Menostar
FDA Panel: Long-Used Osteoporosis Drug Too Risky »
"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"...
Read the FDA Panel: Long-Used Osteoporosis Drug Too Risky article »
Menostar
Menostar Side Effects Center
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, confusion, problems with vision, speech, or balance;
- pain or swelling in your lower leg;
- abnormal vaginal bleeding;
- pain, swelling, or tenderness in your stomach;
- jaundice (yellowing of the skin or eyes); or
- a lump in your breast.
Less serious side effects may include:
- nausea, vomiting, loss of appetite;
- swollen breasts;
- acne or skin color changes;
- decreased sex drive, impotence, or difficulty having an orgasm;
- migraine headaches or dizziness;
- vaginal pain, dryness, or discomfort;
- swelling of your ankles or feet;
- depression; 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) »
Additional Menostar Information
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.
Updated & New
