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Finasteride FDA Alerts

The FDA Alerts below may be specifically about finasteride or relate to a group or class of drugs which include finasteride.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for finasteride

FDA Alerts Health Care Providers, Compounders and Consumers of Potential Risks Associated with Compounded Topical Finasteride Products

Apr 22, 2025 | Audience: Health Care Providers, Compounders, Consumers

April 22, 2025 -- FDA has become aware of reports of adverse events involving compounded topical finasteride products potentially putting consumers at risk. The agency is aware of some compounders and telemedicine platforms that market topical formulations of finasteride either as a single active ingredient (finasteride alone) or in combination with other active ingredients, such as finasteride combined with minoxidil, to treat hair loss.

There are two FDA-approved oral finasteride products for different indications currently available in the U.S.:

  • Proscar was approved on June 19, 1992
  • Propecia was approved on December 19, 1997

Currently, there is no FDA-approved topical formulation of finasteride. Compounded topical finasteride products do not have FDA-approved labeling. There are potential serious risks associated with the use of compounded topical finasteride products.  

Review and discussion

FDA has become aware of reports of adverse events associated with the use of compounded topical finasteride. There were 32 cases reported to the FDA Adverse Event Reporting System between 2019 and 2024. Absorption of finasteride through the skin into the bloodstream is expected, and the reports describe adverse events that are consistent with those reported in association with the approved oral finasteride products, such as erectile dysfunction, anxiety, suicidal ideation, brain fog, depression, fatigue, insomnia, decreased libido and testicular pain following the use of compounded topical products with finasteride alone or in combination with other active ingredients.

Most of the reports FDA has received state the adverse events continued to persist after product discontinuation. In some cases, consumers expressed they were not aware of the potential adverse events associated with the use of topical finasteride, and other patients reported that they were told by the prescribers that there was no risk of any adverse event because the product was topical.

In the reports, consumers said they wished they had been informed about the possible side effects. Some consumers expressed they became very depressed, suffering with pain and their lives were ruined because of these symptoms.

In addition to safety concerns described in the labeling of FDA-approved oral finasteride products, topical finasteride poses other risks such as local reactions including irritation, erythema, dryness/scaling, stinging and burning, and greater potential risk for inadvertent exposure to others, specifically females, through transfer of applied product.

Approved finasteride products are contraindicated in pregnancy because of the potential to cause abnormalities of a male fetus in a pregnant woman. Studies have shown that women should not handle crushed or broken finasteride tablets due to the possibility of absorption and the subsequent potential risk to a pregnancy. The coating on FDA-approved finasteride tablets prevents contact with finasteride during normal handling, provided the tablets have not been broken or crushed. However, compounded topical finasteride products do not have a coating, and other compounded formulations may also not have this coating.

Conclusion

There are no FDA-approved topical products with finasteride alone or in combination with other ingredients. Compounded drugs are not FDA-approved, which means FDA has not evaluated their safety, effectiveness or quality prior to marketing. Consumers and health care providers have reported adverse events associated with the use of compounded topical finasteride products. Consumers expressed they were unaware of the potential adverse events with use of topical finasteride.  

FDA recommends:

  • Health care providers educate patients on potential risks of using compounded topical finasteride including the risks stemming from the handling by and transferring to female individuals. There may be an increased risk for inadvertent exposure to others with topical formulations compared to the approved oral formulations.
  • Consumers should consult with health care providers and compounders regarding potential risks prior to initiation of treatment using compounded topical finasteride.

FDA encourages consumers, health care providers and compounders to report adverse events or quality problems experienced with the use of compounded drugs including compounded topical finasteride to FDA’s MedWatch Adverse Event Reporting program:

Source: FDA

5-alpha reductase inhibitors (5-ARIs): Label Change - Increased Risk of Prostate Cancer

Jun 9, 2011 | Audience: Urology, Family Medicine, Internal Medicine

Drugs in the 5-ARI class include finasteride and dutasteride. These drugs are marketed under the brand-names Proscar, Propecia, Avodart, and Jalyn

ISSUE: FDA notified healthcare professionals that the Warnings and Precautions section of the labels for the 5-alpha reductase inhibitor (5-ARI) class of drugs has been revised to include new safety information about the increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer).

BACKGROUND: The new safety information is based on FDA’s review of two large, randomized controlled trials––the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial. Proscar, Avodart, and Jalyn are approved to improve symptoms of an enlarged prostate gland (benign prostatic hyperplasia or BPH). Proscar and Avodart are also approved to reduce the risk of urinary retention or surgery related to an enlarged prostate.Propecia is approved to treat male pattern hair loss.

RECOMMENDATION: Prior to initiating therapy with 5-ARIs, perform appropriate evaluation to rule out other urological conditions, including prostate cancer, that might mimic benign prostatic hyperplasia (BPH). See Drug Safety Communication for a Data Summary and additional information.


Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 

[06/09/2011 - Drug Safety Communication - FDA]

Citalopram And Finasteride by Greenstone: Recall - Possible Mislabeling

Mar 28, 2011 | Audience: Risk Manager, Pharmacy, Family Practice

ISSUE: Greenstone LLC announced a recall of medicines with lot number FI0510058-A on the label. Bottles labeled as Citalopram (used to treat depression) may contain Finasteride (used for the treatment of benign prostatic hyperplasia). Women who are, or may become pregnant, should not take or handle Finasteride due to the possible risk of side effects which may cause abnormalities to the external genitalia of a developing male fetus. Citalopram is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs) or pimozide; it is also contraindicated in patients with a hypersensitivity to Citalopram or any of the inactive ingredients in the tablet. Patients who discontinue Citalopram abruptly by inadvertently taking the mislabeled product may experience discontinuation symptoms and/or worsening of depression.

BACKGROUND: This includes Citalopram 10mg Tablets (100-count bottle) and Finasteride 5mg Tablets (90-count bottle), both distributed in the U.S. market. The recall is due to the possibility that incorrect labels have been placed on the bottles by a third-party manufacturer.

RECOMMENDATION: Bottles of either Citalopram or Finasteride with lot number FI050058-A should be returned. Patients who believe they may have ingested the wrong medication should contact their physician as soon as possible.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 

[03/26/2011 - Press Release - Greenstone]

    

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