Activella Side Effects
Please note - some side effects for Activella may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
Side Effects of Activella - for the Consumer
Activella
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Activella:
Seek medical attention right away if any of these SEVERE side effects occur when using Activella:Back pain; breast tenderness or pain; headache; mild hair loss; nausea; stomach cramps, bloating, or pain; vaginal spotting or breakthrough bleeding; vomiting; weight changes.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); calf or leg pain, swelling, or tenderness; chest pain; confusion; discharge from the nipples; fainting; irregular heartbeat; lumps in the breast; mental or mood changes (eg, depression, irritability, memory loss); numbness of an arm or leg; one-sided weakness; severe or persistent breast pain; severe or persistent dizziness, headache, or stomach pain; severe, persistent, or recurring abnormal vaginal bleeding; speech changes (eg, slurred speech); sudden severe nausea or vomiting; sudden shortness of breath; sudden unusual weight gain; swelling of hands or feet; unusual vaginal discharge, itching, or odor; vision changes (eg, double vision, sudden vision loss); yellowing of the skin or eyes.
Activella Side Effects - for the Professional
Activella
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.
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|
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%* | 4%* |
| Other Events | 2% | 3% | 3% | 0% | 6% | 4% |
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.
|
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.
TopSide Effects by Body System
Gastrointestinal
Gastrointestinal side effects have included nausea (8% to 11%), abdominal pain (6% to 7%), diarrhea (4% to 5%), flatulence (4% to 5%), and dyspepsia (1% to 5%).
General
General side effects have included headache (18% to 20%), asthenia (8% to 12%), back pain (9% to 11%), flu syndrome (5% to 9%), pain (4% to 6%), and accidental injury (4% to 5%).
Genitourinary
Genitourinary side effects have included breast pain (25% to 31%), dysmenorrhea (20% to 21%), vaginitis (6% to 13%), menstrual disorder (6% to 12%), suspicious Papanicolaou smear (4% to 8%), and leukorrhea (5%). Endometrial thickening (10% to 4%) and vaginal hemorrhage (26% to 12%) have also been reported.
Local
Local side effects have included reactions at the application site (2% to 6%).
Psychiatric
Psychiatric side effects have included nervousness (3% to 6%) and depression (3% to 6%).
Respiratory
Respiratory side effects have included rhinitis (7% to 13%), respiratory disorder (7% to 12%), pharyngitis (4% to 10%), and sinusitis (4% to 9%).
TopMore resources:
Activella - Includes detailed dosage instructions.
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