Short answer: Taken alone, Provera's label lists bleeding changes, spotting, breast tenderness, nausea, skin reactions, depression, sleep changes, dizziness, headache and weight change, without percentages. Its boxed warning covers estrogen plus progestin therapy: in the WHI study, conjugated estrogens with medroxyprogesterone raised the risk of blood clots, stroke, heart attack and invasive breast cancer, and of probable dementia in women 65 and older.
What Provera is approved for: Provera is approved to treat secondary amenorrhea (periods that have stopped) and abnormal uterine bleeding caused by hormonal imbalance with no physical cause such as fibroids or uterine cancer, and to help prevent endometrial hyperplasia (overgrowth of the uterine lining) in postmenopausal women with a uterus who take daily conjugated estrogens 0.625 mg tablets (Indications and Usage).
Source
PROVERA (medroxyprogesterone acetate tablets, USP), prescribing information and Patient Information. Pfizer (Pharmacia & Upjohn). DailyMed, version published June 30, 2026. DailyMed setid a586be28-96af-4fed-a13f-9b94fd4c7405
WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY
Estrogen plus progestin therapy is not used to prevent heart disease or dementia. In the Women's Health Initiative (WHI), postmenopausal women aged 50 to 79 taking daily conjugated estrogens 0.625 mg with medroxyprogesterone acetate 2.5 mg for 5.6 years had higher risks of deep vein clots, lung clots, stroke and heart attack than on placebo, and a higher risk of invasive breast cancer. In women 65 and older, 4 years of the same treatment raised the risk of probable dementia. Progestins with estrogens are prescribed at the lowest effective dose for the shortest time that fits the treatment goals.
These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Provera.
| Event | Relative risk CE/MPA vs placebo | CE/MPA per 10,000 women-years (n=8,506) | Placebo per 10,000 women-years (n=8,102) |
|---|---|---|---|
| CHD events | 1.23 (0.99–1.53) | 41 | 34 |
| Non-fatal MI | 1.28 (1.00–1.63) | 31 | 25 |
| CHD death | 1.10 (0.70–1.75) | 8 | 8 |
| All strokes | 1.31 (1.03–1.68) | 33 | 25 |
| Ischemic stroke | 1.44 (1.09–1.90) | 26 | 18 |
| Deep vein thrombosis | 1.95 (1.43–2.67) | 26 | 13 |
| Pulmonary embolism | 2.13 (1.45–3.11) | 18 | 8 |
| Invasive breast cancer | 1.24 (1.01–1.54) | 41 | 33 |
| Colorectal cancer | 0.61 (0.42–0.87) | 10 | 16 |
| Endometrial cancer | 0.81 (0.48–1.36) | 6 | 7 |
| Cervical cancer | 1.44 (0.47–4.42) | 2 | 1 |
| Hip fracture | 0.67 (0.47–0.96) | 11 | 16 |
| Vertebral fractures | 0.65 (0.46–0.92) | 11 | 17 |
| Lower arm/wrist fractures | 0.71 (0.59–0.85) | 44 | 62 |
| Total fractures | 0.76 (0.69–0.83) | 152 | 199 |
| Overall mortality | 1.00 (0.83–1.19) | 52 | 52 |
| Global index | 1.13 (1.02–1.25) | 184 | 165 |
Daily conjugated estrogens 0.625 mg plus medroxyprogesterone acetate 2.5 mg (CE/MPA) against placebo, 16,608 postmenopausal women aged 50 to 79. Relative risk with 95% confidence interval.
| Body system | Reactions the label lists |
|---|---|
| Genitourinary | 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 |
| Cardiovascular | Thromboembolic disorders including thrombophlebitis and pulmonary embolism |
| Gastrointestinal | Nausea, cholestatic jaundice |
| Skin | Urticaria, pruritus, edema and generalized rash; acne, alopecia and hirsutism |
| Eyes | Neuro-ocular lesions, for example retinal thrombosis and optic neuritis |
| Central nervous system | Mental depression, insomnia, somnolence, dizziness, headache, nervousness |
| Miscellaneous | Hypersensitivity reactions (anaphylaxis, angioedema), allergic rash, change in weight, pyrexia, edema/fluid retention, fatigue, decreased glucose tolerance |
The label gives no rates for Provera taken alone.
| Histological result | Placebo (n=119) | CEE (n=119) | Provera + CEE (n=118) |
|---|---|---|---|
| Normal/No hyperplasia | 116 (97) | 45 (38) | 112 (95) |
| Simple (cystic) hyperplasia | 1 (1) | 33 (28) | 4 (3) |
| Complex (adenomatous) hyperplasia | 1 (1) | 27 (22) | 2 (2) |
| Atypia | 0 | 14 (12) | 0 |
| Adenocarcinoma | 1 (1) | 0 | 0 |
3-year, double-blind, placebo-controlled study of 356 postmenopausal women aged 45 to 64 with a uterus. CEE is conjugated equine estrogens 0.625 mg a day; the Provera group took medroxyprogesterone acetate 10 mg a day for 12 days plus CEE. Each woman is counted once, at her most extreme abnormal result.
| Finding | CEE alone (n=283) | MPA 5 mg + CEE (n=277) | MPA 10 mg + CEE (n=272) |
|---|---|---|---|
| Cystic hyperplasia | 55 (19) | 3 (1) | 0 |
| Adenomatous hyperplasia without atypia | 2 (1) | 0 | 0 |
1-year study of 832 postmenopausal women aged 45 to 65. CEE is conjugated equine estrogen 0.625 mg every day of a 28-day cycle; the MPA groups added cyclic medroxyprogesterone acetate on days 15 to 28.
Effects on the endometrium: after 3 years, 95% of women on Provera 10 mg (12 days a month) plus conjugated estrogens 0.625 mg had no hyperplasia, against 38% on conjugated estrogens alone and 97% on placebo. In a 1-year study, cystic hyperplasia occurred in 19% on estrogen alone, 1% with Provera 5 mg and none with Provera 10 mg.
In the WHI estrogen plus progestin study, the rate of venous blood clots was about twice that on placebo: 35 versus 17 per 10,000 women-years. The raised risk showed in the first year and persisted.
Among women who had used hormone therapy before, the relative risk of invasive breast cancer was 1.86 (46 versus 25 cases per 10,000 women-years); among those who had not, it was 1.09 (40 versus 36). Breast cancers on CE plus MPA were larger and found at a more advanced stage.
Ovarian cancer: relative risk 1.58 (95% CI 0.77–3.24), 4 versus 3 cases per 10,000 women-years, not statistically significant.
Probable dementia in women aged 65 to 79 (WHIMS, 4 years): 40 women on CE plus MPA and 21 on placebo were diagnosed; relative risk 2.05 (95% CI 1.21–3.48). The absolute risk is printed as 45 versus 22 per 10,000 women-years under Warnings, and 45 versus 33 under Clinical Studies.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Who should not use it. Provera is not used with undiagnosed abnormal genital bleeding, known, suspected or past breast cancer, estrogen- or progesterone-dependent tumors, active or past deep vein clots, lung clots, stroke or heart attack, a past anaphylactic reaction or angioedema to Provera, liver impairment or disease, or known or suspected pregnancy.
Heart attack, stroke and blood clots. Estrogen plus progestin therapy raised the risk of lung clots, deep vein clots, stroke and heart attack, and is stopped right away if any occurs or is suspected. Where possible it is stopped 4 to 6 weeks before surgery linked to clots, or during long immobilization.
Breast cancer. Estrogen plus progestin raised the risk of invasive breast cancer and of abnormal mammograms. Yearly breast exams by a provider and monthly self-exams are advised, with mammograms based on age and risk.
Endometrial cancer. Estrogen alone raises endometrial cancer risk in women with a uterus; adding a progestin reduces the risk of endometrial hyperplasia. Persistent or recurring abnormal bleeding is investigated, including endometrial sampling when indicated.
Ovarian cancer. The WHI estrogen plus progestin study showed a statistically non-significant increase in ovarian cancer.
Probable dementia. In women 65 and older, estrogen plus progestin raised the risk of probable dementia. It is unknown whether this applies to younger women.
Vision problems. Therapy is stopped pending an eye exam after sudden vision loss, bulging eyes, double vision or migraine, and stopped for good if the exam shows optic disc swelling or retinal blood vessel damage.
Other risks. The Precautions section also covers raised blood pressure, high triglycerides, liver impairment or past cholestatic jaundice, fluid retention, low calcium and worsening of other conditions.
From the Patient Information that comes with Provera:
Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.