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

Progesterone 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. Progesterone is also used to prevent overgrowth in the lining of the uterus in postmenopausal women who are receiving estrogen hormone replacement therapy.

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

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

You should not use progesterone 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 progesterone can increase your risk of blood clots, stroke, heart attack, or breast cancer.

To make sure this medicine 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 progesterone 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 Menopause Formula Progesterone (Topical) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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

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 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.

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