Letairis Side Effects

Generic Name: ambrisentan

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

Not all side effects for Letairis may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to ambrisentan: oral tablet

In addition to its needed effects, some unwanted effects may be caused by ambrisentan (the active ingredient contained in Letairis). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when 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

If any of the following symptoms of overdose occur while taking ambrisentan, get emergency help immediately:

Symptoms of overdose
  • Blurred vision
  • confusion
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • sweating

Some of the side effects that can occur with ambrisentan may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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 increases
Postmarketing reports: Autoimmune hepatitis including cases of exacerbation, 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

Very common (10% or more): Peripheral edema (17%)
Common (1% to 10%): Flushing, palpitations, hypotension, right ventricular failure, chest pain
Postmarketing reports: Heart failure (associated with fluid retention)

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%).

Respiratory

Common (1% to 10%): Nasal congestion, sinusitis, nasopharyngitis, rhinitis, cough, upper respiratory infection, bronchitis
Uncommon (0.1% to 1%): Pulmonary hypertension
Postmarketing reports: Epistaxis, dyspnea

The occurrence of nasal congestion was dose-dependent.

Gastrointestinal

Common (1% to 10%): Abdominal pain, constipation, nausea
Postmarketing reports: Vomiting, diarrhea

Nervous system

Very common (10% or more): Headache (16.8%)
Common (1% to 10%): Dizziness
Postmarketing reports: Syncope

Hypersensitivity

Uncommon (0.1% to 1%): 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

Postmarketing reports: Visual disturbance

Other

Common (1% to 10%): Fatigue
Postmarketing reports: Asthenia

Psychiatric

Common (1% to 10%): Insomnia

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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