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This medication comes with several important safety warnings and precautions that need to be considered before and during treatment. It is essential to consult your healthcare provider for any questions or concerns.

• Pregnancy Warning: This medication must not be used during pregnancy due to the risk of severe harm to an unborn baby. Women of childbearing potential should use reliable birth control methods before, during, and for one month after treatment. A pregnancy test is required before initiating treatment. If pregnancy occurs or is suspected, contact your healthcare provider immediately.

• Enrollment in REMS Program: For females who can become pregnant, this medication is only available through the Ambrisentan REMS program, which is designed to enhance safety by ensuring adherence to the recommended precautions.

• Fluid Retention: The medication may cause fluid retention in the body, potentially leading to swelling or shortness of breath. This is particularly concerning for individuals with a history of heart failure, as it can exacerbate the condition. Notify your healthcare provider if you experience symptoms such as shortness of breath, swelling in limbs, irregular heartbeat, inability to exercise, or fatigue.

• Anemia Risk: There is a potential for the medication to lower hemoglobin levels, which could lead to anemia. Monitoring of hemoglobin levels is advised during treatment, especially in the initial weeks, to prevent severe anemia.

• Contraindications: Do not use this medication if you are currently pregnant or if you have a lung condition called idiopathic pulmonary fibrosis (IPF).

In case of any emergency or signs of overdose, seek immediate medical attention. Always discuss any other medications or substances you are taking with your healthcare provider to avoid harmful interactions.

Common side effects:

• Stuffy or runny nose
• Flushing
• Swelling in the arms or legs
• Sinus infections

• Inflammation

  Serious side effects:

• Fluid buildup in the body
• Difficulty breathing
• Swelling in the lower limbs
• Irregular heartbeat
• Chest pain
• Difficulty exercising
• Unusual tiredness
• Unexpected weight gain
• Signs of liver problems
• Persistent nausea or vomiting
• Loss of appetite
• Severe stomach pain
• Dark urine
• Yellowing of the skin or eyes
• Severe allergic reactions
• Rash
• Severe dizziness
• Difficulty breathing
• Swelling of the face, tongue, or throat

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• sparsentan