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 |