Pregabalin and Oedema peripheral: is the FAERS signal real?
Pregabalin ↔ Oedema peripheral
Pregabalin, like gabapentin, reduces excitatory neurotransmitter release at calcium channels and commonly causes peripheral oedema through vasodilation and fluid retention (5,399 co-reports, PRR 3.5), along with weight gain, somnolence, and dizziness. The oedema is dose-related and usually benign but can be mistaken for heart or kidney failure; pregabalin additionally carries a labelled risk of respiratory depression with opioids.
Regulatory basis: pregabalin (Lyrica) prescribing information — peripheral oedema; respiratory-depression warning with opioids.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Oedema develops over weeks |
| Strength | met | PRR 3.5, moderate |
| Consistency | met | Consistent across gabapentinoids |
| Specificity | partial | Shared with gabapentin |
| Biological gradient | met | Dose-related |
| Plausibility | met | Vasodilation and fluid-retention mechanism |
| Coherence | met | Fits the pharmacology |
| Experiment | met | Trials recorded oedema |
| Analogy | met | Direct class analogy to gabapentin |
This table is this page's own qualitative read of the literature cited above, not an automated or citation-gated assessment — see the note at the bottom of this page.
✓ Trial evidence found — Pregabalin Peripheral Neuropathic Pain Study (NCT00141219)
| Adverse event | Pregabalin (n=162) · Placebo (n=78) | |
|---|---|---|
| Face oedema | 10/162 | 1/78 |
| Oedema peripheral | 10/162 | 0/78 |
| Generalized oedema | 7/162 | 0/78 |
Post-marketing signal terms appear in this trial's posted adverse-event tables; per-arm counts shown as affected/at-risk. View on ClinicalTrials.gov →