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.
boxed warning
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.
boxed warning
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.
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings
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): 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