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How to report a side effect to Egypt’s pharmacovigilance centre

How to report a side effect to Egypt’s pharmacovigilance centre

Saturday, October 31, 2026schedule9 min read
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How to report a medicine side effect to the Egyptian Pharmacovigilance Center at the Egyptian Drug Authority: the online form, what to write down, what happens next and who can report, from the Authority’s own pages and documents.

To report a side effect in Egypt, use the Egyptian Drug Authority’s (EDA) online form, in Arabic or English, or call its hotline, 15301 (read 23 October 2026). Have ready the medicine’s name and batch number, what happened and when, and your other medicines. Tell your pharmacist or doctor too: the form gives you no medical help.

This guide uses the EDA’s own pages, its FAQ document and the form’s own text, read on 23 October 2026. We did not submit a report, so it covers what the form asks and what the EDA says it does with a report, not what became of any one. It cannot say whether a symptom comes from a medicine or what to do about it: that is for your pharmacist or doctor.

In short:

  • The EDA’s Egyptian Pharmacovigilance Center takes reports from citizens free of charge (read 23 October 2026). Its FAQ document says health-care workers and companies can report too.
  • You only need to suspect the medicine: the form asks for effects you suspect it caused, and the FAQ document says the person reporting carries no responsibility or consequences.
  • Keep the box. The form asks for details printed on the pack.

Last checked: 23 October 2026, on the pages under Sources. Phone numbers and forms change, so confirm them before you rely on them.

How do I report a side effect in Egypt?

The EDA’s reporting page covers medicines, vaccines, cosmetics and medical devices, and says reporting is free (read 23 October 2026). It links one online form, which asks about a medicine. The steps:

  1. Tell your pharmacist, doctor or nurse. A report does not replace that: the form’s terms say you will not get medical assistance by reporting there. The leaflet’s opening note also sends side effects to your doctor or pharmacist: how to read a medicine leaflet shows where. Do not stop or change a medicine because of this guide; ask them first.
  2. Keep the box. The FAQ document asks you to keep the pack when the product itself is suspected.
  3. Open the form. The Arabic and English versions of the reporting page link the same address, vigiflow-eforms.who-umc.org/eg/med, and tell you to select Arabic or English on the form. The form’s terms say it is hosted by the Uppsala Monitoring Centre in Sweden.
  4. Fill in the sections (table below), tick the box accepting the form’s terms, add your contact details, and send. The page says the team needs your contact details to follow up, and the form offers an email receipt.

Other routes, as the EDA lists them (read 23 October 2026):

RouteWhat the EDA says
Hotline 15301Its contact page lists pharmacovigilance information and reporting adverse events for pharmaceutical products or medical devices among its services, with no hours. It is a line for inquiries and reports, not medical help.
Emailpv.followup@edaegypt.gov.eg, printed in its FAQ document (file properties: November 2025) and in the form’s terms. The contact page lists info@edaegypt.gov.eg and complain@edaegypt.gov.eg instead.
After a vaccineThe reporting page lists events after immunisation, but the FAQ document says to phone a Ministry of Health hotline, printed there as 105. We could not settle at a Ministry page which route applies, so ask your pharmacist or doctor how to report.
Community pharmacyAn EDA initiative, announced in November 2021, aims for community pharmacies to offer reporting of adverse drug reactions. The page does not say which pharmacies take part or how a patient reports there, so ask yours.

If your worry is a possible violation involving a product or an establishment rather than a reaction, the contact page lists a separate report for that: see how to check a medicine against EDA warnings.

What do I write down in the report?

The form’s own field labels, read from its published definition on 23 October 2026 (we did not fill it in), ask for the items below. The Arabic in quotes is the form’s wording.

Write downWhat the form asks
The medicine«الاسم الكامل للدواء»: the full name as printed on the inner or outer pack, and the company name printed on it.
The batch number«رقم الدفعة», the batch (lot) number printed on the pack. The EDA warnings guide explains what it is.
How you used itThe reason for taking it, how much, and the start and end dates (the form says to leave the end date blank if you still take it).
What happened, and when«صف ما حدث»: in your own words, with the date it started and what has happened since, plus a choice for how it has turned out: recovered, recovering, not recovered, and so on.
Whether it was seriousThe form has a Seriousness section: death, life threatening, disabling or incapacitating, hospital stay caused or prolonged, birth defect, or another medically important condition. The FAQ document’s own list of serious effects is close: death, permanent disability, a threat to life, hospital admission or a longer stay, a birth defect, or a need for medical intervention.
Everything else you takeEvery medicine you took before the reaction, herbal and other alternative products included, and a short medical history: the form says some reactions appear only alongside past or current illness, special diets, smoking, alcohol or allergies.
The patientAge or date of birth (the form needs one of the two), sex and weight.

What happens after I report?

The FAQ document (file properties: November 2025) says the Center’s pharmacists study each report, may contact you for missing details, and enter it in the national database of adverse effects. It gives the aim as learning more about product safety and spotting new adverse effects from the data collected. For a suspected faulty product, it says the follow-up may include one or all of: a review of the company, samples from the company, and samples from where the complaint came from, tested against specifications.

The reporting page says all report information, including the identities of the patient and the reporter, is kept strictly confidential (read 23 October 2026). The form’s terms add that information without personal data is shared with bodies such as the WHO, regulators and drug companies, and that summary statistics are published. They name the Egyptian center as the data controller. Neither the pages nor the document promise you a reply about your own case or say what caused it. Those questions stay with your pharmacist or doctor.

In Egypt: what is the pharmacovigilance centre, and who can report?

The WHO describes pharmacovigilance as the science and activities for detecting, assessing, understanding and preventing adverse effects or any other medicine- or vaccine-related problem (read 23 October 2026). The EDA’s FAQ document gives the same definition with a wider list of products: pharmaceutical and biological products, food supplements and others. Its pages call the Egyptian unit «مركز اليقظة الصيدلية المصري», part of the Central Administration for Pharmaceutical Care; the form’s Arabic terms call it «المركز المصري لليقظة الدوائية». Egypt is listed as a full member of the WHO Programme for International Drug Monitoring since 2001, on the programme’s member list, last modified 13 August 2026.

The FAQ document says doctors, nurses, pharmacists, dentists and other health-care providers, patients and their relatives, and drug companies can report. If you report for someone else, the form’s terms ask you to make sure you have the patient’s consent. The UK medicines regulator likewise says only a suspicion is needed to report, in its Yellow Card guidance, updated 24 July 2025.

Where Medigize stands

Medigize is a navigation tool. It is not part of the EDA, and it does not collect side-effect reports or sell, recommend or rate medicines. We are building a record that moves with the patient, shared only with their consent. If you would like to follow that work, you can register your interest.

Frequently asked questions

How do I report a side effect in Egypt?

Use the online form linked from the Egyptian Drug Authority’s reporting page, or call 15301, and tell your pharmacist or doctor as well (read 23 October 2026).

What is Egypt’s pharmacovigilance centre?

The Egyptian Pharmacovigilance Center, part of the EDA’s Central Administration for Pharmaceutical Care, which assesses and follows up reports from the public (read 23 October 2026).

Do I have to be sure the medicine caused the side effect?

No. The form asks for effects you suspect your medicine caused (read 23 October 2026), and the EDA’s FAQ document says the person reporting carries no responsibility or consequences (file properties: November 2025).

Is my report confidential?

The EDA says all report information, including the identities of the patient and the reporter, is kept strictly confidential (read 23 October 2026). The form’s terms add that information without personal data is shared with bodies such as the WHO, regulators and drug companies.

Is hotline 15301 an emergency number?

No. The EDA’s contact page lists it for inquiries and reports, among them pharmacovigilance and violations (read 23 October 2026). In an emergency, go to the nearest emergency department.

Medigize is a non-diagnostic navigation tool. This is general information, not medical advice. In an emergency, call an ambulance or go to the nearest emergency department.

Sources

  1. Egyptian Drug Authority (EDA): reporting adverse drug reactions and medical devices, read 23 October 2026
  2. Egyptian Drug Authority (EDA): the Arabic version of the same reporting page, read 23 October 2026
  3. VigiFlow eForms: Egypt medicines reporting form, linked from the EDA reporting page (field labels and terms read from its published definition, no report submitted), read 23 October 2026
  4. Egyptian Drug Authority (EDA): frequently asked questions on individual case safety reports, ICSRs (Arabic PDF, undated text, file properties show 26 November 2025), read 23 October 2026
  5. Egyptian Drug Authority (EDA): contact us, with hotline 15301, read 23 October 2026
  6. Egyptian Drug Authority (EDA): the pharmacovigilance pharmaceutical care initiative for community pharmacies, read 23 October 2026
  7. World Health Organization (WHO): pharmacovigilance, no date shown, read 23 October 2026
  8. Uppsala Monitoring Centre (UMC): members of the WHO Programme for International Drug Monitoring, last modified 13 August 2026, read 23 October 2026
  9. UK Medicines and Healthcare products Regulatory Agency (MHRA): the Yellow Card scheme, guidance for healthcare professionals, patients and the public, updated 24 July 2025, read 23 October 2026

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