Balsalazide

Introduction

Written by Ashley Wong, PharmD
Medically reviewed by Alex Brewer, PharmD, MBA
Updated on October 6, 2023

Balsalazide (bal SAL a zide) is a generic medication prescribed for ulcerative colitis in adults and some children. Balsalazide belongs to a group of drugs called aminosalicylates.

Side effects of balsalazide

Balsalazide may cause mild or serious side effects. The content below discusses the more common mild side effects of balsalazide and its serious side effects. This article doesn’t include all possible side effects of the drug. Side effects can vary based on your age, overall health, and any other medications you take.

Mild side effects

The list below includes more common mild side effects reported with balsalazide.

This article doesn’t discuss all possible mild side effects of the drug. To learn more about balsalazide’s side effects, ask your doctor or pharmacist. You can also refer to the prescribing information for balsalazide listed in the “Resources” section.

With many drugs, mild side effects may go away within a few days or a couple of weeks. If the side effects are bothersome, tell your doctor or pharmacist. They may be able to suggest ways to manage them.

Balsalazide oral capsule’s mild side effects include:

• headache
• nausea and vomiting
• diarrhea
• general pain in the abdomen
• mild allergic reaction*

* For details about this side effect, see the “Interactions and warnings for balsalazide” section.

Serious side effects

The list below includes serious side effects of balsalazide.

This article doesn’t discuss all possible serious side effects of the drug. To learn more about balsalazide’s side effects, ask your doctor or pharmacist. You can also refer to the prescribing information for balsalazide listed in the “Resources” section.

With many drugs, serious side effects are possible but not common. If you have serious side effects from this drug, call your doctor right away. If you’re having severe symptoms or a medical emergency, call 911 or a local emergency number.

In general, balsalazide’s serious side effects include:

• kidney problems
• pancreatitis (inflammation of the pancreas)
• serious skin reactions
• blockage in the upper stomach
• sensitivity to sunlight
• extreme sensitivity reaction, which can cause inflammation in body organs such as the heart or lungs
• severe allergic reaction*

* For details about this side effect, see the “Interactions and warnings for balsalazide” section.

Common questions about balsalazide

Below you’ll find answers to a few commonly asked questions about balsalazide.

Is balsalazide similar to mesalamine?

Yes, in some ways. Balsalazide and mesalamine both are approved to treat ulcerative colitis. They belong to the same group of drugs called aminosalicylates. And they work similarly to treat ulcerative colitis.

Balsalazide is available only as a capsule. Mesalamine is available in several different forms, including tablet, capsule, rectal enema, and rectal suppository.

Talk with your doctor if you have questions about the treatment that’s right for your condition.

Can balsalazide cause long-term side effects?

Yes, balsalazide may cause long-term side effects in some cases. These can occur if you take the drug for a long time. Examples of long-term side effects reported with balsalazide include kidney problems, such as kidney failure.

Talk with your doctor to learn more about these side effects and how to manage them.

Talk with your doctor if you have questions about possible long-term side effects with balsalazide.

What brand names are available for balsalazide?

Balsalazide is available as the brand-name medication Colazal. A generic medication is an identical copy of the active drug in a brand-name medication. (An active drug is the ingredient that makes a medication work.) Generic drugs are believed to be as effective and safe as brand-name drugs. And generic drugs typically cost less than brand-name drugs.

If you have more questions about either version of this drug, talk with your doctor or pharmacist.

Is balsalazide a steroid?

No, balsalazide is not a steroid. It belongs to a group of drugs called aminosalicylates, which lower inflammation in your body.

In some cases, doctors prescribe steroids for ulcerative colitis. Steroids are also known as corticosteroids. They reduce inflammation by weakening your immune system. Because of how they work, corticosteroids cause some side effects different from balsalazide.

To learn more about balsalazide or corticosteroids, talk with your doctor.

How does balsalazide work? And how long does it take to start working?

With ulcerative colitis, you have inflammation and sores in the lining of your colon, rectum, or both. Balsalazide works by stopping your body from making certain compounds that cause inflammation and sores. This relieves your symptoms.

It can take a few weeks for balsalazide to relieve your symptoms. Be sure to take the medication exactly as prescribed, even if you don’t feel better right away.

Talk with your doctor or pharmacist if you’d like to learn more about how balsalazide works.

Use of balsalazide

The Food and Drug Administration (FDA) approves prescription drugs such as balsalazide for certain conditions. Balsalazide’s approved use is described below.

Use for ulcerative colitis

Doctors may prescribe balsalazide for treating active, mild to moderate ulcerative colitis. It’s used for this purpose in adults and children ages 5 years and older. It’s usually prescribed as a short-term treatment.

Ulcerative colitis causes inflammation and sores (ulcers) in the lining of your colon, rectum, or both. This results in symptoms such as stomach pain, diarrhea, and bloody stools. At times, the disease may flare up and cause symptoms. At other times, the disease may go into remission, which means you have no symptoms. Balsalazide lowers inflammation in your colon and rectum, which relieves your symptoms.

Doctors may limit treatment with balsalazide to up to 12 weeks in adults and up to 8 weeks in children.

Interactions and warnings for balsalazide

Below, you’ll find information about balsalazide’s possible interactions and warnings.

Interactions of balsalazide

Certain things may affect how a drug works. These include getting vaccines, consuming alcohol or certain foods, or taking the drug with other medications. This effect is called a drug interaction.

Before you take balsalazide, ask your doctor to check for possible interactions. Be sure to tell them about any of the following you take or use:

• prescription or over-the-counter drugs
• vitamins, herbs, or supplements

To learn about drug-condition interactions, see the “Warnings for balsalazide” section below.

Warnings for balsalazide

Some people should not take balsalazide, and others should take it cautiously.

Balsalazide could cause harm to people with certain health conditions. This effect is called a drug-condition interaction. Other factors can also affect whether balsalazide is a safe option for you.

Ask your doctor about specific warnings for balsalazide, and be sure to tell your doctor about your:

• current health, including any allergies to medications
• past health conditions or surgeries

Allergic reaction

Balsalazide can cause an allergic reaction in some people. Severe allergic reactions are rare but possible.

If you’ve had an allergic reaction to balsalazide or any of its ingredients, your doctor likely will not prescribe balsalazide. They can tell you about medications that are safer options for you.

A mild allergic reaction may cause the following symptoms:

• skin rash
• itchiness
• flushing (temporary warmth, redness, or deepening of skin color)

A severe allergic reaction may cause the following symptoms:

• swelling under your skin, usually in your hands, feet, eyelids, or lips
• swelling of your mouth, throat, or tongue, which can cause breathing problems

If you have an allergic reaction to balsalazide, call your doctor right away. If you have severe symptoms, call 911 or a local emergency number.

Overdose of balsalazide

You should not take more balsalazide than your doctor prescribes. For some drugs, doing so may lead to harmful effects or overdose.

If you think you’ve taken too much balsalazide, call your doctor or pharmacist right away. Or you could call 800-222-1222 to speak with someone at America’s Poison Centers. You can also use its online resource. If you have symptoms that are concerning, call 911 or a local emergency number immediately. You can also go to the closest emergency room.

Pregnancy or breastfeeding and balsalazide

The information below discusses balsalazide and pregnancy and breastfeeding.

Balsalazide and pregnancy

In general, balsalazide is considered safe to take during pregnancy. That said, ask your doctor whether they feel it’s safe for you.

Balsalazide and breastfeeding
In general, balsalazide is considered safe to take while breastfeeding. But it may cause diarrhea in a breastfed child. If your child develops diarrhea during your treatment with balsalazide, let your doctor know right away.

What to ask your doctor

Let your doctor know if you have questions about balsalazide or would like more details about it.

Here’s a list of some possible questions you may want to ask your doctor:

• Do I need to take balsalazide if I’m not having any symptoms?
• What should I do if I’m having difficulty swallowing my balsalazide doses?
• Are there any drug interactions I should be aware of and try to avoid when taking balsalazide?

Resources

• Balsalazide disodium capsules, for oral use. (2022). https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/029833fa-ec5c-6a39-e063-6294a90aa063/spl-doc
• Food and Drug Administration. (2023). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm

Disclaimer: Optum Perks has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.