Activella Side Effects
Generic name: estradiol / norethindrone
Medically reviewed by Drugs.com. Last updated on May 27, 2024.
Note: This document provides detailed information about Activella Side Effects associated with estradiol / norethindrone. Some dosage forms listed on this page may not apply specifically to the brand name Activella.
Applies to estradiol / norethindrone: oral tablet.
Other dosage forms:
Important warnings
This medicine can cause some serious health issues
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects. These visits may be every 3 to 6 months. Blood or urine tests, pelvic exam, breast exam, and mammogram (breast x-ray) may be needed to check for unwanted effects, unless your doctor tells you otherwise. Be sure to keep all appointments.
It is unlikely that a postmenopausal woman may become pregnant. But, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.
Using this medicine may increase your risk for having blood clots, strokes, or heart attacks. This risk may continue even after you stop using the medicine. Your risk for these serious problems is even greater if you have high blood pressure, high cholesterol in your blood, diabetes, or if you are overweight or smoke cigarettes. Contact your doctor immediately if you experience chest pain, confusion, difficulty speaking, double vision, headaches, an inability to move arms, legs or facial muscle, or an inability to speak.
Using this medicine for a long period of time may increase your risk of endometrial cancer, breast cancer, or uterine cancer. Talk with your doctor about this risk. Do not use this medicine if you have had your uterus (womb) removed (hysterectomy). Check with your doctor immediately if your experience abnormal vaginal bleeding.
Using this medicine may increase your risk of dementia, especially in women 65 years of age and older.
This medicine may increase your risk of having gallbladder disease. Check with your doctor if you start to have stomach pains, nausea, and vomiting.
Check with your doctor immediately if severe headache or sudden loss of vision or any other change in vision occurs while you are using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
Tell your doctor or dentist who treats you knows that you are using this medicine before any kind of surgery (eg, surgery that will require inactivity for a long time) or emergency treatment. Your doctor will decide whether you should continue using this medicine. This medicine may also affect the results of certain medical tests.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
Serious side effects of Activella
Along with its needed effects, estradiol / norethindrone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking estradiol / norethindrone:
More common side effects
- body aches or pain
- chills or fever
- cold or flu-like symptoms
- difficulty breathing
- headache
- itching of the vagina or genital area
- non-menstrual vaginal bleeding
- pain during sexual intercourse
- thick, white vaginal discharge with no odor or with a mild odor
- unusual tiredness or weakness
Incidence not known
- blistering, peeling, or loosening of the skin
- breast tenderness
- change in vaginal discharge
- change in vision
- chest pain, discomfort, or tightness
- clay-colored stools
- clear or bloody discharge from the nipple
- confusion
- dark urine
- difficulty speaking
- difficulty swallowing
- dizziness or lightheadedness
- double vision
- fainting
- fast heartbeat
- inability to move the arms, legs, or facial muscles
- inability to speak
- joint or muscle pain
- loss of appetite
- lump in the breast or under the arm
- nausea and vomiting
- noisy breathing
- pain in the ankles or knees
- pain or discomfort in the arms, jaw, back, or neck
- pain or feeling of pressure in the pelvis
- pain, redness, or swelling in the arm or leg
- painful, red lumps under the skin, mostly on the legs
- pains in the stomach, side, or abdomen, possibly radiating to the back
- problems with memory or speech
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red, irritated eyes
- redness or swelling of the breast
- skin rash, hives, or itching
- sores, ulcers, or white spots in the mouth or on the lips
- stomach pain
- sweating
- trouble breathing
- trouble recognizing objects
- trouble thinking and planning
- trouble walking
- unexpected or excess milk flow from the breasts
Other side effects of Activella
Some side effects of estradiol / norethindrone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common side effects
- back pain
- cramps
- crying
- euphoria
- mental depression
- paranoia
- quick to react or overreact emotionally
- rapidly changing moods
- trouble sleeping
- weakness
- weight gain
Incidence not known
- changes in appetite
- changes in sexual ability, desire, drive, or performance
- excess air or gas in the stomach or intestines
- increased hair growth, especially on the face
- patchy brown or dark brown discoloration of the skin
- trouble wearing contact lenses
For healthcare professionals
Applies to estradiol / norethindrone: oral tablet, transdermal film extended release.
General adverse events
The most common adverse events were vaginal bleeding and breast pain/tenderness. Vaginal bleeding usually occurred in the first months of treatment. Breast pain usually disappeared after a few months of therapy.[Ref]
Genitourinary
- Very common (10% or more): Vaginal hemorrhage (26%), breast pain (24%), post-menopausal bleeding (11%), endometrial thickening (10%), breast tenderness, menstruation irregular
- Common (1% to 10%): Ovarian cyst, uterine fibroid, breast edema, breast enlargement, uterine fibroids aggravated, uterine fibroids recurrence, uterine fibroids
- Uncommon (0.1% to 1%): Endometrial hyperplasia, dysmenorrhea
- Rare (less than 0.1%): Fallopian tube cysts, endocervical polyps
- Postmarketing reports: Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow, breakthrough bleeding, spotting, increase in size of uterine leiomyomata, change in amount of cervical secretion, changes in cervical ectropion, pre-menstrual-like syndrome, cystitis-like syndrome, nipple discharge, galactorrhea, fibrocystic breast changes, vulvovaginal pruritus[Ref]
Nervous system
- Very common (10% or more): Headache (22%)
- Common (1% to 10%): Migraine or migraine aggravated, dizziness
- Rare (less than 0.1%): Paresthesia
- Postmarketing reports: Dizziness, exacerbation of epilepsy, dementia, chorea, stroke[Ref]
Cardiovascular
- Common (1% to 10%): Blood pressure increase
- Uncommon (0.1% to 1%): Thrombophlebitis superficial, venous thromboembolism
- Rare (less than 0.1%): Thrombophlebitis deep, deep venous thromboembolism
- Postmarketing reports: Deep and superficial vein thrombosis, thrombophlebitis, myocardial infarction, stroke, hypertension aggravated[Ref]
Gastrointestinal
- Very common (10% or more): Nausea (11%)
- Common (1% to 10%): Gastroenteritis, diarrhea, abdominal pain, abdominal distention, abdominal discomfort
- Uncommon (0.1% to 1%): Flatulence, bloating
- Postmarketing reports: Vomiting, abdominal cramps, pancreatitis, dyspepsia[Ref]
Psychiatric
- Common (1% to 10%): Insomnia, emotional lability, depression or depression aggravated
- Uncommon (0.1% to 1%): Nervousness, changes in libido
- Postmarketing reports: Mental depression, mood disturbances, irritability, anxiety[Ref]
Other
- Very common (10% or more): Accidental injury (17%)
- Common (1% to 10%): Weight increase, weight decreased, edema peripheral, pain, asthenia
- Uncommon (0.1% to 1%): Drug ineffective
- Postmarketing reports: Fatigue, edema[Ref]
Musculoskeletal
- Very common (10% or more): Back pain (10%)
- Common (1% to 10%): Pain in extremity, leg cramps[Ref]
Immunologic
- Very common (10% or more): Nasopharyngitis (21%), upper respiratory tract infection (18%), sinusitis (15%)
- Common (1% to 10%): Infection viral, moniliasis genital, genital candidiasis or vaginitis[Ref]
Dermatologic
- Common (1% to 10%): Acne, rash, pruritus, dry skin
- Uncommon (0.1% to 1%): Alopecia, hirsutism, urticaria, skin reactions, skin discoloration
- Postmarketing reports: Chloasma or melasma that may persist when drug is discontinued, erythema multiforme, erythema nodosum, hemorrhagic eruption, loss of scalp hair, seborrhea, skin rash, seborrhea, angioneurotic edema[Ref]
Oncologic
- Uncommon (0.1% to 1%): Breast cancer
- Rare (less than 0.1%): Uterine leiomyoma
- Postmarketing reports: Ovarian cancer, endometrial cancer[Ref]
Hypersensitivity
- Uncommon (0.1% to 1%): Hypersensitivity
- Rare (less than 0.1%): Allergic reaction
- Postmarketing reports: Anaphylactoid/anaphylactic reactions[Ref]
Respiratory
- Rare (less than 0.1%): Pulmonary embolism, asthma
- Postmarketing reports: Exacerbation of asthma[Ref]
Hepatic
- Uncommon (0.1% to 1%): Gallbladder disease, gallstones, transaminases increased
- Rare (less than 0.1%): Cholelithiasis
- Postmarketing reports: Cholestatic jaundice, gallbladder disease, cholelithiasis aggravated, cholelithiasis recurrence[Ref]
Metabolic
- Common (1% to 10%): Fluid retention
- Postmarketing reports: Changes in appetite, increased triglycerides[Ref]
Ocular
- Postmarketing reports: Retinal vascular thrombosis, intolerance to contact lenses, visual disturbances[Ref]
See also:
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Prempro
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Estrace Vaginal Cream
Estrace Vaginal Cream is used for atrophic urethritis, atrophic vaginitis
References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. Cerner Multum, Inc. "Australian Product Information."
3. (2017) "Product Information. Activella (estradiol-norethindrone)." Gemini Laboratories
4. (2017) "Product Information. Lopreeza (estradiol-norethindrone)." Amneal Pharmaceuticals
5. (2017) "Product Information. Mimvey (estradiol-norethindrone)." Teva Pharmaceuticals USA
6. (2017) "Product Information. Amabelz (estradiol-norethindrone)." Lupin Pharmaceuticals Inc
More about Activella (estradiol / norethindrone)
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Further information
Activella side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.