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Activella

"March 14, 2013 -- Hormone replacement therapy is the most effective treatment for symptoms like hot flashes, and the benefits are likely to outweigh the risks, major medical societies say.

The statement was published in the April issue "...

Activella

Activella Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Activella (estradiol, norethindrone acetate) is used to treat the symptoms of menopause such as feelings of warmth in the face, neck and chest, or sudden intense spells of heat and sweating ("hot flashes" or "hot flushes"); to treat vulvar and vaginal changes (itching, burning, dryness in or around the vagina, difficulty or burning with urination) caused by menopause; and to replace estrogen in conditions such as hypogonadism, removal of the ovaries, or primary ovarian failure that result in a lack of estrogen. It is also used to prevent thinning of the bones (osteoporosis). It is a combination of the female hormones estrogen and pregesterone. This medication is available in generic form. Common side effects include stomach upset, nausea/vomiting, bloating, breast tenderness, headache, or weight changes.

Dosing of Activella is either 1.0 mg/0.5 mg (estradiol, norethindrone acetate) or 0.5 mg/0.1 mg (estradiol, norethindrone acetate). The lowest effective dose and the shortest treatment duration should be used. Activella may interact with anticoagulants (blood thinners). Other drugs may also interact with Activella. Tell your doctor all prescription or over-the-counter medicines and supplements you use. Activella must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor. This medication passes into breast milk. It may reduce the quality and amount of breast milk produced. Consult your doctor before breast-feeding.

Our Activella (estradiol, norethindrone acetate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Activella in Detail - Patient Information: Side Effects

If you experience any of the following serious side effects, stop taking estradiol and norethindrone and seek emergency medical attention or notify your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • shortness of breath or pain in the chest;
  • a painful, red, swollen leg;
  • abnormal vaginal bleeding;
  • pain, swelling, or tenderness in the abdomen;
  • severe headache or vomiting, dizziness, faintness or changes in vision or speech;
  • yellowing of the skin or eyes; or
  • a lump in a breast.

Other, less serious side effects may be more likely to occur. Continue to take estradiol and norethindrone and talk to your doctor if you experience

  • nausea and vomiting;
  • tenderness or enlargement of the breasts;
  • weakness;
  • swelling of the hands or feet;
  • spotty darkening of the skin, particularly on the face;
  • difficulty in wearing contact lenses;
  • vaginal irritation or discomfort; or
  • changes in menstrual cycle, painful menstruation, or break-through bleeding.

Estradiol increases the risk of developing endometrial hyperplasia, a condition that may lead to cancer of the lining of the uterus. Using a progestin, such as norethindrone, with estradiol lowers the risk of developing this condition. Visit your doctor regularly and report any unusual vaginal bleeding right away.

It is unclear to what extent estrogen and progesterone treatments may affect the risk of breast cancer.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Activella (Estradiol, Norethindrone Acetate) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Activella Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Stomach upset, nausea/vomiting, bloating, breast tenderness, headache, or weight changes may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, memory loss), breast lumps, unusual vaginal bleeding (such as spotting, breakthrough bleeding, prolonged/recurrent bleeding), increased or new vaginal irritation/itching/odor/discharge, severe stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine, swelling hands/ankles/feet, increased thirst/urination.

This medication may rarely cause serious problems from blood clots (such as heart attacks, strokes, deep vein thrombosis, pulmonary embolism). Get medical help right away if you have any serious side effects, including: chest/jaw/left arm pain, unusual sweating, sudden/severe headache, weakness on one side of the body, confusion, slurred speech, sudden vision changes (such as partial/complete blindness), pain/redness/swelling of legs, tingling/weakness/numbness in the arms/legs, trouble breathing, coughing up blood, sudden dizziness/fainting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Activella (Estradiol, Norethindrone Acetate)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Activella FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

Clinical Trials Experience

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.

Adverse reactions reported with Activella 1 mg/0.5 mg by investigators in the Phase 3 studies regardless of causality assessment are shown in Table 1.

TABLE 1 : ALL TREATMENT-EMERGENT ADVERSE REACTIONS REGARDLESS OF RELATIONSHIP REPORTED AT A FREQUENCY OF ≥ 5 PERCENT WITH ACTIVELLA 1 MG/0.5 MG

  Endometrial Hyperplasia Study (12-Months) Vasomotor Symptoms Study (3-Months) Osteoporosis Study (2-Years)
Activella1 mg/0.5 mg
(n=295)
1 mg E2
(n=296)
Activella1 mg/0.5 mg
(n=29)
Placebo
(n=34)
Activella1 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 18% 15% 10% 6% 15% 19%
Tract Infection
  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 reactions reported with Activella 0.5 mg/0.1 mg by investigators during the Phase 3 study regardless of causality assessment are shown in Table 2.

TABLE 2 : ALL TREATMENT-EMERGENT ADVERSE REACTIONS REGARDLESS OF RELATIONSHIP REPORTED AT A FREQUENCY OF ≥ 5 PERCENT WITH ACTIVELLA 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%

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Activella. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

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.

Breast

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 and pancreatitis.

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; dementia.

Miscellaneous

Increase or decrease in weight; edema; leg cramps; changes in libido; fatigue; exacerbation of asthma; increased triglycerides; hypersensitivity; anaphylactoid/anaphylactic reactions.

Read the entire FDA prescribing information for Activella (Estradiol, Norethindrone Acetate) »

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Activella - User Reviews

Activella User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Activella sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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