Ortho Evra Side Effects
Please note - some side effects for Ortho Evra may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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Side Effects of Ortho Evra - for the consumer
Ortho Evra
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ortho Evra:
Seek medical attention right away if any of these SEVERE side effects occur when using Ortho Evra:Breast tenderness or enlargement; headache; menstrual cramps; nausea; stomach pain, cramps, or bloating; vaginal spotting or breakthrough bleeding; vomiting.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast lumps; breast pain; calf pain, swelling, or tenderness; changes in vision or speech (eg, loss of vision); chest pain; coughing of blood; mental/mood changes (eg, depression, memory loss); pain, swelling, or tenderness in the stomach; severe headache or vomiting; severe or persistent vaginal bleeding; sudden shortness of breath; swelling of hands or feet; unusual vaginal discharge, itching, or odor; weakness or numbness of an arm or leg; yellowing of the skin or eyes.
For the professional
Ortho Evra
The most common adverse events reported by 9 to 22% of women using ORTHO EVRA® in clinical trials (N= 3,330) were the following, in order of decreasing incidence: breast symptoms, headache, application site reaction, nausea, upper respiratory infection, menstrual cramps, and abdominal pain.
The most frequent adverse events leading to discontinuation in 1 to 2.4% of women using ORTHO EVRA® in the trials included the following: nausea and/or vomiting, application site reaction, breast symptoms, headache, and emotional lability.
Listed below are adverse events that have been associated with the use of combination hormonal contraceptives. These are also likely to apply to combination transdermal hormonal contraceptives such as ORTHO EVRA®.
An increased risk of the following serious adverse reactions has been associated with the use of combination hormonal contraceptives.
- Thrombophlebitis and venous thrombosis with or without embolism
- Arterial thromboembolism
- Pulmonary embolism
- Myocardial infarction
- Cerebral hemorrhage
- Cerebral thrombosis
- Hypertension
- Gallbladder disease
- Hepatic adenomas or benign liver tumors
There is evidence of an association between the following conditions and the use of combination hormonal contraceptives:
- Mesenteric thrombosis
- Retinal thrombosis
The following adverse reactions have been reported in users of combination hormonal contraceptives and are believed to be drug-related:
- Nausea
- Vomiting
- Gastrointestinal symptoms (such as abdominal cramps and bloating)
- Breakthrough bleeding
- Spotting
- Change in menstrual flow
- Amenorrhea
- Temporary infertility after discontinuation of treatment
- Edema
- Melasma which may persist
- Breast changes: tenderness, enlargement, secretion
- Change in weight (increase or decrease)
- Change in cervical erosion and secretion
- Diminution in lactation when given immediately postpartum
- Cholestatic jaundice
- Migraine
- Rash (allergic)
- Mental depression
- Reduced tolerance to carbohydrates
- Vaginal candidiasis
- Change in corneal curvature (steepening)
- Intolerance to contact lenses
The following adverse reactions have been reported in users of combination hormonal contraceptives and a cause and effect association has been neither confirmed nor refuted:
- Pre-menstrual syndrome
- Cataracts
- Changes in appetite
- Cystitis-like syndrome
- Headache
- Nervousness
- Dizziness
- Hirsutism
- Loss of scalp hair
- Erythema multiforme
- Erythema nodosum
- Hemorrhagic eruption
- Vaginitis
- Porphyria
- Impaired renal function
- Hemolytic uremic syndrome
- Acne
- Changes in libido
- Colitis
- Budd-Chiari Syndrome
More resources:
Ortho Evra - Includes detailed dosage instructions.
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