Ziprasidone and QT prolongation: is the FAERS signal real?
Ziprasidone ↔ QT prolongation
Ziprasidone is an atypical antipsychotic with the largest QT effect of its class; the interval prolongation is dose-related and was prominent enough that its approval required food co-administration (to ensure absorption) and warnings about combining it with other QT-prolonging drugs. In this dataset, electrocardiogram QT prolonged carries 265 co-reports (PRR 8.9), and the label warns in patients with electrolyte disturbance or cardiac disease.
Regulatory basis: ziprasidone (Geodon) prescribing information — QT prolongation with dosing/food requirements.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Interval prolongation within days |
| Strength | met | PRR 8.9, moderate |
| Consistency | met | Reproduced across ECG studies |
| Specificity | partial | Shared with other antipsychotics |
| Biological gradient | met | Dose-dependent |
| Plausibility | met | Effect on cardiac repolarisation |
| Coherence | met | Fits the pharmacology |
| Experiment | met | ECG data from trials and safety studies |
| Analogy | met | Analogous to thioridazine and droperidol |
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 — The Modifying the Impact of ICU-Associated Neurological Dysfunction-USA (MIND-USA) Study (NCT01211522)
| Adverse event | Haloperidol (n=192) · Ziprasidone (n=190) · Placebo (n=184) | ||
|---|---|---|---|
| Torsades de pointes | 2/192 | 1/190 | 1/184 |
| Prolonged QTc | 13/192 | 20/190 | 10/184 |
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 →