dutasteride ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
testosterone reductase inhibitors 973 164656-23-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • dutasteride
  • veltride
  • avodart
  • avolve
  • GG745
  • GG-745
A 5-ALPHA-REDUCTASE INHIBITOR that is reported to inhibit both type-1 and type2 isoforms of the enzyme and is used to treat BENIGN PROSTATIC HYPERPLASIA.
  • Molecular weight: 528.54
  • Formula: C27H30F6N2O2
  • CLOGP: 4.94
  • LIPINSKI: 1
  • HAC: 4
  • HDO: 2
  • TPSA: 58.20
  • ALOGS: -5.77
  • ROTB: 4
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.50 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.01 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 60 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class EIF2AK3,GRK2,PDK1,PDK2,PDK4 5
kinase-selectivity-class EIF2AK3,PDK1 2
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 0.731 Moderate 0.66
pfas-class PFAS structural alert (1 = True, 0 = False) 1
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 1 High 1
rat-kpuu-brain Rat brain Kpuu 2.518 % Moderate 0.66

Approvals:

DateAgencyCompanyOrphan
Nov. 20, 2001 FDA GLAXOSMITHKLINE

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
Accidental exposure to product 41.73 37.24 12 289 42354 90585792

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
Conjunctivitis allergic 315.01 12.13 134 35056 5777 42580368
Mycotic allergy 304.88 12.13 124 35066 4767 42581378
Mite allergy 304.54 12.13 125 35065 4921 42581224
Dust allergy 301.24 12.13 126 35064 5206 42580939
Spirometry abnormal 298.79 12.13 124 35066 5022 42581123
Normochromic normocytic anaemia 243.56 12.13 128 35062 8903 42577242
Sleep disorder due to a general medical condition 227.90 12.13 155 35035 17298 42568847
Neuritis 193.29 12.13 97 35093 6123 42580022
Nodule 189.52 12.13 122 35068 12412 42573733
Pulmonary vasculitis 186.77 12.13 95 35095 6171 42579974
Wheezing 165.80 12.13 215 34975 54566 42531579
Drug dispensed to wrong patient 165.06 12.13 45 35145 472 42585673
Arteriosclerosis coronary artery 164.89 12.13 131 35059 18546 42567599
Asthma 163.33 12.13 228 34962 62086 42524059
Eosinophilic granulomatosis with polyangiitis 158.23 12.13 95 35095 8543 42577602
Respiratory symptom 157.86 12.13 104 35086 11002 42575143
Full blood count abnormal 152.96 12.13 154 35036 29722 42556423
Neurological symptom 152.90 12.13 98 35092 9893 42576252
Arteriosclerosis 152.04 12.13 123 35067 17866 42568279
Obstructive airways disorder 144.26 12.13 137 35053 24622 42561523
Forced expiratory volume decreased 127.16 12.13 79 35111 7551 42578594
Productive cough 122.35 12.13 180 35010 51387 42534758
Pulmonary alveolar haemorrhage 116.18 12.13 97 35093 14719 42571426
Total lung capacity abnormal 114.19 12.13 61 35129 4382 42581763
Antineutrophil cytoplasmic antibody positive 112.39 12.13 60 35130 4305 42581840
Pulmonary fibrosis 102.20 12.13 118 35072 26563 42559582
Antimicrobial susceptibility test resistant 101.41 12.13 29 35161 367 42585778
Minimum inhibitory concentration 93.89 12.13 23 35167 151 42585994
Orthostatic hypotension 92.46 12.13 120 35070 30450 42555695
Loss of personal independence in daily activities 90.62 12.13 154 35036 49662 42536483
Toxicity to various agents 88.92 12.13 39 35151 229097 42357048
Hypothyroidism 83.40 12.13 117 35073 31967 42554178
Urinary retention 81.45 12.13 134 35056 42080 42544065
Sopor 80.61 12.13 75 35115 13127 42573018
Therapeutic response delayed 80.51 12.13 28 35162 691 42585454
Gynaecomastia 79.85 12.13 73 35117 12494 42573651
Lung disorder 79.17 12.13 142 35048 47781 42538364
Haemoptysis 79.10 12.13 139 35051 46028 42540117
Vasculitis 71.53 12.13 82 35108 18312 42567833
Breast cancer 70.84 12.13 21 35169 304 42585841
Drug ineffective 68.28 12.13 279 34911 629918 41956227
Thrombosis 65.18 12.13 162 35028 68349 42517796
Wrong patient received product 64.56 12.13 39 35151 3544 42582601
Capillaritis 64.12 12.13 33 35157 2195 42583950
Dyspnoea 60.25 12.13 593 34597 442028 42144117
Therapeutic product effect incomplete 59.51 12.13 160 35030 70779 42515366
Hypoxia 58.14 12.13 157 35033 69629 42516516
Breast tenderness 54.68 12.13 22 35168 821 42585324
Dysuria 52.44 12.13 93 35097 31003 42555142
Completed suicide 51.09 12.13 9 35181 96456 42489689
Nipple pain 49.29 12.13 22 35168 1065 42585080
Myoclonic epilepsy 48.77 12.13 25 35165 1649 42584496
Breast pain 46.96 12.13 24 35166 1573 42584572
Product dispensing error 43.96 12.13 42 35148 7597 42578548
Fall 43.67 12.13 337 34853 234183 42351962
Prostatomegaly 43.43 12.13 38 35152 6139 42580006
Product administration error 43.42 12.13 64 35126 18279 42567866
Off label use 43.10 12.13 330 34860 638005 41948140
Prostate cancer 41.85 12.13 105 35085 44538 42541607
Erectile dysfunction 41.35 12.13 74 35116 24839 42561306
Pulmonary embolism 40.03 12.13 200 34990 119412 42466733
Expired product administered 38.44 12.13 30 35160 4133 42582012
5-alpha-reductase deficiency 37.86 12.13 7 35183 7 42586138
Genitalia external ambiguous 37.44 12.13 12 35178 228 42585917
Foveal degeneration 36.60 12.13 6 35184 0 42586145
Clostridium test positive 35.01 12.13 32 35158 5473 42580672
Dark circles under eyes 34.55 12.13 9 35181 78 42586067
Prostatic specific antigen increased 34.36 12.13 55 35135 16870 42569275
Wrong product administered 33.51 12.13 33 35157 6193 42579952
Forced vital capacity decreased 33.20 12.13 16 35174 924 42585221
Breast enlargement 33.12 12.13 13 35177 454 42585691
Multiple organ dysfunction syndrome 31.05 12.13 21 35169 97014 42489131
Cardiac failure 30.49 12.13 171 35019 106685 42479460
Syncope 30.32 12.13 162 35028 99244 42486901
Asthenia 29.62 12.13 358 34832 280435 42305710
Subarachnoid haematoma 28.01 12.13 10 35180 267 42585878
Product storage error 28.01 12.13 40 35150 11100 42575045
Haematuria 27.98 12.13 108 35082 57691 42528454
Tachyarrhythmia 27.27 12.13 24 35166 3908 42582237
Sepsis 26.25 12.13 81 35109 199253 42386892
Pulmonary function test abnormal 26.16 12.13 20 35170 2674 42583471
Drug abuse 25.86 12.13 29 35161 104742 42481403
FEV1/FVC ratio decreased 25.79 12.13 8 35182 136 42586009
Ossicle disorder 25.55 12.13 6 35184 32 42586113
Product dose omission issue 25.47 12.13 56 35134 154309 42431836
Diffuse idiopathic skeletal hyperostosis 23.46 12.13 6 35184 48 42586097
Hyponatraemic syndrome 23.17 12.13 8 35182 193 42585952
Subdural haematoma 22.28 12.13 55 35135 23083 42563062
Neutropenia 22.24 12.13 87 35103 199344 42386801
Breast induration 22.17 12.13 4 35186 3 42586142
Pain 21.83 12.13 116 35074 244732 42341413
Disorganised speech 21.82 12.13 14 35176 1414 42584731
Cerebral haematoma 21.79 12.13 25 35165 5585 42580560
Nausea 21.40 12.13 217 34973 396582 42189563
Disease progression 20.64 12.13 56 35134 143600 42442545
Breast cancer male 20.27 12.13 9 35181 430 42585715
Brain injury 20.00 12.13 28 35162 7627 42578518
Vertigo 19.85 12.13 68 35122 34279 42551866
Product use in unapproved indication 19.60 12.13 82 35108 184374 42401771
Skin exfoliation 19.58 12.13 77 35113 41476 42544669
Pollakiuria 19.09 12.13 51 35139 22454 42563691
Testicular pain 18.93 12.13 18 35172 3236 42582909
Vomiting 18.85 12.13 151 35039 289572 42296573
Semen volume decreased 18.77 12.13 8 35182 346 42585799
Breast mass 18.36 12.13 10 35180 746 42585399
Gait disturbance 18.27 12.13 141 35049 97859 42488286
Febrile neutropenia 18.25 12.13 85 35105 185618 42400527
Septic shock 17.96 12.13 30 35160 91642 42494503
Atrial fibrillation 17.87 12.13 185 35005 139408 42446737
Eye haematoma 17.61 12.13 6 35184 139 42586006
Rectal haemorrhage 17.32 12.13 84 35106 49522 42536623
Presyncope 17.27 12.13 49 35141 22338 42563807
Malaise 17.17 12.13 258 34932 211898 42374247
Death 17.12 12.13 280 34910 470905 42115240
Myelosuppression 17.12 12.13 6 35184 40455 42545690
Blood pressure systolic increased 16.72 12.13 56 35134 27912 42558233
Intercepted product prescribing error 16.67 12.13 6 35184 164 42585981
Occupational exposure to air contaminants 16.60 12.13 6 35184 166 42585979
Invasive ductal breast carcinoma 16.52 12.13 5 35185 78 42586067
Intraventricular haemorrhage 16.26 12.13 18 35172 3866 42582279
Urinary tract infection 15.90 12.13 138 35052 99146 42486999
Pain in extremity 15.82 12.13 192 34998 150412 42435733
Autonomic nervous system imbalance 15.82 12.13 16 35174 3100 42583045
Treatment failure 15.81 12.13 17 35173 62607 42523538
Obesity 15.72 12.13 39 35151 16420 42569725
General physical health deterioration 15.59 12.13 68 35122 151178 42434967
Diabetes mellitus 15.52 12.13 16 35174 60071 42526074
Drug intolerance 15.13 12.13 27 35163 80397 42505748
Anxiety 15.11 12.13 157 35033 118403 42467742
Heart rate decreased 15.09 12.13 65 35125 36467 42549678
Prostate examination abnormal 15.05 12.13 7 35183 373 42585772
Tongue oedema 15.01 12.13 16 35174 3294 42582851
Urine flow decreased 14.99 12.13 11 35179 1382 42584763
Cardio-respiratory arrest 14.71 12.13 16 35174 58620 42527525
Cardiac arrest 14.68 12.13 44 35146 109276 42476869
Lung hyperinflation 14.65 12.13 10 35180 1121 42585024
Wrong strength 14.47 12.13 5 35185 121 42586024
Lower urinary tract symptoms 14.35 12.13 7 35183 415 42585730
Respiratory arrest 14.30 12.13 3 35187 28421 42557724
Foetal exposure during pregnancy 14.13 12.13 11 35179 47300 42538845
Pemphigoid 14.07 12.13 30 35160 11437 42574708
Medical device site haemorrhage 13.92 12.13 5 35185 136 42586009
Prostatic haemorrhage 13.90 12.13 6 35184 268 42585877
Asthma-chronic obstructive pulmonary disease overlap syndrome 13.89 12.13 11 35179 1548 42584597
Libido decreased 13.85 12.13 19 35171 5079 42581066
Treatment noncompliance 13.67 12.13 7 35183 37665 42548480
Intentional product use issue 13.61 12.13 24 35166 71809 42514336
Labyrinthitis 13.51 12.13 9 35181 969 42585176
Congenital genital malformation male 13.48 12.13 3 35187 12 42586133
Dyspnoea exertional 13.46 12.13 79 35111 50069 42536076
Depression 13.44 12.13 47 35143 111316 42474829
Abnormal sleep-related event 13.36 12.13 7 35183 483 42585662
Procedural haemorrhage 13.36 12.13 14 35176 2827 42583318
Testicular swelling 13.36 12.13 12 35178 2007 42584138
Cytomegalovirus infection 13.31 12.13 5 35185 32301 42553844
Breast disorder male 13.11 12.13 3 35187 14 42586131
Loss of consciousness 13.07 12.13 125 35065 92229 42493916
Proctalgia 12.98 12.13 22 35168 7071 42579074
Residual urine volume increased 12.94 12.13 3 35187 15 42586130
Balance disorder 12.75 12.13 75 35115 47570 42538575
Vascular dementia 12.65 12.13 7 35183 539 42585606
Pulmonary interstitial emphysema syndrome 12.45 12.13 7 35183 556 42585589
Hyperkalaemia 12.44 12.13 111 35079 80347 42505798
Inferior vena cava dilatation 12.43 12.13 8 35182 812 42585333
Blood gases abnormal 12.33 12.13 6 35184 354 42585791
Stress 12.32 12.13 11 35179 44201 42541944
Hypoglycaemia 12.22 12.13 88 35102 59766 42526379
Migraine 12.15 12.13 3 35187 25411 42560734

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Conjunctivitis allergic 435.97 13.50 134 30764 6797 110551604
Dust allergy 424.51 13.50 127 30771 5874 110552527
Mite allergy 424.36 13.50 126 30772 5677 110552724
Spirometry abnormal 422.29 13.50 124 30774 5373 110553028
Mycotic allergy 416.83 13.50 125 30773 5829 110552572
Normochromic normocytic anaemia 331.30 13.50 128 30770 12929 110545472
Pulmonary vasculitis 285.99 13.50 96 30802 6464 110551937
Neuritis 282.37 13.50 98 30800 7301 110551100
Arteriosclerosis coronary artery 262.61 13.50 132 30766 24986 110533415
Eosinophilic granulomatosis with polyangiitis 240.30 13.50 96 30802 10590 110547811
Respiratory symptom 237.94 13.50 105 30793 14840 110543561
Arteriosclerosis 235.23 13.50 122 30776 24645 110533756
Sleep disorder due to a general medical condition 226.48 13.50 155 30743 51957 110506444
Neurological symptom 214.63 13.50 99 30799 15509 110542892
Full blood count abnormal 204.88 13.50 150 30748 55902 110502499
Nodule 203.78 13.50 122 30776 32509 110525892
Obstructive airways disorder 202.28 13.50 138 30760 46011 110512390
Pulmonary alveolar haemorrhage 187.74 13.50 98 30800 20052 110538349
Total lung capacity abnormal 179.90 13.50 62 30836 4521 110553880
Antineutrophil cytoplasmic antibody positive 169.93 13.50 61 30837 5015 110553386
Forced expiratory volume decreased 167.00 13.50 79 30819 13097 110545304
Productive cough 161.82 13.50 179 30719 114126 110444275
Haemoptysis 149.16 13.50 138 30760 71216 110487185
Antimicrobial susceptibility test resistant 124.51 13.50 28 30870 406 110557995
Thrombosis 123.44 13.50 152 30746 108510 110449891
Drug dispensed to wrong patient 119.18 13.50 30 30868 719 110557682
Minimum inhibitory concentration 118.85 13.50 23 30875 150 110558251
Hypoxia 106.90 13.50 155 30743 129360 110429041
Hypothyroidism 102.85 13.50 114 30784 72785 110485616
Vasculitis 102.57 13.50 83 30815 35790 110522611
Asthma 101.30 13.50 219 30679 250072 110308329
Orthostatic hypotension 99.37 13.50 107 30791 66142 110492259
Capillaritis 95.74 13.50 33 30865 2406 110555995
Pulmonary embolism 90.61 13.50 191 30707 214283 110344118
Wheezing 89.53 13.50 211 30687 255019 110303382
Gynaecomastia 87.94 13.50 46 30852 9444 110548957
Therapeutic response delayed 87.93 13.50 27 30871 1363 110557038
Loss of personal independence in daily activities 85.92 13.50 152 30746 149868 110408533
Urinary retention 84.85 13.50 101 30797 69582 110488819
Sopor 84.83 13.50 75 30823 36471 110521930
Haematuria 83.00 13.50 109 30789 82896 110475505
Pulmonary fibrosis 75.42 13.50 116 30782 101926 110456475
Prostate cancer 73.26 13.50 70 30828 37571 110520830
Dyspnoea 72.83 13.50 543 30355 1106329 109452072
Pain 68.14 13.50 101 30797 954854 109603547
Drug interaction 65.55 13.50 295 30603 499888 110058513
Drug ineffective 65.51 13.50 213 30685 1520327 109038074
Syncope 65.16 13.50 162 30736 202374 110356027
Cardiac failure 64.55 13.50 154 30744 187472 110370929
Erectile dysfunction 64.04 13.50 48 30850 18508 110539893
Drug intolerance 60.75 13.50 19 30879 406493 110151908
Joint swelling 60.53 13.50 24 30874 442821 110115580
Wrong patient received product 58.02 13.50 31 30867 6643 110551758
Atrial fibrillation 57.09 13.50 167 30731 229475 110328926
Lung disorder 55.80 13.50 142 30756 179905 110378496
Prostatomegaly 55.49 13.50 26 30872 4216 110554185
Toxicity to various agents 55.12 13.50 33 30865 480522 110077879
Nipple pain 54.70 13.50 18 30880 1138 110557263
Alopecia 54.58 13.50 17 30881 364736 110193665
Fall 54.02 13.50 320 30578 603162 109955239
Therapeutic product effect incomplete 52.07 13.50 159 30739 223646 110334755
Expired product administered 49.07 13.50 30 30868 8290 110550111
Hand deformity 49.07 13.50 3 30895 218503 110339898
Completed suicide 47.24 13.50 6 30892 242375 110316026
Infusion related reaction 46.84 13.50 24 30874 381138 110177263
Clostridium test positive 46.35 13.50 32 30866 10861 110547540
Amaurosis fugax 45.29 13.50 19 30879 2371 110556030
Pemphigus 45.17 13.50 4 30894 214566 110343835
Product dispensing error 44.99 13.50 37 30861 16308 110542093
Dysuria 43.83 13.50 68 30830 60163 110498238
Hyperkalaemia 41.96 13.50 107 30791 135689 110422712
Wrong product administered 41.54 13.50 30 30868 10930 110547471
Subdural haematoma 41.37 13.50 51 30847 36403 110521998
Treatment failure 41.32 13.50 13 30885 277221 110281180
Product administration error 40.53 13.50 51 30847 37166 110521235
Prostatic specific antigen increased 40.17 13.50 31 30867 12480 110545921
Presyncope 39.56 13.50 58 30840 48829 110509572
Acute kidney injury 38.40 13.50 306 30592 635124 109923277
Nausea 37.51 13.50 198 30700 1235492 109322909
Subarachnoid haematoma 37.33 13.50 10 30888 308 110558093
Therapeutic product effect decreased 37.23 13.50 11 30887 244305 110314096
Migraine 36.68 13.50 3 30895 171649 110386752
Asthenia 36.43 13.50 322 30576 688677 109869724
Contraindicated product administered 36.36 13.50 12 30886 248255 110310146
Skin exfoliation 35.74 13.50 77 30821 87574 110470827
Glossodynia 35.70 13.50 9 30889 221995 110336406
Haemorrhagic stroke 35.44 13.50 30 30868 13759 110544642
Forced vital capacity decreased 35.13 13.50 15 30883 1955 110556446
Tachyarrhythmia 34.52 13.50 24 30874 8237 110550164
Psoriatic arthropathy 33.59 13.50 7 30891 196754 110361647
Cerebral haematoma 33.42 13.50 25 30873 9607 110548794
Mobility decreased 32.19 13.50 13 30885 237409 110320992
Ossicle disorder 32.03 13.50 6 30892 32 110558369
Pulmonary function test abnormal 32.00 13.50 19 30879 4981 110553420
Hypoaesthesia 31.45 13.50 25 30873 314198 110244203
Breast tenderness 30.93 13.50 15 30883 2625 110555776
Pericarditis 29.70 13.50 12 30886 219102 110339299
Urinary tract disorder 29.27 13.50 19 30879 5825 110552576
Type 2 diabetes mellitus 28.85 13.50 7 30891 177225 110381176
Diffuse idiopathic skeletal hyperostosis 28.82 13.50 6 30892 59 110558342
Blood cholesterol increased 28.74 13.50 8 30890 184777 110373624
Arthropathy 28.62 13.50 23 30875 287499 110270902
FEV1/FVC ratio decreased 28.50 13.50 8 30890 294 110558107
Blister 28.39 13.50 14 30884 227362 110331039
Semen volume decreased 28.38 13.50 6 30892 64 110558337
Dark circles under eyes 28.00 13.50 9 30889 528 110557873
Impaired healing 27.95 13.50 10 30888 196707 110361694
Intraventricular haemorrhage 27.81 13.50 18 30880 5489 110552912
Stomatitis 27.68 13.50 21 30877 270221 110288180
Drug hypersensitivity 26.83 13.50 54 30844 454036 110104365
Sinusitis 26.80 13.50 26 30872 296662 110261739
Hypoglycaemia 26.52 13.50 82 30816 116022 110442379
Exposure during pregnancy 26.51 13.50 7 30891 167417 110390984
Liver injury 26.40 13.50 5 30893 150408 110407993
Peripheral swelling 25.66 13.50 46 30852 403988 110154413
Headache 25.28 13.50 144 30754 882233 109676168
Dyspnoea exertional 25.18 13.50 75 30823 103985 110454416
Rheumatoid arthritis 25.10 13.50 28 30870 299585 110258816
Disorganised speech 25.00 13.50 14 30884 3289 110555112
Pemphigoid 24.70 13.50 29 30869 19678 110538723
Heart rate decreased 24.31 13.50 64 30834 82692 110475709
Infection 24.13 13.50 40 30858 362160 110196241
Vomiting 23.79 13.50 153 30745 910522 109647879
Hepatic enzyme increased 23.73 13.50 33 30865 320859 110237542
Musculoskeletal stiffness 23.60 13.50 26 30872 279796 110278605
Arthralgia 23.54 13.50 125 30773 779507 109778894
Abdominal discomfort 23.12 13.50 47 30851 393811 110164590
Depression 23.10 13.50 33 30865 317302 110241099
Occupational exposure to air contaminants 23.01 13.50 6 30892 166 110558235
Altered state of consciousness 22.78 13.50 50 30848 57576 110500825
Inflammation 22.51 13.50 13 30885 193225 110365176
Product storage error 22.43 13.50 29 30869 21699 110536702
Vertigo 22.35 13.50 64 30834 86806 110471595
Breast pain 22.16 13.50 20 30878 9980 110548421
Prostate examination abnormal 22.09 13.50 6 30892 195 110558206
Hypersensitivity 21.42 13.50 51 30847 403947 110154454
Swelling 21.37 13.50 41 30857 351000 110207401
Testicular swelling 21.08 13.50 10 30888 1666 110556735
Melaena 21.04 13.50 54 30844 68703 110489698
Breast enlargement 21.01 13.50 10 30888 1679 110556722
Paraesthesia 20.88 13.50 28 30870 276493 110281908
Hyponatraemic syndrome 20.88 13.50 8 30890 789 110557612
Diplopia 20.87 13.50 40 30858 41854 110516547
General physical health deterioration 20.76 13.50 56 30842 425239 110133162
Rectal haemorrhage 20.64 13.50 77 30821 119756 110438645
Urticaria 20.51 13.50 36 30862 318821 110239580
Haemorrhage 20.46 13.50 71 30827 106621 110451780
Testicular pain 20.32 13.50 11 30887 2418 110555983
Intentional product use issue 19.86 13.50 24 30874 247882 110310519
Eye haematoma 19.71 13.50 6 30892 294 110558107
Pulmonary interstitial emphysema syndrome 19.58 13.50 7 30891 568 110557833
Renal failure 19.47 13.50 119 30779 226455 110331946
Pollakiuria 19.38 13.50 40 30858 44155 110514246
Inferior vena cava dilatation 19.38 13.50 8 30890 959 110557442
Discomfort 19.17 13.50 19 30879 214688 110343713
Ill-defined disorder 19.07 13.50 10 30888 156843 110401558
Night sweats 18.71 13.50 7 30891 133976 110424425
Loss of consciousness 18.08 13.50 105 30793 196201 110362200
Breast disorder male 17.94 13.50 3 30895 7 110558394
Weight increased 17.78 13.50 59 30839 419585 110138816
Anaemia 17.76 13.50 232 30666 546854 110011547
Intercepted product prescribing error 17.64 13.50 6 30892 420 110557981
Product use issue 17.61 13.50 38 30860 311657 110246744
Medical device site haemorrhage 17.38 13.50 5 30893 201 110558200
Lactic acidosis 17.13 13.50 61 30837 92750 110465651
Ocular discomfort 16.85 13.50 16 30882 8517 110549884
Hepatocellular injury 16.78 13.50 41 30857 50601 110507800
Benign prostatic hyperplasia 16.77 13.50 23 30875 18211 110540190
Wrong strength 16.69 13.50 5 30893 232 110558169
Haematemesis 16.64 13.50 45 30853 59063 110499338
Lower urinary tract symptoms 16.63 13.50 6 30892 500 110557901
Injury 16.63 13.50 15 30883 177250 110381151
Abnormal sleep-related event 16.49 13.50 7 30891 899 110557502
Procedural haemorrhage 16.45 13.50 13 30885 5414 110552987
Vascular dementia 16.32 13.50 7 30891 922 110557479
Bradycardia 16.19 13.50 86 30812 155431 110402970
Penile size reduced 15.92 13.50 4 30894 95 110558306
Cerebral haemorrhage 15.88 13.50 47 30851 64921 110493480
Gastrointestinal disorder 15.85 13.50 27 30871 241925 110316476
Proctalgia 15.81 13.50 19 30879 13203 110545198
Ejaculation disorder 15.79 13.50 6 30892 578 110557823
Lung hyperinflation 15.66 13.50 9 30889 2220 110556181
Blood loss anaemia 15.48 13.50 22 30876 18003 110540398
Prostate cancer metastatic 15.33 13.50 12 30886 4931 110553470
Body mass index increased 15.29 13.50 9 30889 2321 110556080
Cough 15.07 13.50 196 30702 461445 110096956
Product use in unapproved indication 15.05 13.50 69 30829 447308 110111093
Hallucination 14.90 13.50 62 30836 101370 110457031
Memory impairment 14.80 13.50 20 30878 196924 110361477
Epididymitis 14.76 13.50 9 30889 2475 110555926
Blood immunoglobulin E increased 14.72 13.50 14 30884 7468 110550933
Product dose omission issue 14.50 13.50 44 30854 321738 110236663
Psoriasis 14.17 13.50 11 30887 139982 110418419
Bronchial hyperreactivity 14.12 13.50 10 30888 3534 110554867
Bladder neoplasm 14.10 13.50 8 30890 1926 110556475
Brain stem haematoma 13.92 13.50 4 30894 160 110558241
Breast induration 13.72 13.50 3 30895 38 110558363
Left ventricular dysfunction 13.68 13.50 24 30874 23469 110534932
Gait disturbance 13.62 13.50 128 30770 278080 110280321
Blood testosterone increased 13.57 13.50 7 30891 1395 110557006
Urine flow decreased 13.56 13.50 7 30891 1399 110557002
Tongue oedema 13.55 13.50 14 30884 8242 110550159
Wound infection 13.54 13.50 5 30893 96460 110461941

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC G04CA52 GENITO URINARY SYSTEM AND SEX HORMONES
UROLOGICALS
DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY
Alpha-adrenoreceptor antagonists
ATC G04CB02 GENITO URINARY SYSTEM AND SEX HORMONES
UROLOGICALS
DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY
Testosterone-5-alpha reductase inhibitors
FDA MoA N0000000126 5-alpha Reductase Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D006727 Hormone Antagonists
MeSH PA D058891 5-alpha Reductase Inhibitors
MeSH PA D065088 Steroid Synthesis Inhibitors
FDA EPC N0000175836 5-alpha Reductase Inhibitor
CHEBI has role CHEBI:50781 EC 1.3.1.22 [3-oxo-5ฮฑ-steroid 4-dehydrogenase (NADP<small><sup>+</small></sup>)] inhibitor
CHEBI has role CHEBI:59844 antihyperplasia drug

Related Drugs by ATC class:

G04CA Alpha-adrenoreceptor antagonists 8 drugs
alfuzosindoxazosinfinasteridesilodosinsolifenacintadalafiltamsulosinterazosin
G04CB Testosterone-5-alpha reductase inhibitors 2 drugs
finasteridetadalafil

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

DiseaseRelationSNOMED_IDDOID
Benign prostatic hyperplasia indication 266569009
Priapism contraindication 6273006 DOID:9286
Orthostatic hypotension contraindication 28651003
Oligozoospermia contraindication 88311004
Cataract surgery contraindication 110473004
Disease of liver contraindication 235856003 DOID:409
Syncope contraindication 271594007
Pregnancy, function contraindication 289908002
Dizziness contraindication 404640003
Breastfeeding (mother) contraindication 413712001
Intraoperative floppy iris syndrome contraindication 418801006
High-Grade Prostate Cancer contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.41 acidic
pKa2 13.26 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
3-oxo-5-alpha-steroid 4-dehydrogenase 2 Enzyme INHIBITOR IC50 9.20 WOMBAT-PK CHEMBL
3-oxo-5-alpha-steroid 4-dehydrogenase 1 Enzyme INHIBITOR IC50 8.49 WOMBAT-PK CHEMBL
Glycine receptor subunit alpha-1 Ion channel EC50 6.48 CHEMBL

External reference:

IDSource
4021371 VUID
N0000148790 NUI
D03820 KEGG_DRUG
4021371 VANDF
C0754659 UMLSCUI
CHEMBL1200969 ChEMBL_ID
D000068538 MESH_DESCRIPTOR_UI
DB01126 DRUGBANK_ID
7457 IUPHAR_LIGAND_ID
7586 INN_ID
O0J6XJN02I UNII
6918296 PUBCHEM_CID
228790 RXNORM
16302 MMSL
228246 MMSL
42738 MMSL
d04788 MMSL
009824 NDDF
385570006 SNOMEDCT_US
385572003 SNOMEDCT_US
O0J6XJN02I INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Dutasteride HUMAN PRESCRIPTION DRUG LABEL 1 0115-1438 CAPSULE, LIQUID FILLED 0.50 mg ORAL ANDA 28 sections
Dutasteride and Tamsulosin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 10370-280 CAPSULE 0.50 mg ORAL ANDA 27 sections
Dutasteride Human Prescription Drug Label 1 25000-011 CAPSULE, LIQUID FILLED 0.50 mg ORAL ANDA 28 sections
Dutasteride HUMAN PRESCRIPTION DRUG LABEL 1 31722-131 CAPSULE, LIQUID FILLED 0.50 mg ORAL ANDA 18 sections
Dutasteride and Tamsulosin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 42291-031 CAPSULE 0.50 mg ORAL ANDA 28 sections
Dutasteride HUMAN PRESCRIPTION DRUG LABEL 1 42806-549 CAPSULE, LIQUID FILLED 0.50 mg ORAL ANDA 28 sections
Dutasteride HUMAN PRESCRIPTION DRUG LABEL 1 50090-4010 CAPSULE, LIQUID FILLED 0.50 mg ORAL ANDA 18 sections
Dutasteride Human Prescription Drug Label 1 50090-7305 CAPSULE, LIQUID FILLED 0.50 mg ORAL ANDA 28 sections
Dutasteride HUMAN PRESCRIPTION DRUG LABEL 1 50090-7852 CAPSULE, LIQUID FILLED 0.50 mg ORAL ANDA 28 sections
Dutasteride HUMAN PRESCRIPTION DRUG LABEL 1 51013-190 CAPSULE, LIQUID FILLED 0.50 mg ORAL ANDA 28 sections
Dutasteride HUMAN PRESCRIPTION DRUG LABEL 1 53345-037 CAPSULE, LIQUID FILLED 0.50 mg ORAL ANDA 28 sections
Avodart HUMAN PRESCRIPTION DRUG LABEL 1 54868-5114 CAPSULE, LIQUID FILLED 0.50 mg ORAL NDA 27 sections
JALYN HUMAN PRESCRIPTION DRUG LABEL 2 54868-6328 CAPSULE 0.50 mg ORAL NDA 28 sections
Dutasteride Human Prescription Drug Label 1 59651-021 CAPSULE, LIQUID FILLED 0.50 mg ORAL ANDA 28 sections
Dutasteride and Tamsulosin Hydrochloride Human Prescription Drug Label 2 59651-063 CAPSULE 0.50 mg ORAL ANDA 28 sections
Dutasteride HUMAN PRESCRIPTION DRUG LABEL 1 62112-8068 CAPSULE, LIQUID FILLED 0.50 mg ORAL ANDA 27 sections
Dutasteride HUMAN PRESCRIPTION DRUG LABEL 1 63629-1222 CAPSULE, LIQUID FILLED 0.50 mg ORAL ANDA 18 sections
Dutasteride HUMAN PRESCRIPTION DRUG LABEL 1 63629-1222 CAPSULE, LIQUID FILLED 0.50 mg ORAL ANDA 18 sections
Dutasteride HUMAN PRESCRIPTION DRUG LABEL 1 63629-1223 CAPSULE, LIQUID FILLED 0.50 mg ORAL ANDA 18 sections
Dutasteride HUMAN PRESCRIPTION DRUG LABEL 1 63629-8207 CAPSULE, LIQUID FILLED 0.50 mg ORAL ANDA 18 sections
Dutasteride HUMAN PRESCRIPTION DRUG LABEL 1 65162-750 CAPSULE 0.50 mg ORAL ANDA 18 sections
Dutasteride HUMAN PRESCRIPTION DRUG LABEL 1 68071-2610 CAPSULE, LIQUID FILLED 0.50 mg ORAL ANDA 17 sections
Dutasteride HUMAN PRESCRIPTION DRUG LABEL 1 68071-3732 CAPSULE, LIQUID FILLED 0.50 mg ORAL ANDA 17 sections
Dutasteride HUMAN PRESCRIPTION DRUG LABEL 1 68071-3757 CAPSULE, LIQUID FILLED 0.50 mg ORAL ANDA 28 sections
Dutasteride HUMAN PRESCRIPTION DRUG LABEL 1 68071-3857 CAPSULE, LIQUID FILLED 0.50 mg ORAL ANDA 28 sections
Dutasteride HUMAN PRESCRIPTION DRUG LABEL 1 68071-4821 CAPSULE, LIQUID FILLED 0.50 mg ORAL ANDA 17 sections
Dutasteride and tamsulosin hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 68382-640 CAPSULE 0.50 mg ORAL ANDA 25 sections
Dutasteride and tamsulosin hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 70771-1356 CAPSULE 0.50 mg ORAL ANDA 1 sections
Dutasteride HUMAN PRESCRIPTION DRUG LABEL 1 71205-039 CAPSULE 0.50 mg ORAL ANDA 18 sections
Dutasteride HUMAN PRESCRIPTION DRUG LABEL 1 71205-278 CAPSULE, LIQUID FILLED 0.50 mg ORAL ANDA 18 sections