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Menostar (Estradiol Transdermal System) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Menostar Side Effects Center

What Is Menostar?

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. Menostar 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.

What Are Side Effects of Menostar?

Common side effects of Menostar include:

Tell your doctor if you have serious side effects of Menostar including:

  • chest pain or heavy feeling,
  • pain spreading to the arm or shoulder,
  • 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);
  • 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).

Dosage for Menostar

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.

What Drugs, Substances, or Supplements Interact with Menostar?

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.

Menostar During Pregnancy or Breastfeeding

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.

Additional Information

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.

 

Menostar Consumer Information

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

Remove the skin patch and call your doctor at once if you have:

  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed;
  • 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);
  • unusual vaginal bleeding, pelvic pain;
  • a breast lump;
  • memory problems, confusion, unusual behavior; 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:

  • headache, back pain;
  • stuffy nose, sinus pain, sore throat;
  • vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding;
  • bloating, stomach cramps, nausea, vomiting;
  • breast pain;
  • redness or irritation where the patch was worn;
  • thinning scalp hair; or
  • fluid retention (swelling, rapid weight gain).

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)

 

Menostar 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.

Menostar was investigated in a 2-year double blind, placebo-controlled, multicenter study in the United States. A total of 417 postmenopausal women (208 women on Menostar, 209 on placebo) 60 to 80 years old, with an intact uterus were enrolled in the study. At 24 months, 189 women remained in the Menostar group and 186 remained in the placebo group. Adverse events with an incidence of ≥ 5 percent in the Menostar 14 mcg group and greater than those reported in the placebo group are listed in Table 1.

Table 1: Summary of Most Frequently Reported Treatment Emergent Adverse Reactions ( ≥ 5 percent) by Treatment Groups

Body System Adverse Reactions 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%)
Respiratory 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%)

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of the Climara transdermal system and the Menostar transdermal system. 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 bleeding pattern, pelvic pain

Breast

Breast cancer, breast pain, breast tenderness

Cardiovascular

Changes in blood pressure, palpitations, hot flashes

Gastrointestinal

Vomiting, abdominal pain, abdominal distension, nausea

Skin

Alopecia, hyperhidrosis, night sweats, urticaria, rash

Eyes

Visual disturbances, contact lens intolerance

Central Nervous System

Depression, migraine, paresthesia, dizziness, anxiety, irritability, mood swings, nervousness, insomnia, headache

Miscellaneous

Edema, fatigue, menopausal symptoms, weight increased, application site reaction, anaphylactic reaction

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

&Copy; Menostar Patient Information is supplied by Cerner Multum, Inc. and Menostar Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.