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The safety information below outlines important considerations for the use of this medication. Please review these details carefully and consult your healthcare provider if you have questions or concerns.

• Kidney Concerns: Some individuals on mesalamine have developed kidney issues, including stones, damage, or even failure. Risk increases if you have existing kidney conditions or are using other kidney-affecting drugs, such as NSAIDs (e.g., ibuprofen). Inform your healthcare provider about your medical history and any medications you are currently taking or plan to take.

• Acute Intolerance Syndrome: Some may experience an abnormal reaction to mesalamine, known as acute intolerance syndrome, which can mimic a flare-up of ulcerative colitis. Symptoms include stomach cramps, bloody diarrhea, fever, headache, and rash. Notify your healthcare provider if these symptoms occur, as discontinuation of mesalamine may be necessary.

• Liver Concerns: Although rare, liver issues have been observed in some individuals using mesalamine. If you have liver conditions, discuss the risks and benefits of this medication with your healthcare provider before starting treatment. Contact them immediately if you notice signs of liver problems, such as jaundice, dark urine, fatigue, or right-sided abdominal pain.

• Allergic and Severe Skin Reactions: Allergic reactions to mesalamine, though uncommon, can be severe and potentially life-threatening. Symptoms may include difficulty breathing, severe rash, or organ involvement. Seek medical assistance immediately if you experience symptoms like itching, hives, shortness of breath, chest tightness, or swelling of the lips, tongue, face, or eyes.

• Iron Content: Certain mesalamine tablets and capsules contain iron oxide in their coatings. Discuss with your healthcare provider if you take iron supplements or have conditions that increase your risk of iron overload to prevent adverse effects from excessive iron intake.

• Phenylketonuria Caution: Apriso extended-release capsules contain phenylalanine, which is harmful to individuals with phenylketonuria (PKU). If you have PKU, consult your healthcare provider to consider alternative mesalamine formulations.

Contraindications: This medication is not recommended for individuals with allergies to aspirin or other salicylates. If this applies to you, speak with your healthcare provider before taking this medication.

When taking this medication, you might experience some common side effects which are usually mild and manageable. These include headaches, stomach pain, nausea, diarrhea, indigestion, and occasionally belching or burping. If these symptoms persist or worsen, it is advisable to consult your healthcare provider for guidance. Additionally, some individuals may experience loss of appetite, constipation, vomiting, gas, dizziness, back pain, or symptoms resembling a common cold.

There are rare, yet serious side effects that require immediate medical attention. Be vigilant for any signs of worsening ulcerative colitis symptoms such as increased abdominal pain or bloody diarrhea. Kidney-related issues might manifest as trouble urinating, changes in urine volume, or blood in the urine, often accompanied by back or side pain. Liver problems may present as yellowing of the skin or eyes, dark urine, severe stomach pain, and fatigue.

An allergic reaction, though rare, is serious and can cause rash, hives, swelling, difficulty breathing, and dizziness. Severe skin reactions are also possible, marked by hives, discolored patches, peeling skin, or blisters. If you notice any of these serious side effects, seek urgent medical care immediately. Remember, it's important to report any side effects to your healthcare provider.

When taking mesalamine, be aware that it should not be combined with medications such as balsalazide, olsalazine, and sulfasalazine, as they are very similar. Additionally, mesalamine can interfere with certain lab tests, particularly those measuring urine normetanephrine levels, which may lead to inaccurate results. It is important to inform lab personnel and all your healthcare providers that you are using this medication.

Mesalamine may also interact with a wide range of medications. Before starting mesalamine, ensure your doctor and pharmacist are aware of all medications and supplements you are taking, whether they are prescription, over-the-counter, vitamins, or herbal supplements. Here are some notable interactions:

• It is generally not recommended to use mesalamine with certain non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen, naproxen, or diclofenac, among others. Your doctor might need to adjust dosages if both medications are necessary.
• Mesalamine can also interact with mercaptopurine, which may require dosage adjustments.

Furthermore, using mesalamine with tamarind or warfarin could increase the risk of side effects. If both medications are deemed necessary, the doctor may alter how you take them.

Always consult your healthcare provider for personalized advice and before making any changes to your medication regimen.