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@article{184624,
        author = {Neeta Verma and Aditi Tripathi and Abhash Kumar and Deep Das},
        title = {Signal detection of ferric carboxymaltose-induced serious adverse events: Analysis of FAERS and systematic review of case reports},
        journal = {International Journal of Innovative Research in Technology},
        year = {2025},
        volume = {12},
        number = {4},
        pages = {2752-2764},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=184624},
        abstract = {Objective: To evaluate the safety profile of Ferric Carboxymaltose (FCM) by analyzing serious adverse events (SAEs) reported in the FDA Adverse Event Reporting System (FAERS), with stratification by system organ class (SOC), age, gender, geography, and reporter type. The aim is to identify any emerging safety signals and assess the consistency of reported adverse events with the known safety profile of FCM.
Methodology: A retrospective review of FAERS data was conducted for all adverse event reports associated with FCM from 2008 through March 2024. Data was extracted using the FAERS Open Platform dashboard. Events were categorized by SOC, seriousness, age group, gender, geographical region, and reporter type. Descriptive statistics were used to summarize the frequency and distr,ibution of adverse events.
Results: A total of 7,240 case reports were retrieved. The majority of cases were reported in females (74.1%) and elderly patients (55.5%). The most frequently affected SOCs were General Disorders and Administration Site Conditions (15.6%), Skin and Subcutaneous Tissue Disorders (9.3%), and Nervous System Disorders (9.2%). Serious hypersensitivity reactions, including anaphylaxis, were reported in 521 cases, with 7 fatal outcomes. Overall, 192 fatal events were recorded (2.4% of total events). Most reports originated from healthcare professionals (86.15%) and were evenly distributed between domestic and foreign sources.
Discussion: The adverse events reported for FCM are largely consistent with its known safety profile as outlined in the Summary of Product Characteristics (SmPC). The predominance of female cases may reflect higher exposure due to the prevalence of iron deficiency in women. While serious hypersensitivity reactions were observed, their frequency remains low. No new safety concerns were identified from the FAERS data. Limitations of the FAERS database, including underreporting, incomplete data, and lack of denominator information, were acknowledged.
Conclusion: The review confirms that the safety profile of Ferric Carboxymaltose remains consistent with existing product information. The majority of reported adverse events are expected and non-serious. Continued pharmacovigilance and monitoring are recommended, but no new safety signals were detected that warrant regulatory action.},
        keywords = {},
        month = {September},
        }