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Causality: well established
Causality assessment · Causality: well established
Tacrolimus and Nephrotoxicity: is the FAERS signal real?
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.
Tacrolimus ↔ Nephrotoxicity
n=6,153 co-reports · PRR 5.6 · ROR 5.8
Tacrolimus, a calcineurin-inhibitor immunosuppressant used widely in transplantation, causes kidney injury in much the same way as cyclosporine — acute vasoconstriction and, over time, chronic damage — so its levels and kidney function are monitored closely and doses are minimised. The very high FAERS count (6,153 co-reports, PRR 5.6) reflects both the real effect and the drug's use in a very large transplant population.
Regulatory basis: tacrolimus prescribing information (nephrotoxicity warning; therapeutic drug and renal monitoring).
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Kidney function worsens during therapy and can improve with dose reduction |
| Strength | met | PRR 6 on a very large co-report count |
| Consistency | met | Reproduced across transplant medicine |
| Specificity | met | A calcineurin-inhibitor class effect |
| Biological gradient | met | Dose- and level-related |
| Plausibility | met | Renal vasoconstriction and chronic tubulointerstitial injury are the mechanisms |
| Coherence | met | Coheres with the labelled drug-level and renal monitoring |
| Experiment | partial | Dechallenge (dose reduction) often partly reverses it; no randomized trial |
| Analogy | met | Analogous to nephrotoxicity with cyclosporine |
This page's own qualitative read, not an automated/citation-gated assessment.
✗ No ClinicalTrials.gov results-posting trial in the top search hits for tacrolimus captured acute kidney injury as a coded event; kidney changes are captured through routine renal-function and drug-level monitoring rather than coded trial endpoints.