AMBRISENTAN- ambrisentan tablet, film coated 
Apotex Corp.


Medication Guide 
Ambrisentan Tablets  

(am" bri sen’ tan)

Read this Medication Guide before you start taking ambrisentan tablets and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about ambrisentan tablets?

If you are the parent or caregiver of a female child who started taking ambrisentan tablets before reaching puberty, you should check your child regularly to see if she is developing signs of puberty. Tell your doctor right away if you notice that she is developing breast buds or pubic hair. Your doctor should decide if your child has reached puberty. Your child may reach puberty before having her first menstrual period.

Females can only receive ambrisentan tablets through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Ambrisentan REMS. If you are a female who can get pregnant, you must talk to your doctor, understand the benefits and risks of ambrisentan tablets, and agree to all of the instructions in the Ambrisentan REMS.

Males can receive ambrisentan tablets without taking part in the Ambrisentan REMS.

What are ambrisentan tablets?

Who should not take ambrisentan tablets?

Do not take ambrisentan tablets if:

What should I tell my doctor before taking ambrisentan tablets?

Before you take ambrisentan tablets, tell your doctor if you:

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Ambrisentan tablets and other medicines may affect each other, causing side effects. Do not start any new medicines until you check with your doctor.

Especially tell your doctor if you take the medicine cyclosporine (Gengraf, Neoral, Sandimmune). Your doctor may need to change your dose of ambrisentan tablets.

How should I take ambrisentan tablets?

What should I avoid while taking ambrisentan tablets?

What are the possible side effects of ambrisentan tablets?

Ambrisentan tablets can cause serious side effects including:

The most common side effects of ambrisentan tablets include:

  • swelling of hands, legs, ankles and feet (peripheral edema)
  • stuffy nose (nasal congestion)
  • inflamed nasal passages (sinusitis)
  • hot flashes or getting red in the face (flushing)

Some medicines that are like ambrisentan tablets can cause liver problems. Tell your doctor if you get any of these symptoms of a liver problem while taking ambrisentan tablets:

  • loss of appetite
  • nausea or vomiting
  • fever
  • achiness
  • generally do not feel well
  • pain in the upper right stomach (abdominal) area
  • yellowing of your skin or the whites of your eyes
  • dark urine
  • itching

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of ambrisentan tablets. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ambrisentan tablets?

Store ambrisentan tablets at room temperature between 68°F to 77°F (20°C to 25°C), in the package it comes in.

Keep ambrisentan tablets and all medicines out of the reach of children.

General information about the safe and effective use of ambrisentan tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ambrisentan tablets for a condition for which it was not prescribed. Do not give ambrisentan tablets to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about ambrisentan tablets. If you would like more information, ask your doctor. You can ask your doctor or pharmacist for information about ambrisentan tablets that is written for health professionals.

What are the ingredients in ambrisentan tablets?

Active ingredient: ambrisentan

Inactive Ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose.

The tablets are film-coated with a coating material containing FD&C Red # 40 aluminum lake 38-42% (10 mg only), FDC Red # 40 (5 mg only), polyethylene glycol, polyvinyl alcohol, Sunset yellow aluminum lake 40% (5 mg only), talc and titanium dioxide.

For more information, go to or call 1-800-706-5575.

For more information about the Ambrisentan REMS call 1-888-417-3172 or go to

This Medication Guide has been approved by the U.S. Food and Drug Administration.


5 mg and 10 mg

Manufactured by:Manufactured for:
Apotex Inc.
Toronto, Ontario
Canada M9L 1T9
Apotex Corp.
Weston, Florida
USA 33326

Revised: November 2020

Rev. 8

Revised: 12/2023
Apotex Corp.