General

SFDA: Over 173,000 Reports of Drug Side Effects in the First Half of 2024

As part of its ongoing efforts to ensure the safe use of medications and improve communication with all segments of society, the Saudi Food and Drug Authority (SFDA) has indicated that it received over 173,000 reports of drug side effects during the first half of 2024. These reports were submitted through official reporting channels from various regions across the Kingdom.

The SFDA clarified that the reported side effects are normal and expected occurrences. It noted that these side effects are listed in the medication package inserts and do not affect the use of these drugs. This enables the SFDA to accurately assess the prevalence of these drugs and implement appropriate measures to manage any potential side effects.

The SFDA identified Amlodipine, Atorvastatin, Furosemide, Metformin, and Esomeprazole as the top five drugs reported for side effects in the first half of 2024.

The side effects reported by users of these drugs varied; headaches ranked first among the top five symptoms, at a rate of 5.65%
. This was followed by constipation at 5.65%, nausea at 4.54%, dizziness at 3.8%, and abdominal pain at 3.24%.

The SFDA receives reports of cosmetic or pharmaceutical product misuse and the occurrence of any side effects through its unified call center (19999) or the Saudi Vigilance System via the following link: https://ade.sfda.gov.sa/.

Source: Saudi Press Agency