Quick answers
- What is Macitentan and tadalafil used for?
- The FDA-approved label (Opsynvi, Actelion Pharmaceuticals US, Inc., April 11, 2025) says: “OPSYNVI is a combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor, indicated for chronic treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adult patients of WHO functional class (FC) II–III. Individually, macitentan reduces the risk of clinical worsening events and hospitalization, and tadalafil improves exercise ability. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Macitentan and tadalafil have a boxed warning?
- Yes. The FDA label for Opsynvi has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Macitentan and tadalafil?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Macitentan and tadalafil been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Macitentan and tadalafil?
- 1 company lists prescription products of Macitentan and tadalafil in the FDA NDC Directory, including Actelion Pharmaceuticals US, Inc..
What Macitentan and tadalafil is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
OPSYNVI is a combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor, indicated for chronic treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adult patients of WHO functional class (FC) II–III. Individually, macitentan reduces the risk of clinical worsening events and hospitalization, and tadalafil improves exercise ability. …
— FDA label: Opsynvi, Actelion Pharmaceuticals US, Inc., effective April 11, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Opsynvi |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Actelion Pharmaceuticals US, Inc.2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA218490 OPSYNVI | Actelion | March 22, 2024 | 2, latest April 2, 2025 2025: REMS · 2024: REMS |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2677765, 2677771, 2677773, 2677775 |
|---|---|
| SPL set ID of the quoted label | 6945b183-18d3-40de-afd1-c88e33cc1a63 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA218490 |
| Active ingredients (FDA) | MACITENTAN / TADALAFIL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Opsynvi, Actelion Pharmaceuticals US, Inc., effective April 11, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →