adverse drug reactions

Diclofenac, a widely prescribed nonsteroidal anti-inflammatory drug (NSAID), remains one of the most commonly used analgesics and anti-inflammatory medications worldwide. Despite its therapeutic efficacy, diclofenac is associated with a spectrum of adverse drug reactions (ADRs) ranging from common gastrointestinal and cardiovascular effects to rare but serious complications, including cutaneous hyperpigmentation and Nicolau syndrome. This comprehensive review examines the drug profile, mechanism of action, pharmacokinetics, and detailed analysis of reported ADRs. Special attention is given to uncommon but clinically significant reactions such as Nicolau syndrome following intramuscular administration and drug-induced hyperpigmentation. The review provides evidence-based management strategies, risk factor identification, and monitoring protocols essential for safe clinical practice. Through systematic analysis of clinical trials, case reports, and pharmacovigilance data, this review highlights the importance of appropriate patient selection, route optimization, and vigilant monitoring in minimizing diclofenac-associated morbidity.

Pharmacovigilance is an integral part of clinical research. The potential awareness regarding adverse drug reactions has resulted in the emergence of the practice of Pharmacovigilance. Both clinical trials safety and post marketing pharmacovigilance are very significant in ensuring the drug safety. Pharmacovigilance methods can be categorized as Passive surveillance, Active surveillance, Comparative observational studies, targeted clinical investigations and Descriptive studies. The Central Drugs Standard Control Organization (CDSCO) already initiated a nationwide Pharmacovigilance programme under the aegis of Directorate General of Health Services (DGHS), Ministry of Health & Family Welfare and Government of India. The pharmacovigilance system in India has to be refined with the collaboration of pharmacovigilance experts. Implementation of a robust pharmacovigilance program in India in accordance with the objectives and recommendations of World Health Organization by Central Drugs Standard Control Organization is a prerequisite. It is the need of the hour to improve communication between the healthcare professionals and the public; and educating the health professionals well to understand the benefits/ risks of medicines they prescribe. Developing own national database and sharing information with other regulatory agencies will contribute a lot of required information from worldwide data to take the correct decision on medicines and products.