How to report a medicine side effect in Pakistan
If you suspect a medicine has caused a harmful or unexpected reaction, get medical help first, then report it to DRAP's National Pharmacovigilance Centre, including the medicine's name and batch number. You do not need proof that the medicine was the cause, and patients can report as well as doctors.
First, look after the person
Trouble breathing, swelling of the face or throat, a widespread rash, fainting, fits or severe bleeding are emergencies: go to a hospital immediately. For milder problems, contact your doctor or pharmacist before stopping a prescribed medicine, because stopping some medicines suddenly is itself risky.
What is worth reporting
- Any serious reaction: one that needs hospital care, is life-threatening or causes lasting harm.
- Reactions that are not listed in the leaflet.
- Any reaction to a new medicine or vaccine.
- A medicine that does not work as it normally does, which can point to a substandard or fake batch.
- Reactions in children, pregnant women and older people.
How to report
- Keep the medicine and its packThe batch number, expiry and maker are on it. Take a photo of the pack and the square code.
- Tell your doctor or pharmacistThey can treat the reaction and may file the report for you.
- Report to DRAPDRAP's National Pharmacovigilance Centre accepts reports through an adverse event reporting form and online reporting linked from its website, dra.gov.pk. DRAP has also promoted the Med Safety mobile app for reporting. Provincial pharmacovigilance centres accept reports too.
What to include
| Detail | Example |
|---|---|
| Who was affected | Age, sex, pregnancy, known allergies or illnesses |
| The medicine | Brand name, strength, maker, batch number, expiry |
| How it was taken | Dose, how often, start date, what it was for |
| The reaction | What happened, when it started, how long it lasted |
| What happened next | Stopped the medicine, treatment given, recovered or not |
| Other medicines | Anything else taken at the time, including herbal products |
Why the batch number matters
A reaction caused by the medicine itself can happen with any batch. A cluster of reports from one batch suggests a quality problem: contamination, the wrong strength, or a fake. That is the kind of signal that leads to testing and, where needed, a recall. You can check whether your batch is already listed in our DRAP recall alerts.
Side effect or fake?
If the pack also fails a scan or looks wrong, treat it as a possible fake as well and follow our guide on reporting fake medicine. Mention both the reaction and your doubts about the pack in your report.
Side effect, allergy, or something wrong with the medicine?
Three different things can make a medicine harm you, and it helps to think about which one it might be.
| Type | What it is | Clue |
|---|---|---|
| Known side effect | An effect listed in the leaflet, such as nausea or drowsiness | Mentioned in the leaflet; often mild |
| Allergic reaction | The immune system reacting to the drug | Rash, itching, swelling, breathing trouble; can be sudden |
| Product problem | The pack is fake, contaminated, degraded or substandard | A medicine you have used before suddenly behaves differently; the pack looks wrong; others have the same problem with the same batch |
All three are worth reporting. The third also needs a product complaint.
Worked examples
- A rash after a new antibiotic. Stop and see a doctor. Report the reaction with the brand and batch. Ask the doctor to note the allergy in your records.
- A child's fever syrup that "does nothing". Check the expiry, how it was stored and the dose given. If those are right and another bottle from a different batch works, report a suspected product failure and keep the first bottle.
- Several patients reacting after injections from one batch. A clinic should report each case with the batch number at once. Clusters like this are what pharmacovigilance is designed to catch.
What happens to your report
Reports go into the national pharmacovigilance system, where they are assessed and combined with other reports. Single reports rarely prove anything, but patterns do. Signals can lead to label changes, safety communications, testing of a batch, or in serious cases a recall. Pakistan's reports also feed into WHO's international database, which helps spot problems seen across countries.
Privacy
Reports are used for safety monitoring, not to blame anyone. You can describe the patient without a full name if you prefer. Give enough contact detail for follow-up questions, because a missing batch number or date can make a report hard to use.
Dawa ke side effect ki report
Agar kisi dawa se nuqsan ya ajeeb asar ho to pehle doctor ko dikhayein. Phir dawa ka naam, batch number, kab aur kitni li, aur kya hua, likh kar DRAP ke pharmacovigilance center ko report karein. Pack aur raseed sambhal kar rakhein. Agar pack nakli lage to DRAP ke complaint form par alag shikayat bhi karein.
Reporting for children, pregnancy and older people
Children, pregnant women and older people are often left out of medicine trials, so reports about them are especially valuable. For a child, include age and weight. For pregnancy, include how many weeks pregnant and any other medicines taken. For an older person, list every medicine they take, including herbal products, because interactions are a common cause of problems.
Vaccines
Reactions after vaccination, from a sore arm to a high fever or fainting, can be reported in the same way. Note the vaccine name, batch number from the vial or card, the date and the place where it was given. Falsified vaccines have appeared in DRAP alerts, so the batch number matters.
Keep your own record
Write down the medicine, batch, dates and what happened in a notebook or on your phone, and keep a photo of the pack. If you need to see a different doctor later, or the reaction returns with another medicine, this record is more reliable than memory.
Questions people ask
What is pharmacovigilance?
The work of collecting and studying reports of side effects and other medicine problems after a medicine is on the market, so that rare or new risks are noticed and acted on.
Can a patient report a side effect, or only a doctor?
Both can. Reports from patients and family members are accepted alongside those from doctors, pharmacists and nurses.
Do I need to be sure the medicine caused the problem?
No. You only need to suspect it. Experts assess the link; one report rarely proves anything, but several similar reports can reveal a problem.
Will reporting get my doctor or pharmacist into trouble?
A side-effect report is about the medicine, not about blame. Its purpose is safety monitoring.
Should I report a side effect that is already in the leaflet?
Yes, especially if it is serious, lasts a long time or happens more often than expected. Known effects are still monitored.
Can a pharmacist report a side effect for me?
Yes. Pharmacists and doctors can file the report, and often know which details matter most.
Can I report a reaction to a herbal or homeopathic product?
Yes. Problems with herbal, homeopathic and nutritional products can be reported too. Include the product name, maker and any enlistment number on the pack.
Is there a mobile app for reporting side effects?
DRAP has promoted the Med Safety app for reporting suspected side effects. You can also report through DRAP's website or ask your doctor or pharmacist to report for you.
