Two medicines, side by side
Budesonide vs mesalamine
Budesonide and mesalamine are both labeled for crohn's disease and ulcerative colitis. Drugs@FDA records approvals of budesonide since 1994 and of mesalamine since 1987. Pharmacies paid $0.498 per budesonide DR 3 mg capsule and $0.781 per mesalamine DR 1.2 g tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. Budesonide's other strengths are brand-only: $3.29 per mL (Eohilia 2 mg/10 mL packet). In FDA's classes, budesonide is a corticosteroid and mesalamine an aminosalicylate.
Check it at the source: the budesonide FDA label on DailyMed (effective October 11, 2019); the mesalamine FDA label on DailyMed (effective August 27, 2026).
Highlights of the budesonide record
Budesonide (Pulmicort) · label of October 11, 2019
Used for
From the label: indicationsPULMICORT RESPULES ® is an inhaled corticosteroid indicated for: • Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age ( 1 ) Limitations of Use: Not indicated for the relief of acute bronchospasm ( 1 ) 1.1 Maintenance Treatment of Asthma PULMICORT RESPULES is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. […]
On the market
- Earliest approval on file
- February 14, 1994
- Generic labelers
- 30 labelers
- Pharmacy cost
- $0.498 per capsule
Supply and safety
- Shortage
- No current entry
- Recalls
- 9
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
Source: FDA drug labels via openFDA (Budesonide label of October 11, 2019, Mesalamine label of August 27, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do budesonide and mesalamine differ on the record?
In FDA's classes, budesonide is a corticosteroid and mesalamine an aminosalicylate.
How each works, in its label's words: Budesonide, “Budesonide is an anti-inflammatory corticosteroid that exhibits potent glucocorticoid activity and weak mineralocorticoid activity.”; Mesalamine, “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.”
Generics: budesonide since 2008; mesalamine since 2004 (Drugs@FDA).
| Budesonide | Mesalamine | |
|---|---|---|
| Labeled for | Asthma, Allergies, Crohn's disease and ulcerative colitis | Crohn's disease and ulcerative colitis |
| Pharmacologic class | Corticosteroid | Aminosalicylate |
| How it works (label) | Budesonide is an anti-inflammatory corticosteroid that exhibits potent glucocorticoid activity and weak mineralocorticoid activity. | 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. |
| Half-life (label) | n/a | n/a |
| Earliest approval on file (Drugs@FDA) | February 14, 1994 | December 24, 1987 |
| First generic approved | November 18, 2008 | September 17, 2004 |
| Generic labelers (NDC) | 30 labelers | 34 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.498 per capsule (Budesonide DR 3 mg capsule) | $0.781 per tablet (Mesalamine DR 1.2 g tablet) |
| 12-month price change | -3% | -23% |
| Boxed warning | No | No |
| Shortage now | No current entry | A presentation being discontinued |
| Recalls recorded | 9 | 6 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 58,575 | 55,833 |
| 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)
What next?
- Alternatives to budesonide
- every medicine labeled for the same conditions