Prescription medicine
Macitentan Brand names: Opsumit
Macitentan (Opsumit) is a prescription medicine with an FDA approval on record since 2013. FDA's NDC Directory lists it from 13 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the macitentan FDA label on DailyMed (effective April 11, 2025, Actelion Pharmaceuticals US, Inc.); the NDA 204410 record on Drugs@FDA; every macitentan 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.
OPSUMIT 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 OPSUMIT. Advise use of effective contraception before the initiation of treatment, during treatment, and for one month after stopping treatment with OPSUMIT [see Dosage and Administration (2.2), Use in Specific Populations (8.3) ]. When pregnancy is detected, discontinue OPSUMIT 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, OPSUMIT 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 OPSUMIT as soon as possible ( 5.1 ).
Used for
From the label: indications and usageOPSUMIT is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults to reduce the risks of disease progression and hospitalization for PAH ( 1.1 ).
Forms and strengths
- 10 mg
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- October 18, 2013 Opsumit, Actelion; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 12 first April 6, 2021; 12 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 14 of which 13 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- October 18, 2029 Opsumit 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
- 68,840 through July 30, 2026
What is macitentan used for?
From the label: indications and usageOPSUMIT is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults to reduce the risks of disease progression and hospitalization for PAH ( 1.1 ). 1.1 Pulmonary Arterial Hypertension OPSUMIT is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults to reduce the risks of disease progression and hospitalization for PAH. Effectiveness was established in a long-term study in PAH patients with predominantly WHO Functional Class II–III symptoms treated for an average of 2 years. […]
Conditions named in the indications of macitentan's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Endothelin Receptor Antagonist.
Source: FDA drug label (OPSUMIT), Actelion Pharmaceuticals US, Inc., effective April 11, 2025 (SPL set 1e484a50-55db-4b85-8c57-6cd1b0353abd), via openFDA; the full label on DailyMed
What does the patient leaflet for macitentan 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 OPSUMIT?Serious birth defects. OPSUMIT can cause serious birth defects if taken during pregnancy. Females should not be pregnant when they start taking OPSUMIT or become pregnant during treatment with OPSUMIT. Females who are able to get pregnant should have a negative pregnancy test before beginning treatment with OPSUMIT. 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 OPSUMIT, during treatment, and for one month after stopping OPSUMIT 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 OPSUMIT. […]
From the patient leaflet: What should I avoid while taking OPSUMIT?Do not get pregnant while taking OPSUMIT. See the serious birth defects section of the Medication Guide above called " What is the most important information I should know about OPSUMIT? " If you miss a menstrual period, or think you might be pregnant, call your healthcare provider right away. It is not known if OPSUMIT passes into your breastmilk. You should not breastfeed if you take OPSUMIT. Talk to your healthcare provider about the best way to feed your baby if you take OPSUMIT.
From the patient leaflet: How should I store OPSUMIT?Store OPSUMIT tablets at room temperature between 68 °F and 77 °F (20 °C and 25 °C). Keep OPSUMIT and all medicines out of the reach of children.
Source: FDA drug label (OPSUMIT), Actelion Pharmaceuticals US, Inc., effective April 11, 2025 (SPL set 1e484a50-55db-4b85-8c57-6cd1b0353abd), via openFDA; the full label on DailyMed
Is there a generic for macitentan (Opsumit)?
The FDA approved the first generic macitentan on April 6, 2021. 12 generic applications are approved; 12 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists macitentan from 13 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 5 patents for Opsumit 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.
- 2013 earliest approval on file
- 2021 first generic approved
- 2029 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the macitentan label say about other medicines?
The macitentan label names 5 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 | Moderate dual CYP3A4 and CYP2C9 inhibitors (fluconazole, amiodarone) or use of combined CYP3A4 and CYP2C9 inhibitors may increase exposure to macitentan: avoid co-administration with OPSUMIT ( 7.3 , 12.3 ). |
| Fluconazole | drug interactions | Moderate dual CYP3A4 and CYP2C9 inhibitors (fluconazole, amiodarone) or use of combined CYP3A4 and CYP2C9 inhibitors may increase exposure to macitentan: avoid co-administration with OPSUMIT ( 7.3 , 12.3 ). |
| Ketoconazole | drug interactions | Strong CYP3A4 inhibitors (ketoconazole, ritonavir) increase exposure to macitentan: avoid co-administration with OPSUMIT ( 7.2 , 12.3 ). |
| Rifampin | drug interactions | DRUG INTERACTIONS Strong CYP3A4 inducers (rifampin) reduce exposure to macitentan: avoid co-administration with OPSUMIT ( 7.1 , 12.3 ). |
| Ritonavir | drug interactions | Strong CYP3A4 inhibitors (ketoconazole, ritonavir) increase exposure to macitentan: avoid co-administration with OPSUMIT ( 7.2 , 12.3 ). |
Source: FDA drug label (OPSUMIT), Actelion Pharmaceuticals US, Inc., effective April 11, 2025 (SPL set 1e484a50-55db-4b85-8c57-6cd1b0353abd), via openFDA; the full label on DailyMed
What do FAERS reports show for macitentan?
The FDA Adverse Event Reporting System holds 68,840 reports that list macitentan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 12,527 are coded as a death and 34,017 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.
Reports received each year
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?
5 other medicines are given the same way (oral) and in the same FDA class as macitentan 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 |
|---|---|---|---|---|
| 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
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does macitentan compare with medicines for the same use?
1 side-by-side page set macitentan beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to macitentan
- 5 medicines for the same use
- Other endothelin receptor antagonists
- the pharmacologic class, with prices and generics
- Macitentan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other