The prescribing information for Propecia (finasteride 1 mg) states that it is a 5α-reductase inhibitor indicated for the treatment of male pattern hair loss (androgenetic alopecia) in men only. It gives the recommended dose as one tablet (1 mg) taken once daily. It also states that it is not indicated for use in women or in pediatric patients. A licensed provider decides whether a treatment fits a particular person.
What the label says it is for
The Propecia label states that each film-coated tablet contains 1 mg of finasteride. A generic label for finasteride tablets USP 1 mg (Sun Pharmaceutical) uses the same wording: indicated for the treatment of male pattern hair loss (androgenetic alopecia) in men only.
The Propecia label says its efficacy was demonstrated in men (88% Caucasian) with mild to moderate androgenetic alopecia between 18 and 41 years of age. It also states that efficacy in bitemporal recession has not been established.
For the anterior mid-scalp study, the label states that hair counts were obtained in the anterior mid-scalp area and did not include the area of bitemporal recession or the anterior hairline.
Who the label says it is not for
The Propecia label states that it is not indicated for use in women. It says women who are or may potentially be pregnant should not handle crushed or broken tablets because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus.
The label also reports a 12-month study of 137 postmenopausal women with androgenetic alopecia treated with Propecia (n=67) or placebo (n=70), in which effectiveness could not be demonstrated.
For children, the label states that it is not indicated for use in pediatric patients and that safety and effectiveness in pediatric patients have not been established.
How the label says it is taken
| Question | What the source says |
|---|---|
| What is the recommended dose? | The Propecia label states one tablet (1 mg) taken once daily. |
| With or without food? | The label states it may be administered with or without meals, and that bioavailability of finasteride was not affected by food. |
| When is benefit observed? | The label states that, in general, daily use for three months or more is necessary before benefit is observed. |
| What about continued use? | The label states that continued use is recommended to sustain benefit, which should be re-evaluated periodically, and that withdrawal of treatment leads to reversal of effect within 12 months. |
This table reports the label's wording. It is not personal dosing advice.
What the approval record shows
The Drugs@FDA page for NDA 020788 lists an original approval dated 12/19/1997 (submission ORIG-1, classified as Type 3, New Dosage Form). Under Products on that application, it lists PROPECIA with active ingredient FINASTERIDE, strength 1MG, TABLET;ORAL, marketed as Prescription.
A 2017 systematic review and meta-analysis (J Am Acad Dermatol) states in its abstract that minoxidil and finasteride are FDA-approved and, with the FDA-cleared HairMax LaserComb, are the only treatments recognized by the FDA as treatments of androgenetic alopecia.
What this does not tell you
This guide covers uses, dosing and approval records. It does not cover the label's warnings or adverse reactions.
The efficacy statement describes men aged 18 to 41 with mild to moderate androgenetic alopecia. This guide does not report results for other groups, apart from the women's study above.
The Propecia label and the Sun Pharmaceutical label are two separate documents. Neither is a statement about any other product or seller. A licensed provider decides whether finasteride is appropriate for a particular man and at what dose.