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The study aims to obtain the safety profile of riluzole in the real world and provide reference for clinical drug applications. Proportional reporting ratio (PRR) was used to detect riluzole adverse drug reactions (ADRs) from the data between the first quarter of 2004 and the third quarter of 2022 in the FDA adverse event reporting system database (FAERS). Case reports of riluzole published in PubMed, Embase, and Web of Science before November 2022 were reviewed, and patient’s data were extracted. FAERS analysis identified 86 ADRs. Gastrointestinal system disorders and respiratory, thoracic, and mediastinal disorders account for 12 of the top 20 most frequent ADRs. Similarly, 9 of the 20 highest PRR ADRs were gastrointestinal system disorders and respiratory, thoracic, and mediastinal disorders. Twenty-two published riluzole-associated cases were identified in the literature. Respiratory, thoracic, and mediastinal disorders were the most commonly reported cases ( n  = 9), followed by gastrointestinal disorders, pancreatitis ( n  = 5). Strong ADRs between riluzole and pancreatitis were identified, which reminds clinicians to monitor patients carefully. For patients with respiratory symptoms, clinicians should pay attention to distinguish the cause of their occurrence, and take appropriate measures. Beware that riluzole may increase the risk of inflammatory reactions and inappropriate vasopressin secretion and hyponatremia due to respiratory failure.

Real-world safety profile of riluzole: a systematic analysis of data from the FAERS database and case reports