Dubai: The Emirates Drug Establishment revealed that it received 5,122 reports of suspected adverse drug reactions in the country during the first nine months of 2026, an increase of 16.7% compared to the same period of 2025, which recorded 4,390 reports. The total number of reports during the past year was 5,840, noting that the percentage of serious cases was 20%.
The foundation confirmed that the increase in the number of reports does not necessarily mean an increase in the risks of medicines, specifying six symptoms and signs that appear after using the medicine and require urgent medical assistance. It stressed the importance of reporting suspected cases even without confirming the relationship between the medicine and the symptom.
In detail, the organisation explained that the known side effects of medicines vary depending on the active ingredient, the patient’s health condition, the dose, and the accompanying treatments.
Some antibiotics may be associated with digestive disorders or allergic reactions, while some non-steroidal anti-inflammatory drugs, a class of painkillers, may cause stomach disorders or increase the likelihood of gastrointestinal bleeding in some users. The use of some diabetes medications may also lead to a decrease in blood sugar levels, depending on the type of medication and the accompanying treatments.
GLP-1 medication
The Foundation added that some modern drugs used to treat obesity, including drugs that affect GLP-1 receptors, are associated with five known and documented side effects, including nausea, vomiting, diarrhoea, constipation, and abdominal pain.
The organisation urged patients to pay attention to any new, persistent, or worsening symptoms, especially after starting a particular treatment. It indicated that it receives reports from patients and their caregivers, health practitioners, facilities, and relevant authorities, stressing that multiple reporting sources help complete drug safety data, and that analysing indicators according to the source of the report, the type of drug, and the severity of the condition allows for measuring the development of participation in reporting and monitoring areas that need additional awareness.
It explained that interpreting the increase in the number of reports requires looking at factors including the expansion of reporting channels, the level of interaction of the public and health professionals, the volume of drug use, and any changes in data collection standards, noting that she deals separately with the proportion of serious cases and safety signals resulting from data assessment, to avoid interpreting the increase in reports as an automatic increase in drug risks.
Regarding the reporting mechanism, the institution stated that it allows patients or their caregivers to report any suspected side effect related to a medication or medical product directly, without requiring proof that the medication is the direct cause of the symptom. It explained that the public can submit reports through the dedicated online service for individuals and patients, or inquire through the call centre at 80033784. A separate online service is available for healthcare practitioners and facilities via the institution's official website.
It added that the service requirements for individuals include attaching a report that includes data on the medication and reported side effects, the required data on the patient and the report writer, the date of commencement of treatment, a description of the symptoms and the time of their appearance, along with relevant accompanying health information and medications or dietary supplements, and it can be supported by available documents or pictures that illustrate the condition.
Regarding the procedures followed after receiving the report, the institution explained that the assessment takes into account 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, and the extent to which the information is consistent with known drug safety data.
It added that additional information, if available, regarding the results of medical examinations, the progression of the condition, or changes in treatment may be requested before the report is reviewed in its broader scientific context, including other reports, studies, and safety information provided by the parties obligated to do so, stressing that initial suspicion requires a scientific evaluation before concluding that there is a causal relationship between the drug and the symptom.
Assessment for new symptoms
The Foundation emphasised that serious cases and new, unexpected symptoms are subject to assessment procedures that take into account the nature of the potential risk and the need for rapid intervention. If a pattern emerges that is supported by scientific evidence, the appropriate regulatory action is determined according to the results of the assessment.
It explained that the procedures may include adding clarifications to the drug leaflet, issuing a specific warning to doctors and patients, requiring monitoring and medical examinations before prescribing the drug, restricting its use to certain categories, up to suspending its use or withdrawing it in cases that require urgent measures to protect patients, in accordance with approved scientific and regulatory standards, while informing those concerned of updates on the safety of use through approved regulatory channels.
Regarding the difference between known side effects listed in drug leaflets and those that are rare or dangerous, the institution explained that leaflets include effects that were identified during studies and follow-up, and the degree of prevalence of each effect is clarified when scientific evidence is available that allows for estimating its frequency.
It stressed the distinction between the prevalence of a symptom and its severity. Nausea or headache may be bothersome but have a limited impact on some patients, while some rare effects may be very serious. New information may also emerge as the use of the drug expands, or in patients with concomitant diseases, making the monitoring of the safety of medical products a continuous necessity after marketing approval.
The organisation identified six symptoms and signs that require urgent medical assistance after using the drug, including difficulty breathing, swelling of the tongue or throat, fainting, a severe skin rash accompanied by blisters or peeling, severe and unusual bleeding, and severe and persistent pain accompanied by worrying symptoms.
Less severe, persistent, or worsening symptoms require contacting a doctor or pharmacist to assess the condition and treatment, and to determine the appropriateness of adjusting the dose or changing the medication according to the medical assessment.
