DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Activella (Estradiol) - Side Effects and Adverse Reactions

 
 



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 mg1 mg E2Activella 1.0 mg/0.5 mgPlaceboActivella 1.0 mg/0.5 mgPlacebo
(n=295)(n=296)(n=29)(n=34)(n=47)(n=48)
Body as a Whole
 Back Pain 6% 5% 3% 3% 6%4%
 Headache16%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  Infection18%15%10% 6%15%19%
 Sinusitis 7%11% 7% 0%15%10%
Metabolic and Nutritional
Weight Increase0%0%0%0%9%6%
Urogenital System
 Breast Pain24%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 Viral4%6%0%3%6%6%
 Moniliasis Genital4%7%0%0%6%0%
Secondary Terms
 Injury Accidental4%3%3%0%17% 1 4%
 Other Events2%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 Pain10%4%
 Headache22%19%
 Pain in extremity5%4%
Digestive System
 Nausea5%4%
 Diarrhea6%6%
Respiratory System
 Nasopharyngitis21%18%
Urogenital System
 Endometrial thickening10%4%
 Vaginal hemorrhage26%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 SUSPECTED ACTIVELLA SIDE EFFECTS / ADVERSE REACTIONS

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 considered as verified clinical evidence.

Possible Activella side effects / adverse reactions in 60 year old female

Reported by a consumer/non-health professional from United States on 2012-01-10

Patient: 60 year old female weighing 70.3 kg (154.7 pounds)

Reactions: Breast Cancer Stage II

Adverse event resulted in: life threatening event

Suspect drug(s):
Activella



Possible Activella side effects / adverse reactions in 63 year old female

Reported by a consumer/non-health professional from United States on 2012-02-16

Patient: 63 year old female weighing 54.4 kg (119.7 pounds)

Reactions: Nausea, Breast Mass

Suspect drug(s):
Activella

Other drugs received by patient: Avonex



Possible Activella side effects / adverse reactions in 55 year old female

Reported by a consumer/non-health professional from United States on 2012-06-12

Patient: 55 year old female weighing 68.5 kg (150.7 pounds)

Reactions: Product Formulation Issue

Adverse event resulted in: life threatening event

Suspect drug(s):
Estradiol and Norethindrone Acetate
    Dosage: see above nightly po
    Administration route: Oral
    Start date: 2010-11-30
    End date: 2012-03-31

Activella
    Dosage: see above' nightly po
    Administration route: Oral
    Indication: Menopausal Symptoms
    Start date: 2008-08-01
    End date: 2010-11-01



See index of all Activella side effect reports >>

Drug label data at the top of this Page last updated: 2008-01-24

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017