Esterified estrogens are female sex hormones produced by the ovaries.

Methyltestosterone is a sex hormone that is produced in a man's testicles. Small amounts of testosterone are also produced in a woman's ovaries and adrenal system.

Esterified estrogens and methyltestosterone is a combination medicine used to treat symptoms of menopause such as hot flashes or night sweats. This medicine is usually given only short-term (such as 3 to 6 months).

Esterified estrogens and methyltestosterone may also be used for purposes not listed in this medication guide.

You should not use esterified estrogens and methyltestosterone if you have:

• unusual vaginal bleeding that has not been checked by a doctor;
• severe liver disease;
• if you have had a stroke or blood clot;
• if you have had hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina; or
• if you are pregnant or breastfeeding.

Do not use this medicine if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

Using this medicine can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, if you are overweight, or if you smoke.

Esterified estrogens and methyltestosterone should not be used to prevent heart disease or stroke because this medicine may actually increase your risk of developing these conditions.

Tell your doctor if you have ever had:

• heart disease;
• liver problems, or jaundice caused by pregnancy or taking hormones;
• a thyroid disorder;
• gallbladder disease;
• kidney disease;
• asthma;
• epilepsy or other seizure disorder;
• migraine headaches;
• diabetes;
• depression;
• uterine fibroid tumors;
• a breast lump or abnormal mammogram; or
• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system).

Using this medicine may increase your risk of cancer of the breast, uterus, vagina, or liver. Talk with your doctor about this risk.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Use Covaryx HS (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• 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;
• nausea, vomiting, swelling, rapid weight gain;
• jaundice (yellowing of the skin or eyes);
• changes in skin color;
• a light-headed feeling, like you might pass out;
• unusual vaginal bleeding;
• a breast lump;
• memory problems, confusion, unusual behavior;
• high levels of calcium in your blood--nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy; or

Methyltestosterone can cause symptoms of male features in a woman taking this medicine. Call your doctor if you develop enlarged genitals, male-pattern baldness, excessive body hair growth, increased acne, irregular menstrual periods, or any signs of male characteristics.

Common side effects may include:

• swollen or painful breasts;
• vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding;
• pain or burning when you urinate;
• nausea, vomiting, stomach cramps;
• darkening of facial skin, increased hair growth, loss of scalp hair;
• vision changes, problems with contact lenses;
• swelling, weight gain or loss;
• increased or decreased libido;
• headache, dizziness, depression, anxiety; or
• abnormal liver function tests.

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.

Do not share this medicine with another person, even if they have the same symptoms you have.