Prescription medicine
Macitentan and tadalafil Brand names: Opsynvi
Macitentan and tadalafil (Opsynvi) is a prescription medicine with an FDA approval on record since 2024. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the macitentan and tadalafil FDA label on DailyMed (effective April 11, 2025, Actelion Pharmaceuticals US, Inc.); the NDA 218490 record on Drugs@FDA; every macitentan and tadalafil label on DailyMed.
Highlights of the record
FDA label of April 11, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
EMBRYO-FETAL TOXICITY.
OPSYNVI is contraindicated for use during pregnancy because it may cause fetal harm based on animal data [see Contraindications (4.1), Warnings and Precautions (5.1), Use in Specific Populations (8.1) ]. Therefore, for females of reproductive potential, exclude pregnancy before the start of treatment with OPSYNVI. Advise use of effective contraception before the initiation of treatment, during treatment, and for one month after stopping treatment with OPSYNVI [see Dosage and Administration (2.2), Use in Specific Populations (8.3) ]. When pregnancy is detected, discontinue OPSYNVI as soon as possible [see Warnings and Precautions (5.1) ]. WARNING: EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. Based on animal data, OPSYNVI may cause fetal harm if used during pregnancy ( 4.1 , 5.1 , 8.1 ). Females of reproductive potential: exclude pregnancy before start of treatment. Prevent pregnancy prior to initiation of treatment, during treatment and for one month after treatment by using effective methods of contraception ( 2.2 , 8.3 ). When pregnancy is detected, discontinue OPSYNVI as soon as possible ( 5.1 ).
Used for
From the label: indications and usageOPSYNVI 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.
Forms and strengths
- 10 mg / 20 mg
- 10 mg / 40 mg
Film-coated tablet.
On the market
- Earliest approval on file
- March 22, 2024 Opsynvi, Actelion; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- October 18, 2029 Opsynvi tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 24 through July 30, 2026
What is macitentan and tadalafil used for?
From the label: indications and usageOPSYNVI 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. ( 1.1 ) Individually, macitentan reduces the risk of clinical worsening events and hospitalization, and tadalafil improves exercise ability. ( 1.1 , 14 ) 1.1 Pulmonary Arterial Hypertension OPSYNVI is the combination of macitentan and tadalafil indicated for the chronic treatment of adults with pulmonary arterial hypertension (PAH, WHO Group I and WHO Functional Class (FC) II–III). […]
Conditions named in the indications of macitentan and tadalafil's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Endothelin Receptor Antagonist and Phosphodiesterase 5 Inhibitor.
Source: FDA drug label (OPSYNVI), Actelion Pharmaceuticals US, Inc., effective April 11, 2025 (SPL set 6945b183-18d3-40de-afd1-c88e33cc1a63), via openFDA; the full label on DailyMed
What does the patient leaflet for macitentan and tadalafil say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about OPSYNVI?Serious birth defects. OPSYNVI can cause serious birth defects if taken during pregnancy. Females should not be pregnant when they start taking OPSYNVI or become pregnant during treatment with OPSYNVI. Females who are able to get pregnant should have a negative pregnancy test before beginning treatment with OPSYNVI. Talk to your healthcare provider about your menstrual cycle. Your healthcare provider will decide when to do the pregnancy test and will order a pregnancy test for you depending on your menstrual cycle. Females who are able to get pregnant are females who: have entered puberty, even if they have not started their menstrual period, and have a uterus, and have not gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed. Females who are not able to get pregnant are females who: have not yet entered puberty, or do not have a uterus, or have gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed, or are infertile for other medical reasons and this infertility is permanent and cannot be reversed. Females who are able to get pregnant should use effective birth control before starting treatment with OPSYNVI, during treatment, and for 1 month after stopping OPSYNVI because the medicine may still be in the body. Talk with your healthcare provider or gynecologist (a doctor who specializes in female reproduction) to find out about options for acceptable birth control that you may use to prevent pregnancy during treatment with OPSYNVI. […]
From the patient leaflet: What should I avoid while taking OPSYNVI?Do not have more than 4 alcohol-containing drinks in a short period of time during treatment with OPSYNVI. Drinking too much alcohol can increase your chances of getting low blood pressure, increased heart rate, dizziness, and headache.
From the patient leaflet: How should I store OPSYNVI?Store OPSYNVI tablets at room temperature between 68°F to 77°F (20°C to 25°C). Store OPSYNVI in the package that it comes in to protect from moisture. OPSYNVI contains a desiccant to help keep the tablets dry. Do not discard or eat the desiccant. OPSYNVI bottles have a child-resistant cap. Keep OPSYNVI and all medicines out of the reach of children.
Source: FDA drug label (OPSYNVI), Actelion Pharmaceuticals US, Inc., effective April 11, 2025 (SPL set 6945b183-18d3-40de-afd1-c88e33cc1a63), via openFDA; the full label on DailyMed
Is there a generic for macitentan and tadalafil (Opsynvi)?
No generic macitentan and tadalafil is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 3 patents for Opsynvi tablets: the compound patent runs to December 5, 2025 (pediatric exclusivity to June 5, 2026), and the last listed entry to October 18, 2029. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2024 earliest approval on file
- 2029 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the macitentan and tadalafil label say about other medicines?
The macitentan and tadalafil label names 12 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiodarone | drug interactions | Avoid concomitant use of OPSYNVI with moderate dual inhibitors of CYP3A4 and CYP2C9 (such as fluconazole and amiodarone) [see Clinical Pharmacology (12.3) ]. |
| Amlodipine | drug interactions | Clinical pharmacology studies were conducted to assess the effect of tadalafil on the potentiation of the blood–pressure–lowering effects of selected antihypertensive medications (amlodipine, angiotensin II receptor blockers, bendroflumethiazide, enalapril, and metoprolol). |
| Doxazosin | drug interactions | Therefore, the combination of OPSYNVI and doxazosin is not recommended [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.2) ]. Antihypertensives PDE5 inhibitors, including tadalafil, are mild systemic vasodilators. |
| Enalapril | drug interactions | Clinical pharmacology studies were conducted to assess the effect of tadalafil on the potentiation of the blood–pressure–lowering effects of selected antihypertensive medications (amlodipine, angiotensin II receptor blockers, bendroflumethiazide, enalapril, and metoprolol). |
| Fluconazole | drug interactions | Dual or Combined CYP3A4 and CYP2C9 Inhibitors Concomitant use of moderate dual inhibitors of CYP3A4 and CYP2C9 such as fluconazole is predicted to increase macitentan exposure approximately 4-fold. |
| Itraconazole | drug interactions | Avoid concomitant use of OPSYNVI with strong CYP3A4 inhibitors such as ritonavir, ketoconazole and itraconazole. |
| Ketoconazole | drug interactions | Concomitant use of strong CYP3A4 inhibitors like ketoconazole increase exposure to both macitentan and tadalafil. |
| Metoprolol | drug interactions | Clinical pharmacology studies were conducted to assess the effect of tadalafil on the potentiation of the blood–pressure–lowering effects of selected antihypertensive medications (amlodipine, angiotensin II receptor blockers, bendroflumethiazide, enalapril, and metoprolol). |
| Nitric oxide | contraindications | This potentiation is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway [see Clinical Pharmacology (12.2) ]. |
| Rifampin | drug interactions | Strong inducers of CYP3A4 such as rifampin significantly reduce macitentan exposure. |
| Riociguat | contraindications | Cyclase (GC) Stimulators Coadministration of GC stimulators such as riociguat with OPSYNVI is contraindicated. |
| Ritonavir | drug interactions | Avoid concomitant use of OPSYNVI with strong CYP3A4 inhibitors such as ritonavir, ketoconazole and itraconazole. |
Source: FDA drug label (OPSYNVI), Actelion Pharmaceuticals US, Inc., effective April 11, 2025 (SPL set 6945b183-18d3-40de-afd1-c88e33cc1a63), via openFDA; the full label on DailyMed
What do FAERS reports show for macitentan and tadalafil?
The FDA Adverse Event Reporting System holds 24 reports that list macitentan and tadalafil among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 13 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as macitentan and tadalafil?
6 other medicines are given the same way (oral) and in the same FDA class as macitentan and tadalafil or labeled mainly for the same use (pulmonary arterial hypertension), the same class first. Pulmonary arterial hypertension lists all 11 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Sildenafil | Pulmonary arterial hypertension | 59 labelers | $0.132 per tablet 100 mg tablet | No current entry |
| Ambrisentan | Pulmonary arterial hypertension | 12 labelers | $8.02 per tablet 10 mg tablet | No current entry |
| Bosentan | Pulmonary arterial hypertension | 5 labelers | n/a | No current entry |
| Selexipag | Pulmonary arterial hypertension | 2 labelers | n/a | No current entry |
| Treprostinil | Pulmonary arterial hypertension | none listed | n/a | No current entry |
| Riociguat | Pulmonary arterial hypertension | 1 labeler | n/a | No current entry |
Every medicine labeled for the same conditions as macitentan and tadalafil
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to macitentan and tadalafil
- 6 medicines for the same use
- Other endothelin receptor antagonists
- the pharmacologic class, with prices and generics
- Macitentan and tadalafil side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other