Quick answers
- What is Estradiol cypionate used for?
- The FDA-approved label (Depo-Estradiol, Pharmacia & Upjohn Company LLC, February 28, 2024) says: “DEPO-Estradiol Injection is indicated in the treatment of: 1. Moderate to severe vasomotor symptoms associated with the menopause. 2. Hypoestrogenism due to hypogonadism.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Estradiol cypionate?
- The “Adverse Reactions” section of the FDA label (Depo-Estradiol, Pharmacia & Upjohn Company LLC, February 28, 2024) begins: “See BOXED WARNINGS, WARNINGS and PRECAUTIONS. The following additional adverse reactions have been reported with estrogens and/or progestin therapy. 1.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Estradiol cypionate have a boxed warning?
- Yes. The FDA label for Depo-Estradiol has a boxed warning (“WARNINGS ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Estradiol cypionate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Estradiol cypionate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Estradiol cypionate?
- 1 company lists prescription products of Estradiol cypionate in the FDA NDC Directory, including Pharmacia & Upjohn Company LLC.
What Estradiol cypionate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
DEPO-Estradiol Injection is indicated in the treatment of: 1. Moderate to severe vasomotor symptoms associated with the menopause. 2. Hypoestrogenism due to hypogonadism.
— FDA label: Depo-Estradiol, Pharmacia & Upjohn Company LLC, effective February 28, 2024. Read the full label on DailyMed →
Label quoted: the one for the most common form (injection, intramuscular), Depo-Estradiol, Pharmacia & Upjohn Company LLC; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNINGS ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER
. Read it on the full label →
Estradiol cypionate boxed warning: what the label says
Quoted from the boxed warning of the FDA-approved label.
WARNINGS ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures including endometrial sampling, when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding.
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There is currently no evidence that the use of "natural" estrogens results in a different endometrial risk profile than "synthetic" estrogens at equivalent estrogen doses. (See WARNINGS, malignant neoplasms, Endometrial cancer.) CARDIOVASCULAR AND OTHER RISKS Estrogens with and without progestins should not be used for the prevention of cardiovascular disease. (See WARNINGS, Cardiovascular disorders.) The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo. (See CLINICAL PHARMACOLOGY, Clinical Studies.) The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women or to women taking estrogen-alone therapy. (See CLINICAL PHARMACOLOGY, Clinical Studies.) Other doses of conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT DEPO-ESTRADIOL (AN ESTROGEN HORMONE)? Estrogens increase the chances of getting cancer of the uterus. Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterine (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause. Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. You and your healthcare provider should talk regularly about whether you still need treatment with DEPO-Estradiol.
— FDA label: Depo-Estradiol, Pharmacia & Upjohn Company LLC, effective February 28, 2024. Read the full label on DailyMed →
Estradiol cypionate side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
See BOXED WARNINGS, WARNINGS and PRECAUTIONS. The following additional adverse reactions have been reported with estrogens and/or progestin therapy. 1.
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Genitourinary system Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding, spotting; dysmenorrhea; 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. 2. Breasts Tenderness, enlargement pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer. 3. Cardiovascular Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure. 4. Gastrointestinal Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis, enlargement of hepatic hemangiomas. 5. Skin Chloasma or melasma that may persist when drug is discontinued. Erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus, rash. 6. Eyes Retinal vascular thrombosis; steepening of corneal curvature; intolerance to contact lenses. 7. Central nervous system Headache, migraine, dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy, dementia. 8. Miscellaneous Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; changes in libido; arthralgias; leg cramps; anaphylactoid/anaphylactic reactions including urticaria and angioedema; hypocalcemia; exacerbation of asthma; increased triglycerides.
— FDA label: Depo-Estradiol, Pharmacia & Upjohn Company LLC, effective February 28, 2024. Read the full label on DailyMed →
Estradiol cypionate dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Warming and shaking the vial should redissolve any crystals that may have formed during storage at temperatures lower than recommended. DEPO-Estradiol INJECTION IS FOR INTRAMUSCULAR USE ONLY.
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When estrogen is prescribed for a woman with a uterus, progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be reevaluated periodically as clinically appropriate (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary. (See BOXED WARNINGS and WARNINGS.) For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding. 1. Short-term cyclic use for treatment of moderate to severe vasomotor symptoms, vulval and vaginal atrophy associated with the menopause, the lowest dose and regimen that will control symptoms should be chosen and medication should be discontinued as promptly as possible. Attempts to discontinue or taper medication should be made at 3- to 6-month intervals. The usual dosage range is 1 to 5 mg injected every 3 to 4 weeks. 2. For treatment of female hypoestrogenism due to hypogonadism 1.5 to 2 mg injected at monthly intervals.
— FDA label: Depo-Estradiol, Pharmacia & Upjohn Company LLC, effective February 28, 2024. Read the full label on DailyMed →
Estradiol cypionate in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
F. PREGNANCY DEPO-Estradiol should not be used during pregnancy. See CONTRAINDICATIONS and Boxed WARNINGS.
— FDA label: Depo-Estradiol, Pharmacia & Upjohn Company LLC, effective February 28, 2024. Read the full label on DailyMed →
Estradiol cypionate and breastfeeding
Quoted from the nursing mothers / lactation part of the FDA-approved label.
G. NURSING MOTHERS Estrogen administration to nursing mothers has been shown to decrease the quantity and quality of the milk. Detectable amounts of estrogens have been identified in the milk of mothers receiving this drug. Caution should be exercised when DEPO-Estradiol is administered to a nursing woman.
— FDA label: Depo-Estradiol, Pharmacia & Upjohn Company LLC, effective February 28, 2024. Read the full label on DailyMed →
When Estradiol cypionate should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
Estrogens should not be used in individuals with any of the following conditions: 1. Undiagnosed abnormal genital bleeding. 2. Known or suspected cancer of the breast. 3. Known or suspected estrogen-dependent neoplasia. 4. Active deep vein thrombosis, pulmonary embolism or history of these conditions. 5. Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction). 6. Liver dysfunction or disease. 7.
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DEPO-Estradiol should not be used in patients with known hypersensitivity to its ingredients. 8. Known or suspected pregnancy. There is no indication for DEPO-Estradiol in pregnancy. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy. (See PRECAUTIONS.)
— FDA label: Depo-Estradiol, Pharmacia & Upjohn Company LLC, effective February 28, 2024. Read the full label on DailyMed →
Estradiol cypionate overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
Serious ill effects have not been reported following acute ingestion of large doses of estrogen-containing oral contraceptives by young children. Overdosage of estrogen may cause nausea and vomiting, and withdrawal bleeding may occur in females.
— FDA label: Depo-Estradiol, Pharmacia & Upjohn Company LLC, effective February 28, 2024. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Intramuscular |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Depo-Estradiol |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| estradiol cypionate 5 mg/mL injection | Brand: Depo-Estradiol | $51.91 per mL |
NADAC list of November 4, 2026; these prices took effect on July 1, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Pharmacia & Upjohn Company LLC1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (1)
- ANDA085470Pfizer · August 15, 1979
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 206417, 310187 |
|---|---|
| SPL set ID of the quoted label | 9a4229fd-fecd-4ac1-9c4f-6d442533457f |
| FDA labels (SPL) | 1 |
| FDA applications | 1 ANDA |
| Active ingredients (FDA) | ESTRADIOL CYPIONATE |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
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- Pharmacia & Upjohn Company LLCMaker or distributor
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Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Depo-Estradiol, Pharmacia & Upjohn Company LLC, effective February 28, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →