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Propecia Risks, Side Effects and Legal Warnings

Propecia users have taken legal action against the drug's manufacturer for failing to warn them about the serious risks associated with the hair loss medication. Some Propecia side effects may continue after users stop taking the drug, putting patients at risk of long-term damage.

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Propecia is a brand-name drug that is available as a generic called finasteride. Oral versions of Propecia and finasteride received U.S. Food & Drug Administration (FDA) approval, but some users have experienced side effects like depression, decreased libido and erectile dysfunction.

The FDA has also issued warnings about side effects associated with topical finasteride, including anxiety, brain fog, fatigue, insomnia and suicidal ideation.

Propecia lawsuits have been filed against the medication’s manufacturer, Merck. If you have experienced any of these complications after taking Propecia, you should consider getting legal help to understand your rights.

What Is Propecia (Finasteride) Prescribed For?

Propecia is prescribed to treat male-pattern hair loss, known as androgenetic alopecia. This is when the hair on the top of your head gets thinner, causing you to experience a receding hairline or baldness.

Propecia can also be used to treat benign prostatic hyperplasia. This condition causes an enlarged prostate that results in urinary symptoms like incomplete emptying, straining or urgency.

Propecia Side Effects: Immediate and Long-Term Risks

  • Decreased libido
  • Depression
  • Erectile dysfunction
  • Ejaculation problems
  • Testicular pain

Persistent Adverse Effects

Some Propecia side effects can cause persistent and sometimes irreversible symptoms that might continue after you stop taking the medication.

These side effects may be referred to as Post-Finasteride Syndrome (PFS). PFS can include ongoing mental, neurological, physical and sexual side effects.

No evidence-based treatments exist for post-finasteride syndrome. Patients may have few options for recovery if they are dealing with these long-term side effects.

Warnings, Label Changes and FDA Actions

As problems with Propecia came to light, the FDA required a series of label changes to the Propecia safety information. These included:

  • 2011:
    The FDA revised the label for Propecia to include a warning that erectile dysfunction could occur, even after stopping the drug.
  • 2012:
    The FDA required Merck to include a warning about ejaculation disorders, libido issues and orgasm disorders that may continue after the discontinuation of the drug. The label also needed an updated warning on reports of poor semen quality and male infertility that stabilized after use of the drug was discontinued.

Propecia’s packaging now contains the information required in the 2012 revisions. However, the alert does not take the form of a black box warning, which is the most serious type of warning.

Patient advocacy group Post-Finasteride Syndrome Foundation has unsuccessfully petitioned the FDA to require stronger warnings.

Global Warnings and Label Changes

The FDA isn’t the only agency that wants drugmakers to alert customers about finasteride side effects. The European Medicines Agency requires a warning to patients taking one milligram finasteride tablets to seek medical advice if they experience problems with sexual function.

Additionally, Health Canada recommended that manufacturers update the labels of finasteride-containing products to inform users about the risk of serious muscle-related side effects.

Propecia Lawsuits

People who used Propecia have taken legal action against Merck. Many claims have been consolidated into federal multidistrict litigation (MDL).

An MDL allows similar cases to be grouped and heard before one judge. In the Propecia litigation, multiple plaintiffs who were harmed by the drug had their cases consolidated into a federal MDL in the Eastern District of New York.

Plaintiffs pursuing claims against Merck alleged that the company failed to warn them of the potential side effects, minimized the long-term adverse impacts, knowingly concealed risks of the dangers and inadequately labeled the drug.

Based on internal communications, plaintiffs believe that Merck understated the number of men who experienced Propecia sexual side effects and the duration of those symptoms.

While the original labels downplayed the risk, plaintiffs claim Merck was aware of the devastating effect the drug could have on men’s health many years before the risks were public knowledge.

As the MDL and the number of cases grew, Merck agreed to pay $4.3 million to settle most of the lawsuits. The MDL was closed in 2023.

Settlement details were initially sealed, but a judge later ordered that court records be unsealed. These documents showed that Merck was aware of suicidal behavior in men taking Propecia. Currently, there’s no litigation that we know of for this side effect.

It may still be possible to take legal action if you were harmed by Propecia. You can talk with a lawyer about your options.

Post-Finasteride Syndrome (PFS): A Controversial Condition

While PFS is part of many plaintiff claims against Propecia, there is controversy about this syndrome. PFS is a condition where sexual dysfunction and other physical side effects of using products with finasteride continue after use of the drug has ended.

Many people who used Propecia claimed to have experienced this condition, and the Post-Finasteride Syndrome Foundation argues that the syndrome has adversely impacted the lives of many men.

However, there is some dispute about whether PFS is real. Reasons for doubt include:

  • Most cases are self-reported rather than physician-diagnosed.
  • Some evidence suggests the condition may involve the “nocebo effect,” which means that expecting something negative to happen makes it more likely to occur.
  • Studies haven’t definitively linked ongoing sexual side effects with finasteride use.
  • The first PFS reports began 15 years after the drug was on the market.

Controversy over the syndrome’s existence creates additional challenges for victims since Merck is less likely to make a fair settlement offer if the company does not accept that the medical problems are real.

What Patients Should Know and Do Next

If you or someone you love took Propecia, watch for side effects like sexual dysfunction or cognitive changes. Talk to your doctor and stop taking the medication if you have concerning symptoms.

You should also report side effects to the FDA using its MedWatch program. This allows the FDA to collect data and take appropriate action if there is a pattern of problems with a particular drug.

FDA warnings and alerts help keep the public safe. Reporting health issues caused by Propecia or other drugs could protect others from experiencing dangerous side effects.

If you suffered injuries due to Propecia, you can contact an attorney to better understand your rights.
Get your free case review today and see if you qualify for compensation with Drugwatch.

Please seek the advice of a medical professional before making health care decisions.