Drug Information for FEMCON Fe (norethindrone and ethinyl estradiol tablets,chewable and ferrous fumarate tablets) 0.4 mg / 35 mcg (Warner Chilcott (US), LLC): 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:

    • 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 pain, cramps and bloating)
    • Breakthrough bleeding
    • Spotting
    • Change in menstrual flow
    • Amenorrhea
    • Temporary infertility after discontinuation of treatment
    • Edema/fluid retention
    • Melasma/chloasma which may persist
    • Breast changes: tenderness, pain, enlargement, and secretion
    • Change in weight or appetite (increase or decrease)
    • Change in cervical ectropion and secretion
    • Possible diminution in lactation when given immediately postpartum
    • Cholestatic jaundice
    • Migraine headache
    • Rash (allergic)
    • Mood changes, including depression
    • Vaginitis, including candidiasis
    • Change in corneal curvature (steepening)
    • Intolerance to contact lenses
    • Decrease in serum folate levels
    • Exacerbation of systemic lupus erythematosus
    • Exacerbation of porphyria
    • Exacerbation of chorea
    • Aggravation of varicose veins
    • Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms

    The following adverse reactions have been reported in users of oral contraceptives, and a causal association has been neither confirmed nor refuted:

    • Premenstrual syndrome
    • Cataracts
    • Optic neuritis, which may lead to partial or complete loss of vision
    • Cystitis-like syndrome
    • Headache
    • Nervousness
    • Dizziness
    • Hirsutism
    • Loss of scalp hair
    • Erythema multiforme
    • Erythema nodosum
    • Hemorrhagic eruption
    • Impaired renal function
    • Hemolytic uremic syndrome
    • Budd-Chiari syndrome
    • Acne
    • Changes in libido
    • Colitis
    • Pancreatitis
    • Dysmenorrhea
  • Drug Information Provided by National Library of Medicine (NLM).
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