ArticleFrontiers in pharmacology2024
Risk of drug-induced angioedema: a pharmacovigilance study of FDA adverse event reporting system database.
Article in Frontiers in pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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Who cites it
6 citing papers in PubMed.
- Italian regional data and oropharyngeal adverse events to drugs and vaccines: insights from a 3-year spontaneous reporting (2022-2024).Pharmacological reports : PR · 2026Article
- Drug-Induced Intestinal Angioedema: A Disproportionality Analysis Using the United States Food and Drug Administration Adverse Event Reporting System Database and Literature Review.Medical sciences (Basel, Switzerland) · 2025Review
- Bradykinin-Mediated Angioedema Induced by Drugs.Journal of clinical medicine · 2025Review
- Amlodipine-Associated Angioedema: An Integrated Pharmacovigilance Assessment Using Disproportionality and Interaction Analysis and Case Reviews.Journal of clinical medicine · 2025Article
- Risk of drug-induced pericardial effusion: a disproportionality analysis of the FAERS database.BMC pharmacology & toxicology · 2025Article
- Drug-induced coagulopathies: a real-world pharmacovigilance study using the FDA adverse event reporting system.Frontiers in pharmacology · 2024Article
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4 authors.
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Abstract
Objective: The purpose of this study is to explore and analyze the FDA Adverse Event Reporting System (FAERS) database to identify drug adverse reaction signals associated with angioedema. The findings aim to provide valuable insights for clinical drug safety considerations. Methods: The Open Vigil 2.1 data platform was utilized to collect adverse event reports related to angioedema from the first quarter of 2004 to the fourth quarter of 2023. The reporting odds ratio (ROR) and proportional reporting ratio (PRR) were employed as disproportionality measures to detect adverse reaction signals Sof drugs associated with angioedema. Results: A total of 38,921 reports were retrieved, with the majority being reported by healthcare professionals. The analysis included predominantly adult patients (≥18 years of age), with slightly higher representation of females compared to males. Among the top 30 drugs associated with the occurrence of angioedema, 24 drugs showed positive signals in the risk analysis. Based on the individual drug reporting odds ratio (95% confidence interval) as a measure of risk signal strength, the top five drugs are as follows: lisinopril [ROR (95% CI): 46.43 (42.59-50.62)], enalapril [ROR (95% CI): 43.51 (39.88-47.46)], perindopril [ROR (95% CI): 31.17 (27.5-35.32)], alteplase [ROR (95% CI): 29.3 (26.95-31.85)], ramipril [ROR (95% CI): 20.93 (19.66-22.28)]. After categorizing the drugs, the strongest positive signal was observed in the antithrombotic agents [ROR (95% CI): 22.53 (21.16-23.99)], following that, cardiovascular drugs [ROR (95% CI): 9.17 (8.87-9.48)], antibiotics [ROR (95% CI): 6.42 (5.91-6.96)], immunosuppressors [ROR (95% CI): 5.95 (5.55-6.39)], anti-inflammatory analgesics [ROR (95% CI): 4.65 (4.45-4.86)], antiallergic drugs [ROR (95% CI): 4.47 (3.99-5)], antiasthmatics [ROR (95% CI): 2.49 (2.14-2.89)], blood sugar control drugs [ROR (95% CI): 1.65 (1.38-1.97)], and digestive system drugs [ROR (95% CI): 1.59 (1.45-1.74)] exhibited progressively decreasing ROR values. Conclusion: Many medications are associated with a high risk of angioedema. These medications play a crucial and potentially preventable role in controlling the occurrence of angioedema. It is essential to consider the risk level of drug-induced angioedema in clinical practice to optimize medication therapy.
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