Mesalamine is an aminosalicylate indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults. It is available as delayed-release tablets, extended-release capsules and suppositories for oral and rectal use. MedsAcross supplies Mesalamine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
ROWASA is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults. ROWASA is an aminosalicylate indicated for treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults.
Source: US FDA prescribing information
The mechanism of action of 5-ASA (mesalamine) is not fully understood, but appears to be a topical anti-inflammatory effect on colonic epithelial cells. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase pathways (i.e., prostanoids), and through the lipoxygenase pathways (i.e., leukotrienes and hydroxyeicosatetraenoic acids) is increased in patients with ulcerative colitis, and it is possible that mesalamine diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon.
Source: US FDA prescribing information
Evaluate renal function before initiating therapy with ROWASA. Recommended Dosage The recommended dosage is one rectal instillation (4 grams) once a day, preferably at bedtime, and retained for approximately eight hours for 3 to 6 weeks depending on symptoms and sigmoidoscopic findings. Administration Instructions • Shake the bottle to ensure the suspension is homogeneous. • Remove the protective sheath from the applicator tip. • Assume the correct body position: o Lie on the left side with the lower leg extended and the upper right leg flexed forward for balance. o Alternatively, sit in the knee to chest position. • Gently insert the applicator tip in the rectum pointing toward the umbilicus. • Steadily squeeze the bottle to discharge the medication. • Remain in the position for at least 30 minutes. Administer at bedtime with the objective of retaining it all night.
Source: US FDA prescribing information
ROWASA is contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, sulfites or any other component of this medication. Known or suspected hypersensitivity to salicylates, aminosalicylates, sulfites or any other of the ingredients in ROWASA.
Source: US FDA prescribing information
• Hypersensitivity Reactions: Sulfite-related reactions (ROWASA contains potassium metabisulfite) and sulfasalazine-associated reactions (myocarditis and pericarditis) can occur, evaluate patients immediately and discontinue ROWASA if a hypersensitivity reaction is suspected. • Renal Impairment: Assess renal function at the beginning of treatment and periodically during treatment. Evaluate the risks and benefits of ROWASA in patients with known renal impairment or taking nephrotoxic drug. Discontinue ROWASA if renal function deteriorates while on therapy. • Mesalamine-Induced Acute Intolerance Syndrome: Discontinue treatment if acute intolerance syndrome (cramping, acute abdominal pain, bloody diarrhea, sometimes fever, headache and rash) is suspected. • Hepatic Failure: Evaluate the risks and benefits of using ROWASA in patients with known liver impairment.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypersensitivity reactions • Renal impairment • Mesalamine-induced acute intolerance syndrome • Hepatic failure • Severe cutaneous adverse reactions • Photosensitivity • Nephrolithiasis • Intracranial Hypertension Most common adverse reactions (≥1%) are: gas/flatulence, flu, fever, leg/joint pain, hemorrhoids, rectal pain and hair loss.
Source: US FDA prescribing information
• Nephrotoxic Agents including Non-Steroidal Anti-inflammatory Drugs (NSAIDs): Increased risk of nephrotoxicity, monitor for changes in renal function and mesalamine-related adverse reactions. • Azathioprine or 6-Mercaptopurine: Increased risk of blood dyscrasias, monitor complete blood cell counts and platelet counts.
Source: US FDA prescribing information
Storage Store at controlled room temperature 20°C to 25°C (68°F to 77°F), Excursions permitted to 15°C to 30°C (59°F to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
16 presentations of Mesalamine, sorted by availability.
6 brand names across 1 markets.
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 24 December 1987 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Mesalamine in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 16 presentations of Mesalamine and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 6 brand names for Mesalamine, including Apriso, Canasa, Lialda, Mesalamine Rectal, Pentasa, Rowasa.
Yes. The US FDA first approved Mesalamine on 24 December 1987, according to Drugs@FDA.
At least one listed presentation of Mesalamine must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Mesalamine is classified under ATC code A07EC02 (Mesalamine).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.