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Ortho-Novum - Side Effects & Drug Interactions

[Norethindrone/Ethinyl Estradiol]




ADVERSE REACTIONS

An increased risk of the following serious adverse reactions has been associated with the use of oral contra-ceptives
(See WARNINGS Section).

° Thrombophlebitis and venous thrombosis with or without embolism
° 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
° Melasma which may persist
° Breast changes: tenderness, enlargement, secretion
° Change in weight (increase or decrease)
° Change in cervical erosion and secretion
° Diminution in lactation when given immediately postpartum
° Cholestatic jaundice
° Migraine
° Rash (allergic)
° Mental depression
° Reduced tolerance to carbohydrates
° Vaginal candidiasis
° Change in corneal curvature (steepening)
° Intolerance to contact lenses

The following adverse reactions have been reported in users of oral contraceptives and a causal association
has been neither confirmed nor refuted:

° Pre-menstrual syndrome
° Cataracts
° Changes in appetite
° Cystitis-like syndrome
° Headache
° Nervousness
° Dizziness
° Hirsutism
° Loss of scalp hair
° Erythema multiforme
° Erythema nodosum
° Hemorrhagic eruption
° Vaginitis
° Porphyria
° Impaired renal function
° Hemolytic uremic syndrome
° Acne
° Changes in libido
° Colitis
° Budd-Chiari Syndrome
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