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Causality assessment · Causality: well established

Lithium and Hypothyroidism: is the FAERS signal real?

n=224 co-reports · PRR 5.9 · ROR 6.0
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.
Causality: well established

Lithium ↔ Hypothyroidism

n=224 co-reports · PRR 5.9 · ROR 6.0

Lithium concentrates in the thyroid and interferes with the synthesis and release of thyroid hormone, so it commonly causes hypothyroidism and, less often, goitre or hyperthyroidism. The effect is dose-related, is more common in women and in those with pre-existing thyroid antibodies, and is managed by thyroid-hormone replacement without necessarily stopping the lithium. The 224 co-reports (PRR 5.9) reflect both the real effect and the fact that lithium is typically taken for years, giving the thyroid change time to emerge and be detected on routine testing.

Regulatory basis: lithium prescribing information (thyroid dysfunction; routine thyroid-function monitoring). Established lithium-thyroid literature.

Bradford Hill viewpointStatusNote
Temporality (necessary)metHypothyroidism emerges during long-term therapy and responds to hormone replacement
StrengthpartialPRR 6 on a modest co-report count
ConsistencymetReproduced across decades of lithium-thyroid studies
SpecificitymetA recognised lithium effect, though other drugs can also cause hypothyroidism
Biological gradientmetDose-related and commoner with thyroid antibodies and in women
PlausibilitymetInhibition of thyroid-hormone synthesis/release is the proposed mechanism
CoherencemetCoheres with the labelled routine thyroid monitoring
ExperimentpartialDechallenge (and/or replacement therapy) manages it; no randomized trial
AnalogymetAnalogous to hypothyroidism from amiodarone and interferon

This page's own qualitative read, not an automated/citation-gated assessment.

✗ No ClinicalTrials.gov results-posting trial in the top search hits for lithium captured hypothyroidism; the effect is found by routine thyroid-function testing during long-term lithium therapy, not in trial AE tables.