Causality assessment · Expected pharmacological effect

Losartan and Renal failure: is the FAERS signal real?

n=3,053 co-reports · PRR 2.8 · ROR 2.8

Losartan 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

Losartan ↔ Renal failure

n=3,053 co-reports · PRR 2.8 · ROR 2.8

Losartan is the prototype angiotensin-receptor blocker, and its renal effects mirror the class: reduced efferent-arteriolar tone and filtration pressure can precipitate or worsen renal failure (3,053 co-reports, PRR 2.8), particularly with volume depletion, bilateral renal-artery stenosis, or combined NSAID use. The signal is dominated by the drug's very large prescribing base rather than a property unique to losartan, and function usually recovers after the drug or precipitant is withdrawn.

Regulatory basis: losartan prescribing information — renal impairment; class effect of RAAS blockade.

Bradford Hill viewpoint	Status	Note
Temporality (necessary)	met	Creatinine rises after initiation
Strength	met	PRR 2.8, modest
Consistency	met	Consistent across the ARB class
Specificity	partial	Shared with ACE inhibitors and ARBs
Biological gradient	met	Worse with volume depletion
Plausibility	met	Consequence of RAAS blockade
Coherence	met	Fits the mechanism
Experiment	n/a	Not tested as a trial endpoint
Analogy	met	Analogous to ACE-inhibitor renal effects

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 losartan captured renal failure as a tracked adverse event in a usable structure. Trials of losartan measured renal function as a laboratory safety parameter rather than reporting renal failure as a structured adverse event.