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Drug approval was cautionary withheld in many countries since 2002 because of increase risk of severe liver toxicity. (Bissoli 2010, Walker 2008, Tan 2007, Maciá 2002).
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. (EMA 2010)
Since the last update we have not found any published data on its excretion in breast milk.
Its high 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.
TOPICAL USE:
When topical preparations are used (gel, cream, oral mouthwash etc.), the percentage of the drug that actually reaches the blood circulation is very small. Topically used nimesulide is not expected to have a significant excretion into breastmilk. This form of administration would be compatible with breastfeeding.