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Overview: Balsalazide is used to treat ulcerative colitis. The most common side effects are headache, stomach pain, and diarrhea. Rarely, balsalazide can cause kidney stones. It is important to drink plenty of liquids while taking balsalazide to reduce this risk.

Uses

What is balsalazide used for?

Balsalazide is commonly used to treat ulcerative colitis, which is an inflammatory bowel condition that affects your large intestine.

Balsalazide may also be used for other conditions as determined by your health care provider.

How does balsalazide work (mechanism of action)?

Balsalazide may work by blocking certain natural substances in your large intestine, which reduces inflammation.

How is balsalazide supplied (dosage forms)?

Brands and other names

  • Colazal

Dosage forms and strengths

  • 750 mg oral capsules

How should I store balsalazide?

Balsalazide should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of balsalazide?

The most common side effects of balsalazide are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Headache
  • Stomach pain
  • Diarrhea
  • Nausea or vomiting
  • Infection in the nose or throat, sore throat, or common cold symptoms
  • Joint pain

There may be other side effects of balsalazide that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of balsalazide?

While less common, the most serious side effects of balsalazide are described below, along with what to do if they happen.

Severe Allergic Reactions. Balsalazide may cause allergic reactions, including a specific type of allergic reaction called DRESS. DRESS stands for drug reaction with eosinophilia and systemic symptoms. It is also sometimes called multiorgan hypersensitivity. This is a reaction that can affect multiple parts of the body including your liver, kidneys, and heart. Stop taking the medicine and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Shortness of breath, trouble swallowing, or throat tightness
  • Swelling in your feet, ankles, or legs
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain
  • Dark-colored pee
  • Yellowish skin or whites of your eyes (also called jaundice)

Severe Skin Reactions. Balsalazide can cause severe skin reactions, called Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), that can lead to death if not treated. If you develop a rash, stop balsalazide and call your health care provider right away. Get emergency help if you have any of the following symptoms.

  • Painful red or purple skin that looks burned and peels off
  • Flat red rash or blisters on your skin, mouth, nose, and genitals
  • Red, painful, watery eyes

Inflammation of the Heart Muscle. Myocarditis is when your heart muscle becomes inflamed or irritated. This can affect how well your heart pumps blood. Balsalazide can cause the immune system to cause more inflammation around the heart muscle. Contact your health care right away if you have chest pain, shortness of breath, or trouble breathing.

Kidney Problems. Balsalazide can cause swelling of a small part of your kidneys’ filters, called the tubules. This condition, known as tubulointerstitial nephritis (TIN), can cause your kidneys to not work as well as they should. Stop taking balsalazide and call your health care provider right away if you have any of the following symptoms of TIN. 

  • Increased or decreased amount of urine (pee)
  • Nausea or vomiting
  • Fever
  • Rash
  • High blood pressure
  • Irregular mood swings
  • Confusion or drowsiness
  • Swelling throughout your body or weight gain

Kidney Stones. Balsalazide may cause kidney stones. Drinking plenty of water can help prevent kidney stones. Tell your health care provider right away if you develop severe pain in your side or back or have blood in your urine (pee). Your pee may look pink, red, or brown.

Worsening of Ulcerative Colitis Symptoms. Balsalazide can cause worsening of ulcerative colitis symptoms. It may be difficult to tell if your symptoms are caused by ulcerative colitis or taking balsalazide. Tell your health care provider right away if you have any of the following symptoms, or if they get worse while you are taking balsalazide.

  • Stomach cramps or pain
  • Bloody diarrhea
  • Fever
  • Headache
  • Skin rash

Warnings & Precautions

Who should not use balsalazide?

Allergies to Ingredients. People who are allergic to any of the following should not take balsalazide.

  • Balsalazide
  • Colazal
  • Any other medicine known as a salicylate or an aminosalicylate
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in the specific balsalazide products they stock.

What should I know about balsalazide before using it?

Do not take balsalazide unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share balsalazide with other people, even if they have the same condition as you. It may harm them.

Keep balsalazide out of the reach of children.

Do not chew, cut, or crush balsalazide capsules. Swallow balsalazide capsules whole. If you have trouble swallowing balsalazide, the capsules may be opened and the contents sprinkled onto applesauce. You should chew and swallow the applesauce mixture right away. Taking balsalazide this way may stain your tongue or teeth.

Make sure to drink enough liquids while taking balsalazide. This can help prevent kidney stones. See the Side Effects section for more details. 

Balsalazide may cause your urine (pee) to turn reddish-brown if it comes into contact with bleach, such as in some toilet water. Tell your health care provider if your urine is reddish-brown when it leaves your body (before it touches the toilet water).

Balsalazide can make your skin more sensitive to light from the sun, sunlamps, and tanning beds. This is called photosensitivity. Exposure to this light can cause severe sunburns, blisters, and swelling. If you need to be in sunlight, wear sunscreen, a hat, and clothing that covers your skin.

People who are 65 and older can be at greater risk for some side effects from balsalazide. Talk to your health care provider about your risks if you are in this age group. Keep all of your follow-up appointments with your health care provider, labs, or other testing. 

What should I tell my health care provider before using balsalazide?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if balsalazide is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

Other Medicines and Supplements. Balsalazide may interact with other medicines and supplements. Before taking balsalazide, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if or how balsalazide could affect pregnancy or harm an unborn baby. Tell your health care provider if you are or plan to become pregnant. Your health care provider will advise you if you should take balsalazide while you are pregnant or trying to get pregnant.

Breastfeeding. Balsalazide passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will advise you if you should take balsalazide while breastfeeding. If you breastfeed while taking balsalazide, watch for diarrhea in your infant. 

Interactions

Does balsalazide interact with foods or drinks?

There are no known interactions between balsalazide and foods or drinks.

It is unknown if drinking alcohol will affect balsalazide.

Does balsalazide interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking balsalazide.

  • A nonsteroidal anti-inflammatory drug (NSAID), such as ibuprofen, naproxen, and others, which is in many prescription and OTC products for pain, swelling, and fever
  • Azathioprine (Azasan), which is a medicine that suppresses your immune system
  • 6-mercaptopurine, which is a medicine to treat certain cancers

This may not be a complete list of medicines that can interact with balsalazide. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much balsalazide?

If you or someone else has used too much balsalazide, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of balsalazide?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.