Methotrexate-related drug reactions on kidneys and liver in rheumatoid arthritis: an analysis of spontaneous reports in EudraVigilance
Authors' conclusion
Liver dysfunction was reported nearly three times more often than renal impairment. However, the kidneys need to be especially watched for, since a fatal outcome was considerably more common in renal failure.
Study context
- Population
- Rheumatoid arthritis (RA) patients with spontaneous reports (until 2022) of suspected adverse drug reactions (ADRs) associated with methotrexate (MTX) in EudraVigilance (mean age 62.3 years, 72.6% female)spontaneous reports
- Participants
- 10,319 patients
- Exposure
- Kidney-related vs liver-related MTX ADRs
- Kidneysn = 365
- Livern = 1,082reference
- Outcome
- Fatal outcome
Methodological detailsEudraVigilance database, stratified by organ affected and outcome
- EudraVigilance database
- Stratified by organ affected and outcome
Main finding
As reported in the abstract
Observational data: associations, not effects.
Further findings
Age and comedication (e.g. Non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, metamizole, corticosteroids)
- Patients with kidney ADRs were older and comedication was more common than in liver ADRs
Comedication in fatal vs non-fatal cases
- Comedication more common in fatal than non-fatal cases, for both kidney and liver ADRs
Original publication
Methotrexate-related drug reactions on kidneys and liver in rheumatoid arthritis: an analysis of spontaneous reports in EudraVigilance. Arthritis Res Ther. Published 5 April 2025. doi:10.
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