openFDA
Cure8 regulatory brief
Why This Matters
Mesalamine is a commonly used aminosalicylate for distal ulcerative colitis; label updates on serious hypersensitivity, kidney effects, photosensitivity, and renal monitoring are directly relevant to patients using rectal mesalamine and their clinicians.
Who Should Pay Attention
Adults with distal ulcerative colitis using or considering mesalamine rectal suspension, gastroenterologists, primary care clinicians, and pharmacists.
Study Snapshot
Story typeRegulatory
Evidence typeRegulatory update
Study statusHuman prescription drug
Source depthRegulatory record
What To Know
This is an FDA drug-label (DailyMed) update for mesalamine rectal suspension highlighting indications for active mild to moderate distal ulcerative colitis and expanded warnings/precautions including sulfite-related hypersensitivity, renal impairment (recommend renal monitoring), mesalamine-induced acute intolerance syndrome, hepatic failure, severe cutaneous adverse reactions (SJS/TEN/DRESS), photosensitivity, and reported mesalamine-containing kidney stones.
Dosage and administration for the rectal suspension (4 g once daily at bedtime, retained ~8 hours for 3–6 weeks) and instructions for administration are included in the label.
Keep In Mind
This is the official FDA DailyMed drug label (regulatory record). It provides safety warnings and recommended monitoring (including renal function) and dosing instructions; it is not a clinical trial report. Patients should discuss label risks and monitoring with their clinician before starting or continuing therapy.
Source Details
Review the original publication for the complete reporting, methods, and context.
Regulatory update
Evidence type derived from source or registry metadata.
PublicationopenFDA
PublisherU.S. Food and Drug Administration
SponsorKLM Laboratories Private Limited
Study typeDrug Label Update
Indexed viaopenFDA
Source typeRegulatory record
PublishedNov 3, 2026, 12:00 AM
Content availableRegulatory record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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