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 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, reduce the risk of the need for surgery including transurethral resection of the prostate. Also used for the stimulation of regrowth of hair in men with mild to moderate androgenetic alopecia (male pattern alopecia, hereditary alopecia, common male baldness).
Marketing Status Prescription; Discontinued
ATC Code D11AX10; G04CB01
DrugBank ID DB01216
KEGG ID D00321
MeSH ID D018120
PubChem ID 57363
TTD Drug ID D08IWD
NDC Product Code 68071-3380; 71335-0281; 71335-1898; 76420-074; 71335-0235; 63187-265; 14501-0013; 68645-541; 68788-6976; 65862-370; 68554-0022; 60687-428; 50090-1936; 53104-7714; 68071-4541; 68382-074; 0395-8239; 38779-2410; 71335-1530; 65862-927; 49452-3147; 62756-913; 64918-0706; 70771-1152; 71052-602; 63187-863; 43598-303; 68071-4167; 63629-8180; 65862-149; 76420-151; 71713-096; 71610-515; 68788-6875; 71335-0433; 57237-061; 76420-154; 50090-4697; 55154-8083; 71713-099; 50090-4648; 48087-0092; 55111-172; 71610-520; 64918-0422; 46144-345; 71335-1304; 16729-090; 50268-314; 70518-2287; 70518-2363; 76282-412; 51927-4847; 17856-0090; 67877-288; 51552-1470; 68071-3094; 43598-390; 55111-026; 51508-001; 68071-3306; 68071-3354; 78206-153; 50090-3942; 68071-4808; 16729-089; 53104-7549; 70518-0397; 69097-112; 31722-526; 70518-3182; 68981-021; 61919-733; 57237-062; 71335-1634; 55111-171; 35573-400; 0093-7355; 0904-6830; 67877-455; 68071-2620; 78206-152; 31722-525; 50090-1718
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
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)
Fibrous histiocytoma23.10.01.012; 16.26.01.0120.000534%Not Available
Blood testosterone free decreased13.10.05.0200.000428%Not Available
Disorder of orbit06.08.03.0120.000214%Not Available
Facet joint syndrome17.10.01.015; 15.01.08.0100.000214%Not Available
Growth hormone deficiency05.03.02.0040.000321%Not Available
Dehydroepiandrosterone decreased13.10.09.0120.000428%Not Available
Tenosynovitis stenosans15.04.02.0050.000214%Not Available
Post laminectomy syndrome17.10.03.002; 15.03.04.002; 12.02.13.0020.000321%Not Available
Blood alcohol increased13.17.02.0100.000214%Not Available
Type V hyperlipidaemia14.08.02.002; 03.08.08.0020.000428%Not Available
Androgens abnormal13.10.05.0170.000641%Not Available
Foot deformity15.10.03.0050.000534%Not Available
Optic disc disorder06.09.02.0040.000214%Not Available
Papilloma viral infection11.05.07.0050.000428%Not Available
Pelvic organ injury07.11.01.029; 21.07.04.013; 20.08.01.012; 12.01.09.0180.000214%Not Available
Borrelia infection11.02.17.0030.000214%Not Available
Deformity08.01.03.0220.000214%Not Available
Dysplastic naevus16.26.01.011; 23.10.01.0110.000214%Not Available
Dihydrotestosterone decreased13.10.05.0210.000962%Not Available
Spondylolisthesis15.10.04.0040.000321%Not Available
Eyelid cyst23.07.04.024; 06.04.04.0160.000214%Not Available
Dysbacteriosis12.02.05.047; 07.11.01.0230.000321%Not Available
Hypospermia21.03.03.0070.000534%Not Available
Ligament rupture15.07.02.008; 12.01.07.0140.000534%Not Available
Prostatic calcification21.04.01.0080.000428%Not Available
Asthenospermia21.03.03.0060.000321%Not Available
Quality of life decreased13.18.01.0130.001497%Not Available
Testicular microlithiasis21.13.01.0100.000321%Not Available
Penis injury21.12.01.021; 12.01.15.0060.005345%Not Available
Vertebral foraminal stenosis17.10.01.024; 15.01.08.0150.000214%Not Available
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