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DISPROPORTIONALITY SIGNALS AND DELAYED-ONSET ADVERSE EVENTS ASSOCIATED WITH DAPRODUSTAT IN FAERS: CLINICAL PRIORITIZATION AND TEMPORAL ONSET PROFILING ACROSS CARDIOVASCULAR, THROMBOTIC, HEMATOLOGIC AND NEOPLASTIC EVENTS

AZFAR ATHAR ISHAQUI 1*, SHOAIB ALAM 2, JAVERIA FAROOQ 3, KHALID ORAYJ 1, MUHAMMAD IMRAN 4, SALMAN ASHFAQ AHMAD 4, RAYAH ASIRI 1, ADNAN IQBAL 2, MUHAMMAD BILAL MAQSOOD ⁵

¹ Department of Clinical Pharmacy, College of Pharmacy, King Khalid University, Abha, Saudi Arabia.
2 Department of Pharmacology, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi, Pakistan.
3 Department of Pharmacognosy, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi, Pakistan.
4 Department of Pharmacy, Iqra University, Karachi, Pakistan.
5 Quality and Performance Administration, Eastern Health Cluster, Health Holding Company, Dammam, Saudi Arabia

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To characterize post-marketing safety signals and time-to-onset patterns of adverse events (AEs) associated with daprodustat using FAERS data from 2023 Q1 to 2025 Q4. A retrospective disproportionality analysis was performed using FAERS reports listing daprodustat as the primary suspect. FDA-recommended de-duplication was applied using CASEID, PRIMARYID and FDA_DT. AEs were analysed at MedDRA Preferred Term and System Organ Class levels. Signals were identified using predefined disproportionality thresholds of ROR > 3 with lower 95% CI > 1 and PRR > 2 with lower 95% CI > 1, while clinically relevant findings were interpreted using case counts, signal strength, seriousness outcomes, death reports and time-to-onset patterns. Overall, 1,436 primary-suspect reports were identified, and 1,301 unique cases were retained after de-duplication. Most reports originated from Japan (n = 1,296; 99.6%). A total of 3,773 daprodustat-associated events were analysed, of which 299 Preferred Terms met predefined disproportionality criteria. After excluding haemoglobin (Hb) increased and nephrogenic anaemia from primary AE interpretation as pharmacodynamic and indication-related terms, respectively, selected clinically interpretable signals included hospitalization, Hb decreased, deep vein thrombosis, renal failure and retinal haemorrhage. Complete time-to-onset data were limited, although several serious events were reported more than 91 days after onset. Daprodustat showed clinically relevant safety signals requiring cautious interpretation and further validation.