Causality assessment · Causality: well established

Amphotericin B and Acute kidney injury: is the FAERS signal real?

n=436 co-reports · PRR 4.8 · ROR 5.0

Amphotericin B 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

Amphotericin B ↔ Acute kidney injury

n=436 co-reports · PRR 4.8 · ROR 5.0

Amphotericin B is classically nephrotoxic, causing dose-dependent renal injury with electrolyte wasting that frequently limits therapy; 436 co-reports give PRR 4.8. The label advises renal monitoring, hydration and electrolyte replacement.

Regulatory basis: amphotericin B prescribing information — nephrotoxicity with renal-function and electrolyte monitoring.

Bradford Hill viewpoint	Status	Note
Temporality (necessary)	met	Days to weeks
Strength	met	PRR 4.8 with 436 co-reports
Consistency	met	Consistent across cohorts
Specificity	not established	Acute kidney injury has many causes
Biological gradient	met	Clear dose gradient
Plausibility	met	Known membrane-pore mechanism
Coherence	met	Fits amphotericin's tubular toxicity
Experiment	n/a	Often captured in trials
Analogy	met	Analogous to other nephrotoxic antifungals

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 — High-Dose Fluconazole for the Treatment of Cryptococcal Meningitis in HIV-Infected Individuals (NCT00885703)

Adverse event	Stage 1: 1200mg Fluconazole (n=22) · Stage 1: 1600mg Fluconazole (n=26) · Stage 1: 2000mg Fluconazole (n=24) · Stage 1: Ampho B (n=24)
Acute kidney injury	1/22	0/26	0/24	0/24

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 →