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:

• transdermal patch extended release

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:

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:

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.

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:

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.

Medical Disclaimer