A disproportionality analysis of real-world adverse events associated with tirofiban from the FAERS database
Tirofiban is a glycoprotein IIb/IIIa receptor blocker mainly used alongside other blood thinners in patients with acute coronary syndrome (ACS) undergoing procedures like angioplasty (PCI). Emerging clinical evidence suggests it may also be beneficial during endovascular treatment for ischemic stroke (IS). Because Tirofiban prevents blood clotting, it is important to assess how often it causes serious bleeding or other side effects when used in real-life settings. We used disproportionality analysis to review all FDA-reported adverse events linked to Tirofiban (from 2004 onward), focusing on cases where the drug was the primary suspect. The study results confirmed known AEs such as bleeding and thrombocytopenia. We observed both commonly reported bleeding events (e.g., brain and gut bleeding) and less commonly recognized types, such as hemothorax and hemorrhagic shock. Furthermore, other relatively rare but statistically significant AEs were identified, including acute respiratory failure, hemolysis, prolonged activated partial thromboplastin time (APTT), coagulopathy, and disseminated intravascular coagulation (DIC). The temporal analysis showed the median onset time of AEs was 1 day, which urges immediate monitoring after drug administration, such as symptom surveillance and complete blood count evaluation.
Authors
- Qian Guo (ORCID: https://orcid.org/0000-0003-4815-4458)
- Xingli Xu (ORCID: https://orcid.org/0000-0001-6309-3265)
- Cuiping Zhao (ORCID: https://orcid.org/0000-0003-2509-0914)
- Wenjie Tian (ORCID: https://orcid.org/0000-0002-7853-8463)
- Xiang Li (ORCID: https://orcid.org/0000-0002-0357-6748)
- Mao Yang (ORCID: https://orcid.org/0009-0009-6455-3898)
- Yaxing Li
- Lei Zhang (ORCID: https://orcid.org/0000-0002-6170-4971)
- Chungang Zhai (ORCID: https://orcid.org/0000-0001-9200-5703)
Institutions
- University of Electronic Science and Technology of China (CN)
- Taian City Central Hospital (CN)
- First Affiliated Hospital of Zhengzhou University (CN)
- Qilu Hospital of Shandong University (CN)
- State Key Laboratory for Innovation and Transformation of Luobing Theory
Publication Details
- Journal
- Scientific Reports
- Published
- 2025-09-01
- DOI
- https://doi.org/10.1038/s41598-025-15964-z
- Citations
- 2
- Primary Topic
- Atrial Fibrillation Management and Outcomes
- Type
- article
- Field-Weighted Citation Impact
- 2.78
Funders
- National Natural Science Foundation of China
- China Postdoctoral Science Foundation
- Natural Science Foundation of Shandong Province
- Southwest Medical University