Mycophenolate sodium in combination therapy: a signal detection analysis using the FAERS database

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Author: ZHENG Jingping ¹ ZHANG Zhenpo ¹ MA Lin ² LIANG Yankun ¹ DING Chufeng ¹  XU Qinqin ²  SU Ling ¹

Affiliation: 1. College of Pharmacy, Jinan University, Guangzhou 511443, China 2. Organ Transplant Management Office, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China

Keywords: Mycophenolate sodium FAERS Concomitant therapy Adverse event Pharmacovigilance

DOI: 10.12173/j.issn.2097-4922.202501005

Reference: ZHENG Jingping, ZHANG Zhenpo, MA Lin, LIANG Yankun, DING Chufeng, XU Qinqin, SU Ling. Mycophenolate sodium in combination therapy: a signal detection analysis using the FAERS database[J]. Yaoxue QianYan Zazhi, 2025, 29(10): 1724-1730. DOI: 10.12173/j.issn.2097-4922.202501005.[Article in Chinese]  Copied

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Abstract

Objective To conduct data mining and signal detection on all adverse event (AE) reports for mycophenolate sodium based on the FAERS database.

Methods Signal detection was performed on mycophenolate sodium reports recorded in the FAERS database from the first quarter of 2004 to the fourth quarter of 2023, using a combination of reporting odds ratio (ROR), the Medicines and Healthcare Products Regulatory Agency (MHRA) and Bayesian confidence propagation neural network (BCPNN).

Results A total of 4,842 AE reports related to mycophenolate sodium were collected, including 2,301 (47.5%) in the monotherapy group and 2,541 (52.5%) in the combination therapy group. The most frequently reported outcome in the monotherapy group was death (346 cases, 15.0%), while nausea (104 cases, 4.1%) was most frequently reported AE in the combination therapy group. Calcineurin inhibitors were the predominant co-administered drugs in the combination therapy group. Signal detection identified 27 signals across 12 SOCs in the monotherapy group and 102 signals across 16 system organ class (SOC) in the combination therapy group, with 12 signals overlapping between the two groups.

Conclusion Treatment with mycophenolate sodium in combination with other drugs may increase the complexity and severity of AEs. This combination may not only elevate the risk of known AEs, such as gastrointestinal reactions, infections, and cardiac disorders, but may also lead to new AEs, such as cerebrovascular accidents, visual impairment, and hearing loss.

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