Drug-Induced Intestinal Angioedema: A Disproportionality Analysis Using the United States Food and Drug Administration Adverse Event Reporting System Database and Literature Review.

BACKGROUND

Intestinal angioedema is an important drug-induced adverse effect that is often misdiagnosed due to vague and nonspecific symptoms. This study aimed to identify drugs with potential to cause intestinal angioedema by performing a disproportionality analysis, supplemented with literature review.

METHODS

Using OpenVigil, we extracted relevant individual case safety reports from the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database. Drugs with signal of disproportionate reporting (SDR) of intestinal angioedema were identified. A literature review was performed using PubMed and Embase databases to identify potential suspect drugs.

RESULTS

During 2004-2024, 303 cases of intestinal angioedema were reported to FAERS. Fourteen suspect medications showed SDR; of these, seven drugs were also reported in the literature to have caused intestinal angioedema, including angiotensin-converting enzyme inhibitors, losartan, and acetylsalicyclic acid. A literature search identified 89 relevant articles, providing details of 121 cases. Some drugs linked to intestinal angioedema in the literature did not show SDR.

CONCLUSIONS

Disproportionality analysis as well as a literature review showed that most patients were middle-aged females on antihypertensive therapy. The results will assist health professionals in determining the temporal association of acute abdomen with the suspected drug, potentially avoiding unnecessary interventions and their attendant complications.