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Ambrisentan

Ambrisentan is an endothelin receptor antagonist used to treat pulmonary arterial hypertension (PAH) in adults, improving exercise ability and slowing disease progression.

Brand name Letairis
Drug class Endothelin Receptor Antagonist
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 14 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
Ambrisentan 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

Ambrisentan (Letairis) is a specialist medicine for pulmonary arterial hypertension (high blood pressure in the lung arteries) that blocks endothelin, a chemical that narrows and thickens those vessels, helping adults exercise better and slowing the disease; it has been around since about 2007, is available as a generic and is often paired with tadalafil. Most people manage it reasonably well, and swollen legs or ankles, a stuffy nose, flushing and headache are the usual complaints. Its boxed warning is serious birth defects, so it is never taken in pregnancy, every female patient must join the Ambrisentan REMS safety program, and anyone who could become pregnant needs reliable contraception and monthly pregnancy tests until a month after stopping.

Clinical pearls

  • Swallow the tablet whole without splitting, crushing or chewing it, once daily, with or without food.
  • Weigh yourself often and report rapid weight gain or worsening swelling, which is more likely when combined with tadalafil.
  • Expect regular blood counts, since hemoglobin often dips early, plus liver checks while you stay on it.
  • Make sure every prescriber knows if you take cyclosporine, because it raises ambrisentan levels and limits your dose.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Ambrisentan can cause serious, life-threatening birth defects and must never be taken during pregnancy. Animal studies consistently showed major defects in heart, jaw, palate, thymus, and thyroid development. Because the risk is so serious, all female patients — regardless of age or reproductive status — can only receive ambrisentan through a restricted safety program called the Ambrisentan REMS. Women who can become pregnant must use reliable birth control before starting, throughout treatment, and for one month after the last dose. Pregnancy tests are required before starting, every month during treatment, and one month after stopping. If you become pregnant while taking this medicine, contact your doctor immediately.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet
Earliest FDA record2007
Companies listing it with the FDA13
FDA label last updatedJun 22, 2026
FDA’s strongest warning (boxed)Yes, read the warning

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

What Ambrisentan is used for

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Ambrisentan treats pulmonary arterial hypertension (PAH) in adults — here is the full picture of supported uses:

  • Ambrisentan tablets (generic) and Letairis are each approved to treat PAH (WHO Group 1) in adults, to improve exercise ability and delay clinical worsening.
  • Ambrisentan tablets and Letairis are each approved to be used together with tadalafil to reduce the risk of disease progression and hospitalization for worsening PAH, and to improve exercise ability.
  • Clinical evidence was predominantly from patients with mild-to-moderate PAH symptoms (WHO Functional Class II–III) with idiopathic or heritable PAH, or PAH linked to connective tissue diseases.
  • Ambrisentan is not approved for idiopathic pulmonary fibrosis (IPF), including IPF with pulmonary hypertension (WHO Group 3) — it is contraindicated in that condition.

How Ambrisentan works

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In PAH, the body produces too much of a protein called endothelin-1 (ET-1) — sometimes up to 10 times the normal level in the blood and 9 times the normal level in lung tissue. ET-1 binds to ET-A receptors on pulmonary artery walls, causing those vessels to tighten (vasoconstriction) and the vessel walls to thicken over time. Ambrisentan selectively blocks the ET-A receptor with very high affinity, which relaxes the pulmonary arteries, lowers pressure in those vessels, and reduces the strain on the right side of the heart. Because ambrisentan is highly selective for ET-A over the ET-B receptor (more than 4,000-fold selectivity), it may leave certain protective ET-B functions — like natural vessel dilation and clearance of ET-1 — more intact, though the clinical significance of this selectivity is not fully known.

Ambrisentan dosage

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Ambrisentan tablets and Letairis are each taken once daily by mouth and can be taken with or without food — food does not affect how much of the drug the body absorbs. Tablets must be swallowed whole; do not split, crush, or chew them. Treatment is typically started at the lower dose, with your prescriber adjusting the dose at roughly 4-week intervals if needed and tolerated. Always follow your prescriber's specific instructions and do not change your dose on your own.

Dosing details from the FDA-approved label

From the Ambrisentan 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.

  • Adult Dosage
    • Initiate treatment at 5 mg once daily, with or without tadalafil 20 mg once daily
    • At 4-week intervals, either the dose of ambrisentan or tadalafil can be increased, as needed and tolerated, to ambrisentan 10 mg or tadalafil 40 mg
    • Do not split, crush, or chew tablets.
  • Females of reproductive potential (pregnancy testing)
    • Initiate treatment with ambrisentan only after a negative pregnancy test
    • Obtain monthly pregnancy tests during treatment
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Initiate treatment at 5 mg once daily ( 2.1 ). May be started with tadalafil ( 2.1 ). Titrate at 4-week intervals as needed and tolerated ( 2.1 ). Do not split, crush, or chew tablets ( 2.1 ). 2.1. Adult Dosage Initiate treatment at 5 mg once daily, with or without tadalafil 20 mg once daily. At 4-week intervals, either the dose of ambrisentan or tadalafil can be increased, as needed and tolerated, to ambrisentan tablets, 10 mg or tadalafil 40 mg. Do not split, crush, or chew tablets. 2.2. Pregnancy Testing in Females of Reproductive Potential Initiate treatment with ambrisentan in females of reproductive potential only after a negative pregnancy test. Obtain monthly pregnancy tests during treatment [see Use in Specific Populations (8.3) ] .

Read the full Dosage and Administration section on DailyMed →

Ambrisentan side effects

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Most side effects with ambrisentan are mild to moderate. The most commonly reported include:

Common side effects

  • Peripheral edema (swelling in the legs, ankles, or feet)
  • Nasal congestion (stuffy nose)
  • Sinusitis (sinus inflammation or infection)
  • Flushing (feeling of warmth or redness in the face)
  • Headache (especially when used with tadalafil)
  • Cough (especially when used with tadalafil)
  • Anemia (low red blood cell count, especially when used with tadalafil)
  • Dyspepsia (indigestion or upset stomach, especially when used with tadalafil)
  • Nasal congestion — stuffy or runny nose
  • Anemia — low red blood cell levels (more common with combination therapy)

When to get medical help

  • Call your doctor right away if you notice rapid weight gain or severe swelling — this may be a sign of dangerous fluid retention or heart failure.
  • Seek emergency care if you develop sudden shortness of breath or severe difficulty breathing after starting this medication, which may signal a rare lung condition called pulmonary veno-occlusive disease (PVOD).
  • Contact your doctor if you feel unusually tired, look pale, or have rapid heartbeat — these can be signs of anemia (low blood counts).
  • Tell your doctor immediately if you think you may be pregnant or miss a period while taking this medicine — it can cause serious birth defects.
  • Watch for signs of liver problems — yellowing of skin or eyes, dark urine, unusual fatigue, or upper abdominal pain — and report them to your doctor immediately.
  • Tell your doctor if you experience a significant drop in blood pressure (dizziness, lightheadedness, fainting), especially with a large overdose.

Ambrisentan warnings and precautions

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  • Pregnancy and birth defects (most critical): Ambrisentan causes serious birth defects in animals and must never be used during pregnancy. All female patients must join the Ambrisentan REMS safety program. Women who can become pregnant must use reliable contraception and get monthly pregnancy tests during treatment and for one month after stopping.
  • Fluid retention: Swelling (peripheral edema) is common and can sometimes be severe, leading to hospitalization for worsening heart failure. The risk is higher when ambrisentan is combined with tadalafil.
  • Pulmonary veno-occlusive disease (PVOD): If breathing suddenly worsens after starting treatment, this rare but serious lung condition must be ruled out — and ambrisentan stopped if confirmed.
  • Anemia (low blood counts): Hemoglobin can drop, especially in the first weeks of treatment. Blood counts are checked before starting, at one month, and periodically after that.
  • Sperm count reduction: This class of medication may reduce sperm counts in men. Counsel your doctor if fertility is a concern.
  • Liver concerns: Other drugs in this class have caused liver damage. Report any signs of liver problems right away. Ambrisentan is not recommended for patients with moderate or severe liver disease.

Ambrisentan interactions

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Always tell your prescriber and pharmacist about every medication you take. Key interactions to know:

  • Cyclosporine (used to prevent organ rejection or for autoimmune conditions): Significantly increases ambrisentan levels in the blood — the ambrisentan dose must be limited when these two drugs are used together.
  • Rifampin (an antibiotic for certain infections): Temporarily raises ambrisentan levels when first combined; your prescriber should be aware if you need this antibiotic.
  • Tadalafil: Intentionally combined with ambrisentan for PAH treatment, but the combination increases the chance of swelling and fluid retention compared to either drug alone — your doctor will monitor you closely.

Interactions listed in the FDA-approved label

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

  • Cyclosporine: Multiple dose coadministration resulted in an approximately 2-fold increase in ambrisentan exposure in healthy volunteers. Limit the dose of ambrisentan to 5 mg once daily when coadministered with cyclosporine.
Read the label’s full interactions text

7 DRUG INTERACTIONS Multiple dose coadministration of ambrisentan and cyclosporine resulted in an approximately 2-fold increase in ambrisentan exposure in healthy volunteers; therefore, limit the dose of ambrisentan to 5 mg once daily when coadministered with cyclosporine [see Clinical Pharmacology (12.3) ]. Cyclosporine increases ambrisentan exposure; limit ambrisentan dose to 5 mg once daily ( 7 ).

Drug Interactions In Vitro Studies Studies with human liver tissue indicate that ambrisentan is metabolized by CYP3A, CYP2C19, and uridine 5’-diphosphate glucuronosyltransferases (UGTs) 1A9S, 2B7S, and 1A3S. In vitro studies suggest that ambrisentan is a substrate of the Organic Anion Transporting Polypeptides OATP1B1 and OATP1B3, and P-glycoprotein (P-gp). Drug interactions might be expected because of these factors; however, a clinically relevant interaction has been demonstrated only with cyclosporine [see Drug Interactions (7) ] . In vitro studies found ambrisentan to have little to no inhibition of human hepatic transporters. Ambrisentan demonstrated weak dose-dependent inhibition of OATP1B1, OATP1B3, and NTCP (IC 50 of 47 μM, 45 μM, and approximately 100 μM, respectively) and no transporter-specific inhibition of BSEP, BRCP, P-gp, or MRP2. Ambrisentan does not inhibit or induce drug metabolizing enzymes at clinically relevant concentrations. In Vivo Studies The effects of other drugs on ambrisentan pharmacokinetics and the effects of ambrisentan on the exposure to other drugs are shown in Figure 2 and Figure 3, respectively. Figure 2 Effects of Other Drugs on Ambrisentan Pharmacokinetics Figure 3 Effects of Ambrisentan on Other Drugs Figure 2 Effects of Other Drugs on Ambrisentan Pharmacokinetics Figure 3 Effects of Ambrisentan on Other Drugs

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.

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

Before taking Ambrisentan

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  • Pregnancy: Do not take ambrisentan if you are pregnant — it causes serious birth defects and is strictly contraindicated.
  • Women of all ages: Must enroll in the Ambrisentan REMS program before the prescription can be filled.
  • Women who can become pregnant: Must use reliable contraception before, during, and for one month after stopping treatment.
  • Breastfeeding: It is unknown whether ambrisentan passes into breast milk. You must choose between breastfeeding and taking this medication.
  • Idiopathic pulmonary fibrosis (IPF): Ambrisentan is contraindicated — do not use if you have this diagnosis.
  • Moderate or severe liver disease: Ambrisentan is not recommended in these patients.
  • Anemia before starting: Treatment is not recommended if you already have clinically significant anemia.
  • Children: Safety and effectiveness in pediatric patients have not been established.
  • Older adults (65+): May experience more peripheral edema and somewhat less improvement in exercise capacity compared to younger patients.
  • Kidney disease: Mild or moderate kidney impairment does not appear to significantly affect ambrisentan exposure; no dose adjustment is required. There is no data for severe kidney impairment or patients on hemodialysis.
  • Male fertility: This class of drug may reduce sperm counts — discuss with your doctor if this is a concern.

Ambrisentan overdose

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There is no specific antidote for an ambrisentan overdose. In healthy volunteers who took very large single doses (5 to 10 times the maximum recommended daily dose), symptoms included headache, flushing, dizziness, nausea, and nasal congestion. A very large overdose could cause dangerously low blood pressure (hypotension) that may require medical treatment. If you suspect an overdose, seek emergency medical help or call Poison Control immediately.

What Ambrisentan does in the body

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Ambrisentan lowers pulmonary arterial pressure by relaxing and widening blood vessels in the lungs. In clinical studies, it was shown to reduce NT-proBNP — a blood marker that reflects how hard the heart is working — with the biggest reductions seen when ambrisentan was combined with tadalafil (a 63% reduction at 24 weeks), compared to ambrisentan alone (50%) or tadalafil alone (41%). At the doses used clinically, ambrisentan does not significantly affect the heart's electrical rhythm (QT interval), so abnormal heart rhythms from this effect are not a major concern at standard doses.

How your body processes Ambrisentan

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After taking ambrisentan by mouth, blood levels peak in about 2 hours. Food does not affect absorption, so it can be taken any time of day. Ambrisentan is very tightly bound to proteins in the blood (99%) and is broken down mainly by liver enzymes (CYP3A, CYP2C19, and glucuronidation pathways), with most elimination occurring through non-kidney routes. The effective half-life — the time it takes blood levels to meaningfully drop — is about 9 hours, supporting once-daily dosing. The kidneys play a small role in clearing the drug, so mild or moderate kidney impairment does not require dose changes; however, moderate to severe liver impairment could significantly affect how the body handles ambrisentan.

How to store Ambrisentan

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Store at 25° C (77° F); excursions permitted to 15 – 30° C (59 – 86° F) . Store Letairis in its original packaging.

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

256

Supplements & herbs that interact with Ambrisentan

256 supplements and herbal products have documented interactions with Ambrisentan 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 · 9
  • Moderate · 210
  • Minor · 37
ACTIVATED CHARCOAL Major AMERICAN HELLEBORE Major AMERICAN MISTLETOE Major BEER Major GRAPEFRUIT Major SIBERIAN COCKLEBUR Major ST. JOHN'S WORT Major TYRAMINE Major +248 more
Every supplement checked against Ambrisentan — ranked by severity The full interaction hub: 9 major · 210 moderate · 37 minor · every one linked to its full report. Check Ambrisentan 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

Ambrisentan 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 Ambrisentan 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.

Ambrisentan: pharmacist answers to common questions

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

What exactly does ambrisentan do, and will it cure my PAH?

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Ambrisentan won't cure PAH, but it can make a real difference in how you feel and function. It works by blocking a protein called ET-1 that causes the blood vessels in your lungs to tighten and thicken. By blocking that signal, the vessels relax, pressure drops, and your heart doesn't have to work as hard. In clinical studies, patients were able to walk farther and had fewer disease flare-ups — sometimes even fewer hospitalizations when combined with tadalafil. Think of it as a tool that helps manage and slow the disease, not eliminate it.

Can I take ambrisentan with food, and does it matter what time of day I take it?

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Good news — food doesn't affect how well your body absorbs ambrisentan, so you can take it with or without a meal, whichever works best for your routine. Pick a time of day you can stick to consistently, since it's a once-daily medication. Just make sure you swallow the tablet whole — don't split, crush, or chew it.

I'm a woman of childbearing age. What do I need to know before starting this medication?

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This is really important — ambrisentan can cause very serious birth defects and must never be taken during pregnancy. Before you can even get the prescription filled, you'll need a negative pregnancy test, and you'll need to enroll in a special safety program called the Ambrisentan REMS. You'll also need to use reliable birth control throughout treatment and for a full month after your last dose, plus get a pregnancy test every month. If your period is late or you think you might be pregnant at any point, call your doctor right away. This program exists to protect you and any future pregnancy.

What side effects should I expect, and which ones mean I need to call my doctor?

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The most common side effects are swelling in your legs or ankles, a stuffy nose, sinus problems, and flushing — most people find these manageable. If you're taking ambrisentan with tadalafil, headache, cough, and feeling tired are also more likely. What you should call your doctor about right away: sudden or severe swelling, rapid weight gain, worsening shortness of breath after starting the drug, unusual fatigue or paleness (signs of low blood counts), or any yellowing of your skin or eyes. These can signal something more serious that needs prompt attention.

I take cyclosporine for another condition. Is that a problem?

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Yes, that's definitely something to flag with your prescriber before starting. Cyclosporine causes ambrisentan to build up to about twice its normal level in your blood, which increases the risk of side effects. Your doctor will likely limit you to a lower dose of ambrisentan if you're taking both. Make sure every doctor and your pharmacist knows about all your medications — it helps keep your dose safe.

I'm a man — do I need to worry about anything specific with this medication?

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One thing worth knowing: drugs in ambrisentan's class have been shown to reduce sperm counts in some men. It's not guaranteed to happen to you, but if having children is something you're thinking about now or in the future, bring it up with your doctor before starting treatment. You don't need to enroll in the REMS program the way women do, but the fertility question is worth a conversation. Your doctor can help you weigh the benefits of treatment against your personal concerns.

Is Ambrisentan available over the counter?

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No. Ambrisentan is a prescription medicine: every Ambrisentan 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 Ambrisentan first available?

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The earliest FDA record we hold for Ambrisentan is from 2007: 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 Ambrisentan was first used.

Who makes Ambrisentan?

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13 companies currently list Ambrisentan products in the FDA's NDC Directory, including A-S Medication Solutions, Actavis Pharma, Inc., Apotex Corp.. 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 Ambrisentan on HelloPharmacist

📊Ambrisentan supplement interactions256 checked — ranked by severity 🌿Drug & Supplement CheckerAmbrisentan vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Ambrisentan NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Ambrisentan 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.

Ambrisentan forms and strengths (how it comes)

Ambrisentan 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.

Tablet

By mouth
Brands Letairis
How this form is used
What it may be used for
  • Ambrisentan tablets are used to treat pulmonary arterial hypertension (PAH, WHO Group 1) in adults to improve exercise ability and delay clinical worsening.
  • Ambrisentan tablets are used in combination with tadalafil to reduce disease progression and hospitalization risk in PAH.
  • Letairis is used to treat pulmonary arterial hypertension (PAH, WHO Group 1) in adults to improve exercise ability and delay clinical worsening.
  • Letairis is used in combination with tadalafil to reduce disease progression and hospitalization risk in PAH.
Important instructions
  • Take ambrisentan tablets or Letairis once daily by mouth, with or without food.
  • Swallow ambrisentan tablets and Letairis tablets whole — do not split, crush, or chew them.
  • Dose adjustments for ambrisentan tablets and Letairis are made by your prescriber at approximately 4-week intervals as needed.
  • Female patients must enroll in the Ambrisentan REMS program before Letairis or ambrisentan tablets can be dispensed.
Available strengths 2 strengths
5 mg 10 mg
64 FDA-listed product records ⓘ

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

How Ambrisentan 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.

13 companies list 26 Ambrisentan product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2007. Brand names on the directory include Letairis; the rest are generics.

1
Dose forms ⓘ
13
Labelers (makers, repackagers, distributors)
2
Brand names
26
FDA-listed product records ⓘ
2007
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (7) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

A-S Medication Solutions8%
Actavis Pharma, Inc.8%
Apotex Corp.8%
Aurobindo Pharma Limited8%
Cipla USA Inc.8%
Gilead Sciences, Inc.8%
Other makers54%

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

How widely Ambrisentan is used (Medicaid data)

A general measure of how commonly Ambrisentan 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 Ambrisentan 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.

21,600
Medicaid prescriptions filled (Q1–Q4 2025)
$42.1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Ambrisentan prescribed? Of the 1,601 medications we measure, Ambrisentan ranks #783 by Medicaid prescriptions — more than 51% of them.

Where Ambrisentan ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #783 of 1,601
#778 Valganciclovir 23,219 Rx #779 Cetirizine / Pseudoeph... 22,875 Rx #780 Levetiracetam Injectio... 22,631 Rx #781 Dextromethorphan and Q... 22,121 Rx #782 Ribociclib 21,708 Rx #783 Ambrisentan 21,600 Rx #784 Olopatadine Nasal Spra... 21,523 Rx #785 Diclofenac Transdermal... 21,190 Rx #786 Daridorexant 20,970 Rx #787 Amiloride 20,737 Rx #788 Desloratadine 20,483 Rx

Utilization by Ambrisentan 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 10 mg oral tablet is the most-dispensed Ambrisentan product — about 78% of these Medicaid prescriptions.

ambrisentan 10 MG Oral Tablet Most dispensed

16,777 Medicaid prescriptions (Q1–Q4 2025) 78% of Ambrisentan prescriptions shown $32.5M gross reimbursement (before rebates) ≈ $1,936 per prescription (gross)

Summed across the 9 of 32 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 722116

ambrisentan 5 MG Oral Tablet

4,823 Medicaid prescriptions (Q1–Q4 2025) 22% of Ambrisentan prescriptions shown $9.6M gross reimbursement (before rebates) ≈ $2,000 per prescription (gross)

Summed across the 9 of 36 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 722122

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 Ambrisentan, 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 18 of 68 listed Ambrisentan NDCs with Medicaid activity.

Compare Ambrisentan products

A representative set of FDA-listed product records for Ambrisentan — 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 26 of 26 products — FDA National Drug Code Directory. See every product, package size and price: browse all 26 Ambrisentan NDCs →

Ambrisentan 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 Ambrisentan recalls since July 2021.

✅No Ambrisentan 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) Ambrisentan RxCUI 358274 1 dose form · 2 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 722115 In current FDA listings
    Clinical drug / strength (SCD) 5 MG RxCUI 722122 10 MG RxCUI 722116

Look up RxCUI 358274 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.

💵 What Ambrisentan costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet, Film Coated · Oral 10 mg $8.02 per tablet NDC details & price history
Tablet, Film Coated 10 mg $8.02 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Ambrisentan brand names

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

Letairis

Who makes Ambrisentan: manufacturers and labelers

13 companies list Ambrisentan products with the FDA. By number of product records, the largest are A-S Medication Solutions, Actavis Pharma, Inc., Apotex Corp.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

A-S Medication Solutions 2 Actavis Pharma, Inc. 2 Apotex Corp. 2 Aurobindo Pharma Limited 2 Cipla USA Inc. 2 Gilead Sciences, Inc. 2 Golden State Medical Supply, Inc. 2 Mylan Pharmaceuticals Inc. 2 Quallent Pharmaceuticals Health LLC 2 Sigmapharm Laboratories, LLC 2 Sun Pharmaceutical Industries, Inc. 2 Zydus Lifesciences Limited 2 Zydus Pharmaceuticals USA Inc. 2

Ambrisentan drug class (RxNorm)

Ambrisentan 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

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 Ambrisentan 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.

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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 Jun 22, 2026
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Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Ambrisentan.
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Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
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Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Ambrisentan after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
14
Finished products in the current FDA directory
26
Companies listing them (makers, repackagers, distributors)
13
FDA labeler codes behind them ⓘ
13
Linked representative label ⓘ
Gilead Sciences, Inc
Linked label effective
Jun 22, 2026
Composite sections available
25
Linked SPL Set ID
725d4e73-6c83-477a-adc6-0ae4a133a844
Linked SPL Document ID
2808f55e-aed5-40c7-832b-630e1408951c
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. Gilead Sciences, 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 →