Amabelz Side Effects Center

Last updated on RxList: 10/14/2021
Amabelz Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Amabelz?

Amabelz (estradiol and norethindrone acetate tablets), for oral use is an estrogen and progestin combination indicated in a woman with a uterus for treatment of moderate to severe vasomotor symptoms due to menopause, prevention of postmenopausal osteoporosis, and treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. Amabelz is available in generic form.

What Are Side Effects of Amabelz?

Common side effects of Amabelz include:

Dosage for Amabelz

The dose of Amabelz is one tablet to be taken once daily.

What Drugs, Substances, or Supplements Interact with Amabelz?

Amabelz may interact with St. John's wort, phenobarbital, carbamazepine, rifampin, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, and grapefruit juice. Tell your doctor all medications and supplements you use.

Amabelz During Pregnancy and Breastfeeding

Amabelz should not be used during pregnancy or while breastfeeding. Estrogen administration to nursing women has been shown to decrease the quantity and quality of breast milk.

Additional Information

Our Amabelz (estradiol and norethindrone acetate tablets), for Oral Use 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.

QUESTION

If menopause occurs in a woman younger than ___ years, it is considered to be premature. See Answer
Amabelz Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
  • signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
  • swelling or tenderness in your stomach;
  • jaundice (yellowing of the skin or eyes);
  • memory problems, confusion, unusual behavior;
  • unusual vaginal bleeding, pelvic pain;
  • a lump in your breast; or
  • high levels of calcium in your blood--nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.

Common side effects may include:

  • nausea, vomiting, bloating, stomach cramps;
  • fluid retention (swelling, rapid weight gain);
  • headache;
  • breast pain;
  • thinning scalp hair; or
  • vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding.

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.

SLIDESHOW

What Is Osteoporosis? Treatment, Symptoms, Medication See Slideshow
Amabelz Professional Information

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 Amabelz 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 AMABELZ 1 MG/0.5 MG

  Endometrial Hyperplasia Study
(12-Months )
Vasomotor Symptoms Study
(3-Months )
Osteoporosis Study
(2-years )
Amabelz
1 mg/0.5 mg
(n=295)
1 mg E2
(n=296)
Amabelz
1 mg/0.5 mg
(n=29)
Placebo (n=34) Amabelz
1 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 Tract Infection 18% 15% 10% 6% 15% 19%
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 Amabelz 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 AMABELZ 0.5 MG/0.1 MG

  Amabelz
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 Amabelz. 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 Amabelz (Estradiol And Norethindrone Acetate Tablets)

© Amabelz Patient Information is supplied by Cerner Multum, Inc. and Amabelz Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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