Drug Information for Loestrin 24 Fe (Warner Chilcott (US), LLC): ADVERSE REACTIONS

The most common adverse events reported by 2 - 6% of the 743 women using Loestrin 24 Fe were the following, in order of decreasing incidence: headache, vaginal candidiasis, upper respiratory infection, nausea, menstrual cramps, breast tenderness, sinusitis, vaginitis (bacterial), abnormal cervical smear, acne, urinary tract infection, mood swings, weight gain, vomiting, and metrorrhagia.

Among the 743 women using Loestrin 24 Fe, 46 women (6.2%) withdrew because of an adverse event. Adverse events occurring in 3 or more subjects leading to discontinuation of treatment were, in decreasing order: abnormal bleeding (0.9%), nausea (0.8%), menstrual cramps (0.4%), increased blood pressure (0.4%), and irregular bleeding (0.4%).

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 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, 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 a causal association has been neither confirmed nor refuted:

• Acne
• Budd-Chiari syndrome
• Cataracts
• Colitis
• Changes in libido
• Cystitis-like syndrome
• Dizziness
• Dysmenorrhea
• Erythema multiforme
• Erythema nodosum
• Headache
• Hemorrhagic eruption
• Hemolytic uremic syndrome
• Hirsutism
• Impaired renal function
• Loss of scalp hair
• Nervousness
• Optic neuritis, which may lead to partial or complete loss of vision
• Pancreatitis
• Premenstrual syndrome