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Pharmacovigilance Reporting

Notice a side effect? Report it to our SFDA-authorized Pharmacovigilance team or use the ADR form below. Your feedback helps keep medicines safe in Saudi Arabia.

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Reporting Side Effects

What are side effects?
A side effect, or adverse event, is any unexpected reaction a person may experience after taking a medication, whether prescription, over-the-counter (OTC), herbal remedy, vitamin, or supplement. It can appear as a symptom, sign, or health problem. Side effects can range from mild, such as nausea or drowsiness, to serious reactions that require medical attention.
How can I report side effects?
Safe Medicines, Safer Patients The SFDA and other health authorities monitor all medicines and health products to ensure they are safe and of high quality. Reporting side effects helps identify unexpected or rare reactions, understand their severity and frequency, and guide medical experts in improving medicine safety. Every report contributes to protecting patients and keeping treatments safe.
Will you follow up with me? How will my information be used?
We may contact you if additional information is needed to complete our investigation or meet regulatory requirements, but only when necessary. Every report is valuable, and your original submission provides essential information, even if we don’t follow up directly. Your privacy is important. Any personal data you provide is handled confidentially and used only for drug safety and regulatory purposes. While we may share details with health authorities, your identity will remain protected.
Why is monitoring and reporting side effects important?
You can report a side effect from any medication, supplement, or health product in a few ways: Use our ADR reporting form on our website. Contact our Pharmacovigilance (PV) team directly, available 24/7. Ask your healthcare provider to report the reaction on your behalf. When reporting, it’s helpful to include as much information as possible, such as the product name, the reaction you experienced, when it occurred, and any other medicines or supplements you are taking. Even if you’re unsure whether the product caused the reaction, medical experts carefully review each report to assess the likelihood of a connection. It’s always better to report a possible side effect than to miss an important safety signal.

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