Comparison of safety signals for ibuprofen in children and adults: A real-world pharmacovigilance analysis

Ibuprofen is commonly used as an over-the-counter antipyretic and analgesic. However, children, as vulnerable population, are frequently excluded from pre-market clinical trials. Furthermore, there is a lack of post-marketing safety study. This study aims to evaluate the adverse events (AEs) associated with ibuprofen in both children and adults in real-world practice. The data was obtained from the Adverse Drug Reaction Monitoring Center of Henan Province, covering the period from January 1, 2010 to December 31, 2023. A disproportionality analysis was conducted using the reporting odds ratio (ROR) and the proportional reporting ratio (PRR) to detect risk signals associated with ibuprofen in children (0-17 years) and adults (≥18 years). A total of 1399 reports were recorded for children, while 9813 reports were documented for adults. Ibuprofen-related AEs were primarily associated with gastrointestinal disorders, nervous system disorders and skin and subcutaneous tissue disorders in both children and adults. Rash and pruritus were reported more frequently among children. AEs of gastrointestinal disorders were reported more frequently among adults. White blood cell count decreased (ROR = 12.72, PRR = 12.63) has been proposed as a new AE signal in children. Headache (ROR = 1.26, PRR = 1.26) and dizziness (ROR = 2.11, PRR = 2.04) were identified only in male adults, whereas abdominal discomfort (ROR = 1.25, PRR = 1.24) and rash pruritic (ROR = 2.16, PRR = 2.16) were observed solely in female adults. The toxicity profile of ibuprofen in children and adults exhibited distinct characteristics. Clinicians should provide active monitor based on these characteristic, especially white blood cell count decreased in children.