Causality assessment · Causality: well established

Ranolazine and QT prolongation: is the FAERS signal real?

n=99 co-reports · PRR 5.6 · ROR 5.6

Ranolazine side-effect profile All assessments See in the full list

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.

Causality: well established

Ranolazine ↔ QT prolongation

n=99 co-reports · PRR 5.6 · ROR 5.6

Ranolazine inhibits the late inward sodium current to relieve angina without changing heart rate or blood pressure, but it also modestly prolongs the QT interval — a labelled, dose-dependent effect that is larger in women and in hepatic impairment. In this dataset, electrocardiogram QT prolonged carries 99 co-reports (PRR 5.6). The label warns against combining it with other QT-prolonging drugs, caps the dose in liver disease, and makes congenital long-QT syndrome a contraindication.

Regulatory basis: ranolazine (Ranexa) prescribing information — QT prolongation; contraindicated in congenital long-QT syndrome.

Bradford Hill viewpoint	Status	Note
Temporality (necessary)	met	Interval prolongation visible within days
Strength	met	PRR 5.6, moderate
Consistency	met	Seen across trials and registries
Specificity	partial	Shared with other QT-prolonging drugs
Biological gradient	met	Greater at higher plasma levels
Plausibility	met	Direct effect on repolarisation
Coherence	met	Consistent with ECG data
Experiment	met	Serial ECGs in the pivotal trial showed the same effect
Analogy	met	Analogous to other QT-prolonging antianginals

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.

✗ No ClinicalTrials.gov results-posting trial in the top search hits for ranolazine captured qt prolongation as a tracked adverse event in a usable structure. The pivotal ranolazine trial measured QT change on protocol electrocardiograms rather than reporting it as a coded adverse event.