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)
Polycythaemia01.07.01.0010.000112%Not Available
Polydipsia14.05.02.001; 05.03.03.0020.000090%Not Available
Polyneuropathy17.09.03.0120.000067%Not Available
Polyuria20.02.03.0020.000422%Not Available
Premature ejaculation21.03.01.008; 19.08.01.0020.000742%Not Available
Premature labour18.07.01.0020.000112%Not Available
Presyncope24.06.02.010; 02.11.04.013; 17.02.05.0090.000301%
Proctalgia07.03.02.0010.000202%
Productive cough22.02.03.0050.000220%
Prostate cancer metastatic16.25.01.002; 21.04.02.0040.000067%Not Available
Prostatic disorder21.04.01.0010.000337%Not Available
Prostatic pain21.04.01.0040.000746%
Prostatic specific antigen increased13.23.01.003--Not Available
Prostatism21.04.01.003; 20.02.03.0090.000175%Not Available
Prostatitis21.09.01.0010.002184%Not Available
Pruritus23.03.12.001--
Psychosexual disorder19.08.02.0010.000310%Not Available
Pterygium06.06.02.0060.000045%Not Available
Pupillary reflex impaired17.02.11.007; 06.05.03.0090.000045%Not Available
Radiculopathy17.10.01.0050.000135%
Rapid eye movements sleep abnormal17.15.04.001; 19.02.03.0040.000067%Not Available
Rash23.03.13.001--Not Available
Rash papular23.03.13.0170.000099%Not Available
Rash vesicular23.03.13.0090.000099%Not Available
Raynaud's phenomenon24.04.03.0030.000099%Not Available
Rectal cancer16.13.01.003; 07.21.05.0020.000045%Not Available
Rectal haemorrhage24.07.02.018; 07.12.03.0010.000180%
Renal colic20.02.03.0100.000090%
Renal cyst20.01.04.001; 16.27.01.0010.000391%Not Available
Renal pain20.02.03.0030.000202%Not Available
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