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Expected pharmacological effect
Causality assessment · Expected pharmacological effect
Fingolimod and Bradycardia: 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.
Fingolimod ↔ Bradycardia
n=34 co-reports · PRR 3.0 · ROR 3.1
Fingolimod causes an initial dose-dependent bradycardia from S1P-receptor-mediated cardiac effects and carries a first-dose monitoring requirement; 34 co-reports give PRR 3.0. The label advises observation after the first dose and cardiac assessment.
Regulatory basis: fingolimod (Gilenya) prescribing information — first-dose bradycardia; post-dose cardiac monitoring.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | First hours after the first dose |
| Strength | met | PRR 3.0 with 34 co-reports |
| Consistency | met | Consistent across studies |
| Specificity | not established | Bradycardia is common |
| Biological gradient | met | Clear dose relation |
| Plausibility | met | Known S1P-receptor mechanism |
| Coherence | met | Fits fingolimod's cardiac effect |
| Experiment | n/a | Monitored in trials by design |
| Analogy | met | Analogous to other S1P-modulator bradycardia |
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 — STudy to vAlidate telemetRic ECG Systems for firsT Dose Administration of Fingolimod (START) (NCT01585298)
| Adverse event | Fingolimod (n=6998) |
|---|---|
| Bradycardia | 24/6998 |
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 →