Dubai: Are you having a suspected side effect or reaction to a medication? You can report it to the Emirates Drug Establishment (EDE) – the federal authority responsible for regulating all pharmaceutical products, medical devices, and health-related technologies in the UAE – even if you’re unsure your medicine caused it.

Here’s what you need to know about reporting medicinal side effects in the UAE.

What are medicinal side effects?

Medicinal side effects are unwanted, adverse reactions that are possibly related to a drug. They can range from minor problems, like a runny nose, to life-threatening events, such as a heart attack or liver damage, according to the US Food and Drug Administration (FDA).

Both prescription and over-the-counter medications can have side effects.

The EDE also highlighted that some drugs used to treat diabetes and obesity, including GLP-1 (glucagon-like peptide-1) receptor agonists, are associated with five known and documented side effects: nausea, vomiting, diarrhoea, constipation, and abdominal pain.

The EDE recently revealed that it received 5,122 reports of suspected adverse drug reactions in the first nine months of 2026, up 16.7% from 4,390 in the same period of 2025 – about 20% of the cases were serious.

However, more reports don’t automatically mean riskier medicines, according to the EDE. It said the increase should be read alongside other factors, such as wider reporting channels, more public and professional engagement, and how widely medicines are used in the UAE.

Why should I report a side effect?

The EDE urges patients to pay attention to any new, persistent, or worsening symptoms, especially after starting a particular treatment.

All patients, caregivers, and healthcare professionals can report side effects to the EDE. By reporting a side effect, you can help the EDE build a complete picture of drug safety data, as it measures its effects, and monitors areas that require additional awareness.

Once you submit a report, specialists review it and weigh it against other scientific evidence before deciding whether any action is needed. The EDE takes into account the following information:

The nature of the symptom and the timing of its appearance, compared to the period of drug use.

  • The dosage data.
  • Accompanying treatments.
  • The patient's health condition.
  • The extent to which the information is consistent with known drug safety data.

The report is reviewed in its broader scientific context, alongside other reports, studies, and safety information. If a pattern emerges, backed by scientific evidence, the EDE issues appropriate regulatory action with a focus on rapid intervention. This may include:

  • Adding clarifications to the medicine’s leaflet.
  • Issuing a warning to doctors and patients.
  • Requiring monitoring or medical checks before the medicine is prescribed.
  • Restricting use to certain groups of patients.
  • Suspending or withdrawing the medicine where urgent patient protection is needed.

When should I seek emergency help instead?

Although reporting a side effect is recommended by the EDE, it advises prioritising seeking urgent medical help if you or a family member develops any of the following six warning signs after taking a medication:

  • Difficulty breathing.
  • Swelling of the tongue or throat.
  • Fainting.
  • A severe skin rash with blisters or peeling.
  • Severe and unusual bleeding.
  • Severe and persistent pain with other worrying symptoms.

If you require an ambulance anywhere in the UAE, the number to call is 998. Learn about ambulance services here.

For milder symptoms, the EDE recommends contacting your doctor, who will assess your situation and decide whether to adjust the dose or change the medication.

What documents do I need when reporting a side effect?

Before reporting a side effect, ensure you have the following documents and details at hand so that your report is complete:

Medication details: The name of the medicine, the dosage and the date you started taking it.

Symptoms: A description of your experience, and when it began in relation to starting the medicine.

Personal details: Your details, or if you are reporting on behalf of someone, the patient’s information.

Other medicines and health information: Information on any other medications, dietary supplements or health conditions that may be relevant.

Supporting evidence: Photographs of the symptom, if applicable, or documents to support the presence of the symptom, such as test results or prescriptions.

The EDE specifies that you do not need to prove that the medicine caused the symptom.

How to report a medicinal side effect

The EDE provides a dedicated online reporting service for healthcare practitioners and facilities, via the institution's official website.

Patients and caregivers can report side effects either via the EDE contact centre, or through its online portal. Follow the steps below to complete the process through either avenue.

Report via the EDE contact centre:

Call the EDE on its hotline, 800-33784 (800-eDrug).

A representative will answer your questions and guide you through the process.

Report via the EDE’s website:

  • Visit the EDE portal at ede.gov.ae. Navigate to ‘Services’ and select ‘Reporting Side Effects of Medicines and Medical Products for Individuals’.
  • Click ‘Start Service’ and sign in with your UAE PASS.
  • Fill in all personal details in the form provided, including the medication information and patient information.
  • Describe what happened, in your own words, and include specific details about each medicine and relevant dates.
  • In the Reactions/Symptoms form, entera short description of the symptom (such as migraine, or diarrhoea). Select the start date, and end date, if applicable. Select the outcome of the reaction – from ‘recovered/resolved’ to ‘unknown’.  You can add as many symptoms as you need to.
  • Enter the name and details for each medicine you were taking before the reaction occurred. You can add as many medications and supplements as you need to.
  • Enter a short description of your medical history.
  • Upload documents or pictures to support your report, if you have any. This step is optional.
  • Submit the report.

The processing time is five working days. The EDE may follow up for more information, such as whether the condition has progressed, or if you received any change in treatment.

Fee: Free