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Causality: well established
Causality assessment · Causality: well established
Lithium and Nephrogenic diabetes insipidus: 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.
Lithium ↔ Nephrogenic diabetes insipidus
n=304 co-reports · PRR 301.3 · ROR 305.0
Lithium blunts antidiuretic-hormone signalling in the collecting duct, producing nephrogenic diabetes insipidus with polyuria and polydipsia; 304 co-reports carry an extreme PRR of 301.3. The effect is concentration-related, often insidious over months to years and only partly reversible, so fluid balance and renal function are monitored during long-term therapy.
Regulatory basis: lithium (Eskalith) prescribing information — nephrogenic diabetes insipidus; renal-function monitoring during chronic use.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Insidious over months to years |
| Strength | met | PRR 301.3, an extreme signal |
| Consistency | met | Reproduced across cohorts |
| Specificity | met | Fairly specific to lithium |
| Biological gradient | met | Strong concentration dependence |
| Plausibility | met | Well-defined tubular mechanism |
| Coherence | met | Fits lithium's renal toxicity |
| Experiment | n/a | Too chronic for trial capture |
| Analogy | met | Analogous to demeclocycline-type diabetes insipidus |
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 lithium captured nephrogenic diabetes insipidus as a tracked adverse event in a usable structure. Bipolar maintenance trials rarely run long enough, or code polyuria/dipsia, to detect a chronic tubular toxicity.