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


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


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


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


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


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


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


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


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


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

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