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Ambrisentan Side Effects

Medically reviewed by Last updated on Sep 27, 2023.

Applies to ambrisentan: oral tablet.


Oral route (Tablet)

Embryo-fetal toxicityDo not administer ambrisentan to a pregnant female because it may cause fetal harm. Ambrisentan is very likely to produce serious birth defects if used by pregnant females, as this effect has been seen consistently when it is administered to animals.Exclude pregnancy before the initiation of treatment with ambrisentan. Females of reproductive potential must use acceptable methods of contraception during treatment with ambrisentan and for one month after treatment. Obtain monthly pregnancy tests during treatment and 1 month after discontinuation of treatment.Because of the risks of embryo-fetal toxicity, for all female patients, ambrisentan is only available through a restricted program under a Risk Evaluation and Mitigation (REMS) called the Ambrisentan REMS.

Serious side effects of Ambrisentan

Along with its needed effects, ambrisentan 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

Less common

Incidence not known

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

Symptoms of overdose

Other side effects of Ambrisentan

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

For Healthcare Professionals

Applies to ambrisentan: oral tablet.


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]


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]

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

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


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]


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]


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]


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


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


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


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


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


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

Postmarketing reports: Visual disturbance[Ref]


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

Frequency not reported: Sudden hearing loss[Ref]


Common (1% to 10%): Insomnia[Ref]


Common (1% to 10%): Rash[Ref]


1. Cerner Multum, Inc. "UK Summary of Product Characteristics."

2. (2007) "Product Information. Letairis (ambrisentan)." Gilead Sciences

3. Cerner Multum, Inc. "Australian Product Information."

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.