Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Finasteride
Drug ID BADD_D00898
Description Finasteride is a synthetic 4-azasteroid compound [L10565] and specific inhibitor of steroid Type II 5α-reductase, which is an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). It works in a similar fashion as [dutasteride], which is another 5-alpha-reductase inhibitor, by exerting antiandrogenic effects. Finasteride is an orally active drug that was first approved by the FDA in 1992 for the treatment of benign prostatic hyperplasia to improve symptoms and reduce the risk for acute urinary retention or the need for surgical procedures.[L6244,L10565] In 1998, it was approved by the FDA to treat male pattern hair loss.[L6244] Finasteride is commonly marketed under the brand names Propecia and Proscar to be used aloneo or in combination with [doxazosin], an alpha-blocker. Both benign prostatic hyperplasia and androgenic alopecia are androgen-dependent disorders that are characterized by _in situ_ high levels of DHT.[A178159] In the treatment of benign prostate hyperplasia, alpha-blockers such as [tamsulosin] and [terazosin] are also used. Compared to alpha-blockers that focus on providing the rapid relief of symptoms, 5α-reductase inhibitors aim to target the underlying disease by blocking the effects of the primary androgen involved in benign prostate hyperplasia and androgenic alopecia, thus reducing the risk for secondary complications while providing symptom control.[A2132]
Indications and Usage Finasteride is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention, and reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.[L10565] A combination product with [tadalafil] is also used for the symptomatic treatment of BPH for up to 26 weeks.[L39439] Finasteride is also indicated for the treatment of male pattern hair loss (androgenetic alopecia, hereditary alopecia, or common male baldness) in male patients.[L6235]
Marketing Status approved
ATC Code D11AX10; G04CB01
DrugBank ID DB01216
KEGG ID D00321
MeSH ID D018120
PubChem ID 57363
TTD Drug ID D08IWD
NDC Product Code 65862-370; 50090-4648; 68071-1648; 71205-790; 71335-1898; 71713-096; 38779-2410; 64918-0422; 31722-526; 55154-8083; 65862-927; 68788-8377; 70518-2287; 71610-515; 49452-3147; 16729-090; 31722-525; 55111-171; 61919-733; 69097-112; 60687-428; 63187-265; 65862-149; 68071-3234; 68788-6976; 71335-0433; 71713-099; 71052-602; 0093-7355; 47335-715; 50268-314; 70518-3600; 76420-151; 51508-001; 51927-4847; 53104-7549; 62991-3175; 68382-074; 68645-541; 70518-3182; 76282-412; 50090-4697; 67877-455; 70518-0397; 70518-3616; 70771-1152; 71205-767; 71335-1304; 71335-1634; 76420-074; 0904-6830; 48087-0092; 68981-021; 43598-303; 47335-714; 55111-172; 67877-288; 68071-2999; 71610-520; 14501-0013; 53104-7714; 16729-089; 35573-400; 57237-061; 68071-2695; 71335-1530; 78206-153; 46144-345; 64918-0706; 68554-0022; 50090-1936; 57237-062; 63187-863; 68071-2620; 68071-3306; 68071-3417; 68788-8275; 70518-2363; 70518-3612; 76420-154; 78206-152; 82009-061; 51552-1470; 55111-026; 43598-390; 50090-1718
UNII 57GNO57U7G
Synonyms Finasteride | Chibro-Proscar | Chibro Proscar | Propecia | Propeshia | MK-906 | MK 906 | MK906 | Proscar | Eucoprost
Chemical Information
Molecular Formula C23H36N2O2
CAS Registry Number 98319-26-7
SMILES CC12CCC3C(C1CCC2C(=O)NC(C)(C)C)CCC4C3(C=CC(=O)N4)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)
Generalised anxiety disorder19.06.01.0040.000643%Not Available
Generalised tonic-clonic seizure17.12.01.0020.000292%Not Available
Genital rash23.03.13.016; 21.10.01.0090.000243%Not Available
Gingival bleeding24.07.02.010; 07.09.07.0010.000202%Not Available
Gingival disorder07.09.13.0040.000045%Not Available
Gingival recession07.09.13.0120.000090%Not Available
Glaucoma06.03.01.0020.000220%
Glossitis07.14.01.0010.000045%Not Available
Glucose tolerance impaired14.06.02.001; 05.06.02.0010.000112%
Glycosuria20.02.01.0050.000045%
Goitre14.11.01.008; 05.02.01.0010.000135%Not Available
Gout15.01.06.001; 14.09.01.0010.000256%Not Available
Groin pain15.03.02.0040.000822%Not Available
Gynaecomastia21.05.04.003; 05.05.02.0030.006391%
Haemangioma24.03.06.004; 16.02.01.0020.000090%Not Available
Haematochezia24.07.02.012; 07.12.02.0030.000476%Not Available
Haematoma24.07.01.0010.000243%
Haematospermia24.07.03.008; 21.03.03.0030.000634%Not Available
Haematuria21.10.01.018; 24.07.01.047; 20.02.01.0060.000912%
Haemorrhoids24.10.02.002; 07.15.03.0010.001047%
Hair colour changes23.02.06.0010.000234%
Hair disorder23.02.06.0030.000229%Not Available
Hair growth abnormal23.02.06.0060.000220%Not Available
Hair texture abnormal23.02.06.0040.000189%
Head discomfort17.02.05.0270.000310%Not Available
Headache17.14.01.0010.003991%
Hepatic cirrhosis09.01.04.0010.000045%Not Available
Hepatic cyst16.06.02.001; 09.01.08.0080.000099%Not Available
Hepatic function abnormal09.01.02.0010.000279%Not Available
Hepatic steatosis14.08.04.005; 09.01.07.0030.000422%Not Available
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