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Prescription tablet taken by mouthA progestin hormone. The label describes it as a derivative of progesterone. The FDA pharmacologic class is not listed.

Medroxyprogesterone Acetate

Medroxyprogesterone acetate · Say it: meh-drox-ee-proh-JES-ter-ohn AS-eh-tate

A prescription progestin hormone tablet used to treat periods that have stopped or abnormal uterine bleeding caused by a hormone imbalance, and to help lower the chance of uterine cancer in some postmenopausal women who take estrogen.

Brand names: Depo-ProveraDepo-SubQ Provera

Reading levelLanguage

⬛ Boxed warning (the FDA's strongest warning)

The boxed warning covers cardiovascular disorders, breast cancer, and probable dementia with estrogen plus progestin therapy. Estrogen plus progestin should not be used to prevent heart disease, heart attacks, strokes, or dementia. The Women's Health Initiative (WHI) study reported more deep vein thrombosis, pulmonary embolism, stroke, heart attacks, and invasive breast cancer in postmenopausal women taking daily conjugated estrogens with medroxyprogesterone acetate. A separate study (WHIMS) reported more probable dementia in women 65 or older taking that combination. The label says these risks may be similar with other doses and combinations. Progestins with estrogens should be prescribed at the lowest effective dose and for the shortest time that fits the person's goals and risks. You and your healthcare provider should talk regularly about whether you still need treatment.

Used for

Treating menstrual periods that have stopped (secondary amenorrhea)

Comes as

2.5 mg tablets; 5 mg tablets

Common side effects

Breast tenderness or breast milk discharge, Breakthrough bleeding, spotting, irregular periods, or absence of periods, Vaginal discharge

Key facts
Generic nameMedroxyprogesterone acetate
Brand namesDepo-Provera, Depo-SubQ Provera
Type of medicineA progestin hormone. The label describes it as a derivative of progesterone. The FDA pharmacologic class is not listed.
How it is soldPrescription tablet taken by mouth
Comes as2.5 mg tablets; 5 mg tablets; 10 mg tablets (white, round, scored)
Routeoral
Boxed warningYes, see below
Label date2022-10-09

💊 What is Medroxyprogesterone Acetate used for?

  • Treating menstrual periods that have stopped (secondary amenorrhea)
  • Treating abnormal uterine bleeding caused by a hormone imbalance, when no serious disease such as fibroids or uterine cancer is present
  • Preventing thickening of the uterine lining (endometrial hyperplasia) in women who still have a uterus, are past menopause, and take daily oral conjugated estrogens 0.625 mg tablets

How it works

The label describes medroxyprogesterone acetate as a progestin hormone and a derivative of progesterone. It does not explain in detail how the medicine works in the body.

How it is usually taken

  • The label says to start at the lowest dose and to talk with your healthcare provider about how well that dose is working for you. It says you and your provider should talk regularly, about every 3 to 6 months, about the dose you take and whether you still need treatment. The dose and number of days depend on the reason for use, so follow the instructions from your prescriber or pharmacist. The label does not include details about taking the tablets with food or at a set time of day.

Comes as

  • 2.5 mg tablets
  • 5 mg tablets
  • 10 mg tablets (white, round, scored)

⚠️ Medroxyprogesterone Acetate side effects

Common side effects

  • Breast tenderness or breast milk discharge
  • Breakthrough bleeding, spotting, irregular periods, or absence of periods
  • Vaginal discharge
  • Headache, nervousness, dizziness, or depression
  • Trouble sleeping, sleepiness, or tiredness
  • Symptoms like premenstrual syndrome
  • Itching, rash, or acne
  • Hair loss or extra hair growth
  • Stomach discomfort, nausea, or bloating
  • Fever, weight change, or swelling
  • Changes in vision or sensitivity to contact lenses

Get medical help right away if

  • Get medical help right away if you get hives, have trouble breathing, or have swelling of your face, mouth, tongue, or neck.
  • Get medical help right away if you have signs of a blood clot, stroke, or heart attack. The label says that if any of these events occur or are suspected, estrogen plus progestin therapy should be stopped immediately.
  • Get medical help right away if you notice signs of thrombophlebitis (inflamed veins) or a blood clot.

🛑 Who should not take Medroxyprogesterone Acetate, and who should be careful

The label says not to take it if

  • You have undiagnosed abnormal genital bleeding
  • You have or have had breast cancer
  • You have or are suspected to have estrogen- or progesterone-dependent cancer
  • You have active deep vein thrombosis (DVT) or pulmonary embolism (PE), or a history of these
  • You have active arterial thromboembolic disease, such as stroke or heart attack, or a history of these
  • You are allergic to medroxyprogesterone acetate or any of its ingredients
  • You have liver impairment or disease
  • You are pregnant or suspect you may be pregnant

Tell your doctor before taking it if

  • Tell your provider if you have unusual vaginal bleeding, certain cancers, a past stroke or heart attack, blood clots, or liver problems.
  • Tell your provider if you have asthma, epilepsy, diabetes, migraine, endometriosis, lupus, or problems with your heart, liver, thyroid, or kidneys, or high calcium in your blood. The label says these conditions may mean you need closer checks.
  • Tell your provider if you are going to have surgery or will be on bed rest. The label says your provider will tell you whether you need to stop the medicine.
  • Tell your provider if you are breastfeeding, because the hormone can pass into breast milk.
  • Tell your provider if you think you may be pregnant. The label says you should have a pregnancy test and know the result, and it says the medicine should not be used as a pregnancy test.
  • Tell your provider about all medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

🔀 Medroxyprogesterone Acetate with other medicines, food and alcohol

The label says to discuss these with your doctor or pharmacist

  • The label says some medicines may affect how medroxyprogesterone acetate works, and that it may also affect how other medicines work. It does not list specific medicines in the text provided. Tell your healthcare provider or pharmacist about all medicines you take.

Alcohol and food

The label does not say.

🤰 Medroxyprogesterone Acetate in pregnancy and breastfeeding

Pregnancy

The label says medroxyprogesterone acetate should not be used during pregnancy and lists it as Pregnancy Category X. It says there may be increased risks for hypospadias, clitoral enlargement, and labial fusion in children whose mothers were exposed during the first trimester, but a clear link has not been established. It also says minor birth defects may be more likely if the mother took the medicine during the first 4 months of pregnancy.

Breastfeeding

The label says medroxyprogesterone acetate should not be used during breastfeeding. It says detectable amounts of progestin have been found in the breast milk of nursing mothers who take progestins.

🗓️ Storage, missed doses and taking too much

Storage

Store at 20 to 25 degrees C (68 to 77 degrees F). Keep in a tight, light-resistant container. Keep this and all medicines out of the reach of children.

If a dose is missed

The label does not say.

If too much is taken

The label says an overdose of estrogen plus progestin therapy may cause nausea and vomiting, breast tenderness, dizziness, abdominal pain, drowsiness or fatigue, and withdrawal bleeding. Treatment consists of stopping the medicine and giving appropriate supportive care.

🗒️ Questions to ask about Medroxyprogesterone Acetate

🎯 Check what you understood

1. According to the label, what is the most important warning about this medicine?

2. What does the label say about medicines or supplements you take with this medicine?

3. What does the label say about use during breastfeeding?

❓ Medroxyprogesterone Acetate: frequently asked questions

What is medroxyprogesterone acetate used for?

The label says it is used to treat periods that have stopped and abnormal uterine bleeding caused by hormone imbalance. It is also used to help reduce the chance of uterine cancer in some postmenopausal women who take estrogen.

Is it safe during pregnancy?

The label says it should not be used during pregnancy and lists it as Pregnancy Category X. It also says it should not be used as a test for pregnancy.

What are the main warnings?

The boxed warning says estrogen plus progestin therapy should not be used to prevent heart disease, heart attacks, strokes, or dementia. It also notes increased risks of blood clots, stroke, heart attacks, and breast cancer in the studies described.

What should I do if I have an allergic reaction?

The label says to call your healthcare provider right away if you get hives, problems breathing, or swelling of the face, mouth, tongue, or neck.

What happens if I take too much?

The label says an overdose may cause nausea and vomiting, breast tenderness, dizziness, abdominal pain, drowsiness or fatigue, and withdrawal bleeding. Treatment includes stopping the medicine and giving appropriate supportive care.

🧪 Tests and reports linked to Medroxyprogesterone Acetate

The label text mentions these. If you have one of these reports, get every line of it explained.

📖 Medical words used on this page

  • Allergic reaction

    An allergic reaction is when the immune system overreacts to something harmless, such as a medicine or food, causing symptoms from a rash to swelling.

  • Boxed warning

    A boxed warning is the strongest safety warning on a US medicine label, printed in a box, about a serious or life-threatening risk.

  • Bronchospastic Disease

    Bronchospastic disease means a lung condition, such as asthma, in which the airways tend to tighten suddenly (bronchospasm).

  • Congenital malformations

    Congenital malformations are differences in the structure of the body that are present at birth, such as heart, spine or lip and palate defects.

  • Deep vein thrombosis

    Deep vein thrombosis (DVT) is a blood clot in a deep vein, usually in the leg, which can cause swelling and pain and needs prompt medical care.

  • Edema

    Edema is swelling caused by extra fluid trapped in the body's tissues, often in the feet, ankles and legs.

  • Endometrial cancer

    Endometrial cancer is cancer that starts in the endometrium, the inner lining of the womb (uterus).

  • Inflammation

    Inflammation is the body's response to injury or infection, causing redness, heat, swelling and pain as the immune system works to protect and repair.

  • Major depressive disorder

    Major depressive disorder is a common medical condition with low mood or loss of interest that lasts at least two weeks and affects daily life.

  • Mass

    A mass is a lump or area of tissue, usually larger than a nodule, that takes up space. The word does not say whether it is harmless or not.

  • Menopause

    Menopause is when menstrual periods stop for good because the ovaries make much less estrogen, confirmed after 12 months without a period.

  • Myocardial infarction

    Myocardial infarction is the medical name for a heart attack: part of the heart muscle is damaged because its blood supply is blocked.

  • Overdose

    An overdose means taking more of a medicine or substance than the body can safely handle, which can cause harmful or life-threatening effects.

  • Palliative

    Palliative means care or treatment focused on easing symptoms and improving quality of life, rather than on removing the illness itself.

📖 Medical words on this page

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Source: official FDA drug label (label updated 2022-10-09). Read the full label on DailyMed

MedicDecode explains the official label in plain words. It is not medical advice and does not replace your doctor or pharmacist. Never start, stop or change a medicine because of what you read here.