Prometrium is a female hormone important for the regulation of ovulation and menstruation.

Prometrium is used to cause menstrual periods in women who have not yet reached menopause but are not having periods due to a lack of progesterone in the body. This medicine is also used to prevent overgrowth in the lining of the uterus in postmenopausal women who are receiving estrogen hormone replacement therapy.

Prometrium should not be used to prevent heart disease or dementia, because Prometrium may actually increase your risk of developing these conditions.

Prometrium may also be used for purposes not listed in this medication guide.

You should not use Prometrium if you have: abnormal vaginal bleeding, a history of breast cancer, liver disease, or if you have recently had a heart attack, stroke, or blood clot.

Do not use if you are pregnant.

Prometrium should not be used to prevent heart disease or dementia, because this medicine may actually increase your risk of developing these conditions.

Using Prometrium can increase your risk of blood clots, stroke, heart attack, or breast cancer.

Before taking this medicine

You should not use Prometrium if you are allergic to it, or if you have:

• abnormal vaginal bleeding that a doctor has not checked;
• a history of breast cancer;
• liver disease;
• a peanut allergy;
• if you are pregnant;
• if you have had a stroke, heart attack, or blood clot within the past year; or
• if you have recently had an incomplete miscarriage or "missed" abortion.

Using Prometrium can increase your risk of blood clots, stroke, heart attack, or breast cancer.

To make sure Prometrium is safe for you, tell your doctor if you have:

• heart disease, circulation problems;
• migraines;
• asthma;
• kidney disease;
• seizures or epilepsy;
• a history of depression; or
• risk factors for coronary artery disease (such as high blood pressure, diabetes, lupus, high cholesterol, family history of coronary artery disease, smoking, being overweight).

Do not use Prometrium if you are pregnant. It could harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Progesterone can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Take the Prometrium capsule with a full glass of water. It is best to take the medicine at night because this medicine can make you dizzy or drowsy.

Apply Prometrium cream to the skin as directed by your doctor.

Prometrium is sometimes used for only a short time, such as 10 to 12 days during each menstrual cycle. Follow your doctor's dosing instructions very carefully.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using Prometrium.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using Prometrium.

Store at room temperature away from moisture, heat, and light.

You should not use Prometrium if you are allergic to it, or if you have:

• abnormal vaginal bleeding that a doctor has not checked;
• a history of breast cancer;
• liver disease;
• a peanut allergy;
• if you are pregnant;
• if you have had a stroke, heart attack, or blood clot within the past year; or
• if you have recently had an incomplete miscarriage or "missed" abortion.

Using Prometrium can increase your risk of blood clots, stroke, heart attack, or breast cancer.

To make sure Prometrium is safe for you, tell your doctor if you have:

• heart disease, circulation problems;
• migraines;
• asthma;
• kidney disease;
• seizures or epilepsy;
• a history of depression; or
• risk factors for coronary artery disease (such as high blood pressure, diabetes, lupus, high cholesterol, family history of coronary artery disease, smoking, being overweight).

Do not use Prometrium if you are pregnant. It could harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Progesterone can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Call your doctor if you miss more than one dose of this medication.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Prometrium may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Prometrium may cause serious side effects. Call your doctor at once if you have:

• unusual vaginal bleeding;
• pain or burning when you urinate;
• a breast lump;
• sudden vision problems, severe headache or pain behind your eyes;
• symptoms of depression (sleep problems, weakness, mood changes);
• severe dizziness or drowsiness, spinning sensation, confusion, shortness of breath;
• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with speech or balance;
• signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
• signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

Common side effects of Prometrium may include:

• drowsiness, dizziness;
• breast pain;
• mood changes;
• headache;
• constipation, diarrhea, heartburn;
• bloating, swelling in your hands or feet;
• joint pain;
• hot flashes; or
• vaginal discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

There may be other drugs that can interact with Prometrium. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.