Drug Information for PHYSICIAN LABELING Quasense (Levonorgestrel and Ethinyl Estradiol Tablets USP) 0.15 mg/0.03 mg (91-Day Regimen) Rx only (Watson Pharma, Inc.): ADVERSE REACTIONS

An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS section):

• Thrombophlebitis

• 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 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, enlargement, and secretion

• 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

• Decrease in serum folate levels

• Exacerbation of systemic lupus erythematosus

• Exacerbation of porphyria

• Exacerbation of chorea

• Aggravation of varicose veins

• 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:

• Premenstrual syndrome

• Cataracts

• Optic neuritis which may lead to partial or complete loss of vision

• Cystitis-like syndrome

• Headache

• Nervousness

• Dizziness

• Hirsutism

• Loss of scalp hair

• Erythema multiforme

• Erythema nodosum

• Hemorrhagic eruption

• Impaired renal function

• Hemolytic uremic syndrome

• Budd-Chiari syndrome

• Acne

• Changes in libido

• Colitis

• Pancreatitis

• Dysmenorrhea