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Ambrisentan Side Effects

In Summary

Commonly reported side effects of ambrisentan include: peripheral edema. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to ambrisentan: oral tablet

Warning

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.

Side effects requiring immediate medical attention

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

  • 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

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

Side effects not requiring immediate medical attention

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
  • feeling of warmth
  • redness of the face, neck, arms, and occasionally, upper chest

For Healthcare Professionals

Applies to ambrisentan: oral tablet

Hepatic

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]

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

Frequency not reported: Autoimmune hepatitis, hepatic injury[Ref]

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.[Ref]

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

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

Cardiovascular

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]

Respiratory

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]

Gastrointestinal

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]

Hypersensitivity

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

Genitourinary

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

General

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

Metabolic

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

Musculoskeletal

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

Ocular

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

Postmarketing reports: Visual disturbance[Ref]

Other

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

Frequency not reported: Sudden hearing loss[Ref]

Psychiatric

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

Dermatologic

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

References

1. "Product Information. Letairis (ambrisentan)." Gilead Sciences, Foster City, CA.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

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.