Drug Information for Aviane - 28 DAY (levonorgestrel and ethinyl estradiol tablets, USP) (Barr Laboratories Inc.): ADVERSE REACTIONS

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

    Thromboembolic and thrombotic disorders and other vascular problems (including thrombophlebitis and venous thrombosis with or without pulmonary embolism, mesenteric thrombosis, arterial thromboembolism, myocardial infarction, cerebral hemorrhage, cerebral thrombosis), carcinoma of the reproductive organs and breasts, hepatic neoplasia (including hepatic adenomas or benign liver tumors), ocular lesions (including retinal vascular thrombosis), gallbladder disease, carbohydrate and lipid effects, elevated blood pressure, and headache including migraine.

    The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug related (alphabetically listed):

    • Acne
    • Amenorrhea
    • Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms
    • Breast changes: tenderness, pain, enlargement, secretion
    • Budd-Chiari syndrome
    • Cervical erosion and secretion, change in
    • Cholestatic jaundice
    • Chorea, exacerbation of
    • Colitis
    • Contact lenses, intolerance to
    • Corneal curvature (steepening), change in
    • Dizziness
    • Edema/fluid retention
    • Erythema multiforme
    • Erythema nodosum
    • Gastrointestinal symptoms (such as abdominal pain, cramps, and bloating)
    • Hirsutism
    • Infertility after discontinuation of treatment, temporary
    • Lactation, diminution in, when given immediately postpartum
    • Libido, change in
    • Melasma/chloasma which may persist
    • Menstrual flow, change in
    • Mood changes, including depression
    • Nausea
    • Nervousness
    • Pancreatitis
    • Porphyria, exacerbation of
    • Rash (allergic)
    • Scalp hair, loss of
    • Serum folate levels, decrease in
    • Spotting
    • Systemic lupus erythematosus, exacerbation of
    • Unscheduled bleeding
    • Vaginitis, including candidiasis
    • Varicose veins, aggravation of
    • Vomiting
    • Weight or appetite (increase or decrease), change in

    The following adverse reactions have been reported in users of oral contraceptives:

    • Cataracts
    • Cystitis-like syndrome
    • Dysmenorrhea
    • Hemolytic uremic syndrome
    • Hemorrhagic eruption
    • Optic neuritis, which may lead to partial or complete loss of vision
    • Premenstrual syndrome
    • Renal function, impaired
  • Drug Information Provided by National Library of Medicine (NLM).