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.

Side Effects of Ortho Evra - for the Consumer

Ortho Evra Patch

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 Patch:

Breast tenderness or enlargement; headache; menstrual cramps; mild skin irritation at the application site; nausea; stomach pain, cramps, or bloating; vaginal spotting or breakthrough bleeding; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Ortho Evra Patch:

Severe 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 (eg, double vision, loss of vision); chest pain; confusion; coughing up blood; fainting; mental or mood changes (eg, depression, memory loss); pain, swelling, or tenderness in the stomach; severe headache or vomiting; severe or persistent dizziness; severe or persistent trouble sleeping; severe or persistent vaginal bleeding; slurred speech; sudden shortness of breath; swelling of the hands or feet; symptoms of liver problems (eg, yellowing of the skin or eyes, fever, dark urine, pale stools, loss of appetite); unusual tiredness or weakness; unusual vaginal discharge, itching, or odor; weakness or numbness of an arm or leg.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Ortho Evra Side Effects - for the Professional

Ortho Evra

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
• Vascular events, including venous and arterial thromboembolic events
• Liver disease

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)
* MedDRA version 10.0 † Represents a bundle of similar terms
Reproductive system and breast disorders Breast symptoms† Dysmenorrhea Vaginal bleeding and menstrual disorders†	22.4% 7.8% 6.4%
Gastrointestinal disorders Nausea Abdominal pain† Vomiting Diarrhea	16.6% 8.1% 5.1% 4.2%
Nervous system disorders Headache Dizziness Migraine	21.0% 3.3% 2.7%
General disorders and administration site conditions Application site disorder† Fatigue	17.1% 2.6%
Psychiatric disorders Mood, affect and anxiety disorders†	6.3%
Skin and subcutaneous tissue disorders Acne Pruritus	2.9% 2.5%
Infections and infestations Vaginal yeast infection†	3.9%
Investigations Weight increased	2.7%

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

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1

Represents 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
* MedDRA version 10.0 † Represents a bundle of similar terms
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†

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Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

Gastrointestinal side effects reported by 9% to 22% of women in clinical trials (n=3330) have included nausea, and abdominal pain. Nausea and vomiting led to therapy discontinuation in 1% to 2.4% of women. Side effects reported in connection with the use of combination hormonal contraceptives in general have included gastrointestinal cramps and bloating, nausea, and vomiting.

Respiratory

Respiratory side effects reported by 9% to 22% of women in clinical trials (n=3330) have included upper respiratory infection.

Local

Local side effects reported by 9% to 22% of women in clinical trials (n=3330) have included application site reaction. This side effect led to therapy discontinuation in 1% to 2.4% of women.

Nervous system

Nervous system side effects reported by 9% to 22% of women in clinical trials (n=3330) have included headache. Emotional lability and headache led to therapy discontinuation in 1% to 2.4% of women. Side effects reported in connection with the use of combination hormonal contraceptives in general have included migraine headaches.

Psychiatric

Psychiatric side effects reported in connection with the use of combination hormonal contraceptives in general have included mental depression.

Genitourinary

Genitourinary side effects reported by 9% to 22% of women in clinical trials (n=3330) have included menstrual cramps. Side effects reported in connection with the use of combination hormonal contraceptives in general have included change in menstrual flow, spotting, breakthrough bleeding, amenorrhea, temporary infertility after discontinuation of treatment, change in cervical erosion and secretion, and vaginal candidiasis.

General

General side effects reported by 9% to 22% of women in clinical trials (n=3330) have included breast symptoms. Breast symptoms led to therapy discontinuation in 1% to 2.4% of women. Side effects reported in connection with the use of combination hormonal contraceptives in general have included diminution in lactation when given immediately postpartum, and breast changes, such as tenderness, enlargement, and secretion.

Metabolic

Metabolic side effects reported in connection with the use of combination hormonal contraceptives in general have included edema, changes in weight, and reduced tolerance to carbohydrates.

Dermatologic

Dermatologic side effects reported in connection with the use of combination hormonal contraceptives in general have included persistent melasma.

Ocular

Ocular side effects reported in connection with the use of combination hormonal contraceptives in general have included intolerance to contact lenses and changes in corneal curvature.

Hepatic

Hepatic side effects reported in connection with the use of combination hormonal contraceptives in general have included cholestatic jaundice.

Hypersensitivity

Hypersensitivity side effects reported in connection with the use of combination hormonal contraceptives in general have included rash (allergic).

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