Characterization of adverse reactions to two antihistamine drugs: A descriptive analysis from WHO-VigiAccess
Yiheng Li ,Jing Zhu ,Qian Guo ,Jiaman Liao,Lixia Li,Jing Hu, Xiaoliang Zhang
Abstract
Antihistamines like azelastine and levocabastine are key in treating allergies, including allergic rhinitis, conjunctivitis, and urticaria. This study analyzed adverse drug reactions linked to these drugs using data from the WHO VigiAccess database, comparing their adverse drug reaction profiles to help physicians choose lower-risk options for personalized treatment.
Introduction
Allergic rhinitis (ARs) is a prevalent chronic inflammatory condition with a global prevalence of up to 40%, exhibiting a rising trend in recent years, making it a significant global public health issue . It usually manifests as runny nose, nasal congestion, sneezing, itchy nose, itchy eyes, and itchy throat, and so on Clinically, nasal mucosal congestion, increased secretion of nasal contents, as well as pale edema of the turbinates, can be observed
Materials and methods
Drug sample
It presents the drug structures, main indications, and targets of action of the two drugs primarily studied in this article. Both azelastine and levocabastine are H1-receptor antagonists, effective in the treatment of ARs and allergic conjunctivitis. Azelastine has been in clinical use since 1986, predating the commercialization of levocabastine
Disproportionality analysis We used the Reporting Odds Ratio (ROR) and the Proportional Reporting Ratio (PRR) as two disproportionality reporting methodologies based on the disproportionality analysis. A common technique in pharmacovigilance
Results
Over the study period, 11,592 adverse events related to both drugs were reported. Both had high rates of General disorders and administration site conditions. Azelastine showed more Nervous system disorders. Levocabastine had higher rates of endocrine disorders, injury/poisoning/procedural complications, and Nervous system disorders.
Conclusion
Antihistamines play a crucial role in the treatment of ARs. Studies have shown that WHO-VigiAccess has reported no less than 10, 000 cases of adverse reactions to both azelastine and levocabastine treatments. These adverse reactions were characterized by respiratory dysfunction and neurological abnormalities, consistent with previous studies confirming symptoms such as respiratory burning sensation, mucosal dryness, sedation, and vertigo.
Citation: Li Y, Zhu J, Guo Q, Liao J, Li L, Hu J, et al. (2026) Characterization of adverse reactions to two antihistamine drugs: A descriptive analysis from WHO-VigiAccess. PLoS One 21(8): e0355852. https://doi.org/10.1371/journal.pone.0355852
Editor: Rajeev Singh, Satyawati College, University of Delhi, INDIA
Received: August 18, 2025; Accepted: July 27, 2026; Published: August 12, 2026
Copyright: © 2026 Li et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Data Availability: The study’s original contributions are included in the article.
Funding: This research was partially funded by the National Natural Science Foundation of China (82071023), the Key Project of Medical Science and Technology of Henan Province (SBGJ202102160), and the Scientific Research Project of Colleges and Universities in Henan Province (21A320053). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing interests: The authors have declared that no competing interests exist.
