CLINICAL · IMPORTANT SAFETY INFORMATION

Finasteride Risk Disclosure & Important Safety Information

Effective date: April 29, 2026  ·  Version: 1.0

1. About Finasteride

Finasteride is a 5-alpha reductase inhibitor that reduces the conversion of testosterone to dihydrotestosterone (DHT). It is FDA-approved in oral form for the treatment of male pattern hair loss (androgenetic alopecia) at 1 mg daily and benign prostatic hyperplasia (BPH) at higher doses. Compounded topical finasteride formulations are NOT FDA-approved and carry additional risks discussed below.

2. Who Should Not Take Finasteride

Finasteride is contraindicated or generally not recommended for the following:

• Women who are pregnant, may become pregnant, or breastfeeding. Finasteride can cause serious birth defects (specifically abnormalities of the external genitalia of male fetuses). Pregnant women should not handle crushed or broken tablets.
• Children and adolescents under 18. Finasteride is not approved for pediatric use.
• Individuals with known hypersensitivity or allergy to finasteride or its excipients.
• Individuals with severe hepatic (liver) impairment, due to extensive hepatic metabolism.
• Individuals with a history of certain mood disorders, depression, or suicidal ideation may require additional clinical evaluation before starting therapy.

3. Common Side Effects

Common adverse effects associated with oral finasteride include, but are not limited to:

• Decreased libido (sex drive).
• Erectile dysfunction.
• Ejaculation disorders, including reduced ejaculate volume.
• Breast tenderness or enlargement (gynecomastia).
• Skin rash or hypersensitivity reactions.
• Testicular pain or discomfort.

4. Serious and Persistent Adverse Effects (Including Post-Finasteride Syndrome)

Reports submitted to the FDA Adverse Event Reporting System (FAERS) and described in peer-reviewed medical literature describe serious adverse events that, in some cases, have persisted after discontinuation of the medication. These reports include:

• Persistent sexual dysfunction — including loss of libido, erectile dysfunction, reduced ejaculate volume, and genital sensory changes lasting months or years after stopping the medication.
• Persistent neuropsychiatric symptoms — including anxiety, depression, panic attacks, brain fog, cognitive impairment, sleep disturbance, and emotional blunting.
• Suicidal ideation and completed suicide. Recent analysis of the FAERS database has indicated disproportionate safety signals for finasteride compared to control medications, including reports of suicidal ideation and increased reports of suicide.
• Other persistent symptoms — including fatigue, insomnia, dry skin, decreased motivation, and reduced muscle mass.

The constellation of these persistent symptoms is sometimes referred to in the medical literature as "Post-Finasteride Syndrome" (PFS). The exact incidence, mechanism, and reversibility of these symptoms remain the subject of ongoing scientific debate and research.

5. FDA Safety Alert on Compounded Topical Finasteride (2025)

In 2025, the U.S. Food and Drug Administration issued a public safety alert regarding compounded topical finasteride products. The alert noted reports of adverse events similar to those associated with oral finasteride — including erectile dysfunction, anxiety, suicidal ideation, brain fog, depression, fatigue, insomnia, decreased libido, and testicular pain — following the use of compounded topical finasteride alone or in combination with other active ingredients.

Several reports indicated that adverse events continued to persist after the product was discontinued. Additionally, the FDA noted that some consumers reported they were not adequately informed of these risks before using the product, and some patients reported being told that there was no risk of adverse effects because the product was topical — a representation that the FDA's review does not support.

Compounded topical finasteride is not FDA-approved. Compounded medications are prepared by licensed compounding pharmacies based on a provider's prescription and clinical judgment, but they have not undergone the FDA's review process for safety, efficacy, or quality control. Their use involves additional clinical and regulatory uncertainty.

6. Effects on Prostate-Specific Antigen (PSA)

Finasteride can lower serum PSA levels by approximately 50% in men, which may affect prostate cancer screening interpretation. Men using finasteride should inform any healthcare provider ordering PSA testing about their use of finasteride.

7. Drug Interactions

Disclose all medications, supplements, and herbal products to your provider before starting finasteride. Although finasteride has a relatively low risk of interactions, it is metabolized by the liver and may interact with other medications affecting hepatic enzymes.

8. What to Do If You Experience Adverse Effects

• If you experience any concerning physical or psychological symptoms while taking finasteride, contact your provider promptly.
• If you experience thoughts of self-harm or suicide, seek immediate help: call or text 988 (Suicide & Crisis Lifeline) in the United States, call 911, or go to the nearest emergency room.
• You may discontinue finasteride at any time. Discuss with your provider whether tapering is appropriate.
• Adverse events can be reported to the FDA MedWatch program at www.fda.gov/medwatch or 1-800-FDA-1088.

9. Important Considerations Before Choosing Finasteride

• Finasteride must be taken consistently to maintain results; effects typically reverse within 12 months of discontinuation, except where persistent adverse effects occur (see Section 4).
• Finasteride is one of several treatment options for hair loss. Alternatives include topical minoxidil, low-level laser therapy, lifestyle modifications, hair restoration procedures, and other approaches. The decision to use finasteride should be made in consultation with a licensed provider after considering the risks, benefits, and alternatives.
• Treatment effects on hair vary by individual and are not guaranteed.
• You may decline finasteride at any time and request alternative options or no treatment.

10. No Doctor-Patient Relationship From This Page

The information on this page is provided for educational and informed consent purposes. It does not constitute medical advice and does not establish a doctor-patient relationship. A licensed provider affiliated with Medmi's clinical network must independently evaluate you, confirm clinical appropriateness, and prescribe treatment as they deem medically appropriate. Submitting a request through Medmi does not guarantee a prescription.

11. Acknowledgment

By proceeding through Medmi's intake process and acknowledging the corresponding consent checkbox, you confirm that:

• You have read and understood the information in this Risk Disclosure.
• You understand that finasteride may cause sexual, neuropsychiatric, and other adverse effects, some of which may persist after discontinuation.
• You understand that compounded topical finasteride is not FDA-approved and carries additional risks identified by the FDA in 2025.
• You have had the opportunity to ask questions of a licensed provider about these risks before starting treatment.
• You understand you may decline finasteride at any time and request alternatives or no treatment.
• You agree to promptly notify your provider of any adverse effects you may experience.

12. Sources and Further Reading

• FDA — Alerts on Compounded Topical Finasteride: FDA.gov
• FDA Drug Safety — Finasteride prescribing information: PROPECIA® (finasteride) label
• FAERS — Adverse event reporting database: FAERS
• NIH PMC — Post-finasteride syndrome literature review: PMC7253896
• NIH PMC — FDA Warning Regarding Finasteride and Suicidal Ideation: PMC10172713
• 988 Suicide & Crisis Lifeline (USA): call or text 988, or visit 988lifeline.org

This document is provided for informational and informed consent purposes only and does not replace direct consultation with a licensed healthcare provider. The information is current as of the effective date listed above and may be updated as new evidence emerges. If you are currently taking finasteride and experiencing concerning symptoms, contact your provider promptly. In a medical emergency, call 911 or go to the nearest emergency room.