Norethindrone acetate and ethinyl estradiol for menopause

Femhrt Side Effects Center

What Is Femhrt?

Femhrt (norethindrone acetate, ethinyl estradiol) is a combination of the female hormones estrogen and progesterone used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. It is also used to prevent osteoporosis. Femhrt is available in generic form.

What Are Side Effects of Femhrt?

Common side effects of Femhrt include:

• 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

Seek medical care or call 911 at once if you have the following serious side effects:

• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Femhrt

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.

What Drugs, Substances, or Supplements Interact with Femhrt?

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.

Femhrt During Pregnancy or Breastfeeding

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.

Additional Information

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.

QUESTION

Femhrt Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed;
• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
• swelling or tenderness in your stomach;
• jaundice (yellowing of the skin or eyes);
• unusual vaginal bleeding, pelvic pain;
• a breast lump;
• memory problems, confusion, unusual behavior; or
• high levels of calcium in your blood--nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.

Common side effects may include:

• stomach pain;
• bloating, swelling, weight gain;
• breast pain;
• light vaginal bleeding or spotting;
• thinning scalp hair; or
• headache.

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.

SLIDESHOW

Femhrt Professional 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 System *

Postmarketing Experience

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.

Genitourinary System

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.

Breasts

Tenderness, enlargement, breast pain, nipple pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer; breast disorder; breast mass; breast enlargement.

Cardiovascular

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.

Gastrointestinal

Nausea, vomiting; cholestatic jaundice; pancreatitis, enlargement of hepatic hemangiomas; bloating, abdominal cramps; abdominal pain; increased incidence of gallbladder disease; cholecystitis; cholelithiasis.

Skin

Chloasma or melasma that may persist when drug is discontinued; generalized erythema; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; rash, pruritus.

Eyes

Retinal vascular thrombosis; visual impairment; intolerance to contact lenses.

Central Nervous System (CNS)

Headache; migraine; dizziness; depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy, dementia; paresthesia; insomnia.

Miscellaneous

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)

© Femhrt Patient Information is supplied by Cerner Multum, Inc. and Femhrt Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.