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.
Common side effects of Letairis include: peripheral edema. See below for a comprehensive list of adverse effects.
Applies to ambrisentan: oral tablet
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:
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking ambrisentan:
Symptoms of overdose
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:
Applies to ambrisentan: oral tablet
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.
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
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
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
Common (1% to 10%): Abdominal pain, constipation, nausea, vomiting
Postmarketing reports: Diarrhea
Very common (10% or more): Headache (19.4%)
Common (1% to 10%): Dizziness, syncope
Frequency not reported: Tinnitus
Common (1% to 10%): Hypersensitivity
Common (1% to 10%): Urinary tract infection
The most common adverse reactions included: peripheral edema, nasal congestion, sinusitis, and flushing.
Very common (10% or more): Fluid retention
Common (1% to 10%): Arthralgia
Common (1% to 10%): Blurred vision, visual impairment
Postmarketing reports: Visual disturbance
Common (1% to 10%): Fatigue, asthenia
Frequency not reported: Sudden hearing loss
Common (1% to 10%): Insomnia
Common (1% to 10%): Rash
Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.
Source: Drugs.com Letairis