← All causality assessments
Expected pharmacological effect
Causality assessment · Expected pharmacological effect
Amlodipine (dihydropyridine CCBs) and Peripheral oedema: is the FAERS signal real?
A written Bradford Hill assessment of one drug–event pair. The grade is a judgement about the signal, not a statement that this drug causes this event in any one person; FAERS counts are reports, not rates.
Amlodipine (dihydropyridine CCBs) ↔ Peripheral oedema
n=4,541 co-reports · PRR 3.0 · ROR 3.0
Amlodipine, one of the most prescribed blood-pressure drugs, commonly causes ankle and leg swelling for the same reason as other dihydropyridines: it dilates the precapillary arterioles more than the veins, raising capillary pressure and pushing fluid into the tissues. The effect is dose-related and is often reduced by adding an ACE inhibitor or ARB. The very high FAERS count (4,541 co-reports, PRR 3.0) reflects both the real effect and amlodipine's enormous patient population.
Regulatory basis: amlodipine prescribing information (peripheral oedema as a common adverse reaction). Established dihydropyridine-oedema literature.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Oedema develops during treatment and resolves after withdrawal |
| Strength | met | PRR 3 with a very large co-report count — common but not highly disproportionate |
| Consistency | met | Reproduced across dihydropyridine trials |
| Specificity | met | A class effect of dihydropyridines, rare with verapamil/diltiazem |
| Biological gradient | partial | Dose-related |
| Plausibility | met | Precapillary arteriolar dilation raising capillary pressure is the mechanism |
| Coherence | met | Coheres with the labelled oedema and the RAAS-blocker combination strategy |
| Experiment | partial | Dechallenge (withdrawal) usually resolves it; no randomized trial |
| Analogy | met | Analogous to oedema with nifedipine and other dihydropyridines |
This page's own qualitative read, not an automated/citation-gated assessment.
✗ No ClinicalTrials.gov results-posting trial in the top search hits for amlodipine captured peripheral oedema as a coded event; the effect is characterised in antihypertensive trials and managed clinically rather than recorded as a single trial AE table.