Mesalamine
Mesalamine is an aminosalicylate (anti-inflammatory bowel medicine) used to treat and keep in remission ulcerative colitis, and to treat ulcerative proctitis, proctosigmoiditis and distal ulcerative colitis, depending on the product.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 43 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
How we combine label and product data →
Mesalamine is an anti-inflammatory medicine for ulcerative colitis that calms inflammation right at the lining of the colon. It is the usual first choice for mild to moderate disease, has been on the U.S. market since about 1987 and is available generically. Most people tolerate it well, and headache, gas and belly pain are what people notice most. The main thing to watch is the kidneys, so expect a kidney blood test before you start and periodically after, and drink plenty of fluids. Call your prescriber if cramping, bloody diarrhea, fever or rash appear soon after starting, because a rare intolerance reaction can look just like a flare.
Clinical pearls
- The form is chosen by where the inflammation sits, and brands release the drug in different parts of the gut, so do not swap them on your own.
- Swallow oral forms whole, since crushing or chewing can ruin the coating that carries the drug to the colon.
- Avoid regular ibuprofen or naproxen while on mesalamine, since these NSAIDs add to the risk of kidney problems.
- If you also take azathioprine or mercaptopurine, expect regular blood count checks, since the combination can affect blood cells.
Patient information guide — a plain-language walkthrough of Mesalamine, written from its FDA label.
What Mesalamine is used for
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Mesalamine is used for ulcerative colitis and related lower-bowel inflammation. Approvals differ by product.
- Lialda (oral delayed-release tablet): inducing and maintaining remission in adults, and treating it in children weighing at least 24 kg.
- Mesalamine delayed-release tablets: inducing and maintaining remission in adults.
- Pentasa (oral capsule) and mesalamine extended-release capsules: inducing remission and treating mildly to moderately active ulcerative colitis in adults.
- Apriso (extended-release capsule): maintaining remission in adults.
- Mesalamine delayed-release capsules: treating mildly to moderately active ulcerative colitis in patients 5 and older, and maintaining remission in adults.
- Rowasa, sfRowasa and mesalamine enemas (rectal): active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults.
- Canasa and mesalamine suppositories (rectal): mildly to moderately active ulcerative proctitis in adults.
How Mesalamine works
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Mesalamine appears to work as a local anti-inflammatory on the lining of the colon. How exactly it works is not fully understood.
People with ulcerative colitis make more inflammatory chemicals in the gut lining. Mesalamine may reduce inflammation by blocking cyclooxygenase and lowering prostaglandin production in the colon.
Mesalamine dosage
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Your schedule depends on the product. Always follow your prescriber and your product's label.
- Lialda and mesalamine delayed-release tablets: swallowed whole with food, usually once daily.
- Pentasa: swallowed whole or opened onto applesauce or yogurt; taken four times daily.
- Apriso: once daily in the morning, with or without food.
- Mesalamine delayed-release capsules: with or without food, swallowed whole.
- Rowasa and sfRowasa enemas: once daily at bedtime, kept in about eight hours.
- Canasa and mesalamine suppositories: once daily at bedtime for 3 to 6 weeks. If you miss a dose, use it as soon as possible unless it is almost time for the next. Never double up.
Drink plenty of fluids with any form.
Dosing details from the FDA-approved label
From the Mesalamine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Adults: induction of remission of mildly to moderately active ulcerative colitis (Lialda delayed-release tablets)
- 2.4 g to 4.8 g (two to four 1.2-g tablets) once daily
- Swallow tablets whole, do not split or crush; administer with food; drink an adequate amount of fluids; evaluate renal function before starting and periodically
- Adults: maintenance of remission of ulcerative colitis (Lialda delayed-release tablets)
- 2.4 g (two 1.2-g tablets) once daily
- Administer with food; swallow tablets whole
- Pediatric patients weighing 24 kg to 35 kg: mildly to moderately active ulcerative colitis (Lialda)
- Week 0 to Week 8: 2.4 g (two 1.2-g tablets) once daily
- After Week 8: 1.2 g (one 1.2-g tablet) once daily
- For patients weighing at least 24 kg who can swallow tablets whole
- Pediatric patients weighing greater than 35 kg to 50 kg: mildly to moderately active ulcerative colitis (Lialda)
- Week 0 to Week 8: 3.6 g (three 1.2-g tablets) once daily
- After Week 8: 2.4 g (two 1.2-g tablets) once daily
- For patients who can swallow tablets whole
- Pediatric patients weighing greater than 50 kg: mildly to moderately active ulcerative colitis (Lialda)
- Week 0 to Week 8: 4.8 g (four 1.2-g tablets) once daily
- After Week 8: 2.4 g (two 1.2-g tablets) once daily
- For patients who can swallow tablets whole
- Adults: rectal suppository (Mesalamine Rectal Suppositories, Canasa)
- 1000 mg administered rectally once daily at bedtime for 3 to 6 weeks depending on symptoms and sigmoidoscopic findings
- Safety and effectiveness beyond 6 weeks have not been established; do not cut or break the suppository; retain one to three hours or longer, if possible
- Rectal suspension (Rowasa, sfRowasa)
- One rectal instillation (4 grams) once a day, preferably at bedtime, retained for approximately eight hours, for 3 to 6 weeks depending on symptoms and sigmoidoscopic findings
- Shake the bottle; evaluate renal function before starting and periodically; drink an adequate amount of fluids
- Adults: induction of remission and symptomatic treatment of mildly to moderately active ulcerative colitis (Pentasa capsules)
- 1 g (4 Pentasa 250 mg capsules or 2 Pentasa 500 mg capsules) administered orally four times daily
- Swallow capsules whole, or open and sprinkle entire contents onto applesauce or yogurt and consume immediately; evaluate renal function before starting and periodically
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Administration Instructions • Evaluate renal function prior to initiation of mesalamine delayed-release tablets and periodically while on therapy. • Swallow mesalamine delayed-release tablets whole; do not split or crush. • Administer mesalamine delayed-release tablets with food [see Clinical Pharmacology ( 12.3 )] . • Drink an adequate amount of fluids [see Warnings and Precautions ( 5.8 )] . Adults • The recommended dosage for the induction of remission in adult patients with mildly to moderately active ulcerative colitis is 2.4 g to 4.8 g (two to four 1.2 g tablets) taken once daily. • The recommended dosage for the maintenance of remission is 2.4 g (two 1.2 g tablets) taken once daily. Pediatric Patients The recommended dosage for treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg who can swallow tablets whole is shown in Table 1: Table 1: Recommended Dosage of Mesalamine Delayed-release Tablets for the Treatment of Mildly to Moderately Active Ulcerative Colitis in Pediatric Patients Weighing at least 24 kg Weight of Pediatric Patient Once Daily Mesalamine Delayed-release Tablets Dosage Week 0 to Week 8 After Week 8 24 kg to 35 kg 2.4 g (two 1.2 g tablets) 1.2 g (one 1.2 g tablet) Greater than 35 kg to 50 kg 3.6 g (three 1.2 g tablets) 2.4 g (two 1.2 g tablets) Greater than 50 kg 4.8 g (four 1.2 g tablets) 2.4 g (two 1.2 g tablets) Administration Instructions • Evaluate renal function prior to initiation of mesalamine delayed-release tablets and periodically while on therapy. ( 2 , 5.1 ) • Swallow mesalamine delayed-release tablets whole; do not split or crush. ( 2 ) • Administer mesalamine delayed-release tablets with food. ( 2 ) • Drink an adequate amount of fluids. ( 2 , 5.8 ) Recommended Dosage in Adults • For induction of remission : 2.4 g to 4.8 g (two to four 1.2 g tablets) once daily. ( 2 ) • For maintenance of remission : 2.4 g (two 1.2 g tablets) once daily.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Mesalamine side effects
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Common side effects
- Headache
- Gas (flatulence)
- Abdominal pain
- Diarrhea
- Abnormal liver function tests
- In children: vomiting, upper respiratory infection, anemia, viral infection
When to get medical help
- Call your doctor if you have cramping, severe belly pain, bloody diarrhea, fever, headache or rash. This could be an acute intolerance reaction that looks like a colitis flare.
- Get help right away for signs of an allergic-type reaction, including possible heart, kidney, liver or lung involvement.
- Stop and call your doctor for severe skin reactions or rash with blistering, peeling or fever.
- Tell your doctor if you notice changes in kidney function or kidney problems.
- Report possible liver problems, especially if you already have liver disease.
- Report kidney stones or flank pain.
In adult trials, the most common side effects were:
- Headache
- Gas
- Abdominal pain
- Diarrhea
- Abnormal liver function tests
In children, common side effects also include vomiting, upper respiratory infection, anemia and viral infection. Seek care for severe belly pain with bloody diarrhea, fever or rash, severe skin reactions, signs of allergic reaction, or kidney or liver problems.
Mesalamine warnings and precautions
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Kidney problems are the leading concern. Kidney function should be checked before and during treatment, and the drug stopped if it worsens.
- Acute intolerance syndrome can look like a colitis flare. It occurred in about 3% of patients in trials.
- Allergic-type reactions can involve the heart, kidneys, liver or lungs.
- Liver failure has been reported in people with existing liver disease.
- Severe skin reactions (such as SJS/TEN and DRESS) have been reported.
- Delayed-release tablets should be avoided with upper GI obstruction such as pyloric stenosis.
- Sun sensitivity can be worse with eczema.
- Kidney stones made of mesalamine can occur and are not seen on standard X-ray or CT.
Mesalamine interactions
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A few drug types call for extra monitoring.
- NSAIDs and other kidney-harming drugs: higher risk of kidney problems.
- Azathioprine or 6-mercaptopurine: higher risk of blood disorders, so blood counts should be checked.
- Antacids with Apriso: avoid taking together.
- Urinary normetanephrine tests: may read falsely high with some lab methods.
Interactions listed in the FDA-approved label
From the Mesalamine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Nephrotoxic agents, including non-steroidal anti-inflammatory drugs (NSAIDs): Concurrent use with mesalamine may increase the risk of nephrotoxicity. Monitor patients taking nephrotoxic drugs for changes in renal function and mesalamine-related adverse reactions.
- Azathioprine or 6-mercaptopurine: Concurrent use with mesalamine and/or any other drugs known to cause myelotoxicity may increase the risk for blood disorders, bone marrow failure, and associated complications. If concomitant use cannot be avoided, monitor blood tests, including complete blood cell counts and platelet counts.
- Urinary normetanephrine measurements: Use of mesalamine delayed-release tablets may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection. Consider an alternative, selective assay for normetanephrine.
Read the label’s full interactions text
7 DRUG INTERACTIONS Nephrotoxic Agents including NSAIDs : Increased risk of nephrotoxicity; monitor for changes in renal function and mesalamine-related adverse reactions. ( 7.1 ) Azathioprine or 6-Mercaptopurine : Increased risk of blood dyscrasias; monitor complete blood cell counts and platelet counts. ( 7.2 ) 7.1 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) ] . 7.2 Azathioprine and 6-Mercaptopurine The concurrent use of mesalamine with azathioprine or 6-mercaptopurine and/or any other drugs known to cause myelotoxicity may increase the risk for blood disorders, bone marrow failure, and associated complications. If concomitant use of mesalamine delayed-release tablets and azathioprine or 6-mercaptopurine cannot be avoided, monitor blood tests, including complete blood cell counts and platelet counts. 7.3 Interference with Urinary Normetanephrine Measurements Use of mesalamine delayed-release tablets may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection [see Warnings and Precautions (5.9) ] . Consider an alternative, selective assay for normetanephrine.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Mesalamine
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- Do not use with a known allergy to salicylates, aminosalicylates or product ingredients.
- Tell your doctor about kidney or liver disease.
- Avoid delayed-release tablets with upper digestive blockage.
- Older adults (65+): blood counts should be monitored, and starting at the low end of dosing may be considered.
- Pregnancy: studies have not reliably linked mesalamine to birth defects or miscarriage, and active colitis itself can harm pregnancy outcomes.
- Breastfeeding: small amounts pass into milk. Watch the baby for diarrhea.
- Children: use depends on the product and weight or age.
Mesalamine overdose
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Mesalamine is related to salicylates, so too much can cause salicylate toxicity. Signs include nausea, vomiting, abdominal pain, fast breathing, ringing in the ears, headache, dizziness, confusion and seizures. There is no specific antidote. Treatment follows standard care for salicylate toxicity, such as preventing further absorption and correcting fluid and electrolyte imbalances. Seek emergency help or call poison control.
What Mesalamine does in the body
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Mesalamine appears to act locally on the cells lining the colon. It may reduce inflammation by blocking cyclooxygenase and lowering prostaglandin production there.
How your body processes Mesalamine
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About 21% to 22% of a dose of delayed-release tablets is absorbed, and the rest stays in the gut. Blood levels are detectable after a couple of hours and peak at around 9 to 12 hours when fasting. A high-fat meal delays absorption but raises exposure. The body converts mesalamine mainly to N-acetyl-5-aminosalicylic acid, and the kidneys clear it. Levels are higher in older adults and in people with reduced kidney function.
How to store Mesalamine
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Store at room temperature 15°C to 25°C (59°F to 77°F); excursions permitted to 30°C (86°F).
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Mesalamine
17 supplements and herbal products have documented interactions with Mesalamine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 7
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Mesalamine: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Mesalamine — the kind of thing our pharmacy team would talk through with you at the counter.
What is mesalamine for?
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How should I take it?
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What side effects are common?
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Do I need any tests while taking it?
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Can I take it with ibuprofen or other pain relievers?
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Is it safe in pregnancy or while breastfeeding?
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Is Mesalamine available over the counter?
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When was Mesalamine first available?
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Who makes Mesalamine?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Mesalamine on HelloPharmacist
Mesalamine forms and strengths (how it comes)
Mesalamine is available in 6 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Delayed-release tablet
How this form is used
- Lialda is used for inducing and maintaining remission of mildly to moderately active ulcerative colitis in adults, and treating it in children weighing at least 24 kg.
- Mesalamine delayed-release tablets are used for inducing and maintaining remission in adults.
- Lialda tablets are swallowed whole, not split or crushed, with food, once daily.
- Mesalamine delayed-release tablets are swallowed whole with food.
Extended-release capsule
How this form is used
- Apriso is used to maintain remission of ulcerative colitis in adults.
- Mesalamine extended-release capsules are used for inducing remission and treating mildly to moderately active ulcerative colitis in adults.
- Apriso is taken once daily in the morning, with or without meals.
- Apriso capsules are swallowed whole, not cut, broken, crushed or chewed.
- Avoid taking Apriso with antacids.
Rectal suppository
How this form is used
- Canasa and mesalamine suppositories treat mildly to moderately active ulcerative proctitis in adults.
- Canasa is inserted rectally once daily at bedtime for 3 to 6 weeks, depending on symptoms.
- Do not cut or break Canasa suppositories. Try to keep one in for one to three hours or longer.
- Canasa can stain fabrics, flooring and other surfaces.
Enema
How this form is used
- Rowasa and sfRowasa treat active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults.
- Mesalamine rectal suspension enema is used for the same conditions in adults.
- Rowasa and sfRowasa are used once a day, preferably at bedtime, and kept in for about eight hours.
- Rowasa and sfRowasa: shake the bottle first and lie on your left side, or use the knee-to-chest position.
Delayed-release capsule
How this form is used
- Mesalamine delayed-release capsules treat mildly to moderately active ulcerative colitis in patients 5 and older.
- Mesalamine delayed-release capsules help maintain remission of ulcerative colitis in adults.
- Mesalamine delayed-release capsules can be taken with or without food.
- Mesalamine delayed-release capsules are swallowed whole. If a patient cannot swallow them, they can be opened and the inner tablets swallowed.
- Mesalamine delayed-release 400 mg capsules should not be swapped for an 800 mg tablet.
Capsule
How this form is used
- Pentasa is used for inducing remission and treating mildly to moderately active ulcerative colitis in adults.
- Pentasa capsules are swallowed whole, not crushed or chewed.
- Pentasa capsules may instead be opened and the contents sprinkled on applesauce or yogurt, then eaten right away.
- Pentasa is taken four times daily.
Mesalamine on the U.S. market: products, makers and brands
How Mesalamine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
70 companies list 223 Mesalamine product records with the FDA, mostly as delayed-release tablet, extended-release capsule, rectal suppository; the earliest marketing or approval year on record is 1987. Brand names on the directory include Apriso, Asacol HD, Delzicol and 9 more; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (39) · Kit (12) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Mesalamine is used (Medicaid data)
A general measure of how commonly Mesalamine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Mesalamine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Mesalamine prescribed? Of the 1,601 medications we measure, Mesalamine ranks #416 by Medicaid prescriptions — more than 74% of them.
Utilization by Mesalamine product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
mesalamine 1200 MG Delayed Release Oral Tablet Most dispensed
Summed across the 10 of 26 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 686429
24 HR mesalamine 375 MG Extended Release Oral Capsule
Summed across the 8 of 25 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 825130
mesalamine 1000 MG Rectal Suppository
Summed across the 9 of 27 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 248420
mesalamine 500 MG Extended Release Oral Capsule
Summed across the 2 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 476362
mesalamine 800 MG Delayed Release Oral Tablet
Summed across the 3 of 18 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 833234
mesalamine 66.7 MG/ML Enema
Summed across the 8 of 26 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 238151
mesalamine 400 MG Delayed Release Oral Capsule
Summed across the 1 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1368954
mesalamine 250 MG Extended Release Oral Capsule
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 314092
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Mesalamine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 42 of 138 listed Mesalamine NDCs with Medicaid activity.
Compare Mesalamine products
A representative set of FDA-listed product records for Mesalamine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 250 mg | — | Patheon Manufacturing Services LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 500 mg | — | Patheon Manufacturing Services LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 250 mg | Oral | Takeda Pharmaceuticals America, Inc. × 3 listings | NDA | View NDC → |
| 500 mg | Oral | Takeda Pharmaceuticals America, Inc. × 3 listings | NDA | View NDC → |
| 💊Delayed-release capsule | ||||
| 400 mg | Oral | A-S Medication Solutions × 2 listings | NDA | View NDC → |
| 400 mg | Oral | Allergan, Inc. × 2 listings | NDA | View NDC → |
| 400 mg | Oral | American Health Packaging × 4 listings | ANDA | View NDC → |
| 400 mg | Oral | AvKARE | ANDA | View NDC → |
| 400 mg | Oral | Greenstone LLC | NDA AUTHORIZED GENERIC | View NDC → |
| 400 mg | Oral | Remedyrepack Inc. × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 400 mg | Oral | Teva Pharmaceuticals USA, Inc. × 3 listings | ANDA | View NDC → |
| 💊Delayed-release tablet | ||||
| 800 mg | Oral | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Find on DailyMed ↗ |
| 1.2 g | Oral | A-S Medication Solutions | ANDA | Find on DailyMed ↗ |
| 1.2 g | Oral | Actavis Pharma, Inc. × 3 listings | ANDA | View NDC → |
| 800 mg | Oral | Allergan, Inc. | NDA | View NDC → |
| 800 mg | Oral | American Health Packaging × 3 listings | ANDA | View NDC → |
| 1.2 g | Oral | American Health Packaging × 3 listings | ANDA | View NDC → |
| 800 mg | Oral | Amneal Pharmaceuticals LLC | ANDA | View NDC → |
| 800 mg | Oral | AvKARE | ANDA | View NDC → |
| 1.2 g | Oral | AvKARE | ANDA | View NDC → |
| 1.2 g | Oral | Bryant Ranch Prepack × 3 listings | ANDA | View NDC → |
| 1.2 g | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 1.2 g | Oral | Chartwell RX, LLC × 2 listings | ANDA | View NDC → |
| 1.2 g | — | Cosmo SpA | DRUG FOR FURTHER PROCESSING | View NDC → |
| 1.2 g | Oral | Golden State Medical Supply, Inc. × 3 listings | ANDA | View NDC → |
| 1.2 g | Oral | Lannett Company Inc. × 2 listings | ANDA | View NDC → |
| 1.2 g | Oral | Major Pharmaceuticals × 3 listings | ANDA | View NDC → |
| 1.2 g | Oral | Northstar Rx LLC. × 2 listings | ANDA | View NDC → |
| 💊Enema | ||||
| 4 g/60 mL | Rectal | ANI Pharmaceuticals, Inc. × 3 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 4 g/60 mL | Rectal | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 4 g/60 mL | Rectal | Bryant Ranch Prepack | ANDA | View NDC → |
| 4 g/60 mL | Rectal | Encube Ethicals, Inc. | ANDA | View NDC → |
| 4 g/60 mL | Rectal | Encube Ethicals Private Limited | ANDA | View NDC → |
| 4 g/60 mL | Rectal | KLM Laboratories Private Limited | ANDA | View NDC → |
| 4 g/60 mL | Rectal | Meda Pharmaceuticals Inc. × 4 listings | NDA | View NDC → |
| 4 g/60 mL | Rectal | Padagis Israel Pharmaceuticals Ltd × 3 listings | ANDA | View NDC → |
| 4 g/60 mL | Rectal | Viatris Specialty LLC × 3 listings | NDA | View NDC → |
| 💊Extended-release capsule | ||||
| 0.375 g | Oral | Alembic Pharmaceuticals Inc. × 2 listings | ANDA | View NDC → |
| 0.375 g | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 0.375 g | Oral | American Health Packaging × 3 listings | ANDA | View NDC → |
| 375 mg | Oral | Aphena Pharma Solutions - Tennessee, LLC | NDA | View NDC → |
| 0.375 g | Oral | Ascend Laboratories, LLC × 3 listings | ANDA | View NDC → |
| 0.375 g | Oral | Aurobindo Pharma Limited × 2 listings | ANDA | View NDC → |
| 0.375 g | Oral | AvPAK × 2 listings | ANDA | View NDC → |
| 375 mg | Oral | Bryant Ranch Prepack × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 375 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 0.375 g | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 0.375 g | Oral | Ingenus Pharmaceuticals, LLC | ANDA | View NDC → |
| 375 mg | Oral | Lupin Pharmaceuticals, Inc. × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 0.375 g | Oral | Mylan Pharmaceuticals Inc. × 3 listings | ANDA | View NDC → |
| 375 mg | Oral | Oceanside Pharmaceuticals × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 375 mg | Oral | Salix Pharmaceuticals, Inc. × 3 listings | NDA | View NDC → |
| 250 mg | Oral | Sandoz Inc × 3 listings | ANDA | View NDC → |
| 500 mg | Oral | Sandoz Inc × 2 listings | ANDA | View NDC → |
| 500 mg | Oral | Sun Pharmaceutical Industries Inc. × 3 listings | ANDA | View NDC → |
| 375 mg | Oral | Teva Pharmaceuticals USA, Inc. × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 0.375 g | Oral | Upsher-Smith Laboratories, LLC × 2 listings | ANDA | View NDC → |
| 0.375 g | Oral | Zydus Lifesciences Limited × 2 listings | ANDA | View NDC → |
| 0.375 g | Oral | Zydus Pharmaceuticals (USA) Inc. | ANDA | View NDC → |
| 0.375 g | Oral | Zydus Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 💊Rectal suppository | ||||
| 1000 mg | Rectal | Actavis Pharma, Inc. × 3 listings | ANDA | View NDC → |
| 1000 mg | Rectal | Allergan, Inc. × 3 listings | NDA | View NDC → |
| 1000 mg | Rectal | Amneal Pharmaceuticals NY LLC | ANDA | View NDC → |
| 1000 mg | Rectal | Amring Pharmaceuticals Inc. × 2 listings | ANDA | View NDC → |
| 1000 mg | Rectal | Bryant Ranch Prepack × 4 listings | ANDA | View NDC → |
| 1000 mg | Rectal | Camber Pharmaceuticals, Inc. × 3 listings | ANDA | View NDC → |
| 1000 mg | Rectal | Greenstone LLC × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 1000 mg | Rectal | Mylan Pharmaceuticals Inc. | ANDA | View NDC → |
| 1000 mg | Rectal | Northstar Rx LLC. × 3 listings | ANDA | View NDC → |
| 1000 mg | Rectal | Rising Pharmaceuticals, Inc. | ANDA | View NDC → |
| 1000 mg | Rectal | Rising Pharma Holdings, Inc. × 2 listings | ANDA | View NDC → |
| 1000 mg | Rectal | Sandoz Inc | ANDA | View NDC → |
| 1000 mg | Rectal | Zydus Lifesciences Limited × 2 listings | ANDA | View NDC → |
| 1000 mg | Rectal | Zydus Pharmaceuticals (USA) Inc. | ANDA | View NDC → |
| 1000 mg | Rectal | Zydus Pharmaceuticals USA Inc. × 2 listings | ANDA | View NDC → |
| 💊Kits | ||||
| — | — | Bryant Ranch Prepack × 6 listings | ANDA | View NDC → |
| — | — | Padagis Israel Pharmaceuticals Ltd × 6 listings | ANDA | View NDC → |
| 💊Bulk drug substance | ||||
| 50 kg/50 kg | — | Aurobindo Pharma Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Cambrex Karlskoga AB | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Chemi Spa × 4 listings | BULK INGREDIENT | View NDC → |
| 25 kg/25 kg | — | CTX Lifesciences Pvt. Ltd. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Dasami Lab Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Divi's Laboratories Limited × 5 listings | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Erregierre SpA × 3 listings | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Infar Sa | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | IOL Chemicals and Pharmaceuticals Ltd. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Ipca Laboratories Limited | BULK INGREDIENT | View NDC → |
| 1 g/g | — | Letco Medical, Llc | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
| 1 kg/kg | — | Maithri Drugs Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Matrix Pharmacorp Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | MSN Life Sciences Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Optimus Drugs Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | PharmaZell GmbH × 7 listings | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
| 1 kg/kg | — | PharmaZell GmbH × 2 listings | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Professional Compounding Centers of America | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
| 1 kg/kg | — | Professional Compounding Centers of America dba PCCA | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
| 50 kg/50 kg | — | Sun Pharmaceutical Industries, Inc. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Syntese A/S | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Wanbury Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Zydus Lifesciences Limited | BULK INGREDIENT | View NDC → |
Showing 200 of 223 products — FDA National Drug Code Directory. See every product, package size and price: browse all 223 Mesalamine NDCs →
Mesalamine side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Mesalamine — a signal of what to watch for, not proof the drug caused it.
The effects most often named in FDA reports that mention Mesalamine are colitis ulcerative, diarrhoea, condition aggravated; about 75% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Mesalamine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Mesalamine FDA approval history
How Mesalamine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Mesalamine was first approved by the FDA in 1987 (Brand: ROWASA · Mylan Speciality Lp); the first generic version was approved in 2004. It remains available in U.S. pharmacies today.
Source: Drugs@FDA.
Mesalamine recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list 2 Mesalamine recalls since July 2021. One of them is still ongoing and is listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical Industries Limited, Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries… Lots: Lot #s: MHD0606A, MHD0612A, Exp. 04/30/2024; MHD0613A, MHD0652A, MHD0657A, MHD0672A, MHD0673A, Exp. 05/31/2024; MHD0767A, MHD0768A, MHD0769A, MHD0785A, MHD0799A, MHD0800A, MHD0801A, Exp. 06/30/2024; MHD0827A, MHD0828A, MHD0875A, MHD0876A,… FDA record D-0350-2024 →
- Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Ph… Lots: Lot #s: DNE0875A Exp. 01/31/2025; DNE0876A, DNE0877A, DNE1080A, DNE1081A Exp. 02/28/2025; DNE1147A, DNE1148A Exp. 03/31/2025. FDA record D-0268-2024 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 52582 5 dose forms · 10 strengths
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Dose form (SCDF) Delayed Release Oral Capsule RxCUI 1368953In current FDA listingsClinical drug / strength (SCD) 400 MGRxCUI 1368954 -
Dose form (SCDF) Delayed Release Oral Tablet RxCUI 372784In current FDA listings -
Dose form (SCDF) Enema RxCUI 372785In current FDA listingsClinical drug / strength (SCD) 66.7 MG/MLRxCUI 238151 -
Dose form (SCDF) Extended Release Oral Capsule RxCUI 372783In current FDA listingsClinical drug / strength (SCD) 24 HR mesalamine 375 MGRxCUI 825130250 MGRxCUI 314092500 MGRxCUI 476362 -
Dose form (SCDF) Rectal Suppository RxCUI 372786In current FDA listings
Look up RxCUI 52582 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Mesalamine supply and shortage status
Whether Mesalamine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Mesalamine is not in shortage right now; the FDA has 3 past shortage records for it.
✅No current shortage of Mesalamine on recordSource: openFDA, from the FDA Drug Shortages database.
Mesalamine brand names
Mesalamine is sold under 12 brand names in the FDA directory — Apriso, Asacol HD, Delzicol, Lialda and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Mesalamine: manufacturers and labelers
70 companies list Mesalamine products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, American Health Packaging, Takeda Pharmaceuticals America, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 46 more on the FDA NDC directory.
Mesalamine drug class (RxNorm)
Mesalamine belongs to the Aminosalicylate class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Mesalamine page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Takeda Pharmaceuticals America, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →