Oral Finasteride

Safety Information

Before you start using finasteride and each time you get a refill, please review this important safety information. This information may be updated. It does not replace discussing your medical condition or treatment with your doctor or healthcare provider.

What is the FDA approved use of finasteride?

• Finasteride is FDA-approved as an oral medication to treat benign prostatic hyperplasia (Proscar) and androgenetic alopecia (Propecia) in men.
• Finasteride has not been FDA-approved for topical use in men or women. However, it may be prescribed off-label in topical compounded formulations to treat hair loss. Please note that oral finasteride has also not been approved for use in women, for any indication.

What should I tell my healthcare provider before taking finasteride?

Please inform your doctor or healthcare provider if any of the following apply:

• You have a personal or family history of prostate cancer, breast cancer
• You have prostate or urinary symptoms such as reduced urine flow, difficulty urinating or pain
• You have a history of any serious mental health conditions
• You are pregnant, trying to get pregnant, or are breastfeeding

Who should not take finasteride?

You should not take finasteride if you: 

• Have ever had an allergic reaction to finasteride or any other ingredients in the treatment
• Finasteride should not be used by women who are pregnant, may be pregnant or are breastfeeding
• Finasteride should not be used by infants or children

What are the possible side effects of finasteride?

The following side effects have been reported with finasteride use:

• Breast tenderness and enlargement. You should inform your doctor or healthcare provider if you notice any breast lumps, pain or nipple discharge
• Depression, anxiety, brain fog, suicidal ideation
• Decreased libido (sex drive)
• Allergic reactions (e.g., rash, itching, hives and swelling of the lips, tongue, throat, and face)
• Problems with ejaculation
• Testicular pain
• Erectile dysfunction (difficulty achieving or maintaining an erection)
• Male infertility and/or poor semen quality
  

Please note that finasteride has only been formally studied in male patients, so the side effect profile above is specific to clinical studies in men. Preliminary data on the use of finasteride in female patients has shown the following possible side effects:

• Decreased libido (sex drive)
• Breast tenderness and enlargement
• Mood changes (e.g., depression)
• Fatigue
• Muscle soreness
• Weight gain

There is some evidence that finasteride can increase the risk of some breast and prostate cancers.

The above lists do not represent all potential side effects, medication interactions or study data relating to the safety of finasteride. It is important to talk to your doctor, healthcare provider and/or pharmacist if you are experiencing any side effects. A comprehensive review of the potential safety risks of using finasteride can be found at this link: https://pubmed.ncbi.nlm.nih.gov/27672412/.

If you are experiencing a medical emergency or allergic reaction, call 911 or seek immediate medical attention. You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Additional safety information can be found here, in the Digital Prescriber’s Reference for finasteride: https://www.pdr.net/drug-summary/?drugLabelId=378.