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The following safety information outlines important risks and precautions associated with the use of balsalazide (Colazal). Please review these details carefully and consult with your healthcare provider if you have any questions or concerns.

• Kidney Damage: Balsalazide (Colazal) can lead to kidney damage, especially in individuals with pre-existing kidney issues or those taking other kidney-harming medications such as NSAIDs or diuretics. If you have a history of kidney problems or are on such medications, inform your healthcare provider.

• Kidney Stones: There is a risk of developing kidney stones while taking balsalazide (Colazal). To reduce this risk, maintain good hydration. Contact your healthcare provider if you experience difficulties with urination, changes in urine volume, blood in your urine, or back or side pain.

• Acute Intolerance Syndrome: Rarely, balsalazide (Colazal) may cause acute intolerance syndrome, typically occurring 1 to 3 weeks after starting the medication. Symptoms usually resolve after discontinuing the medication or beginning corticosteroid treatment.

• Allergic Reactions: Severe allergic reactions, including life-threatening conditions like facial swelling and anaphylaxis, can occur. Seek emergency medical help if you experience hives, rash, swelling of the lips or tongue, or difficulty breathing. This risk is higher for those allergic to sulfasalazine, other aminosalicylates, or salicylates.

• Severe Skin Reactions: Balsalazide (Colazal) can cause serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS syndrome.

• Liver Problems: Although uncommon, liver failure has been reported in individuals with liver issues taking medications similar to balsalazide (Colazal). Inform your healthcare provider if you have a history of liver problems.

• Sun Sensitivity: Individuals with skin conditions like eczema may experience increased sun sensitivity while taking this medication, leading to easier sunburn. Extra precautions against sun exposure are advised.

• Gut Blockage: Those with or at risk of bowel obstruction should avoid balsalazide (Colazal) as it can delay the medication reaching the colon. Symptoms of a bowel obstruction include severe stomach cramping, pain, vomiting, constipation, or a hard or swollen abdomen. Inform your prescriber immediately if these occur.

Contraindications:

• Do not use balsalazide (Colazal) if you have an allergy to aspirin or other salicylates, such as mesalamine and sulfasalazine. Consult your healthcare provider for alternatives and further guidance.

When taking this medication, some individuals may experience mild side effects such as headache, nausea, vomiting, joint pain, diarrhea, abdominal pain, and loss of appetite. These symptoms are generally not severe and often resolve on their own. However, if they persist or worsen, it is advisable to seek guidance from a healthcare provider. Other common mild side effects include indigestion, passing gas, a stuffy or runny nose, sore throat, cough, trouble sleeping, tiredness, and fever.

In rare instances, more serious side effects can occur. These include kidney problems, which may present as a change in urine amount, dry and itchy skin, muscle cramps, or swelling in the extremities. Liver issues could also arise, indicated by yellowing of the skin or eyes, stomach bloating, and dark urine. Additionally, the medication can exacerbate ulcerative colitis symptoms, such as increased abdominal pain and rectal bleeding.

Serious skin reactions and allergic reactions are also possible but uncommon. Symptoms of a severe allergic reaction may include rash, itching, swelling of the face, tongue, or throat, severe dizziness, and trouble breathing. If any of these serious side effects occur, immediate medical attention is necessary. Always consult with a healthcare professional if you have concerns about side effects, and seek urgent care if severe symptoms develop.

Balsalazide, also known as Colazal, can interact with various medications and supplements. It is crucial to inform your doctor and pharmacist about all medications or supplements you are currently taking, including prescribed, over-the-counter, vitamins, and herbal products, to avoid potential interactions.

Potential Drug Interactions

1. Dichlorphenamide: This medication may interact with Balsalazide. It is important to discuss this with your healthcare provider.

2. Mesalamine: Balsalazide is very similar to mesalamine. Therefore, avoid using oral mesalamine products while taking Balsalazide to prevent overlap in medication effects.

3. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and Salicylates: Using Balsalazide with medications such as Ibuprofen, Naproxen, or other similar drugs is generally not recommended unless specifically advised by your doctor. If both are prescribed together, your doctor might adjust the dosage or frequency to prevent adverse effects.

4. Tamarind and Warfarin: Combining these with Balsalazide could increase the risk of certain side effects. Your doctor may need to modify how you take these medications to ensure safety and effectiveness.

Additionally, Balsalazide may interfere with certain laboratory tests, such as urine normetanephrine levels, potentially leading to inaccurate results. It is vital to inform lab personnel and all your healthcare providers about your use of this medication.