Essian Side Effects

Generic name: esterified estrogens / methyltestosterone

Note: This document contains side effect information about esterified estrogens / methyltestosterone. Some of the dosage forms listed on this page may not apply to the brand name Essian.

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

For the Consumer

Applies to esterified estrogens / methyltestosterone: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking esterified estrogens / methyltestosterone: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

• sudden numbness or weakness, especially on one side of the body;

• sudden severe headache, confusion, problems with vision, speech, or balance;

• swelling, rapid weight gain;

• confusion, unusual thoughts or behavior;

• pain, swelling, or tenderness in your stomach;

• nausea, stomach pain, loss of appetite jaundice (yellowing of the skin or eyes);

• breast lump, nipple discharge;

• acne, skin color changes, increased facial hair, male pattern baldness, voice changes; or

• changes in your menstrual periods, break-through bleeding.

Less serious side effects of esterified estrogens / methyltestosterone may include:

• mild nausea, stomach upset;

• swollen or painful breasts;

• headache;

• hair loss;

• depression, anxiety; or

• decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

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.

Oncologic

Oncologic side effects have included increase risk of breast cancer

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.

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.

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.

Ocular

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

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.

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.

Hypersensitivity

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

Respiratory

Respiratory side effects have included exacerbation of asthma.

General

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

Metabolic

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

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