Balsalazide
Balsalazide is a prodrug used to treat inflammatory bowel diseases, particularly ulcerative colitis, by acting in the colon to reduce inflammation.
Balsalazide is a prodrug that delivers mesalamine directly to the colon to treat inflammatory bowel conditions like ulcerative colitis.
Key facts at a glance
- ATC
- A07EC04
- RxNorm
- 18747
- Generic
- Balsalazide
- Class
- atc-a07
- Brands
- Colazal
- Availability
- rx
- Lactation
- unknown
- Routes
- oral
- Forms
- tablet, capsule
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 750mg three times daily
- Maximum
- consult physician
- Frequency
- every 8 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 75mg/kg/day in divided doses
- Maximum
- consult physician
- Frequency
- every 8 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 750mg three times daily
- Maximum
- consult physician
- Frequency
- every 8 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
8 groupspregnancy
first trimesteruse lowest effective dose
use only if benefits outweigh potential risks to fetus
regular prenatal care and fetal monitoring
Use with caution and monitor for adverse effects.
pregnancy
second trimesteruse lowest effective dose
continue therapy only if benefits outweigh risks
regular prenatal check-ups and ultrasound monitoring
Use with caution and monitor for adverse effects.
pregnancy
third trimesteruse lowest effective dose
discontinue if possible near delivery, consider alternatives
fetal monitoring and assessment of preterm labor signs
Use with caution and monitor for adverse effects.
lactation
breastfeedingno adjustment needed
considered compatible with breastfeeding
monitor infant for diarrhea or unusual symptoms
pediatric_age
children 5 to 17 yearsweight-based dosing
approved for ulcerative colitis in pediatric patients
regular growth and development monitoring
geriatric
elderlystart with lower dose, adjust based on renal function
use with caution due to age-related decline in renal function
monitor renal function regularly
Use with caution and monitor for adverse effects.
renal_impairment
mild to moderateuse with caution, monitor renal function
avoid in severe renal impairment
regular serum creatinine and renal function monitoring
Use with caution and monitor for adverse effects.
hepatic_impairment
mild to moderateuse with caution
use only if benefits outweigh risks
monitor liver function tests
Use with caution and monitor for adverse effects.
Statistics and clinical data
Drug class
Colonic anti-inflammatory agent belonging to the aminosalicylate class
FDA approval year
FDA approved Balsalazide disodium for treatment of ulcerative colitis
Primary indication
Therapeutic indication for ulcerative colitis including active disease and maintenance of remission
Mechanism of action
Balsalazide is converted by colonic bacteria to active 5-ASA which reduces inflammation locally
Balsalazide is primarily used to treat mild to moderate ulcerative colitis, including inducing and maintaining remission. It may also be used for other inflammatory bowel conditions as determined by a healthcare provider.
Balsalazide is administered orally and travels intact through the stomach and small intestine to reach the colon. Once in the colon, bacterial azoreductase enzymes cleave the molecule, releasing equimolar amounts of mesalamine (the active anti-inflammatory component) and a carrier moiety. The mesalamine then exerts its therapeutic effect locally in the colon.
Balsalazide capsules should be swallowed whole with water; do not crush or chew. Common side effects may include headache, abdominal pain, or diarrhea. Rare but serious side effects can include kidney problems and blood disorders. Patients with sulfa allergy should use caution as the carrier moiety is a sulfonamide-related compound. Regular monitoring may be required for long-term use.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
WellAlly may earn a referral fee from linked resources at no extra cost to you. Editorial content is never influenced by commercial relationships.
This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy