Causality assessment · Causality: well established

Indapamide and Hyponatraemia: is the FAERS signal real?

n=1,318 co-reports · PRR 28.2 · ROR 30.4

Indapamide side-effect profile All assessments See in the full list

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

Indapamide ↔ Hyponatraemia

n=1,318 co-reports · PRR 28.2 · ROR 30.4

Indapamide is a thiazide-like diuretic whose most consequential electrolyte effect is hyponatraemia (1,318 co-reports, PRR 28.2), especially in older women, where it can cause confusion, falls, and seizures. The mechanism combines diuretic-induced sodium loss with impaired urinary dilution; the label advises monitoring electrolytes, and the effect usually resolves on withdrawal.

Regulatory basis: indapamide prescribing information — hyponatraemia.

Bradford Hill viewpoint	Status	Note
Temporality (necessary)	met	Sodium falls over days to weeks
Strength	met	PRR 28.2, large
Consistency	met	Consistent across thiazide diuretics
Specificity	partial	Shared with thiazides
Biological gradient	met	Worse with higher doses and low intake
Plausibility	met	Diuretic-induced sodium loss
Coherence	met	Fits the mechanism
Experiment	n/a	Not a trial endpoint
Analogy	met	Analogous to thiazide hyponatraemia

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 — Efficacy and Safety of GMRx2 Compared to Dual Combinations for the Treatment of Hypertension (NCT04518293)

Adverse event	Not Randomized (n=859) · GMRx2 (n=551) · Dual - TA (n=282) · Dual - TI (n=276)
Hyponatremia	19/859	28/551	12/282	14/276

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 →