Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and Associated Health Risks: A Pharmacovigilance-Based Review
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Abstract
Nonsteroidal anti-inflammatory drugs (NSAIDs) are among the most widely consumed therapeutic agents worldwide due to their proven efficacy in relieving pain, reducing inflammation, and controlling fever. However, extensive clinical experience and pharmacovigilance data have revealed that NSAIDs are associated with a considerable burden of adverse effects, posing significant challenges to patient safety. Gastrointestinal complications such as ulceration, bleeding, and perforation remain the most frequently reported toxicities, while cardiovascular events including myocardial infarction, stroke, and hypertension have emerged as major concerns, particularly with long-term or high-dose use. Additionally, NSAIDs may contribute to renal impairment, electrolyte imbalance, and hematological abnormalities through prostaglandin inhibition and platelet dysfunction. Global pharmacovigilance programs, including those managed by the World Health Organization (WHO) and national regulatory authorities, have played a pivotal role in identifying, characterizing, and quantifying these risks. Data derived from spontaneous reporting systems, signal detection algorithms, and post-marketing surveillance have enriched current understanding of drug safety profiles and highlighted differences in risk across NSAID classes and patient populations. Such evidence has informed clinical guidelines, risk minimization measures, and labeling updates aimed at optimizing NSAID use. This review consolidates current evidence from pharmacovigilance studies, clinical trials, and real-world data to provide an integrated overview of NSAID-associated health risks. Emphasis is placed on modern methodologies for adverse event detection, global regulatory responses, and strategies for rational prescribing to balance therapeutic benefits with minimized patient harm.