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Updated: Dec 30, 2025
Human Liver Microphysiological System for Assessing Drug-Induced Liver Toxicity In Vitro
Published on: January 31, 2022
Methylprednisolone-related liver injury: A descriptive study using the French pharmacovigilance database
Judith Cottin1, Sabrina Pierre1, Véronique Pizzoglio1
1Service Hospitalo-Universitaire de Pharmacotoxicologie, Centre de Pharmacovigilance, Hospices Civils de Lyon, CHU-Lyon, 69003 Lyon, France.
Purpose:
Hepatotoxicity associated with methylprednisolone (MP) is rarely reported in the literature. The aim of the present study was to review the characteristics of acute liver injury associated with intravenous (IV) or oral MP registered in the French pharmacovigilance database (FPD).
Methods:
All cases with MP coded as suspected, concomitant, or interacting drug associated with liver injury as the adverse effect reported up to May 2016 were extracted from the FPD. Cases were identified using the "Drug related hepatic disorders" Standard Medical Query.
Results:
A total of 97 cases of liver injury associated with MP were analysed; 58.8% were women and the median age was 46 years (range: 1-91). MP was used for an autoimmune disease in 47.6% of cases including 26 cases of multiple sclerosis, and was IV in 79.4% of cases. Nearly three-quarters of patients (73,2%) had a hepatocellular type of injury, the severity of which was mainly mild (45%) or moderate (31%). Most patients (92%) spontaneously and fully recovered within a mean 38.4 days. A rechallenge using the IV route was performed in 13 patients and for 10 (76.9%) this was positive (the initial type of injury was hepatocellular for all these cases). Regarding IV route of administration (n=77), MP was coded as the only suspected drug in 22% of cases.
Discussion:
The results suggest that IV MP causality should be considered in case of acute liver injury while data for oral MP is insufficient; systematic liver monitoring for high-dose IV MP may be recommended.
Insights
Methylprednisolone (MP) can cause rare liver injury, primarily hepatocellular, especially with IV administration. Most cases resolve spontaneously, but monitoring high-dose IV MP is advised.
Area of Science:
- Pharmacovigilance
- Hepatology
- Clinical Pharmacology
Background:
- Hepatotoxicity from methylprednisolone (MP) is infrequently documented.
- Acute liver injury is a potential adverse effect of corticosteroid therapy.
Purpose of the Study:
- To characterize acute liver injury associated with intravenous (IV) or oral MP.
- To analyze cases reported in the French pharmacovigilance database (FPD).
Main Methods:
- Extracted 97 cases of MP-associated liver injury from FPD up to May 2016.
- Utilized "Drug related hepatic disorders" Standard Medical Query for case identification.
Main Results:
- The majority of patients (58.8%) were women, with a median age of 46.
- Hepatocellular injury (73.2%) was most common, predominantly mild to moderate, with 92% full recovery.
- IV MP was the primary route (79.4%), and rechallenge confirmed causality in 76.9% of tested cases.
Conclusions:
- Causality between IV methylprednisolone and acute liver injury should be considered.
- Data on oral MP liver injury is limited; liver monitoring for high-dose IV MP may be warranted.
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