"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 Patient Information Including Side Effects
Brand Names: Clinagen LA 40, Delestrogen, Dep Gynogen, Depo-Estradiol, Estragyn LA 5, Gynogen LA 20, Menaval-20
Generic Name: estradiol injection (Pronunciation: ess tra DYE ol)
- What is estradiol injection (Delestrogen)?
- What are the possible side effects of estradiol injection?
- What is the most important information I should know about estradiol injection?
- What should I discuss with my health care provider before using estradiol injection?
- How should I use estradiol injection?
- What happens if I miss a dose?
- What happens if I overdose?
- What should I avoid while using estradiol injection?
- What other drugs will affect estradiol injection?
- Where can I get more information?
What is estradiol injection (Delestrogen)?
Estradiol is a form of estrogen. Estrogen is a female sex hormone necessary for many processes in the body.
Estradiol 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.
Estradiol injection may also be used for other purposes not listed in this medication guide.
What are the possible side effects of estradiol injection?
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 Delestrogen (estradiol valerate) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about estradiol injection?
Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, or abnormal vaginal bleeding.
This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.
Estradiol increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estradiol may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using estradiol injection.
Long-term estradiol treatment may increase your risk of breast cancer, heart attack, or stroke. Talk with your doctor about your individual risks before using estradiol long-term. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.
Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using estradiol.
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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