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Letairis

Generic Name: ambrisentan (AM bri SEN tan)
Brand Names: Letairis
Letairis is used to treat pulmonary arterial hypertension (PAH). Learn about side effects, interactions and indications.
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Drug Information:
Letairis (ambrisentan) prevents thickening of the blood vessels, especially those in the lungs and heart. Ambrisentan also lowers blood pressure in your lungs, helping your heart pump blood more efficiently. Letairis is used to treat pulmonary arterial hypertension (PAH) in adults. It improves your ability to exercise and prevents your condition from getting worse. Letairis is sometimes used with a medicine called tadalafil (Adcirca). For women, Letairis is available only from a certified pharmacy under a special program. You must be registered in the program and sign agreements to use birth control and undergo pregnancy and blood testing. Learn more

Letairis Side Effects

Letairis Side Effects

Note: This document contains side effect information about ambrisentan. Some of the dosage forms listed on this page may not apply to the brand name Letairis.

In Summary

Common side effects of Letairis include: peripheral edema. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to ambrisentan: oral tablet

Warning

Oral route (Tablet)

Do not administer ambrisentan to a pregnant female because it may cause fetal harm. Exclude pregnancy before the start of treatment, monthly during treatment, and one month after stopping treatment. Use adequate contraception and prevent pregnancy during treatment and for one month after treatment. Letairis® is only available through a restricted distribution program under a Risk Evaluation and Mitigation (REMS), called the Letairis REMS.

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:

More common

  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • rapid weight gain
  • tingling of the hands or feet
  • unusual weight gain or loss

Less common

  • Cough
  • fast, irregular, pounding, or racing heartbeat or pulse
  • fever
  • headache
  • muscle aches
  • pain or tenderness around the eyes and cheekbones
  • sore throat
  • stuffy or runny nose
  • tightness of the chest
  • trouble breathing
  • unusual tiredness or weakness

Incidence not known

  • Abdominal or stomach pain or tenderness
  • chest pain
  • clay colored stools
  • dark urine
  • decrease in the amount of urine
  • decreased appetite
  • dilated neck veins
  • extreme fatigue
  • irregular breathing
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • nausea and vomiting
  • noisy, rattling breathing
  • pale skin
  • skin rash, itching
  • troubled breathing at rest
  • troubled breathing with exertion
  • yellow skin or eyes

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

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:

Less common

  • Difficulty having a bowel movement (stool)
  • feeling of warmth
  • redness of the face, neck, arms, and occasionally, upper chest

For Healthcare Professionals

Applies to ambrisentan: oral tablet

Hepatic

Common (1% to 10%): Hepatic transaminase increased

Frequency not reported: Autoimmune hepatitis, hepatic injury

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.

Hematologic

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.

Common (1% to 10%): Hemoglobin decreased, anemia

Postmarketing reports: Decreases in hemoglobin and hematocrit resulting in anemia requiring transfusion

Cardiovascular

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%).

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

Respiratory

The occurrence of nasal congestion was dose-dependent.

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

Gastrointestinal

Common (1% to 10%): Abdominal pain, constipation, nausea, vomiting

Postmarketing reports: Diarrhea

Nervous system

Very common (10% or more): Headache (19.4%)

Common (1% to 10%): Dizziness, syncope

Frequency not reported: Tinnitus

Hypersensitivity

Common (1% to 10%): Hypersensitivity

Genitourinary

Common (1% to 10%): Urinary tract infection

General

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

Metabolic

Very common (10% or more): Fluid retention

Musculoskeletal

Common (1% to 10%): Arthralgia

Ocular

Common (1% to 10%): Blurred vision, visual impairment

Postmarketing reports: Visual disturbance

Other

Common (1% to 10%): Fatigue, asthenia

Frequency not reported: Sudden hearing loss

Psychiatric

Common (1% to 10%): Insomnia

Dermatologic

Common (1% to 10%): Rash

Editorial References and Review

Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.

Source: Drugs.com Letairis