Provera: Uses, dosage, side effects, warnings & patient reviews

What is Provera?

Provera is the brand name for the prescription drug medroxyprogesterone acetate, a synthetic form of the hormone progesterone. It is classified as a progestin and is a member of the women’s health medication category.

Medroxyprogesterone acetate works by transforming the uterine lining (endometrium). In a woman with adequate levels of estrogen, it changes the endometrium from a proliferative state to a secretory state. This action helps regulate the menstrual cycle, stops abnormal bleeding from an overgrown lining, and induces a scheduled menstrual period. Importantly, it provides essential protection against endometrial hyperplasia (overgrowth that can lead to cancer) in postmenopausal women who are taking estrogen alone.

It is crucial to distinguish oral Provera tablets from the injectable contraceptive formulation, Depo-Provera, which contains the same active ingredient but is used for long-term birth control. Provera tablets are not FDA-approved for contraception.

How to Take Provera

Provera must be taken exactly as prescribed by a healthcare provider. The dosage and duration of treatment depend entirely on the specific medical condition being treated.

Administration Guidelines

Provera tablets are taken orally, usually once daily. They may be taken with or without food. For conditions like secondary amenorrhea or abnormal uterine bleeding, treatment is typically given for 5 to 10 days. Bleeding usually occurs within 3 to 7 days after stopping the medication.

When used in combination with estrogen therapy for menopausal hormone therapy, Provera is usually taken for 10-14 days each month (cyclic therapy) or daily (continuous therapy), following the estrogen. This regimen is critical to prevent estrogen-induced endometrial overgrowth. For information on managing menopause symptoms, see this resource on menopause.

Important Notes

• Follow the Prescribed Schedule: Do not alter the dosing schedule or duration without consulting your doctor.
• Missed Dose: Guidance on missed doses is included in official prescribing information. Patients should contact their healthcare provider for individual advice.
• Completion of Course: For cyclic therapy, complete the full prescribed course to achieve the intended hormonal effect and scheduled withdrawal bleed.

Side Effects of Provera

Like all hormonal medications, Provera can cause side effects. The following table categorizes potential adverse reactions based on frequency.

Bone Health Consideration

Long-term use of progestins, particularly at higher doses, may affect bone mineral density. Adequate calcium and vitamin D intake is important. For related supplements, refer to information on adult multivitamins containing these nutrients.

What is Provera Used For?

Provera is prescribed for specific hormonal conditions in women. Its uses are based on its ability to regulate and stabilize the endometrial lining.

FDA-Approved Uses

• Secondary Amenorrhea: Treatment of missed menstrual periods (amenorrhea) in women who have previously had cycles, where the cause is not pregnancy.
• Abnormal Uterine Bleeding: Treatment of irregular, heavy, or prolonged uterine bleeding due to a hormonal imbalance (dysfunctional uterine bleeding) in the absence of organic pathology.
• Endometrial Protection: Prevention of endometrial hyperplasia (a precursor to uterine cancer) in postmenopausal women who are receiving conjugated estrogen therapy. This is a critical component of menopausal hormone therapy.

Off-Label Uses (Physician-Directed)

Under medical supervision, Provera may also be used in other contexts, such as part of a treatment regimen for endometriosis or in specific fertility protocols. For instance, it is sometimes used to induce a withdrawal bleed before starting ovulation induction drugs like Clomid (clomiphene). It is not a first-line treatment for endometriosis; alternatives like Danazol may be considered for that condition.

Important Safety Concerns and Black Box Warning

Provera carries significant safety considerations that must be understood before use.

Cardiovascular and Thromboembolic Risks

The FDA has issued a Black Box Warning, the strongest safety alert, for estrogen-plus-progestin therapy. It states that this therapy should not be used for the prevention of cardiovascular disease or dementia. Furthermore, it is associated with increased risks of:

• Deep vein thrombosis (DVT) and pulmonary embolism (PE)
• Stroke and myocardial infarction (heart attack)
• Invasive breast cancer

These risks were identified in the Women’s Health Initiative (WHI) study. The risk-benefit profile must be individually evaluated, and therapy should be prescribed at the lowest effective dose for the shortest duration consistent with treatment goals.

Malignancy Risks

While Provera is used to prevent estrogen-induced endometrial cancer, the effect of combined hormone therapy on breast cancer risk is complex. The WHI study found an increased risk of invasive breast cancer with combined therapy. Regular breast exams and mammograms are recommended for women on hormone therapy.

Visual Disturbances

Discontinuation of progestin therapy should be considered if there is a sudden onset or change in migraine patterns, or if there is a sudden partial or complete loss of vision, sudden onset of proptosis (bulging eyes), diplopia (double vision), or other ocular disturbances.

Glucose Tolerance and Fluid Retention

Progestins may decrease glucose tolerance. Diabetic patients should be monitored closely. Because progestins may cause some degree of fluid retention, they should be used with caution in patients with conditions that might be aggravated by this effect (e.g., epilepsy, migraine, asthma, cardiac or renal dysfunction).

Critical Warnings and Contraindications

Absolute Contraindications

Provera is contraindicated in patients with:

• Known or suspected pregnancy.
• Current or past history of thromboembolic disorders (e.g., DVT, PE, stroke, MI).
• Severe liver disease or liver tumors.
• Known or suspected hormone-sensitive cancers (e.g., breast, endometrial).
• Undiagnosed abnormal genital bleeding.
• Known hypersensitivity to medroxyprogesterone acetate or any tablet component.

Pregnancy and Fertility Warning

Provera is not indicated for use during pregnancy. It should not be used as a diagnostic test for pregnancy. Use of the drug in early pregnancy may increase the risk of miscarriage, fetal congenital anomalies (including heart and limb defects), and low birth weight.

Bone Mineral Density (BMD)

Long-term use of the injectable form (Depo-Provera) is associated with significant loss of BMD. The effect of oral medroxyprogesterone acetate on BMD is less pronounced but should be considered, especially in women with other risk factors for osteoporosis. For non-hormonal alternatives for bone protection in postmenopausal women, see information on Evista (raloxifene).

Depression and Mood Disorders

Provera can exacerbate depression or other mood disorders. Patients with a history of depression should be closely monitored. The drug should be discontinued if serious depression occurs.

Provera Dosage Information

Dosage is highly individualized based on the condition being treated and patient response. The following table outlines standard regimens; always follow the specific prescription from your healthcare provider.

Important Administration Notes

• Do Not Adjust Dose: Do not change your dose or stop taking Provera without consulting your doctor, as this may cause irregular bleeding or loss of therapeutic effect.
• Monitoring: Regular follow-up with a healthcare provider is necessary to monitor response, side effects, and continued need for therapy.
• Missed Periods: If you are taking Provera for amenorrhea and do not have a withdrawal bleed after a course, contact your doctor to rule out pregnancy or other conditions.

Drug Interactions with Provera

Medroxyprogesterone acetate may interact with other medications, potentially altering its effectiveness or increasing side effect risks. A comprehensive review of all concurrent therapies with a healthcare provider is essential.

Additional Information

Storage and Handling

Store Provera tablets at room temperature between 20°C to 25°C (68°F to 77°F), in a tightly closed container, and away from light, excess heat, and moisture. Keep all medications out of the reach of children and pets.

Active Ingredient and Availability

The active ingredient is medroxyprogesterone acetate. Provera is the brand-name product; generic versions are widely available. Generic medications contain the same active ingredient in the same strength and are required to be bioequivalent to the brand-name drug.

Reporting Side Effects

Patients are encouraged to report negative side effects of prescription drugs to their healthcare provider and to the relevant national regulatory authority (e.g., the FDA in the United States via MedWatch). Reporting helps monitor drug safety in the broader population.

Medical Supervision

Provera is a potent hormonal medication. Its use requires a prescription and ongoing medical supervision to ensure the indication remains appropriate, the dose is correct, and any potential risks are monitored. Regular check-ups, including gynecological exams and breast screenings as appropriate, are part of safe therapy.

References and Medical Sources

The information on this page is based on official prescribing information and authoritative medical guidelines.

1. U.S. Food and Drug Administration (FDA). Provera (medroxyprogesterone acetate) Tablets Prescribing Information. [Revised 2018]. https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011839s071lbl.pdf
2. American College of Obstetricians and Gynecologists (ACOG). Practice Bulletin No. 136: Management of Abnormal Uterine Bleeding Associated With Ovulatory Dysfunction. Obstetrics & Gynecology. 2013.
3. The North American Menopause Society (NAMS). The 2022 Hormone Therapy Position Statement of The North American Menopause Society. Menopause. 2022.
4. Drugs.com. Medroxyprogesterone Professional Monograph. [Updated 2024]. https://www.drugs.com/monograph/medroxyprogesterone.html

Disclaimer: The information on this site is provided for informational purposes only and is not medical advice. It does not replace professional medical consultation, diagnosis, or treatment. Do not self-medicate based on the information presented on this site. Always consult with a doctor or other qualified healthcare professional before making any decisions about your health.