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)
Abdominal discomfort07.01.06.001--Not Available
Agitation19.06.02.001; 17.02.05.0120.000728%
Altered state of consciousness19.07.01.003; 17.02.04.0010.000683%Not Available
Amnesia19.20.01.001; 17.03.02.001--
Anaemia01.03.02.0010.000842%
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Anorgasmia19.08.01.001--
Anuria20.01.03.0020.000341%Not Available
Anxiety19.06.02.002--
Apathy19.04.04.0020.000228%Not Available
Aphasia19.21.01.001; 17.02.03.0010.000228%
Apnoea22.02.01.0010.000228%
Arrhythmia02.03.02.0010.000842%Not Available
Asthenia08.01.01.0010.002549%Not Available
Atrial fibrillation02.03.03.0020.000228%
Basal cell carcinoma23.08.02.001; 16.03.02.0010.000228%Not Available
Blepharitis23.03.04.012; 06.04.04.0010.000228%Not Available
Bradycardia02.03.02.0020.000797%Not Available
Breast cancer21.05.01.003; 16.10.01.0010.000797%Not Available
Breast enlargement21.05.04.001--Not Available
Breast pain21.05.05.0030.000569%
Breast swelling21.05.05.008--Not Available
Breast tenderness21.05.05.004--Not Available
Cardiac failure02.05.01.0010.000797%
Cataract06.06.01.0010.000683%
Cerebral infarction24.04.06.002; 17.08.01.0040.000228%Not Available
Cerebral venous thrombosis24.01.04.005; 17.08.03.0020.000797%Not Available
Chest pain02.02.02.011; 22.12.02.003; 08.01.08.002--Not Available
Choking sensation22.12.03.004; 19.01.02.0020.000228%Not Available
Cholestasis09.01.01.0010.000341%Not Available
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