Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Dutasteride
Drug ID BADD_D00736
Description Dutasteride is an oral synthetic 4-azasteroid commonly marketed under the trade name Avodart. It is a novel dual 5α-reductase inhibitor that works by blocking both isoforms of 5α-reductase enzymes in a potent, selective, and irreversible manner.[A1909] Type I and II 5α-reductase enzymes convert testosterone into dihydrotestosterone (DHT), a primary hormonal mediator that plays a role in the development and enlargement of the prostate gland. Dutasteride was approved by the FDA in 2001 for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men as monotherapy or in combination with the α-adrenergic antagonist [tamsulosin] to enhance the therapeutic response. Its clinical efficacy against benign prostate hyperplasia in male patients is comparable to that of [finasteride], a specific type II 5α-reductase inhibitor. However, unlike finasteride, dutasteride is not yet indicated for the treatment of androgenic alopecia although it was demonstrated to be effective in several randomized, double-blind, placebo-controlled trials in androgenetic alopecia.[A178333,A178336]
Indications and Usage Indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate gland to improve symptoms, and reduce the risk of acute urinary retention and the need for BPH-related surgery alone or in combination with [tamsulosin].[L10568]
Marketing Status approved; investigational
ATC Code G04CB02
DrugBank ID DB01126
KEGG ID D03820
MeSH ID D000068538
PubChem ID 6918296
TTD Drug ID D0A9YA
NDC Product Code 11014-0027; 64918-1904; 63629-1222; 63629-1223; 65162-750; 71205-039; 71205-278; 11014-0247; 64566-0013; 25000-011; 10695-152; 11014-0340; 59057-004; 73309-169; 53345-037; 72865-140; 14501-0006; 65862-797; 31722-131; 11014-0215; 64918-1032; 51013-190; 64380-763; 70771-1347; 10888-8101; 11014-0428; 51508-006; 10888-8108; 38779-3086; 53104-7612; 59057-005; 64918-1031; 71052-601; 42806-549; 69784-712; 51552-1551; 51927-5120; 61187-002; 64566-0015; 59651-021; 63629-8207; 70518-2378; 63379-016; 68554-0079; 51407-157; 68071-2610; 72578-019; 11014-0216; 11014-0392; 55111-076; 62991-3182
UNII O0J6XJN02I
Synonyms Dutasteride | 17beta-N-(2,5-bis(trifluoromethyl))phenyl-carbamoyl-4-aza-5alpha-androst-1-en-3-one | Avodart | GG 745 | 745, GG | GG-745 | GG745 | GI198745
Chemical Information
Molecular Formula C27H30F6N2O2
CAS Registry Number 164656-23-9
SMILES CC12CCC3C(C1CCC2C(=O)NC4=C(C=CC(=C4)C(F)(F)F)C(F)(F)F)CCC5C3(C=CC(=O)N5)C
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Hallucination19.10.04.0030.000455%
Hepatic adenoma16.06.01.002; 09.04.01.002--Not Available
Hepatic function abnormal09.01.02.0010.000569%Not Available
Hepatic steatosis14.08.04.005; 09.01.07.0030.000228%Not Available
Hepatitis09.01.07.0040.000455%Not Available
Hyperaesthesia23.03.03.080; 17.02.06.004--Not Available
Hyperglycaemia14.06.02.002; 05.06.02.0020.000569%
Hyperhidrosis23.02.03.004; 08.01.03.0280.000842%
Hyperprolactinaemia05.03.01.0020.000501%Not Available
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
Hypoglycaemia14.06.03.001; 05.06.03.0010.000228%
Hyponatraemia14.05.04.0020.000910%
Hypotension24.06.03.0020.000956%
Immune system disorder10.02.01.001--Not Available
Insomnia17.15.03.002; 19.02.01.0020.000842%
Interstitial lung disease22.01.02.003; 10.02.01.0330.000683%Not Available
Intracranial pressure increased17.07.02.0020.000569%Not Available
Jaundice23.03.03.030; 09.01.01.004; 01.06.04.0040.000341%Not Available
Jaundice cholestatic09.01.01.0050.000455%Not Available
Lactic acidosis14.01.01.0020.000228%Not Available
Leukopenia01.02.02.0010.000228%Not Available
Libido decreased21.03.02.005; 19.08.03.0010.001115%
Loss of consciousness17.02.04.0040.001024%Not Available
Loss of libido19.08.03.003--Not Available
Maculopathy06.09.03.0070.000341%Not Available
Malaise08.01.01.0030.001639%
Memory impairment19.20.01.003; 17.03.02.0030.000455%
Muscle atrophy17.05.03.004; 15.05.03.003--Not Available
Myalgia15.05.02.0010.001457%
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