Causality assessment · Expected pharmacological effect

Cyclosporine and Acute kidney injury: is the FAERS signal real?

n=1,777 co-reports · PRR 2.2 · ROR 2.2

Cyclosporine 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

Cyclosporine ↔ Acute kidney injury

n=1,777 co-reports · PRR 2.2 · ROR 2.2

Cyclosporine causes dose-related renal vasoconstriction and nephrotoxicity, both acutely and after chronic use; 1,777 co-reports give PRR 2.2. The label advises renal-function and level monitoring with dose adjustment.

Regulatory basis: cyclosporine prescribing information — nephrotoxicity; renal-function and trough-level monitoring.

Bradford Hill viewpoint	Status	Note
Temporality (necessary)	met	Days to weeks
Strength	met	PRR 2.2 with 1,777 co-reports
Consistency	met	Consistent across studies
Specificity	not established	Renal impairment is common post-transplant
Biological gradient	met	Level/dose-related
Plausibility	met	Known vasoconstriction mechanism
Coherence	met	Fits cyclosporine's renal effect
Experiment	n/a	Often monitored in trials
Analogy	met	Analogous to tacrolimus 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 — Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM) (NCT01950819)

Adverse event	Everolimus Plus@Reduced CNI (n=1014) · MPA Plus Standard@CNI (n=1012)
Acute kidney injury	46/1014	37/1012

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 →