|Manufacturer:||Shire US Inc.|
The following events have been identified during post-approval use of products which contain (or are metabolized to) mesalamine in clinical practice.
Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.
These events have been chosen for inclusion due to a combination of seriousness, frequency of reporting, or potential causal connection to mesalamine:Gastrointestinal: Reports of hepatotoxicity, including elevated liver function tests (SGOT/AST, SGPT/ALT, GGT, LDH, alkaline phosphatase, bilirubin), jaundice, cholestatic jaundice, cirrhosis, and possible hepatocellular damage including liver necrosis and liver failure.
Some of these cases were fatal.One case of Kawasaki-like syndrome which included hepatic function changes was also reported.