Baclofen vs Meloxicam: side effects in FDA adverse event reports
At a glance
| Baclofen | Meloxicam | |
|---|---|---|
| Drug class | gamma-Aminobutyric Acid-ergic Agonist | Nonsteroidal Anti-inflammatory Drug |
| Brand names | – | – |
| FAERS reports | 85,584 | 57,729 |
| Serious | 67% | 58% |
| Death outcome | 6,458 | 3,732 |
| Boxed warning | No | Yes RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information |
Signals both drugs share
No strong shared signal after removing coding and lab terms.
Labeled signals distinctive to Baclofen
- None stood out among the strongest labeled signals.
Labeled signals distinctive to Meloxicam
- Duodenal ulcer perforation — n=648, PRR 35.1 Labeled — boxed warning
- Sleep disorder due to general medical condition, insomnia type — n=443, PRR 26.8 Labeled (related wording)
- Peripheral venous disease — n=305, PRR 30.0 Labeled (related wording)
- Rheumatoid lung — n=66, PRR 26.6 Labeled (related wording)
Common questions
Which has more reported side effects, Baclofen or Meloxicam?
Baclofen has 85,584 FAERS reports and Meloxicam 57,729. 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 (67% vs 58%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Baclofen and Meloxicam share?
They share no strong flagged signal after artifacts and lab terms are removed.
Is Baclofen or Meloxicam 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.