Finasteride is a 5-alpha reductase inhibitor sold in the U.S. under 3 brand and generic names, for alopecia, hirsutism and prostatic hyperplasia. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Propecia (application NDA020788). Other finasteride products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
PROPECIA may be administered with or without meals. The recommended dose of PROPECIA is one tablet (1 mg) taken once daily. In general, daily use for three months or more is necessary before benefit is observed. Continued use is recommended to sustain benefit, which should be re-evaluated periodically. Withdrawal of treatment leads to reversal of effect within 12 months. PROPECIA may be administered with or without meals ( 2 ). One tablet (1 mg) taken once daily ( 2 ). In general, daily use for three months or more is necessary before benefit is observed ( 2 ).
The most common adverse reactions, reported in ≥1% of patients treated with PROPECIA and greater than in patients treated with placebo are: decreased libido, erectile dysfunction and ejaculation disorder ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Clinical Studies for PROPECIA (finasteride 1 mg) in the Treatment of Male Pattern Hair Loss In three controlled clinical trials for PROPECIA of 12-month duration, 1.4% of patients taking PROPECIA (n=945) were discontinued due to adverse experiences that were considered to be possibly, probably or definitely drug-related (1.6% for placebo; n=934). Clinical adverse experiences that were reported as possibly, probably or definitely drug-related in ≥1% of patients treated with PROPECIA or placebo are presented in Table 1 . TABLE 1: Drug-Related Adverse Experiences for PROPECIA (finasteride 1 mg) in Year 1 (%) MALE PATTERN HAIR LOSS PROPECIA N=945 Placebo N=934 Decreased Libido 1.8 1.3 Erectile Dysfunction 1.3 0.7…
PROPECIA is contraindicated in the following: Pregnancy. Finasteride use is contraindicated in women when they are or may potentially be pregnant. Because of the ability of Type II 5α-reductase inhibitors to inhibit the conversion of testosterone to 5α-dihydrotestosterone (DHT), finasteride may cause abnormalities of the external genitalia of a male fetus of a pregnant woman who receives finasteride. If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the pregnant woman should be apprised of the potential hazard to the male fetus. [See Warnings and Precautions (5.1) , Use in Specific Populations (8.1) , How Supplied/Storage and Handling (16) and Patient Counseling Information (17) .] In female rats, low doses of finasteride administered during pregnancy have produced abnormalities of the external genitalia in male offspring. Hypersensitivity to any component of this medication. Pregnancy ( 4 , 5.1 , 8.1 , 16 ). Hypersensitivity to any components of this product ( 4 ).
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Tablet | Generic | $2 | View → | |
| 2 | 70/100 | Prescription | Tablet | Generic |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| F1 | 1 mg | red | round | — |
| E;61 | 5 mg | blue | round | — |
| F5 | 5 mg | blue | round | — |
| E;61 | 5 mg | blue | round | — |
| H;37 | 5 mg | blue | round | — |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Cytochrome P450-Linked Drug Metabolizing Enzyme System No drug interactions of clinical importance have been identified. Finasteride does not appear to affect the cytochrome P450-linked drug-metabolizing enzyme system. Compounds that have been tested in man include antipyrine, digoxin, propranolol, theophylline, and warfarin and no clinically meaningful interactions were found. 7.2 Other Concomitant Therapy Although specific interaction studies were not performed, finasteride doses of 1 mg or more were concomitantly used in clinical studies with acetaminophen, acetylsalicylic acid, α-blockers, analgesics, angiotensin-converting enzyme (ACE) inhibitors, anticonvulsants, benzodiazepines, beta blockers, calcium-channel blockers, cardiac nitrates, diuretics, H 2 antagonists, HMG-CoA reductase inhibitors, prostaglandin synthetase inhibitors (also referred to as NSAIDs), and quinolone anti-infectives without evidence of clinically significant adverse interactions.
| $2 |
| View → |
| 3 | Not yet rated | Prescription | Tablet | Generic | $2 | View → |