Reclipsen (Desogestrel / Ethinyl Estradiol) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (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

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 the 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