Ortho Evra (Norelgestromin / Ethinyl Estradiol Transdermal) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

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 (see WARNINGS Section).

• Thrombophlebitis and venous thrombosis with or without embolism
• Arterial thromboembolism
• Pulmonary embolism
• Mycardial 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
• 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
• Allergic reaction, including rash, urticaria and angioedema
• 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-menstral syndrome
• Cataracts
• Changes in appetite
• Cystitis-like syndrome
• Headache
• Nervousness
• Dizziness
• Hirsutism
• Loss of scalp hair
• Erythema multiforme
• Erythema multiforme
• Erythema nodosum
• Hemorrhagic eruption
• Vaginitis
• Porphyria
• Impaired renal function
• Hemolytic uremic syndrome
• Acne
• Change in libido
• Colitis
• Budd-Chiari Syndrome

REPORTS OF SUSPECTED ORTHO EVRA SIDE EFFECTS / ADVERSE REACTIONS

Possible Ortho Evra side effects / adverse reactions in 40 year old female

Reported by a consumer/non-health professional from Portugal on 2011-10-17

Patient: 40 year old female

Reactions: Inappropriate Schedule of Drug Administration, Menstruation Irregular, Tendonitis

Adverse event resulted in: disablity

Suspect drug(s):
Ortho Evra

Other drugs received by patient: Arcoxia; Tizanidine HCL; Ogasto; Adalgur

Possible Ortho Evra side effects / adverse reactions in 15 year old female

Reported by a consumer/non-health professional from Brazil on 2011-10-31

Patient: 15 year old female weighing 45.0 kg (99.0 pounds)

Reactions: OFF Label USE, Visual Impairment

Suspect drug(s):
Ortho Evra

Possible Ortho Evra side effects / adverse reactions in 25 year old female

Reported by a consumer/non-health professional from Brazil on 2011-11-18

Patient: 25 year old female weighing 66.0 kg (145.2 pounds)

Reactions: Anaemia, Vaginal Haemorrhage

Suspect drug(s):
Ortho Evra