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Brand Names: Provera

Generic Name: medroxyprogesterone (oral) (Pronunciation: me DROX ee proe JES ter one)

• What is medroxyprogesterone (Provera)?
• What are the possible side effects of medroxyprogesterone (Provera)?
• What is the most important information I should know about medroxyprogesterone (Provera)?
• What should I discuss with my healthcare provider before taking medroxyprogesterone (Provera)?
• How should I take medroxyprogesterone (Provera)?
• What happens if I miss a dose (Provera)?
• What happens if I overdose (Provera)?
• What should I avoid while taking medroxyprogesterone (Provera)?
• What other drugs will affect medroxyprogesterone (Provera)?
• Where can I get more information?

What is medroxyprogesterone (Provera)?

Medroxyprogesterone is a progestin (a form of progesterone), a female hormone that helps regulate ovulation (the release of an egg from an ovary) and menstrual periods.

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

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

Medroxyprogesterone 10 mg-BAR

round, white, imprinted with b, 555 779

Medroxyprogesterone 10 mg-GRE

round, white, imprinted with G 3742

Medroxyprogesterone 10 mg-QUA

round, white, imprinted with G4 63, 832

Medroxyprogesterone 2.5 mg-BAR

round, white, imprinted with b, 555 872

Medroxyprogesterone 2.5 mg-GRE

round, peach, imprinted with G 3740

Medroxyprogesterone 5 mg-BAR

round, white, imprinted with b, 555 873

Medroxyprogesterone 5mg-ESI

elliptical, lavender, imprinted with LOGO, CYC RIN

Medroxyprogesterone 5mg-GRE

hexagonal, white, imprinted with G 3741

Provera 2.5 mg

round, orange, imprinted with PROVERA 2.5

Provera 5 mg

hexagonal, white, imprinted with PROVERA 5

What are the possible side effects of medroxyprogesterone (Provera)?

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

Call your doctor at once if you have any of these serious side effects:

• sudden numbness or weakness, especially on one side of the body;
• sudden headache, confusion, problems with vision, speech, or balance;
• chest pain, sudden cough, wheezing, rapid breathing, fast heart rate;
• pain or swelling in one or both legs;
• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
• vaginal bleeding if you have already gone through menopause;
• feeling like you might pass out;
• a breast lump;
• symptoms of depression (sleep problems, dizziness, mood changes, headache);
• fever;
• jaundice (yellowing of the skin or eyes); or
• swelling in your hands, ankles, or feet.

Less serious side effects may include:

• spotting or breakthrough bleeding;
• changes in your menstrual periods;
• vaginal itching or discharge;
• breast tenderness or discharge;
• mild itching or skin rash;
• increased acne, hair growth, loss of scalp hair;
• sleep problems (insomnia);
• changes in appetite or weight,
• mild stomach pain, bloating, nausea; or
• skin color changes.

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.

What is the most important information I should know about medroxyprogesterone (Provera)?

You should not use this medication if you are pregnant, or if you have liver disease, a hormone-related cancer such as breast or uterine cancer, a history of stroke or blood clot, or abnormal vaginal bleeding that has not been checked by a doctor.

Medroxyprogesterone will not prevent heart disease, breast cancer, or dementia, and may actually increase the risk of developing these conditions in post-menopausal women. Medroxyprogesterone may also increase the risk of uterine or ovarian cancer in some women. Long-term treatment with estrogens and progestins (such as medroxyprogesterone) may also increase your risk of heart attack, blood clot, or stroke.

Talk to your doctor about your specific risks and benefits of taking this medication, especially if you smoke or are overweight. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.