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Drug-Induced Intestinal Angioedema: A Disproportionality Analysis Using the United States Food and Drug
Poovizhi Bharathi Rajaduraivelpandian1, Rashmi R Rao1, Ashwin Kamath1
1Department of Pharmacology, Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Manipal, India.
Medical Sciences (Basel, Switzerland)
|December 24, 2025
Summary
Drug-induced intestinal angioedema is often misdiagnosed. This study identified suspect drugs, including ACE inhibitors, using safety reports and literature reviews, aiding diagnosis and preventing complications.
Area of Science:
- Pharmacovigilance
- Drug Safety
- Gastroenterology
Background:
- Intestinal angioedema is a significant drug-induced adverse event.
- Vague symptoms often lead to misdiagnosis of intestinal angioedema.
- Identifying causative drugs is crucial for patient safety.
Purpose of the Study:
- To identify drugs potentially causing intestinal angioedema.
- Utilize disproportionality analysis and literature review for drug identification.
- Improve diagnosis and management of drug-induced intestinal angioedema.
Main Methods:
- Extracted individual case safety reports from the FDA Adverse Event Reporting System (FAERS) via OpenVigil.
- Performed signal of disproportionate reporting (SDR) analysis to identify suspect drugs.
- Conducted literature reviews using PubMed and Embase to corroborate findings.
Main Results:
- 303 intestinal angioedema cases reported to FAERS (2004-2024).
- Fourteen suspect medications showed SDR; seven were confirmed by literature review (e.g., ACE inhibitors, losartan, aspirin).
- Some drugs identified in literature did not show SDR in FAERS data.
Conclusions:
- Most affected patients were middle-aged females on antihypertensive therapy.
- Findings aid clinicians in linking acute abdomen to suspected drugs.
- Early identification can prevent unnecessary interventions and complications.
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