Letairis Side Effects

Generic name: ambrisentan

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.

Some side effects of Letairis may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to ambrisentan: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking ambrisentan (the active ingredient contained in Letairis) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• anxiety, sweating, pale skin, severe shortness of breath, wheezing, gasping for breath, cough with foamy mucus, chest pain, fast or uneven heart rate;

• swelling of the feet, ankles, or legs;

• pounding heartbeats or fluttering in your chest; or

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• stuffy nose, sinus pain; or

• flushing (warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to ambrisentan: oral tablet

Hepatic

Hepatic side effects have included dose-dependent liver injury manifested primarily by elevation of serum aminotransferases (ALT or AST), but sometimes accompanied by abnormal liver function (elevated bilirubin). The combination of aminotransferases greater than 3 times the upper limit of normal and total bilirubin 2 times the upper limit of normal is a marker for potentially serious hepatic injury.

Hematologic

Hematologic side effects have included decreases in hemoglobin concentration and hematocrit. Postmarketing reports have included anemia. There have been postmarketing reports of decreases in hemoglobin concentration and hematocrit that have resulted in anemia requiring transfusion. In the long-term open-label extension of the two pivotal clinical studies, mean decreases from baseline (ranging from 0.9 to 1.2 g/dL) in hemoglobin concentrations persisted for up to 4 years of treatment.

Cardiovascular

Cardiovascular side effects have included peripheral edema, palpitations, and flushing. Fluid retention has been reported during postmarketing use of ambrisentan (the active ingredient contained in Letairis) Additional postmarketing reports have included heart failure (associated with fluid retention).

Respiratory

Respiratory side effects have included dyspnea, nasal congestion, sinusitis, and nasopharyngitis.

Gastrointestinal

Gastrointestinal side effects have included abdominal pain and constipation. Postmarketing experience has included nausea and vomiting.

Nervous system

Nervous system side effects have included headache, asthenia, dizziness, and fatigue.

Hypersensitivity

Hypersensitivity side effects have included postmarketing reports of angioedema and rash.

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