FDA-filed SPL labeling · retrieved through openFDA

Balsalazide

Balsalazide is an aminosalicylate anti-inflammatory used to treat mildly to moderately active ulcerative colitis in adults and children as young as 5 years old.

Brand names ColazalGiazoBalsalazide Disodium
Drug classes ⓘ Aminosalicylate
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 9 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveFeb 22, 2024
Clinical labels in scope ⓘ9
AvailabilityRx
Earliest approval/marketing year ⓘ2000
FDA-listed product records ⓘ33
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 22, 2026
⭐ Balsalazide at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Balsalazide is an oral anti-inflammatory used to treat mildly to moderately active ulcerative colitis in adults and in children ages 5 and up. It works locally in the colon, so very little enters the bloodstream. Take it as directed, stay well hydrated, have your kidney function monitored, and contact your doctor promptly if your symptoms worsen or you notice any signs of a serious reaction.
How we write & review this content — our editorial policy →

📖 Balsalazide: Patient Information Guide

A plain-language walkthrough of Balsalazide — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Balsalazide is an aminosalicylate used to reduce inflammation in the colon. Here are the conditions it is approved to treat:

  • Mildly to moderately active ulcerative colitis in adults — treatment is typically for up to 12 weeks based on clinical trial data (Balsalazide Disodium and Colazal capsules)
  • Mildly to moderately active ulcerative colitis in children and adolescents ages 5 through 17 — treatment is approved for up to 8 weeks (Balsalazide Disodium and Colazal capsules)
⚙️How it works▾

Balsalazide is what's called a prodrug — it's designed to pass through the stomach and small intestine intact, without being broken down. Once it reaches the colon, bacteria there cleave the molecule and release mesalamine (also called 5-ASA), which is the part that actually fights inflammation. Mesalamine works locally on the colon's lining, likely by blocking the production of inflammatory chemicals (arachidonic acid metabolites) that are overactive in ulcerative colitis. Because the action is mostly local — not systemic — only a small amount of the drug enters the bloodstream.

💊How it's taken▾

Balsalazide disodium capsules are taken by mouth three times daily, and can be taken with or without food. Capsules should be swallowed whole; if swallowing is difficult, the capsule contents can be sprinkled on applesauce and eaten right away. Treatment in adults typically lasts up to 8 weeks, with some patients in trials continuing up to 12 weeks. In children ages 5–17, treatment is for up to 8 weeks. Always follow your prescriber's exact instructions regarding how many capsules to take and for how long.

  • Can be taken with or without food
  • Drink plenty of fluids throughout treatment
  • Do not cut, crush, break, or chew capsules
  • If opening capsules to sprinkle, use applesauce — consume the mixture immediately, do not save it
🤒Side effects — in detail▾

The most common side effects reported in clinical trials include:

  • Headache
  • Abdominal pain
  • Diarrhea
  • Nausea and vomiting
  • Respiratory infections
  • Joint pain (arthralgia)
  • Fatigue
  • Gas (flatulence) and indigestion

Children in clinical trials reported similar side effects, plus upper abdominal pain and fever more frequently. Serious reactions — including kidney damage, severe skin reactions, liver problems, and heart inflammation — are rare but require prompt medical attention if they occur.

⚠️Warnings & precautions▾
  • Kidney damage: Balsalazide can cause kidney inflammation or failure in rare cases. Kidney function should be checked before starting and monitored during treatment. Stop the medication if kidney function worsens.
  • Kidney stones: Stones made of mesalamine can form and are invisible on standard X-rays or CT scans. Staying well hydrated helps reduce this risk.
  • Intolerance syndrome: A small number of patients develop worsening cramps, bloody diarrhea, fever, or rash — symptoms that can mimic a colitis flare but are actually a reaction to the drug. Stop the medication and contact your doctor if this happens.
  • Serious skin reactions: Rare but life-threatening skin conditions (Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, AGEP) have been reported. Stop the medication at the first sign of blistering, peeling, or a spreading rash.
  • Heart inflammation: Myocarditis (heart muscle inflammation) and pericarditis (inflammation around the heart) have been reported. Seek immediate care for chest pain or palpitations.
  • Liver problems: Liver failure has occurred in patients with pre-existing liver disease. Tell your doctor about any liver conditions before starting.
  • Photosensitivity: Patients with pre-existing skin conditions like eczema may be more sensitive to sunlight. Use sunscreen and protective clothing when outdoors.
  • Older adults: People 65 and older may have a higher risk of blood cell abnormalities (low white blood cells or platelets) — blood counts should be monitored.
🔀What it interacts with▾

Balsalazide can interact with certain other medications. Let your doctor and pharmacist know about everything you take:

  • NSAIDs (ibuprofen, naproxen, etc.): Combining these with balsalazide raises the risk of kidney damage — kidney function should be monitored closely
  • Azathioprine or 6-mercaptopurine: These immune-suppressing drugs, sometimes used for inflammatory bowel disease, can increase the risk of serious blood disorders and bone marrow problems when combined with balsalazide — blood counts should be checked regularly
  • Other nephrotoxic drugs (medications known to stress the kidneys): Increased risk of kidney damage — monitor kidney function
  • Urinary normetanephrine lab test: Balsalazide's metabolite can interfere with this urine test and produce falsely high results — tell your lab or doctor you're taking this medication if this test is ordered

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Allergy to salicylates, aminosalicylates, or sulfasalazine: Do not take balsalazide — it is contraindicated if you have a known or suspected hypersensitivity to these
  • Kidney disease or reduced kidney function: Use with caution; kidney function must be assessed before starting and monitored during treatment
  • Liver disease: Discuss risks and benefits with your doctor before starting, as liver failure has been reported in patients with pre-existing liver problems
  • Upper GI obstruction or pyloric stenosis: Avoid balsalazide — a blockage in the upper digestive tract can prevent the drug from reaching the colon where it works
  • Pregnancy: Available data have not shown a clear link between mesalamine and birth defects, but uncontrolled ulcerative colitis itself carries risks in pregnancy — discuss with your doctor
  • Breastfeeding: Mesalamine passes into breast milk in small amounts; watch for diarrhea in the nursing infant and consult your doctor
  • Children under 5: Safety and effectiveness have not been established for this age group
  • Adults 65 and older: Higher risk of blood cell abnormalities — complete blood counts and platelet counts should be monitored
  • Pre-existing skin conditions (eczema, atopic dermatitis): May be more prone to severe photosensitivity — use sunscreen and protective clothing
🚑If you take too much▾

Taking too much balsalazide may cause symptoms similar to salicylate (aspirin-type) toxicity: nausea, vomiting, abdominal pain, ringing in the ears, rapid breathing, dizziness, confusion, or seizures. Severe overdose can affect electrolyte balance and may harm the kidneys or liver. There is no specific antidote — seek emergency medical care immediately if an overdose is suspected.

📡Pharmacodynamics — effects in the body▾

Balsalazide is converted in the colon to mesalamine (5-ASA), which acts locally on the colon's inner lining to reduce inflammation. Mesalamine appears to work by blocking the production of inflammatory chemicals — specifically arachidonic acid metabolites produced through both the cyclooxygenase and lipoxygenase pathways — which are overactive in people with ulcerative colitis. Because the drug acts locally rather than throughout the body, systemic exposure is minimal.

🔬Pharmacokinetics — how your body processes it▾

Balsalazide is designed to be acid-insoluble, so it passes through the stomach and small intestine essentially intact and reaches the colon as a prodrug. Once there, bacteria break it down into mesalamine (5-ASA) and an inert carrier molecule; mesalamine is then further metabolized into N-acetyl-5-aminosalicylic acid (N-Ac-5-ASA). Only a small amount of the drug and its metabolites is absorbed into the bloodstream — most of the therapeutic action is local. The majority of the drug is recovered in the feces; a small fraction is excreted in the urine. Eating a high-fat meal before taking the capsules can reduce and delay absorption, though this likely has little impact on how well the drug works since its effects are primarily local in the colon.

📦How to store it▾

Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15ºC and 30ºC (59ºF and 86ºF).

📄 Written from Balsalazide’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

17

Supplements & herbs that interact with Balsalazide

17 supplements and herbal products have documented interactions with Balsalazide in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 1
  • Moderate · 7
  • Minor · 9
ACTIVATED CHARCOAL Major COFFEE CHARCOAL Moderate EUROPEAN MANDRAKE Moderate GLUCOMANNAN Moderate GUAR GUM Moderate GUM ARABIC Moderate SLIPPERY ELM Moderate TRAGACANTH Moderate +9 more
Every supplement checked against Balsalazide — ranked by severity The full interaction hub: 1 major · 7 moderate · 9 minor · every one linked to its full report. Check Balsalazide against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Balsalazide — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is balsalazide and what does it do for ulcerative colitis? ▾
Balsalazide is an anti-inflammatory medication designed specifically to work in your colon. It travels through your digestive system mostly unchanged until bacteria in the colon break it apart and release the active ingredient, mesalamine. Mesalamine then works right at the colon lining to reduce the inflammation that causes your ulcerative colitis symptoms — things like diarrhea, cramping, and rectal bleeding. Because it acts locally, very little of the drug gets into your bloodstream.
Can I open the capsule if I have trouble swallowing it? ▾
Yes — if you or your child can't swallow the capsule whole, you can open it and sprinkle the contents onto a small amount of applesauce. Just make sure to chew and swallow the whole mixture right away; don't save it for later. One heads-up: the powder can temporarily stain your teeth or tongue, so don't be alarmed if you notice some discoloration after taking it this way.
What side effects should I expect, and when should I call my doctor? ▾
The most common side effects are headache, stomach pain, diarrhea, nausea, vomiting, joint pain, and fatigue. Most of these are manageable and tend to settle down. That said, call your doctor right away if your colitis symptoms seem to be getting worse rather than better — cramping, bloody diarrhea, or fever can sometimes be a sign that your body is reacting to the medication itself rather than improving. Also seek immediate care for chest pain, severe skin blistering or peeling, or any signs that your kidneys aren't working well, like much less urine than normal.
Does it matter if I take this with food or on an empty stomach? ▾
You can take balsalazide with or without food — there's no strict requirement either way. However, it's important to drink plenty of fluids throughout your treatment. This helps protect your kidneys and reduces the risk of kidney stones, which can very rarely form from this medication. Just follow whatever schedule works for you and is consistent with your prescriber's instructions.
Is it safe to take if I'm pregnant or breastfeeding? ▾
The available data on mesalamine — the active ingredient balsalazide releases — haven't shown a clear link to birth defects. That said, untreated ulcerative colitis during pregnancy carries its own risks, so it's really a conversation to have with your doctor to weigh the benefits against any potential concerns. If you're breastfeeding, small amounts of mesalamine do pass into breast milk. Watch your baby for any signs of diarrhea and let your doctor know so they can help you decide the best course of action.
Are there any medications I should avoid while taking balsalazide? ▾
Two main categories to watch out for: first, NSAIDs like ibuprofen (Advil, Motrin) or naproxen (Aleve) — when combined with balsalazide, they can increase the risk of kidney damage, so check with your doctor before using them regularly. Second, if you're taking azathioprine or 6-mercaptopurine for your colitis or another condition, the combination can raise the risk of blood cell problems, so your doctor will want to keep an eye on your blood counts. Make sure your prescriber and pharmacist know about everything you're taking.
Is Balsalazide available over the counter? ▾
Balsalazide is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Balsalazide first available? ▾
Balsalazide has been available in the United States since at least 2000, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Balsalazide? ▾
Balsalazide is supplied by 14 manufacturers listed in the FDA NDC Directory, including PharmaZell GmbH, Apotex Corp., Bryant Ranch Prepack.

💬 Answers drafted from Balsalazide’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

📊Balsalazide supplement interactions17 checked — ranked by severity 🌿Drug & Supplement CheckerBalsalazide vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Balsalazide NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Balsalazide comes

Balsalazide is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Capsule

By mouth
Brands Balsalazide Disodium Colazal
How this form is used
What it may be used for
  • Balsalazide Disodium capsules are used to treat mildly to moderately active ulcerative colitis in adults and in children ages 5 through 17
  • Colazal capsules are used to treat mildly to moderately active ulcerative colitis in adults and in children ages 5 through 17
Important instructions
  • Balsalazide Disodium capsules should be swallowed whole; do not cut, crush, break, or chew them
  • Balsalazide Disodium capsules may be opened and sprinkled on a small amount of applesauce for patients who cannot swallow capsules — the mixture must be chewed and swallowed immediately and not stored
  • Balsalazide Disodium capsules can be taken with or without food
  • Balsalazide Disodium capsules require adequate fluid intake throughout treatment to help reduce the risk of kidney stones
Available strengths 1 strength
750 mg
24 FDA-listed product records ⓘ

📊 Balsalazide across the U.S. market

How Balsalazide appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms ⓘ
14
Manufacturers
2
Brand names
33
FDA-listed product records ⓘ
2000
First marketed ⓘ

Also listed with the FDA, not a patient dose form: Powder (9) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

PharmaZell GmbH21%
Apotex Corp.9%
Bryant Ranch Prepack9%
Hikma Pharmaceuticals USA Inc.9%
PD-Rx Pharmaceuticals, Inc.9%
AvPAK6%
Other makers36%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Balsalazide is used

A general measure of how commonly Balsalazide is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Balsalazide is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

8,799
Medicaid prescriptions filled (Q1–Q4 2025)
$858,870 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Balsalazide prescribed? Of the 1,596 medications we measure, Balsalazide ranks #949 by Medicaid prescriptions — more than 41% of them.

Where Balsalazide ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #949 of 1,596
#944 Calcium, Magnesium, Po... 9,091 Rx #945 Aminophylline 9,002 Rx #946 Estradiol Topical 8,927 Rx #947 Eptinezumab-jjmr Injec... 8,909 Rx #948 Pitavastatin 8,812 Rx #949 Balsalazide 8,799 Rx #950 Selexipag 8,761 Rx #951 Nitroglycerin Topical 8,740 Rx #952 Fulvestrant Injection 8,707 Rx #953 Fulvestrant 8,707 Rx #954 Beclomethasone Nasal S... 8,632 Rx

Utilization by Balsalazide product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

balsalazide disodium 750 MG Oral Capsule

8,799 Medicaid prescriptions (Q1–Q4 2025) 100% of Balsalazide prescriptions shown $858,870 gross reimbursement (before rebates) ≈ $98 per prescription (gross)

Summed across the 3 of 18 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 885857

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Balsalazide, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 3 of 18 listed Balsalazide NDCs with Medicaid activity.

🔍 Compare Balsalazide products

A representative set of FDA-listed product records for Balsalazide — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 33 of 33 products — FDA National Drug Code Directory. See every product, package size and price: browse all 33 Balsalazide NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Balsalazide RxCUI 18747 2 dose forms · 2 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 374634 In current FDA listings
    Clinical drug / strength (SCD) disodium 750 MG RxCUI 885857
  2. Dose form (SCDF) Oral Tablet RxCUI 1243576 No current FDA listing
    Clinical drug / strength (SCD) disodium 1100 MG RxCUI 1243577

Look up RxCUI 18747 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Colazal Giazo Balsalazide Disodium

🏭 Manufacturers & labelers

PharmaZell GmbH 7 Apotex Corp. 3 Bryant Ranch Prepack 3 Hikma Pharmaceuticals USA Inc. 3 PD-Rx Pharmaceuticals, Inc. 3 AvPAK 2 Golden State Medical Supply, Inc. 2 Salix Pharmaceuticals, Inc 2 Zydus Lifesciences Limited 2 Zydus Pharmaceuticals (USA) Inc. 2 Carnegie Pharmaceuticals, LLC 1 Formosa Laboratories, Inc. 1 Oceanside Pharmaceuticals 1 Signa S.A. de C.V. 1

RxNorm drug class

Balsalazide belongs to the Aminosalicylate class.

Pharmacologic class Aminosalicylate
Drug family (ATC) Aminosalicylic acid and similar agents

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Feb 22, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Balsalazide.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Balsalazide after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
9
NDC products indexed
33
Distinct labelers/manufacturers represented
14
Linked representative label ⓘ
Hikma Pharmaceuticals USA Inc.
Linked label effective
Feb 22, 2024
Composite sections available
21
Linked SPL Set ID
a0498308-14b2-4456-8e13-795f6fc8ea30
Linked SPL Document ID
6f5a92d7-1828-44ea-8265-0ed1b3bef16c
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 9 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Hikma Pharmaceuticals USA Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.