Drug Information for WATSON PHARMARevised: June 2005IN-5260/SPHYSICIAN LABELING Brevicon (Norethindrone and Ethinyl Estradiol Tablets USP, 0.5 mg/0.035 mg) Norinyl 1+35 (Norethindrone and Ethinyl Estradiol Tablets USP, 1 mg/0.035 mg) Norinyl 1+50 (Norethindrone and Mestranol Tablets USP, 1 mg/0.05 mg) Rx Only (Watson Pharma, Inc.): ADVERSE REACTIONS

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  • An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS section):

    • Thrombophlebitis

    • Arterial thromboembolism

    • Pulmonary embolism

    • Myocardial infarction

    • Cerebral hemorrhage

    • Cerebral thrombosis

    • Hypertension

    • Gallbladder disease

    • Hepatic adenomas, carcinomas or benign liver tumors

    There is evidence of an association between the following conditions and the use of oral contraceptives, although additional confirmatory studies are needed:

    • Mesenteric thrombosis

    • Retinal thrombosis

    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

    • Budd-Chiari syndrome

    • Acne

    • Changes in libido

    • Colitis

  • Drug Information Provided by National Library of Medicine (NLM).
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