Causality assessment · Expected pharmacological effect

Mannitol and Renal failure: is the FAERS signal real?

n=592 co-reports · PRR 19.0 · ROR 21.4

Mannitol 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.

Expected pharmacological effect

Mannitol ↔ Renal failure

n=592 co-reports · PRR 19.0 · ROR 21.4

Mannitol is an osmotic diuretic; at high doses or in patients with pre-existing renal impairment it can accumulate, cause osmotic nephrosis, and precipitate or worsen acute renal failure (592 co-reports, PRR 19.0). Crystallisation in the tubules and shifts in fluid balance contribute, which is why the label advises against use in established anuria and calls for careful dosing in renal impairment.

Regulatory basis: mannitol prescribing information — renal failure; osmotic-nephrosis literature.

Bradford Hill viewpoint	Status	Note
Temporality (necessary)	met	Renal injury follows high-dose therapy
Strength	met	PRR 19.0, large
Consistency	met	Recognised in case series
Specificity	partial	Shared with other osmotic agents
Biological gradient	met	Dose-related accumulation
Plausibility	met	Osmotic-nephrosis mechanism
Coherence	met	Fits the mechanism
Experiment	n/a	Not tested as a trial endpoint
Analogy	met	Analogous to other osmotic-diuretic nephrotoxicity

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 — Adaptive COVID-19 Treatment Trial 4 (ACTT-4) (NCT04640168)

Adverse event	Remdesivir Plus Baricitinib (n=503) · Remdesivir Plus Dexamethasone (n=482)
Acute kidney injury	9/503	4/482
Renal failure	2/503	0/482

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 →