"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
Delestrogen Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Delestrogen (estradiol valerate injection) is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. It is also used to treat a lack of estrogen that is caused by ovarian failure or a condition called hypogonadism. Some forms of estradiol injection are used in men to treat the symptoms of prostate cancer. It is a form of estrogen, a female hormone. This medication is available in generic form. Common side effects include nausea, vomiting, loss of appetite, swollen breasts, acne or skin color changes, decreased sex drive, impotence, difficulty having an orgasm, migraine headaches or dizziness, vaginal pain/dryness/discomfort, swelling of ankles or feet, depression, or changes in menstrual periods, break-through bleeding.
The usual dosage of Delestrogen is 10 to 20 mg every four weeks. Delestrogen may interact with St. John's wort, phenobarbital, blood thinners, ritonavir, carbamazepine, rifampin, or antibiotics. Tell your doctor all medications and supplements you use. Delestrogen should not be used during pregnancy. It can cause birth defects. Tell your doctor if you become pregnant during treatment. Use birth control during treatment. This medication can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Breastfeeding while using this drug is not recommended.
Our Delestrogen (estradiol valerate injection) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Delestrogen in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- sudden numbness or weakness, especially on one side of the body;
- sudden headache, confusion, problems with vision, speech, or balance;
- pain or swelling in your lower leg;
- abnormal vaginal bleeding;
- pain, swelling, or tenderness in your stomach;
- jaundice (yellowing of the skin or eyes); or
- a lump in your breast.
Less serious side effects may include:
- nausea, vomiting, loss of appetite;
- swollen breasts;
- acne or skin color changes;
- decreased sex drive, impotence, or difficulty having an orgasm;
- migraine headaches or dizziness;
- vaginal pain, dryness, or discomfort;
- swelling of your ankles or feet;
- depression; or
- changes in your menstrual periods, break-through bleeding.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Delestrogen (Estradiol valerate) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Delestrogen FDA Prescribing Information: Side Effects
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 adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
The following additional adverse reactions have been reported with estrogen and/or progestin therapy.
Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding; spotting; dysmenorrhea, increase in size of uterine leiomyomata; vaginitis, including vaginal can-didiasis; change in amount of cervical secretion; changes in cervical ectropion; ovarian cancer; endometrial hyperplasia; endometrial cancer.
Retinal vascular thrombosis; intolerance to contact lenses.
Central Nervous System
Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthalgias; leg cramps; changes in libido; urticaria, angioedema, anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides.
Read the entire FDA prescribing information for Delestrogen (Estradiol valerate) »
Additional Delestrogen Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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