Gabapentin vs Duloxetine: side effects in FDA adverse event reports
At a glance
| Gabapentin | Duloxetine | |
|---|---|---|
| Drug class | – | – |
| Brand names | – | Duloxetine Hydrochloride |
| FAERS reports | 362,501 | 69,247 |
| Serious | 63% | 71% |
| Death outcome | 34,219 | 7,117 |
| Boxed warning | No | Yes SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term st |
Signals both drugs share
| Reaction | Gabapentin | Duloxetine | Label screen (A / B) |
|---|---|---|---|
| Fibromyalgia | 1,880 · PRR 4.8 | 2,027 · PRR 10.1 | Not in label — unassessed / Likely indication confounding |
| Nephrogenic anaemia | 1,020 · PRR 15.9 | 285 · PRR 7.2 | Not in label — unassessed / Not in label — unassessed |
| Pre-existing condition improved | 630 · PRR 6.3 | 434 · PRR 8.2 | Not in label — unassessed / Not in label — unassessed |
| Hyperparathyroidism secondary | 524 · PRR 14.9 | 153 · PRR 7.2 | Not in label — unassessed / Not in label — unassessed |
| Rebound acid hypersecretion | 490 · PRR 10.8 | 180 · PRR 6.9 | 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 Duloxetine
- Hyperhidrosis — n=6,948, PRR 6.3 Labeled adverse reaction
- Suicidal ideation — n=6,330, PRR 8.3 Labeled — boxed warning
- Agitation — n=4,709, PRR 7.6 Labeled adverse reaction
- Irritability — n=4,502, PRR 9.0 Labeled adverse reaction
- Vertigo — n=3,929, PRR 7.7 Labeled adverse reaction
- Nightmare — n=2,838, PRR 9.9 Labeled adverse reaction
- Affect lability — n=2,801, PRR 45.6 Labeled (related wording)
- Serotonin syndrome — n=2,015, PRR 13.1 Labeled — boxed warning
Common questions
Which has more reported side effects, Gabapentin or Duloxetine?
Gabapentin has 362,501 FAERS reports and Duloxetine 69,247. 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 71%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Gabapentin and Duloxetine share?
Both drugs carry disproportionality signals for fibromyalgia, nephrogenic anaemia, pre-existing condition improved, hyperparathyroidism secondary, rebound acid hypersecretion. Shared signals often reflect a shared drug class or the condition both are used for.
Is Gabapentin or Duloxetine 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.