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Ambrisentan

Warning

This medication must not be used during pregnancy because it can harm an unborn baby. See also Precautions section.

For female patients to receive this medication in the United States, they must understand, agree to, and carefully follow the requirements of the Ambrisentan REMS Program. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

Precautions

Before taking ambrisentan, tell your doctor or pharmacist if you are allergic to it; or to other endothelin receptor blockers (such as bosentan); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, certain lung conditions (pulmonary fibrosis), anemia.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be at greater risk for swelling ankles/feet while using this drug.

This medication can affect fertility in males. Ask your doctor for more details.

This medication must not be used during pregnancy. It may harm an unborn baby. If you are planning pregnancy, become pregnant, or think you may be pregnant, tell your doctor right away. Women who may become pregnant must have a negative pregnancy test before starting this medication, once a month while taking it, and for 1 month after stopping the medication. Consult your doctor for more details and to discuss reliable forms of birth control. Unless otherwise directed by your doctor, it is recommended that at least 2 reliable forms of birth control (such as birth control pills, condoms) be used while taking this medication and for 1 month after stopping the medication. Birth control should still be used, even if your partner had a vasectomy.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

Side Effects

Stuffy nose, runny nose, or flushing may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: fast heartbeat, extreme tiredness, swelling ankles/feet, sudden/unexplained weight gain.

Other medications that are like ambrisentan may rarely cause very serious liver problems. Tell your doctor right away if you develop symptoms of liver disease, including: nausea/vomiting that doesn't stop, loss of appetite, severe stomach/abdominal pain, dark urine, yellowing eyes/skin.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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Drug information is selected from data included with permission and copyrighted by First DataBank, Inc. This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your healthcare professional. Always seek the advice of your healthcare professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your healthcare professional. This information does not contain any assurances that this product is safe, effective or appropriate for you.

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