Death due to Diclofenac Sodium: A Case Report

Authors

  • Minakshi Ghuge*
  • Jyoti Bobde**
  • Deepak Bhosle**

Keywords:

adverse event; diclofenac sodium; hypersensitivity; NSAIDs; pharmacovigilance; WHO-UMC scale.

Abstract

Introduction: Diclofenac sodium, a commonly used non-steroidal anti-inflammatory drug (NSAID), is generally regarded as safe for postoperative analgesia. However, rare but severe hypersensitivity reactions such as anaphylaxis have been reported. This case report describes a fatal adverse event following intravenous administration of diclofenac.

Case report: A 43-year-old female patient who underwent a total laparoscopic hysterectomy for uterine fibroids was prescribed injection diclofenac by intravenous route. Shortly after initiating a 75 mg diclofenac infusion, the patient developed a burning sensation, erythema, shortness of breath, and generalised pruritus, followed by unconsciousness and cardiovascular collapse. Despite immediate discontinuation of the infusion and administration of emergency medications, including chlorpheniramine, hydrocortisone, adrenaline, and inotropes, the patient did not recover and succumbed to cardiac arrest approximately 24 hours later. The reaction was categorised as a serious and life-threatening adverse drug reaction (ADR) and reported to the pharmaco-

vigilance system. Causality assessment using the WHO-UMC scale suggested a “possible” link with diclofenac, and the event was classified as Level 7 (lethal) according to Hartwig's severity assessment.

Conclusion: This case highlights the potential for severe anaphylaxis following intravenous NSAID use, emphasising the need for heightened clinical vigilance, thorough drug history evaluation, and emergency preparedness during perioperative analgesic administration.

Published Date

07-May-2026