Amabelz
- Generic Name: estradiol and norethindrone acetate tablets
- Brand Name: Amabelz
Amabelz (Estradiol And Norethindrone Acetate Tablets) side effects drug center
- Related Drugs
- back pain,
- headache,
- pain in the extremities,
- nausea,
- diarrhea,
- stomach pain or upset,
- insomnia,
- 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.
- 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.
- 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.
- Cardiovascular Disorders [see BOX WARNING, WARNINGS AND PRECAUTIONS]
- Malignant Neoplasms [see BOX WARNING, WARNINGS AND PRECAUTIONS,]
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.
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:
Common side effects may include:
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.
Read the entire detailed patient monograph for Amabelz (Estradiol And Norethindrone Acetate Tablets)
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.