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

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

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

You should not use this medicine if you are allergic to medroxyprogesterone, 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.

Medroxyprogesterone 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.

Use Amen (Oral) 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; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine 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 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.

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