Two medicines, side by side
Mesalamine vs sulfasalazine
Mesalamine and sulfasalazine are both labeled for crohn's disease and ulcerative colitis. Drugs@FDA records approvals of mesalamine since 1987 and of sulfasalazine since 1950. Pharmacies paid $0.781 per mesalamine DR 1.2 g tablet and $0.199 per sulfasalazine 500 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like.
Check it at the source: the mesalamine FDA label on DailyMed (effective August 27, 2026); the sulfasalazine FDA label on DailyMed (effective May 29, 2026).
Highlights of the mesalamine record
Mesalamine (Pentasa) · label of August 27, 2026
Used for
From the label: indicationsAPRISO ® 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.
On the market
- Earliest approval on file
- December 24, 1987
- Generic labelers
- 34 labelers
- Pharmacy cost
- $0.781 per tablet
Supply and safety
- Shortage
- A presentation being discontinued
- Recalls
- 6
Highlights of the sulfasalazine record
Sulfasalazine (Azulfidine) · label of May 29, 2026
Used for
From the label: indicationsAZULFIDINE Tablets are indicated: • in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and • for the prolongation of the remission period between acute attacks of ulcerative colitis.
On the market
- Earliest approval on file
- June 20, 1950
- Generic labelers
- 5 labelers
- Pharmacy cost
- $0.199 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 0
Source: FDA drug labels via openFDA (Mesalamine label of August 27, 2026, Sulfasalazine label of May 29, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do mesalamine and sulfasalazine differ on the record?
Both are in FDA's class aminosalicylates.
Generics: mesalamine since 2004; sulfasalazine since 1973 (Drugs@FDA).
| Mesalamine | Sulfasalazine | |
|---|---|---|
| Labeled for | Crohn's disease and ulcerative colitis | Crohn's disease and ulcerative colitis, Rheumatoid arthritis |
| Pharmacologic class | Aminosalicylate | Aminosalicylate |
| How it works (label) | The mechanism of action of mesalamine (5-ASA) is not fully understood, but appears to be a local anti-inflammatory effect on colonic epithelial cells. | n/a |
| Half-life (label) | n/a | The observed plasma half-life for intravenous sulfasalazine is 7.6 ± 3.4 hours. |
| Earliest approval on file (Drugs@FDA) | December 24, 1987 | June 20, 1950 |
| First generic approved | September 17, 2004 | November 12, 1973 |
| Generic labelers (NDC) | 34 labelers | 5 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.781 per tablet (Mesalamine DR 1.2 g tablet) | $0.199 per tablet (Sulfasalazine 500 mg tablet) |
| 12-month price change | -23% | +10% |
| Boxed warning | No | No |
| Shortage now | A presentation being discontinued | No current entry |
| Recalls recorded | 6 | 0 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 55,833 | 77,784 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
Do their labels mention each other?
Mesalamine label, warnings and precautionsAs with sulfasalazine, mesalamine-induced hypersensitivity reactions may present as internal organ involvement, including myocarditis, pericarditis, nephritis, hepatitis, pneumonitis and hematologic abnormalities.
Source: FDA drug labels via openFDA
What next?
- Alternatives to mesalamine
- every medicine labeled for the same conditions