Amabelz Side Effects

Generic name: estradiol / norethindrone

Medically reviewed by Drugs.com. Last updated on May 27, 2024.

Note: This document provides detailed information about Amabelz Side Effects associated with estradiol / norethindrone. Some dosage forms listed on this page may not apply specifically to the brand name Amabelz.

Applies to estradiol / norethindrone: oral tablet.

Other dosage forms:

• transdermal patch extended release

Important warnings This medicine can cause some serious health issues

Oral route (tablet)

Estrogen Plus Progestin Therapy. Cardiovascular Disorders and Probable Dementia. The Women’s Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of deep vein thrombosis (DVT), pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogen (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg), relative to placebo.The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily conjugated estrogen (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg), relative to placebo.

It is unknown whether this finding applies to younger postmenopausal women.Do not use estrogen plus progestogen therapy for the prevention of cardiovascular disease or dementia.Breast Cancer. The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer.Only daily oral 0.625 mg CE and 2.5 mg MPA were studied in the estrogen plus progestin substudy of the WHI.

Therefore the relevance of the WHI findings regarding adverse cardiovascular events, dementia and breast cancer to lower CE plus other MPA doses, other routes of administration, or other estrogen plus progestogen products is not know.

Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products.

Discuss with your patient the benefits and risks of estrogen plus progestogen therapy, taking into account her individual risk profile.Prescribe estrogens with or without progestogens at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.Estrogen-Alone Therapy. Endometrial Cancer. There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens.Adding a progestogen to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer.Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.

Cardiovascular Disorders and Probable Dementia. The WHI estrogen-alone substudy reported increased risks of stroke and DVT in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogen (0.625 mg)-alone, relative to placebo.The WHIMS estrogen-alone ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily conjugated estrogen (0.625 mg)-alone, relative to placebo.

It is unknown whether this finding applies to younger postmenopausal women.Do not use estrogen-alone therapy for the prevention of cardiovascular disease or dementia.Only daily oral 0.625 mg CE was studied in the estrogen-alone substudy of the WHI.

Therefore, the relevance of the WHI findings adverse cardiovascular events and dementia to lower CE doses, other routes of administration, or other estrogen-alone products is not known.

With out such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products.

Discuss with your patient the benefits and risks of estrogen-alone therapy, taking into account her individual risk profile.Prescribe estrogens with or without progestogens at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Serious side effects of Amabelz

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
• 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 Amabelz

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
• 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]

Further information

Amabelz 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.

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

Medical Disclaimer