Skip to the answer

Bosentan

Bosentan is an endothelin receptor antagonist used to treat pulmonary arterial hypertension (PAH), a type of high blood pressure in the lungs, in adults and in children 3 years and older.

Brand name Tracleer
Drug classes Cytochrome P450 2c9 Inducers
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 8 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Bosentan at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Bosentan (Tracleer) is a specialist medicine for pulmonary arterial hypertension (PAH), high blood pressure in the lung arteries, that blocks both receptors for endothelin-1, a natural substance that narrows blood vessels; the first drug of its kind, it has been around since about 2001 and is available as a generic. Most people tolerate it fairly well, and headache, flushing and leg swelling are what people usually notice. The catch is its boxed warning for liver damage and major birth defects, which is why it comes only through the Bosentan REMS program, with liver blood tests before starting and every month, plus monthly pregnancy tests when pregnancy is possible.

Clinical pearls

  • Bosentan weakens hormonal birth control (the pill, patches, shots, implants), so these cannot be the only method used.
  • Never combine it with cyclosporine or the diabetes medicine glyburide, and antifungals like fluconazole can push bosentan levels up sharply.
  • Report nausea, belly pain, yellow skin or eyes, or unusual tiredness right away, since these can signal liver injury.
  • Weigh yourself regularly at first, because fluid buildup and quick weight gain can show up within weeks of starting.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Bosentan can cause serious liver damage and major birth defects. Because of this, it is only available through a restricted program called the Bosentan REMS, in which prescribers, patients and pharmacies must enroll.

Liver: In studies, about 11% of patients had liver enzyme (ALT/AST) levels more than 3 times normal. Rare cases of cirrhosis and liver failure have been reported. Your liver must be tested before you start and every month. Warning signs include nausea, vomiting, fever, belly pain, yellow skin or eyes, and unusual tiredness. Treatment should be stopped if enzyme rises come with these symptoms or with raised bilirubin.

Pregnancy: Bosentan is likely to cause major birth defects. Pregnancy must be ruled out before starting, and monthly pregnancy tests are needed. Females who can become pregnant must use two reliable methods of contraception during treatment and for one month after. Hormonal birth control alone is not enough.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet
Earliest FDA record2001
Companies listing it with the FDA6
FDA label last updatedNov 17, 2025
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Bosentan, written from its FDA label.

What Bosentan is used for

▾

Bosentan is used to treat pulmonary arterial hypertension (PAH), WHO Group 1.

  • Adults: to improve exercise ability and decrease clinical worsening of PAH (Tracleer and bosentan tablets).
  • Children 3 years and older with idiopathic or congenital PAH: to improve pulmonary vascular resistance, which is expected to improve exercise ability (Tracleer and bosentan tablets).
  • The studies in adults mostly included people with idiopathic or heritable PAH, PAH linked to connective tissue diseases, and PAH linked to congenital heart disease.

How Bosentan works

▾

Bosentan blocks endothelin receptors (ET-A and ET-B). Endothelin-1 is a natural substance that acts on blood vessel walls. Its levels are higher in the blood and lung tissue of people with PAH, which points to a role in the disease.

Blocking these receptors works against endothelin-1's effects. The label notes the clinical impact of blocking both receptors is unknown.

Bosentan dosage

▾

Bosentan is taken by mouth twice a day, and food does not change how much is absorbed. Doses are based on age and weight. Treatment generally starts lower for the first 4 weeks and may then increase. Doses above the usual maximum did not add enough benefit to outweigh the liver risk.

  • Dispersible tablets (tablets for oral suspension) are mixed in a small amount of water right before use.
  • Liver tests are needed before treatment and monthly.
  • Follow your prescriber and label for your exact dose and for what to do about a missed dose.

Dosing details from the FDA-approved label

From the Bosentan prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Patients >12 years of age and >40 kg
    • Initial 4 weeks: 62.5 mg twice daily
    • Maintenance (after 4 weeks): 125 mg twice daily
    • Maximum: Doses above 125 mg twice daily did not appear to confer additional benefit sufficient to offset the increased risk of hepatotoxicity
    • Patients older than 12 years of age initiate at 62.5 mg orally twice daily; for patients weighing greater than 40 kg, increase to 125 mg after 4 weeks
  • Patients 12 years of age and younger, 8-16 kg
    • Initial 4 weeks: 32 mg twice daily
    • Maintenance (after 4 weeks): 32 mg twice daily
    • Dosage based on weight (Table 1)
  • Patients 12 years of age and younger, >16-24 kg
    • Initial 4 weeks: 48 mg twice daily
    • Maintenance (after 4 weeks): 48 mg twice daily
    • Dosage based on weight (Table 1)
  • Patients 12 years of age and younger, >24-40 kg
    • Initial 4 weeks: 64 mg twice daily
    • Maintenance (after 4 weeks): 64 mg twice daily
    • Dosage based on weight (Table 1)
  • Patients on ritonavir for at least 10 days (starting bosentan)
    • Start at the recommended initial dose once daily or every other day based upon individual tolerability
    • If bosentan is already being taken, discontinue at least 36 hours before starting ritonavir; after at least 10 days of ritonavir, resume at the recommended initial dose once daily or every other day
  • Patients developing aminotransferase elevations >3 and ≤5 × ULN (adults and pediatric patients >12 years and >40 kg)
    • Confirm by another aminotransferase test
    • If confirmed, reduce the daily dose to 62.5 mg twice daily or interrupt treatment, and monitor aminotransferase levels at least every 2 weeks
    • If levels return to pretreatment values, may continue or reintroduce at 62.5 mg twice daily, reassessing aminotransferase levels within 3 days; all other pediatric patients: interrupt treatment with no prior dose reduction
  • Patients developing aminotransferase elevations >5 and ≤8 × ULN
    • Confirm by another aminotransferase test
    • If confirmed, stop treatment and monitor aminotransferase levels at least every 2 weeks
    • Once levels return to pretreatment values, adults and pediatric patients >12 years and >40 kg: consider reintroduction at 62.5 mg twice daily; all other pediatric patients: consider reintroduction at the prior dose, with reassessment within 3 days
  • Patients developing aminotransferase elevations >8 × ULN
    • Stop treatment permanently
    • No experience with reintroduction in these circumstances
  • Patients with pre-existing hepatic impairment
    • No dose adjustment is required in patients with mildly impaired liver function
    • Avoid initiation in patients with aminotransferases >3 × ULN
Read the label’s full dosing text

2. DOSAGE AND ADMINISTRATION • Patients older than 12 years of age: initiate at 62.5 mg orally twice daily; for patients weighing greater than 40 kg, increase to 125 mg orally twice daily after 4 weeks ( 2.2 ). • Patients 12 years of age and younger: dosage is based on weight, see Table 1 ( 2.2 ). • Reduce the dose and closely monitor patients developing aminotransferase elevations more than 3 x Upper Limit of Normal (ULN) ( 2.1 ). 2.1 Required Monitoring Healthcare professionals who prescribe bosentan tablets for oral suspension must enroll in the Bosentan REMS Program and must comply with the required monitoring to minimize the risks associated with bosentan [see Warnings and Precautions (5.3) ] . Obtain a pregnancy test in females of reproductive potential prior to bosentan treatment, monthly during treatment and one month after stopping bosentan. Initiate treatment with bosentan in females of reproductive potential only after a negative pregnancy test [see Boxed Warning , Contraindications (4.1) , Warnings and Precautions (5.3) , Use in Specific Populations (8.1 , 8.3) ] . Measure liver aminotransferase levels prior to initiation of treatment and then monthly [see Warnings and Precautions (5.1) ] . 2.2 Recommended Dosage Administer bosentan orally following the dosing recommendations in Table 1. Doses above 125 mg twice daily did not appear to confer additional benefit sufficient to offset the increased risk of hepatotoxicity. Table 1: Dosing Recommendations Initial 4 weeks Maintenance (after 4 weeks) Patients >12 years of age and >40 kg 62.5 mg twice daily 125 mg twice daily Patients >12 years of age and <40 kg 62.5 mg twice daily 62.5 mg twice daily Patients ≤12 years of age ≥4-8 kg ˃8-16 kg ˃16-24 kg ˃24-40 kg 16 mg twice daily 32 mg twice daily 48 mg twice daily 64 mg twice daily 16 mg twice daily 32 mg twice daily 48 mg twice daily 64 mg twice daily 2.3 Administration Bosentan tablets for oral suspension (dispersible tablets) should be administered orally twice daily. Disperse tablets for oral suspension, or dispersible tablet half, in a minimal amount of water immediately before administration. Store divided dispersible tablet pieces at 20 ºC to 25 ºC (68 ºF to 77 ºF) in the opened blister for up to 7 days.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Bosentan side effects

▾

The most common side effects in studies were:

Common side effects

  • Respiratory tract infection (colds, sinus and nose or throat infections)
  • Headache
  • Swelling (edema), often in the legs
  • Chest pain
  • Flushing
  • Low blood pressure
  • Joint pain
  • Palpitations (awareness of your heartbeat)

When to get medical help

  • Call your doctor right away if you have nausea, vomiting, fever, belly pain, yellowing of the skin or eyes (jaundice), or unusual tiredness. These can be signs of liver injury.
  • Get help right away for swelling of the face, lips, tongue or throat, a severe rash, or trouble breathing. These can be signs of a serious allergic reaction.
  • Tell your doctor about fast swelling, weight gain or fluid buildup. Fluid retention can happen within weeks of starting.
  • Report signs of fluid in the lungs (pulmonary edema), as this may point to a lung condition called pulmonary veno-occlusive disease.
  • Contact your doctor right away if you are or think you may be pregnant, or if your period is late.
  • Report unusual tiredness or paleness, which can be signs of low hemoglobin (anemia).

In children taking the dispersible tablet, upper respiratory infections and fever were common. Seek help for signs of liver problems, allergic reactions such as angioedema, or fast fluid buildup.

Bosentan warnings and precautions

▾
  • Liver injury: Enzyme rises are dose-related and often silent, so monthly blood tests are required. Stop and call your doctor if enzyme rises come with symptoms or raised bilirubin.
  • Birth defects: Bosentan is likely to cause major birth defects. Pregnancy testing and reliable contraception are required.
  • Fluid retention: It can occur within weeks and may need a water pill or other care.
  • Pulmonary veno-occlusive disease: If fluid in the lungs appears, your doctor may consider this condition and whether to stop bosentan.
  • Lower sperm counts: This has been seen with bosentan.
  • Lower hemoglobin: Levels should be checked after 1 and 3 months and then every 3 months.

Bosentan interactions

▾

Bosentan is processed by CYP2C9 and CYP3A liver enzymes and also speeds up those enzymes, so it can change other drug levels.

  • Cyclosporine A: not allowed, as it raises bosentan levels sharply.
  • Glyburide: not allowed, due to higher liver enzyme risk.
  • Hormonal contraceptives: may be less effective, so use additional methods.
  • Combinations of a CYP2C9 inhibitor (such as fluconazole or amiodarone) with a strong or moderate CYP3A inhibitor (such as ketoconazole, itraconazole, erythromycin or diltiazem): not recommended.
  • Warfarin: levels fell in healthy volunteers, though patients with PAH showed no clinically relevant change in INR.

Interactions listed in the FDA-approved label

From the Bosentan prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • CYP2C9 inhibitor (such as fluconazole or amiodarone) plus a strong CYP3A inhibitor (e.g. ketoconazole, itraconazole) or moderate CYP3A inhibitor (e.g. amprenavir, erythromycin, fluconazole, diltiazem): Will likely lead to large increases in plasma concentrations of bosentan. Coadministration of such combinations with bosentan is not recommended.
  • Drugs metabolized by CYP3A and CYP2C9: Bosentan is an inducer of CYP3A and CYP2C9, so plasma concentrations of drugs metabolized by these isozymes will be decreased when bosentan is coadministered.
  • Drugs metabolized by CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP3A: Bosentan had no relevant inhibitory effect on any CYP isozyme in vitro, so it is not expected to increase plasma concentrations of drugs metabolized by these enzymes.
  • Hormonal contraceptives (oral, injectable, transdermal, implantable): May not be reliable when bosentan is coadministered; average decreases of norethindrone and ethinyl estradiol levels were 14% and 31%, with decreases as much as 56% and 66% in individual subjects. Females should practice additional methods of contraception and not rely on hormonal contraception alone.
  • Ritonavir: Inhibition of CYP enzymes may increase the plasma concentration of bosentan. In patients on ritonavir for at least 10 days, start bosentan at the recommended initial dose once daily or every other day based upon tolerability; discontinue bosentan at least 36 hours before starting ritonavir.
Read the label’s full interactions text

7 DRUG INTERACTIONS Cytochrome P450: Coadministration of bosentan with drugs metabolized by CYP2C9 and CYP3A can increase exposure to bosentan and/or the coadministered drug ( 4.2 , 4.3 , 7.1 ). Hormonal contraceptives: Bosentan use decreases contraceptive exposure and reduces effectiveness ( 7.2 ). 7.1 Cytochrome P450 Drug Interactions Bosentan is metabolized by CYP2C9 and CYP3A. Inhibition of these enzymes may increase the plasma concentration of bosentan [see Clinical Pharmacology ( 12.3 )] . Concomitant administration of both a CYP2C9 inhibitor (such as fluconazole or amiodarone) and a strong CYP3A inhibitor (e.g. ketoconazole, itraconazole) or a moderate CYP3A inhibitor (e.g. amprenavir, erythromycin, fluconazole, diltiazem) with bosentan will likely lead to large increases in plasma concentrations of bosentan. Coadministration of such combinations of a CYP2C9 inhibitor plus a strong or moderate CYP3A inhibitor with bosentan is not recommended. Bosentan is an inducer of CYP3A and CYP2C9. Consequently plasma concentrations of drugs metabolized by these two isozymes will be decreased when bosentan is coadministered. Bosentan had no relevant inhibitory effect on any CYP isozyme in vitro (CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP3A). Consequently, bosentan is not expected to increase the plasma concentrations of drugs metabolized by these enzymes. Figure 1 CYP3A induction-mediated effect of bosentan on other drugs Figure 2 Effect of other drugs on bosentan 7.2 Hormonal Contraceptives Hormonal contraceptives, including oral, injectable, transdermal, and implantable forms, may not be reliable when bosentan is coadministered. Females should practice additional methods of contraception and not rely on hormonal contraception alone when taking bosentan [see Use in Specific Populations ( 8.3 )] .

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿266 supplements and herbs with documented Bosentan interactions, ranked by severity Check Bosentan against a supplement or herb →

Before taking Bosentan

▾
  • Pregnancy or possible pregnancy: contraindicated.
  • Females who can become pregnant: need pregnancy tests and two reliable contraception methods unless they have an IUD or tubal sterilization.
  • Breastfeeding: not advised during treatment.
  • Men: sperm counts may fall and fertility may be affected.
  • Liver disease or raised liver enzymes: starting bosentan is generally avoided. Moderate liver impairment raised bosentan levels several-fold.
  • Allergy to bosentan: do not take it.
  • Children: used from age 3 years for idiopathic or congenital PAH, with weight-based dosing.
  • Severe kidney impairment: bosentan levels were essentially unchanged.

Bosentan overdose

▾

Bosentan has been given in high doses without major consequences, with headache the most common effect. A reported overdose in an adolescent caused nausea, vomiting, low blood pressure, dizziness, sweating and blurred vision, and he recovered within 24 hours with blood pressure support. Dialysis is unlikely to remove it. Get emergency help if you take too much.

What Bosentan does in the body

▾

Bosentan competitively blocks ET-A and ET-B endothelin receptors, with slightly higher affinity for ET-A. It can lower hemoglobin and hematocrit, mostly in the first few weeks, and can raise liver enzymes in a dose-related way.

How your body processes Bosentan

▾

After oral dosing, bosentan peaks in 3 to 5 hours and has a half-life of about 5 hours. About 50% is absorbed, unaffected by food. It is more than 98% bound to proteins, processed by the liver and cleared mainly in bile. Less than 3% appears in urine. Steady state is reached in 3 to 5 days, and levels fall somewhat over time because bosentan speeds up its own metabolism.

How to store Bosentan

▾

Store at 20 ºC to 25 ºC (68 ºF to 77 ºF). temperatures apply to both film-coated and dispersible tablets. stored under the same conditions and used within 7 days.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

266

Supplements & herbs that interact with Bosentan

266 supplements and herbal products have documented interactions with Bosentan in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 11
  • Moderate · 216
  • Minor · 39
ACTIVATED CHARCOAL Major AMERICAN HELLEBORE Major AMERICAN MISTLETOE Major APPLE Major BEER Major GRAPEFRUIT Major SIBERIAN COCKLEBUR Major ST. JOHN'S WORT Major +258 more
Every supplement checked against Bosentan — ranked by severity The full interaction hub: 11 major · 216 moderate · 39 minor · every one linked to its full report. Check Bosentan against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Bosentan has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

COENZYME Q10 Insufficient Evidence
See the full Bosentan nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Bosentan: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Bosentan — the kind of thing our pharmacy team would talk through with you at the counter.

What is bosentan for?

▾
It treats pulmonary arterial hypertension, or high blood pressure in the lung arteries. In adults it helps you exercise better and slows worsening. It is also used in children 3 years and older with idiopathic or congenital PAH.

How do I take it?

▾
You take it by mouth twice a day, with or without food. Dispersible tablets get mixed in a little water right before you take them. Your dose depends on your age and weight, so follow your prescriber and label.

Why do I need monthly blood tests?

▾
Bosentan can raise liver enzymes and, rarely, cause serious liver damage. Monthly tests catch problems early, often before you feel anything. Call us right away if you get nausea, vomiting, fever, belly pain, yellow skin or eyes, or unusual tiredness.

Can I take bosentan if I could get pregnant?

▾
Only with strict precautions. Bosentan is likely to cause major birth defects, so you need a negative pregnancy test first and monthly tests. You must use two reliable birth control methods during treatment and for a month after, unless you have an IUD or tubal sterilization. Birth control pills or other hormonal methods alone may not work well.

What side effects are common?

▾
Colds and other respiratory infections, headache, swelling, flushing, low blood pressure and anemia are the most common. Tell your doctor about fast swelling or weight gain. Seek help right away for face or throat swelling or a severe rash.

Are there medicines I should avoid?

▾
Yes. You must not take cyclosporine A or glyburide with bosentan. Several other medicines, such as fluconazole, ketoconazole and erythromycin, can raise bosentan levels, so always show your pharmacist your full medicine list.

Is Bosentan available over the counter?

▾
No. Bosentan is a prescription medicine: every Bosentan product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Bosentan first available?

▾
The earliest FDA record we hold for Bosentan is from 2001: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Bosentan was first used.

Who makes Bosentan?

▾
6 companies currently list Bosentan products in the FDA's NDC Directory, including Actelion Pharmaceuticals US, Inc., Zydus Lifesciences Limited, Zydus Pharmaceuticals USA Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Bosentan on HelloPharmacist

📊Bosentan supplement interactions266 checked — ranked by severity 🌿Drug & Supplement CheckerBosentan vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Bosentan NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Bosentan Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Bosentan forms and strengths (how it comes)

Bosentan is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Bosentan inactive ingredients by manufacturer.

Tablet

By mouth
Brands Tracleer
How this form is used
What it may be used for
  • Tracleer tablets are used to treat PAH (WHO Group 1) in adults to improve exercise ability and slow clinical worsening.
  • Tracleer is also used in children 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance.
  • Bosentan tablets have the same PAH uses in adults and in children 3 years and older.
Important instructions
  • Tracleer film-coated tablets and tablets for oral suspension are taken by mouth twice daily.
  • Tracleer tablets for oral suspension are dispersed in a small amount of water right before use.
  • Bosentan film-coated tablets are taken by mouth twice daily.
Available strengths 3 strengths
32 mg 62.5 mg 125 mg
36 FDA-listed product records ⓘ

Bosentan on the U.S. market: products, makers and brands

How Bosentan appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

6 companies list 14 Bosentan product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2001. Brand names on the directory include Tracleer; the rest are generics.

1
Dose forms ⓘ
6
Labelers (makers, repackagers, distributors)
2
Brand names
14
FDA-listed product records ⓘ
2001
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (10) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Actelion Pharmaceuticals US, Inc.21%
Zydus Lifesciences Limited21%
Zydus Pharmaceuticals USA Inc.21%
Actavis Pharma, Inc.14%
Sun Pharmaceutical Industries, Inc.14%
Lupin Pharmaceuticals, Inc.7%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Bosentan is used (Medicaid data)

A general measure of how commonly Bosentan is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Bosentan is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

852
Medicaid prescriptions filled (Q1–Q4 2025)
$6.7M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Bosentan prescribed? Of the 1,601 medications we measure, Bosentan ranks #1,306 by Medicaid prescriptions — more than 18% of them.

Where Bosentan ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,306 of 1,601
#1,301 Nicardipine 890 Rx #1,302 Carbidopa / Entacapone... 868 Rx #1,303 Cysteamine 867 Rx #1,304 Etomidate 858 Rx #1,305 Salsalate 856 Rx #1,306 Bosentan 852 Rx #1,307 Nepafenac Ophthalmic 849 Rx #1,308 Codeine 849 Rx #1,309 Mesna 848 Rx #1,310 Lorlatinib 846 Rx #1,311 Aluminum Hydroxide 844 Rx

Utilization by Bosentan product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 32 mg tablet for oral suspension is the most-dispensed Bosentan product — about 72% of these Medicaid prescriptions.

bosentan 32 MG Tablet for Oral Suspension Most dispensed

612 Medicaid prescriptions (Q1–Q4 2025) 72% of Bosentan prescriptions shown $5.8M gross reimbursement (before rebates) ≈ $9,453 per prescription (gross)

Summed across the 2 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1989081

bosentan 62.5 MG Oral Tablet

130 Medicaid prescriptions (Q1–Q4 2025) 15% of Bosentan prescriptions shown $775,396 gross reimbursement (before rebates) ≈ $5,965 per prescription (gross)

Summed across the 2 of 23 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 349253

bosentan 125 MG Oral Tablet

110 Medicaid prescriptions (Q1–Q4 2025) 13% of Bosentan prescriptions shown $102,158 gross reimbursement (before rebates) ≈ $929 per prescription (gross)

Summed across the 2 of 23 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 656659

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Bosentan, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 6 of 56 listed Bosentan NDCs with Medicaid activity.

Compare Bosentan products

A representative set of FDA-listed product records for Bosentan — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 14 of 14 products — FDA National Drug Code Directory. See every product, package size and price: browse all 14 Bosentan NDCs →

Bosentan recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Bosentan recalls since July 2021.

✅No Bosentan recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Bosentan RxCUI 75207 2 dose forms · 3 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 378980 In current FDA listings
    Clinical drug / strength (SCD) 62.5 MG RxCUI 349253 125 MG RxCUI 656659
  2. Dose form (SCDF) Tablet for Oral Suspension RxCUI 1989080 In current FDA listings
    Clinical drug / strength (SCD) 32 MG RxCUI 1989081

Look up RxCUI 75207 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Bosentan brand names

Bosentan is sold under one brand name in the FDA directory — Tracleer. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Tracleer

Who makes Bosentan: manufacturers and labelers

6 companies list Bosentan products with the FDA. By number of product records, the largest are Actelion Pharmaceuticals US, Inc., Zydus Lifesciences Limited, Zydus Pharmaceuticals USA Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Actelion Pharmaceuticals US, Inc. 3 Zydus Lifesciences Limited 3 Zydus Pharmaceuticals USA Inc. 3 Actavis Pharma, Inc. 2 Sun Pharmaceutical Industries, Inc. 2 Lupin Pharmaceuticals, Inc. 1

Bosentan drug class (RxNorm)

Bosentan belongs to the Endothelin Receptor Antagonist class.

Pharmacologic class Endothelin Receptor Antagonist
Drug family (ATC) Antihypertensives for pulmonary arterial hypertension
How it works Endothelin Receptor Antagonists, Cytochrome P450 2C9 Inducers, Cytochrome P450 3A Inducers

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Bosentan page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Nov 17, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Bosentan.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Bosentan after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
8
Finished products in the current FDA directory
14
Companies listing them (makers, repackagers, distributors)
6
FDA labeler codes behind them ⓘ
7
Linked representative label ⓘ
Actelion Pharmaceuticals US, Inc.
Linked label effective
Nov 17, 2025
Composite sections available
24
Linked SPL Set ID
749e42fb-2fe0-45dd-9268-b43bb3f4081c
Linked SPL Document ID
f52a8c9c-529d-4bd8-9bfb-d91161935c20
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Actelion Pharmaceuticals US, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →