Gabapentin vs Baclofen: side effects in FDA adverse event reports
At a glance
| Gabapentin | Baclofen | |
|---|---|---|
| Drug class | – | gamma-Aminobutyric Acid-ergic Agonist |
| Brand names | – | – |
| FAERS reports | 362,501 | 85,584 |
| Serious | 63% | 67% |
| Death outcome | 34,219 | 6,458 |
| Boxed warning | No | No |
Signals both drugs share
| Reaction | Gabapentin | Baclofen | Label screen (A / B) |
|---|---|---|---|
| Trigeminal neuralgia | 412 · PRR 6.5 | 207 · PRR 13.2 | Likely indication confounding / Not in label — unassessed |
| Hypertonic bladder | 263 · PRR 5.7 | 158 · PRR 14.2 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Gabapentin
- Infusion site pain — n=1,220, PRR 6.0 Labeled (related wording)
- Infusion site erythema — n=754, PRR 5.7 Labeled (related wording)
- Infusion site swelling — n=569, PRR 5.8 Labeled (related wording)
- Suspected suicide — n=441, PRR 5.8 Labeled (related wording)
- Infusion site infection — n=232, PRR 6.5 Labeled (related wording)
- Accidental death — n=229, PRR 8.0 Labeled (related wording)
Labeled signals distinctive to Baclofen
- None stood out among the strongest labeled signals.
Common questions
Which has more reported side effects, Gabapentin or Baclofen?
Gabapentin has 362,501 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 (63% vs 67%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Gabapentin and Baclofen share?
Both drugs carry disproportionality signals for trigeminal neuralgia, hypertonic bladder. Shared signals often reflect a shared drug class or the condition both are used for.
Is Gabapentin 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.