Riociguat and Hypotension: is the FAERS signal real?
Riociguat ↔ Hypotension
Riociguat stimulates soluble guanylate cyclase to relax vascular smooth muscle, lowering pulmonary and systemic pressures; hypotension is therefore expected (3,401 co-reports, PRR 11.2), particularly when combined with nitrates or PDE5 inhibitors, which is why the label contraindicates that combination. Syncope and symptomatic hypotension require dose titration and blood-pressure monitoring in pulmonary-hypertension use.
Regulatory basis: riociguat (Adempas) prescribing information — hypotension; contraindicated with nitrates and PDE5 inhibitors.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Blood-pressure fall is immediate |
| Strength | met | PRR 11.2, large |
| Consistency | met | Seen across trials and practice |
| Specificity | partial | Shared with PDE5 inhibitors and nitrates |
| Biological gradient | met | Dose-related |
| Plausibility | met | Direct vasodilation mechanism |
| Coherence | met | Fits the mechanism |
| Experiment | met | Trials measured blood-pressure reduction |
| Analogy | met | Analogous to PDE5-inhibitor hypotension |
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 to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH) (NCT00810693)
| Adverse event | Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT (n=254) · Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT (n=63) · Placebo (n=126) | ||
|---|---|---|---|
| Hypotension | 1/254 | 0/63 | 0/126 |
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 →