Causality assessment · Expected pharmacological effect

Treprostinil and Headache: is the FAERS signal real?

n=17,283 co-reports · PRR 4.7 · ROR 5.3

Treprostinil 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

Treprostinil ↔ Headache

n=17,283 co-reports · PRR 4.7 · ROR 5.3

Treprostinil, a prostacyclin analogue given by infusion or inhalation, produces the same vasodilator symptom cluster as epoprostenol, and headache dominates the reaction profile here (17,283 co-reports, PRR 4.7) — the count reflecting its use in large pulmonary-hypertension registries. Infusion-site pain, diarrhoea, and flushing accompany it, all intrinsic to prostacyclin effect.

Regulatory basis: treprostinil (Remodulin) prescribing information — headache and vasodilator effects.

Bradford Hill viewpoint	Status	Note
Temporality (necessary)	met	Headache soon after starting
Strength	met	PRR 4.7 with a very large count
Consistency	met	Consistent across prostacyclin registries
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 epoprostenol 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 — Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine (NCT00775463)

Adverse event	Placebo (n=76) · Treprostinil Diethanolamine (n=71)
Headache	32/76	52/71

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 →