Common side effects may occur when you start using ORTHO EVRA, but they tend to decrease over time and may gradually disappear. In clinical trials, the most common side effects women experienced were breast symptoms, a reaction of the site of application, headache, nausea, upper respiratory infection, and menstrual cramps. May 17, 2005 - Evra is the one where you stick it on you, like the nicotine patch and leave it. The patch is just like the pill though, if you found no side effects on the. There were women, hundreds of women posting on a support forum who.
Generic Name:ethinyl estradiol / norelgestromin
Medically reviewed by Drugs.com. Last updated on Dec 1, 2018.
- Side Effects
Note: This document contains side effect information about ethinyl estradiol / norelgestromin. Some of the dosage forms listed on this page may not apply to the brand name Ortho Evra.
For the Consumer
Applies to ethinyl estradiol / norelgestromin: transdermal patch extended release
Warning
Transdermal route (Patch, Extended Release)
Cigarette smoking increases the risk of serious cardiovascular side effects from hormonal contraceptive use. This risk increases with age and with the number of cigarettes smoked and is marked in women over 35 years of age. Women who are over 35 years of age and smoke should not use ethinyl estradiol / norelgestromin. A significantly increased risk of venous thromboembolism was found among women aged 15 to 44 years who used ethinyl estradiol / norelgestromin patch compared with oral contraceptives containing 30 to 35 mcg of ethinyl estradiol (EE) and either levonorgestrel or norgestimate. Increased estrogen exposure from the patch may increase the risk of adverse events, including venous thromboembolism, compared with oral contraceptives.
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
- loss of voice
- sneezing
- unusual tiredness or weakness
Incidence not known
- changes in skin color
- chest pain or discomfort
- confusion
- dark urine
- fainting
- inability to speak
- itching
- lack or loss of appetite
- light-colored stools
- lightheadedness
- 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
- 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
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
![Side Side](https://sun9-7.userapi.com/c840427/v840427524/8f3fb/TW1hMcJQxfQ.jpg)
Postmarketing reports: Contact lens intolerance/complication[Ref]
Immunologic
Uncommon (0.1% to 1%): Hypersensitivity
Postmarketing reports: Allergic reaction[Ref]
References
1. 'Product Information. Ortho Evra (ethinyl estradiol-norelgestromin).' Janssen Pharmaceuticals, Titusville, NJ.
2. Cerner Multum, Inc. 'UK Summary of Product Characteristics.' O 0
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.
Related questions
More about Ortho Evra (ethinyl estradiol / norelgestromin)
Consumer resources
Other brands:Xulane
Professional resources
Related treatment guides
Generic Name:ethinyl estradiol and norelgestromin (transdermal) (EH thi nil ESS tra DYE ol and nor ell JESS tro min)
Brand Names:Ortho Evra, Xulane
Brand Names:Ortho Evra, Xulane
Medically reviewed by Drugs.com. Last updated on Feb 4, 2019.
- Overview
The Ortho Evra brand name has been discontinued in the U.S. If generic versions of this product have been approved by the FDA, there may be generic equivalents available.
What is Ortho Evra?
Ortho Evra is a contraceptive skin patch containing a combination of female hormones (ethinyl estradiol and norelgestromin) that prevent ovulation (the release of an egg from an ovary). This medicine also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.
Ortho Evra skin patches are used as contraception to prevent pregnancy.
Ortho Evra may also be used for purposes not listed in this medication guide.
Important information
Your risk of serious blood clot may be higher with the use of Ortho Evra skin patches than with the use of birth control pills.
Using hormonal birth control can increase your risk of blood clots, stroke, or heart attack, especially if you have certain other conditions, or if you are overweight.
Smoking can greatly increase your risk of blood clots, stroke, or heart attack while using Ortho Evra. You should not use Ortho Evra if you smoke and are older than 35 years of age.
You should not use Ortho Evra if you have any of the following conditions: uncontrolled high blood pressure, heart disease, a blood-clotting disorder, diabetic problems with your eyes or kidneys, unusual vaginal bleeding, liver disease or liver cancer, severe migraine headaches, or if you have ever had breast or uterine cancer, a heart attack, a stroke, or a blood clot.
Do not use Ortho Evra if you are pregnant or if you have recently had a baby.
Before taking this medicine
Using Ortho Evra can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is highest during your first year of using birth control. Your risk is also high when you restart this medicine after not using for 4 weeks or longer.
Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Your risk increases the older you are and the more you smoke. You should not use Ortho Evra if you smoke and are over 35 years old.
Do not use Ortho Evra if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before using Ortho Evra.
You should not use Ortho Evra if you have:
- abnormal vaginal bleeding that has not been checked by a doctor;
- history of heart attack, stroke, or blood clot;
- heart problems such as uncontrolled valve disorder, or a rhythm disorder that causes blood clots in the heart;
- an inherited blood-clotting disorder that causes your blood to clot more than normal;
- untreated or uncontrolled high blood pressure;
- problems with your eyes, kidneys or circulation caused by diabetes;
- a history of hormone-related cancer such as breast or uterine cancer;
- liver disease or cancer; or
- severe migraine headaches (with aura, numbness, weakness, or vision changes), especially if you are older than 35.
Your risk of serious blood clot may be higher with the use of Ortho Evra skin patches than with the use of birth control pills.
To make sure Ortho Evra is safe for you, tell your doctor if you have:
- heart disease, high blood pressure;
- a history of depression;
- gallbladder disease;
- diabetes; or
- a history of jaundice caused by pregnancy or birth control pills.
The hormones in Ortho Evra skin patches can pass into breast milk and may harm a nursing baby. This medicine may also slow breast milk production. Do not use if you are breast-feeding a baby.
How should I use Ortho Evra?
Use Ortho Evra patches exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use more skin patches or wear them for longer than recommended by your doctor. You will apply your first patch on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).
Place the Ortho Evra patch on your skin and press it into place firmly for 10 seconds. Make sure the edges stick well. You will wear the patch for a full week.
Apply the Ortho Evra patch to clean, dry skin on any of these areas: the outside of your upper arm, your stomach, your buttocks, or your upper back. Do not apply the patch to skin that is broken or irritated, or to a skin area that may be rubbed by tight clothing (such as a waistband).
Remove the patch and apply a new one on the same day each week for three weeks in a row. At the end of the third week, remove the patch and do not apply a new one for 7 full days. Your period should start during this time Do not allow more than 7 days to pass before starting your next 3-week patch cycle..
Check your Ortho Evra patch every day to make sure it is sticking well. If a patch comes loose or falls off, throw it away and apply a new one. You may need to use back-up birth control, such as condoms or a spermicide, if a patch has been off for more than 24 hours. Follow your doctor's instructions.
You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.
If you need surgery or medical tests or if you will be on bed rest, you may need to stop using Ortho Evra for a short time. Any doctor or surgeon who treats you should know that you are using this medicine.
While using Ortho Evra, you will need to visit your doctor regularly.
After removing a skin patch fold it in half, sticky side in, and throw it away in a place where children and pets cannot get to it. Do not flush a used patch down the toilet.
Store the skin patches at room temperature away from moisture and heat. Do not freeze or refrigerate. Keep each patch in its foil pouch until you are ready to apply it.
Ortho Evra dosing information
Usual Adult Dose for Contraception:
The initial dosage of Ortho Evra patches for contraception is the placement of one patch on the skin of the upper outer arm, or abdomen, or buttocks, weekly for 3 weeks (21 total days), which is to remain in place for 7 days, the fourth week is drug free.
A new Ortho Evra patch is placed on the skin one-week after the last patch was removed. Regardless of withdrawal bleed presence, the new transdermal patch is placed on the skin the same day (at any time) as it was done in the previous cycle.
If an Ortho Evra patch is partially or completed detached for less than 1 day (up to 24 hours), reapply it to the same place or replace it with a new patch immediately. No backup contraception is needed. If this event occurs for more than 1 day (24 hours or more), or if the woman is not sure how long the patch has been detached, she should stop the current contraceptive cycle and start a new cycle immediately by applying a new patch. Backup contraception, such as condoms, spermicide, or diaphragm, must be used for the first week of the new cycle.
In women switching from a combination oral contraceptive, begin use of the patch on the first day of withdrawal bleeding. If there is no withdrawal bleeding within 5 days of the last active (hormone-containing) tablet, pregnancy must be ruled out. If the patch is placed later than the first day of withdrawal bleeding, but within the 7 days from the last oral active tablet, a second method of contraception (non-hormonal) should be added for the first 7 days.
In women with a miscarriage or a complete first trimester abortion, begin use of the patch immediately. An additional method of contraception would not be needed if therapy is started immediately.
In women who choose not to breast-feed after childbirth, begin use of the Ortho Evra patch no sooner than 4 weeks after childbirth. Postpartum women who have not had a period should add a second method of contraception (non-hormonal) for the first 7 days of patch use.
A new Ortho Evra patch is placed on the skin one-week after the last patch was removed. Regardless of withdrawal bleed presence, the new transdermal patch is placed on the skin the same day (at any time) as it was done in the previous cycle.
If an Ortho Evra patch is partially or completed detached for less than 1 day (up to 24 hours), reapply it to the same place or replace it with a new patch immediately. No backup contraception is needed. If this event occurs for more than 1 day (24 hours or more), or if the woman is not sure how long the patch has been detached, she should stop the current contraceptive cycle and start a new cycle immediately by applying a new patch. Backup contraception, such as condoms, spermicide, or diaphragm, must be used for the first week of the new cycle.
In women switching from a combination oral contraceptive, begin use of the patch on the first day of withdrawal bleeding. If there is no withdrawal bleeding within 5 days of the last active (hormone-containing) tablet, pregnancy must be ruled out. If the patch is placed later than the first day of withdrawal bleeding, but within the 7 days from the last oral active tablet, a second method of contraception (non-hormonal) should be added for the first 7 days.
In women with a miscarriage or a complete first trimester abortion, begin use of the patch immediately. An additional method of contraception would not be needed if therapy is started immediately.
In women who choose not to breast-feed after childbirth, begin use of the Ortho Evra patch no sooner than 4 weeks after childbirth. Postpartum women who have not had a period should add a second method of contraception (non-hormonal) for the first 7 days of patch use.
See also:
Ortho Evra dosage information (in more detail)
What happens if I miss a dose?
If you forget to change your Ortho Evra patch at the end of the week, change it as soon as you remember. If it has been 24 hours or longer since your scheduled patch change, apply a new patch and start the cycle over (3 weeks wearing a weekly patch,1 week off). Do not use extra patches to make up the missed dose.
Missing a dose increases your risk of becoming pregnant and you may need to use back-up birth control. Follow the weekly patch schedule closely.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using Ortho Evra?
Do not smoke while using Ortho Evra, especially if you are older than 35 years of age.
Grapefruit and grapefruit juice may interact with ethinyl estradiol and norelgestromin and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.
Avoid using creams, lotions, powders, or other medications on the skin where you apply the patch, or it may not stick to your skin.
Ortho Evra will not protect you from sexually transmitted diseases - including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.
Ortho Evra side effects
Get emergency medical help if you have any signs of an allergic reaction to Ortho Evra skin patches: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using Ortho Evra and call your doctor at once if you have:
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- signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with balance, sudden vision loss;
- signs of a blood clot in the lung - chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
- signs of a blood clot in your leg - pain, swelling, warmth, or redness in one or both legs;
- heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
- liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- a change in the pattern or severity of migraine headaches;
- swelling in your hands, ankles, or feet;
- a breast lump; or
- symptoms of depression - sleep problems, weakness, tired feeling, mood changes.
Common Ortho Evra side effects may include:
- nausea, stomach pain;
- breast tenderness or swelling;
- headache, anxiety, mood changes;
- skin irritation, redness, itching, or swelling where the patch was worn;
- menstrual cramps; or
- irregular vaginal bleeding or spotting.
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 other drugs will affect Ortho Evra?
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Ortho Evra, especially:
- acetaminophen, ascorbic acid (vitamin C);
- antifungal medicine - fluconazole, itraconazole, ketoconazole, voriconazole;
- cholesterol-lowering medicines - atorvastatin, rosuvastatin; or
- HIV or AIDS medicines - atazanavir, etravirine, indinavir.
This list is not complete. Other drugs may interact with Ortho Evra, including prescription and over-the-counter medicines, vitamins, and herbal products. Some drugs can make Ortho Evra less effective, which may result in pregnancy. Not all possible interactions are listed in this medication guide.
See also:
Ortho Evra drug interactions (in more detail)
Further information
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Ortho Evra patches only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Copyright 1996-2019 Cerner Multum, Inc. Version: 10.05.
Related questions
More about Ortho Evra (ethinyl estradiol / norelgestromin)
Consumer resources
Other brands:Xulane