Medical Editor: John P. Cunha, DO, FACOEP
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. Common side effects of Amabelz include:
- back pain,
- pain in the extremities,
- stomach pain or upset,
- mood changes,
- upper respiratory tract infection,
- sinus infection,
- runny or stuffy nose,
- weight gain,
- breast pain,
- post-menopausal bleeding,
- uterine fibroid vaginal hemorrhage,
- ovarian cysts,
- endometrial thickening,
- viral infections,
- genital yeast infections, and
- accidental injury.
The dose of Amabelz is one tablet to be taken once daily. 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 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.
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.
The following serious adverse reactions are discussed elsewhere in the labeling:
- Cardiovascular Disorders [see BOX WARNING, WARNINGS AND PRECAUTIONS]
- Malignant Neoplasms [see BOX WARNING, WARNINGS AND PRECAUTIONS,]
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
|Vasomotor Symptoms Study
1 mg/0.5 mg
|1 mg E2
1 mg/0.5 mg
1 mg/0.5 mg
|Body as a Whole|
|Upper Respiratory Tract Infection||18%||15%||10%||6%||15%||19%|
|Metabolic and Nutritional|
|*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
0.5 mg/0.1 mg
|Body as a Whole|
|Pain in extremity||5%||4%|
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.
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.
Retinal vascular thrombosis, intolerance to contact lenses.
Central Nervous System
Read the entire FDA prescribing information for Amabelz (Estradiol And Norethindrone Acetate Tablets)