Safety of Celecoxib in Elderly Patients With Osteoarthritis: A Real-World Analysis Based on the FAERS Database

Clin Ther. 2026 Jul 3:S0149-2918(26)00219-5. doi: 10.1016/j.clinthera.2026.06.007. Online ahead of print.

ABSTRACT

PURPOSE: Celecoxib, a selective cyclooxygenase-2 (COX-2) inhibitor, is frequently recommended for elderly patients with osteoarthritis because it provides effective analgesia with fewer gastrointestinal complications than nonselective NSAIDs. Nevertheless, this agent is not devoid of toxicity, and its adverse-effect profile remains incompletely elucidated.

METHODS: From the FAERS database, a sum of 19,024,945 adverse event reports spanning from Q1 2004 to Q1 2025 was extracted. Disproportionality analyses-reporting odds ratio (ROR), proportional reporting ratio (PRR) and the Bayesian Confidence Propagation Neural Network (BCPNN)-were employed to characterize them. Besides, the temporal pattern of adverse events was evaluated utilizing the Weibull shape parameter (WSP).

FINDINGS: A cumulative total of 1239 reports on adverse events associated with celecoxib were identified. Analyses found that: (1) In patients with osteoarthritis treated with celecoxib, adverse responses were strongly linked with the System Organ Class (SOC) level, specifically "general disorders and administration site conditions" (a = 676, ROR = 1.32), and with the Preferred Term (PT) level for "drug ineffective" (a = 145, ROR = 2.73). In the subgroup analysis, a relatively strong reporting signal for myocardial infarction was observed among male OA patients (a = 31, ROR = 1.41), whereas the reporting signal for "drug ineffective" was more pronounced among female OA patients (a = 144, ROR = 2.57) (2) Celecoxib-related AEs demonstrated an early-failure pattern.

IMPLICATIONS: To our knowledge, this study stands as the inaugural one to reveal that celecoxib-induced adverse events gradually diminish over time. We further corroborate a stronger signal for "myocardial infarction" in male than in female osteoarthritis patients. These results highlight the imperative of exercising increased caution in prescribing celecoxib to individuals with predisposing medical issues in order to avoid causing serious adverse reactions. Physicians and patients should evaluate the risk-benefit balance and intended treatment duration on an individual basis, and promptly discontinue the medication and modify the therapy when indicated.

PMID:42399116 | DOI:10.1016/j.clinthera.2026.06.007