Activella
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Activella
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.
Adverse events reported with Activella (estradiol, norethindrone acetate) 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 (estradiol, norethindrone acetate) 1.0 MG/0.5 MG
| Endometrial Hyperplasia Study (12-Months) | Vasomotor Symptoms Study (3-Months) | Osteoporosis Study (2years) | ||||
| Activella 1.0 mg/0.5 mg (n=295) |
1 mg E2 (n=296) |
Activella 1.0 mg/0.5 mg (n=29) |
Placebo (n=34) |
Activella (estradiol, norethindrone acetate) 1.0 mg/0.5 mg (n=47) |
Placebo (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%* | 4%* |
| Other Events | 2% | 3% | 3% | 0% | 6% | 4% |
| * including one upper extremity fracture in each group | ||||||
Adverse events reported with Activella (estradiol, norethindrone acetate) 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 (estradiol, norethindrone acetate) 0.5 MG/0.1 MG
| Activella 0.5 mg/0.1 mg (n=194) |
Placebo (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:
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; premenstrual-like syndrome; cystitis-like syndrome; ovarian cancer; endometrial hyperplasia; endometrial cancer.
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; changes in appetite; cholestatic jaundice; abdominal pain/cramps, flatulence, bloating; 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; seborrhea; hirsutism; itching; skin rash; pruritus.
Eyes
Retinal vascular thrombosis, intolerance to contact lenses.
Central nervous system
Headache; migraine; dizziness; mental depression; chorea; insomnia; nervousness; mood disturbances; irritability; exacerbation of epilepsy; probable dementia.
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.
Read the Activella (estradiol, norethindrone acetate) Side Effects Center for a complete guide to possible side effects »
DRUG INTERACTIONS
Drug/Laboratory Test Interactions
- Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count; increased factors II, VII antigen, VIII coagulant activity, IX, X, XII, VII-X complex, and beta-thromboglobulin; decreased levels of anti-factor Xa and antithrombin III, decreased antithrombin III activity, increased levels of fibrinogen and fibrinogen activity; increased plasminogen antigen and activity.
- Increased thyroid-binding globulin (TBG) levels leading to increased circulating total thyroid hormone levels as measured by protein-bound iodine (PBI), T4 levels (by column or by radioimmunoassay), or T3 levels by radioimmunoassay. T3 resin uptake is decreased, reflecting the elevated TBG. Free T4 and free T3 concentrations are unaltered. Patients on thyroid replacement therapy may require higher doses of thyroid hormone.
- Other binding proteins may be elevated in serum (i.e., corticosteroid binding globulin (CBG), SHBG) leading to increased total circulating corticosteroids and sex steroids, respectively. Free hormone concentrations may be decreased. Other plasma proteins may be increased (angiotensinogen/rennin substrate, alpha-1 antitrypsin, ceruloplasmin).
- Increased plasma HDL and HDL2cholesterol subfraction concentration, reduced LDL cholesterol concentration, increased triglyceride levels.
- Impaired glucose tolerance.
- Reduced response to metyrapone test.
Last reviewed on RxList: 9/29/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Activella Information
Activella - User Reviews
Activella User Reviews
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