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Trivora (Levonorgestrel / Ethinyl Estradiol / Levonorgestrel / Ethinyl Estradiol / Levonorgestrel / Ethinyl Estradiol) - Side Effects and Adverse Reactions

 
 



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 disorders and other vascular problems (including thrombophlebitis, arterial thromboembolism, pulmonary embolism, myocardial infarction, cerebral hemorrhage, cerebral thrombosis), carcinoma of the reproductive organs, 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.

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 pain, 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, pain, enlargement, secretion.
Change in weight or appetite (increase or decrease).
Change in cervical erosion and secretion.
Diminution in lactation when given immediately postpartum.
Cholestatic jaundice.
Rash (allergic).
Mood changes, including depression.
Vaginitis, including candidiasis.
Change in corneal curvature (steepening).
Intolerance to contact lenses.
Mesenteric thrombosis.
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:

Congenital anomalies.
Premenstrual syndrome.
Cataracts.
Optic neuritis, which may lead to partial or complete loss of vision.
Cystitis-like syndrome.
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.
Sickle-cell disease.
Cerebral-vascular disease with mitral valve prolapse.
Lupus-like syndromes.
Pancreatitis.
Dysmenorrhea.

Drug label data at the top of this Page last updated: 2007-04-02

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