"The U.S. Food and Drug Administration on Wednesday approved a request by Danco Laboratories to expand authorized use of its abortion pill Mifeprex (mifepristone), formerly known as RU-486, to 70 days of gestation from 49 days.
NuvaRing Side Effects Center
NuvaRing (etonogestrel and ethinyl estradiol vaginal ring) contains a combination of female hormones in a flexible contraceptive vaginal ring used to prevent pregnancy. Common side effects of Nuvaring include vaginal infections and irritation, vaginal itching or discharge, headache, nausea, vomiting, bloating, stomach cramps, changes in weight or appetite, breast pain/tenderness/swelling, headache, nervousness, dizziness, tired feeling, freckles or darkening of facial skin, increased hair growth, loss of scalp hair, problems with contact lenses, changes in your menstrual periods, decreased sex drive, and other side effects associated with hormonal contraceptives.
Nuvaring is inserted once a month for 3 weeks and then removed. A new ring is inserted after a 7 day break. Miconazole increases blood concentrations of etonogestrel or ethinyl estradiol. Nonoxynol-9 spermicide gel did not affect the blood concentration of etonogestrel or ethinyl estradiol. Contraceptive hormones may be secreted in breast milk and may potentially cause jaundice and breast enlargement in the nursing child. Nuvaring is contraindicated during pregnancy.
Our Nuvaring Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
NuvaRing in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using this medication and call your doctor at once if you have a serious side effect such as:
- sudden numbness or weakness, especially on one side of the body;
- sudden and severe headache, confusion, problems with vision, speech, or balance;
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- sudden cough, wheezing, rapid breathing, coughing up blood;
- pain, swelling, warmth, or redness in one or both legs;
- a change in the pattern or severity of migraine headaches;
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- swelling in your hands, ankles, or feet;
- a breast lump; or
- symptoms of depression (sleep problems, weakness, tired feeling, mood changes).
Less serious side effects may include:
- mild nausea, vomiting, bloating, stomach cramps, changes in weight or appetite;
- breast pain, tenderness, or swelling;
- headache, nervousness, dizziness, tired feeling;
- freckles or darkening of facial skin, increased hair growth, loss of scalp hair;
- problems with contact lenses; or
- vaginal itching or discharge, changes in your menstrual periods, decreased sex drive.
Read the entire detailed patient monograph for NuvaRing (Etonogestrel, Ethinyl Estradiol Vaginal Ring)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
NuvaRing Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: lumps in the breast, mental/mood changes (such as new/worsening depression), severe stomach/abdominal pain, unusual changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding, missed periods), dark urine, yellowing eyes/skin.
Very rarely, the ring has been accidentally placed into the bladder. Tell your doctor right away if you have urgent/frequent/burning/painful urination and cannot find the ring in your vagina.
This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as deep vein thrombosis, heart attack, pulmonary embolism, stroke). Get medical help right away if any of these side effects occur: chest/jaw/left arm pain, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, slurred speech, sudden shortness of breath/rapid breathing, unusual headaches (including headaches with vision changes/lack of coordination, worsening of migraines, sudden/very severe headaches), unusual sweating, weakness on one side of the body, vision problems/changes (such as double vision, partial/complete blindness).
Rarely, a very serious (possibly fatal) bacterial infection (toxic shock syndrome-TSS) has occurred in women using vaginal rings. Remove this product and get medical help right away if you develop symptoms of toxic shock syndrome, including: sudden high fever, severe/sudden dizziness, fainting, unusual muscle pain, sunburn-like rash.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for NuvaRing (Etonogestrel, Ethinyl Estradiol Vaginal Ring)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
NuvaRing FDA Prescribing Information: Side Effects
The following serious adverse reactions with the use of CHCs are discussed elsewhere in the labeling.
- Serious cardiovascular events and stroke [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
- Vascular events [see WARNINGS AND PRECAUTIONS]
- Liver disease [see WARNINGS AND PRECAUTIONS]
Adverse reactions commonly reported by CHC users are:
- Irregular uterine bleeding
- Breast tenderness
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Trials with a duration of 6 to 13 28-day cycles provided safety data. In total, 2,501 women, aged 18 to 41 contributed 24,520 cycles of exposure.
Common Adverse Reactions ( ≥ 2%): vaginitis (13.8%), headache (including migraine) (11.2%), mood changes (e.g., depression, mood swings, mood altered, depressed mood, affect lability) (6.4%), devicerelated events (e.g., expulsion/discomfort/foreign body sensation) (6.3%), nausea/vomiting (5.9%), vaginal discharge (5.7%), increased weight (4.9%), vaginal discomfort (4.0%), breast pain/discomfort/tenderness (3.8%), dysmenorrhea (3.5%), abdominal pain (3.2%), acne (2.4%), and decreased libido (2.0%).
Adverse Reactions ( ≥ 1%) Leading to Study Discontinuation: 13.0% of the women discontinued from the clinical trials due to an adverse reaction; the most common adverse reactions leading to discontinuation were device-related events (2.7%), mood changes (1.7%), headache (including migraine) (1.5%) and vaginal symptoms (1.2%).
The following adverse reactions have been identified during post-approval use of NuvaRing. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune system disorders: hypersensitivity
Nervous system disorders: stroke/cerebrovascular accident
Skin and subcutaneous tissue disorders: urticaria, chloasma
Read the entire FDA prescribing information for NuvaRing (Etonogestrel, Ethinyl Estradiol Vaginal Ring)
Additional NuvaRing Information
NuvaRing - User Reviews
NuvaRing User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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