Medicine guide

Macitentan

10 mg · Tablet, Film Coated

Prescription only
Endothelin Receptor Antagonist

Active substance: Macitentan
Made by: Zydus Pharmaceuticals USA Inc.
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2026-05-20

What it is

Endothelin Receptor Antagonist

Used for

Macitentan tablets are endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in

The label’s usual adult dose

10 mg once daily.

Full directions ↓

Serious warning

EMBRYO-FETAL TOXICITY Macitentan 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 )].

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

13other products contain Macitentan — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

Macitentan tablets are 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 Macitentan tablets are 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.
Patients had idiopathic and heritable PAH (57%), PAH caused by connective tissue disorders (31%), and PAH caused by congenital heart disease with repaired shunts (8%) [see Clinical Studies ( 14.1 )] .

From the official label · 2026-05-20 · DailyMed

How it works

From this product’s own US prescribing label.

Endothelin (ET)-1 and its receptors (ET A and ET B ) mediate a variety of deleterious effects, such as vasoconstriction, fibrosis, proliferation, hypertrophy, and inflammation.
In disease conditions such as PAH, the local ET system is upregulated and is involved in vascular hypertrophy and in organ damage.

Peak level after8 h

How the body breaks it down

Macitentan is metabolized primarily by oxidative depropylation of the sulfamide to form the pharmacologically active metabolite.

How it leaves the body

In a study in healthy subjects with radiolabeled macitentan, approximately 50% of radioactive drug material was eliminated in urine but none was in the form of unchanged drug or the active metabolite.

With food

Macitentan may therefore be taken with or without food.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-05-20

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

EMBRYO-FETAL TOXICITY Macitentan 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 macitentan.
Advise use of effective contraception before the initiation of treatment, during treatment, and for one month after stopping treatment with macitentan [see Dosage and Administration ( 2.2 ), Use in Specific Populations ( 8.3 )].
When pregnancy is detected, discontinue macitentan 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, macitentan 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 macitentan as soon as possible ( 5.1 ).

Quoted from the official label, section “Boxed Warning”.

Do not take it if

Pregnancy ( 4.1 ) Hypersensitivity ( 4.2 )
4.1 Pregnancy Macitentan may cause fetal harm when administered to a pregnant woman.
Macitentan is contraindicated in females who are pregnant.
Macitentan was consistently shown to have teratogenic effects when administered to animals.
If macitentan is used during pregnancy, advise the patient of the potential risk to a fetus [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )] .
4.2 Hypersensitivity Macitentan is contraindicated in patients with a history of a hypersensitivity reaction to macitentan or any component of the product [see Adverse Reactions ( 6.2 )] .

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

10 mg once daily.
Doses higher than 10 mg once daily have not been studied in patients with PAH and are not recommended ( 2.1 ).
2.1 Recommended Dosage The recommended dosage of macitentan tablets are 10 mg once daily for oral administration.
Doses higher than 10 mg once daily have not been studied in patients with PAH and are not recommended.
2.2 Pregnancy Testing in Females of Reproductive Potential Exclude pregnancy before initiating treatment with macitentan tablets in females of reproductive potential [see Boxed Warning, Contraindications ( 4.1 ), Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.3 )] .

Quoted from the official label, section “Dosage & Administration”.

Other warnings

ERAs cause hepatotoxicity and liver failure.
Obtain baseline liver enzymes and monitor as clinically indicated ( 5.2 ).
Fluid retention may require intervention ( 5.3 ).
Decreases in hemoglobin ( 5.4 ).
Pulmonary edema in patients with pulmonary veno-occlusive disease.
If confirmed, discontinue treatment ( 5.5 ).
Decreases in sperm count have been observed in patients taking ERAs ( 5.6 ).
5.1 Embryo-fetal Toxicity Based on data from animal reproduction studies, macitentan may cause fetal harm when administered to a pregnant patient and is contraindicated during pregnancy.
The available human data for ERAs do not establish the presence or absence of major birth defects related to the use of macitentan.
Advise patients who can become pregnant of the potential risk to a fetus.
Obtain a pregnancy test prior to initiation of therapy with macitentan.
Advise patients who can become pregnant to use effective contraceptive methods prior to initiation of treatment, during treatment, and for one month after discontinuation of treatment with macitentan.
When pregnancy is detected, discontinue use as soon as possible [see Dosage and Administration ( 2.2 ), Contraindications ( 4.1 ), and Use in Specific Populations ( 8.1 , 8.3 )].
5.2 Hepatotoxicity ERAs have caused elevations of aminotransferases, hepatotoxicity, and liver failure.
The incidence of elevated aminotransferases in the study of macitentan in PAH is shown in Table 1.
Table 1 Incidence of Elevated Aminotransferases in the SERAPHIN Study Macitentan 1 0 mg Placebo ( N=242 ) (N =2 4 9 ) > 3 x ULN 3.4 % 4.5% > 8 x ULN 2.1% 0.4% In the placebo-controlled study of macitentan, discontinuations for hepatic adverse events were 3.3% in the macitentan 10 mg group vs. 1.6% for placebo.
Obtain liver enzyme tests prior to initiation of macitentan and repeat during treatment as clinically indicated [see Adverse Reactions ( 6.2 )] .
Advise patients to report symptoms suggesting hepatic injury (nausea, vomiting, right upper quadrant pain, fatigue, anorexia, jaundice, dark urine, fever, or itching).
If clinically relevant aminotransferase elevations occur, or if elevations are accompanied by an increase in bilirubin > 2 x ULN, or by clinical symptoms of hepatotoxicity, discontinue macitentan.
Consider re initiation of macitentan when hepatic enzyme levels normalize in patients who have not experienced clinical symptoms of hepatotoxicity.
5.3 Fluid Retention Peripheral edema and fluid retention are known clinical consequences of PAH and known effects of ERAs.
In the placebo-controlled study of macitentan in PAH, the incidence of edema was 21.9% in the macitentan 10 mg group and 20.5% in the placebo group.
Patients with underlying left ventricular dysfunction may be at particular risk for developing significant fluid retention after initiation of ERA treatment.
In a small study of macitentan in patients with pulmonary hypertension because of left ventricular dysfunction, more patients in the macitentan group developed significant fluid retention and had more hospitalizations because of worsening heart failure compared to those randomized to placebo.
Postmarketing cases of edema and fluid retention occurring within weeks of starting macitentan, some requiring intervention with a diuretic or hospitalization for decompensated heart failure, have been reported [see Adverse Reactions ( 6.2 )] .
Monitor for signs of fluid retention after macitentan initiation.
If clinically significant fluid retention develops, evaluate the patient to determine the cause, such as macitentan or underlying heart failure, and the possible need to discontinue macitentan.
5.4 Hemoglobin Decrease Decreases in hemoglobin concentration and hematocrit have occurred following administration of other ERAs and were observed in clinical studies with macitentan.
These decreases occurred early and stabilized thereafter.
In the placebo-controlled study of macitentan in PAH, macitentan 10 mg caused a mean decrease in hemoglobin from baseline to up to 18 months of about 1 g/dL compared to no change in the placebo group.
A decrease in hemoglobin to below 10 g/dL was reported in 8.7% of the macitentan 10 mg group and in 3.4% of the placebo group.
Decreases in hemoglobin seldom require transfusion.
Initiation of macitentan is not recommended in patients with severe anemia.
Measure hemoglobin prior to initiation of treatment and repeat during treatment as clinically indicated [see Adverse Reactions ( 6.1 )] .
5.5 Pulmonary Edema with Pulmonary Veno-occlusive Disease (PVOD) Should signs of pulmonary edema occur, consider the possibility of associated PVOD.
If confirmed, discontinue macitentan.
5.6 Decreased Sperm Counts Macitentan, like other ERAs, may have an adverse effect on spermatogenesis.
Counsel men about potential effects on fertility [see Use in Specific Populations ( 8.3 ) and Nonclinical Toxicology ( 13.1 )] .

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Macitentan may cause fetal harm when administered to a pregnant woman.
Macitentan is contraindicated in females who are pregnant.
Macitentan was consistently shown to have teratogenic effects when administered to animals.
If macitentan is used during pregnancy, advise the patient of the potential risk to a fetus [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )] .
Risk Summary Based on data from animal reproduction studies, macitentan may cause embryo-fetal toxicity, including birth defects and fetal death, when administered to a pregnant female and is contraindicated during pregnancy.
There are risks to the mother and the fetus associated with pulmonary arterial hypertension in pregnancy [see Clinical Considerations] .
Available data from postmarketing reports and published literature over decades of use with ERAs in the same class as macitentan have not identified an increased risk of major birth defects; however, these data are limited.
Methodological limitations of these postmarketing reports and published literature include lack of a control group; limited information regarding dose, duration, and timing of drug exposure; and missing data.
These limitations preclude establishing a reliable estimate of the risk of adverse fetal and neonatal outcomes with maternal ERA use.
Macitentan was teratogenic in rabbits and rats at all doses tested.
If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, advise the patient of the risk to a fetus [see Contraindications ( 4.1 )] .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Disease-associated Maternal and/or Embryo/Fetal Risk In patients with pulmonary arterial hypertension, pregnancy is associated with an increased rate of maternal and fetal morbidity and mortality, including spontaneous abortion, intrauterine growth restriction and premature labor.
Data Animal Data In both rabbits and rats, there were cardiovascular and mandibular arch fusion abnormalities.
Administration of macitentan to female rats from late pregnancy through lactation caused reduced pup survival and impairment of the male fertility of the offspring at all dose levels tested.
Risk Summary There are no data on the presence of macitentan in human milk, the effects on the breastfed infant, or the effect on milk production.
Because of the potential for serious adverse reactions in breastfed infants from macitentan advise women not to breastfeed during treatment with macitentan.
IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed.
( 8.2 )
8.1 Pregnancy Risk Summary Based on data from animal reproduction studies, macitentan may cause embryo-fetal toxicity, including birth defects and fetal death, when administered to a pregnant female and is contraindicated during pregnancy.
There are risks to the mother and the fetus associated with pulmonary arterial hypertension in pregnancy [see Clinical Considerations] .
Available data from postmarketing reports and published literature over decades of use with ERAs in the same class as macitentan have not identified an increased risk of major birth defects; however, these data are limited.
Methodological limitations of these postmarketing reports and published literature include lack of a control group; limited information regarding dose, duration, and timing of drug exposure; and missing data.
These limitations preclude establishing a reliable estimate of the risk of adverse fetal and neonatal outcomes with maternal ERA use.
Macitentan was teratogenic in rabbits and rats at all doses tested.
If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, advise the patient of the risk to a fetus [see Contraindications ( 4.1 )] .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Disease-associated Maternal and/or Embryo/Fetal Risk In patients with pulmonary arterial hypertension, pregnancy is associated with an increased rate of maternal and fetal morbidity and mortality, including spontaneous abortion, intrauterine growth restriction and premature labor.
Data Animal Data In both rabbits and rats, there were cardiovascular and mandibular arch fusion abnormalities.
Administration of macitentan to female rats from late pregnancy through lactation caused reduced pup survival and impairment of the male fertility of the offspring at all dose levels tested.
8.2 Lactation Risk Summary There are no data on the presence of macitentan in human milk, the effects on the breastfed infant, or the effect on milk production.
Because of the potential for serious adverse reactions in breastfed infants from macitentan advise women not to breastfeed during treatment with macitentan.
8.3 Females and Males of Reproductive Potential Based on data from animal reproductive toxicity studies, macitentan can cause fetal harm, including birth defects and fetal death, when administered to a pregnant patient and is contraindicated during pregnancy [see Contraindications ( 4.1 ), and Use in Specific Populations ( 8.1 )].
Pregnancy Testing Verify that patients who can become pregnant are not pregnant prior to initiating macitentan.
The patient should contact their physician immediately for pregnancy testing if onset of menses is delayed or pregnancy is suspected.
If the pregnancy test is positive, the physician and patient should discuss the risks to the pregnancy, and the fetus.
Contraception Patients who can become pregnant who are using macitentan should use an effective method of contraception prior to initiation of treatment, during treatment, and for one month after discontinuation of treatment with macitentan to prevent pregnancy [see Warnings and Precautions ( 5.1 )].
Infertility Based on findings in animals, macitentan may impair fertility in males of reproductive potential.
It is not known whether effects on fertility would be reversible [see Warnings and Precautions ( 5.6 ), Adverse Reactions ( 6.1 ) and Nonclinical Toxicology ( 13.1 )] .
8.4 Pediatric Use The safety and effectiveness of macitentan in pediatric patients have not been established for the treatment of PAH.
Pediatric information describing a clinical study in which efficacy was not demonstrated is approved for Actelion Pharmaceuticals US, Inc.'s Opsumit (macitentan) tablets.
However, due to Actelion Pharmaceuticals US, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.
8.5 Geriatric Use Of the total number of subjects in the clinical study of macitentan for PAH, 14% were 65 and over.
No overall differences in safety or effectiveness were observed between these subjects and younger subjects.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Strong CYP3A4 inducers (rifampin) reduce exposure to macitentan:
avoid coadministration with macitentan ( 7.1 , 12.3 ).
Strong CYP3A4 inhibitors (ketoconazole, ritonavir) increase exposure to macitentan:
avoid coadministration with macitentan ( 7.2 , 12.3 ).
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 macitentan ( 7.3 , 12.3 ).
7.1 Strong CYP3A4 Inducers Strong inducers of CYP3A4 such as rifampin significantly reduce macitentan exposure.
Concomitant use of macitentan with strong CYP3A4 inducers should be avoided [see Clinical Pharmacology ( 12.3 )] .
7.2 Strong CYP3A4 Inhibitors Concomitant use of strong CYP3A4 inhibitors like ketoconazole approximately double macitentan exposure.
Many HIV drugs like ritonavir are strong inhibitors of CYP3A4.
Avoid concomitant use of macitentan with strong CYP3A4 inhibitors [see Clinical Pharmacology ( 12.3 )] .
Use other PAH treatment options when strong CYP3A4 inhibitors are needed as part of HIV treatment [see Clinical Pharmacology ( 12.3 )] .
7.3 Moderate 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 based on physiologically based pharmacokinetic (PBPK) modeling.
Avoid concomitant use of macitentan with moderate dual inhibitors of CYP3A4 and CYP2C9 (such as fluconazole and amiodarone) [see Clinical Pharmacology ( 12.3 )] .
Concomitant treatment of both a moderate CYP3A4 inhibitor and moderate CYP2C9 inhibitor with macitentan should also be avoided [see Clinical Pharmacology ( 12.3 )] .

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Macitentan has been administered as a single dose of up to and including 600 mg to healthy subjects (60 times the approved dosage).
Adverse reactions of headache, nausea and vomiting were observed.
In the event of an overdose, standard supportive measures should be taken, as required.
Dialysis is unlikely to be effective because macitentan is highly protein-bound.

Quoted from the official label, section “Overdosage”.

Use in children

The safety and effectiveness of macitentan in pediatric patients have not been established for the treatment of PAH.
Pediatric information describing a clinical study in which efficacy was not demonstrated is approved for Actelion Pharmaceuticals US, Inc.'s Opsumit (macitentan) tablets.
However, due to Actelion Pharmaceuticals US, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.

Quoted from the official label, section “Pediatric Use”.

Use in older people

Of the total number of subjects in the clinical study of macitentan for PAH, 14% were 65 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.

Quoted from the official label, section “Geriatric Use”.

Side effects

Clinically significant adverse reactions that appear in other sections of the labeling include:
Embryo-fetal Toxicity [see Warnings and Precautions ( 5.1 )] Hepatotoxicity [see Warnings and Precautions ( 5.2 )] Fluid Retention [see Warnings and Precautions ( 5.3 )] Decrease in Hemoglobin [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (more frequent than placebo by ≥ 3%) are anemia, nasopharyngitis/pharyngitis, bronchitis, headache, influenza, and urinary tract infection ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Safety data for macitentan were obtained primarily from one placebo-controlled clinical study in 742 patients with PAH (SERAPHIN study) [see Clinical Studies ( 14.1 )] .
The exposure to macitentan in this trial was up to 3.6 years with a median exposure of about 2 years (N=542 for 1 year;
N=429 for 2 years; and N=98 for more than 3 years).
The overall incidence of treatment discontinuations because of adverse events was similar across macitentan 10 mg and placebo treatment groups (approximately 11%).
Table 2 presents adverse reactions more frequent on macitentan than on placebo by ≥ 3%.
Table 2 Adverse Reactions Adverse Reaction Macitentan 10 mg Placebo ( N=242 ) (N=249) (%) (%) Anemia 13 3 Nasopharyngitis/pharyngitis 20 13 Bronchitis 12 6 Headache 14 9 Influenza 6 2 Urinary tract infection 9 6
6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of macitentan.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune system disorders :
hypersensitivity reactions (angioedema, pruritus and rash) Vascular disorders:
flushing Respiratory, thoracic and mediastinal disorders :
nasal congestion Gastrointestinal disorders:
Elevations of liver aminotransferases (ALT, AST) and liver injury have been reported with macitentan use; in most cases alternative causes could be identified (heart failure, hepatic congestion, autoimmune hepatitis).
Endothelin receptor antagonists have been associated with elevations of aminotransferases, hepatotoxicity, and cases of liver failure [see Warnings and Precautions ( 5.2 )].
General disorders and administration site conditions : edema/fluid retention.
Cases of edema and fluid retention occurred within weeks of starting macitentan, some requiring intervention with a diuretic, fluid management or hospitalization for decompensated heart failure [see Warnings and Precautions ( 5.3 )] .
Cardiac disorders : symptomatic hypotension

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

Advise patient to read FDA-approved patient labeling (Medication Guide).
Embryo-Fetal Toxicity Counsel female patients of reproductive potential about the need to use effective methods of contraception prior to initiation of treatment with macitentan, during treatment and for one month after treatment discontinuation.
Females of reproductive potential should have a negative pregnancy test prior to treatment with macitentan [see Contraindications ( 4.1 ), and Use in Specific Populations ( 8.1 , 8.3 )].
Patients should be instructed to contact their physician if they suspect they may be pregnant.
Patients should seek additional contraceptive advice from a gynecologist or similar expert as needed.
Educate and counsel females of reproductive potential on the use of emergency contraception in the event of unprotected sex or contraceptive failure.
Advise pre-pubertal females to report any changes in their reproductive status immediately to her prescriber.
Review the Medication Guide with female patients.
Lactation Advise women not to breastfeed during treatment with macitentan [see Use in Specific Populations ( 8.2 )].
Hepatotoxicity Some members of this pharmacological class are hepatotoxic.
Educate patients on signs of hepatotoxicity.
Advise patients that they should contact their doctor if they have unexplained nausea, vomiting, right upper quadrant pain, fatigue, anorexia, jaundice, dark urine, fever, or itching [see Warnings and Precautions ( 5.2 )] .
Fluid Retention Educate patients on signs of fluid retention.
Advise patients that they should contact their doctor if they have unusual weight increase or swelling of the ankles or legs [see Warnings and Precautions ( 5.3 )] .

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

FORMS AND STRENGTHS Macitentan tablets, 10 mg are white to off-white colored, round-shaped, biconvex, film-coated tablet debossed with "MT" on one side and "10" on other side. Tablet:10 mg ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

Macitentan Tablets, 10 mg are white to off-white colored, round-shaped, biconvex, film-coated tablet debossed with "MT" on one side and "10" on other side and are supplied as follows:
NDC 70710-1166-3 in bottles of 30 tablets with child-resistant closure NDC 70710-1166-5 in carton of 15 (5 x 3) unit-dose tablets
Store at 20ºC to 25ºC (68ºF to 77ºF).
Excursions are permitted between 15°C and 30°C (59°F and 86°F). [See USP Controlled Room Temperature].
Keep out of reach of children.

Quoted from the official label, section “How Supplied”.

What is in it

Macitentan is an endothelin receptor antagonist.
The chemical name of macitentan is N-[5-(4-Bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N' propylsulfamide.
It has a molecular formula of C 19 H 20 Br 2 N 6 O 4 S and a molecular weight of 588.28.
Macitentan is achiral and has the following structural formula:
Macitentan is a white to cream color crystalline powder and freely soluble in dichloromethane, soluble in acetone and ethyl acetate.
It is insoluble in water.
In the solid state macitentan is very stable, is not hygroscopic, and is not light sensitive.
Each film-coated tablet intended for once daily oral administration contains 10 mg of macitentan and in addition each tablet contains following inactive ingredients:
lactose monohydrate, microcrystalline cellulose, povidone, polysorbate, sodium stearyl fumarate and sodium starch glycolate.
The tablets are film-coated with a coating material containing glyceryl monocaprylocaprate, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide.
Image

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Lactoselactose monohydrateMilk sugar: matters with lactose intolerance or a milk allergy.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (14)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 14 of 14

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

European UnionNo exact match for this strength and form

Every strength and form (3)

Canada1 matching products

OPSUMIT 10 mg · tablet

Every strength and form (2)

Netherlands12 matching products

Every strength and form (13)

Details

Made by	Zydus Pharmaceuticals USA Inc.
Active substance	Macitentan
Strength	10 mg
Form	Tablet, Film Coated
Route	Oral
Packs	30 TABLET, FILM COATED in 1 BOTTLE · 5 BLISTER PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 BLISTER PACK
NDC	70710-1166

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

13 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Tablet, Film Coated12 products
- 10 mg12
  10 mg · 12 companies
  +4 more
Tablet1 products
- 10 mg

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Macitentan10 mgPrescription onlyTablet, Film Coated Mylan Pharmaceuticals Inc. · Macitentan Macitentan10 mgPrescription onlyTablet, Film Coated Teva Pharmaceuticals, Inc. · Macitentan Macitentan10 mgPrescription onlyTablet, Film Coated Sandoz Inc · Macitentan Macitentan10 mgPrescription onlyTablet Torrent Pharmaceuticals Limited · Macitentan Macitentan10 mgPrescription onlyTablet, Film Coated Laurus Labs Limited · Macitentan Macitentan10 mgPrescription onlyTablet, Film Coated Alembic Pharmaceuticals Limited · Macitentan

See every product with Macitentan