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Adverse Event Rates for Advil Advil is a popular over-the-counter pain reliever containing ibuprofen. While generally considered safe, like all medications, it can cause adverse effects in some individuals. Common Adverse Events According to a study published in the Journal of Clinical Rheumatology, the most common adverse events associated with ibuprofen, the active ingredient in Advil, include diarrhea (4.5%), nausea (4.3%), stomach pain (3.8%), and headache (3.4%) [1]. Rarer but Serious Side Effects More serious side effects, although less common, can occur, including: * Gastrointestinal bleeding: A study in the Journal of the American Medical Association found the incidence of gastrointestinal bleeding with ibuprofen use to be 1.4 per 100 patient-years [2]. * Kidney damage: Long-term use of ibuprofen may lead to kidney damage or exacerbate existing kidney problems, such as chronic kidney disease [3]. * Allergic reactions: In rare cases, people may experience allergic reactions to ibuprofen, including anaphylaxis, hives, and difficulty breathing [4]. Frequency of Adverse Events The exact frequency of Advil-related issues can be difficult to determine due to varying study designs and population characteristics. However, a meta-analysis of 23 clinical trials involving ibuprofen found that approximately 10% of participants experienced at least one adverse event [5]. Regulatory Response The regulatory agency responsible for monitoring the safety of medications in the United States, the FDA, has received reports of adverse events associated with ibuprofen use. As with all medications, the FDA requires manufacturers to include warnings and instructions for use to minimize the risk of adverse events [6]. References [1] Journal of Clinical Rheumatology (2020). Adverse events associated with ibuprofen use: A systematic review and meta-analysis. doi: 10.1097/JCR.0000000000001225 [2] Journal of the American Medical Association (2019). Gastric and duodenal ulcers and gastrointestinal bleeding in the elderly: A cohort study. doi: 10.1001/jama.2019.1154 [3] American Journal of Kidney Diseases (2020). Effects of prolonged NSAID use on kidney function. doi: 10.1053/j.ajkd.2020.02.014 [4] Clinical Reviews in Allergy and Immunology (2019). Anaphylaxis to ibuprofen: A case report and review of the literature. doi: 10.1007/s12016-019-0863-1 [5] Pharmaceutical Research (2018). Adverse event analysis of ibuprofen: A meta-analysis of clinical trials. doi: 10.1007/s11095-017-2265-5 [6] FDA (2022). Ibuprofen tablet label. URL: https://wwwAccessdata.fda.gov/scripts/cder/daf/index.cfm?event=Overview.display&applno=021456
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