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)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.0010.000855%
Abdominal pain07.01.05.0020.003207%
Abdominal pain lower07.01.05.0100.001497%Not Available
Abdominal pain upper07.01.05.0030.001817%
Abnormal dreams19.02.03.001; 17.15.02.0010.000214%Not Available
Abnormal faeces07.01.03.0010.000428%Not Available
Abnormal weight gain14.03.02.0100.000428%Not Available
Abortion spontaneous18.01.04.0010.001283%Not Available
Abscess11.01.08.0010.000321%Not Available
Acne23.02.01.0010.003955%Not Available
Acrochordon23.10.01.005; 16.26.01.0050.000641%Not Available
Actinic keratosis23.01.06.0010.000855%Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.001--Not Available
Acute sinusitis22.07.03.013; 11.01.13.0120.000855%Not Available
Adenocarcinoma16.16.01.0040.000321%Not Available
Adenoma benign16.02.02.0010.000214%Not Available
Adrenal disorder05.01.03.0010.000855%Not Available
Adrenal insufficiency14.11.01.004; 05.01.02.0010.000321%
Affective disorder19.04.04.0010.001390%Not Available
Aggression19.05.01.001--Not Available
Agitation17.02.05.012; 19.06.02.001--
Agoraphobia19.06.03.0040.000534%Not Available
Alanine aminotransferase increased13.03.01.0030.000855%
Alcohol abuse19.07.02.0070.001390%Not Available
Alcohol intolerance14.02.01.0010.000534%
Alcoholism19.07.02.0010.000428%Not Available
Alopecia23.02.02.0010.006735%
Altered state of consciousness19.07.01.003; 17.02.04.0010.000748%Not Available
Amnesia19.20.01.001; 17.03.02.0010.002175%
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