Ortho Evra
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Ortho Evra
Ortho Evra Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Ortho Evra (norelgestromin / ethinyl estradiol) used as contraception to prevent pregnancy. It contains a combination of female hormones. Common side effects include vaginal bleeding between periods (spotting) during the first few months of use. If this bleeding is persistent or unusually heavy, contact your doctor. Nausea, vomiting, headache, redness/irritation at the application site, dizziness, breast tenderness/enlargement, vaginal discomfort/irritation, increased vaginal discharge, missed/irregular periods, acne, or stomach cramping/bloating may occur.
The Ortho Evra system uses a 28-day (four-week) cycle. A new patch is applied the same day each week for three weeks (21 total days). Week Four is patch-free. Withdrawal bleeding is expected during this time. Ortho Evra may interact with acetaminophen, ascorbic acid (vitamin C), bosentan, griseofulvin, prednisolone, theophylline, cyclosporine, St. John's wort, antibiotics, seizure medicines, barbiturates, or medication to treat HIV or AIDS. Tell your doctor all medications and supplements you use. Ortho Evra must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor. If you have just given birth or had a pregnancy loss/abortion after the first 3 months, consult your doctor about birth control, and find out when it is safe to use birth control containing estrogen, such as this medication. The medication from this patch passes into breast milk and may have undesirable effects on the nursing infant. Consult your doctor before breast-feeding.
Our Ortho Evra (norelgestromin / ethinyl estradiol) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Ortho Evra in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using the patches and call your doctor at once if you have any of these serious side effects:
- sudden numbness or weakness, especially on one side of the body;
- sudden severe headache, confusion, problems with vision, speech, or balance;
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- a change in the pattern or severity of migraine headaches;
- upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
- swelling in your hands, ankles, or feet;
- a breast lump; or
- symptoms of depression (sleep problems, weakness, mood changes).
Less serious side effects:
- mild nausea, vomiting, bloating, stomach cramps;
- unusual or unpleasant taste in your mouth;
- breast pain, tenderness, or swelling;
- freckles or darkening of facial skin;
- increased hair growth, loss of scalp hair;
- changes in weight or appetite;
- problems with contact lenses;
- vaginal itching or discharge;
- changes in your menstrual periods, decreased sex drive; or
- headache, nervousness, dizziness, tired feeling.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Ortho Evra (Norelgestromin, Ethinyl Estradiol Transdermal) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Ortho Evra Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: changes in vaginal bleeding (e.g., continuous spotting, sudden heavy bleeding, missed periods), unwanted facial/body hair (hirsutism), dark patches on the skin (melasma), mental/mood changes (e.g., depression, suicidal thoughts, persistent trouble sleeping), swelling of the ankles/feet, weight changes (gain or loss), problem wearing contact lenses.
This medication may rarely cause serious (sometimes fatal) blood clot problems (e.g., thrombosis, pulmonary embolism, stroke, heart attack). The risk for blood clots may be higher for the birth control patch than for the pill. Seek immediate medical attention if you experience: tingling/weakness/numbness in the arms/legs, pain/swelling/warmth in the groin/calf, chest/jaw/left arm pain, confusion, coughing up blood, sudden shortness of breath, sudden dizziness/fainting, weakness on one side of the body, vision problems/changes, slurred speech, sudden severe headaches, headaches that are different from those you may have experienced in the past (e.g., headaches with other symptoms such as vision changes/lack of coordination, existing migraines becoming worse).
Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: lumps in the breast, severe stomach/abdominal/pelvic pain, yellowing eyes/skin, unusual tiredness, dark urine.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Ortho Evra (Norelgestromin, Ethinyl Estradiol Transdermal)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Ortho Evra FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
The following serious adverse reactions with the use of combination hormonal contraceptives, including ORTHO EVRA®, are discussed elsewhere in the labeling:
- Serious cardiovascular events and smoking (see WARNINGS)
- Vascular events, including venous and arterial thromboembolic events (see WARNINGS)
- Liver disease (see WARNINGS and PRECAUTIONS)
Adverse reactions commonly reported by users of combination hormonal contraceptives are:
- Irregular uterine bleeding
- Nausea
- Breast tenderness
- Headache
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to ORTHO EVRA® in 3330 sexually active women (3322 of whom had safety data) who participated in three Phase 3 clinical trials designed to evaluate contraceptive efficacy and safety. These subjects received six or 13 cycles of contraception (ORTHO EVRA® or an oral contraceptive comparator in 2 of the trials). The women ranged in age from 18 to 45 years and were predominantly white (91%).
The most common adverse reactions reported during clinical trials were breast symptoms, headache, application site disorder, nausea, dysmenorrhea and abdominal pain. The most common events leading to discontinuation were application site reaction, breast symptoms (including breast discomfort, engorgement and pain), nausea and/or vomiting, headache and emotional lability.
Adverse drug reactions reported by ≥2.5% of ORTHO EVRA®-treated subjects in these trials are shown in Table 7.
Table 7: Adverse Drug Reactions Reported by ≥ 2.5%
of ORTHO EVRA®-treated
Subjects in Three Phase 3 Clinical Trials
| System/Organ Class* Adverse reaction | ORTHO EVRA® (n=3322) |
| Reproductive system and breast disorders | |
| Breast symptoms† | 22.4% |
| Dysmenorrhea | 7.8% |
| Vaginal bleeding and menstrual disorders† | 6.4% |
| Gastrointestinal disorders | |
| Nausea | 16.6% |
| Abdominal pain† | 8.1% |
| Vomiting | 5.1% |
| Diarrhea | 4.2% |
| Nervous system disorders | |
| Headache | 21.0% |
| Dizziness | 3.3% |
| Migraine | 2.7% |
| General disorders and administration site conditions | |
| Application site disorder† | 17.1% |
| Fatigue | 2.6% |
| Psychiatric disorders | |
| Mood, affect and anxiety disorders† | 6.3% |
| Skin and subcutaneous tissue disorders | |
| Acne | 2.9% |
| Pruritus | 2.5% |
| Infections and infestations | |
| Vaginal yeast infection† | 3.9% |
| Investigations | |
| Weight increased | 2.7% |
| * MedDRA version 10.0 † Represents a bundle of similar terms |
|
Additional adverse drug reactions that occurred in < 2.5 % of ORTHO EVRA® treated subjects in the above clinical trials datasets are:
Gastrointestinal disorders: Abdominal distension
General disorders and administration site conditions: Fluid retention1, malaise
Hepatobiliary disorders: Cholecystitis
Investigations: Blood pressure increased, lipid disorders1
Musculoskeletal and connective tissue disorders: Muscle spasms
Psychiatric disorders: Insomnia, libido decreased, libido increased
Reproductive system and breast disorders: Galactorrhea, genital discharge, premenstrual syndrome, uterine spasm, vaginal discharge, vulvovaginal dryness
Respiratory, thoracic and mediastinal disorders: Pulmonary embolism
Skin and subcutaneous tissue disorders: Chloasma, dermatitis contact, erythema, skin irritation
1Represents a bundle of similar terms
Postmarketing Experience
The following adverse reactions (Table 8) have been identified during postapproval use of ORTHO EVRA®. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Table 8: Alphabetical List of Adverse Drug Reactions
Identified During Postmarketing Experience with ORTHO EVRA®/EVRA® by System Organ Class*
| System Organ Class | Adverse Drug Reactions |
| Cardiac disorders | Myocardial infarction† |
| Endocrine disorders | Hyperglycemia, insulin resistance |
| Eye disorders | Contact lens intolerance or complication |
| Gastrointestinal disorders | Colitis |
| General disorders and administration site conditions | Application site reaction†, edema† |
| Hepatobiliary disorders | Blood cholesterol abnormal, cholelithiasis, cholestasis, hepatic lesion, jaundice cholestatic, low density lipoprotein increased |
| Immune system disorders | Allergic reaction†, urticaria |
| Investigations | Blood glucose abnormal, blood glucose decreased |
| Metabolism and nutrition disorders | Increased appetite |
| Neoplasms benign, malignant and unspecified (Incl cysts and polyps) | Breast cancer†, cervix carcinoma, hepatic adenoma, hepatic neoplasm |
| Nervous system disorders | Dysgeusia, migraine with aura |
| Psychiatric disorders | Anger, emotional disorder, frustration, irritability |
| Reproductive system and breast disorders | Breast mass, cervical dysplasia, fibroadenoma of breast, menstrual disorder†, suppressed lactation, uterine leiomyoma |
| Skin and subcutaneous tissues disorders | Alopecia, eczema, erythema multiforme, erythema nodosum, photosensitivity reaction, pruritus generalized, rash†, seborrheic dermatitis, skin reaction |
| Vascular disorders | Arterial thrombosis†, cerebrovascular accident†, deep vein thrombosis†, hemorrhage intracranial†, hypertension, hypertensive crisis, pulmonary embolism†, thrombosis† |
| * MedDRA version 10.0 † Represents a bundle of similar terms |
|
Read the entire FDA prescribing information for Ortho Evra (Norelgestromin, Ethinyl Estradiol Transdermal) »
Additional Ortho Evra Information
Ortho Evra - User Reviews
Ortho Evra User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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