Activella (Estradiol) - Side Effects and Adverse Reactions

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ADVERSE REACTIONS

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.

Adverse events reported with Activella 1.0 mg/0.5 mg by investigators in the Phase 3 studies regardless of causality assessment are shown in Table 6.

TABLE 6: ALL TREATMENT-EMERGENT ADVERSE EVENTS REGARDLESS OF RELATIONSHIP REPORTED AT A FREQUENCY OF ≥5% WITH ACTIVELLA 1.0 MG/0.5 MG

Endometrial Hyperplasia Study
(12-Months)

Vasomotor Symptoms Study
(3-Months)

Osteoporosis Study
(2 years)

Activella 1.0 mg/0.5 mg 1 mg E2 Activella 1.0 mg/0.5 mg Placebo Activella 1.0 mg/0.5 mg Placebo

(n=295) (n=296) (n=29) (n=34) (n=47) (n=48)

Body as a Whole

Back Pain 6% 5% 3% 3% 6% 4%

Headache 16% 16% 17% 18% 11% 6%

Digestive System

Nausea 3% 5% 10% 0% 11% 0%

Gastroenteritis 2% 2% 0% 0% 6% 4%

Nervous System

Insomnia 6% 4% 3% 3% 0% 8%

Emotional Lability 1% 1% 0% 0% 6% 0%

Respiratory System

Upper Respiratory Tract Infection 18% 15% 10% 6% 15% 19%

Sinusitis 7% 11% 7% 0% 15% 10%

Metabolic and Nutritional

Weight Increase 0% 0% 0% 0% 9% 6%

Urogenital System

Breast Pain 24% 10% 21% 0% 17% 8%

Post-Menopausal Bleeding 5% 15% 10% 3% 11% 0%

Uterine Fibroid 5% 4% 0% 0% 4% 8%

Ovarian Cyst 3% 2% 7% 0% 0% 8%

Resistance mechanism

Infection Viral 4% 6% 0% 3% 6% 6%

Moniliasis Genital 4% 7% 0% 0% 6% 0%

Secondary Terms

Injury Accidental 4% 3% 3% 0% 17% ¹ 4%

Other Events 2% 3% 3% 0% 6% 4%

¹ including one upper extremity fracture in each group

Adverse events reported with Activella 0.5 mg/0.1 mg by investigators during the Phase 3 study regardless of causality assessment are shown in Table 7.

TABLE 7: ALL TREATMENT-EMERGENT ADVERSE EVENTS REGARDLESS OF RELATIONSHIP REPORTED AT A FREQUENCY OF ≥5% WITH ACTIVELLA 0.5 MG/0.1 MG

Activella 0.5 mg/0.1 mg

Placebo

(n=194) (n=200)

Body as a Whole

Back Pain 10% 4%

Headache 22% 19%

Pain in extremity 5% 4%

Digestive System

Nausea 5% 4%

Diarrhea 6% 6%

Respiratory System

Nasopharyngitis 21% 18%

Urogenital System

Endometrial thickening 10% 4%

Vaginal hemorrhage 26% 12%

The following adverse reactions have been reported with estrogen and/or progestin therapy:

1. 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; pre-menstrual-like syndrome; cystitis-like syndrome; ovarian cancer; endometrial hyperplasia; endometrial cancer.

2. Breasts

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

3. Cardiovascular

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

4. Gastrointestinal

Nausea, vomiting; changes in appetite; cholestatic jaundice; abdominal pain/cramps, flatulence, bloating; increased incidence of gallbladder disease; pancreatitis; enlargement of hepatic hemangiomas.

5. Skin

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

6. Eyes

Retinal vascular thrombosis, intolerance to contact lenses.

7. Central nervous system

Headache; migraine; dizziness; mental depression; chorea; insomnia; nervousness; mood disturbances; irritability; exacerbation of epilepsy; probable dementia.

8. Miscellaneous

Increase or decrease in weight; aggravation of porphyria; edema; leg cramps; changes in libido; fatigue; reduced carbohydrate tolerance; anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides; back pain; arthralgia; myalgia.

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO ACTIVELLA

Below is a sample of reports where side effects / adverse reactions may be related to Activella. The information is not vetted and should not be cosidered as verified clinical evidence.

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

Reported by a lawyer from United States on 2007-04-06

Patient: 59 year old female weighing 78.5 kg (172.6 pounds)

Reactions: Breast Cancer

Suspect drug(s):
Activella
Dosage: unk, unk
Indication: Menopausal Symptoms

Premarin
    Dosage: .0625 mg.
    Administration route: Oral
    Indication: Menopausal Symptoms
    Start date: 1995-03-01
    End date: 2003-01-01

Estratest H.s.
    Dosage: unknown
    Administration route: Oral
    Indication: Menopausal Symptoms
    Start date: 1998-03-01
    End date: 2003-01-01

Medroxyprogesterone Acetate
    Dosage: 2.5 mg, unk
    Indication: Menopausal Symptoms
    Start date: 1997-12-01

Other drugs received by patient: Provera; Synthroid; Effexor XR; Coumadin