What the label lists and what reports show
Medroxyprogesterone side effects
Medroxyprogesterone's FDA label lists its adverse reactions in its own words. FAERS holds 49,531 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is meningioma (11,275 reports).
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the medroxyprogesterone FDA label on DailyMed (effective June 29, 2026, Pharmacia & Upjohn Company LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of PROVERA?The following side effects have been reported with the use of PROVERA alone: • breast tenderness • breast milk secretion • breakthrough bleeding • spotting (minor vaginal bleeding) • irregular periods • amenorrhea (absence of menstrual periods) • vaginal secretions • headaches • nervousness • dizziness • depression • insomnia, sleepiness, fatigue • premenstrual syndrome-like symptoms • thrombophlebitis (inflamed veins) • blood clot • itching, hives, skin rash • acne • hair loss, hair growth • abdominal discomfort • nausea • bloating • fever • increase in weight • swelling • changes in vision and sensitivity to contact lenses Call your healthcare provider right away if you get hives, problems breathing, swelling of the face, mouth, tongue or neck The following side effects have been reported with the use of PROVERA with an estrogen. […]
Source: FDA drug label, NDA011839 (Pfizer), as published by Pharmacia & Upjohn Company LLC, effective June 29, 2026 (SPL set a586be28-96af-4fed-a13f-9b94fd4c7405), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsSee 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: 1. Genitourinary system Abnormal uterine bleeding (irregular, increase, decrease), change in menstrual flow, breakthrough bleeding, spotting, amenorrhea, changes in cervical erosion and cervical secretions. 2. Breasts Breast tenderness, mastodynia or galactorrhea has been reported. 3. Cardiovascular Thromboembolic disorders including thrombophlebitis and pulmonary embolism have been reported. 4. Gastrointestinal Nausea, cholestatic jaundice. 5. …
Table 1. Frequently Reported Adverse Reactions in the Contraception Studies (>1%)
This table is printed in the Depo-SubQ Provera label published by Pharmacia & Upjohn Company LLC of December 18, 2025; the label quoted above does not print one.
| Adverse Reaction | Frequency |
|---|---|
| Dysfunctional uterine bleeding (irregular, increase, decrease, spotting) | 18% |
| Headache | 9% |
| Increased weight (see below) | 7% |
| Amenorrhea | 6% |
| Injection site reactions (such as pain/tenderness, nodule/lump, persistent… | 6% |
| Vaginitis, including candidiasis and bacterial | 5% |
| Abdominal pain | 4% |
| Urinary tract infections | 4% |
| Acne | 4% |
| Depression | 3% |
| Decreased libido | 3% |
| Nausea | 3% |
| Back pain | 3% |
| Breast pain/tenderness | 2% |
| Fatigue | 2% |
| Anxiety | 1% |
| Irritability | 1% |
| Dizziness | 1% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, NDA011839 (Pfizer), as published by Pharmacia & Upjohn Company LLC, effective June 29, 2026 (SPL set a586be28-96af-4fed-a13f-9b94fd4c7405), via openFDA; the full label on DailyMed
What do FAERS reports show?
49,531 reports list medroxyprogesterone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 988 are coded as a death and 5,086 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (2,763, against a median of 820 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 22 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Medroxyprogesterone: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions