Cabergoline is used for:

Treating disorders associated with high levels of the hormone prolactin, either due to tumors in the pituitary gland or to unknown causes. It may also be used for other conditions as determined by your doctor.

Cabergoline is a dopamine receptor agonist. It works by blocking prolactin secretion from the pituitary gland.

Do NOT use Cabergoline if:

• you are allergic to any ingredient in Cabergoline or to ergot derivatives (eg, ergotamine)
• you have uncontrolled high blood pressure
• if you have a history of certain fibrotic (scarring) disorders (eg, of the lung, heart, kidneys)
• you are taking a butyrophenone (eg, haloperidol), metoclopramide, a phenothiazine (eg, chlorpromazine), or a thioxanthene (eg, thiothixene)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Cabergoline:

Some medical conditions may interact with Cabergoline. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have liver problems or high blood pressure, or if you take medicine that may lower your blood pressure
• if you have certain serious problems cause by pregnancy (eg, high blood pressure, seizures)

Some MEDICINES MAY INTERACT with Cabergoline. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Macrolides (eg, clarithromycin) because they may increase the risk of Cabergoline’s side effects
• Butyrophenones (eg, haloperidol), metoclopramide, phenothiazines (eg, chlorpromazine), or thioxanthenes (eg, thiothixene) because they may decrease Cabergoline’s effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cabergoline may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Important safety information:

• Cabergoline may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Cabergoline with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Cabergoline may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Some patients taking Cabergoline have developed certain behavioral changes (eg, increased gambling or sexual urges). These effects usually go away when treatment with Cabergoline is stopped. Contact your doctor right away if you notice any unusual behavioral changes.
• If you think you may be pregnant, contact your doctor so that a pregnancy test can be arranged.
• Lab tests, including heart function, may be performed while you use Cabergoline. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Cabergoline should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cabergoline while you are pregnant. It is not known if Cabergoline is found in breast milk. Do not breast-feed while taking Cabergoline.

Possible side effects of Cabergoline:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; headache; indigestion; nausea; tiredness or weakness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); behavior changes (eg, aggression, increased gambling or sexual urges); chest pain; confusion; cough; depression; fainting; hallucinations; irregular heartbeat; mood or mental changes; shortness of breath; sudden unexplained weight gain; swelling of hands or feet; vision disturbances.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.