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Differences in Reported Anaphylaxis Associated with Common Nonsteroidal Anti-Inflammatory Drugs: A Pharmacovigilance
Suwei Liu1, Haoyang Yu1, Yuxin Wu1
1College of Acupuncture-Moxibustion and Tuina, Shandong University of Traditional Chinese Medicine, Jinan, China.
International Archives of Allergy and Immunology
|July 2, 2026
Summary
Nonsteroidal anti-inflammatory drugs (NSAIDs) consistently signal anaphylaxis in adverse event reports. However, reporting patterns and severe outcomes vary significantly among specific NSAIDs like ibuprofen and diclofenac.
Area of Science:
- Pharmacovigilance and Drug Safety
- Clinical Immunology
- Real-World Evidence Studies
Background:
- Nonsteroidal anti-inflammatory drugs (NSAIDs) are a frequent cause of hypersensitivity reactions.
- Limited real-world data exists comparing specific NSAIDs regarding anaphylaxis reporting.
Purpose of the Study:
- To analyze anaphylaxis reporting patterns and disproportionality signals for five NSAIDs in the FDA Adverse Event Reporting System (FAERS).
- To compare severe outcomes and indication contexts for NSAID-associated anaphylaxis.
Main Methods:
- Cross-sectional pharmacovigilance study of FAERS data (2015Q1-2025Q2).
- Analysis of anaphylaxis reports for ibuprofen, diclofenac, naproxen, celecoxib, and meloxicam.
- Disproportionality assessment using multiple statistical methods.
Main Results:
- All five NSAIDs exhibited disproportionality signals for anaphylaxis.
- Anaphylaxis reporting proportions varied (1.18%-2.09%), with ibuprofen and diclofenac having higher rates.
- Demographic and geographic reporting patterns differed, and severe outcomes varied across NSAIDs.
Conclusions:
- NSAIDs demonstrate consistent disproportionality for anaphylaxis in FAERS.
- Significant heterogeneity exists in reporting patterns and outcomes among individual NSAIDs, necessitating further investigation.
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