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 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 surgery.
Marketing Status Prescription
ATC Code G04CB02
DrugBank ID DB01126
KEGG ID D03820
MeSH ID D000068538
PubChem ID 6918296
TTD Drug ID D0A9YA
NDC Product Code 71205-039; 11014-0247; 10888-8101; 71052-601; 11014-0340; 51552-1551; 65862-797; 50090-4010; 31722-131; 51927-5120; 73309-169; 64380-763; 10888-8108; 11014-0215; 64566-0015; 63629-1222; 70518-2378; 14501-0006; 51013-190; 42806-549; 51407-157; 0173-0712; 25000-011; 11014-0216; 63379-016; 11014-0027; 64918-1032; 71205-278; 59057-005; 68071-2610; 70771-1347; 64918-1904; 63629-1223; 11014-0428; 59057-004; 51508-006; 38779-3086; 61187-002; 55111-076; 63629-8207; 65162-750; 64566-0013; 68071-4821; 53104-7612; 72578-019; 53345-037; 72865-140; 64918-1031; 11014-0392; 68554-0079
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Breast disorder21.05.04.004--Not Available
Inflammation08.01.05.0070.001565%Not Available
Libido disorder21.03.02.006; 19.08.03.004--Not Available
Ischaemic stroke17.08.01.018; 24.04.06.0100.001043%Not Available
Malnutrition14.03.02.0040.001565%Not Available
Mental disorder19.07.01.002--Not Available
Neoplasm progression16.16.02.0050.000272%Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.004173%
Erectile dysfunction19.08.04.001; 21.03.01.0070.004173%
Disease progression08.01.03.038--
Renal impairment20.01.03.0100.001043%Not Available
Hypertransaminasaemia09.01.02.0050.002086%Not Available
Acute kidney injury20.01.03.0160.002608%
Lower urinary tract symptoms20.02.02.0230.001043%Not Available
Drug-induced liver injury12.03.01.044; 09.01.07.0230.002086%Not Available
Breast disorder male21.05.04.0080.001565%Not Available
Metastases to bone16.22.02.005; 15.09.03.0060.001043%Not Available
Metastases to lymph nodes01.09.01.015; 16.22.02.0060.000408%Not Available
Sopor19.02.04.002; 17.02.04.0210.002086%Not Available
Acanthoma23.10.01.010; 16.26.01.0100.000272%Not Available
Sperm concentration zero13.20.01.0150.001043%Not Available
Invasive ductal breast carcinoma21.05.01.021; 16.10.01.0130.000272%Not Available
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