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Expected pharmacological effect
Causality assessment · Expected pharmacological effect
Linezolid and Lactic acidosis: 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.
Linezolid ↔ Lactic acidosis
n=1,018 co-reports · PRR 23.2 · ROR 24.0
Linezolid is an oxazolidinone antibiotic; by inhibiting mitochondrial protein synthesis it can cause lactic acidosis, which appears here as 1,018 co-reports (PRR 23.2) and is more common with courses longer than two weeks. The effect is dose- and duration-related and usually reverses on withdrawal, and the label advises monitoring for recurrent nausea, acidosis, and low bicarbonate during prolonged therapy.
Regulatory basis: linezolid (Zyvox) prescribing information — lactic acidosis with prolonged use; monitoring guidance.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Onset after 1–2 weeks |
| Strength | met | PRR 23.2, large |
| Consistency | met | Reproduced across case series |
| Specificity | met | Fairly specific to linezolid |
| Biological gradient | met | Dose- and duration-related |
| Plausibility | met | Mitochondrial protein-synthesis inhibition |
| Coherence | met | Fits the mechanism |
| Experiment | n/a | Too rare for trial detection |
| Analogy | met | Analogous to other mitochondrial-toxin lactic acidosis |
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 linezolid captured lactic acidosis as a tracked adverse event in a usable structure. Lactic acidosis is uncommon and tied to prolonged courses, so short-course trials did not capture it as a coded event.