Epoprostenol and Headache: is the FAERS signal real?
Epoprostenol ↔ Headache
Epoprostenol is a prostacyclin (PGI2) infusion that dilates systemic and pulmonary vessels; headache from vasodilation is among its most common and dose-limiting effects (2,295 co-reports, PRR 5.9), along with flushing, jaw pain, and diarrhoea. These effects are intrinsic to prostacyclin pharmacology and are managed by titrating the continuous infusion rather than by stopping therapy.
Regulatory basis: epoprostenol (Flolan) prescribing information — headache and vasodilator effects.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Headache within hours of infusion |
| Strength | met | PRR 5.9, moderate |
| Consistency | met | Consistent across prostacyclin use |
| Specificity | partial | Shared with other prostacyclins |
| Biological gradient | met | Dose-related |
| Plausibility | met | Vasodilation mechanism |
| Coherence | met | Fits the mechanism |
| Experiment | met | Trials recorded vasodilator effects |
| Analogy | met | Analogous to treprostinil headache |
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 — A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR) (NCT04576988)
| Adverse event | Sotatercept Plus Background PAH Therapy (DBPC Period) (n=163) · Placebo Plus Background PAH Therapy (DBPC Period) (n=160) · Sotatercept Plus Background PAH Therapy (LTDB Period) (n=158) · Placebo Plus Background PAH Therapy (LTDB Period) (n=142) | |||
|---|---|---|---|---|
| Headache | 33/163 | 24/160 | 9/158 | 6/142 |
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 →