Prescription medicine
Mesalamine Brand names: Pentasa, Canasa, Rowasa, Lialda, Apriso
Mesalamine (Pentasa) is a prescription medicine with an FDA approval on record since 1987. FDA's NDC Directory lists it from 34 generic labelers, and pharmacies paid $0.781 per mesalamine DR 1.2 g tablet in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
Check it at the source: the mesalamine FDA label on DailyMed (effective August 27, 2026, Salix Pharmaceuticals, Inc.); the NDA 19618 record on Drugs@FDA; every mesalamine label on DailyMed.
Highlights of the record
FDA label of August 27, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageAPRISO ® is indicated for the maintenance of remission of ulcerative colitis in adults.
Forms and strengths
- 0.375 g
- 1.2 g
- 250 mg
- 375 mg
- 400 mg
- 500 mg
- 800 mg
- 1000 mg
- 4 g/60ml
Delayed-release tablet; extended-release capsule; suppository; suspension; kit.
On the market
- Earliest approval on file
- December 24, 1987 Rowasa, Mylan Speciality Lp; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 35 first September 17, 2004; 31 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 38 of which 34 under generic applications, 4 under brand applications, repackagers included
- Last listed patent
- May 1, 2030 Apriso capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.781 per tablet Mesalamine DR 1.2 g tablet
- Shortage (FDA)
- None current 3 past records
- Recalls by its makers (FDA)
- 6 since 2013 0 Class I among all firms' recalls; latest February 5, 2024; 2 more by firms not listed as its makers
- FAERS reports
- 55,833 through July 30, 2026
What is mesalamine used for?
From the label: indications and usageAPRISO ® is indicated for the maintenance of remission of ulcerative colitis in adults. APRISO is an aminosalicylate indicated for the maintenance of remission of ulcerative colitis in adults.
Conditions named in the indications of mesalamine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Aminosalicylate.
Source: FDA drug label (APRISO), Salix Pharmaceuticals, Inc., effective August 27, 2026 (SPL set 7951139c-b271-45a4-b523-34b23800917b), via openFDA; the full label on DailyMed
Is there a generic for mesalamine (Pentasa)?
The FDA approved the first generic mesalamine on September 17, 2004. 35 generic applications are approved; 31 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists mesalamine from 34 labelers under a generic (ANDA) application and from 4 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Pentasa capsules; a patent listed only for Apriso capsules runs to May 1, 2030. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1987 earliest approval on file
- 2004 first generic approved
- 2030 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for mesalamine (Pentasa)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.781 per Mesalamine DR 1.2 g tablet, down 23% from $1.01 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Mesalamine DR 1.2 g tablet (generic)
- Lialda DR 1.2 g tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Mesalamine 1,000 mg supp | Generic | $1.28 per unit | n/a | -19% |
| Mesalamine 4 g/60 mL enema | Generic | $0.0984 per mL | n/a | -11% |
| Mesalamine 4 g/60 mL kit | Generic | $134.90 per kit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +16% |
| Mesalamine 800 mg DR tablet | Generic | $4.02 per tablet | $120.61 | -8% |
| Mesalamine DR 1.2 g tablet | Generic | $0.781 per tablet | $23.43 | -23% |
| Mesalamine DR 400 mg capsule | Generic | $2.70 per capsule | $80.97 | +24% |
| Mesalamine ER 0.375 gram capsule | Generic | $0.478 per capsule | $14.34 | +4% |
| Canasa 1,000 mg suppository | Brand | $37.11 per suppository many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -0.5% |
| Lialda DR 1.2 g tablet | Brand | $8.95 per tablet | $268.40 | -0.3% |
| Pentasa 250 mg capsule | Brand | $2.90 per capsule | $87.03 | -0.4% |
| Pentasa 500 mg capsule | Brand | $5.83 per capsule | $174.79 | +0.2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is mesalamine in shortage?
No mesalamine presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 3 records are all marked to be discontinued, the latest updated September 16, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Mesalamine, Capsule, Extended Release, .375 g (NDC 0378-1375-78) | Mylan Pharmaceuticals Inc., a Viatris Company | To Be Discontinued | August 25, 2026 |
| Pentasa, Capsule, Extended Release, 250 mg (NDC 54092-189-81) | Takeda Pharmaceuticals USA Inc. | To Be Discontinued | September 16, 2026 |
| Pentasa, Capsule, Extended Release, 500 mg (NDC 54092-191-12) | Takeda Pharmaceuticals USA Inc. | To Be Discontinued | September 16, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has mesalamine been recalled?
The FDA's Enforcement Report lists 8 recalls naming mesalamine since 2013: 0 Class I (the most serious), 7 Class II, 1 Class III; 1 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of mesalamine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 5, 2024 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | Failed Dissolution Specifications: Out of specification for dissolution. |
| January 18, 2024 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. |
| October 30, 2020 | Class II | AVKARE Inc. | Failed Dissolution Specifications |
| October 28, 2020 | Class II | Teva Pharmaceuticals USA | Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing. |
| February 20, 2020 | Class II | Teva Pharmaceuticals USA | Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing. |
| December 2, 2016 | Class III | Shire PLC | Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules |
| May 20, 2014 | Class II | Cambrex Charles City Inc not a listed maker | Presence of Particulate Matter: Stainless steel in a chemical reactor dissolved into the API solution and was detected in the finished product. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: MESALAMINE DR, Capsule, 400 mg may have potentially been mislabeled as the following drug: CHLOROPHYLLIN COPPER COMPLEX, Tablet, 100 mg … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the mesalamine label say about other medicines?
The mesalamine label names 4 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name mesalamine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Azathioprine | drug interactions | DRUG INTERACTIONS 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: |
| Epinephrine | warnings and precautions | The alternatives to using epinephrine in a life-threatening situation may not be satisfactory. |
| Mercaptopurine | drug interactions | Azathioprine or 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. |
| Sulfasalazine | warnings and precautions | As with sulfasalazine, mesalamine-induced hypersensitivity reactions may present as internal organ involvement, including myocarditis, pericarditis, nephritis, hepatitis, pneumonitis and hematologic abnormalities. |
Other labels that name mesalamine
Source: FDA drug label (APRISO), Salix Pharmaceuticals, Inc., effective August 27, 2026 (SPL set 7951139c-b271-45a4-b523-34b23800917b), via openFDA; the full label on DailyMed
What do FAERS reports show for mesalamine?
The FDA Adverse Event Reporting System holds 55,833 reports that list mesalamine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,749 are coded as a death and 17,399 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as mesalamine?
4 other medicines are given the same way (oral) and in the same FDA class as mesalamine or labeled mainly for the same use (crohn's disease and ulcerative colitis), the same class first. Crohn's disease and ulcerative colitis lists all 29 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Sulfasalazine | Crohn's disease and ulcerative colitis | 5 labelers | $0.199 per tablet 500 mg tablet | No current entry |
| Balsalazide | Crohn's disease and ulcerative colitis | 9 labelers | $0.344 per capsule 750 mg capsule | No current entry |
| Olsalazine | Crohn's disease and ulcerative colitis | none listed | $15.70 per capsule 250 mg capsule | No current entry |
| Etrasimod arginine | Crohn's disease and ulcerative colitis | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as mesalamine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does mesalamine compare with medicines for the same use?
3 side-by-side pages set mesalamine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to mesalamine
- 4 medicines for the same use
- Other aminosalicylates
- the pharmacologic class, with prices and generics
- Mesalamine side effects
- the label's list beside FAERS reports
- Mesalamine shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other