Mesalamine is an aminosalicylate sold in the U.S. under 10 brand and generic names, for ulcerative colitis, proctitis and sigmoid diseases. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Asacol Hd (application NDA021830). Other mesalamine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Dosage The recommended dosage is 1.5 g (four 0.375 g capsules) once daily in the morning. ( 2 ) Administration Instructions Evaluate renal function before initiating therapy with mesalamine extended-release capsules. ( 2 ) Swallow the capsules whole. Do not cut, break, crush or chew the capsules. ( 2 ) Avoid co-administration with antacids. ( 2 , 7.1 ) Drink an adequate amount of fluids. ( 2 , 5.7 ) Take mesalamine extended-release capsules without regard to meals. ( 2 ) Dosage The recommended dosage in adults is 1.5 g (four 0.375 g capsules) orally once daily in the morning. Administration Instructions Evaluate renal function before initiating therapy with mesalamine extended-release capsules [see Warnings and Precautions (5.1) ] . Swallow mesalamine extended-release capsules whole. Do not cut, break, crush or chew the capsules. Avoid co-administration of mesalamine extended-release capsules with antacids [see Drug Interactions (7.1) ] . Drink an adequate amount of fluids [see Warnings and Precautions (5.7) ] . Take mesalamine extended-release capsules without regard to meals [see Clinical Pharmacology (12.3) ] .
The following clinically significant adverse reactions are described elsewhere in labeling: Renal Impairment [see Warnings and Precautions (5.1) ] Mesalamine-Induced Acute Intolerance Syndrome [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Hepatic Failure [see Warnings and Precautions (5.4) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.5) ] Photosensitivity [see Warnings and Precautions (5.6) ] Nephrolithiasis [see Warnings and Precautions (5.7) ] Most common adverse reactions (≥3%) are: headache, diarrhea, upper abdominal pain, nausea, and nasopharyngitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Upsher-Smith Laboratories, LLC at 1-855-899-9180 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to mesalamine extended-release capsules in 557 patients, including 354 exposed for at least 6 months and 250 exposed for greater than one year. Mesalamine extended-release capsules were studied in two placebo-controlled trials (n=367 treated with mesalamine…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Tablet | Generic | $27 | View → | |
| 2 | 70/100 | Prescription | Suppository | Generic |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| AN360 | 800 mg | red | oval | — |
| S476 | 1.2 g | red, brown | oval | — |
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Mesalamine Extended-Release Capsules
Failed Dissolution Specifications: Out of specification for dissolution.
SUN PHARMACEUTICAL INDUSTRIES INC · Feb 5, 2024
Mesalamine Delayed-Release Tablets
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 2024
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Mesalamine Extended-Release Capsules are contraindicated in patients with hypersensitivity to salicylates or aminosalicylates or to any of the components of Mesalamine Extended-Release Capsules [see Warnings and Precautions (5.3) , Adverse Reactions (6.2) , Description (11) ] . Known or suspected hypersensitivity to salicylates, aminosalicylates, or any component of mesalamine extended-release capsules. ( 4 , 5.3 )
Nephrotoxic Agents including NSAIDs : Increased risk of nephrotoxicity; monitor for changes in renal function and mesalamine-related adverse reactions. ( 7.2 ) Azathioprine or 6-Mercaptopurine : Increased risk of blood disorders; monitor complete blood cell counts and platelet counts. ( 7.3 ) 7.1 Antacids Because the dissolution of the coating of the granules in mesalamine extended-release capsules depends on pH, avoid co-administration of mesalamine extended-release capsules with antacids [see Dosage and Administration (2) ] . 7.2 Nephrotoxic Agents, Including Non-Steroidal Anti-Inflammatory Drugs The concurrent use of mesalamine with known nephrotoxic agents, including non-steroidal anti-inflammatory drugs (NSAIDs) may increase the risk of nephrotoxicity. Monitor patients taking nephrotoxic drugs for changes in renal function and mesalamine-related adverse reactions [see Warnings and Precautions (5.1) ] . 7.3 Azathioprine or 6-Mercaptopurine The concurrent use of mesalamine with azathioprine or 6-mercaptopurine and/or other drugs known to cause myelotoxicity may increase the risk for blood disorders, bone marrow failure, and associated complications. If concomitant use of mesalamine extended-release capsules and azathioprine or 6-mercaptopurine cannot be avoided, monitor blood tests, including complete blood cell counts and platelet counts. 7.4 Interference with Urinary…
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| 3 | 70/100 | Prescription | Capsule | Generic | $27 | View → |
| 4 | 70/100 | Prescription | Capsule | Generic | $27 | View → |
| 5 | Not yet rated | Prescription | Capsule | Generic | $27 | View → |
| 6 | Not yet rated | Prescription | Tablet | Generic | $27 | View → |
| 7 | Not yet rated | Prescription | Tablet | Generic | $27 | View → |
| 8 | Not yet rated | Prescription | Capsule | Generic | $27 | View → |
| 9 | Not yet rated | Prescription | Suspension | Generic | $27 | View → |
| 10 | Not yet rated | Prescription | Enema | Generic | $27 | View → |