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)
Neutrophil count increased13.01.06.0110.001043%Not Available
Nipple pain21.05.05.0090.001565%Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.0070.002086%
Orgasm abnormal21.03.02.013; 19.08.01.004--
Orthostatic hypotension24.06.03.004; 17.05.01.0200.005737%Not Available
Pain08.01.08.004--
Palpitations02.01.02.0030.001043%
Pancreatic carcinoma16.13.10.001; 07.21.09.0020.000272%Not Available
Papilloedema17.07.02.004; 06.09.02.002; 24.03.07.0010.001043%
Pemphigoid23.03.01.004; 10.04.02.0020.003651%Not Available
Pollakiuria20.02.02.0070.001043%
Premature ejaculation21.03.01.008; 19.08.01.002--Not Available
Presyncope24.06.02.010; 17.02.05.009; 02.01.02.0070.002608%
Prostate cancer metastatic16.25.01.002; 21.04.02.0040.000544%Not Available
Prostatic specific antigen increased13.22.01.0010.003129%Not Available
Pruritus23.03.12.0010.002086%
Pulmonary embolism24.01.06.001; 22.06.02.001--Not Available
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Rash erythematous23.03.06.0030.001043%Not Available
Rash pruritic23.03.12.0020.003129%Not Available
Renal failure20.01.03.0050.000544%Not Available
Respiratory failure22.02.06.002; 14.01.04.0030.000408%
Retrograde ejaculation21.03.01.006--Not Available
Rhabdomyolysis15.05.05.0020.002086%
Seizure17.12.03.001--
Semen volume decreased13.20.01.001--Not Available
Sexual dysfunction21.03.02.003; 19.08.05.002--Not Available
Skin reaction23.03.03.013; 10.01.03.019--Not Available
Somnolence19.02.05.003; 17.02.04.006--
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