Balsalazide

Balsalazide is a prescription medication used to treat mild to moderately active ulcerative colitis.

• Balsalazide is available under various brand names: Colazal, Giazo

Common side effects of Balsalazide include:

• headache.
• mild or occasional nausea, vomiting, stomach pain, diarrhea.
• joint pain.
• fever; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

Serious side effects of Balsalazide include:

• hives. 
• difficult breathing. 
• swelling of the face, lips, tongue, or throat.
• pain or burning when you urinate.
• worsening colitis symptoms--fever, stomach pain, cramps, or bloody diarrhea.
• kidney problems--little or no urinating, swelling, rapid weight gain.
• liver problems--upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands, and feet.

Rare side effects of Balsalazide include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Capsule

• 750 mg (colazal)

Ulcerative colitis

Adult dosage 

• Capsule: 2.25 g 3 times daily for 8 to 12 weeks.
• Tablet: males: 3.3 g twice daily for up to 8 weeks.

Pediatric dosage

• Children above 5 years and adolescents below 17 years: oral: capsules:
• 2.25 g (three 750 mg capsules) 3 times daily (total daily dose: 6.75 g/day) for up to 8 weeks. Or
• 750 mg (one capsule) 3 times daily (total daily dose: 2.25 g/day) for up to 8 weeks.

Adolescents above 18 years: oral:

• Capsule: 2.25 g (three 750 mg capsules) 3 times daily (total daily dose: 6.75 g/day) for up to 8 to 12 weeks.
• Tablet: males: 3.3 g (three 1.1 g tablets) twice daily (total daily dose: 6.6 g/day) for up to 8 weeks.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Balsalazide has severe interactions with no other drugs.
• Balsalazide has serious interactions with the following drugs:
  • baricitinib
  • measles, mumps, rubella, and varicella vaccine, live
  • varicella virus vaccine lives
• Balsalazide has moderate interactions with the following drugs:
  • acetazolamide
  • azithromycin
  • brinzolamide
  • clarithromycin
  • erythromycin base
  • erythromycin ethylsuccinate
  • erythromycin lactobionate
  • erythromycin stearate
  • griseofulvin
  • methazolamide
  • mycophenolate
  • pivmecillinam
  • probenecid
  • roxithromycin
  • temocillin
  • ticarcillin
  • voclosporin
  • warfarin
• Balsalazide has minor interactions with at least 125 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• You should not use this medicine if you are allergic to balsalazide or mesalamine, or to aspirin or other salicylates (including Kaopectate, Pamprin, Pepto-Bismol, Tricosal, Trilisate, and others).
• Capsules should not be given to child younger than 5 years old
• Tablets should not be given to anyone younger than 18 years old

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Balsalazide?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Balsalazide?”

Cautions

• Balsalazide tablets contain sodium. Talk to your doctor before using this form of balsalazide if you are on a low salt diet
• Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
• Balsalazide is usually taken only for a short time (8 to 12 weeks). Follow your doctor's dosing instructions very carefull
• Follow your doctor's instructions about any restrictions on food, beverages, or activity

Pregnancy and Lactation

• Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether balsalazide will harm an unborn baby. However, having active ulcerative colitis during pregnancy may cause premature delivery or low birth weight. The benefit of treating ulcerative colitis may outweigh any risks to the baby.
• Lactation
  • If you are breastfeeding, tell your doctor if you notice diarrhea in the nursing baby.