olsalazine
Regulatory sources consulted
Approved indications
- Maintenance of ulcerative colitis remission in adults intolerant of sulfasalazine.
Contraindications
Absolute
- Known or suspected hypersensitivity to salicylates, aminosalicylates, or excipients.
Clinical warnings
- Major warning · Renal function must be assessed before and during treatment. — DailyMed/FDA label
- Major warning · It may cause renal impairment, mesalamine-induced acute intolerance syndrome, hypersensitivity, hepatic failure, severe cutaneous reactions, photosensitivity, and nephrolithiasis. — DailyMed/FDA label
- Major warning · Maintain adequate fluid intake and discontinue for symptoms of acute intolerance or hypersensitivity reaction. — DailyMed/FDA label
Drug interactions
- ModerateNSAIDs or other nephrotoxic drugs
Mechanism: It increases the risk of nephrotoxicity.
Recommendation: Monitor renal function and mesalamine-related adverse reactions.
DailyMed/FDA label
- ModerateAzathioprine, mercaptopurine, or other myelotoxic drugs
Mechanism: It increases the risk of blood dyscrasias and bone marrow failure.
Recommendation: If it cannot be avoided, monitor complete blood count and platelets.
DailyMed/FDA label
- ModerateVaricella vaccine
Mechanism: Salicylates after vaccination may increase the theoretical risk of Reye syndrome.
Recommendation: Avoid olsalazine for 6 weeks after vaccination.
DailyMed/FDA label
Adverse events
Common (≥1%)
Diarrhea · abdominal pain or cramps · nausea · arthralgia · rash · upper respiratory infection
Rare but serious
Renal impairment or interstitial nephritis · hepatic failure · myocarditis · pancreatitis · SJS/TEN · DRESS · blood dyscrasias