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 embolism
- Arterial thromboembolism
- Pulmonary embolism
- Myocardial infarction
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- Cerebral hemorrhage
- Cerebral thrombosis
- Hypertension
- Gallbladder disease
- Hepatic adenomas or benign liver tumors
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There is evidence of an association between the following conditions and the use of combination hormonal contraceptives:
The following additional adverse reactions have been reported in users of combination hormonal 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
- Decrease in serum folate levels
- Exacerbation of porphyria
- Aggravation of varicose veins
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- 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
- Exacerbation of systemic lupus erythematosus
- Exacerbation of chorea
- Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms
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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
- Cataracts
- Cystitis-like syndrome
- Headache
- Nervousness
- Dizziness
- Hirsutism
- Loss of scalp hair
- Erythema multiforme
- Dysmenorrhea
- Pancreatitis
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- Erythema nodosum
- Hemorrhagic eruption
- Impaired renal function
- Hemolytic uremic syndrome
- Acne
- Changes in libido
- Colitis
- Budd-Chiari Syndrome
- Optic neuritis, which may lead to partial or complete loss of vision
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REPORTS OF SUSPECTED NUVARING SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Nuvaring. The information is not vetted and should not be considered as verified clinical evidence.
Possible Nuvaring side effects / adverse reactions in 34 year old female
Reported by a individual with unspecified qualification from United States on 2011-10-03
Patient: 34 year old female weighing 67.6 kg (148.7 pounds)
Reactions: Restless Legs Syndrome, Pulmonary Embolism, Pelvic Pain, Tricuspid Valve Incompetence, Hypokalaemia, Fatigue, Oedema Peripheral, Depression, Heart Rate Irregular, Muscle Spasms, Pneumonitis, Phlebitis, Viral Infection, Pneumonia, Cytomegalovirus Test Positive, Urinary Tract Infection, Anaemia, Ovarian Cyst, Vaginal Discharge, Varicose Vein, Anxiety, Pulmonary Valve Incompetence, Epstein-Barr Virus Antigen Positive, Presyncope, Mitral Valve Incompetence, Thrombophlebitis, Bronchitis, Arthritis, Deep Vein Thrombosis
Adverse event resulted in: hospitalization, disablity
Suspect drug(s):
Aspirin
Indication: Deep Vein Thrombosis
Nuvaring
Nuvaring
Indication: Product Used FOR Unknown Indication
Start date: 2009-03-10
End date: 2009-07-30
Other drugs received by patient: Multi-Vitamin; Claritin
Possible Nuvaring side effects / adverse reactions in 29 year old female
Reported by a lawyer from United States on 2011-10-03
Patient: 29 year old female weighing 81.6 kg (179.6 pounds)
Reactions: Post Stroke Depression, Atelectasis, Pleuritic Pain, Pulmonary Embolism, Pyrexia, Abortion Spontaneous, Cardiomegaly, Uterine Leiomyoma, Abortion Missed, Pleural Effusion, Pneumonia, Hiatus Hernia, Vulvovaginal Mycotic Infection, Dyspnoea, Intra-Uterine Death, Abortion Threatened, Urinary Tract Infection, Maternal Exposure During Pregnancy, Anaemia, Ovarian Cyst, Maternal Exposure Before Pregnancy, Pulmonary Infarction, Anxiety, Leukocytosis
Adverse event resulted in: life threatening event, hospitalization
Suspect drug(s):
Blood Thinners
Indication: Pulmonary Embolism
Nuvaring
Dosage: vag
Indication: Contraception
Start date: 2005-11-01
Nuvaring
Dosage: vag
Indication: Contraception
Start date: 2004-01-01
End date: 2008-01-01
Other drugs received by patient: Darvocet; Valium
Possible Nuvaring side effects / adverse reactions in 38 year old female
Reported by a lawyer from United States on 2011-10-04
Patient: 38 year old female weighing 86.2 kg (189.6 pounds)
Reactions: Dyspnoea, Pneumonia, Dilatation Ventricular, Hypotension, Pulmonary Embolism, Rash, Liver Disorder, Syncope, Presyncope, Chest Pain, Bradycardia, Deep Vein Thrombosis, Polycystic Ovaries
Adverse event resulted in: hospitalization, disablity
Suspect drug(s):
Nuvaring
Indication: Migraine
Start date: 2008-01-01
End date: 2009-04-26
Nuvaring
Indication: Contraception
Start date: 2008-01-01
End date: 2009-04-26
Other drugs received by patient: Vicodin; Keppra; Axert; Diamox SRC; Zanaflex; Skelaxin; Xanax
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