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Ena Side Effects

Generic Name: estradiol / norethindrone

Note: This document contains side effect information about estradiol / norethindrone. Some of the dosage forms listed on this page may not apply to the brand name Ena.

For the Consumer

Applies to estradiol/norethindrone: oral tablet

Other dosage forms:

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

  • Body aches or pain
  • chills or fever
  • cold or flu-like symptoms
  • difficulty breathing
  • headache
  • itching of the vagina or genital area
  • nonmenstrual 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

  • Abdominal or stomach pain
  • blistering, peeling, or loosening of the skin
  • change in vaginal discharge
  • chest pain, discomfort, or tightness in chest
  • 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
  • sudden shortness of breath or troubled breathing
  • sweating
  • trouble recognizing objects
  • trouble thinking and planning
  • trouble walking

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

  • Back pain
  • breast 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

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]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Amabelz (estradiol-norethindrone)." Lupin Pharmaceuticals Inc, Baltimore, MD.

4. "Product Information. Lopreeza (estradiol-norethindrone)." Amneal Pharmaceuticals, Glasgow, KY.

5. "Product Information. Mimvey (estradiol-norethindrone)." Teva Pharmaceuticals USA, North Wales, PA.

6. "Product Information. Activella (estradiol-norethindrone)." Gemini Laboratories, Bridgewater, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

More about Ena (estradiol / norethindrone)

Consumer resources

Other brands: Activella, CombiPatch, Mimvey, Lopreeza

Professional resources

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