Note: This document contains side effect information about ethinyl estradiol / norelgestromin. Some dosage forms listed on this page may not apply to the brand name Ortho Evra.
Applies to ethinyl estradiol / norelgestromin: transdermal patch extended release.
Warning
Transdermal route (Patch, Extended Release)
Cardiovascular Risk Associated with Smoking, Risk of Venous Thromboembolism, and Pharmacokinetic Profile of Ethinyl EstradiolWomen over 35 years old who smoke should not use norelgestromin and ethinyl estradiol transdermal system.Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptives (CHC) use.There may be an increased risk of venous thromboembolism (VTE) among women who use the norelgestromin and ethinyl estradiol transdermal system compared to women who used certain oral contraceptives.The pharmacokinetic (PK) profile of ethinyl estradiol (EE) for the norelgestromin and ethinyl estradiol transdermal system is different from the PK profile for oral contraceptives in that it has a higher areas under the time-concentration curve, steady state concentrations and lower peak concentrations.
Serious side effects of Ortho Evra
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 of Ortho Evra
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]
