A clinical study on nimesulide hepatotoxicity

Manju K. Nair, Rema M. N., Shenoy K. T.


Background: Hepatic injury can occur with the use of nimesulide, a non steroidal anti-inflammatory drug. This study was done to evaluate the hepatic and renal functions in patients with rheumatological complaints receiving nimesulide for 2 weeks.

Methods: Fifty patients with rheumatological complaints treated at orthopaedic outpatient clinic of a tertiary care centre with nimesulide 100mg twice daily were enrolled in this study. The sociodemographic details, details of comorbidities, history of use of alcohol or tobacco, indication for treatment with nimesulide etc. were recorded in a predesigned proforma. All patients were followed up for two weeks and reviewed at the end of each week for any gastrointestinal adverse effects, changes in blood routine, liver function tests and renal function tests. Data collected was entered in Microsoft Excel 2010, analysed and results were expressed as mean and standard deviation.

Results: Out of the fifty patients analysed, mean age was 39 years. 66 % were males. Among liver function tests, only serum albumin and serum aspartate aminotransferase (SGPT) were altered after treatment with nimesulide. Blood urea nitrogen, serum creatinine and blood routine remained normal. No gastrointestinal adverse effects were noted.

Conclusions: Nimesulide produced changes in serum albumin and SGPT levels without prominent gastrointestinal or renal adverse effects.


Hepatotoxicity, Liver function, Nimesulide, Serum albumin

Full Text:



Bjorkman D. Nonsteroidal anti-inflammatory drug-associated toxicity of the liver, lower gastrointestinal tract, and esophagus. Am J Med. 1998 Nov 2;105(5):17S-21S.

Rainsford KD. Relationship of nimesulide safety to its pharmacokinetics: assessment of adverse reactions. Rheumatology (Oxford, England). 1999 May 1;38(suppl_1):4-10.

Bevilacqua M, Magni E. Recent contributions to knowledge of the mechanism of action of nimesulide. Drugs. 1993 Nov 1;46(1):40-7.

Dammann HG. Preferential COX-2 inhibition: its clinical relevance for gastrointestinal non-steroidal anti-inflammatory rheumatic drug toxicity. J Gastroenterol. 1999 Jan;37(1):45-58.

Bjarnason I, Thjodleifsson B. Gastrointestinal toxicity of non-steroidal anti-inflammatory drugs: the effect of nimesulide compared with naproxen on the human gastrointestinal tract. Rheumatology (Oxford, England). 1999 May 1;38(suppl_1):24-32.

Hirata T, Ukawa H, Kitamura M, Takeuchi K. Effects of selective cyclooxygenase-2 inhibitors on alkaline secretory and mucosal ulcerogenic responses in rat duodenum. Life Sci. 1997 Sep 12;61(16):1603-11.

Bessone F, Fay F, Fay O, Vorobioff J, Passamonti MS, Godoy A. Nimesulide. Hepatology. 1997;26(4):483A.

Schattner A, Sokolovskaya N, Cohen J. Fatal hepatitis and renal failure during treatment with nimesulide. J Iinternal Med. 2000 Jan;247(1):153-5.

Andrade RJ, Lucena MI, Fernández MC, González M. Letters to the Editor: Fatal hepatitis associated with nimesulide. J Hepatol. 2000 Jan 1;32(1):174.

Bernareggi A. Clinical Pharmacokinetics of nimesulide. Clin Pharmacokinet. 1998;35(4):247-4.

Leone R, Conforti A, Ghiotto E, Moretti U, Valvo E, Velo GP. Nimesulide and renal impairment. Eur J Clin Pharmacol. 1999 Apr 1;55(2):151-4.

Peruzzi L, Gianoglio B, Porcellini MG, Coppo R. Neonatal end-stage renal failure associated with maternal ingestion of cyclo-oxygenase-type-1 selective inhibitor nimesulide as tocolytic. Lancet. 1999 Nov 6;354(9190):1615.