"If you do not want to get pregnant, there are many birth control options to choose from. No one product is best for everyone. The only sure way to avoid pregnancy and sexually transmitted infections (STIs or STDs) is not to have any sexual"...
Ortho Evra Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Ortho Evra (norelgestromin/ethinyl estradiol) contains a combination of female hormones used as contraception to prevent pregnancy. 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.
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; difficult 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 and 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;
- sudden cough, wheezing, rapid breathing, coughing up blood;
- pain, swelling, warmth, or redness in one or both legs;
- a change in the pattern or severity of migraine headaches;
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- swelling in your hands, ankles, or feet;
- a breast lump; or
- symptoms of depression (sleep problems, weakness, tired feeling, mood changes).
Less serious side effects may include:
- mild nausea (especially when you first start taking this medicine), vomiting, bloating, stomach cramps;
- breast tenderness or swelling, nipple discharge;
- 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; or
- changes in your menstrual periods, decreased sex drive.
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.
This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.
Tell your doctor right away if you have any serious side effects, including: lumps in the breast, mental/mood changes (such as new/worsening depression), severe stomach/abdominal pain, unusual changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding, missed periods), dark urine, yellowing eyes/skin.
This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as deep vein thrombosis, heart attack, pulmonary embolism, stroke). Get medical help right away if any of these side effects occur: chest/jaw/left arm pain, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, slurred speech, sudden shortness of breath/rapid breathing, unusual headaches (including headaches with vision changes/lack of coordination, worsening of migraines, sudden/very severe headaches), unusual sweating, weakness on one side of the body, vision problems/changes (such as double vision, partial/complete blindness).
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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
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
- Breast tenderness
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
|ORTHO EVRA (n=3322)|
|Reproductive system and breast disorders|
|Vaginal bleeding and menstrual disordersf||6.4%|
|Nervous system disorders|
|General disorders and administration site conditions|
|Application site disorder†||17.1%|
|Mood, affect and anxiety disorders†||6.3%|
|Skin and subcutaneous tissue disorders|
|Infections and infestations|
|Vaginal yeast infection†||3.9%|
|* 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
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
|System Organ Class||Adverse Drug Reactions|
|Cardiac disorders||Myocardial infarctiont|
|Endocrine disorders||Hyperglycemia, insulin resistance|
|Eye disorders||Contact lens intolerance or complication|
|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
1Represents a bundle of similar terms
Read the entire FDA prescribing information for Ortho Evra (Norelgestromin, Ethinyl Estradiol Transdermal)
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