Balsalazide is a prescription anti-inflammatory medicine used to treat mild to moderate ulcerative colitis (UC) in adults and in children 5 years and older. It belongs to the aminosalicylate (5-ASA) family and is designed to deliver mesalamine—the actual active anti-inflammatory—directly to the colon. By targeting the site of inflammation, balsalazide can reduce rectal bleeding, urgency, abdominal pain, and diarrhea and help you reach remission.
Quick disclaimer: This article is for education only and isn’t a substitute for professional medical advice. Always follow your clinician’s instructions.
What Is Balsalazide?
Balsalazide is a prodrug of mesalamine. It’s made of mesalamine linked to an inert carrier by an azo bond. That bond survives the trip through your stomach and small intestine. When the capsule reaches the colon, colonic bacteria break the bond and release mesalamine right where the inflammation is. This local delivery helps maximize effect while limiting body-wide exposure.
Brand names & forms
- Colazal® (balsalazide disodium) capsules: 750 mg each; also available as generic.
- Giazo® tablets: 1.1 g each; indicated for induction of remission in males with mild–moderate UC (up to 8 weeks).
Why this matters: ulcerative colitis affects the colon and rectum, so a medicine engineered to arrive intact in the colon can be especially useful.
How Does Balsalazide Work?
The mesalamine released in the colon acts locally on the mucosa to calm inflammation. Although the full picture is complex, key actions include:
- Inhibiting inflammatory mediators (e.g., prostaglandins and leukotrienes) through cyclooxygenase and lipoxygenase pathways.
- Reducing cytokine signaling and oxidative stress in the intestinal lining.
- Supporting mucosal healing, which can reduce bleeding and stool frequency.
Because mesalamine acts in the gut lumen and on the intestinal lining, only small amounts usually enter the bloodstream when the drug is used as intended.
Who Is Balsalazide For?
Your clinician may prescribe balsalazide if you have:
- Mild to moderate active ulcerative colitis (adults and children ≥5 years).
- Disease predominately in the colon where 5-ASA drugs are first-line for induction of remission.
- A preference for capsule/tablet therapy rather than rectal formulations, or as part of a combined plan (see below).
If your UC is severe, extensive, or accompanied by fever, dehydration, or systemic symptoms, you may need additional treatments such as corticosteroids, biologics, or JAK inhibitors. Your gastroenterologist will tailor therapy to your disease severity and history.
Balsalazide vs. Mesalamine (and Other 5-ASAs)
All 5-ASA medicines ultimately deliver mesalamine to the colon, but they use different delivery systems:
- Balsalazide: bacteria-activated azo bond releases mesalamine in the colon.
- Other mesalamine brands (e.g., delayed-release or pH-dependent formulations): coatings or microgranules that open at specific pH levels or times.
- Sulfasalazine: an older 5-ASA prodrug; effective, but some people experience more systemic side effects due to the sulfapyridine carrier.
Which is “best”? It depends on your disease location, tolerability, cost, and dosing preference. For distal disease (rectum/sigmoid), clinicians often add rectal mesalamine (suppository or enema) to oral therapy—this combo can speed symptom relief and improve healing.
Dosage and How to Take It
Use the regimen your prescriber gives you. The following are typical reference ranges, not personal medical advice.
Adults (capsules; Colazal® or generic)
- Induction: 2.25 g three times daily (that’s 3 × 750 mg capsules TID, total 6.75 g/day) for up to 8 weeks. Some patients need up to 12 weeks for full response.
Adults (tablets; Giazo® — males only)
- Induction: 3 × 1.1 g tablets twice daily (6.6 g/day) for up to 8 weeks.
Pediatric patients (≥5 years; capsules)
- Induction doses are commonly 2.25 g TID (6.75 g/day) for up to 8 weeks. Lower regimens (e.g., 0.75 g TID) are sometimes used based on weight and response. Your pediatric gastroenterologist will choose the right plan.
Maintenance
- After remission, many clinicians continue a lower total daily dose (often around 3 g/day, in divided doses) to maintain remission. Maintenance specifics vary; follow your prescriber’s guidance.
How to take
- Swallow capsules or tablets whole with water; you can take them with or without food.
- Take doses consistently; 5-ASA medicines work best when you don’t miss doses.
- If you struggle with large capsules, ask your clinician about options—don’t crush or open capsules unless your healthcare provider says it’s safe for your specific product.
Missed dose
- Take it when you remember unless it’s close to the next dose. Do not double the dose.
What Results Can You Expect?
Many people begin to notice improvement over several weeks, with less bleeding, fewer stools, and reduced urgency. Complete mucosal healing can take longer and is assessed by your clinician. If you’re not improving—or if symptoms worsen—contact your care team; your plan may need adjustment.
Side Effects
Most people tolerate balsalazide well. When side effects occur, they’re often mild and may improve with continued use.
Common (usually mild)
- Headache
- Abdominal pain or cramping
- Nausea or diarrhea
- Gas or bloating
- Upper respiratory symptoms (e.g., congestion)
- Joint aches or fatigue
Less common but important (seek medical advice promptly)
- Acute 5-ASA intolerance syndrome: sudden worsening abdominal pain, bloody diarrhea, fever, headache, rash. This can mimic a flare—do not self-treat; call your clinician.
- Kidney problems (rare but serious for the 5-ASA class): swelling, reduced urination, unexplained fatigue. Routine kidney function tests are often recommended.
- Liver issues (uncommon): upper-right abdominal pain, dark urine, yellowing of eyes/skin.
- Hypersensitivity reactions (rare): chest pain, breathing trouble, severe rash—emergency care is warranted.
Report any new or severe symptoms to your healthcare professional, especially if you have a history of kidney or liver disease.
Warnings and Precautions
- Allergy: Do not use if you’re hypersensitive to salicylates/5-ASA compounds.
- Kidneys: 5-ASAs have been linked (rarely) to interstitial nephritis. Many clinicians check baseline and periodic renal labs (e.g., creatinine, urinalysis), especially if you’re older, dehydrated, have kidney disease, hypertension, diabetes, or use other nephrotoxic medicines.
- Liver: Use with caution in hepatic impairment; your clinician may monitor liver tests.
- Pregnancy & breastfeeding: 5-ASA drugs are generally considered low risk when clinically indicated. Discuss risks and benefits with your obstetrician/gastroenterologist.
- Pediatrics: Approved for children ≥5 years (capsules). Dosing is weight-/age-guided—follow your pediatric specialist’s plan.
- Do not substitute products without guidance: Balsalazide capsules and Giazo tablets have different strengths/formulations and labeling; follow your exact prescription.
Drug Interactions
While balsalazide acts locally, interactions still matter:
- Azathioprine or 6-mercaptopurine (6-MP): Using 5-ASA medicines with these can increase thioguanine levels and the risk of bone-marrow suppression (low white cells). Your team may adjust doses and monitor blood counts closely.
- Nephrotoxic drugs/NSAIDs: Combining with medicines that stress the kidneys may increase risk—renal labs may be checked more frequently.
- Antacids/PPIs: Usually not an issue for balsalazide (bacteria-activated), but always tell your clinician about all medicines and supplements, including over-the-counter products and herbal remedies.
Practical Tips for Better Control
- Take it every day as prescribed; set reminders if needed.
- Hydrate and follow diet advice from your IBD team; good hydration supports bowel health.
- Track your symptoms (stool count, urgency, bleeding, pain) and bring the notes to visits.
- If your UC is primarily distal, ask about adding rectal mesalamine for faster relief.
- Don’t stop suddenly without guidance—abrupt discontinuation may trigger a flare.
- Keep all follow-up labs and appointments so your care team can adjust therapy safely.
Balsalazide vs. Other UC Treatments (Quick Comparison)
| Treatment | What it is | Typical role |
|---|---|---|
| Balsalazide / Mesalamine (5-ASA) | Local colonic anti-inflammatory | First-line for mild–moderate UC (induction ± maintenance) |
| Sulfasalazine | Older 5-ASA prodrug | Effective; sometimes more systemic side effects |
| Rectal mesalamine | Suppository/enema 5-ASA | Distal UC; often combined with oral 5-ASA |
| Corticosteroids | Systemic or rectal steroids | Short-term rescue for flares; not for long-term maintenance |
| Immunomodulators (AZA/6-MP) | Immune suppression | Steroid-sparing maintenance in select patients |
| Biologics/JAK inhibitors | Targeted immune therapies | Moderate–severe or refractory UC |
Your clinician will select (and sequence) therapies based on severity, disease extent, prior response, and safety.
Cost, Access, and Generic Options
- Generic balsalazide capsules are widely available and typically lower cost than brand products.
- Giazo® is brand-only; costs vary.
- Pricing depends on country, pharmacy, and insurance. Ask about generic pricing, copay cards, or discount programs if budget is a concern.
Storage & Handling
- Store at room temperature, away from heat and moisture.
- Keep out of the reach of children and pets.
- Do not share your prescription—even if someone has similar symptoms.
Frequently Asked Questions (FAQs)
Q1. Is balsalazide a steroid?
No. Balsalazide is a 5-ASA anti-inflammatory, not a corticosteroid.
Q2. How long does it take to work?
Many people notice improvement in several weeks. Full remission and mucosal healing can take longer and are assessed by your clinician.
Q3. Can I open the capsules?
Swallow capsules whole unless your clinician gives specific instructions for your product. Do not crush/chew without medical guidance.
Q4. Can I take balsalazide with food?
Yes—with or without food. Choose what your stomach tolerates best and be consistent.
Q5. What if my symptoms worsen on balsalazide?
Call your care team. A sudden uptick in pain, bloody diarrhea, fever, or dehydration needs prompt evaluation to rule out intolerance, infection, or a flare that requires a different approach.
Q6. Do I need blood tests?
Your clinician may monitor kidney function (and sometimes liver tests) before starting and periodically thereafter—especially if you have risk factors or take interacting medicines.
Q7. Is balsalazide safe in pregnancy or while breastfeeding?
5-ASAs are generally considered low risk when clinically indicated. Always discuss your specific situation with your obstetrician and gastroenterologist.
Q8. Is there a balsalazide suppository or enema?
No. Balsalazide is oral. For distal disease, your clinician may add rectal mesalamine products to your plan.
Q9. Can I use balsalazide long-term?
Many patients use a lower daily dose for maintenance after induction, but your plan is individualized. Don’t change or stop without medical guidance.
Q10. What’s the difference between Colazal® and Giazo®?
Both deliver balsalazide, but Colazal is a 750 mg capsule used in both sexes and in pediatrics (≥5 years), while Giazo is a 1.1 g tablet indicated for induction in males only. Doses and labeling differ—follow your exact prescription.
Key Takeaways
- Balsalazide is a colon-targeted 5-ASA prodrug that releases mesalamine where UC inflammation lives.
- It is first-line for mild to moderate UC and can be used in adults and children ≥5 years.
- Typical adult induction: 6.75 g/day (capsules) in three divided doses for up to 8 weeks; Giazo for males: 6.6 g/day for up to 8 weeks.
- Watch for signs of intolerance, and keep up with kidney/liver monitoring as directed.
- Combining oral therapy with rectal mesalamine for distal disease often improves outcomes.
