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Ortho Tri-Cyclen - Patient Info

[Noregestimate/Ethinyl Estradiol]




INFORMATION FOR THE PATIENT

See Patient Labeling printed below.

ADVERSE REACTIONS

An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (See WARNINGS Section).

° 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

The following adverse reactions have been reported in patients receiving oral 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 oral contraceptives and the 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
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