Provera is a form of progesterone (a hormone) that is used to treat conditions such as absent or irregular menstrual periods, or abnormal uterine bleeding.

Provera is also used to decrease the risk of endometrial hyperplasia (a condition that may lead to uterine cancer) while taking estrogens.

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

Provera should not be used to prevent heart disease, stroke, or dementia. This medicine may actually increase your risk of developing these conditions.

Long-term use of medroxyprogesterone may increase your risk of cancer of the breast, uterus, or ovaries. Talk with your doctor about this risk.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Provera is usually given for only a few days in a row each month.

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

If you need major surgery or will be on long-term 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 Provera.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Provera.

Store at room temperature away from moisture and heat.

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

• abnormal vaginal bleeding that has not been checked by a doctor;

• liver disease;

• a history of heart attack, stroke, or blood clot; or

• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina.

May cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant.

Provera should not be used to prevent heart disease, stroke, or dementia. This medicine may actually increase your risk of developing these conditions.

Tell your doctor if you have ever had:

• heart problems;

• liver problems;

• asthma;

• migraine headaches;

• a thyroid disorder;

• endometriosis (severe pelvic pain);

• jaundice caused by pregnancy or birth control pills;

• kidney disease;

• high or low blood levels of calcium;

• a seizure;

• diabetes; or

• lupus.

Using this medicine can increase your risk of blood clots, stroke, or heart attack, especially if you have high blood pressure, diabetes, high cholesterol, if you are overweight, or if you smoke.

Long-term use of medroxyprogesterone may increase your risk of cancer of the breast, uterus, or ovaries. Talk with your doctor about this risk.

Do not breastfeed.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

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

Avoid smoking while you are taking Provera. Smoking greatly increases your risk of blood clots.

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

Provera may cause serious side effects. Stop using Provera and call your doctor at once if you have:

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• liver problems--loss of appetite, upper stomach pain, tiredness, fever, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• unusual vaginal bleeding;

• confusion, memory problems;

• a breast lump; or

• symptoms of depression--sleep problems, weakness, tired feeling, mood changes.

Common side effects of Provera may include:

• spotting or breakthrough bleeding;

• changes in your menstrual periods;

• vaginal itching or discharge;

• headache, dizziness, feeling nervous or depressed;

• breast tenderness or discharge;

• stomach discomfort, bloating, nausea, vomiting;

• itching, rash, acne, hair growth, hair loss;

• premenstrual type symptoms (bloating, fluid retention, mood changes);

• weight gain;

• bruising or swelling of your veins;

• tiredness, trouble sleeping; or

• vision changes and difficulty wearing contact lenses.

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.

Other drugs may affect Provera, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.