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 3952.10 9.73 1999 203533 26023 53117511
Dysphoria 3414.48 9.73 1129 204403 4220 53139314
Affect lability 2820.54 9.73 1136 204396 8239 53135295
Irritability 2203.63 9.73 1413 204119 29540 53113994
Suicidal ideation 1850.48 9.73 1667 203865 58844 53084690
Agitation 1655.92 9.73 1545 203987 57081 53086453
Paraesthesia 1357.24 9.73 2037 203495 125478 53018056
Sensory disturbance 1302.00 9.73 737 204795 12149 53131385
Hyperhidrosis 1206.26 9.73 1667 203865 95126 53048408
Vertigo 1194.68 9.73 1268 204264 54813 53088721
Anxiety 1148.55 9.73 2415 203117 194289 52949245
Insomnia 1119.25 9.73 2320 203212 184752 52958782
Nightmare 793.95 9.73 610 204922 17141 53126393
Dizziness 720.43 9.73 3087 202445 369172 52774362
Mood swings 719.49 9.73 572 204960 16914 53126620
Tinnitus 607.28 9.73 666 204866 29853 53113681
Hypomania 544.31 9.73 298 205234 4584 53138950
Lethargy 516.38 9.73 820 204712 52940 53090594
Tremor 501.49 9.73 1332 204200 124404 53019130
Serotonin syndrome 488.86 9.73 555 204977 25851 53117683
Confusional state 475.65 9.73 1736 203796 192485 52951049
Depression 423.75 9.73 1607 203925 181445 52962089
Pemphigus 383.49 9.73 3 205529 104028 53039506
Headache 314.34 9.73 3301 202231 533520 52610014
Withdrawal syndrome 298.27 9.73 370 205162 18931 53124603
Suicide attempt 268.86 9.73 652 204880 57516 53086018
Glossodynia 247.07 9.73 44 205488 100247 53043287
Nausea 241.77 9.73 4167 201365 751924 52391610
Maternal exposure during pregnancy 235.40 9.73 155 205377 155484 52988050
Neutropenia 232.14 9.73 165 205367 159020 52984514
Hand deformity 227.86 9.73 29 205503 84820 53058714
Alopecia 223.44 9.73 349 205183 234234 52909300
Febrile neutropenia 218.93 9.73 66 205466 104870 53038664
Sleep disorder 214.77 9.73 604 204928 58266 53085268
Anaemia 212.84 9.73 469 205063 276249 52867285
Systemic lupus erythematosus 212.21 9.73 109 205423 125305 53018229
Pyrexia 210.15 9.73 821 204711 402372 52741162
Contraindicated product administered 205.18 9.73 135 205397 135494 53008040
Crying 203.28 9.73 332 205200 21930 53121604
Disturbance in attention 193.87 9.73 417 205115 33966 53109568
Fibromyalgia 177.51 9.73 469 205063 43606 53099928
Synovitis 170.61 9.73 102 205430 107791 53035743
Feeling abnormal 169.42 9.73 994 204538 134307 53009227
Thrombocytopenia 168.91 9.73 171 205361 138556 53004978
Completed suicide 168.36 9.73 1008 204524 137193 53006341
Stubbornness 165.29 9.73 56 205476 229 53143305
Pericarditis 161.36 9.73 27 205505 64379 53079155
Acute kidney injury 161.33 9.73 474 205058 253394 52890140
Rash 155.99 9.73 1043 204489 445148 52698386
Wound 148.38 9.73 84 205448 91473 53052061
Drug intolerance 147.65 9.73 361 205171 205132 52938402
Mood altered 144.47 9.73 220 205312 13681 53129853
Pancytopenia 142.29 9.73 87 205445 90841 53052693
Treatment failure 137.05 9.73 176 205356 128227 53015307
Abdominal discomfort 135.91 9.73 419 205113 220643 52922891
Memory impairment 133.37 9.73 663 204869 84094 53059440
Rheumatoid arthritis 133.30 9.73 691 204841 313840 52829694
Fatigue 132.54 9.73 3714 201818 726792 52416742
Infusion related reaction 131.92 9.73 250 205282 155707 52987827
Hypersensitivity 121.34 9.73 411 205121 210254 52933280
Electric shock 120.31 9.73 65 205467 972 53142562
Thinking abnormal 120.25 9.73 174 205358 10334 53133200
Dyspnoea 119.88 9.73 1567 203965 584665 52558869
Anger 118.87 9.73 189 205343 12201 53131333
Arthropathy 117.66 9.73 229 205303 141224 53002310
Duodenal ulcer perforation 117.50 9.73 4 205528 35179 53108355
Somnolence 117.25 9.73 1072 204460 166662 52976872
Panic attack 116.43 9.73 256 205276 21162 53122372
Joint swelling 114.31 9.73 490 205042 234148 52909386
Migraine 109.93 9.73 605 204927 79812 53063722
Discomfort 106.97 9.73 126 205406 95346 53048188
Malignant neoplasm progression 105.73 9.73 73 205459 71468 53072066
Pneumonia 105.66 9.73 1031 204501 406138 52737396
General physical health deterioration 103.25 9.73 261 205271 146681 52996853
Lower respiratory tract infection 103.09 9.73 119 205413 90862 53052672
Disease progression 101.38 9.73 147 205385 101773 53041761
Platelet count decreased 99.78 9.73 164 205368 107935 53035599
Swelling 98.09 9.73 391 205141 190714 52952820
Depressed mood 96.65 9.73 338 205194 36626 53106908
Cardiac failure 93.30 9.73 116 205416 85728 53057806
Anti-cyclic citrullinated peptide antibody positive 93.26 9.73 52 205480 57120 53086414
Septic shock 92.62 9.73 63 205469 62166 53081368
Drug reaction with eosinophilia and systemic symptoms 88.54 9.73 11 205521 32789 53110745
Off label use 86.11 9.73 1291 204241 470921 52672613
Gastrointestinal tube insertion 84.74 9.73 54 205478 1113 53142421
Sepsis 83.36 9.73 287 205245 146142 52997392
Gastric bypass 83.16 9.73 59 205473 1461 53142073
Intentional product misuse 83.15 9.73 394 205138 48998 53094536
Folliculitis 82.35 9.73 12 205520 31697 53111837
C-reactive protein abnormal 79.73 9.73 5 205527 25865 53117669
Affective disorder 77.37 9.73 101 205431 5438 53138096
Sleep disorder due to general medical condition, insomnia type 77.21 9.73 4 205528 24345 53119189
Coordination abnormal 76.80 9.73 153 205379 11798 53131736
Restless legs syndrome 76.28 9.73 190 205342 17033 53126501
Infection 75.27 9.73 374 205158 171831 52971703
Erythema 75.04 9.73 330 205202 156639 52986895
Renal impairment 73.58 9.73 130 205402 83188 53060346
Neutrophil count decreased 72.68 9.73 50 205482 49048 53094486
Tardive dyskinesia 71.83 9.73 119 205413 7951 53135583
Inappropriate antidiuretic hormone secretion 71.62 9.73 170 205362 14781 53128753
Blood creatinine increased 71.18 9.73 131 205401 82531 53061003
Haemoglobin decreased 69.74 9.73 282 205250 137025 53006509
Mucosal inflammation 69.66 9.73 39 205493 42745 53100789
Interstitial lung disease 68.22 9.73 75 205457 58547 53084987
Aggression 67.34 9.73 221 205311 23182 53120352
Pleural effusion 67.23 9.73 151 205381 88428 53055106
Multiple sclerosis relapse 66.41 9.73 345 205187 44508 53099026
Abnormal behaviour 66.10 9.73 210 205322 21656 53121878
Post-traumatic stress disorder 65.28 9.73 86 205446 4672 53138862
Muscle injury 65.25 9.73 17 205515 29749 53113785
Premature delivery 65.25 9.73 11 205521 26093 53117441
Drug ineffective 65.23 9.73 2534 202998 814711 52328823
Fall 64.15 9.73 1821 203711 356619 52786915
Amnesia 64.07 9.73 344 205188 44944 53098590
Leukopenia 63.63 9.73 116 205416 73347 53070187
Ascites 63.57 9.73 37 205495 39698 53103836
Therapeutic product effect decreased 63.23 9.73 259 205273 125396 53018138
Stomatitis 63.16 9.73 182 205350 97976 53045558
Product substitution issue 63.01 9.73 168 205364 15698 53127836
Abnormal dreams 62.54 9.73 131 205401 10470 53133064
Death 62.51 9.73 984 204548 356248 52787286
Renal failure 60.95 9.73 242 205290 118210 53025324
Pneumonia aspiration 60.95 9.73 278 205254 34023 53109511
Blister 60.79 9.73 133 205399 78620 53064914
Therapy interrupted 59.98 9.73 188 205344 19248 53124286
Product use issue 59.36 9.73 306 205226 139278 53004256
Bone marrow failure 59.15 9.73 21 205511 30094 53113440
Atrial fibrillation 58.80 9.73 226 205306 111426 53032108
Somatic symptom disorder 58.56 9.73 55 205477 2043 53141491
Mania 58.29 9.73 136 205396 11693 53131841
Peripheral swelling 57.57 9.73 512 205020 205596 52937938
Prescribed overdose 57.33 9.73 149 205383 13710 53129824
Coma 57.19 9.73 421 205111 61362 53082172
Multiple organ dysfunction syndrome 56.64 9.73 79 205453 55598 53087936
Sopor 56.16 9.73 194 205338 20890 53122644
Loss of consciousness 56.15 9.73 680 204852 113532 53030002
Intentional self-injury 55.87 9.73 219 205313 25065 53118469
Alanine aminotransferase increased 55.25 9.73 585 204947 94510 53049024
Hallucination 53.38 9.73 373 205159 53465 53090069
Rheumatoid factor positive 53.34 9.73 48 205484 41150 53102384
Hyperkalaemia 53.20 9.73 79 205453 54177 53089357
White blood cell count abnormal 53.15 9.73 83 205449 5275 53138259
White blood cell count decreased 52.85 9.73 273 205259 124202 53019332
Impaired healing 52.43 9.73 105 205427 64100 53079434
Cytomegalovirus infection 51.66 9.73 7 205525 19532 53124002
Dry mouth 50.20 9.73 397 205135 59153 53084381
Lactic acidosis 49.94 9.73 42 205490 37211 53106323
Hypotension 49.90 9.73 684 204848 253392 52890142
Drug interaction 48.41 9.73 1146 204386 218183 52925351
Hallucination, visual 48.18 9.73 171 205361 18661 53124873
Gastrointestinal haemorrhage 47.36 9.73 155 205377 80175 53063359
Coma blister 47.34 9.73 19 205513 136 53143398
Cardiac failure congestive 46.77 9.73 191 205341 92566 53050968
Neck deformity 46.74 9.73 48 205484 1991 53141543
Hypocalcaemia 45.97 9.73 28 205504 29309 53114225
Extremity contracture 45.72 9.73 39 205493 1274 53142260
Nasal turbinate hypertrophy 45.45 9.73 30 205502 658 53142876
Intervertebral discitis 45.12 9.73 55 205477 2762 53140772
Respiratory failure 44.05 9.73 218 205314 100294 53043240
Device expulsion 43.27 9.73 31 205501 29782 53113752
Pulmonary oedema 42.90 9.73 89 205443 53634 53089900
Helicobacter infection 42.22 9.73 53 205479 39016 53104518
Muscle twitching 41.90 9.73 149 205383 16277 53127257
Weight increased 41.87 9.73 1058 204474 203509 52940025
Seizure 40.23 9.73 712 204820 128797 53014737
Neck mass 40.16 9.73 58 205474 3438 53140096
Sleep apnoea syndrome 39.87 9.73 202 205330 25800 53117734
Aspartate aminotransferase increased 39.86 9.73 497 205035 83532 53060002
Gastrointestinal disorder 39.56 9.73 195 205337 89809 53053725
Pulmonary fibrosis 39.28 9.73 22 205510 24113 53119421
Oedema peripheral 39.05 9.73 445 205087 170342 52973192
Cough 38.92 9.73 726 204806 256167 52887367
Rapid eye movements sleep abnormal 38.03 9.73 15 205517 102 53143432
Palmar-plantar erythrodysaesthesia syndrome 37.69 9.73 18 205514 21588 53121946
Colitis microscopic 37.66 9.73 84 205448 7010 53136524
Restlessness 37.48 9.73 210 205322 27877 53115657
Balance disorder 37.34 9.73 439 205093 72768 53070766
Vision blurred 37.10 9.73 498 205034 85106 53058428
Influenza like illness 37.04 9.73 378 205154 60481 53083053
Ill-defined disorder 36.93 9.73 85 205447 49359 53094175
Dehydration 36.88 9.73 443 205089 167967 52975567
Surgery 36.86 9.73 230 205302 31734 53111800
Dyskinesia 36.67 9.73 229 205303 31604 53111930
Hyperaesthesia 36.54 9.73 94 205438 8595 53134939
Neoplasm progression 36.24 9.73 37 205495 29882 53113652
Multiple sclerosis 36.22 9.73 203 205329 26950 53116584
Urinary retention 36.12 9.73 210 205322 28256 53115278
Nervousness 35.96 9.73 219 205313 29959 53113575
Product use in unapproved indication 35.86 9.73 269 205263 112020 53031514
Metabolic surgery 35.57 9.73 31 205501 1043 53142491
Concussion 35.51 9.73 87 205445 7717 53135817
Pruritus 35.30 9.73 862 204670 292970 52850564
Hyperreflexia 35.02 9.73 70 205462 5410 53138124
Hypomagnesaemia 34.47 9.73 27 205505 24784 53118750
Temperature intolerance 34.08 9.73 88 205444 8065 53135469
Tachyphrenia 33.97 9.73 34 205498 1367 53142167
Bradycardia 33.55 9.73 150 205382 70906 53072628
Pulmonary malformation 33.32 9.73 15 205517 147 53143387
Opsoclonus myoclonus 33.23 9.73 15 205517 148 53143386
Hypersomnia 33.21 9.73 138 205394 16217 53127317
Hot flush 33.18 9.73 302 205230 46858 53096676
Cognitive disorder 33.18 9.73 290 205242 44488 53099046
Epistaxis 33.08 9.73 144 205388 68566 53074968
Paranoia 32.97 9.73 108 205424 11316 53132218
Impaired driving ability 32.44 9.73 59 205473 4248 53139286
Akathisia 32.27 9.73 89 205443 8482 53135052
Rheumatoid nodule 31.97 9.73 4 205528 11860 53131674
Deep vein thrombosis 31.81 9.73 188 205344 82725 53060809
Bronchial neoplasm 31.73 9.73 20 205512 404 53143130
Morbid thoughts 31.68 9.73 23 205509 591 53142943
Rubber sensitivity 31.51 9.73 38 205494 1887 53141647
Rash maculo-papular 31.48 9.73 41 205491 29708 53113826
Hypokalaemia 31.40 9.73 230 205302 96287 53047247
Psychotic disorder due to a general medical condition 31.38 9.73 16 205516 211 53143323
Sacroiliitis 30.97 9.73 43 205489 2457 53141077
Disorientation 30.26 9.73 257 205275 39102 53104432
Bipolar disorder 30.13 9.73 81 205451 7605 53135929
Therapy cessation 30.06 9.73 198 205334 27827 53115707
Melaena 29.95 9.73 41 205491 29088 53114446
Libido decreased 29.75 9.73 44 205488 2665 53140869
Acute myeloid leukaemia 29.69 9.73 14 205518 16918 53126616
Hostility 29.59 9.73 34 205498 1603 53141931
Anorgasmia 29.59 9.73 22 205510 587 53142947
Pulmonary eosinophilia 29.51 9.73 16 205516 241 53143293
Haemoptysis 29.30 9.73 39 205493 28000 53115534
Loss of libido 29.30 9.73 31 205501 1332 53142202
Stiff person syndrome 29.28 9.73 16 205516 245 53143289
Product dose omission issue 29.21 9.73 955 204577 190665 52952869
Personality disorder 29.12 9.73 55 205477 4076 53139458
Proteinuria 28.65 9.73 17 205515 18051 53125483
Bruxism 28.58 9.73 48 205484 3243 53140291
Mental disorder 28.48 9.73 176 205356 24200 53119334
Gastric banding 28.37 9.73 11 205521 71 53143463
C-reactive protein increased 28.18 9.73 150 205382 67736 53075798
Bronchial haemorrhage 28.02 9.73 20 205512 500 53143034
Blood pressure increased 27.97 9.73 724 204808 139755 53003779
Formication 27.69 9.73 53 205479 3968 53139566
Pre-existing condition improved 27.54 9.73 81 205451 8008 53135526
Condition aggravated 27.44 9.73 904 204628 296230 52847304
Drug resistance 27.38 9.73 22 205510 19940 53123594
Bone density abnormal 27.30 9.73 46 205486 3116 53140418
Complex regional pain syndrome 27.19 9.73 38 205494 2185 53141349
Dissociation 27.04 9.73 38 205494 2196 53141338
Anaphylactic reaction 27.01 9.73 124 205408 58202 53085332
Agranulocytosis 26.95 9.73 31 205501 23718 53119816
Reversible cerebral vasoconstriction syndrome 26.90 9.73 38 205494 2207 53141327
Metastases to bone 26.89 9.73 21 205511 19307 53124227
Tearfulness 26.30 9.73 53 205479 4121 53139413
Gastrooesophageal reflux disease 26.21 9.73 456 205076 82207 53061327
Coronary artery disease 26.18 9.73 56 205476 33381 53110153
Autonomic dysreflexia 26.02 9.73 16 205516 309 53143225
Hip arthroplasty 25.94 9.73 42 205490 27820 53115714
Acute respiratory distress syndrome 25.90 9.73 31 205501 23301 53120233
Speech disorder 25.61 9.73 247 205285 38934 53104600
Live birth 25.58 9.73 13 205519 15046 53128488
Cerebral infarction 25.54 9.73 34 205498 24410 53119124
Gastrostomy 25.53 9.73 20 205512 578 53142956
Disseminated intravascular coagulation 25.50 9.73 23 205509 19696 53123838
Anovulatory cycle 25.37 9.73 12 205520 133 53143401
Pregnancy 25.17 9.73 52 205480 31389 53112145
Pulmonary arterial hypertension 25.14 9.73 41 205491 27081 53116453
Vomiting 25.10 9.73 2232 203300 494907 52648627
Libido increased 24.99 9.73 26 205506 1095 53142439
Delusion 24.91 9.73 102 205430 11907 53131627
Hypoglycaemia 24.71 9.73 130 205402 58883 53084651
Ejection fraction decreased 24.66 9.73 24 205508 19824 53123710
Metastases to liver 24.46 9.73 28 205504 21468 53122066
Oesophageal spasm 24.39 9.73 39 205493 2529 53141005
Major depression 24.00 9.73 74 205458 7508 53136026
Torsade de pointes 23.99 9.73 10 205522 12995 53130539
Pneumonitis 23.96 9.73 52 205480 30836 53112698
Neuralgia 23.92 9.73 164 205368 23357 53120177
Head injury 23.87 9.73 176 205356 25657 53117877
Plasma cell myeloma 23.86 9.73 99 205433 47775 53095759
Rebound nasal congestion 23.75 9.73 8 205524 32 53143502
Psychotic disorder 23.61 9.73 168 205364 24217 53119317
Psychomotor hyperactivity 23.57 9.73 89 205443 10007 53133527
Sleep terror 23.40 9.73 22 205510 818 53142716
Cholestasis 23.36 9.73 47 205485 28648 53114886
Foetal death 23.22 9.73 4 205528 9343 53134191
Thrombotic microangiopathy 23.19 9.73 4 205528 9333 53134201
Hypoxia 23.12 9.73 123 205409 55557 53087977
Emotional disorder 22.69 9.73 105 205427 12925 53130609
Drug hypersensitivity 22.68 9.73 1244 204288 263998 52879536
Nasopharyngitis 22.28 9.73 567 204965 191728 52951806
Respiratory distress 22.28 9.73 62 205470 33765 53109769
Endometrial ablation 22.18 9.73 22 205510 875 53142659
Thunderclap headache 22.12 9.73 12 205520 181 53143353
Myelodysplastic syndrome 22.06 9.73 19 205513 16641 53126893
Dyspnoea exertional 22.01 9.73 123 205409 54877 53088657
Eosinophilia 21.97 9.73 30 205502 21305 53122229
Hyperglycaemia 21.83 9.73 80 205452 40004 53103530
Peritonitis bacterial 21.67 9.73 5 205527 9500 53134034
Angioedema 21.60 9.73 86 205446 41990 53101544
Toxic epidermal necrolysis 21.46 9.73 36 205496 23514 53120020
Shock 21.43 9.73 35 205497 23104 53120430
Hallucination, auditory 21.34 9.73 96 205436 11677 53131857
Hypoaesthesia 21.34 9.73 667 204865 132328 53011206
Irritable bowel syndrome 21.27 9.73 91 205441 43541 53099993
Depressive symptom 21.23 9.73 42 205490 3222 53140312
Decreased interest 21.15 9.73 42 205490 3231 53140303
Myocardial infarction 21.11 9.73 263 205269 99091 53044443
Mydriasis 21.02 9.73 93 205439 11233 53132301
Peritonitis 20.85 9.73 32 205500 21655 53121879
Hypoalbuminaemia 20.84 9.73 8 205524 10928 53132606
Circulatory collapse 20.44 9.73 35 205497 22679 53120855
Blood calcium decreased 20.21 9.73 28 205504 19766 53123768
Right ventricular failure 20.20 9.73 21 205511 16822 53126712
Pneumocystis jirovecii pneumonia 20.12 9.73 20 205512 16358 53127176
Metabolic acidosis 20.04 9.73 89 205443 42153 53101381
Toxic skin eruption 19.95 9.73 13 205519 13126 53130408
Accidental exposure to product 19.94 9.73 38 205494 23636 53119898
Granulomatous liver disease 19.87 9.73 20 205512 810 53142724
Galactorrhoea 19.76 9.73 46 205486 3949 53139585
Aplastic anaemia 19.73 9.73 4 205528 8317 53135217
Skin necrosis 19.71 9.73 8 205524 10564 53132970
Clonus 19.70 9.73 48 205484 4243 53139291
Antinuclear antibody negative 19.68 9.73 12 205520 228 53143306
Abdominal pain 19.68 9.73 796 204736 255107 52888427
Tuberculosis 19.65 9.73 9 205523 11062 53132472
Cardiogenic shock 19.64 9.73 23 205509 17459 53126075
Pulmonary congestion 19.54 9.73 20 205512 16136 53127398
Haemodialysis 19.44 9.73 6 205526 9398 53134136
Phagophobia 19.37 9.73 7 205525 36 53143498
Tubulointerstitial nephritis 19.32 9.73 21 205511 16483 53127051
Homicidal ideation 19.26 9.73 29 205503 1785 53141749
Aspergillus infection 19.09 9.73 3 205529 7493 53136041
Macular degeneration 19.08 9.73 12 205520 12349 53131185
Angina unstable 18.99 9.73 3 205529 7465 53136069
Liver function test increased 18.91 9.73 47 205485 26581 53116953
Hypercalcaemia 18.88 9.73 41 205491 24307 53119227
Coombs positive haemolytic anaemia 18.75 9.73 14 205518 376 53143158
Flat affect 18.67 9.73 25 205507 1380 53142154
Metastases to lung 18.58 9.73 11 205521 11693 53131841
Ankle fracture 18.52 9.73 118 205414 16397 53127137
Conversion disorder 18.50 9.73 28 205504 1731 53141803
Osteonecrosis of jaw 18.48 9.73 74 205458 36072 53107462
Infective pulmonary exacerbation of cystic fibrosis 18.40 9.73 10 205522 11146 53132388
Fluid overload 18.33 9.73 51 205481 27780 53115754
Haematotoxicity 18.31 9.73 4 205528 7893 53135641
Asphyxia 18.13 9.73 57 205475 5844 53137690
Demyelination 18.09 9.73 59 205473 6168 53137366
Bacteraemia 17.97 9.73 20 205512 15529 53128005
Hypnopompic hallucination 17.95 9.73 7 205525 46 53143488
Pustular psoriasis 17.93 9.73 46 205486 4198 53139336
Ischaemic stroke 17.83 9.73 26 205506 17967 53125567
Gait disturbance 17.77 9.73 765 204767 158077 52985457
Tenosynovitis 17.77 9.73 8 205524 9931 53133603
Premature labour 17.75 9.73 13 205519 12349 53131185
Respiratory tract malformation 17.72 9.73 8 205524 79 53143455
Acute myocardial infarction 17.66 9.73 67 205465 33168 53110366
CYP3A4 polymorphism 17.63 9.73 8 205524 80 53143454
Decreased appetite 17.54 9.73 664 204868 214310 52929224
Road traffic accident 17.45 9.73 163 205369 25468 53118066
Drug screen positive 17.44 9.73 43 205489 3829 53139705
Tension 17.38 9.73 39 205493 3267 53140267
Hyperacusis 17.38 9.73 29 205503 1949 53141585
Inflammation 17.24 9.73 139 205393 56997 53086537
Oliguria 17.21 9.73 7 205525 9231 53134303
Device related infection 17.15 9.73 39 205493 22747 53120787
Lung cyst 17.05 9.73 9 205523 128 53143406
Dysphemia 17.05 9.73 33 205499 2491 53141043
Middle insomnia 16.99 9.73 84 205448 10624 53132910
Spinal operation 16.87 9.73 59 205473 6392 53137142
Pulseless electrical activity 16.83 9.73 4 205528 7450 53136084
Pulmonary embolism 16.81 9.73 325 205207 114117 53029417
Panic disorder 16.78 9.73 34 205498 2654 53140880
Haemorrhage 16.62 9.73 143 205389 57844 53085690
Drug eruption 16.52 9.73 46 205486 25048 53118486
Impulse-control disorder 16.39 9.73 18 205514 807 53142727
Breast cancer metastatic 16.34 9.73 21 205511 15307 53128227
Caesarean section 16.23 9.73 26 205506 17294 53126240
Sleep talking 16.22 9.73 20 205512 1016 53142518
Basal cell carcinoma 16.22 9.73 42 205490 23427 53120107
Therapeutic response changed 16.20 9.73 19 205513 916 53142618
Diplopia 16.17 9.73 136 205396 20629 53122905
Muscle spasms 16.17 9.73 654 204878 134141 53009393
Diffuse large B-cell lymphoma 16.10 9.73 3 205529 6622 53136912
Myoclonus 16.08 9.73 110 205422 15654 53127880
Polyarthritis 16.05 9.73 5 205527 7784 53135750
Mean cell haemoglobin concentration increased 16.04 9.73 14 205518 472 53143062
Gastric ulcer 16.01 9.73 42 205490 23327 53120207
Apathy 16.00 9.73 69 205463 8243 53135291
Bipolar I disorder 15.98 9.73 26 205506 1711 53141823
Tic 15.98 9.73 23 205509 1359 53142175
Pathogen resistance 15.88 9.73 3 205529 6557 53136977
Self-injurious ideation 15.79 9.73 31 205501 2365 53141169
Second primary malignancy 15.77 9.73 4 205528 7128 53136406
Heart rate decreased 15.69 9.73 81 205451 36866 53106668
Metastases to central nervous system 15.66 9.73 14 205518 12043 53131491
Chronic obstructive pulmonary disease 15.61 9.73 155 205377 60918 53082616
Hyponatraemic encephalopathy 15.55 9.73 11 205521 271 53143263
Mobility decreased 15.42 9.73 204 205328 76067 53067467
Feeling of despair 15.39 9.73 28 205504 2017 53141517
Feelings of worthlessness 15.37 9.73 12 205520 345 53143189
Hepatitis C antibody positive 15.33 9.73 8 205524 111 53143423
Respiratory tract infection 15.16 9.73 71 205461 33153 53110381
Intervertebral disc protrusion 15.16 9.73 140 205392 21805 53121729
Pulmonary haemorrhage 15.12 9.73 4 205528 6929 53136605
Pulmonary hypertension 15.10 9.73 83 205449 37187 53106347
Therapy non-responder 15.05 9.73 119 205413 49001 53094533
Intentional overdose 15.05 9.73 352 205180 66853 53076681
Haemolytic anaemia 14.96 9.73 11 205521 10428 53133106
Metastases to lymph nodes 14.93 9.73 5 205527 7435 53136099
Pseudomonas infection 14.93 9.73 11 205521 10417 53133117
Poor quality sleep 14.87 9.73 116 205416 17207 53126327
Intentional dose omission 14.83 9.73 48 205484 4997 53138537
Congenital tricuspid valve atresia 14.83 9.73 6 205526 44 53143490
Stillbirth 14.67 9.73 4 205528 6793 53136741
Lung disorder 14.67 9.73 116 205416 47763 53095771
Herpes simplex reactivation 14.65 9.73 12 205520 370 53143164
Panic reaction 14.64 9.73 41 205491 3942 53139592
Haematuria 14.59 9.73 58 205474 28331 53115203
Ophthalmic vein thrombosis 14.55 9.73 8 205524 124 53143410
Red blood cell count decreased 14.53 9.73 80 205452 35823 53107711
Impatience 14.52 9.73 12 205520 375 53143159
Anaphylactic shock 14.51 9.73 40 205492 21853 53121681
Immunisation reaction 14.47 9.73 5 205527 22 53143512
Oesophageal food impaction 14.45 9.73 9 205523 178 53143356
Transfusion 14.34 9.73 19 205513 13668 53129866
Oxygen saturation decreased 14.16 9.73 209 205323 76516 53067018
Cataplexy 14.10 9.73 21 205511 1280 53142254
Chest discomfort 14.07 9.73 285 205247 99410 53044124
Arteriosclerosis coronary artery 13.90 9.73 67 205465 8387 53135147
Spondyloarthropathy 13.90 9.73 16 205516 756 53142778
Scar 13.81 9.73 90 205442 12603 53130931
Cerebral haemorrhage 13.75 9.73 64 205468 29932 53113602
Bradyphrenia 13.74 9.73 57 205475 6693 53136841
Phobia of driving 13.69 9.73 3 205529 0 53143534
Overdose 13.69 9.73 526 205006 107210 53036324
Productive cough 13.67 9.73 146 205386 56583 53086951
Alcoholism 13.66 9.73 28 205504 2203 53141331
Tachyphylaxis 13.57 9.73 10 205522 263 53143271
Rales 13.57 9.73 13 205519 10819 53132715
Abortion induced 13.56 9.73 13 205519 10813 53132721
Blood lactate dehydrogenase increased 13.55 9.73 41 205491 21740 53121794
Uraemic encephalopathy 13.49 9.73 9 205523 201 53143333
Bronchial disorder 13.46 9.73 20 205512 1216 53142318
Trigeminal neuralgia 13.42 9.73 35 205497 3226 53140308
Red blood cell sedimentation rate increased 13.38 9.73 59 205473 27998 53115536
Bone erosion 13.27 9.73 14 205518 11138 53132396
Feeling drunk 13.27 9.73 40 205492 4009 53139525
Depression suicidal 13.25 9.73 23 205509 1596 53141938
Oedema 13.21 9.73 204 205328 74142 53069392
Lung diffusion test decreased 13.18 9.73 15 205517 700 53142834
Poisoning 13.16 9.73 95 205437 13755 53129779
Drug abuse 13.11 9.73 338 205194 65188 53078346
Tumour lysis syndrome 13.07 9.73 7 205525 7867 53135667
Gun shot wound 13.00 9.73 7 205525 104 53143430
Gambling disorder 12.94 9.73 21 205511 1379 53142155
Blood pressure diastolic abnormal 12.81 9.73 9 205523 8736 53134798
Urinary incontinence 12.81 9.73 178 205354 30643 53112891
Holmes-Adie pupil 12.80 9.73 5 205527 33 53143501
Sensitivity to weather change 12.70 9.73 52 205480 6070 53137464
Autonomic nervous system imbalance 12.67 9.73 30 205502 2604 53140930
Fear of injection 12.62 9.73 3 205529 5586 53137948
Cardiac arrest 12.56 9.73 270 205262 93397 53050137
Haemorrhage intracranial 12.55 9.73 20 205512 13332 53130202
Blood cholesterol increased 12.51 9.73 137 205395 52852 53090682
Clostridium difficile colitis 12.45 9.73 37 205495 19728 53123806
Hepatic function abnormal 12.45 9.73 87 205445 36812 53106722
Escherichia infection 12.35 9.73 17 205515 12033 53131501
Hepatobiliary scan abnormal 12.34 9.73 6 205526 71 53143463
Leukopenia neonatal 12.32 9.73 5 205527 37 53143497
Unintended pregnancy 12.27 9.73 4 205528 6049 53137485
Polyneuropathy 12.27 9.73 20 205512 13213 53130321
Enterococcal infection 12.26 9.73 7 205525 7591 53135943
Status epilepticus 12.25 9.73 25 205507 15159 53128375
Dysphagia 12.17 9.73 418 205114 83979 53059555
Intrusive thoughts 12.14 9.73 8 205524 175 53143359
Urinary hesitation 12.10 9.73 26 205506 2115 53141419
Femur fracture 12.08 9.73 96 205436 39489 53104045
Bronchospasm 12.02 9.73 29 205503 16569 53126965
Sexual dysfunction 11.99 9.73 34 205498 3292 53140242
Radiation fibrosis 11.98 9.73 5 205527 40 53143494
Haemolysis 11.98 9.73 5 205527 6491 53137043
Oesophageal pain 11.97 9.73 32 205500 2994 53140540
Eyelid myoclonus 11.88 9.73 5 205527 41 53143493
Cataract 11.83 9.73 128 205404 49492 53094042
Nephrotic syndrome 11.81 9.73 3 205529 5342 53138192
Suspected product quality issue 11.79 9.73 8 205524 184 53143350
Rapid eye movement sleep behaviour disorder 11.79 9.73 8 205524 184 53143350
Vasculitis 11.71 9.73 25 205507 14915 53128619
Hypophosphataemia 11.71 9.73 10 205522 8795 53134739
Scoliosis 11.65 9.73 55 205477 6827 53136707
Impulsive behaviour 11.64 9.73 21 205511 1503 53142031
Sciatic nerve injury 11.59 9.73 11 205521 414 53143120
Drug tolerance decreased 11.56 9.73 7 205525 7351 53136183
Lymphadenopathy 11.50 9.73 87 205445 36168 53107366
Polyglandular autoimmune syndrome type II 11.48 9.73 5 205527 45 53143489
Acute pulmonary oedema 11.44 9.73 9 205523 8246 53135288
Maternal exposure during breast feeding 11.43 9.73 34 205498 3383 53140151
Progressive multifocal leukoencephalopathy 11.41 9.73 83 205449 12046 53131488
Anuria 11.35 9.73 19 205513 12421 53131113
Daydreaming 11.31 9.73 10 205522 343 53143191
Supraventricular tachyarrhythmia 11.27 9.73 6 205526 87 53143447
Micturition urgency 11.26 9.73 64 205468 8538 53134996
Device difficult to use 11.25 9.73 14 205518 10345 53133189
Neuropsychiatric symptoms 11.23 9.73 13 205519 618 53142916
Lung infiltration 11.21 9.73 25 205507 14682 53128852
Renal injury 11.16 9.73 13 205519 9891 53133643
Food craving 11.15 9.73 21 205511 1553 53141981
Disturbance in sexual arousal 11.15 9.73 6 205526 89 53143445
Asthma 11.14 9.73 327 205205 108645 53034889
Posterior reversible encephalopathy syndrome 11.11 9.73 29 205503 16131 53127403
Phonophobia 11.09 9.73 10 205522 352 53143182
Hepatic steatosis 11.06 9.73 152 205380 26107 53117427
Cushingoid 11.05 9.73 7 205525 7175 53136359
Purple glove syndrome 11.04 9.73 8 205524 205 53143329
Alveolar bone resorption 11.02 9.73 5 205527 50 53143484
Duodenal ulcer 11.00 9.73 8 205524 7628 53135906
Visual impairment 10.99 9.73 363 205169 72549 53070985
Sluggishness 10.99 9.73 42 205490 4750 53138784
Feeling jittery 10.98 9.73 82 205450 12001 53131533
Spasmodic dysphonia 10.92 9.73 6 205526 93 53143441
Blood pressure diastolic decreased 10.91 9.73 31 205501 16772 53126762
Disability 10.90 9.73 84 205448 12414 53131120
Parosmia 10.86 9.73 41 205491 4609 53138925
Ventricular hypoplasia 10.75 9.73 7 205525 150 53143384
Electrolyte imbalance 10.74 9.73 37 205495 18847 53124687
Rectal haemorrhage 10.71 9.73 105 205427 41376 53102158
Dissociative disorder 10.71 9.73 8 205524 215 53143319
Chronic kidney disease 10.70 9.73 111 205421 43259 53100275
Atelectasis 10.69 9.73 40 205492 19886 53123648
Skin haemorrhage 10.68 9.73 53 205479 6714 53136820
Arthralgia 10.61 9.73 1509 204023 438274 52705260
Tricuspid valve incompetence 10.54 9.73 25 205507 14371 53129163
Klebsiella infection 10.54 9.73 9 205523 7917 53135617
Muscular weakness 10.54 9.73 483 205049 100509 53043025
Intestinal cyst 10.53 9.73 6 205526 100 53143434
Alcohol use 10.51 9.73 24 205508 2034 53141500
Trigger finger 10.49 9.73 36 205496 3863 53139671
Myocardial ischaemia 10.49 9.73 21 205511 12823 53130711
Pain in jaw 10.48 9.73 103 205429 40566 53102968
Alcohol abuse 10.46 9.73 24 205508 2040 53141494
Abortion spontaneous 10.45 9.73 122 205410 46513 53097021
Hepatitis A antibody positive 10.45 9.73 5 205527 57 53143477
Knee arthroplasty 10.43 9.73 81 205451 33488 53110046
Osteopenia 10.41 9.73 36 205496 18319 53125215
Shock haemorrhagic 10.41 9.73 12 205520 9171 53134363
Epstein-Barr virus infection 10.39 9.73 8 205524 7410 53136124
Ligament injury 10.39 9.73 17 205515 1124 53142410
Electric shock sensation 10.39 9.73 7 205525 159 53143375
Skin ulcer 10.38 9.73 89 205443 36030 53107504
Pericardial effusion 10.38 9.73 62 205470 27216 53116318
Prescribed underdose 10.35 9.73 99 205433 15568 53127966
Accommodation disorder 10.33 9.73 10 205522 386 53143148
Blood alkaline phosphatase increased 10.31 9.73 220 205312 41142 53102392
Escherichia urinary tract infection 10.25 9.73 17 205515 11156 53132378
Chest pain 10.04 9.73 615 204917 189570 52953964
Suspected suicide attempt 10.03 9.73 6 205526 110 53143424
Acute hepatic failure 10.03 9.73 32 205500 16688 53126846
Colitis 9.98 9.73 107 205425 41445 53102089
Exposure via breast milk 9.97 9.73 20 205512 1550 53141984
Pyometra 9.94 9.73 6 205526 112 53143422
Acute respiratory failure 9.91 9.73 75 205457 31183 53112351
Foot amputation 9.91 9.73 9 205523 320 53143214
Exposure during pregnancy 9.88 9.73 387 205145 124473 53019061
Lung neoplasm 9.85 9.73 5 205527 5791 53137743
Central nervous system lesion 9.83 9.73 70 205462 10092 53133442
Post-traumatic neck syndrome 9.82 9.73 21 205511 1702 53141832
Osteonecrosis 9.80 9.73 61 205471 26514 53117020
Lactation disorder 9.79 9.73 9 205523 325 53143209
Clostridium difficile infection 9.79 9.73 65 205467 27828 53115706
Pneumothorax 9.79 9.73 29 205503 15478 53128056
Blood urea increased 9.78 9.73 60 205472 26171 53117363
Foetal exposure during pregnancy 9.77 9.73 86 205446 34629 53108905
Hepatotoxicity 9.77 9.73 65 205467 27815 53115719
Hyperuricaemia 9.76 9.73 4 205528 5252 53138282
Somnambulism 9.76 9.73 44 205488 5358 53138176
Tachypnoea 9.75 9.73 30 205502 15824 53127710

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 1283.76 11.33 685 65641 19546 32427654
Dysphoria 1236.90 11.33 367 65959 1944 32445256
Affect lability 1162.17 11.33 392 65934 3336 32443864
Suicidal ideation 768.60 11.33 630 65696 37453 32409747
Irritability 672.70 11.33 488 65838 24166 32423034
Sensory disturbance 568.56 11.33 268 66058 5810 32441390
Vertigo 500.69 11.33 407 65919 23876 32423324
Paraesthesia 499.41 11.33 608 65718 58336 32388864
Agitation 472.91 11.33 583 65743 56653 32390547
Anxiety 466.09 11.33 758 65568 95247 32351953
Insomnia 447.94 11.33 763 65563 99585 32347615
Hyperhidrosis 389.60 11.33 594 65732 70574 32376626
Nightmare 330.50 11.33 248 66078 12918 32434282
Dizziness 264.36 11.33 982 65344 208636 32238564
Tinnitus 258.22 11.33 241 66085 17008 32430192
Hypomania 233.81 11.33 109 66217 2300 32444900
Tremor 226.37 11.33 507 65819 80770 32366430
Confusional state 225.09 11.33 722 65604 142393 32304807
Lethargy 223.76 11.33 343 65983 40885 32406315
Completed suicide 219.46 11.33 542 65784 91975 32355225
Mood swings 214.28 11.33 158 66168 8007 32439193
Serotonin syndrome 192.98 11.33 216 66110 18901 32428299
Headache 166.84 11.33 816 65510 195381 32251819
Depression 163.73 11.33 502 65824 96558 32350642
Nausea 143.31 11.33 1130 65196 319719 32127481
Sleep disorder 134.55 11.33 215 66111 26537 32420663
Suicide attempt 132.46 11.33 261 66065 37983 32409217
Pyrexia 128.45 11.33 290 66036 319678 32127522
Febrile neutropenia 121.47 11.33 46 66280 119520 32327680
Anger 104.17 11.33 125 66201 11779 32435421
Fatigue 102.80 11.33 1129 65197 349572 32097628
Thrombocytopenia 100.16 11.33 93 66233 148206 32298994
Withdrawal syndrome 95.93 11.33 121 66205 12001 32435199
Acute kidney injury 90.68 11.33 302 66024 293166 32154034
Anaemia 88.49 11.33 204 66122 223420 32223780
Gastrointestinal tube insertion 84.65 11.33 46 66280 1356 32445844
Somnolence 74.97 11.33 413 65913 103384 32343816
Intentional self-injury 74.43 11.33 115 66211 13785 32433415
Neutropenia 73.63 11.33 110 66216 142065 32305135
Pancytopenia 69.23 11.33 51 66275 91184 32356016
Feeling abnormal 66.72 11.33 272 66054 60151 32387049
Fall 62.04 11.33 642 65684 195559 32251641
Disturbance in attention 61.37 11.33 144 66182 23609 32423591
Dyspnoea 59.93 11.33 463 65863 361582 32085618
Sepsis 58.72 11.33 150 66176 158684 32288516
Memory impairment 57.84 11.33 198 66128 40281 32406919
Multiple organ dysfunction syndrome 53.05 11.33 39 66287 69815 32377385
Hepatic enzyme increased 52.77 11.33 181 66145 36856 32410344
Leukopenia 51.89 11.33 29 66297 60093 32387107
Sexual dysfunction 51.71 11.33 64 66262 6225 32440975
Disease progression 51.25 11.33 61 66265 86801 32360399
Respiratory disorder neonatal 50.83 11.33 32 66294 1247 32445953
Platelet count decreased 49.84 11.33 99 66227 114492 32332708
Intentional overdose 48.89 11.33 191 66135 41410 32405790
Pleural effusion 48.19 11.33 54 66272 78938 32368262
Blood creatinine increased 48.17 11.33 76 66250 96056 32351144
Haemoglobin decreased 46.57 11.33 110 66216 119561 32327639
Renal failure 45.92 11.33 132 66194 134346 32312854
Loss of consciousness 45.64 11.33 307 66019 82400 32364800
Mucosal inflammation 45.30 11.33 7 66319 33427 32413773
Toxicity to various agents 44.67 11.33 557 65769 177484 32269716
Malignant neoplasm progression 43.31 11.33 58 66268 78438 32368762
Cardiac failure 40.89 11.33 78 66248 91595 32355605
Antidepressant drug level above therapeutic 40.86 11.33 15 66311 167 32447033
Therapy interrupted 40.70 11.33 65 66261 8013 32439187
Sedation 40.12 11.33 105 66221 18421 32428779
Migraine 38.56 11.33 87 66239 13898 32433302
Respiratory failure 38.22 11.33 103 66223 107079 32340121
Myoclonus 38.12 11.33 89 66237 14540 32432660
General physical health deterioration 37.27 11.33 116 66210 115143 32332057
Septic shock 37.02 11.33 52 66274 68937 32378263
Gastric bypass 36.73 11.33 16 66310 286 32446914
Urinary hesitation 35.57 11.33 33 66293 2308 32444892
Analgesic drug level above therapeutic 35.39 11.33 15 66311 250 32446950
Ascites 35.24 11.33 19 66307 40172 32407028
Road traffic accident 35.10 11.33 96 66230 17285 32429915
Pain 35.02 11.33 557 65769 186999 32260201
Urinary retention 34.96 11.33 155 66171 35542 32411658
Pneumonia 34.81 11.33 513 65813 354739 32092461
Haemorrhage 33.33 11.33 31 66295 49417 32397783
Balance disorder 33.26 11.33 164 66162 39295 32407905
Aggression 31.99 11.33 162 66164 39227 32407973
Product use in unapproved indication 31.69 11.33 83 66243 87121 32360079
Major depression 31.27 11.33 42 66284 4429 32442771
Mania 31.24 11.33 64 66262 9568 32437632
Cytomegalovirus infection 30.93 11.33 7 66319 25457 32421743
Drug resistance 30.67 11.33 5 66321 22960 32424240
Cough 30.26 11.33 163 66163 138654 32308546
Dehydration 30.04 11.33 148 66178 128810 32318390
C-reactive protein increased 29.20 11.33 33 66293 48069 32399131
Disorientation 28.23 11.33 139 66187 33286 32413914
Metabolic acidosis 28.04 11.33 25 66301 40674 32406526
Abnormal dreams 27.89 11.33 57 66269 8507 32438693
Surgery 27.89 11.33 72 66254 12527 32434673
Amnesia 27.84 11.33 113 66213 24923 32422277
Atrial fibrillation 27.72 11.33 133 66193 116571 32330629
Self esteem decreased 27.62 11.33 16 66310 535 32446665
Renal impairment 27.36 11.33 96 66230 91876 32355324
Overdose 26.99 11.33 284 66042 86793 32360407
Disseminated intravascular coagulation 26.92 11.33 7 66319 23169 32424031
Yawning 26.65 11.33 16 66310 572 32446628
Hypokalaemia 26.24 11.33 45 66281 55049 32392151
Drug hypersensitivity 25.94 11.33 246 66080 73154 32374046
Agranulocytosis 25.59 11.33 8 66318 23469 32423731
Initial insomnia 24.83 11.33 31 66295 3041 32444159
Bone marrow failure 24.36 11.33 16 66310 30388 32416812
Toxic epidermal necrolysis 24.34 11.33 6 66320 20587 32426613
Feeling jittery 24.14 11.33 35 66291 3964 32443236
Homicidal ideation 23.21 11.33 28 66298 2652 32444548
Convulsive threshold lowered 22.70 11.33 14 66312 526 32446674
Hallucination 22.55 11.33 184 66142 52435 32394765
Myocardial infarction 22.46 11.33 157 66169 125519 32321681
Neuropathy peripheral 22.42 11.33 248 66078 76734 32370466
Erectile dysfunction 22.42 11.33 90 66236 19749 32427451
Fibromyalgia 22.35 11.33 28 66298 2756 32444444
White blood cell count decreased 22.20 11.33 103 66223 91095 32356105
Acute respiratory distress syndrome 22.04 11.33 12 66314 25241 32421959
Multiple sclerosis relapse 21.76 11.33 63 66263 11718 32435482
Agitation neonatal 21.70 11.33 18 66308 1084 32446116
International normalised ratio increased 21.61 11.33 42 66284 48993 32398207
Interstitial lung disease 21.29 11.33 65 66261 64936 32382264
Hallucination, auditory 20.73 11.33 57 66269 10293 32436907
Acute stress disorder 20.71 11.33 9 66317 160 32447040
Electric shock sensation 20.66 11.33 6 66320 29 32447171
Growth hormone deficiency 20.58 11.33 10 66316 232 32446968
Clonus 20.53 11.33 26 66300 2588 32444612
Peritonitis 20.40 11.33 10 66316 22320 32424880
Bradyphrenia 20.30 11.33 35 66291 4594 32442606
Hypotension 20.09 11.33 315 66011 215795 32231405
Acute myeloid leukaemia 20.08 11.33 7 66319 19167 32428033
Complex regional pain syndrome 19.95 11.33 13 66313 538 32446662
Dystonia 19.81 11.33 57 66269 10566 32436634
Neuralgia 19.69 11.33 61 66265 11774 32435426
Pneumocystis jirovecii pneumonia 19.57 11.33 7 66319 18863 32428337
Respiratory distress 19.47 11.33 26 66300 35220 32411980
Intentional product misuse 19.37 11.33 133 66193 35918 32411282
Infusion related reaction 19.28 11.33 40 66286 45559 32401641
Oedema peripheral 19.19 11.33 145 66181 113946 32333254
Haematuria 19.15 11.33 44 66282 48317 32398883
Somnambulism 19.09 11.33 28 66298 3204 32443996
Wrong drug 18.90 11.33 7 66319 80 32447120
Abnormal behaviour 18.85 11.33 105 66221 26361 32420839
Hypocalcaemia 18.65 11.33 12 66314 23042 32424158
Dysmetropsia 18.56 11.33 4 66322 3 32447197
Feeling guilty 18.46 11.33 10 66316 293 32446907
Rash maculo-papular 18.38 11.33 18 66308 28004 32419196
Cardiac failure congestive 18.27 11.33 100 66226 84752 32362448
Haemoptysis 18.25 11.33 25 66301 33500 32413700
Post concussion syndrome 18.23 11.33 7 66319 89 32447111
Tardive dyskinesia 18.23 11.33 37 66289 5494 32441706
Acute myocardial infarction 18.17 11.33 55 66271 55094 32392106
Sleep sex 18.02 11.33 4 66322 4 32447196
Drug reaction with eosinophilia and systemic symptoms 17.91 11.33 24 66302 32461 32414739
Angioedema 17.87 11.33 29 66297 36260 32410940
Delirium 17.79 11.33 152 66174 43894 32403306
Prescribed overdose 17.67 11.33 51 66275 9468 32437732
Therapy cessation 17.58 11.33 72 66254 15941 32431259
Psychotic disorder 17.52 11.33 93 66233 22927 32424273
Delirium tremens 17.50 11.33 12 66314 541 32446659
Neonatal tachypnoea 17.32 11.33 8 66318 165 32447035
Restless legs syndrome 17.32 11.33 44 66282 7580 32439620
Erythema 17.32 11.33 99 66227 83006 32364194
Affective disorder 17.21 11.33 28 66298 3505 32443695
Sleep-related eating disorder 17.11 11.33 10 66316 340 32446860
Neutrophil count decreased 17.01 11.33 45 66281 47094 32400106
Muscle spasticity 17 11.33 37 66289 5768 32441432
Compulsive shopping 16.91 11.33 11 66315 454 32446746
Pneumonitis 16.88 11.33 22 66304 30112 32417088
Paedophilia 16.76 11.33 4 66322 7 32447193
Steatohepatitis 16.65 11.33 10 66316 358 32446842
Hypersomnia 16.63 11.33 58 66268 11903 32435297
Colitis ulcerative 16.57 11.33 7 66319 17044 32430156
Drug tolerance 16.53 11.33 22 66304 2299 32444901
Rash 16.28 11.33 315 66011 209018 32238182
Gastrointestinal haemorrhage 16.28 11.33 107 66219 86775 32360425
Gait disturbance 16.19 11.33 242 66084 80166 32367034
Depression suicidal 16.16 11.33 17 66309 1385 32445815
Productive cough 16.11 11.33 28 66298 34088 32413112
Coronary artery disease 16.07 11.33 50 66276 49656 32397544
Pericardial effusion 16.00 11.33 14 66312 22988 32424212
Mental disorder 15.65 11.33 65 66261 14483 32432717
Lymphopenia 15.62 11.33 5 66321 14451 32432749
Orgasm abnormal 15.54 11.33 7 66319 136 32447064
Apathy 15.51 11.33 39 66287 6676 32440524
Liver function test abnormal 15.50 11.33 115 66211 31832 32415368
Blood lactate dehydrogenase increased 15.50 11.33 13 66313 21792 32425408
Epistaxis 15.48 11.33 60 66266 55795 32391405
Thinking abnormal 15.47 11.33 35 66291 5600 32441600
Speech sound disorder 15.44 11.33 7 66319 138 32447062
Dry mouth 15.43 11.33 93 66233 24026 32423174
Depressed mood 15.37 11.33 76 66250 18224 32428976
Hyperlipasaemia 15.11 11.33 11 66315 546 32446654
Nephropathy toxic 15.09 11.33 3 66323 11943 32435257
Axillary pain 15.04 11.33 9 66317 320 32446880
Urethral discharge 15.03 11.33 4 66322 13 32447187
Neoplasm progression 14.88 11.33 11 66315 19647 32427553
Cholestasis 14.87 11.33 20 66306 27013 32420187
Neonatal hyponatraemia 14.79 11.33 6 66320 89 32447111
Drug screen positive 14.73 11.33 29 66297 4212 32442988
Paranoia 14.70 11.33 52 66274 10747 32436453
Ventricular hypoplasia 14.67 11.33 6 66320 91 32447109
Cerebral infarction 14.62 11.33 21 66305 27593 32419607
Seizure 14.57 11.33 295 66031 103559 32343641
Retrograde ejaculation 14.47 11.33 9 66317 343 32446857
Treatment failure 14.42 11.33 37 66289 39126 32408074
Muscle twitching 14.36 11.33 45 66281 8739 32438461
Bradycardia 13.98 11.33 87 66239 71475 32375725
Bipolar disorder 13.92 11.33 27 66299 3879 32443321
Blood urea increased 13.91 11.33 28 66298 32245 32414955
Cardiogenic shock 13.86 11.33 13 66313 20649 32426551
Narcissistic personality disorder 13.83 11.33 4 66322 19 32447181
Suicidal behaviour 13.78 11.33 16 66310 1455 32445745
Angina pectoris 13.77 11.33 27 66299 31399 32415801
Libido decreased 13.73 11.33 30 66296 4688 32442512
Rhabdomyolysis 13.55 11.33 81 66245 67184 32380016
Psychopathic personality 13.52 11.33 3 66323 3 32447197
Tubulointerstitial nephritis 13.51 11.33 12 66314 19565 32427635
Pulmonary fibrosis 13.51 11.33 9 66317 16965 32430235
Loss of employment 13.50 11.33 10 66316 510 32446690
Homicide 13.42 11.33 13 66313 960 32446240
Influenza like illness 13.34 11.33 98 66228 27042 32420158
Stomatitis 13.33 11.33 40 66286 40189 32407011
Pulmonary embolism 13.28 11.33 108 66218 83551 32363649
Chills 13.23 11.33 99 66227 77985 32369215
Selective eating disorder 13.21 11.33 17 66309 1719 32445481
Helplessness 13.21 11.33 5 66321 61 32447139
Ureteric haemorrhage 13.16 11.33 6 66320 120 32447080
Anaphylactic reaction 13.15 11.33 26 66300 30146 32417054
Lung disorder 13.13 11.33 31 66295 33723 32413477
Facial spasm 13.02 11.33 7 66319 202 32446998
Palmar-plantar erythrodysaesthesia syndrome 13.01 11.33 8 66318 15741 32431459
Lymphadenopathy 13.00 11.33 22 66304 27060 32420140
Chest injury 12.99 11.33 16 66310 1548 32445652
Myelodysplastic syndrome 12.99 11.33 13 66313 20025 32427175
Restlessness 12.90 11.33 91 66235 24790 32422410
Dyspnoea exertional 12.73 11.33 39 66287 38922 32408278
Brief psychotic disorder with marked stressors 12.68 11.33 7 66319 213 32446987
Hypoxia 12.60 11.33 59 66267 52073 32395127
Concussion 12.60 11.33 19 66307 2228 32444972
Melaena 12.58 11.33 33 66293 34632 32412568
Tumour lysis syndrome 12.57 11.33 7 66319 14540 32432660
Ileus 12.44 11.33 9 66317 16256 32430944
Stiff person syndrome 12.40 11.33 6 66320 138 32447062
Reflexes abnormal 12.32 11.33 8 66318 329 32446871
Haematochezia 12.28 11.33 40 66286 39168 32408032
Hyperreflexia 12.25 11.33 22 66304 2982 32444218
Autonomic dysreflexia 12.16 11.33 5 66321 77 32447123
Hyperglycaemia 12.14 11.33 39 66287 38352 32408848
Alanine aminotransferase increased 12.05 11.33 226 66100 78253 32368947
Death 12.05 11.33 648 65678 381869 32065331
Dyskinesia 12.04 11.33 86 66240 23517 32423683
Central nervous system stimulation 11.99 11.33 3 66323 7 32447193
Drug withdrawal syndrome neonatal 11.93 11.33 24 66302 3540 32443660
Alcoholism 11.90 11.33 24 66302 3548 32443652
Asthma 11.79 11.33 48 66278 44017 32403183
Gastric ulcer 11.77 11.33 9 66317 15800 32431400
Drug screen false positive 11.75 11.33 11 66315 778 32446422
Mitral valve incompetence 11.68 11.33 8 66318 14863 32432337
Deep vein thrombosis 11.66 11.33 79 66247 63634 32383566
Pseudomonas infection 11.63 11.33 5 66321 12051 32435149
Abdominal pain 11.61 11.33 225 66101 149304 32297896
Hyperkalaemia 11.55 11.33 89 66237 69661 32377539
Mood altered 11.37 11.33 42 66284 8862 32438338
Loss of proprioception 11.37 11.33 7 66319 262 32446938
Crying 11.34 11.33 32 66294 5864 32441336
Abdominal compartment syndrome 11.33 11.33 12 66314 985 32446215

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 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 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 13668-110 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 31722-168 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 31 sections
Duloxetine HUMAN PRESCRIPTION DRUG LABEL 1 31722-169 CAPSULE, DELAYED RELEASE 30 mg ORAL ANDA 31 sections
Duloxetine HUMAN PRESCRIPTION DRUG LABEL 1 31722-170 CAPSULE, DELAYED RELEASE 60 mg ORAL ANDA 31 sections
Duloxetine Human Prescription Drug Label 1 31722-581 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 30 sections