Class Name(s):

• 56:36 Anti-inflammatory Agents

Pronunciation:

• (bal sal' a zide)

Brand Name(s):

• Colazal^®
• Giazo^®Â¶; also available generically

WHY is this medicine prescribed?

Balsalazide is used to treat ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) in adults and children 5 years of age and older. Balsalazide is an anti-inflammatory drug. It is converted in the body to mesalamine and works by reducing bowel inflammation, diarrhea, rectal bleeding, and stomach pain.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Balsalazide comes as a capsule to take by mouth. It is usually taken with or without food three times a day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take balsalazide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Balsalazide is usually taken for 8 weeks, but it may be taken for up to 12 weeks. Continue to take balsalazide even if you feel well. Do not stop taking balsalazide without talking to your doctor.

Swallow the capsules whole; do not split, chew, or crush them. If you cannot swallow the capsules or if you are giving this medication to a child, you may open the capsules and sprinkle the contents over 2 teaspoonfuls (approximately 10 mL) of applesauce. Eat the mixture right away and swallow; if necessary you can chew the mixture. If you are taking balsalazide capsules mixed with applesauce, you should know that your teeth and tongue may be stained.

Drink plenty of fluids while taking balsalazide capsules.

Are there OTHER USES for this medication?

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking balsalazide,

• tell your doctor and pharmacist if you are allergic to balsalazide, salicylate pain relievers such as aspirin, choline magnesium trisalicylate, choline salicylate, diflunisal, magnesium salicylate (Doan's, others), mesalamine (Apriso, Pentasa), salsalate, sulfasalazine (Azulfidine); any other medications; or any of the ingredients in balsalazide capsules. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• The following nonprescription or herbal products may interact with balsalazide: aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn). Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking balsalazide. Do not start any of these medications while taking balsalazide without discussing with your healthcare provider.
• tell your doctor if you have or have ever had a skin condition such as eczema (atopic dermatitis; a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes), kidney stones, liver or kidney disease, or pyloric stenosis (a condition in which the stomach empties slowly).
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking balsalazide, call your doctor.
• plan to avoid unnecessary or prolonged exposure to the sunlight and to wear protective clothing, sunglasses, and sunscreen. Balsalazide may make your skin sensitive to sunlight.
• you should know that balsalazide should not be taken by people who have received the varicella virus (chicken pox) vaccine in the past six weeks because of the risk of Reye's syndrome (a serious condition in which fat builds up on the brain, liver, and other body organs).
• you should know that balsalazide may cause a serious reaction. Many of the symptoms of this reaction are similar to the symptoms of ulcerative colitis, so it may be difficult to tell if you are experiencing a reaction to the medication or a flare (episode of symptoms) of your disease. Call your doctor if you experience some or all of the following symptoms: stomach pain or cramping, bloody diarrhea, fever, headache, or rash.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Side effects from balsalazide can occur. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• abdominal pain
• upset stomach
• diarrhea
• vomiting
• joint or muscle pain
• difficulty falling or staying asleep
• tiredness
• gas
• runny nose, cough, fever, sore throat, or flu-like symptoms
• loss of appetite
• constipation
• dry mouth
• mouth sores
• painful menstrual periods

If you experience any of the following symptoms, or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

• rash, hives, itching or peeling or blistering skin
• swelling of the eyes, face, lips, tongue, mouth, or throat
• difficulty breathing or swallowing
• new or worsening cough
• shortness of breath
• chest pain
• extreme tiredness
• yellowing of the skin or eyes
• pain in the right upper part of the stomach
• pale stools
• difficult or painful urination or cloudy, discolored or bloody urine
• side or back pain
• bloating or swelling of the stomach
• increased diarrhea
• increased rectal bleeding

Balsalazide may cause your urine to become discolored, reddish-brown when it comes in contact with any surface or water (e.g., in the toilet). Call your doctor if your urine is discolored.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• nausea, vomiting, and abdominal pain
• fast or shallow breathing
• ringing in ears
• headache
• dizziness
• confusion
• seizures

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location - one that is up and away and out of their sight and reach. http://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website http://goo.gl/c4Rm4p for more information.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your response to balsalazide. Before you have any laboratory tests, tell the laboratory personnel that you take balsalazide, as this medication may interfere with some laboratory tests.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™ Copyright, 2025. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: February 15, 2024.