FAERS Analyses Uncover Diverse Drug Safety Risks Across Therapeutic Areas
Recent studies using FDA Adverse Event Reporting System data have identified drug-associated cardiovascular risks, pediatric dry eye, and venlafaxine adverse effects. Findings highlight the importance of pharmacovigilance monitoring.
Multiple recent analyses of the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) have highlighted a range of drug-associated safety concerns, from cardiovascular events in adults to dry eye in children and rare side effects of an antidepressant. The studies underscore the value of real-world pharmacovigilance data in identifying known and potential adverse effects.
A comprehensive study published in PLoS One analyzed 1,560,242 cardiovascular-related reports from the FAERS database spanning the first quarter of 2004 to the fourth quarter of 2024. Using four signal detection methods, researchers identified strong associations between the drugs rofecoxib, phenylpropanolamine, and rosiglitazone and cardiovascular disease, with reporting odds ratios of 73.4, 66.8, and 58.69, respectively. These medications have since been withdrawn or restricted. Subgroup analyses suggested testosterone-related drugs may be associated with cardiovascular risk in elderly and male patients, while alendronic acid may be linked to increased risk in female patients. Potential cardiovascular risks were also suggested for paricalcitol, busulfan, gemtuzumab ozogamicin, clofarabine, and clofazimine.
Separately, a pharmacovigilance study presented at the ARVO 2026 meeting analyzed FAERS data from 2004 to 2024 for patients aged 0 to 18 years, identifying 919 pediatric reports containing the term "dry eye." The analysis found significant associations with dupilumab, with an overall reporting odds ratio of 28.7, and the specific formulation Dupixent (Sanofi/Regeneron) with an ROR of 26.6. Retinoid therapies also showed strong signals, including isotretinoin brand Accutane with an ROR of 19.2 and tretinoin with an ROR of 11.3. Moderate associations were found for systemic antihistamines such as cetirizine (ROR: 3.14) and the hormonal contraceptive norgestimate (ROR: 6.53). The authors recommended routine ocular surface assessments for children and adolescents taking these medications.
Another analysis examined two decades of FAERS data to assess the safety profile of venlafaxine, a commonly prescribed antidepressant. The study confirmed known risks associated with the drug while documenting rare late-onset adverse events. Subgroup analyses revealed distinct patterns among certain patient populations, aiming to inform healthcare professionals about potential considerations for long-term prescribing practices.
Together, these investigations demonstrate how systematic mining of spontaneous adverse event reports can reveal both established and emerging drug safety signals across different therapeutic areas.