Prescription medicine
Ambrisentan Brand names: Letairis
Ambrisentan (Letairis) is a prescription medicine with an FDA approval on record since 2007. FDA's NDC Directory lists it from 12 generic labelers, and pharmacies paid $8.02 per ambrisentan 10 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the ambrisentan FDA label on DailyMed (effective September 3, 2026, Apotex Corp.); the NDA 22081 record on Drugs@FDA; every ambrisentan label on DailyMed.
Highlights of the record
FDA label of September 3, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
EMBRYO-FETAL TOXICITY.
Ambrisentan tablets are contraindicat ed for use during pregnancy because it may cause major birth defects if used by pregnant patients, based on studies in animals [see Contraindications (4.1), Warnings and Precautions (5.1), and Use in Specific Populations (8.1)]. Therefore, for females of reproductive potential, exclude pregnancy before the initiation of treatment must use acceptable methods of contraception during treatment with ambrisentan tablets. Advise use of effective contraception before initiation, during treatment, and for one month after treatment with ambrisentan tablets [see Dosage and Administration (2.2), Contraindications (4.1), Warnings and Precautions (5.1), and Use in Specific Populations (8.1, 8.3)]. When pregnancy is detected, discontinue ambrisentan tablets as soon as possible (5.1). WARNING: EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. Based on animal data ambrisentan tablets may cause fetal harm if used during pregnancy (4.1, 5.1, 8.1). Females of reproductive potential: Exclude pregnancy before the start of treatment. Use effective contraception prior to initiation of treatment, during treatment, and for one month after treatment with ambrisentan tablets. (2.2, 4.1, 5.1, 8.1, 8.3) W hen pregnancy is detected, discontinue ambrisentan tablets as soon as possible (5.1).
Used for
From the label: indications and usageAmbrisentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adult patients: To improve exercise ability and delay clinical worsening.
Forms and strengths
- 5 mg
- 10 mg
Film-coated tablet.
On the market
- Earliest approval on file
- June 15, 2007 Letairis, Gilead; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 9 first March 28, 2019; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 13 of which 12 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- October 14, 2031 Letairis tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $8.02 per tablet Ambrisentan 10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 124,133 through July 30, 2026
What is ambrisentan used for?
From the label: indications and usageAmbrisentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adult patients: To improve exercise ability and delay clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II–III symptoms and etiologies of idiopathic or heritable PAH (60%) or PAH associated with connective tissue diseases (34%). Ambrisentan tablets are an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adult patients: To improve exercise ability and delay clinical worsening. […]
Conditions named in the indications of ambrisentan's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Endothelin Receptor Antagonist.
Source: FDA drug label (Ambrisentan), Apotex Corp., effective September 3, 2026 (SPL set 291a782a-77e1-8a8e-e1c8-2626f305c2b7), via openFDA; the full label on DailyMed
What does the patient leaflet for ambrisentan say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ambrisentan tablets?Serious birth defects. Ambrisentan tablets can cause serious birth defects if taken during pregnancy. Females should not be pregnant when they start taking ambrisentan tablets or become pregnant during treatment with ambrisentan tablets. Females who are able to get pregnant should have a negative pregnancy test before beginning treatment with ambrisentan tablets. Talk to your doctor about your menstrual cycle. Your doctor will decide when to do a pregnancy test, and will order a pregnancy test for you depending on your menstrual cycle. Females who are able to get pregnant are females who: have entered puberty, even if they have not started their menstrual period, and have a uterus, and have not gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed. Females who are not able to get pregnant are females who: have not yet entered puberty, or do not have a uterus, or have gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed, or who are infertile for any other medical reason and this infertility is permanent and cannot be reversed Females who are able to get pregnant should use effective contraception before beginning ambrisentan tablets, during treatment with ambrisentan tablets, and for one month after stopping ambrisentan tablets because the medicine may still be in the body. Talk with your doctor or gynecologist (a doctor who specializes in female reproduction) to find out about options for acceptable forms of birth control that you may use to prevent pregnancy during treatment with ambrisentan tablets. […]
From the patient leaflet: What should I avoid while taking ambrisentan tablets?Do not get pregnant while taking ambrisentan tablets. (See the serious birth defects section of the Medication Guide above called "What is the most important information I should know about ambrisentan tablets ?" ) If you miss a menstrual period, or think you might be pregnant, call your doctor right away. It is not known if ambrisentan passes into your breast milk. You should not breastfeed if you are taking ambrisentan tablets. Talk to your doctor about the best way to feed your baby if you take ambrisentan tablets.
From the patient leaflet: How should I store ambrisentan tablets?Store ambrisentan tablets at room temperature between 68°F to 77°F (20°C to 25°C), in the package it comes in. Keep ambrisentan tablets and all medicines out of the reach of children.
Source: FDA drug label (Ambrisentan), Apotex Corp., effective September 3, 2026 (SPL set 291a782a-77e1-8a8e-e1c8-2626f305c2b7), via openFDA; the full label on DailyMed
Is there a generic for ambrisentan (Letairis)?
The FDA approved the first generic ambrisentan on March 28, 2019. 9 generic applications are approved; 7 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists ambrisentan from 12 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 3 patents for Letairis tablets, the last expiring on October 14, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2007 earliest approval on file
- 2019 first generic approved
- 2031 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ambrisentan (Letairis)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $8.02 per Ambrisentan 10 mg tablet, down 18% from $9.85 on November 19, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Ambrisentan 10 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ambrisentan 10 mg tablet | Generic | $8.02 per tablet | $240.74 | -18% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the ambrisentan label say about other medicines?
The ambrisentan label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name ambrisentan. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cyclosporine | drug interactions | 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) ]. |
| Tadalafil | warnings and precautions | Peripheral edema/fluid retention is more common with Letairis plus tadalafil than with Letairis or tadalafil alone. |
Source: FDA drug label (Ambrisentan), Apotex Corp., effective September 3, 2026 (SPL set 291a782a-77e1-8a8e-e1c8-2626f305c2b7), via openFDA; the full label on DailyMed
What do FAERS reports show for ambrisentan?
The FDA Adverse Event Reporting System holds 124,133 reports that list ambrisentan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 17,005 are coded as a death and 52,456 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ambrisentan?
6 other medicines are given the same way (oral) and in the same FDA class as ambrisentan or labeled mainly for the same use (pulmonary arterial hypertension), the same class first. Pulmonary arterial hypertension lists all 11 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Bosentan | Pulmonary arterial hypertension | 5 labelers | n/a | No current entry |
| Macitentan | Pulmonary arterial hypertension | 13 labelers | n/a | No current entry |
| Macitentan and tadalafil | Pulmonary arterial hypertension | none listed | n/a | No current entry |
| Selexipag | Pulmonary arterial hypertension | 2 labelers | n/a | No current entry |
| Treprostinil | Pulmonary arterial hypertension | none listed | n/a | No current entry |
| Riociguat | Pulmonary arterial hypertension | 1 labeler | n/a | No current entry |
Every medicine labeled for the same conditions as ambrisentan
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does ambrisentan compare with medicines for the same use?
2 side-by-side pages set ambrisentan beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to ambrisentan
- 6 medicines for the same use
- Other endothelin receptor antagonists
- the pharmacologic class, with prices and generics
- Ambrisentan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other