Introduction: Mirvetuximab soravtansine (MIRV) is a first-in-class antibody–drug conjugate (ADC) targeting folate receptor alpha, approved for platinum-resistant ovarian cancer. However, real-world safety data remain limited. 

Objective: To characterize the real-world adverse event reporting profile of mirvetuximab soravtansine, including disproportionality safety signals, time-to-onset patterns, severity and clinical outcomes, and reporting proportions relative to other ADCs.

Methods: Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) data from 2022Q4 through 2025Q4 were analyzed. Disproportionality signals were detected using four algorithms: reporting odds ratio (ROR), proportional reporting ratio, information component, and empirical Bayesian geometric mean. Time-to-onset, severity, subgroup, and comparative analyses with four other FDA-approved ADCs were performed.

Results: We identified 1,252 reports with MIRV containing 2,617 adverse event records (median age 65 years, 99.7% female). Strong reporting signals emerged for keratopathy (ROR: 318.6, 95% confidence interval [CI]: 232.6–436.3), keratitis (ROR: 255.8, 95% CI: 191.3–342.0), blurred vision (ROR: 12.7, 95% CI: 10.3–15.7), peripheral neuropathy (ROR: 14.1, 95% CI: 11.4–17.4), and pneumonitis (ROR: 37.0, 95% CI: 29.1–46.9). Gastrointestinal events occurred early (median <7 days), while ocular and neurological events showed delayed onset (median >30 days). Death was reported in 9.2% of all reports and 19.4% of pneumonitis reports. MIRV showed the highest reporting proportion for ocular toxicity among ADCs (24.4% vs. <3% for most comparators), while trastuzumab deruxtecan showed a higher reporting proportion for pneumonitis (13.5% vs. 6.8%).

Conclusion: This disproportionality analysis characterizes the adverse event reporting profile of MIRV in FAERS, identifying strong reporting signals for ocular toxicity, peripheral neuropathy, and pneumonitis. The observed temporal patterns, based on a subset with available onset data, suggest early vigilance for gastrointestinal symptoms and sustained ophthalmologic surveillance. These hypothesis-generating findings may inform monitoring strategies and patient counseling.