Depo® Estradiol Cypionate Injection, USP

(Commercial Product)

Available Dosage Strengths

5 mg/mL

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Product Overview

Description

Estradiol cypionate is a long-acting injectable ester of 17β-estradiol, the principal estrogen produced by the ovaries in premenopausal women. It is formulated for intramuscular (IM) injection, typically in oil-based solutions allowing for slow release and prolonged systemic activity.

Mechanism of Action

Estradiol binds to estrogen receptors, which are widely distributed in reproductive tissues, the brain, bone, liver, and vasculature. Upon receptor binding, estradiol influences gene transcription, which may lead to a broad range of systemic and local effects:

Endometrial proliferation in the absence of a progesterone or progestogen.
Negative feedback on the hypothalamic-pituitary axis (reduces FSH and LH)
Maintenance of bone density via inhibition of bone resorption
Thermoregulatory stabilization, reducing hot flashes and night sweats
Cardiovascular and lipid effects (e.g., improves HDL/LDL ratio)
Neurotransmitter modulation affecting mood and cognition

Adverse Reactions

Common:

Breast tenderness
Nausea
Headache
Fluid retention
Bloating
Mood changes
Breakthrough vaginal bleeding or spotting
Injection site discomfort

Contraindications & Precautions

Absolute Contraindications:

Known or suspected breast cancer or estrogen-dependent neoplasia
Undiagnosed abnormal genital bleeding
Active or history of thromboembolic disorders (e.g., DVT, PE, stroke)
Active liver dysfunction or disease
Known hypersensitivity to estradiol cypionate or its formulation components (e.g., sesame oil)

Precautions:

Women with a history of hormone-sensitive cancers
Hypertension or cardiovascular disease
Migraine with aura
Diabetes mellitus
Hypertriglyceridemia
In women with an intact uterus, a progestogen must be co-administered to reduce the risk of endometrial hyperplasia and cancer.
Routine monitoring of breast, pelvic, and cardiovascular health is advised during therapy.

Storage

Store at 20°C to 25°C (68°F to 77°F) in a dry place, away from heat and light. DO NOT REFRIGERATE. Do not freeze. Keep out of reach of children and pets.

References

Clinical Pharmacology (Elsevier) – Estradiol Cypionate Monograph; accessed August 2025 through: https://www.clinicalkey.com/pharmacology/monograph/1330?n=Estradiol
FDA Label – Depo-Estradiol (estradiol cypionate injection); accessed August 2025 through: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009747s037lbl.pdf
MedlinePlus – Estradiol Injection (systemic) accessed August 2025 through: https://medlineplus.gov/druginfo/meds/a682750.html

Disclaimer

This information is for educational purposes only. This compounded product has not been reviewed, approved, or evaluated by the Food and Drug Administration for safety and effectiveness. This product is not intended to diagnose, treat, cure, or prevent any disease. No claims are made regarding treatment, cure, or prevention of any disease or condition.

This information may not cover all possible drug information about this product. Call your doctor for medical advice and/or about side effects. You may report side effects to the FDA at 1-800-FDA-1088. A Wells Pharmacy Network pharmacist will be happy to answer any questions. For consultation, please call 1-800-622-4510.