Oral contraceptives are indicated for use by women to prevent pregnancy. Oral contraceptives do not protect
against HIV infection (AIDS) and other sexually transmitted diseases.
IMPORTANT SAFETY INFORMATION
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
Cigarette smoking increases the risk of serious cardiovascular events from oral contraceptive use. This risk
increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For
this reason, oral contraceptives should not be used by women who are over 35 years of age and smoke.
Do not prescribe oral contraceptives to women who are known to have the following conditions:
- A high risk of arterial or venous thrombotic diseases. Examples include women who are known to smoke, if
over age 35, or women who have: deep vein thrombosis or pulmonary embolism, now or in the past;
cerebrovascular disease; coronary artery disease; thrombogenic valvular or thrombogenic rhythm diseases of the
heart; inherited or acquired hypercoagulopathies; uncontrolled hypertension; diabetes with vascular disease;
or headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35.
- Liver tumors, benign or malignant, or liver disease.
- Renal impairment or adrenal insufficiency.
- Undiagnosed abnormal uterine bleeding.
- Pregnancy, because there is no reason to use oral contraceptives during pregnancy.
- Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past.
- Hypersensitivity to any component of the oral contraceptive product.
- Use of Hepatitis C drug combinations containing ombitasavir/paritaprevir/ritonavori, with or without dasabuvir, due to the potential for ALT elevations
Serious adverse reactions associated with the use of oral contraceptives include thrombophlebitis; arterial
thromboembolism; pulmonary embolism; myocardial infarction; cerebral hemorrhage; cerebral thrombosis;
hypertension; gallbladder disease; hepatic adenomas or benign liver tumors; liver enzyme elevations with concomitant hepatitis C treatment; hyperkalemia; carbohydrate and lipid
metabolic effects; ectopic pregnancy; delayed follicular atresia/ovarian cysts; carcinoma of the breast and
reproductive organs; genital bleeding irregularities; and onset of or change in migraine/headache.
Common adverse reactions reported for oral contraceptives include menstrual irregularities or disorders;
irregular uterine bleeding; nausea; vomiting; breast pain, tenderness or discomfort; headache; migraine; vaginal
infection; genital discharge; weight changes (increased or decreased); abdominal pain, tenderness or discomfort;
anxiety symptoms; depression or mood changes or disorders; acne; fatigue; irritability; decreased libido; affect
lability; flatulence, nervousness, and rash.
Before prescribing any oral contraceptive on this chart, please read the accompanying full Prescribing
Information for the specific product.