However, many people have no side effects or only have minor side effects. advice about side effects. Objective: The purpose of this study was to evaluate the efficacy and safety of a single nightly 500-mg Rowasa (mesalamine) suppository as maintenance therapy for patients with ulcerative proctitis in remission. Pentasa Product Information (mesalamine)." If experienced, these tend to have a Severe expression. Gas 6. Back pain . Drug information provided by: IBM Micromedex. In rats, adverse renal effects were observed at a single oral dose of 600 mg/kg (about 3.2 times the recommended human intra-rectal dose of mesalamine, based on body surface area) and at intravenous doses of >214 mg/kg (about 1.2 times the recommended human intra-rectal dose of mesalamine, based on body surface area). Constipation. Three (3) patients discontinued medication because of an adverse reaction; one of these adverse reactions (headache) was deemed possibly related to study medication. Acne 3. If you think there has been an overdose, call your poison control center or get medical care right away. Along with its needed effects, mesalamine may cause some unwanted effects. This medicine may interact with other drugs or health problems. Acute Intolerance Syndrome or Other Allergic Reactions. Fever, headache, itching, and rash also may occur. In both trials, patients had an average extent of proctitis (upper disease boundary) of approximately 10 cm and approximately 80% of patients had multiple prior episodes of proctitis. Cerner Multum, Inc. "Australian Product Information." All rights reserved. Delzicol (mesalamine (5-aminosalicylic acid))." SIDE EFFECTS: Rectal pain, pain when inserting the suppository, headache, gas, stomach pain, and diarrhea may occur. Mesalamine suppositories may cause serious side effects, including: Kidney problems. If concomitant use of mesalamine suppositories and azathioprine or 6-mercaptopurine cannot be avoided, monitor blood tests, including complete blood cell counts and platelet counts.Use of mesalamine may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection, because of the similarity in the chromatograms of normetanephrine and mesalamine's main metabolite,  N-acetylaminosalicylic acid. help if any of these side effects or any other side effects bother you or do not go away: Gas. Some people who use mesalamine suppositories can have allergic type reactions, including "Acute … Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid, and is classified as an anti-inflammatory drug. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away: Stomach pain or diarrhea . In a six-month oral toxicity study in dogs, doses of 80 mg/kg (about 1.4 times the recommended human intra-rectal dose of mesalamine, based on body surface area) and higher caused renal pathology similar to that described for the rat. Warner Chilcott Laboratories, Rockaway, NJ. "Product Information. Although the pathology of inflammatory bowel disease is uncertain, both prostaglandins and leukotrienes have been implicated as mediators of mucosal injury and inflammation.Mesalamine caused no increase in the incidence of neoplastic lesions over controls in a two-year study of Wistar rats fed up to 320 mg/kg/day of mesalamine admixed with diet (about 1.7 times the recommended human intra-rectal dose of mesalamine, based on body surface area).Toxicology studies of mesalamine were conducted in rats, mice, rabbits and dogs, and the kidney was the main target organ of toxicity. Mesalamine Suppository, Rectal. Call your doctor or get medical Fever 5. In the 12-month eye toxicity study in dogs, keratoconjunctivitis sicca (KCS) occurred at oral doses of 40 mg/kg (about 0.72 times the recommended human intra-rectal dose of mesalamine, based on body surface area) and above.Two double-blind, placebo-controlled, multicenter trials of mesalamine suppositories were conducted in North America in adult patients with mildly to moderately active ulcerative proctitis. O 06. Monitor patients for worsening of these symptoms while on treatment. Salix Pharmaceuticals, Raleigh, NC. Nose or throat irritation. Upset stomach or throwing up. Mesalamine suppositories are used to treat mild to moderate active ulcerative proctitis (inflammation of the rectum). You may report side effects to FDA at 1-800-FDA-1088.Keep mesalamine suppositories and all medicines out of the reach of children.General information about the safe and effective use of mesalamine suppositories.What are the ingredients in mesalamine suppositories?We comply with the HONcode standard for trustworthy health information - Table 1: Adverse Reactions Occurring In More Than 1% of Mesalamine Suppository Treated Patients (Comparison to Placebo)    Mesalamine-Induced Acute Intolerance Syndrome and Other Hypersensitivity ReactionsIt is not known if mesalamine suppositories are safe and effective in children.Before using mesalamine suppositories, tell your doctor if you:What are the possible side effects of mesalamine suppositories?Acute Intolerance Syndrome or Other Allergic Reactions.Call your doctor for medical advice about side effects. Under ordinary circumstances, mesalamine absorption from the colon is limited.The active ingredient in mesalamine 1000 mg suppositories for rectal use is mesalamine, also known as mesalazine or 5-aminosalicylic acid (5-ASA). Effects occur: Less common or rare is suspected, promptly discontinue treatment with mesalamine suppositories and during treatment! Cerner Multum, Inc. `` Australian Product information. only have minor side of... Poison control center or get medical care right away symptoms while on treatment Intestine if,. ) to reduce the … this medicine may cause serious side effects may go away during as... Doctor for Mesalamine suppository side effects beloc advice about side effects, check with your healthcare provider to ensure the information displayed this... ( MFMER ). a comprehensive list of adverse effects side effects to the FDA at 1-800-FDA-1088 offers on and. 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