Estratest

• Overview
• Consumer Information
• Professional Information

 

Estratest Side Effects Center

What Is Estratest?

Estratest (esterified estrogens and methyltestosterone) is a combination of female sex hormones and a form of the male hormone testosterone used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation.

What Are Side Effects of Estratest?

Common side effects of Estratest include:

• dizziness,
• lightheadedness,
• headache,
• stomach upset,
• bloating,
• nausea,
• weight changes,
• increased/decreased interest in sex,
• breast tenderness/swelling/pain,
• hair loss,
• depression,
• anxiety,
• impotence, or
• difficulty having an orgasm.

Tell your doctor if you have unlikely but serious side effects of Estratest including:

• mental/mood changes (e.g., severe depression, memory loss),
• breast lumps,
• swelling of hands or feet,
• unusual vaginal bleeding (e.g., spotting, breakthrough bleeding, prolonged or recurrent bleeding),
• unusual vaginal discharge/itching/odor,
• changes in skin color,
• yellowing eyes or skin,
• unusual tiredness,
• stomach or abdominal pain,
• persistent nausea or vomiting,
• dark urine, or
• worsening of seizures.

Dosage for Estratest

The usual dosage range is 1 to 2 tablets of Estratest taken before bed once daily as recommended by the physician. Use the lowest dose that will control symptoms and discontinue as soon as possible. Administration should be cyclic (e.g., three weeks on and one week off).

What Drugs, Substances, or Supplements Interact with Estratest?

Estratest may interact with blood thinners, insulin, ketoconazole, St. John's wort, rifampin, antidepressants, seizure medicines, antibiotics, or HIV/AIDS medicines. Tell your doctor all medications and supplements you are taking.

Estratest During Pregnancy or Breastfeeding

Estratest must not be used during pregnancy. It may harm a fetus. This medication is not usually used in women of childbearing age and is unlikely to be used during pregnancy or breastfeeding.

Additional Information

Our Estratest (esterified estrogens and methyltestosterone) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Estratest Consumer Information

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.

Read the entire detailed patient monograph for Estratest (Esterified Estrogens and Methyltestosterone)

 

Estratest Professional Information

SIDE EFFECTS

See BOXED WARNINGS, WARNINGS and PRECAUTIONS.

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. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Associated with Estrogens

(See WARNINGS regarding induction of neoplasia, adverse effects on the fetus, increased incidence of gallbladder disease, and adverse effects similar to those of oral contraceptives, including thromboembolism). The following additional adverse reactions have been reported with estrogen and/or progestin therapy.

Genitourinary System: 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; cystitis-like syndrome.

Breasts: Tenderness; enlargement; pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer.

Cardiovascular: Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure.

Gastrointestinal: Nausea; vomiting; abdominal cramps; bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis, enlargement of hepatic hemangiomas.

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

Eyes: Retinal vascular thrombosis, steepening of corneal curvature, intolerance to contact lenses.

Central Nervous System: Headache, migraine, dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy, dementia.

Miscellaneous: Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthralgias; leg cramps; changes in libido; urticaria, angioedema, anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides.

Associated with Methyltestosterone

Endocrine and Urogenital

Female: The most common side effects of androgen therapy are amenorrhea and other menstrual irregularities, inhibition of gonadotropin secretion, and virilization, including deepening of the voice and clitoral enlargement. The latter usually is not reversible after androgens are discontinued. When administered to a pregnant woman, androgens cause virilization of external genitalia of the female fetus.

Skin and Appendages: Hirsutism, male pattern of baldness, and acne.

Fluid and Electrolyte Disturbances: Retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates.

Gastrointestinal: Nausea, cholestatic jaundice, alterations in liver function test, rarely hepatocellular neoplasms, and peliosis hepatis. (See WARNINGS.)

Hematologic: Suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, and polycythemia.

Central Nervous System: Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia.

Metabolic: Increased serum cholesterol.

Miscellaneous: Inflammation and pain at the site of intramuscular injection or subcutaneous implantation of testosterone containing pellets, stomatitis with buccal preparations, and rarely anaphylactoid reactions.

Read the entire FDA prescribing information for Estratest (Esterified Estrogens and Methyltestosterone)

&Copy; Estratest Patient Information is supplied by Cerner Multum, Inc. and Estratest Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.