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Causality: well established
Causality assessment · Causality: well established
Isoniazid and Peripheral neuropathy: 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.
Isoniazid ↔ Peripheral neuropathy
n=227 co-reports · PRR 3.1 · ROR 3.2
Isoniazid is a first-line antituberculosis drug; by competing with pyridoxine it causes a dose-related peripheral neuropathy, which appears here as 227 co-reports (PRR 3.1). Risk rises with malnutrition, diabetes, alcohol use, and slow acetylator status, and the label advises pyridoxine supplementation to prevent it.
Regulatory basis: isoniazid prescribing information — peripheral neuropathy and pyridoxine supplementation.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Neuropathy after weeks of therapy |
| Strength | met | PRR 3.1, modest |
| Consistency | met | Reproduced across case series |
| Specificity | met | Fairly specific to isoniazid |
| Biological gradient | met | Dose-related |
| Plausibility | met | Pyridoxine antagonism |
| Coherence | met | Fits the mechanism |
| Experiment | met | Trials recorded neuropathy |
| Analogy | met | Analogous to other pyridoxine-antagonist drugs |
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 — Shortening Treatment by Advancing Novel Drugs (NCT02342886)
| Adverse event | DS-TB: 4 Months Moxifloxacin + PA-824 (100 mg) + Pyrazinamide (n=65) · DS-TB: 4 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide (n=71) · DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide (n=67) · DS-TB: 2 Months HRZE/ 4 Months HR (n=68) | |||
|---|---|---|---|---|
| Neuropathy peripheral | 1/65 | 0/71 | 2/67 | 4/68 |
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 →