Recommended Topic Related To:

Menostar

"March 7, 2013 -- An FDA panel voted to stop recommending calcitonin salmon for the treatment of osteoporosis in women who are at least five years past menopause.

The committee voted 12-9 against continued marketing of the drug, citing"...

Menostar

Menostar Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Menostar (estradiol) Transdermal System is a form of estrogen, a female sex hormone, used to treat certain symptoms of menopause such as dryness, burning, and itching of the vaginal area. It also reduces urgency or irritation of urination. Menostar skin patches are also used to treat ovarian disorders, infertility, and abnormal vaginal bleeding. Some estradiol skin patches are used to prevent postmenopausal osteoporosis. Common side effects include nausea, vomiting, loss of appetite, swollen breasts, acne, skin color changes, decreased sex drive, impotence, difficulty having an orgasm, migraine headaches, dizziness, vaginal pain, dryness, or discomfort, swelling of your ankles or feet, depression, changes in your menstrual periods, or break-through bleeding.

The adhesive side of the Menostar transdermal system should be placed on a clean, dry area of the lower abdomen. Menostar should not be applied to or near the breasts. The sites of application must be rotated, with an interval of at least 1-week allowed between applications to a particular site. Menostar may interact with carbamazepine, phenobarbital, St. John's wort, blood thinners, antibiotics, antifungals, or ritonavir and other HIV/AIDS medications. Tell your doctor all medications and supplements you use. Do not use Menostar if you are pregnant. It can cause birth defects. Tell your doctor right away if you become pregnant during treatment. Use birth control while you are using this medication. This drug can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use Menostar while breastfeeding.

Our Menostar (estradiol) Transdermal System 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Menostar in Detail - Patient Information: Side Effects

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

Call your doctor at once if you have a serious side effect such as:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden severe headache, sudden vision changes, problems with speech or balance;
  • sudden cough, wheezing, rapid breathing, coughing up blood;
  • pain, swelling, warmth, or redness in one or both legs;
  • pain, swelling, or tenderness in your stomach;
  • jaundice (yellowing of the skin or eyes);
  • unusual vaginal bleeding;
  • a lump in your breast;
  • numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes; or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

  • upset stomach, bloating, constipation;
  • acne or skin color changes, increased facial hair, thinning scalp hair;
  • mild headache, back pain, joint pain;
  • cold symptoms such as stuffy nose, sneezing, sinus pain, sore throat;
  • breast swelling and tenderness, nipple discharge; or
  • changes in your menstrual periods, break-through 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.

Read the entire detailed patient monograph for Menostar (Estradiol Transdermal System) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Menostar FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

See BOXED WARNINGS, WARNINGS and PRECAUTIONS.

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. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Summary of Most Frequently Reported Treatment Emergent Adverse Experiences/Medical Events ( ≥ 5%) By Treatment Groups

AE per Body System Menostar 14 mcg/day
(N=208)
Placebo
(N=209)
Body as a Whole 95 (46%) 100 (48%)
  Abdominal Pain 17 (8%) 17 (8%)
  Accidental Injury 29 (14%) 23 (11%)
  Infection 11 (5%) 10 (5%)
  Pain 26 (13%) 26 (12%)
Cardiovascular 20 (10%) 19 (9%)
Digestive System 52 (25%) 44 (21%)
  Constipation 11 (5%) 6 (3%)
  Dyspepsia 11 (5%) 9 (4%)
Metabolic and Nutritional Disorders 25 (12%) 22 (11%)
Musculoskeletal System 54 (26%) 51 (24%)
  Arthralgia 24 (12%) 13 (6%)
  Arthritis 11 (5%) 15 (7%)
  Myalgia 10 (5%) 6 (3%)
Nervous System 30 (14%) 23 (11%)
  Dizziness 11 (5%) 6 (3%)
Repiratory System 62 (30%) 67 (32%)
  Bronchitis 12 (6%) 9 (4%)
  Upper Respiratory Infection 33 (16%) 35 (17%)
Skin and Appendages 50 (24%) 54 (26%)
  Application Site Reaction 18 (9%) 18 (9%)
  Breast Pain 10 (5%) 8 (4%)
Urogenital System 66 (32%) 40 (19%)
  Cervical Polyps 13 (6%) 4 (2%)
  Leukorrhea 22 (11%) 3 (1%)

The following additional adverse reactions have been reported with estrogens and/or progestin therapy.

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; ovarian cancer; endometrial hyperplasia; endometrial cancer.

Breasts

Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer.

Cardiovascular

Deep and superficial venous thrombosis; pulmonary embolism; thrombo-phlebitis; myocardial infarction; stroke; increase in blood pressure.

Gastrointestinal

Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis; enlargement of hepatic hemangiomas.

Skin

Chloasma or melasma, which may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hir-sutism; pruritus, rash.

Eyes

Retinal vascular thrombosis; intolerance to contact lenses.

Central nervous system

Headache; migraine; dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy; dementia.

Miscellaneous

Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthalgias; leg cramps; changes in libido; anaphylactoid/ana-phylactic reactions including urticaria and angioedema; hypocalcemia; exacerbation of asthma; increased triglycerides.

Read the entire FDA prescribing information for Menostar (Estradiol Transdermal System) »

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Healthy Bones

Get tips and advances in treatment.