Letairis Side Effects

Generic name: ambrisentan

Medically reviewed by Drugs.com. Last updated on Feb 13, 2025.

Note: This document provides detailed information about Letairis Side Effects associated with ambrisentan. Some dosage forms listed on this page may not apply specifically to the brand name Letairis.

Applies to ambrisentan: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can cause very serious birth defects. Use a highly effective birth control or 2 forms of effective birth control to keep from getting pregnant while you are using this medicine (even if the medicine is temporarily stopped), and for at least 1 month after your last dose. The most effective forms of birth control are hormone birth control pills, patches, shots, vaginal rings, or implants, or a vasectomy (for men). One of these forms of birth control should be combined with a condom, a diaphragm, or a cervical cap. If a partner’s vasectomy is the chosen method of contraception, a hormone or barrier method must be used along with this method. If you think you have become pregnant while using this medicine, tell your doctor right away.

If you are a woman who can get pregnant, you must have a negative pregnancy test before you will be allowed to take this medicine. You will also be required to have a pregnancy test every month during your treatment and for 1 month after treatment with this medicine. If you miss a period while you are using this medicine, tell your doctor right away.

This medicine may cause fluid retention (edema) in some patients. Check with your doctor right away if you are gaining weight rapidly, have swelling in your hands, ankles, feet, or all over the body, or if you have trouble breathing while you are using this medicine.

Check with your doctor right away if you start to have nausea, vomiting, fever, dark urine or pale stools, a loss of appetite, stomach pain, or yellow eyes or skin. These could be signs of liver injury.

This medicine may decrease the amount of sperm men make, which may affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.

Pulmonary edema (swelling in the lungs) may occur with this medicine. Check with your doctor right away if you have chest pain, difficult, fast, or noisy breathing, blue lips and fingernails, pale skin, increased sweating, or coughing that sometimes produces a pink frothy sputum.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Letairis

Along with its needed effects, ambrisentan (the active ingredient contained in Letairis) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ambrisentan:

Get emergency help immediately if any of the following symptoms of overdose occur while taking ambrisentan:

Symptoms of overdose

• blurred vision
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• sweating

Other side effects of Letairis

Some side effects of ambrisentan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to ambrisentan: oral tablet.

General adverse events

The most common adverse reactions included: peripheral edema, nasal congestion, sinusitis, and flushing.^[Ref]

Hematologic

• Common (1% to 10%): Hemoglobin decreased, anemia
• Postmarketing reports: Decreases in hemoglobin and hematocrit resulting in anemia requiring transfusion^[Ref]

Decreases in hemoglobin and hematocrit were observed during the first few weeks of treatment and appeared to stabilize thereafter. Mean decreases in hemoglobin were 0.8 mg/dL with marked decreases in hemoglobin (greater than 15% decrease from baseline resulting in a value below the lower limit of normal) occurring in 7% of all patients. The frequency of a marked decrease in hemoglobin was greater with the 10 mg dose. The mechanism involved is unknown, but does not appear to be the result of hemorrhage or hemolysis.^[Ref]

Cardiovascular

• Very common (10% or more): Peripheral edema (up to 28.4%)
• Common (1% to 10%): Flushing, palpitations, hypotension, right ventricular failure, chest pain, cardiac failure^[Ref]

The incidence of peripheral edema in younger patients was similar to placebo (14% vs 13%) while the incidence in patients 65 years or older was greater in patients receiving drug (29% vs 4%).^[Ref]

Respiratory

• Very common (10% or more): Nasal congestion (up to 10.4%)
• Common (1% to 10%): Sinusitis, nasopharyngitis, rhinitis, cough, upper respiratory infection, bronchitis, dyspnea, dyspnea exacerbated, pulmonary hypertension, epistaxis^[Ref]

The occurrence of nasal congestion was dose-dependent.^[Ref]

Gastrointestinal

• Common (1% to 10%): Abdominal pain, constipation, nausea, vomiting
• Postmarketing reports: Diarrhea^[Ref]

Nervous system

• Very common (10% or more): Headache (19.4%)
• Common (1% to 10%): Dizziness, syncope
• Frequency not reported: Tinnitus^[Ref]

Hypersensitivity

• Common (1% to 10%): Hypersensitivity^[Ref]

Genitourinary

• Common (1% to 10%): Urinary tract infection^[Ref]

Hepatic

• Common (1% to 10%): Hepatic transaminase increased
• Frequency not reported: Autoimmune hepatitis, hepatic injury^[Ref]

The cumulative incidence of hepatic transaminases elevations greater than 3 times the upper limit of normal was 3.5% with a mean exposure duration of 79.5 weeks. The 12-week incidence was 0.8% (placebo-treated patients 2.3%). Hepatic transaminase elevations of greater than 8 times the upper limit of normal were reported in 0.2% of patients at 12 weeks and hepatic transaminase elevations greater than 6 times the upper limit of normal were reported in 0.5% at 1-year. An elevation of bilirubin to 2 times the upper limit of normal was reported in 1 case.^[Ref]

Metabolic

• Very common (10% or more): Fluid retention^[Ref]

Musculoskeletal

• Common (1% to 10%): Arthralgia^[Ref]

Ocular

• Common (1% to 10%): Blurred vision, visual impairment
• Postmarketing reports: Visual disturbance^[Ref]

Other

• Common (1% to 10%): Fatigue, asthenia
• Frequency not reported: Sudden hearing loss^[Ref]

Psychiatric

• Common (1% to 10%): Insomnia^[Ref]

Dermatologic

• Common (1% to 10%): Rash^[Ref]

See also:

Further information

Letairis side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer