PATIENT INFORMATION

Cabergoline (ka ber′ goe leen) Tablets
f or oral use

What are cabergoline tablets?

Cabergoline tablets are a prescription medicine used to treat a condition called hyperprolactinemia (increased levels of prolactin) in adults.

Cabergoline tablets are not for use to prevent or suppress breastfeeding after having given birth (postpartum lactation).

It is not known if cabergoline tablets are safe and effective in children.

Who should not take cabergoline tablets?

Do not take cabergoline tablets if you:

• have uncontrolled high blood pressure.
• are allergic to medicines called ergot derivatives.
• have a history of heart valve disorders.
• have a history of fibrosis in your heart, chest, lungs or abdomen.

• have heart problems.
• have low blood pressure.
• have liver problems.
• are pregnant or plan to become pregnant. It is not known if cabergoline tablets will harm your unborn baby. Tell your health care provider if you become pregnant or think you are pregnant during treatment with cabergoline tablets. A pregnancy test should be done if you think you may be pregnant. You and your health care provider should discuss whether to continue treatment with cabergoline tablets.
• are breastfeeding or plan to breastfeed. Talk to your health care provider about the best way to feed your baby if you take cabergoline tablets. Do not breastfeed during treatment while taking cabergoline tablets.
• Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Cabergoline tablets may affect the way other medicines work, and other medicines may affect the way cabergoline tablets work.

• Take cabergoline tablets exactly how your health care provider tells you to take it.
• Your health care provider should check for heart valve problems before starting treatment with cabergoline tablets.
• Take cabergoline tablets by mouth 2 times weekly or as directed by your health care provider.
• Take cabergoline tablets with or without food.
• Your health care provider should check your prolactin levels about every 4 weeks initially, and periodically thereafter, and may change your dose if needed.

If you take too many cabergoline tablets, call your Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

Cabergoline tablets can cause serious side effects, including:

• Heart valve problems and fibrosis (scarring). Cabergoline tablets can cause heart valve problems and fibrosis in the heart, chest, lungs or areas of the stomach (abdomen). Call your health care provider right away if you get any of the following signs or symptoms of heart valve problems and fibrosis:
  • shortness of breath
  • chest pain
  • persistent cough
  • difficulty with breathing when lying down
  • swelling in the arms or legs
  • pain in the side (flank)
  • lump or tenderness in abdomen
• Decreased blood pressure (orthostatic hypotension). You may feel dizzy or lightheaded when you rise too quickly from a sitting or lying position. Talk to your health care provider if you have dizziness or lightheadedness.
• Unusual and uncontrollable (compulsive) urges. Some people taking cabergoline tablets have had unusual strong urges to gamble and gambling that cannot be controlled (compulsive gambling), and other compulsive urges including sexual urges, shopping, and eating or binge eating. Talk to your health care provider if you notice that you are having new or unusual strong urges or behaviors.

The most common side effects of cabergoline tablets include:

•  nausea

•  headache

•  dizziness

These are not all the possible side effects of cabergoline tablets. For more information, ask your health care provider including your pharmacist. Call your health care provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. 

• Store cabergoline tablets at room temperature between (20°C to 25°C) 68°F to 77°F in the original container.

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

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use cabergoline tablets for a condition for which it was not prescribed. Do not give cabergoline tablets to other people, even if they have the same symptoms you have. It may harm them. You can ask your health care provider, including your pharmacist, for information that is written for health care providers.

Active ingredient: cabergoline.

Inactive ingredients: anhydrous lactose and leucine.

Manufactured In Czech Republic By: Teva Czech Industries s.r.o., Opava-Komarov, Czech Republic

Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054

For more information, call Teva at 1-888-838-2872.

This Patient Information has been approved by the U.S. Food and Drug Administration.                                                 Rev. A 6/2025