Causality assessment · Causality: well established

Droperidol and QT prolongation: is the FAERS signal real?

n=39 co-reports · PRR 14.1 · ROR 14.4

Droperidol 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

Droperidol ↔ QT prolongation

n=39 co-reports · PRR 14.1 · ROR 14.4

Droperidol is a butyrophenone antiemetic/sedative that prolongs the QT interval and has caused fatal torsades de pointes; the FDA added a boxed warning in 2001 requiring a baseline 12-lead ECG and continuous monitoring before use. In this dataset, electrocardiogram QT prolonged carries 39 co-reports (PRR 14.1) — a small count because ECG-mandated use is now highly restricted, but the signal itself is well established.

Regulatory basis: droperidol (Inapsine) prescribing information — boxed warning for QT prolongation and torsades de pointes (FDA 2001).

Bradford Hill viewpoint	Status	Note
Temporality (necessary)	met	Interval prolongation within minutes to hours
Strength	met	PRR 14.1, large
Consistency	met	Reproduced in case series
Specificity	partial	Shared with other QT-prolonging drugs
Biological gradient	met	Dose-related
Plausibility	met	Effect on cardiac repolarisation
Coherence	met	Fits the pharmacology
Experiment	met	ECG monitoring is mandated because of it
Analogy	met	Analogous to haloperidol and ziprasidone

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 — E7 TCR T Cells for Human Papillomavirus-Associated Cancers (NCT02858310)

Adverse event	Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells (n=3) · Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells (n=3) · Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells (n=6) · Phase II Cohort; Arm 2: Phase II: 1 x 10^11 E7 Cells (n=18)
Activated partial thromboplastin time prolonged	0/3	0/3	0/6	1/18
Investigations - Other, specify: Prolonged QTcB interval (EKG)	0/3	0/3	0/6	1/18

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 →