Check the Finasteride and Dutasteride Mood Warning in Pakistan: DRAP Alert 63
DRAP Safety Alert 63 adds suicidal thoughts to the warnings for oral finasteride and dutasteride. See which tablets are covered and what patients should do.
Short answer: DRAP's Safety Alert No. 63 of 3 February 2026 says oral finasteride and dutasteride medicines can cause mood changes, including depression and, less often, suicidal thoughts. If you take either and feel low, hopeless or have thoughts of self-harm, talk to your doctor straight away. If you are in danger, go to the nearest hospital.
Finasteride 1 mg is the tablet many men take for hair loss. Finasteride 5 mg and dutasteride 0.5 mg are prescribed for an enlarged prostate. They are different uses of related medicines, and the alert covers all of them.
We read the alert on DRAP's safety page on 12 October 2026. This article keeps to what DRAP says. It is written for patients and their families, and it is not a reason to stop a medicine without advice.
DRAP adds suicidal thoughts to the warnings for finasteride and dutasteride
DRAP's expert committee met on 31 December 2025. It decided that registration holders must list suicidal ideation, which means suicidal thoughts, among the adverse reactions of oral finasteride and dutasteride medicines, with the frequency "unknown".
The decision follows a May 2025 review by the European Medicines Agency's safety committee. That committee confirmed a causal link between oral finasteride and suicidal ideation. It did not find the same link for dutasteride but asked for the mood warning to be added as a precaution, because the two medicines work in the same way.
DRAP had already discussed the topic in March 2023, after similar decisions in Singapore and Canada. The February 2026 alert is the public notice of the latest decision.
Which tablets and capsules are covered
Three products are named. Each has a different use, and the dose tells you which one you have.
| Medicine | Strength | Used for, per the alert |
|---|---|---|
| Finasteride tablet | 1 mg | Early stages of male pattern hair loss, men aged 18 to 41 |
| Finasteride tablet | 5 mg | Enlarged prostate, called benign prostatic hyperplasia |
| Dutasteride capsule | 0.5 mg | Enlarged prostate |
The alert says most reported cases of suicidal thoughts were in people taking the 1 mg tablet for hair loss. It also says finasteride used on the skin did not show enough evidence to change the warning.
The benefits still outweigh the risks, but your mood matters
The European committee concluded that the benefits of finasteride and dutasteride continue to outweigh their risks for approved uses. DRAP's alert repeats this. It is not telling people to stop. It is telling doctors to weigh psychological risk before prescribing.
The alert also notes that sexual problems from finasteride may play a part in low mood for some patients. The 1 mg product information in Europe will tell patients to seek advice if they have such problems. A patient card is being added to those packs there. We could not confirm from DRAP whether such a card will appear in Pakistan.
The frequency is "unknown", so there is no number. Take the risk seriously but proportionately.
What to do if you take one of these medicines
DRAP advises patients to consult their doctor immediately if they notice mood changes, including depression or suicidal thoughts, during treatment.
- Read the strip or box and note whether it says finasteride or dutasteride and the strength.
- Tell family members what the medicine is and that low mood should be taken seriously.
- If you feel persistently low, hopeless or have thoughts of self-harm, speak to your doctor straight away.
- Do not stop a prostate medicine suddenly without advice. Ask the doctor what to do about the medicine.
- If you are in immediate danger, go to the nearest emergency department or ask someone to take you.
Free mental health care exists in government hospitals. The route to a psychiatrist is set out in seeing a psychiatrist at a government hospital, and the national plan is described in Pakistan's mental health policy.
Report any mood change to DRAP
DRAP asks patients and professionals to report reactions through its Med Vigilance e-reporting system or the VigiMobile app. You do not need to be sure the tablet caused the change. The National Pharmacovigilance Centre is on 051 9255981.
The steps, with what to have ready, are in how to report a medicine side effect to DRAP. Be careful: do not buy hair loss or prostate tablets from sellers who do not show a pharmacy licence. Checking that a pharmacy is licensed in Punjab takes a minute.
Common questions
Is finasteride banned in Pakistan?
No. The alert is a safety warning and a label change. The medicines remain registered for their approved uses.
Does the warning cover minoxidil or hair oil?
No. The alert covers oral finasteride and dutasteride. It does not name minoxidil. For skin products with finasteride, it says the evidence was not enough to change the warning.
Does dutasteride cause suicidal thoughts?
The review did not establish a link for dutasteride. Mood information will be added to its label as a precaution because it works like finasteride.
Who is most affected?
The alert says most reported cases were in people using 1 mg finasteride for hair loss caused by male hormones.
What if my relative seems low after starting it?
Take it seriously and contact the doctor who prescribed it. The alert tells doctors to advise patients to consult them at the earliest when such thoughts appear.
Can I check if my tablet is registered?
Yes. Use DRAP's medicine registration search, explained in how to check a medicine is registered.
How we verified this
What we checked, where we read it, and what we could not confirm.
We read DRAP Safety Alert No. 63 dated 3 February 2026 and DRAP's safety updates page on 12 October 2026. This is a summary of the alert and not medical advice.
About the author
Public Services and Education Journalist
Fajr Riaz is a journalist and content writer at Pakistan Era, based in Lahore. She covers the questions people meet in everyday life in Pakistan: how a public service works, what a change in the rules means, and where to find a reliable answer.
