Applies to ethinyl estradiol / norelgestromin: transdermal patch extended release.

Serious side effects

Along with its needed effects, ethinyl estradiol / norelgestromin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ethinyl estradiol / norelgestromin:

More common

• Body aches or pain
• chills
• cough
• difficulty with breathing
• ear congestion
• fever
• headache
• loss of voice
• nasal congestion
• runny nose
• sneezing
• sore throat
• unusual tiredness or weakness

Incidence not known

• Anxiety
• changes in skin color
• chest pain or discomfort
• confusion
• dark urine
• diarrhea
• dizziness
• eye pain
• fainting
• inability to speak
• itching
• lack or loss of appetite
• light-colored stools
• lightheadedness
• nausea
• numbness in the hands
• pain in the stomach
• pain in the chest, groin, or legs, especially the calves
• pain or discomfort in the arms, jaw, back, or neck
• pain, tenderness, or swelling of the foot or leg
• pounding in the ears
• rash
• seizures
• slow or fast heartbeat
• slurred speech
• sudden headache
• sudden loss of coordination
• sudden, severe weakness or numbness in the arm or leg on one side of the body
• sweating
• swelling, pain, or tenderness in the upper abdominal or stomach area
• temporary blindness
• unpleasant breath odor
• vision changes
• vomiting of blood
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking ethinyl estradiol / norelgestromin:

Symptoms of overdose

• Unusual vaginal bleeding in women
• vomiting

Other side effects

Some side effects of ethinyl estradiol / norelgestromin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Burning, itching, or redness of the skin
• menstrual cramps
• pain, soreness, swelling, or discharge from the breast or breasts
• swelling or soreness at the patch site

Incidence not known

• Absent, missed, or irregular menstrual periods
• bloody vaginal discharge
• brown, blotchy spots on exposed skin
• change in amount of vaginal discharge
• change in menstrual flow
• decreased amount of breast milk
• discouragement
• dry mouth
• feeling sad or empty
• increase or decrease in weight
• increased hunger or thirst
• increased urination
• irritability
• itching of the vagina or outside of the genitals
• light vaginal bleeding between periods and after sexual intercourse
• loss of interest or pleasure
• pain during sexual intercourse
• stomach cramps or bloating
• stopping of menstrual bleeding
• swelling
• thick, white curd-like vaginal discharge without odor or with mild odor
• trouble concentrating
• trouble sleeping

For Healthcare Professionals

Applies to ethinyl estradiol / norelgestromin: transdermal film extended release.

General

The most frequently reported side effects were breast symptoms, nausea/vomiting, headache, application site disorder, abdominal pain, dysmenorrhea, vaginal bleeding and menstrual disorders, and mood affect and anxiety disorders.^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (16.6%)

Common (1% to 10%): Abdominal pain, vomiting, diarrhea, abdominal distention

Postmarketing reports: Colitis^[Ref]

Nervous system

Very common (10% or more): Headache (21%)

Common (1% to 10%): Dizziness, migraine

Rare (less than 0.1%): Cerebrovascular accident

Frequency not reported: Stroke

Postmarketing reports: Dysgeusia, migraine with aura, hemorrhage intracranial, cerebral hemorrhage, abnormal taste^[Ref]

Respiratory

Rare (less than 0.1%): Pulmonary embolism

Postmarketing reports: Pulmonary artery thrombosis^[Ref]

Genitourinary

Very common (10% or more): Breast symptoms (22.4%), breast tenderness

Common (1% to 10%): Dysmenorrhea, vaginal bleeding/menstrual disorder, vaginal yeast infection/candidiasis, vulvovaginal infection, uterine spasm, vaginal discharge

Uncommon (0.1% to 1%): Galactorrhea, premenstrual syndrome, vulvovaginal dryness

Rare (less than 0.1%): Genital discharge

Frequency not reported: Uterine bleeding irregular

Postmarketing reports: Lactation suppressed, menstrual disorder^[Ref]

Local

Very common (10% or more): Application site disorder (17.1%)

Common (1% to 10%): Application site reaction

Rare (less than 0.1%): Application site pustule

Postmarketing reports: Erosion, abscess^[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Hypertension, blood pressure increased

Rare (less than 0.1%): Arterial thromboembolism

Postmarketing reports: Myocardial infarction, arterial thrombosis, cerebrovascular accident, deep vein thrombosis, hypertension, hypertensive crisis, thrombosis, venous thromboembolism^[Ref]

Psychiatric

Common (1% to 10%): Mood disorder, affect disorder, anxiety

Uncommon (0.1% to 1%): Insomnia, libido decreased

Rare (less than 0.1%): Libido increased

Postmarketing reports: Anger, emotional disorder, frustration, irritability^[Ref]

Metabolic

Uncommon (0.1% to 1%): Hypercholesterolemia, fluid retention, appetite increase, lipid disorder

Postmarketing reports: Hyperglycemia, insulin resistance, blood glucose decreased, blood glucose increased, blood cholesterol abnormal, low density lipoprotein increased, blood glucose abnormal^[Ref]

Dermatologic

Common (1% to 10%): Acne, pruritus, rash, skin reaction, skin irritation

Uncommon (0.1% to 1%): Alopecia, allergic dermatitis, eczema, urticaria, photosensitivity, contact dermatitis, erythema

Frequency not reported: Chloasma

Postmarketing reports: Erythema multiforme, erythema nodosum, seborrheic dermatitis, pustular rash, angioedema, exfoliative rash^[Ref]

Hepatic

Rare (less than 0.1%): Cholecystitis, cholelithiasis

Postmarketing reports: Cholestasis, hepatic lesion, cholestatic jaundice^[Ref]

Other

Common (1% to 10%): Fatigue, weight increased, malaise

Uncommon (0.1% to 1%): Edema, peripheral edema

Rare (less than 0.1%): Swelling

Postmarketing reports: Face edema, pitting edema, localized edema^[Ref]

Musculoskeletal

Common (1% to 10%): Muscle spasm^[Ref]

Oncologic

Rare (less than 0.1%): Fibroadenoma of breast, uterine leiomyoma

Postmarketing reports: Breast cancer, cervix carcinoma, hepatic adenoma, hepatic neoplasm, breast mass, cervical dysplasia^[Ref]

Ocular

Postmarketing reports: Contact lens intolerance/complication^[Ref]

Immunologic

Uncommon (0.1% to 1%): Hypersensitivity

Postmarketing reports: Allergic reaction^[Ref]