NuvaRing Side Effects

Please note - some side effects for NuvaRing may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of NuvaRing - for the Consumer

NuvaRing Ring

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using NuvaRing Ring:

Breast tenderness or enlargement; change in appetite; changes in weight; dizziness; headache; mild hair loss; nausea; nervousness; stomach cramps or bloating; vaginal spotting or breakthrough bleeding.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); absent menstrual period; breast discharge; breast lumps; calf or leg pain, swelling, or tenderness; change in the amount of urine produced; chest pain or heaviness; confusion; coughing of blood; dark urine; fainting; mental or mood changes (eg, depression); migraines; numbness of an arm or leg; one-sided weakness; pale stools; persistent, severe, or recurring headache or dizziness; persistent vaginal spotting; severe pain or tenderness in the stomach; shortness of breath; slurred speech; sudden, severe headache or vomiting; swelling of the fingers, hands, legs, or ankles; symptoms of toxic shock syndrome (eg, diarrhea, dizziness, sudden fever, sunburn-like rash on the face or body, or vomiting); unusual or severe vaginal bleeding; unusual tiredness or weakness; vaginal irritation, discharge, or change in secretions; vision changes (eg, double vision, sudden vision loss); yellowing of the skin or eyes (with or without fever).

NuvaRing Side Effects - for the Professional

NuvaRing

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:

• Thrombophlebitis and venous thrombosis with or without embolism
• Cerebral hemorrhage
• Cerebral thrombosis
• Hypertension
• Arterial thromboembolism
• Gallbladder disease
• Pulmonary embolism
• Myocardial infarction
• Hepatic adenomas or benign liver tumors

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

• Mesenteric thrombosis
• Retinal 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

Side Effects by Body System

Genitourinary

Genitourinary side effects reported by 5% to 14% of women include vaginitis and leukorrhea. The most common events leading to discontinuation in 1% to 2.5% of women include foreign body sensation, coital problems, and device expulsion. Vaginal/cervical erosion or ulceration in women using ethinyl estradiol and etonogestrel vaginal ring has been rarely reported. In some cases, the ring adhered to vaginal tissue, necessitating removal by a healthcare provider. There have been rare reports of inadvertent insertions of ethinyl estradiol and etonogestrel vaginal ring into the urinary bladder, which required cystoscopic removal. Healthcare providers should assess for ring insertion into the urinary bladder in ethinyl estradiol and etonogestrel vaginal ring users who present with persistent urinary symptoms and are unable to locate the ring.

Respiratory

Respiratory side effects reported by 5% to 14% of women include upper respiratory tract infection and sinusitis.

Gastrointestinal

Gastrointestinal side effects reported by 5% to 14% of women include nausea. Combination contraceptives have been associated with reports of abdominal cramping, bloating, and vomiting.

General

General side effects reported by 5% to 14% of women include weight gain and headache. The most common adverse effect leading to discontinuation in 1% to 2.5% of women was emotional lability and weight gain.

Hematologic

Hematologic side effects associated with the use of combination hormonal contraceptives include thromboembolic disorders.

Cardiovascular

Cardiovascular side effects reported with the use of combination hormonal contraceptives include hypertension and myocardial infarction.

Hepatic

Hepatic side effects reported with the use of combination hormonal contraceptives include hepatic adenomas and benign liver tumors.

Ocular

Ocular side effects reported with the use of combination hormonal contraceptives include retinal thrombosis, changes in corneal curvature (steepening), and intolerance to contact lenses.

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