Mesalamine and Pancreatitis: is the FAERS signal real?
Mesalamine ↔ Pancreatitis
Mesalamine (5-aminosalicylic acid) is the mainstay of ulcerative colitis treatment; acute pancreatitis is a rare, idiosyncratic effect (636 co-reports here, PRR 4.6) that appears shortly after the drug is started, and it recurs if the drug is reintroduced. The reaction is one reason a short drug holiday is considered when pancreatitis develops in inflammatory bowel disease.
Regulatory basis: mesalamine prescribing information — pancreatitis; drug-induced pancreatitis literature.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Onset within days to weeks |
| Strength | met | PRR 4.6, modest |
| Consistency | met | Reproduced across case reports |
| Specificity | not established | Not specific to mesalamine |
| Biological gradient | not established | Idiosyncratic (not dose-related) |
| Plausibility | met | Proposed immuno-allergic mechanism |
| Coherence | partial | Consistent with drug-induced pancreatitis |
| Experiment | n/a | Too rare for trial detection |
| Analogy | met | Analogous to sulfasalazine pancreatitis |
This table is this page's own qualitative read of the literature cited above, not an automated or citation-gated assessment — see the note at the bottom of this page.
✓ Trial evidence found — Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis (NCT01124149)
| Adverse event | MMX Mesalamine/ Mesalazine (Acute Phase) (n=717) · MMX Mesalamine/ Mesalazine (Maintenance Phase) (n=461) | |
|---|---|---|
| Pancreatitis acute | 1/717 | 0/461 |
Post-marketing signal terms appear in this trial's posted adverse-event tables; per-arm counts shown as affected/at-risk. View on ClinicalTrials.gov →