29880205
Fluid overload 12.14 10.91 13 62142 19079 29871244
Palmar-plantar erythrodysaesthesia syndrome 12.06 10.91 8 62147 14862 29875461
Lymphadenopathy 12.03 10.91 20 62135 24356 29865967
Hypoalbuminaemia 12.02 10.91 4 62151 11088 29879235
Anaphylactic reaction 12.01 10.91 25 62130 27957 29862366
Central nervous system stimulation 11.94 10.91 3 62152 7 29890316
Fine motor delay 11.88 10.91 6 62149 149 29890174
Ileus 11.79 10.91 9 62146 15546 29874777
Tumour lysis syndrome 11.78 10.91 6 62149 12879 29877444
Cyanosis 11.77 10.91 5 62150 11930 29878393
Anti-neutrophil cytoplasmic antibody positive vasculitis 11.75 10.91 10 62145 613 29889710
Divorced 11.66 10.91 3 62152 8 29890315
Pulmonary valve disease 11.62 10.91 5 62150 85 29890238
Tubulointerstitial nephritis 11.58 10.91 12 62143 17879 29872444
Neuropathy peripheral 11.55 10.91 208 61947 70267 29820056
Device related infection 11.49 10.91 11 62144 17004 29873319
Social avoidant behaviour 11.46 10.91 21 62134 2842 29887481
Hyperkalaemia 11.44 10.91 85 62070 65925 29824398
Product monitoring error 11.42 10.91 16 62139 1725 29888598
Acute coronary syndrome 11.42 10.91 7 62148 13566 29876757
Loss of employment 11.37 10.91 9 62146 498 29889825
Loss of proprioception 11.36 10.91 7 62148 258 29890065
Blue toe syndrome 11.36 10.91 6 62149 164 29890159
Product prescribing error 11.12 10.91 66 62089 16667 29873656
Malnutrition 10.97 10.91 5 62150 11444 29878879

Pharmacologic Action:

SourceCodeDescription
ATC N06AX21 NERVOUS SYSTEM
PSYCHOANALEPTICS
ANTIDEPRESSANTS
Other antidepressants
FDA MoA N0000000102 Norepinephrine Uptake Inhibitors
FDA MoA N0000000109 Serotonin Uptake Inhibitors
FDA EPC N0000175749 Serotonin and Norepinephrine Reuptake Inhibitor
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
CHEBI has role CHEBI:35469 thymoanaleptics

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

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 noradrenaline transporter Transporter INHIBITOR Ki 8.22 CHEMBL CHEMBL
Sodium-dependent serotonin transporter Transporter INHIBITOR Ki 9.62 CHEMBL CHEMBL
5-hydroxytryptamine receptor 2C GPCR ANTAGONIST Ki 6 IUPHAR
Sodium-dependent dopamine transporter Transporter Ki 6.62 CHEMBL
5-hydroxytryptamine receptor 2B GPCR Ki 5.68 PDSP
5-hydroxytryptamine receptor 7 GPCR Ki 5.65 PDSP
Histamine H1 receptor GPCR Ki 5.64 PDSP
5-hydroxytryptamine receptor 1D GPCR Ki 5.52 PDSP
5-hydroxytryptamine receptor 1E GPCR Ki 5.43 PDSP
5-hydroxytryptamine receptor 1B GPCR Ki 5.40 PDSP
5-hydroxytryptamine receptor 1F GPCR Ki 5.35 PDSP
5-hydroxytryptamine receptor 6 GPCR ANTAGONIST Ki 6.40 IUPHAR
5-hydroxytryptamine receptor 1A GPCR Ki 5.30 PDSP
5-hydroxytryptamine receptor 2A GPCR ANTAGONIST Ki 6.30 IUPHAR
Sodium-dependent dopamine transporter Transporter IC50 6.43 CHEMBL
Sodium-dependent serotonin transporter Transporter Ki 10.09 CHEMBL
Transporter Transporter Ki 8.52 CHEMBL

External reference:

IDSource
D01179 KEGG_DRUG
136434-34-9 SECONDARY_CAS_RN
4021477 VANDF
C4256038 UMLSCUI
CHEBI:36795 CHEBI
29E PDB_CHEM_ID
60835 PUBCHEM_CID
CHEMBL1175 ChEMBL_ID
CHEMBL1200328 ChEMBL_ID
DB00476 DRUGBANK_ID
D000068736 MESH_DESCRIPTOR_UI
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 13668-110 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
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 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
Duloxetine Human Prescription Drug Label 1 27241-164 CAPSULE, DELAYED RELEASE 40 mg ORAL ANDA 31 sections
Irenka HUMAN PRESCRIPTION DRUG LABEL 1 27437-298 CAPSULE, DELAYED RELEASE 40 mg ORAL ANDA 26 sections
Duloxetine Human Prescription Drug Label 1 31722-581 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 30 sections
Duloxetine Human Prescription Drug Label 1 31722-582 CAPSULE, DELAYED RELEASE 30 mg ORAL ANDA 30 sections
Duloxetine Human Prescription Drug Label 1 31722-583 CAPSULE, DELAYED RELEASE 60 mg ORAL ANDA 30 sections
Duloxetine Hydrochloride Human Prescription Drug Label 1 33342-160 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 31 sections