Valsartan and Acute kidney injury: is the FAERS signal real?
Valsartan ↔ Acute kidney injury
Valsartan is an angiotensin-receptor blocker; blocking angiotensin II dilates the efferent arteriole and lowers glomerular filtration pressure, so acute kidney injury is an expected, mechanism-based effect (3,260 co-reports, PRR 4.4), concentrated in patients who are volume-depleted, have renal-artery stenosis, or take NSAIDs or diuretics. The label advises monitoring renal function, and the effect typically reverses when the drug or precipitant is withdrawn.
Regulatory basis: valsartan (Diovan) prescribing information — renal impairment and acute kidney injury.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Creatinine rises within days |
| Strength | met | PRR 4.4, moderate |
| 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 efferent-arteriolar dilation |
| Coherence | met | Fits the mechanism |
| Experiment | n/a | Not tested as a trial endpoint |
| Analogy | met | Direct class analogy to ACE inhibitors |
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 — Safety and Tolerability During Open-label Treatment With LCZ696 in Patients With CHF and Reduced Ejection Fraction (NCT02226120)
| Adverse event | LCZ696 (n=1980) |
|---|---|
| Acute kidney injury | 18/1980 |
| Renal impairment | 8/1980 |
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 →