"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.
- Clinician Information:
Femhrt Patient Information Including Side Effects
Brand Names: femhrt, femhrt 1 mg/5 mcg
Generic Name: ethinyl estradiol and norethindrone (HRT) (Pronunciation: ETH in ill ess tra DYE ole/ nor ETH in drone)
- What are ethinyl estradiol and norethindrone (Femhrt)?
- What are the possible side effects of my ethinyl estradiol and norethindrone (Femhrt)?
- What is the most important information I should know about ethinyl estradiol and norethindrone (Femhrt)?
- What should I discuss with my healthcare provider before taking ethinyl estradiol and norethindrone (Femhrt)?
- How should I take ethinyl estradiol and norethindrone (Femhrt)?
- What happens if I miss a dose (Femhrt)?
- What happens if I overdose (Femhrt)?
- What should I avoid while taking my ethinyl estradiol and norethindrone (Femhrt)?
- What other drugs will affect ethinyl estradiol and norethindrone (Femhrt)?
- Where can I get more information?
What are ethinyl estradiol and norethindrone (Femhrt)?
Ethinyl estradiol is a form of estrogen. Estrogen is a female sex hormone necessary for many processes in the body.
Norethindrone is a form of progesterone. Progesterone is a female hormone important for the regulation of ovulation and menstruation.
The combination of ethinyl estradiol and norethindrone is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. It is also used to prevent osteoporosis.
Estradiol and norethindrone may also be used for other purposes not listed in this medication guide.
What are the possible side effects of my ethinyl estradiol and norethindrone (Femhrt)?
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.
Stop using this medication and call your doctor at once if you have any of these serious side effects:
- sudden numbness or weakness, especially on one side of the body;
- sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance;
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or
- gallbladder problems (pain in your upper right stomach area with nausea and vomiting);
- jaundice (yellowing of the skin or eyes); or
- a breast lump.
Less serious side effects may include:
- mild nausea, vomiting, stomach pain;
- breast tenderness or swelling;
- freckles or darkening of facial skin;
- increased hair growth, loss of scalp hair;
- changes in weight or appetite;
- problems with contact lenses;
- runny nose;
- vaginal itching or discharge;
- changes in your menstrual periods, decreased sex drive; or
- headache, dizziness, sleep problems.
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 Femhrt (norethindrone acetate, ethinyl estradiol) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about ethinyl estradiol and norethindrone (Femhrt)?
This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row.
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, abnormal vaginal bleeding, if you have recently had a stroke or heart attack, if you have had your uterus removed (hysterectomy), or if you have ever had an allergic reaction to birth control pills or other hormones.
Before taking ethinyl estradiol and norethindrone, tell your doctor if you have high blood pressure or heart disease, high cholesterol, gallbladder disease, diabetes, asthma, seizures, liver disease, a thyroid disorder, high levels of calcium in your blood, migraine headaches or a history of depression, fibroid tumors in your uterus, or a history of breast cancer or an abnormal mammogram.
Avoid smoking while using this medication. Smoking can increase your risk of blood clots, stroke, or heart attack caused by taking hormones.
Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using ethinyl estradiol and norethindrone.
Additional Femhrt 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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