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Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with the extent of smoking (in epidemiologic studies, 15 or more cigarettes per day was associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from oral contraceptive use. This risk increases with age and with the amount of smoking (15 or more cigarettes per day has been associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should not smoke.

WARNINGS Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with the extent of smoking (in epidemiologic studies, 15 or more cigarettes per day was associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

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): 1. Acne 2. Amenorrhea 3. Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms 4. Breast changes: tenderness, pain, enlargement, secretion 5. Budd-Chiari syndrome 6. Cervical erosion and secretion, change in 7. Cholestatic jaundice 8. Chorea, exacerbation of 9. Colitis 10. Contact lenses, intolerance to 11. Corneal curvature (steepening), change in 12. Dizziness 13. Edema/fluid retention 14. Erythema multiforme 15. Erythema nodosum 16. Gastrointestinal symptoms (such as abdominal pain, cramps, and bloating) 17. Hirsutism 18. Infertility after discontinuation of treatment, temporary 19. Lactation, diminution in, when given immediately postpartum 20. Libido, change in 21. Melasma/chloasma which may persist 22. Menstrual flow, change in 23. Mood changes, including depression 24. Nausea 25. Nervousness 26. Pancreatitis 27. Porphyria, exacerbation of 28. Rash (allergic) 29. Scalp hair, loss of 30. Serum folate levels, decrease in 31. Spotting 32. Systemic lupus erythematosus, exacerbation of 33. Unscheduled bleeding 34. Vaginitis, including candidiasis 35. Varicose veins, aggravation of 36. Vomiting 37. Weight or appetite (increase or decrease), change in The following adverse reactions have been reported in users of oral contraceptives: 1. Cataracts 2. Cystitis-like syndrome 3. Dysmenorrhea 4. Hemolytic uremic syndrome 5. Hemorrhagic eruption 6. Optic neuritis, which may lead to partial or complete loss of vision 7. Premenstrual syndrome 8. Renal function, impaired