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Expected pharmacological effect
Causality assessment · Expected pharmacological effect
Ganciclovir and Neutropenia: 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.
Ganciclovir ↔ Neutropenia
n=531 co-reports · PRR 8.1 · ROR 8.5
Ganciclovir suppresses bone marrow and commonly causes neutropenia, which is dose-limiting and is accentuated by other myelosuppressive drugs; 531 co-reports give PRR 8.1. The label requires frequent blood-count monitoring and dose adjustment.
Regulatory basis: ganciclovir prescribing information — neutropenia and thrombocytopenia; blood-count monitoring.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Weeks of therapy |
| Strength | met | PRR 8.1 with 531 co-reports |
| Consistency | met | Consistent across cohorts |
| Specificity | not established | Neutropenia has many causes |
| Biological gradient | met | Dose-related |
| Plausibility | met | Known nucleoside-analogue marrow toxicity |
| Coherence | met | Fits ganciclovir's myelosuppression |
| Experiment | n/a | Often coded in trials |
| Analogy | met | Analogous to other myelosuppressive antivirals |
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 — IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients (NCT00294515)
| Adverse event | Valganciclovir up to 100 Days (n=164) · Valganciclovir up to 200 Days (n=156) | |
|---|---|---|
| Neutropenia | 3/164 | 9/156 |
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 →