Finasteride ADRs Soar 10,000% Week Over Week, Says World Health Organization

Startling rise exceeds 2024 record by 42%—with 6 months still to go in 2025—and includes 119 new reports of suicidal ideation

May 17, 2025

Dear Friends:

At this speed, a “crash” could spell epidemiological disaster.

Week over week, the all-time number of adverse drug reactions (ADRs) for finasteride rose from 22,297 to 25,329, or 13%, including two new suicides, and 119 new reports of suicidal ideation.

That, according to the World Health Organization’s VigiBase database of ADRs, officials at which confirmed the statistics directly to the PFS Foundation

Alarming Analysis

To give you some idea of what a 13% upswing in a single week means in the context of reporting that stretches back 32 years, consider this:

For the first 17 weeks of 2025, the average rise in new finasteride ADRs reported to the WHO was 29.5, ranging from a low of five per week to a high of 42. But for the week ending May 11, the number of new ADRs clocked in at 3,032.

That’s a 10,178% rise over the year-to-date weekly average.

The WHO has been aggregating finasteride ADRs from its 194 member states since 1993, when the drug was granted market authorization by the US Food and Drug Administration (FDA). In 2024, they shot to a record 2,127, representing a 181% rise over 2023.

If we run the same calculation for 2025, we get a 42% rise over last year’s record. However, there are still 34 weeks to go in the year. If such growth continues through December, it could signal a full-blown PFS epidemic.

Now consider one more thing: On Jan. 1 of this year, total finasteride ADRs stood at 21,794. Today, they stand at 25,329, which means a year-to-date total of 3,535 new ADRs. Divide that by the 128 days that have passed between Jan. 1 and May 9 (the most recent day of reporting to the WHO) and we get an average of more than 27 ADRs per day.

Or, more than one new ADR every hour of every day thus far in 2025.

25,000-foot view

Over the past decade, total finasteride ADRs have risen 101%, from 12,586 to 25,329, while suicidal ideation—which the European Medicinces Agency (EMA) last week confirmed as an official side effect of the drug—has spiked 321%, from 171 to 720.

For the same period, suicide attempt has climbed 107%, from 27 to 56, and completed suicide has escalated 182%, from 40 to 113.

While the WHO declined to offer any interpretation of this data, it would seem reasonable to believe it’s related to recent actions by drug-regulatory authorities including the FDA, MHRA and EMA, along with media coverage of PFS in the US, UK, Canada, Spain, Russia and elsewhere.

“Beginning this week, we’re advising all drug-regulatory authorities outside the US to watch the VigiBase data on finasteride ADRs very closely, and act accordingly in terms of doing no harm to their citizens,” said PFS Foundation President Philip Recchia.

“Don’t depend on new guidance from the FDA, which may not arrive until years from now—if ever.”

The gains in Spain

On Monday, El Confidencial, Spain’s largest online newspaper—which broke the story of PFS patient Carlos Sarasa González-Aller’s death leap from atop his office building—published an interview with Recchia (The Man Who Has Spent 25 Years Studying Finasteride) (English).

In it, reporter Alfredo Pascual references the EMA’s recent findings regarding a causal relationship between finaseride use and suicidality. “The study is a vindication for Recchia and the PFS Foundation, who have long been accused of spreading alarm and fueling the nocebo effect,” he writes, before thusly quoting Recchia:

“You have no idea what it’s been like these past few years, with so many so-called ‘respectable’ doctors telling us PFS was all in the patients’ heads. That’s like telling Dachau prisoners that the guards marching toward their barracks are just the boogeyman.

“From what we know, the potential dangers of finasteride far outweigh its benefits. In that light, it would make sense for health authorities to suspend its use until we have a better understanding of the risks.”

A day later, ABC, another national Spanish newspaper, ran a story headlined, Mother of a finasteride victim: “If the drug were banned, my son would still be alive” (English).

“A day before the EMA confirmed a link between the drug finasteride…and suicidal thoughts, Juana A. stepped forward to explain to ABC the most painful experience of her life: the death of her son Pedro (fictitious name) on which, she blames the use of this controversial drug,” writes Esther Armora.

“‘I’ve decided to make it public, even if it hurts me to remember, to prevent other parents from going through what we’re going through,’ says the mother. She sums up the new EMA warning as a positive step, but calls for more drastic measures to prevent the drug from continuing to take lives.”

Finasteride was originally developed by Merck & Co., Inc., and first approved by the US Food and Drug Administration in 1993 as Proscar (5 mg, for enlarged prostate), and again in 1997, as Propecia (1 mg, for hair loss).

In June 2021, Merck spun off its Organon subsidiary as an independent public company (NYSE: OGN). Founded in the Netherlands in 1923, Organon bills itself as a “global health care company dedicated to making a world of difference for women, their families and the communities they care for.”

Among the Merck products Organon acquired in the deal were Proscar and Propecia. To report adverse events for either finasteride product, call the Organon Service Center at (844)674-3200, or email Service_Center@Organon.com.

Anyone living in the US who suffers from PFS should also report his or her symptoms to the US FDA. Anyone living outside the US who suffers from PFS should report his or her symptoms to the US FDA as well as to his or her local DRA, as directed on our Report Your Side Effects page.

If you or a loved one are suffering from PFS, and feeling depressed or unstable, please don’t hesitate to contact the PFS Foundation as soon as possible via our Patient Support hotline: social@pfsfoundation.org

Thank you.