Adverse Event Profile of Apremilast: Pharmacovigilance Study Based on FDA Adverse Event Reporting System (FAERS)

AI Summary

FAERS analysis Q1 2014 to Q1 2024: 122,287 apremilast reports, 238,215 reactions, 60 signals across 24 SOCs; GI, skin, musculoskeletal most frequent.
Most reported preferred terms were diarrhoea, nausea and headache, indicating predominant gastrointestinal and neurological symptoms.
Unexpected signals included multiple allergic reactions and tumour reports; significant disproportionality noted for gastrointestinal, psychiatric and infection-related ADEs, requiring monitoring.

Exp Dermatol. 2026 Jul;35(7):e70303. doi: 10.1111/exd.70303.

ABSTRACT

This study aims to assess the adverse event profile of apremilast using FDA Adverse Event Reporting System (FAERS) data to identify potential safety risks and support clinical use. FAERS data from Q1 2014 to Q1 2024 were analysed. Adverse drug events (ADEs) related to apremilast were extracted and evaluated using four signal detection methods: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM). A total of 122 287 apremilast-related AE reports, encompassing 238 215 adverse reactions across 24 System Organ Classes (SOCs) and 60 apremilast-induced AE signals, were identified. Gastrointestinal disorders, skin and subcutaneous tissue disorders, and musculoskeletal and connective tissue disorders were the most frequently reported SOCs. Common Preferred Terms (PTs) included diarrhoea, nausea, and headache. Notably, some adverse effects not listed in the drug package insert were found, such as multiple allergic reactions and tumour signals. This study identified significant disproportionality signals for ADEs reported with apremilast, particularly concerning gastrointestinal reactions, psychiatric disorders, and infections. While these findings do not establish causality, they offer valuable real-world insights that underscore the importance of continued clinical monitoring and warrant further pharmacoepidemiologic investigation.

PMID:42366928 | DOI:10.1111/exd.70303

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