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Causality: well established
Causality assessment · Causality: well established
Minocycline and Drug-induced lupus: 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.
Minocycline ↔ Drug-induced lupus
n=569 co-reports · PRR 29.6 · ROR 31.0
Minocycline is a well-recognised cause of drug-induced lupus, typically with arthralgia, myalgia and positive antinuclear antibodies that resolve after withdrawal; 569 co-reports give PRR 29.6. The label lists lupus-like syndrome among its hypersensitivity reactions.
Regulatory basis: minocycline prescribing information — lupus-like syndrome and autoimmune reactions.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Months of therapy |
| Strength | met | PRR 29.6 with 569 co-reports |
| Consistency | met | Reproduced across cohorts |
| Specificity | met | Fairly specific to minocycline |
| Biological gradient | not established | Not clearly dose-related |
| Plausibility | met | Plausible immune mechanism |
| Coherence | met | Fits tetracycline-induced autoimmunity |
| Experiment | n/a | Too chronic for trial capture |
| Analogy | met | Analogous to hydralazine/procainamide lupus |
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 minocycline captured drug-induced lupus as a tracked adverse event in a usable structure. Long-term minocycline trials for acne did not code drug-induced lupus as an adverse event.