Provera

What Is Provera?

Provera (medroxyprogesterone) is a form of the female hormone progesterone used to treat secondary amenorrhea; abnormal bleeding from the uterus due to hormonal imbalance and not due to fibroids, or cancer; and to prevent endometrial hyperplasia in postmenopausal women who have not undergone a hysterectomy and are receiving conjugated estrogens. Provera is used for contraception and for treating endometrial or renal cancer. A generic version of Provera is available.

What Are Side Effects of Provera?

Side effects of Provera include:

• breast tenderness or discharge,
• hives,
• itching,
• skin rash,
• increased acne,
• hair growth,
• loss of scalp hair,
• spotting or break-through bleeding,
• changes in menstrual periods,
• vaginal itching or discharge,
• changes in appetite,
• increased or decreased weight,
• nausea,
• stomach pain,
• bloating,
• fever,
• sleep problems (insomnia), and
• jaundice (yellowing of the skin or eyes), or
• skin color changes.

Provera may increase risk of heart attacks, stroke, breast cancer, blood clots, and pulmonary emboli in postmenopausal women.

Dosage for Provera

The dose of Provera varies depending on the indication. Provera inhibits fertility at high doses.

What Drugs, Substances, or Supplements Interact with Provera?

Provera may interact with other drugs. Tell your doctor all medications and supplements you use. Avoid smoking while taking Provera due to a greatly increased risk of blood clots.

Provera During Pregnancy and Breastfeeding

Provera passes into breast milk and may harm a nursing baby. Consult your doctor before breastfeeding.

Additional Information

Our Provera Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Provera Consumer Information

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

Call your doctor at once if you have:

• vaginal bleeding if you have already gone through menopause;
• a light-headed 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);
• swelling in your hands, ankles, or feet;
• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• 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 in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
• signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

Common side effects may include:

• spotting or breakthrough bleeding;
• changes in your menstrual periods;
• vaginal itching or discharge;
• breast tenderness or discharge;
• headache, dizziness, feeling nervous or depressed;
• bruising or swelling of your veins;
• premenstrual type symptoms (bloating, fluid retention, mood changes);
• sleep problems (insomnia);
• itching, rash, acne, hair growth, loss of scalp hair;
• stomach discomfort, bloating, nausea;
• weight gain; 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.

Read the entire detailed patient monograph for Provera (Medroxyprogesterone Acetate Tablets)

 

Provera Professional Information

SIDE EFFECTS

See BOXED WARNINGS, WARNINGS, and PRECAUTIONS.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The following adverse reactions have been reported in women taking PROVERA tablets, without concomitant estrogens treatment:

Genitourinary System

Abnormal uterine bleeding (irregular, increase, decrease), change in menstrual flow, breakthrough bleeding, spotting, amenorrhea, changes in cervical erosion and cervical secretions.

Breasts

Breast tenderness, mastodynia or galactorrhea has been reported.

Cardiovascular

Thromboembolic disorders including thrombophlebitis and pulmonary embolism have been reported.

Gastrointestinal

Nausea, cholestatic jaundice.

Skin

Sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash have occurred. Acne, Sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash have occurred. Acne, alopecia and hirsutism have been reported.

Eyes

Neuro-ocular lesions, for example, retinal thrombosis, and optic neuritis.

Central Nervous System

Mental depression, insomnia, somnolence, dizziness, headache, nervousness.

Miscellaneous

Hypersensitivity reactions (for example, anaphylaxis and anaphylactoid reactions, angioedema), rash (allergic) with and without pruritus, change in weight (increase or decrease), pyrexia, edema/fluid retention, fatigue, decreased glucose tolerance.

The following adverse reactions have been reported with estrogen plus progestin therapy.

Genitourinary System

Abnormal uterine bleeding/spotting, or flow; breakthrough bleeding; spotting; dysmenorrheal/pelvicpain; increase in size of uterine leiomyomata; vaginitis, including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; ovarian cancer; endometrial hyperplasia; endometrial cancer.

Breasts

Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer.

Cardiovascular

Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure.

Gastrointestinal

Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis; enlargement of hepatic hemangiomas.

Skin

Chloasma or melasma that may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus, rash.

Eyes

Retinal vascular thrombosis, intolerance to contact lenses.

Central Nervous System

Headache; migraine; dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy, dementia.

Miscellaneous

Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthalgias; leg cramps; changes in libido; urticaria, angioedema, anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides.

Read the entire FDA prescribing information for Provera (Medroxyprogesterone Acetate Tablets)