Drug approval was cautionary withheld in many countries since 2002 because of increase risk of severe liver toxicity. The FDA never approved it for use in the USA.
The EMA (European Medicines Agency) introduced limitations for use by narrowing indication profile, shortening duration of treatment, age restriction for younger than 12 year, and avoiding it in pregnancy and breastfeeding.
Latest update failed to find relevant data on breastfeeding.
Its high molecular weight and plasma protein binding make excretion into breast milk unlikely. However, anti-inflammatory drugs that are known to be safer for both the mother and the infant should be preferred.
Very Low Risk
Compatible. Not risky for breastfeeding or infant.
Moderately safe. Mild risk possible. Follow up recommended. Read the Comment.
Poorly safe. Evaluate carefully. Use a safer alternative. Read the Comment.
Very High Risk
Not recommended. Cessation of breastfeeding or alternative.
- Νιμεσουλίδη (Greek)
- نيميسوليد (Arabic)
- Нимесулид (Cyrillic)
- 尼美舒利 (Chinese)
- ニメスリド (Japanese)
- C13 H12 N2 O5 S (Molecular formula)
- 4′-Nitro-2′-phenoxymethanesulphonanilide (Chemical name)
- M01AX17; M02AA26 (ATC Code/s)
Drug trade names
- Agencia Europea del Medicamento (EMeA). Nimesulida. Revisión del perfil de seguridad. 2010 Full text (in our servers)
- European Medicine Agency (EMeA). Nimesulide. AMENDMENTS OF THE SUMMARY OF \ PRODUCT CHARACTERISTICS 2010 Full text (in our servers)
- Bissoli F. Nimesulide-induced hepatotoxicity and fatal hepatic failure. Singapore Med J. 2008Abstract Full text (in our servers)
- Walker SL, Kennedy F, Niamh N, McCormick PA. Nimesulide associated fulminant hepatic failure. Pharmacoepidemiol Drug Saf. 2008Abstract
- Tan HH, Ong WM, Lai SH, Chow WC. Nimesulide-induced hepatotoxicity and fatal hepatic failure. Singapore Med J. 2007Abstract Full text (in our servers)
- Maciá MA, Carvajal A, del Pozo JG, Vera E, del Pino A. Hepatotoxicity associated with nimesulide: data from the Spanish Pharmacovigilance System. Clin Pharmacol Ther. 2002Abstract