Indicated for use by women to prevent pregnancy.

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke.

If feasible, stop Yasmin at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism.

Start Yasmin no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.

COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes), although, in general, the risk is greatest among older (>35 years of age), hypertensive women who also smoke. COCs also increase the risk for stroke in women with other underlying risk factors.

Based on presently available information on Yasmin, DRSP-containing COCs may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing the progestin levonorgestrel or some other progestins.

Oral contraceptives must be used with caution in women with cardiovascular disease risk factors.

Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while taking COCs.

Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs.

Carefully monitor prediabetic and diabetic women who are taking Yasmin. COCs may decrease glucose tolerance in a dose-related fashion.

Consider alternative contraception for women with uncontrolled dyslipidemia. A small proportion of women will have adverse lipid changes while on COCs.

Women with a history of depression should be carefully observed and Yasmin discontinued if depression recurs to a serious degree.

Yasmin is contraindicated in females who are known to have or develop the following conditions:

• Renal impairment
• Adrenal insufficiency
• A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: Smoke, if over age 35
• Have deep vein thrombosis or pulmonary embolism, now or in the past
• Have cerebrovascular disease
• Have coronary artery disease
• Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation)
• Have inherited or acquired hypercoagulopathies
• Have uncontrolled hypertension
• Have diabetes mellitus with vascular disease
• Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35
• Undiagnosed abnormal uterine bleeding
• Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive
• Liver tumor (benign or malignant) or liver disease
• Pregnancy, because there is no reason to use COCs during pregnancy
• Use of Hepatitis C drug combinations containing ombitasvir, paritaprevir/ritonavir, with or without dasabuvir due to the potential for ALT elevations 

Stop Yasmin if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions.

Studies suggest a small increased relative risk of developing gallbladder disease among COC users.

Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the effectiveness of COCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampin, topiramate and products containing St. John’s wort.

Concomitant administration of moderate or strong CYP3A4 inhibitors such as azole antifungals (e.g., ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (e.g., clarithromycin, erythromycin), diltiazem, and grapefruit juice can increase the plasma concentrations of the estrogen or the progestin or both.

Significant changes (increase or decrease) in the plasma concentrations of estrogen and progestin have been noted in some cases of co-administration with HIV/HCV protease inhibitors or with non-nucleoside reverse transcriptase inhibitors.

COCs significantly decrease plasma concentrations of lamotrigine, likely due to induction of lamotrigine glucuronidation.

There is a potential for an increase in serum potassium concentration in women taking Yasmin with other drugs that may increase serum potassium concentration.

Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation.

Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because serum concentration of thyroid-binding globulin increases with use of COCs.

There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids.

When possible, advise the nursing mother to use other forms of contraception until she has weaned her child.

Estrogen-containing COCs can reduce milk production in breastfeeding mothers. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk. 

GoToSource

• Polycystic ovary syndrome. GoToSource

• Acne. GoToSource

• Premenstrual dysphoric disorder. GoToSource

• Hirsutism. GoToSource 

• Bulimia nervosa. GoToSource

Deep vein thrombosis (blood clot forms in deep veins in body) and pulmonary embolism (blockage of  artery in lungs). GoToSource

Gallbladder disease. GoToSource

Myocardial infarction and ischemic stroke. GoToSource

Hyperkalemia (high blood potassium level). GoToSource

Increased triglyceride levels. GoToSource

Pancreatitis (inflammation of pancreas). GoToSource

Increased risk of breast cancer. GoToSource

Weight gain, migraines and depression. GoToSource

Lawsuits filed for heart attacks, strokes, deep vein thrombosis, pulmonary embolism, blood clots, abnormal heart rhythm, gallbladder injury, pancreatitis and death.