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This document outlines crucial safety and warning information regarding the use of mesalamine (Rowasa). It is essential to read these points carefully and discuss any concerns with your healthcare provider.

• Serious Allergic Reactions and Skin Reactions: Mesalamine (Rowasa) can cause severe allergic reactions, which may be life-threatening. Symptoms include difficulty breathing, chest tightness, and swelling of the face, lips, tongue, or eyes. Skin-related allergic reactions may manifest as hives, itchiness, skin pain, redness, blisters, or peeling. Discontinue use immediately and seek emergency medical assistance if you experience any allergic reactions. Those with allergies to mesalamine, sulfites, or a history of asthma should be particularly cautious.

• Kidney Issues: If you have a history of kidney problems, inform your healthcare provider before starting mesalamine (Rowasa). The drug is processed through the kidneys, and impaired kidney function can lead to medication build-up and increased risk of side effects. Some individuals have experienced serious kidney problems, including failure, while on mesalamine. Discuss potential risks and benefits with your healthcare provider, especially if you have a history of kidney issues, are taking other kidney-affecting medications, or are on sulfasalazine (Azulfidine).

• Liver Concerns: Those with pre-existing liver conditions may experience worsened liver function while taking mesalamine (Rowasa). Notify your prescriber about any liver conditions prior to starting treatment so they can assess the risks and benefits appropriately.

• Acute Intolerance Syndrome: Some individuals may not tolerate mesalamine (Rowasa) well, resulting in acute intolerance syndrome. Symptoms include abdominal pain, bloody diarrhea, fever, headache, or rash, which can mimic a UC flare-up. Cease taking the medication and contact your healthcare provider immediately if these symptoms occur.

Contraindications highlight specific conditions under which mesalamine (Rowasa) should not be used due to potential health risks. Consult your healthcare provider if any of the following apply to you:

• Allergy to sulfites
• Allergy to salicylates, including aspirin or bismuth subsalicylate (Pepto-Bismol)

This guidance is to ensure safe and effective use of mesalamine (Rowasa).

When taking this medication, some individuals might experience mild side effects such as stomach pain, cramps, or discomfort, affecting about 8% of users. Headaches are also common, seen in approximately 7% of patients, while gas and nausea occur in about 6% of cases. Other mild effects include flu-like symptoms, diarrhea, constipation, and stomach bloating. If these symptoms persist or worsen, it is advisable to consult a healthcare provider for guidance.

Additionally, some users have reported experiencing pain, soreness, or burning at the rectum, leg or joint pain, back pain, and hemorrhoids. Other noted side effects include kidney stones, hair loss, dizziness, tiredness or weakness, cold-like symptoms, sore throat, fever, itching, and rash or spots on the skin. Although these symptoms can be bothersome, they are generally not severe.

However, there are rare but serious side effects that require immediate medical attention. These include allergic reactions characterized by itchy, red rashes, shortness of breath, chest tightness, and swelling of the lips, tongue, face, or eyes. Severe skin reactions, such as painful redness, blisters, and a severe rash, also fall into this category. Furthermore, an acute intolerance syndrome may occur, presenting with severe stomach pain, bloody diarrhea, nausea, fever, headache, and rash. If any of these serious side effects occur, it is crucial to seek urgent medical care.

Mesalamine (Rowasa) can interact with various medications and supplements. It's crucial to inform your doctor and pharmacist about all drugs and supplements you are taking, including prescriptions, over-the-counter items, vitamins, and herbal products. Not all possible interactions are listed here.

Certain medications are generally not recommended to be used with Mesalamine, unless necessary. If you need to take these medications together, your doctor might adjust the dosage or frequency. These include:

• Aceclofenac, Acemetacin, Amtolmetin Guacil, Balsalazide, and many others listed above.

Additionally, some medications might increase the risk of side effects when taken with Mesalamine, but might still be necessary. In such cases, your doctor will closely monitor your treatment:

• Tamarind and Warfarin.

Please also note that this medication may interfere with specific lab tests, such as urine normetanephrine levels, potentially leading to false results. It's important to let the lab personnel and all your healthcare providers know that you are using Mesalamine.