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)
Illness anxiety disorder19.24.01.0020.000067%Not Available
Abnormal loss of weight14.03.02.0190.000279%Not Available
Adjustment disorder with depressed mood19.23.01.0020.000067%Not Available
Alopecia areata23.02.02.008; 10.04.02.0110.000045%Not Available
Astigmatism06.02.04.0090.000067%Not Available
Bladder sphincter atony17.05.01.023; 20.03.03.0060.000045%Not Available
Breast disorder male21.05.04.0080.000090%Not Available
Breathing-related sleep disorder17.15.04.005; 22.02.01.028; 19.02.05.0080.000090%Not Available
Cervical spinal stenosis17.10.02.006; 15.10.04.0060.000144%Not Available
Chronic gastritis07.08.02.005; 11.07.01.016; 10.04.04.0110.000099%Not Available
Empty sella syndrome05.03.04.0090.000121%Not Available
Epididymal cyst16.36.02.002; 21.13.02.0030.000854%Not Available
Grief reaction19.23.01.0030.000099%Not Available
Haemangioma of skin24.03.06.008; 16.26.01.013; 23.10.01.0130.000175%Not Available
Immunodeficiency common variable10.03.01.0060.000157%Not Available
Lumbar spinal stenosis17.10.03.004; 15.10.04.0080.000067%Not Available
Mitral valve prolapse02.07.01.0080.000112%Not Available
Muscle hypertrophy15.05.03.0300.000045%Not Available
Nasal turbinate hypertrophy22.04.03.0210.000090%Not Available
Overweight14.03.02.0210.000121%Not Available
Penile size reduced21.12.01.0180.002755%Not Available
Penile vascular disorder24.03.10.001; 21.12.01.0200.000121%Not Available
Pityriasis rosea23.03.08.0030.000045%Not Available
Plantar fascial fibromatosis15.03.05.0280.000045%Not Available
Post inflammatory pigmentation change23.05.03.0020.000045%Not Available
Post-traumatic stress disorder19.06.06.0020.000225%Not Available
Prostate cancer recurrent21.04.02.008; 16.25.01.0050.000067%Not Available
Reading disorder19.21.05.0030.000067%Not Available
Seasonal affective disorder19.04.04.0070.000198%Not Available
Seminoma21.13.02.004; 16.25.03.0020.000045%Not Available
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