Estradiol / levonorgestrel Side Effects

Not all side effects for estradiol / levonorgestrel may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to estradiol / levonorgestrel: weekly patch

Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Headache; irregular vaginal bleeding or spotting; mild breast pain; mild hair loss; nausea; skin redness or irritation at the application site; stomach cramps or bloating; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur while taking estradiol / levonorgestrel:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bulging eyes; calf or leg pain, swelling, redness, or tenderness; chest pain; confusion; coughing up blood; discharge from the nipples; fainting; lumps in the breast; memory problems; mental or mood changes (eg, depression); numbness of an arm or leg; one-sided weakness; severe or persistent breast pain; severe or persistent dizziness, headache, or stomach pain; severe, persistent, or recurring abnormal vaginal bleeding; speech changes (eg, slurred speech); sudden severe nausea or vomiting; sudden shortness of breath; sudden unusual weight gain; swelling of hands or feet; unusual tiredness or weakness; unusual vaginal discharge, itching, or odor; vision changes (eg, double vision, sudden vision loss); yellowing of the skin or eyes.

For Healthcare Professionals

Applies to estradiol / levonorgestrel: transdermal film extended release

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.[Ref]

Dermatologic

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

Gastrointestinal

Gastrointestinal side effects have included flatulence (3.8%).[Ref]

Genitourinary

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

Musculoskeletal

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

Oncologic

Oncologic side effects have included endometrial and breast cancer.[Ref]

Psychiatric

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

Respiratory

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

Metabolic

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

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%).[Ref]

Hypersensitivity

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

References

1. "Product Information. Climara Pro (estradiol-levonorgestrel)." Berlex Laboratories, Wayne, NJ.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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