Recommended Topic Related To:

Provera

"Nov. 26, 2012 -- Pediatricians should routinely talk to their teen patients about emergency birth control and write them prescriptions for “morning-after pills” so they can get them quickly if necessary, according to a new policy statement from t"...

Provera

Provera Side Effects Center

Pharmacy Editor: Omudhome Ogbru, PharmD

Provera (medroxyprogesterone) tablets are used for treating 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 is available. Side effects include breast tenderness, hives, acne, hair growth and hair loss, break-through bleeding, increased or decreased weight, nausea, fever, insomnia, and jaundice. Provera may increase risk of heart attacks, stroke, breast cancer, blood clots, and pulmonary emboli in postmenopausal women.

The dose of Provera varies depending on the indication. Provera inhibits fertility at high doses. It should not be given during pregnancy. Provera is secreted in breast milk. The effect on the infant has not been determined.

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

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 Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Provera in Detail - Patient Information: Side Effects

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.

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

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Provera Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, bloating, breast tenderness, headache, change in vaginal discharge, mood swings, blurred vision, dizziness, drowsiness, or weight gain/loss may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these serious side effects occur: unusual vaginal bleeding (e.g., spotting, breakthrough bleeding), mental/mood changes (e.g., depression, memory loss), swelling of the hands/feet, frequent/burning/painful urination, breast lumps, dark patches on the skin or face (melasma), yellowing eyes/skin, unusual tiredness.

This medication may rarely cause very serious (possibly fatal) problems from blood clots (e.g., heart attack, stroke, blood clots in the lungs or legs, blindness). Seek immediate medical attention if you experience any of the following: chest/jaw/left arm pain, weakness on one side of the body, slurred speech, sudden vision changes (e.g., blurred/double vision, loss of vision, bulging eyes), confusion, sudden severe headache, severe dizziness, fainting, trouble breathing, coughing up blood, pain/redness/swelling/weakness of the arms/legs, calf pain/swelling that is warm to the touch.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Provera (Medroxyprogesterone Acetate Tablets)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Provera FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 progestins, including PROVERA (medroxyprogesterone acetate tablets) 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, 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 additional adverse reactions have been reported with estrogen and/or progestin therapy.

Genitourinary system

Abnormal uterine bleeding/spotting, or flow; breakthrough bleeding; spotting; dysmenorrheal/pelvic pain; 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/anaplylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides.

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

A A A

Provera - User Reviews

Provera User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Provera sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.