Gabapentin vs Tramadol: side effects in FDA adverse event reports
At a glance
| Gabapentin | Tramadol | |
|---|---|---|
| Drug class | – | – |
| Brand names | – | Tramadol Hydrochloride |
| FAERS reports | 362,501 | 37,420 |
| Serious | 63% | 90% |
| Death outcome | 34,219 | 7,344 |
| Boxed warning | No | Yes SERIOUS AND LIFE-THREATENING RISKS FROM USE OF TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS Addiction, Abuse, and Misuse Because the use of tramadol hydrochl |
Signals both drugs share
No strong shared signal after removing coding and lab terms.
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 Tramadol
- Dependence — n=7,827, PRR 91.9 Labeled adverse reaction
- Muscle injury — n=884, PRR 67.6 Labeled adverse reaction
- Peripheral venous disease — n=669, PRR 112.8 Labeled (related wording)
- Nasal oedema — n=208, PRR 73.5 Labeled (related wording)
- Subcutaneous drug absorption impaired — n=67, PRR 78.5 Labeled (related wording)
Common questions
Which has more reported side effects, Gabapentin or Tramadol?
Gabapentin has 362,501 FAERS reports and Tramadol 37,420. 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 90%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Gabapentin and Tramadol share?
They share no strong flagged signal after artifacts and lab terms are removed.
Is Gabapentin or Tramadol 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.