Estratest (Esterified Estrogens) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

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 estrogenic therapy, including oral contraceptives:

1. Genitourinary system: Breakthrough bleeding; spotting; change in menstrual flow; dysmenorrhea; premenstrual-like syndrome; amenorrhea during and after treatment; increase in size of uterine fibromyomata; vaginal candidiasis; change in cervical erosion and in degree of cervical secretion; cystitis-like syndrome.
2. Breasts: Tenderness; enlargement; secretion.
3. Gastrointestinal: Nausea; vomiting; abdominal cramps; bloating; cholestatic jaundice.
4. Skin: Chloasma or melasma which may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism.
5. Eyes: Steepening of corneal curvature; intolerance to contact lenses.
6. Central Nervous System: Headache, migraine, dizziness; mental depression; chorea.
7. Miscellaneous: Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; changes in libido.

ASSOCIATED WITH METHYLTESTOSTERONE

Endocrine and Urogenital.

1. 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.
2. Skin and Appendages: Hirsutism, male pattern of baldness, and acne.
3. Fluid and Electrolyte Disturbances: Retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates.
4. Gastrointestinal: Nausea, cholestatic jaundice, alterations in liver function test, rarely hepatocellular neoplasms, and peliosis hepatis (see WARNINGS).
5. Hematologic: Suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, and polycythemia.
6. Nervous System. Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia.
7. Metabolic: Increased serum cholesterol.
8. 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.

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO ESTRATEST

Possible Estratest side effects / adverse reactions in 59 year old female

Reported by a lawyer from United States on 2007-02-21

Patient: 59 year old female weighing 70.7 kg (155.5 pounds)

Reactions: Breast Cancer Female

Suspect drug(s):
Climara
    Dosage: 0.05 mg/d, cont, transdermal
    Indication: Menopausal Symptoms
    Start date: 1997-01-01
    End date: 1998-01-01

Premarin
    Dosage: 0.625 mg
    Indication: Menopausal Symptoms
    Start date: 1991-01-01
    End date: 1994-01-01

Ogen
    Dosage: 1.25 mg
    Indication: Menopausal Symptoms
    Start date: 1991-01-01
    End date: 1991-01-01

Provera
    Dosage: 10 mg
    Indication: Menopausal Symptoms
    Start date: 1991-01-01

Estratest
    Indication: Menopausal Symptoms
    Start date: 1991-01-01
    End date: 1992-01-01

Estrace
    Dosage: 1 mg
    Indication: Menopausal Symptoms
    Start date: 1992-01-01
    End date: 1997-01-01

Medroxyprogesterone
    Dosage: 10 g
    Indication: Menopausal Symptoms
    Start date: 1993-01-01
    End date: 1995-01-01

Activella
    Indication: Menopausal Symptoms
    Start date: 2000-01-01
    End date: 2001-01-01

Prempro
    Indication: Menopausal Symptoms

Menest
    Dosage: 3 mg
    Indication: Menopausal Symptoms
    Start date: 1999-01-01
    End date: 2000-01-01

Estratab
    Dosage: 3 mg
    Indication: Menopausal Symptoms
    Start date: 1998-01-01
    End date: 1999-01-01

Possible Estratest side effects / adverse reactions in 51 year old female

Reported by a pharmacist from United States on 2007-02-21

Patient: 51 year old female weighing 58.1 kg (127.8 pounds)

Reactions: Breast Cancer Female

Suspect drug(s):
Climara
    Dosage: see image
    Indication: Menopausal Symptoms
    Start date: 2001-01-01
    End date: 2001-01-01

Climara
    Dosage: see image
    Indication: Menopausal Symptoms
    Start date: 2001-01-01
    End date: 2002-01-01

Premarin
    Indication: Menopausal Symptoms
    Start date: 1998-01-01
    End date: 2003-01-01

Estratest
    Indication: Menopausal Symptoms
    Start date: 1999-01-01
    End date: 2001-01-01

Other drugs received by patient: Lipitor /net/ (Atorvastatin Calcium); Synthroid; Fosamax; Miacalcin; Levaquin

Possible Estratest side effects / adverse reactions in 58 year old female

Reported by a physician from United States on 2007-03-15

Patient: 58 year old female

Reactions: Pulmonary Hypertension, Biopsy Breast Abnormal, Diabetes Mellitus, Dilatation Ventricular, Tricuspid Valve Incompetence, Treatment Noncompliance, Surgery, Atrial Hypertrophy, Oedema Peripheral, Breast Hyperplasia, Echocardiogram, Back Pain, Supraventricular Tachycardia, Breast Cancer Female, Cholelithiasis, Ventricular Dysfunction, Cholecystectomy, Homicidal Ideation, Scan Myocardial Perfusion Abnormal, Head Injury, Breast Cancer Stage IV, Pain, Hemiparesis, Fall, Fatigue, Fibrocystic Breast Disease, Coronary Artery Bypass, Dizziness, Lymphoedema, Atrial Flutter, Urinary Tract Infection, Atrial Fibrillation, Cerebrovascular Accident, Cardiac Pacemaker Insertion, Arthralgia, Mitral Valve Incompetence, Infarction

Adverse event resulted in: hospitalization

Suspect drug(s):
Vivelle
    Indication: Hormone Replacement Therapy
    Start date: 1985-01-01
    End date: 1995-01-01

Premarin
    Dosage: 10 mg, unk
    Administration route: Oral
    End date: 1996-08-01

Provera
    Dosage: 0.625 mg, unk
    Administration route: Oral
    End date: 1996-08-01

Cycrin
    Indication: Hormone Replacement Therapy
    Start date: 1985-01-01
    End date: 1995-01-01

Curretab
    Indication: Hormone Replacement Therapy
    Start date: 1985-01-01
    End date: 1995-01-01

Estrace
    Indication: Hormone Replacement Therapy
    Start date: 1985-01-01
    End date: 1995-01-01

MPA
    Indication: Hormone Replacement Therapy
    Start date: 1985-01-01
    End date: 1995-01-01

Estratest
    Indication: Hormone Replacement Therapy
    Start date: 1985-01-01
    End date: 1995-01-01

Prempro
    Dosage: 0.625/25 mg, unk
    Indication: Hormone Replacement Therapy
    Start date: 1996-08-01
    End date: 2002-08-01