Study Flags Systemic Medications Associated With Uveitis Risk

A new FAERS database analysis identified 13 FDA-approved systemic medications with disproportionately high uveitis reporting signals among 7,301 adverse events logged from 2003 to 2024. The strongest associations were seen with cidofovir and rifabutin, alongside notable signals for biologics, MEK inhibitors, BRAF inhibitors and moxifloxacin. While the findings are hypothesis-generating and cannot establish causality, they reinforce the importance of monitoring at-risk patients for ocular inflammation when prescribing immunologic, anti-infective or oncologic therapies. Photo: Tammy Than, OD. Click image to enlarge. Among the etiologies of uveitis, medications such as bisphosphonates, immune checkpoint inhibitors and moxifloxacin have been identified as potential contributors to the disease. However, population-based research of drug-related uveitis remains limited. A new study sought to address this knowledge gap using the FDA Adverse Event Reporting System (FAERS) database to identify drugs that were disproportionately reported for uveitis events. Their findings were recently published in Canadian Journal of Ophthalmology. The study included a total of 7,301 uveitis events between 2003 and 2024. The mean age of patients in these reports was 49.9 ± 20 years. Overall, 31.9% patients were male, 49.3% were femal, and 18.8% did not report sex. Notably, most uveitis cases (56.5%) were reported after 2022. Geographically, the highest proportion of cases was reported in North America (49.6%), followed by Europe (28.4%) and Asia (11.5%). Researchers conducted disproportionality analyses by comparing drug-specific uveitis reports with the background reporting rate across all other drugs in the database. Reporting odds ratios (RORs) with 95% confidence intervals were calculated.  According to the results, 13 pharmacological agents were identified as being disproportionately associated with high reporting rates of uveitis. The strongest safety signals were observed for cidofovir (ROR = 103.8) and rifabutin (ROR = 77.4). Additional signals were detected for cobimetinib (ROR = 30.5), foscarnet (ROR = 29.0), infliximab (ROR = 18.1), dabrafenib (ROR = 16.4), vemurafenib (ROR = 16.2), trametinib (ROR = 15.5), brodalumab (ROR = 14.9), binimetinib (ROR = 11.3), encorafenib (ROR = 11.2), ipilimumab (ROR = 11.0) and moxifloxacin (ROR = 10.3). “Interpretation of these associations must consider underlying disease indications, which may independently predispose patients to ocular inflammation,” the authors wrote. “For instance, cidofovir and foscarnet are antivirals predominantly used in immunocompromised individuals, particularly those with cytomegalovirus (CMV) retinitis, where ocular inflammation is an inherent feature of the disease process. Rifabutin and moxifloxacin are commonly prescribed for infectious conditions, such as Mycobacterium avium complex and bacterial respiratory infections, which can independently trigger ocular inflammation through immunity-mediated or microbial mechanisms. “In contrast, biologic agents, MEK inhibitors and BRAF inhibitors are primarily used in autoimmune and oncologic settings, including rheumatoid arthritis, psoriasis and melanoma, where immune dysregulation or paraneoplastic inflammation may overlap with drug-related effects,” they continued. “Differentiating between disease-associated and drug-induced uveitis, therefore, remains challenging and highlights the need to integrate pharmacovigilance findings with clinical context in future studies.”They noted the patients at greatest risk include those with pre-existing autoimmune or inflammatory disorders, prior ocular inflammation, or infectious etiologies, such as CMV retinitis. “Individuals receiving multiple immunomodulatory or cytotoxic agents, or those with cancer-related immune dysregulation, may also exhibit amplified susceptibility to drug-induced uveitis,” wrote the authors. “Proposed mechanisms include immune complex deposition, immune checkpoint dysregulation, cytokine imbalance and direct ocular toxicity.”Limitations noted by the researchers included the voluntary reporting of FAERS, which may result in under-reporting, selective reporting and incomplete data. Newer agents like nivolumab and pembrolizumab may be under-reported because of their relatively recent approval, they added. “Disproportionality analysis identifies potential associations but cannot account for exposure timing or establish causality, as it relies on relative reporting frequencies rather than absolute risk. Thus, findings should be considered hypothesis-generating,” they wrote.These findings offer critical insights into the ocular safety profiles of these systemic medications, underscoring the need for heightened vigilance when prescribing these drugs to patients at increased risk of uveitis, the authors concluded in their paper. Click here for the journal source. Butt F, et al. A real-world pharmacovigilance analysis of uveitis from systemic medications. Canadian Journal of Ophthalmology. April 8, 2026. [Epub ahead of print.] This article was developed by the editorial staff in conjunction with experts in the field. In the process, AI may have been among the editorial tools used to meet the goals of human editors, who approved all content.