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Expected pharmacological effect
Causality assessment · Expected pharmacological effect
Diltiazem (non-dihydropyridine CCBs) and Bradycardia / AV block: 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.
Diltiazem (non-dihydropyridine CCBs) ↔ Bradycardia / AV block
n=540 co-reports · PRR 6.3 · ROR 6.3
Diltiazem, like verapamil, slows AV-node conduction by blocking calcium channels, so bradycardia and heart block are expected, dose-related consequences of its mechanism rather than idiosyncratic reactions. The risk is greater with other rate-slowing drugs and in patients with conduction disease or heart failure, which is why it is used cautiously in those settings. The 540 co-reports (PRR 6.3) reflect both the real effect and the drug's wide use for hypertension and rate control.
Regulatory basis: diltiazem prescribing information (bradycardia/AV block warning; caution in heart failure).
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Bradycardia occurs during treatment and resolves after withdrawal |
| Strength | met | PRR 6 on a moderate co-report count |
| Consistency | met | Reproduced across calcium-channel-blocker practice |
| Specificity | met | Shared with verapamil and other AV-node-slowing drugs |
| Biological gradient | partial | Dose-related and worse with conduction disease |
| Plausibility | met | AV-node calcium-channel blockade is the mechanism |
| Coherence | met | Coheres with the labelled cautions |
| Experiment | partial | Dechallenge (withdrawal) reverses it; no randomized trial |
| Analogy | met | Analogous to bradycardia with verapamil and beta-blockers |
This page's own qualitative read, not an automated/citation-gated assessment.
✗ No ClinicalTrials.gov results-posting trial in the top search hits for diltiazem captured bradycardia or AV block as a coded event; the effect is handled by clinical and ECG monitoring rather than coded into trial AE tables.