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Provera

Generic Name: medroxyprogesterone (oral) (me DROX ee proe JES ter one)
Brand Name: Provera
Physician reviewed Provera (oral) patient information - includes Provera description, dosage and directions.

Average Savings for medroxyprogesterone aceta (generic): 32.67%
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Drug Information:
Provera is a progestin (a form of Progesterone), a female hormone that helps regulate ovulation (the release of an egg from an ovary) and menstrual periods. Provera is used to treat conditions such as absent or irregular menstrual periods, or abnormal uterine bleeding. This medicine is also used to decrease the risk of endometrial hyperplasia (a condition that may lead to uterine cancer) while taking estrogens. Provera is also used to prevent overgrowth in the lining of the uterus in postmenopausal women who are receiving estrogen hormone replacement Therapy. Learn more

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Provera Side Effects

Note: This document contains side effect information about medroxyprogesterone. Some of the dosage forms listed on this page may not apply to the brand name Provera.

For the Consumer

Applies to medroxyprogesterone: oral tablet

Other dosage forms:

  • intramuscular suspension

Warning

Oral route (Tablet)

Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. Studies have demonstrated an increased risk of DVT, pulmonary embolism, stroke and myocardial infarction in postmenopausal women during treatment with daily oral conjugated estrogens combined with medroxyPROGESTERone acetate, relative to placebo. Studies have also demonstrated estrogen plus progestin increases risk of developing probable dementia in postmenopausal women 65 years of age or older. It is unknown whether this finding applies to younger postmenopausal women. An increased risk of invasive breast cancer has also been found in studies. In the absence of comparable data, these risks should be assumed to be similar for other doses of estrogens and progestins, and other combinations and dosage forms of estrogens and progestins. Progestins with estrogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Along with its needed effects, medroxyprogesterone (the active ingredient contained in Provera) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking medroxyprogesterone:

Incidence not known

  • Abdominal or stomach pain
  • absent, missed, or irregular menstrual periods
  • anxiety
  • blurred vision
  • breast pain or tenderness
  • changes in skin color
  • chills
  • clay-colored stools
  • cough
  • dark urine
  • decrease in amount of urine
  • diarrhea
  • difficulty swallowing
  • dizziness or lightheadedness
  • eye pain
  • fainting
  • fast heartbeat
  • fever
  • headache
  • hives or welts, itching, redness, swelling, or skin rash
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • menstrual changes
  • nausea
  • noisy, rattling breathing
  • pain in the chest, groin, or legs, especially the calves
  • pain, tenderness, or swelling of the foot or leg
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • severe, sudden headache
  • shortness of breath
  • slurred speech
  • stopping of menstrual bleeding
  • sudden loss of coordination
  • sudden, severe weakness or numbness in the arm or leg
  • sudden, unexplained shortness of breath
  • swelling of the fingers, hands, feet, or lower legs
  • troubled breathing at rest
  • unexpected or excess milk flow from the breasts
  • unpleasant breath odor
  • unusual tiredness or weakness
  • vaginal bleeding or spotting
  • vision changes
  • vomiting of blood
  • weight gain
  • yellow eyes or skin

Some side effects of medroxyprogesterone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

  • Blemishes on the skin
  • discouragement
  • feeling sad or empty
  • hair loss, thinning of hair
  • increased hair growth, especially on the face
  • irritability
  • lack of appetite
  • loss of interest or pleasure
  • nervousness
  • pimples
  • sleepiness or unusual drowsiness
  • tiredness
  • trouble concentrating
  • trouble sleeping
  • weight changes

For Healthcare Professionals

Applies to medroxyprogesterone: compounding powder, intramuscular suspension, oral tablet, subcutaneous suspension

Gastrointestinal

Very common (10% or more): Abdominal pain/discomfort (up to 11.2%)

Common (1% to 10%): Nausea, bloating, abdominal distention, diarrhea, vomiting, constipation

Uncommon (0.1% to 1%): Dry mouth

Postmarketing reports: Gastrointestinal disturbances, rectal bleeding

Genitourinary

Very common (10% or more): Amenorrhea (up to 68%), bleeding (up to 57.3%), uterine bleeding irregularities (up to 35%)

Common (1% to 10%): Dysmenorrhea, leukorrhea, vaginitis, intermenstrual bleeding, urinary tract infection, vaginal candidiasis, vaginitis, vaginitis bacterial, abnormal cervix smear, metrorrhagia, menometrorrhagia, menstruation irregular, vaginal hemorrhage, erectile dysfunction, genitourinary tract infection, pelvic pain, dyspareunia

Frequency not reported: Uterine cervical erosions, cervical discharge, vulvovaginal dryness, premenstrual syndrome, vaginal cyst, ovarian cyst, lack of return to fertility, sensation of pregnancy

Postmarketing reports: Unexpected pregnancy, uterine hyperplasia, oligomenorrhea, prolonged anovulation

Metabolic

Very common (10% or more): Increase weight (up to 37%)

Common (1% to 10%): Increased appetite, decreased appetite

Uncommon (0.1% to 1%): Diabetes mellitus exacerbated, hypercalcemia, fluid retention

Frequency not reported: Elevations of serum calcium and potassium levels, exacerbation of diabetes mellitus

Postmarketing reports: Decreased glucose tolerance, changes in appetite, excessive thirst

Weight gain is more frequently encountered than weight loss during medroxyprogesterone therapy. In women using intramuscular medroxyprogesterone for contraception, the mean weight gain after one year of therapy is 2.5 kg. After two, four, and six years, patients gain a mean of 3.7, 6.3, and 7.5 kg, respectively.

Nervous system

Very common (10% or more): Nervousness (10.8%)

Common (1% to 10%): Dizziness

Rare (less than 0.1%): Cerebral infarction, somnolence

Frequency not reported: Loss of concentration, adrenergic-like effects, migraine, seizure, VII th nerve paralysis, syncope

Postmarketing reports: Paralysis, facial palsy, paresthesia, drowsiness

Other

Very common (10% or more): Headache (up to 16.5%)

Common (1% to 10%): Asthenia, fatigue, edema /fluid retention, breast pain, breast tenderness

Frequency not reported: Chills, fever, vertigo, breast atrophy, breast mass, nipple exudate bloody, breast enlargement

Postmarketing reports: Changes in breast size

Cardiovascular

The majority of cases of thromboembolic disease during hormonal therapy have been attributed to estrogens and not to progestogens. However, it has been demonstrated that this drug, at least at high doses, can produce a hypercoagulable state. Whether or not this contributes to the development of thrombotic events remains unknown.

Common (1% to 10%): Hot flashes

Uncommon (0.1% to 1%): Cardiac failure congestive, thrombophlebitis

Rare (less than 0.1%): Myocardial infarction, embolism, thrombosis, blood pressure increased

Frequency not reported: Tachycardia, palpitations

Postmarketing reports: Deep vein thrombosis, varicose veins

Dermatologic

Common (1% to 10%): Acne, no hair growth/alopecia, rash, hyperhidrosis

Uncommon (0.1% to 1%): Hirsutism, urticaria, pruritus, chloasma

Frequency not reported: Lipodystrophy acquired, dermatitis, ecchymosis, scleroderma, skin striae, erythema multiforme, erythema nodosum

Postmarketing reports: Axillary swelling, excessive sweating and body odor, dry skin, melasma

Musculoskeletal

Common (1% to 10%): Leg cramps, arthralgia, back pain, limb pain, pain in extremity

Uncommon (0.1% to 1%): Muscle spasms

Frequency not reported: Gluteal infiltration and abscess formation

Postmarketing reports: Chest pain, osteoporosis including osteoporotic fractures, loss of bone mineral density, scleroderma

Psychiatric

Common (1% to 10%): Depression, insomnia, anxiety, irritability, decreased libido

Uncommon (0.1% to 1%): Euphoria, changes in libido

Rare (less than 0.1%): Confusion

Frequency not reported: Anorgasmia, emotional disturbance, affective disorder,

Postmarketing reports: Increased libido

Respiratory

Common (1% to 10%): Bronchitis, influenza, nasopharyngitis, pharyngitis, sinusitis, upper respiratory tract infection

Uncommon (0.1% to 1%): Pulmonary embolism

Frequency not reported: Dysphonia

Postmarketing reports: Dyspnea, asthma, hoarseness

Endocrine

Uncommon (0.1% to 1%): Corticoid-like effects

Frequency not reported: Cushingoid syndrome, galactorrhea

Postmarketing reports: Prevention of lactation with or without hyperprolactinemia

Hepatic

Uncommon (0.1% to 1%): Abnormal hepatic function, jaundice cholestatic

Postmarketing reports: Abnormal liver function test, abnormal hepatic enzyme

Hypersensitivity

Frequency not reported: Allergic reactions including angioedema, anaphylactic reaction, anaphylactoid reaction

Immunologic

Frequency not reported: White blood cell count increased, platelet count increased

Postmarketing reports: Anemia, blood dyscrasia

Local

Frequency not reported: Injection site abscess, injection site infection, injection site nodule/lump, injection site pain/tenderness, injection site persistent atrophy/indentation/dimpling

Ocular

Frequency not reported: Retinal embolism and thrombosis, cataract diabetic, visual impairment

Renal

Frequency not reported: Glycosuria

Oncologic

A significant increase in the incidence of breast cancer in beagle dogs in addition to an apparent increase in the incidence of endometrial cancer in rhesus monkeys was noted in early animal carcinogenicity studies.

Postmarketing reports: Cervical cancer, breast cancer, endometrial hyperplasia, breast lumps or nipple bleeding, nipple discharge

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Provera (www.drugs.com/provera.html).