Nuvaring (Etonogestrel / Ethinyl Estradiol Vaginal Ring) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

The most common adverse events reported by five to 14% of women using NuvaRing® in clinical trials (n=2501) were the following: vaginitis, headache, upper respiratory tract infection, vaginal secretion, sinusitis, weight gain, and nausea.

The most frequent system-organ class adverse events leading to discontinuation in one 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/vaginal secretion), 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):

Thrombophlebitis and venous thrombosis with or without embolismCerebral hemorrhageCerebral thrombosisHypertensionArterial thromboembolismGallbladder diseasePulmonary embolismMyocardial infarctionHepatic adenomas or benign liver tumors

There is evidence of an association between the following conditions and the use of combination hormonal contraceptives:

Mesenteric thrombosisRetinal thrombosis

The following additional adverse reactions have been reported in users of combination hormonal contraceptives and are believed to be drug-related:

• Nausea
• Change in weight or appetite (increase or decrease)
• Vomiting
• Change in cervical ectropion and secretion
• Gastrointestinal symptoms (such as abdominal pain, cramps and bloating)
• Possible diminution in lactation when given immediately postpartum
• Breakthrough bleeding
• Cholestatic jaundice
• Spotting
• Migraine headache
• Change in menstrual flow
• Rash (allergic)
• Amenorrhea
• Mood changes, including depression
• Temporary infertility after discontinuation of treatment
• Vaginitis, including candidiasis
• Edema/fluid retention
• Change in corneal curvature (steepening)
• Melasma/chloasma which may persist
• Breast changes: tenderness, pain enlargement, and secretion
• 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 additional adverse reactions have been reported in users of combination hormonal contraceptives and a causal association has been neither confirmed nor refuted:

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

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO NUVARING

Possible Nuvaring side effects / adverse reactions in 22 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2007-01-03

Patient: 22 year old female weighing 53.5 kg (117.8 pounds)

Reactions: Fatigue, Mood Altered, Anger, Depression, Somnolence, Asthenia, Metrorrhagia

Suspect drug(s):
Nuvaring

Possible Nuvaring side effects / adverse reactions in 33 year old female

Reported by a consumer/non-health professional from United States on 2007-01-03

Patient: 33 year old female weighing 68.5 kg (150.7 pounds)

Reactions: Vein Disorder, Pain, Pulmonary Embolism, Deep Vein Thrombosis

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Nuvaring

Possible Nuvaring side effects / adverse reactions in 27 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2007-01-16

Patient: 27 year old female

Reactions: Pulmonary Embolism

Adverse event resulted in: hospitalization

Suspect drug(s):
Nuvaring