Estradiol/Levonorgestrel Side Effects

Please note - some side effects for Estradiol/Levonorgestrel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Estradiol/Levonorgestrel - for the Consumer

Estradiol/Levonorgestrel Weekly Patch

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Estradiol/Levonorgestrel Weekly Patch:

Headache; irregular vaginal bleeding or spotting; mild breast pain; mild hair loss; nausea; stomach cramps or bloating; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast lumps; breast pain; calf pain or tenderness; changes in vision or speech (eg, change in contact lens fit, loss of vision); chest pain; coughing of blood; dizziness; fainting; mental or mood changes (eg, severe depression, memory loss); pain, swelling, or tenderness in the stomach; severe headache or vomiting; severe, persistent, or unusual vaginal bleeding; slurred speech; sudden shortness of breath; swelling of hands or feet; unusual vaginal discharge, itching, or odor; weakness or numbness of an arm or leg; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .

Side Effects by Body System

Cardiovascular

Cardiovascular side effects have included myocardial infarction and stroke as well as venous thrombosis and pulmonary embolism. Hypertension has been reported in 3.3 % of patients in one study.

Dermatologic

Dermatologic side effects have included application site reactions (40.6%) and rash (2.4%).

Gastrointestinal

Gastrointestinal side effects have included flatulence (3.8%).

Genitourinary

Genitourinary side effects have included urinary tract infection (3.3%), vaginal bleeding (36.8%), breast pain (18.9%), and vaginitis (1.9%).

Musculoskeletal

Musculoskeletal side effects have included back pain (6.1%) and arthralgia (4.2%).

Oncologic

Oncologic side effects have included endometrial and breast cancer.

Psychiatric

Psychiatric side effects have included depression (5.7%) and headache (5.2%).

Respiratory

Respiratory side effects have included bronchitis (4.2%), sinusitis (3.8%), and upper respiratory infection (13.2%).

Metabolic

Metabolic side effects have included edema (3.8%) and weight gain (2.8%)

General

General side effects have included infection (3.3%), abdominal pain (4.2%), flu syndrome (4.7%), pain (5.2%), and accidental injury (3.3%).

Hypersensitivity

Hypersensitivity side effects have included urticaria, angioedema, and anaphylactoid/anaphylactic reactions.

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