Pharmacovigilance
Patient safety
A medicine is watched for as long as it is in use. If you have had a side effect from a product supplied by SVAX, or you suspect something is wrong with its quality, tell us. Every report is read and assessed, and reports are what make a medicine safer for the next patient.
This page is not for medical emergencies
If you or someone with you needs urgent medical help, contact a doctor or call 997 for emergency medical services in the Kingdom of Saudi Arabia. SVAX cannot give medical advice or discuss an individual course of treatment.
What counts as a side effect
Any unwanted symptom or reaction that appears while a medicine is being used, whether or not you are sure the medicine caused it. Report it even if it seems minor, is already listed in the leaflet, or happened while the medicine was being used differently from the approved instructions. You do not have to be certain. Judging whether the medicine was responsible is our work, and the regulator's, not yours.
Who can report
Anyone. A patient, a family member or carer, or a healthcare professional. You do not need a doctor to report on your behalf.
Also worth telling us about
- A medicine that did not work as expected
- A suspected quality defect: damaged packaging, an unusual colour, smell or appearance
- Use during pregnancy or breastfeeding
- A medication error, an overdose, or use outside the approved instructions
- Exposure to the medicine at work
- Suspected transmission of an infectious agent through a medicine
- Use in a child or in an elderly patient
What to include
Send whatever you have. A report with gaps in it is still worth sending.
- Who it concerns: age group and sex. A full name is not needed.
- The medicine: name, strength, and the batch number and expiry date from the pack
- What happened, when it started, how long it lasted and how it ended
- Any other medicines being taken at the same time
- How to reach you, in case we need to ask one follow-up question
Report a side effect
Fill in what you know. A report with gaps in it is still worth sending, and nothing below is a test you can fail.
Reporting to SVAX
Email us, with ‘Adverse event report’ in the subject line, or write to the head office.
Head office
4568 Prince Mohammed Ibn Abdulaziz Branch
Bin Hamran Towers (B), 5th Floor, Suite 510-B
Jeddah 23432, Kingdom of Saudi Arabia
What happens next
A member of our pharmacovigilance team reads and assesses every report. We may come back to you once for a detail that is missing, which is why the contact question is on the list above. Where the regulations require it, the report is passed to the Saudi Food and Drug Authority.
How your information is handled
Reports are treated as confidential and used for drug safety purposes only. We keep the personal details needed to assess the report and to follow it up, and we share what the regulations require us to share with the health authorities. Reports are never used for marketing.