Background: Nimesulide is a relatively new non-steroidal anti-inflammatory
drug that is gaining popularity in many countries because it is a selective
cyclooxygenase 2 inhibitor. Occasionally, treatment is associated with mil
d elevation of liver enzymes, which return to normal upon discontinuation o
f the drug. Several cases of nimesulide-induced symptomatic hepatitis were
also recently reported, but these patients all recovered.
Objectives: To report the characteristics of liver injury induced by nimesu
lide.
Patients and Methods: We report retrospectively six patients, five of them
females with a median age of 59 years, whose aminotransferase levels rose a
fter they took nimesulide for joint pains. In all. patients nimesulide was
discontinued, laboratory tests for viral and autoimmune causes of hepatitis
were performed, and sufficient followup was available.
Results: One patient remained asymptomatic. Four patients presented with sy
mptoms, including fatigue, nausea and vomiting, which had developed several
weeks after they began taking nimesulide (median 10 weeks, range 2-13). He
patocellular injury was observed with median peak serum alanine aminotransf
erase 15 rimes the upper limit of normal (range 4-35), reversing to normal
2-4 months after discontinuation of the drug. The remaining patient develop
ed symptoms, but continued taking the drug for another 2 weeks. She subsequ
ently developed acute hepatic failure with encephalopathy and hepatorenal s
yndrome and died 6 weeks after hospitalization. In none of the cases did se
rological tests for hepatitis A, B and C, Epstein-Barr virus and cytomegalo
virus, as well as autoimmune hepatitis reveal findings.
Conclusions: Nimesulide may cause liver damage. The clinical presentation m
ay vary from abnormal liver enzyme levels with no symptoms, to fatal hepati
c failure. Therefore, monitoring liver enzymes after initiating therapy wit
h nimesulide seems prudent.