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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 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

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
• Decrease in serum folate levels
• Exacerbation of porphyria
• Aggravation of varicose veins
• 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
• Exacerbation of systemic lupus erythematosus
• Exacerbation of chorea
• 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 the association has been neither confirmed nor refuted:

• Pre-menstrual syndrome
• Cataracts
• Cystitis-like syndrome
• Headache
• Nervousness
• Dizziness
• Hirsutism
• Loss of scalp hair
• Erythema multiforme
• Dysmenorrhea
• Pancreatitis
• Erythema nodosum
• Hemorrhagic eruption
• Impaired renal function
• Hemolytic uremic syndrome
• Acne
• Changes in libido
• Colitis
• Budd-Chiari Syndrome
• Optic neuritis, which may lead to partial or complete loss of vision