Aspirin vs Mesalamine: side effects in FDA adverse event reports
At a glance
| Aspirin | Mesalamine | |
|---|---|---|
| Drug class | Nonsteroidal Anti-inflammatory Drug, Platelet Aggregation Inhibitor | Aminosalicylate |
| Brand names | Cardiaspirin Protect | – |
| FAERS reports | 533,828 | 55,824 |
| Serious | 71% | 75% |
| Death outcome | 48,985 | 2,749 |
| Boxed warning | No | No |
Signals both drugs share
| Reaction | Aspirin | Mesalamine | Label screen (A / B) |
|---|---|---|---|
| Radiculopathy | 364 · PRR 6.1 | 228 · PRR 35.5 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Aspirin
- None stood out among the strongest labeled signals.
Labeled signals distinctive to Mesalamine
- Rectal tenesmus — n=120, PRR 40.5 Labeled (related wording)
Common questions
Which has more reported side effects, Aspirin or Mesalamine?
Aspirin has 533,828 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 (71% vs 75%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Aspirin and Mesalamine share?
Both drugs carry disproportionality signals for radiculopathy. Shared signals often reflect a shared drug class or the condition both are used for.
Is Aspirin 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.