Drug Information for Junel ™ 21 Day (norethindrone acetate and ethinyl estradiol tablets, USP) Junel ™ Fe28 Day (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets*)*Ferrous fumarate tablets are not USP for dissolution and assay. (BARR LABORATORIES, 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 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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