(medroxyprogesterone acetate)

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What are the possible side effects of PROVERA?

What are the possible side effects of PROVERA?

The following side effects have been reported with the use of PROVERA alone:

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breast tenderness
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breast milk secretion
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breakthrough bleeding
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spotting (minor vaginal bleeding)
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irregular periods
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amenorrhea (absence of menstrual periods)
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vaginal secretions
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headaches
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nervousness
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dizziness
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depression
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insomnia, sleepiness, fatigue
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premenstrual syndrome-like symptoms
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thrombophlebitis (inflamed veins)
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blood clot
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itching, hives, skin rash
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acne
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hair loss, hair growth
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abdominal discomfort
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nausea
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bloating
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fever
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increase in weight
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swelling
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changes in vision and sensitivity to contact lenses

Call your healthcare provider right away if you get hives, problems breathing, swelling of the face, mouth, tongue or neck

The following side effects have been reported with the use of PROVERA with an estrogen.

Side effects are grouped by how serious they are and how often they happen when you are treated.

Serious, but less common side effects include:

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heart attack
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stroke
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blood clots
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dementia
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breast cancer
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cancer of the uterus
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cancer of the ovary
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high blood pressure
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high blood sugar
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gallbladder disease
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liver problems
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changes in your thyroid hormone levels
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enlargements of benign tumors ("fibroids")

Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:

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new breast lumps
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unusual vaginal bleeding
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changes in vision and speech
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sudden new severe headaches
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severe pains in your chest or legs with or without shortness of breath, weakness and fatigue
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memory loss or confusion

Less serious, but common side effects include:

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headache
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breast pain
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irregular vaginal bleeding or spotting
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stomach or abdominal cramps, bloating
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nausea and vomiting
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hair loss
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fluid retention
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vaginal yeast infection

These are not all the possible side effects of PROVERA with or without estrogen. For more information, ask your healthcare provider or pharmacist for advice about side effects. Tell your healthcare provider if you have side effect that bothers you or does not go away. You may report side effects to Pfizer at 1-800-438-1985 or FDA at 1-800-FDA-1088.

Additional Resources

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Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer medication, please call (800) 438-1985.

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or by calling (800) 332-1088.