Balsalazide

FDA label

Read the full label on DailyMed ↗

Renal Assess renal function at baseline and periodically; evaluate risk/benefit and monitor in impairment (no fixed dose adjustment)

Hepatic Caution — reports of hepatic failure in pre-existing liver disease; evaluate risk/benefit

Instructions

• Take with or without food
• Maintain adequate fluid intake

Contraindications

• Known or suspected hypersensitivity to salicylates or aminosalicylates (or balsalazide metabolites)

Cautions

• Renal impairment (interstitial nephritis, renal failure) — assess renal function
• Mesalamine-induced acute intolerance syndrome (may mimic a UC flare) — discontinue if suspected
• Hypersensitivity incl. myocarditis/pericarditis
• Hepatic failure in pre-existing liver disease
• Severe cutaneous reactions (SJS/TEN, DRESS, AGEP); photosensitivity; nephrolithiasis; high sodium content

Adverse reactions

• Anemia
• Diarrhea
• Pharyngolaryngeal pain
• Urinary tract infection
• Arthralgia, insomnia, musculoskeletal pain

Pregnancy Human data have not reliably shown increased risk; no adverse developmental effects in animals

Lactation Mesalamine and metabolite present in milk in small amounts (RID ≤0.1%); monitor infant for diarrhea