European Journal of Biomedical and Pharmaceutical Sciences

THERAPEUTIC UTILITY VERSUS TOXICITY: PHARMACOVIGILANCE INSIGHTS INTO PARACETAMOL-ASSOCIATED ADVERSE DRUG REACTIONS

Relli Harshitha, Muppidi Pushpa Latha, Thollamadugu Naga Siva Saranya, G.Manoj Raj, Lasini Puvvala, Geddam Ratna Priya*

ABSTRACT

Acetaminophen, often known as paracetamol, is distinguished from conventional non-steroidal anti-inflammatory medications (NSAIDs) by its distinct central mode of action as a non-acidic, non-opioid analgesic agent. Despite being widely used for more than a century. Its central mode of action sets it apart from NSAIDs; it targets several pathways in the Central Nervous System (CNS) as a prodrug. It acts as a vital antipyretic for infectious diseases and is recommended for acute conditions such as migraines, dental pain, and musculoskeletal aches. Intravenous use for postoperative pain and the closure of the patent ductus arteriosus in premature neonates are examples of specialized applications. From the standpoint of a clinical pharmacist, managing paracetamol needs to strike a balance between its broad therapeutic index and its high utility. Although safe at therapeutic levels, an analysis of data from 2016 to 2026 reveals that it is often linked to gastrointestinal distress and, more importantly, “therapeutic misadventure.” This happens when patients mix multi-ingredient products and inadvertently overdose. Additionally, recent studies have linked gastrointestinal bleeding and elevated blood pressure to long-term high-dose therapy. Organ-related disorders are rare, but severe hypersensitivity continues to be a major concern. This review highlights the critical role that pharmacists play in patient education, early ADR detection, and multimodal analgesic regimen supervision. Pharmacists make sure paracetamol stays a safe mainstay of contemporary medicine by spotting possible toxicity and stopping careless overdoses. In modern practice, this framework helps physicians balance the drug's significant therapeutic benefits against its changing safety profile.

Keywords: Paracetamol, adverse drug reactions, pharmacovigilance, safety profile, and drug monitoring.