Balsalazide

Risk of exacerbation of ulcerative colitis

Photosensitivity reported; advice patients with pre-existing skin conditions to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors

Nephrolithiasis reported; stones containing mesalamine, the active moiety, are undetectable by standard radiography or computed tomography (CT). ensure adequate fluid intake during treatment

Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) reported with use, discontinue therapy at first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation

Mesalamine-induced hypersensitivity reactions may present as internal organ involvement, including myocarditis, pericarditis, nephritis, hepatitis, pneumonitis, and hematologic abnormalities; evaluate patients immediately if signs or symptoms of hypersensitivity reaction present; discontinue therapy if alternative etiology cannot be established

There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalamine; because balsalazide is converted to mesalamine, evaluate risks and benefits of using this medication in patients with known liver impairment

Pyloric stenosis or other organic or functional obstruction in upper gastrointestinal tract may cause prolonged gastric retention of this drug, which would delay mesalamine release in the colon; avoid this drug in patients at risk of upper gastrointestinal tract obstruction

Use of mesalamine may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection