← All causality assessments
Causality: well established
Causality assessment · Causality: well established
Propofol and Infusion syndrome: 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.
Propofol ↔ Infusion syndrome
n=910 co-reports · PRR 12.9 · ROR 13.2
Propofol is an intravenous anaesthetic; with high-dose, prolonged infusion it causes propofol-related infusion syndrome — metabolic acidosis, rhabdomyolysis, cardiac failure, and renal injury (rhabdomyolysis 910 co-reports here, PRR 12.9). The syndrome is a direct consequence of impaired mitochondrial fatty-acid oxidation, and the label advises limiting dose and duration and monitoring for the early signs.
Regulatory basis: propofol prescribing information — propofol-related infusion syndrome; dose/duration limits.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Onset during prolonged infusion |
| Strength | met | PRR 12.9, large |
| Consistency | met | Reproduced across case series |
| Specificity | met | Fairly specific to propofol |
| Biological gradient | met | Dose- and duration-related |
| Plausibility | met | Mitochondrial fatty-acid oxidation defect |
| Coherence | met | Fits the mechanism |
| Experiment | n/a | Rare in trials |
| Analogy | met | Analogous to other anaesthetic-related myotoxicity |
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 propofol captured infusion syndrome as a tracked adverse event in a usable structure. Infusion syndrome is rare and confined to high-dose prolonged use, so anaesthetic trials did not capture it as a coded event.