Causality assessment · Expected pharmacological effect

Voriconazole and Hallucination: is the FAERS signal real?

n=704 co-reports · PRR 6.6 · ROR 6.7

Voriconazole 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.

Expected pharmacological effect

Voriconazole ↔ Hallucination

n=704 co-reports · PRR 6.6 · ROR 6.7

Voriconazole is a triazole antifungal; in addition to visual disturbances and photosensitivity, it causes hallucinations at a rate higher than other azoles (hallucination 704 co-reports here, PRR 6.6), especially with high plasma concentrations. The effect is dose-related and reversible, and monitoring of trough levels is advised.

Regulatory basis: voriconazole prescribing information — visual and CNS adverse events including hallucinations.

Bradford Hill viewpoint	Status	Note
Temporality (necessary)	met	Hallucinations during therapy
Strength	met	PRR 6.6, moderate
Consistency	met	Reproduced across series
Specificity	partial	Shared across the azole class
Biological gradient	met	Related to plasma concentration
Plausibility	met	Central CNS effect of the triazole
Coherence	met	Fits the pharmacology
Experiment	met	Trials recorded CNS events
Analogy	met	Analogous to other azole CNS effects

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 — Voriconazole (Vfend) Drug Use Investigation (Regulatory Post Marketing Commitment Plan) (NCT01151085)

Adverse event	Voriconazole (n=946)
Hallucination	11/946
Hallucination, visual	3/946
Hallucination, auditory	1/946

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 →