Diclofenac vs Baclofen: side effects in FDA adverse event reports
At a glance
| Diclofenac | Baclofen | |
|---|---|---|
| Drug class | – | gamma-Aminobutyric Acid-ergic Agonist |
| Brand names | Diclofenac Sodium | – |
| FAERS reports | 149,524 | 85,584 |
| Serious | 60% | 67% |
| Death outcome | 13,473 | 6,458 |
| Boxed warning | Yes RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased ris | No |
Signals both drugs share
No strong shared signal after removing coding and lab terms.
Labeled signals distinctive to Diclofenac
- Glossodynia — n=7,814, PRR 75.3 Labeled (related wording)
- Duodenal ulcer perforation — n=5,286, PRR 370.3 Labeled — boxed warning
- Subcutaneous drug absorption impaired — n=259, PRR 127.5 Labeled (related wording)
- Hepatic enzyme — n=96, PRR 313.9 Labeled (related wording)
- Intestinal diaphragm disease — n=88, PRR 65.3 Labeled (related wording)
Labeled signals distinctive to Baclofen
- None stood out among the strongest labeled signals.
Common questions
Which has more reported side effects, Diclofenac or Baclofen?
Diclofenac has 149,524 FAERS reports and Baclofen 85,584. 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 (60% vs 67%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Diclofenac and Baclofen share?
They share no strong flagged signal after artifacts and lab terms are removed.
Is Diclofenac or Baclofen 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.