Covaryx H.S.

• It is used to prevent or lower the signs of the change of life (menopause).
• It may be given to you for other reasons. Talk with the doctor.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Applies to esterified estrogens / methyltestosterone: oral tablet

Cardiovascular

Cardiovascular side effects have included increased risks of myocardial infarction, pulmonary embolism, deep and superficial venous thrombosis, stroke, and increased blood pressure.[Ref]

Oncologic

Oncologic side effects have included increase risk of breast cancer[Ref]

Genitourinary

Genitourinary side effects have included changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow, breakthrough bleeding, spotting, dysmenorrhea, 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, and cystitis-like syndrome. Side effects involving the breasts have included tenderness, enlargement, pain, nipple discharge, galactorrhea, and fibrocystic breast changes. Side effects of androgen therapy are amenorrhea and other menstrual irregularities, and virilization, including deepening of the voice and clitoral enlargement. The latter usually is not reversible after androgens are discontinued.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, abdominal cramps, bloating, cholestatic jaundice, increased incidence of gallbladder disease, pancreatitis, and enlargement of hepatic hemangiomas. Additional side effects have included alterations in liver function test, rarely hepatocellular neoplasms, and peliosis hepatis.[Ref]

Dermatologic

Dermatologic side effects have included chloasma or melasma that may persist when drug is discontinued, erythema multiforme, erythema nodosum, hemorrhagic eruption, loss of scalp hair, hirsutism, pruritus, acne, and rash.[Ref]

Ocular

Ocular side effects have included retinal vascular thrombosis, steepening of corneal curvature, and intolerance to contact lenses.[Ref]

Nervous system

Nervous system side effects have included headache, migraine, dizziness, mental depression, chorea, nervousness, mood disturbances, irritability, exacerbation of epilepsy, and dementia. Additional side effects have included increased or decreased libido, headache, anxiety, depression, and generalized paresthesia.[Ref]

Hematologic

Hematologic side effects have included suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, polycythemia, and aggravation of porphyria.[Ref]

Hypersensitivity

Hypersensitivity side effects have included urticaria, angioedema, and anaphylactoid/anaphylactic reactions.[Ref]

Respiratory

Respiratory side effects have included exacerbation of asthma.[Ref]

General

General side effects have included increase or decrease in weight, edema, arthralgias, and leg cramps.[Ref]

Metabolic

Metabolic side effects have included reduced carbohydrate tolerance, increased serum cholesterol, retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates.[Ref]

Some side effects of Covaryx HS may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.