ADVERSE REACTIONS
The most common adverse events reported by 5 to 14% of women using NuvaRing® in clinical trials (n=2501) were the following: vaginitis, headache, upper respiratory tract infection, leukorrhea, sinusitis, weight gain, and nausea.
The most frequent system-organ class adverse events leading to discontinuation in 1 to 2.5% of women using NuvaRing® in the trials included the following: device related events (foreign body sensation, coital problems, device expulsion), vaginal symptoms (discomfort/vaginitis/leukorrhea), headache, emotional lability, and weight gain.
Listed below are adverse reactions that have been associated with the use of combination hormonal contraceptives. These are also likely to apply to combination vaginal hormonal contraceptives, such as NuvaRing®.
An increased risk of the following serious adverse reactions has been associated with the use of combination hormonal contraceptives (see CONTRAINDICATIONS and WARNINGS):
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Thrombophlebitis and venous thrombosis with or without embolism
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Arterial thromboembolism
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Pulmonary embolism
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Myocardial infarction
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Cerebral hemorrhage
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Cerebral thrombosis
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Hypertension
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Gallbladder disease
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Hepatic adenomas or benign liver tumors
There is evidence of an association between the following conditions and the use of combination hormonal contraceptives:
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Mesenteric thrombosis
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Retinal thrombosis
The following additional adverse reactions have been reported in users of combination hormonal contraceptives and are believed to be drug-related:
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Nausea
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Vomiting
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Gastrointestinal symptoms (such as abdominal cramps and bloating)
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Breakthrough bleeding
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Spotting
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Change in menstrual flow
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Amenorrhea
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Temporary infertility after discontinuation of treatment
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Edema
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Melasma which may persist
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Breast changes: tenderness, enlargement, secretion
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Change in weight (increase or decrease)
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Change in cervical erosion and secretion
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Diminution in lactation when given immediately postpartum
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Cholestatic jaundice
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Migraine
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Rash (allergic)
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Mental depression
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Reduced tolerance to carbohydrates
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Vaginal candidiasis
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Change in corneal curvature (steepening)
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Intolerance to contact lenses
The following additional adverse reactions have been reported in users of combination hormonal contraceptives and a causal association has been neither confirmed nor refuted:
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Pre-menstrual syndrome
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Cataracts
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Changes in appetite
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Cystitis-like syndrome
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Headache
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Nervousness
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Dizziness
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Hirsutism
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Loss of scalp hair
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Erythema multiforme
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Erythema nodosum
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Hemorrhagic eruption
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Vaginitis
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Porphyria
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Impaired renal function
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Hemolytic uremic syndrome
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Acne
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Changes in libido
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Colitis
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Budd-Chiari Syndrome
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