"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.
Femhrt Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Femhrt (norethindrone acetate, ethinyl estradiol) is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. It is also used to prevent osteoporosis. It is a combination of the female hormones estrogen and progesterone. This medication is available in generic form. Common side effects 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 menstrual periods, decreased sex drive, headache, dizziness, or sleep problems.
The recommended dose of Femhrt is to take the prescribed amount once daily for the treatment of moderate to severe vasomotor symptoms associated with menopause. Femhrt may interact with acetaminophen, cyclosporine, prednisolone, theophylline, St. John's wort, antibiotics, seizure medications, rifampin, or HIV or AIDS medications. Tell your doctor all medications and supplements you use. Do not use Femhrt if you are pregnant. This medication can cause birth defects. The hormones in this medication can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breastfeeding.
Our Femhrt (norethindrone acetate, ethinyl estradiol) 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.
Femhrt 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.
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 entire detailed patient monograph for Femhrt (Norethindrone Acetate, Ethinyl Estradiol)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Femhrt FDA Prescribing Information: Side Effects
The following serious adverse reactions are discussed elsewhere in the labeling:
- Cardiovascular Disorders [see BOXED WARNING, WARNINGS AND PRECAUTIONS].
- Malignant Neoplasms [see BOXED WARNING, WARNINGS AND PRECAUTIONS].
Clinical Trials Experience
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.
Adverse reactions reported by ≥ 5 percent of subjects in controlled clinical studies of femhrt are shown in Table 1.
Table 1: Associated Adverse
Reactions Reported by ≥ 5 Percent of Subjects by Body Systema
|BODY SYSTEM/Adverse Reaction||Placebo
N = 247
|Number (Percent) of Subjects|
N = 244
N = 258
|BODY AS A WHOLE||23 (12.8)||30 (16.9)||30 (15.7)|
|Edema - Generalized||10 (4.0)||12 (4.9)||11 (4.3)|
|Headache||12 (4.9)||14 (5.7)||16 (6.2)|
|DIGESTIVE SYSTEM||8 (4.4)||17 (9.6)||25 (13.1)|
|Abdominal Pain||3 (1.2)||13 (5.3)||14 (6.8)|
|UROGENITAL SYSTEM||20 (11.1)||34 (19.2)||45 (23.6)|
|Breast Pain||9 (3.6)||22 (9.0)||20 (7.8)|
|aThe total number of subjects for each body system may be less than the number of subjects with AEs in that body system because a subject may have had more than one AE per body system|
The following additional adverse reactions have been identified during post-approval use of femhrt. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding; spotting; 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; uterine cancer; vaginal hemorrhage; ovarian cyst; irregular menstruation; metrorrhagia; menorrhagia; dysmenorrhea; uterine enlargement.
Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; thrombosis; chest pain; myocardial infarction; cerebrovascular accident (stroke); transient ischemic attack; hemiparesis; increase in blood pressure; irregular heart rate; palpitations; dyspnea.
Nausea, vomiting; cholestatic jaundice; pancreatitis, enlargement of hepatic hemangiomas; bloating, abdominal cramps; abdominal pain; increased incidence of gallbladder disease; cholecystitis; cholelithiasis.
Retinal vascular thrombosis; visual impairment; intolerance to contact lenses.
Central Nervous System (CNS)
Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthralgias; leg cramps; back pain; changes in libido; urticaria, angioedema, anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides; blood glucose abnormal; fatigue; myalgia; hypersensitivity.
Read the entire FDA prescribing information for Femhrt (Norethindrone Acetate, Ethinyl Estradiol)
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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