Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and Associated Health Risks: A Pharmacovigilance-Based Review

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.