Provera contains the active ingredient medroxyprogesterone acetate, which is a progesterone derivative. It is formulated as tablets for oral administration, available in strengths of 2.5 mg, 5 mg, and 10 mg. Key inactive ingredients include crospovidone, lactose monohydrate, and magnesium stearate.

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. Take your doses at regular intervals. Do not take your medication more often than directed.

Talk to your care team about the use of this medication in children. Special care may be needed. While this medication may be prescribed for children as young as 13 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Breast tissue changes, new lumps, redness, pain, or discharge from the nipple
• Gallbladder problems—severe stomach pain, nausea, vomiting, fever
• Increase in blood pressure
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
• Unusual vaginal discharge, itching, or odor
• Vaginal bleeding after menopause, pelvic pain
• Worsening mood, feelings of depression

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Breast pain or tenderness
• Change in sex drive or performance
• Headache
• Irregular menstrual cycles or spotting
• Nausea
• Weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Blood vessel disease or a history of a blood clot in the lungs or legs
• Breast, cervical, or vaginal cancer
• Heart disease
• Kidney disease
• Liver disease
• Migraine
• Recent miscarriage or abortion
• Mental depression
• Seizures
• Stroke
• Vaginal bleeding that has not been evaluated
• An unusual or allergic reaction to medroxyprogesterone, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

• Barbiturate medications for inducing sleep or treating seizures
• Bosentan
• Carbamazepine
• Phenytoin
• Rifampin
• St. John's Wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. You will need a regular breast and pelvic exam.

If you have any reason to think you are pregnant, stop taking this medication at once and contact your care team.

What are the most serious risks of this medication?

Do not use this medicine to prevent heart disease. Using this medicine along with an estrogen for hormone replacement may increase your chances of having a blood clot in your limbs or lungs, a heart attack, or stroke.

Using this medicine with an estrogen for hormone replacement may increase your risk for breast cancer. Talk to your healthcare provider before taking this medicine if you have ever had cancer. Call your healthcare provider right away if you get new breast lumps.

Using this medicine with an estrogen for hormone replacement may increase the risk for dementia in older women, based on a study of women 65 years of age or older.