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)
Speech disorder22.02.05.034; 19.19.02.002; 17.02.08.0030.001043%Not Available
Stomatitis07.05.06.0050.000272%
Suicidal ideation19.12.01.0030.001043%
Swelling face23.04.01.018; 10.01.05.0180.001043%Not Available
Syncope24.06.02.012; 17.02.04.008; 02.01.02.0080.004694%
Tenderness08.01.08.005--Not Available
Testicular pain21.13.01.005--
Testicular swelling21.13.01.003--Not Available
Thrombocytopenia01.08.01.0020.001043%Not Available
Transient ischaemic attack24.04.06.005; 17.08.04.0010.002086%
Tremor17.01.06.0020.001565%
Urinary retention20.02.02.0110.007302%
Urticaria23.04.02.001; 10.01.06.0010.001043%
Vertigo17.02.12.002; 04.04.01.0030.001043%
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Weight increased13.15.01.006--
White blood cell count increased13.01.06.0130.001043%Not Available
Localised oedema02.05.04.006; 14.05.06.009; 08.01.07.011--
Balance disorder17.02.02.0070.001043%Not Available
Deep vein thrombosis24.01.02.0030.001565%Not Available
Prostatomegaly21.04.01.0020.001565%Not Available
Orgasmic sensation decreased21.03.02.008; 19.08.01.003--Not Available
Musculoskeletal stiffness15.03.01.0050.001043%Not Available
Male sexual dysfunction21.03.02.012; 19.08.05.003--Not Available
Nipple swelling21.05.05.011--Not Available
Disturbance in sexual arousal19.08.04.003--Not Available
Blood alkaline phosphatase increased13.04.02.0040.001565%
Prostate cancer21.04.02.002; 16.25.01.0010.005170%Not Available
Breast cancer male16.10.01.002; 21.05.01.008--Not Available
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