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This document outlines essential safety information and warnings related to the use of this medication. It is crucial to understand these risks and take necessary precautions. Always consult your healthcare provider if you have any questions or concerns.

• Kidney Issues: There is a risk of developing kidney problems, including kidney stones, damage, or failure, particularly if you have a history of kidney issues or use other kidney-impacting medications like NSAIDs (e.g., ibuprofen). Inform your healthcare provider of your medical history and all medications you are currently taking or plan to take.

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

• Liver Concerns: While rare, liver problems have been observed in individuals using mesalamine, including those with pre-existing liver issues. Be aware of symptoms like yellowing of the skin or eyes, dark urine, fatigue, or pain on the right side of the abdomen, and contact your healthcare provider immediately if these arise.

• Allergic Reactions: Although uncommon, severe allergic reactions can occur, which may be life-threatening. Symptoms include difficulty breathing, severe rash, and swelling of the lips, tongue, face, or eyes. Seek immediate medical attention if these symptoms develop.

• Iron Content: Certain mesalamine tablets and capsules contain iron oxide. Discuss with your healthcare provider if you are taking iron supplements or have conditions that increase iron levels in your body to prevent iron overload.

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

Contraindications:

• Aspirin or Salicylate Allergy: Do not use this medication if you have an allergy to aspirin or other salicylates. Consult your healthcare provider for suitable alternatives.

When using this medication, you might experience some common side effects, which are usually mild. These include headache, stomach upset, nausea, diarrhea, indigestion, constipation, and joint or muscle pain. If these symptoms persist or worsen, it's advisable to consult your healthcare provider for guidance. Sometimes, you may notice belching, loss of appetite, vomiting, gas, dizziness, or back pain. Additionally, symptoms akin to a common cold or upper respiratory infection may occur, along with the appearance of a rash.

In rare instances, more serious side effects can arise, necessitating immediate medical attention. These include worsening symptoms of ulcerative colitis, such as increased abdominal pain or bloody diarrhea. Kidney problems might manifest as trouble urinating, a change in urine volume, or blood in the urine. Liver issues could be indicated by yellowing of the skin or eyes and dark urine. An allergic reaction, though uncommon, may present with fever, swollen lymph nodes, rash, itching, severe dizziness, or trouble breathing. Severe skin reactions, such as hives or blistering, also require urgent care.

If any of these severe symptoms appear, it's critical to seek medical attention promptly. While a very serious allergic reaction to this medication is rare, it's important to monitor your health and contact a healthcare provider if you have concerns about any side effects not listed here.

When taking Mesalamine, it is important to avoid using medications like Balsalazide, olsalazine, and Sulfasalazine, as they are quite similar and could cause interactions. Additionally, Mesalamine might affect certain lab tests, such as those measuring urine normetanephrine levels, which could lead to inaccurate results. Make sure that lab staff and all your healthcare providers are aware of your Mesalamine use.

Mesalamine can also interact with a wide range of other medications and supplements, both prescribed and over-the-counter, including vitamins and herbal products. It’s crucial to inform your doctor and pharmacist about all the medications and supplements you are taking to avoid potential interactions.

Specifically, Mesalamine is usually not recommended to be used alongside certain drugs, including Aceclofenac, Ibuprofen, Diclofenac, Ketoprofen, and many others, unless absolutely necessary. In such cases, your doctor may adjust the dosage or frequency of either medication.

Furthermore, combining Mesalamine with medications like Tamarind and Warfarin could increase the risk of side effects, though it might be necessary for your treatment plan. Your doctor might make changes to how you take these medications to manage this risk effectively.