Prednisone vs Mesalamine: side effects in FDA adverse event reports
At a glance
| Prednisone | Mesalamine | |
|---|---|---|
| Drug class | Corticosteroid | Aminosalicylate |
| Brand names | – | – |
| FAERS reports | 499,794 | 55,824 |
| Serious | 79% | 75% |
| Death outcome | 52,153 | 2,749 |
| Boxed warning | No | No |
Signals both drugs share
| Reaction | Prednisone | Mesalamine | Label screen (A / B) |
|---|---|---|---|
| Deep vein thrombosis postoperative | 1,287 · PRR 80.1 | 276 · PRR 61.5 | Not in label — unassessed / Not in label — unassessed |
| Dislocation of vertebra | 1,083 · PRR 39.3 | 270 · PRR 51.8 | Not in label — unassessed / Not in label — unassessed |
| Adjustment disorder with depressed mood | 1,072 · PRR 47.2 | 267 · PRR 57.3 | Not in label — unassessed / Not in label — unassessed |
| Lupus vulgaris | 814 · PRR 91.1 | 281 · PRR 116.2 | Not in label — unassessed / Not in label — unassessed |
| Retinitis | 721 · PRR 31.4 | 290 · PRR 78.9 | Likely indication confounding / Not in label — unassessed |
| Steroid dependence | 506 · PRR 61.4 | 207 · PRR 121.1 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Prednisone
- Duodenal ulcer perforation — n=4,860, PRR 82.3 Labeled (related wording)
- Nocardiosis — n=888, PRR 21.9 Labeled (related wording)
- Steroid diabetes — n=492, PRR 21.0 Labeled (related wording)
- Secondary immunodeficiency — n=420, PRR 22.4 Labeled (related wording)
Labeled signals distinctive to Mesalamine
- Rectal tenesmus — n=120, PRR 40.5 Labeled (related wording)
Common questions
Which has more reported side effects, Prednisone or Mesalamine?
Prednisone has 499,794 FAERS reports and Mesalamine 55,824. More reports does not mean more dangerous: volume follows how widely and how long a drug has been used, prescription vs over-the-counter status, and publicity. The seriousness share (79% vs 75%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Prednisone and Mesalamine share?
Both drugs carry disproportionality signals for deep vein thrombosis postoperative, dislocation of vertebra, adjustment disorder with depressed mood, lupus vulgaris, retinitis. Shared signals often reflect a shared drug class or the condition both are used for.
Is Prednisone or Mesalamine safer?
FAERS cannot answer that: it has no denominator and no comparator. Use this page to see which risks are already on each label and which signals are unlabeled, then check the prescribing information and your clinician for your situation.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, openFDA count queries for seriousness and deaths. Pair chosen because it is a commonly searched comparison. Generated 2026-10-08.