Medical Editor: John P. Cunha, DO, FACOEP
What Is Ortho Evra?
Ortho Evra (norelgestromin/ethinyl estradiol) contains a combination of female hormones used as contraception to prevent pregnancy.
What Are Side Effects of Ortho Evra?
Ortho Evra may cause serious side effects including:
- hives,
- difficulty breathing,
- swelling of your face, lips, tongue, or throat,
- sudden numbness or weakness (especially on one side of the body),
- sudden severe headache,
- slurred speech,
- problems with vision or balance,
- sudden vision loss,
- stabbing chest pain,
- shortness of breath,
- coughing up blood,
- pain or warmth in one or both legs,
- chest pain or pressure,
- pain spreading to your jaw or shoulder,
- nausea,
- sweating,
- loss of appetite,
- upper stomach pain,
- tiredness,
- dark urine,
- clay-colored stools,
- yellowing of the skin or eyes (jaundice),
- severe headache,
- pounding in your neck or ears,
- change in the pattern or severity of migraine headache,
- swelling in your hands, ankles, or feet,
- breast lump,
- sleep problems,
- weakness,
- tired feeling, and
- mood changes
Get medical help right away, if you have any of the symptoms listed above.
Common side effects of Ortho Evra include vaginal bleeding between periods (spotting) during the first few months of use. If this bleeding is persistent or unusually heavy, contact your doctor. Other side effects of Ortho Evra include:
- nausea (especially when you first start taking Ortho Evra),
- vomiting,
- headache,
- redness/irritation at the application site,
- dizziness,
- breast tenderness/enlargement/swelling,
- nipple discharge,
- vaginal discomfort/irritation/itching,
- increased vaginal discharge,
- missed/irregular menstrual periods,
- acne,
- stomach cramping,
- bloating,
- freckles or darkening of facial skin,
- increased hair growth,
- loss of scalp hair,
- changes in weight or appetite,
- problems with contact lenses, or
- decreased sex drive.
Tell your doctor if you have any serious side effects of Ortho Evra including:
- lumps in the breast,
- mental/mood changes (such as new or worsening depression),
- severe stomach or abdominal pain,
- dark urine, or
- yellowing eyes or skin.
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Ortho Evra
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.
What Drugs, Substances, or Supplements Interact with Ortho Evra?
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 During Pregnancy or Breastfeeding
Ortho Evra must not be used during pregnancy. If you become pregnant or think you may be pregnant while using Ortho Evra, 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 Ortho Evra. The medication from the Ortho Evra patch passes into breast milk and may have undesirable effects on the nursing infant. Consult your doctor before breastfeeding.
Additional Information
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.
SLIDESHOW
Choosing Your Birth Control Method See SlideshowGet emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using this medicine and call your doctor at once if you have:
- signs of a stroke--sudden numbness or weakness (especially on one side of the body), severe headache, problems with vision or speech;
- signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, swelling or pain in an arm or leg;
- heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
- severe headache, pounding in your neck or ears;
- jaundice (yellowing of the skin or eyes);
- swelling in your hands, ankles, or feet;
- a change in the pattern or severity of migraine headaches; or
- symptoms of depression--sleep problems, weakness, tired feeling, mood changes.
Common side effects may include:
- breast pain or swelling;
- nausea;
- menstrual cramps, breakthrough bleeding;
- headache, anxiety, mood changes; or
- skin reactions where a patch was worn--redness, irritation, itching, rash, pain, or swelling.
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.
QUESTION
Which of the following are methods for contraception? See AnswerSIDE 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 stroke [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
- Vascular events, including venous and arterial thromboembolic events [see WARNINGS AND PRECAUTIONS]
- 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 clinical 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 ( ≥ 5%) reported during clinical trials were breast symptoms, nausea/vomiting, headache, application site disorder, abdominal pain, dysmenorrhea, vaginal bleeding and menstrual disorders, and mood, affect and anxiety disorders. 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 3.
Table 3: 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 symptomsf | 22.4% |
| Dysmenorrhea | 7.8% |
| Vaginal bleeding and menstrual disordersf | 6.4% |
| Gastrointestinal disorders | |
| Nausea | 16.6% |
| Abdominal painf | 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
Postmarketing Experience
The following adverse reactions (Table 4) 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 4: 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 infarctiont |
| Endocrine disorders | Hyperglycemia, insulin resistance |
| Eye disorders | Contact lens intolerance or complication |
| Gastrointestinal disorders | Colitis |
| General disorders and administration site conditions | Application site reaction†, edemat† |
| 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, rasht, seborrheic dermatitis, skin reaction |
| Vascular disorders | Arterial thrombosis† cerebrovascular accident† deep vein thrombosis†, hemorrhage intracranial†, hypertension, hypertensive crisis, pulmonary embolism† thrombosist |
| * MedDRA version 10.0 † Represents a bundle of similar terms |
|
REFERENCES
1Represents a bundle of similar terms
Read the entire FDA prescribing information for Ortho Evra (Norelgestromin, Ethinyl Estradiol Transdermal)
© Ortho Evra Patient Information is supplied by Cerner Multum, Inc. and Ortho Evra Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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