Brand name · Etonogestrel and ethinyl estradiol
Nuvaring: adverse event reports filed with FDA
18,643 reports list it as a suspect or interacting product, 2004–2026. Class: Estrogen.
- 18,643
- reports as suspect product
- 0.1% of all reports · about 829 a year
- 55
- reports, 12 months to June 2026
- 70 in the 12 months before
- 49.2%
- marked serious by the reporter
- 57.2% across the class
- 1.4%
- record death among outcomes, as reported
- 260 reports · not verified by FDA
Between January 2004 and June 2026, 18,643 adverse event reports received by FDA list the brand name Nuvaring (etonogestrel and ethinyl estradiol) as a suspect or interacting product. Reports that mention it only as a concomitant medication (2,527) are left out of every figure here.
In the 12 months to June 2026, 55 reports listed it, down 21% from 70 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 829 reports a year and 0.1% of the 20,646,523 reports in the database, and 14.6% of the reports for the estrogen class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are pulmonary embolism (21%), deep vein thrombosis (14.1%) and inappropriate schedule of drug administration (11.8%). A report can list several reactions, so shares add to more than 100%; 1,929 different terms appear across these reports. Pulmonary embolism is recorded in 21% of these reports, a larger share than in the median estrogen drug (0.2%).
49.2% of the reports are marked serious by the reporter (57.2% across the class); 1.4% record death among the outcomes and 29.9% record hospitalisation, as reported. 50% of the reports came from consumers, and the largest patient age group is 18 to 44 (40.7%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Nuvaring reports recording the termmedian drug in estrogen
- Pulmonary embolisma blood clot in the lung21%3,912
- Deep vein thrombosisa blood clot in a deep vein14.1%2,634
- Inappropriate schedule of drug administrationthe medicine was taken at the wrong times11.8%2,207
- Device expulsionthe device came out7.2%1,335
- No adverse eventno adverse event was reported6.3%1,177
- Metrorrhagia6%1,111
- Headachehead pain5.1%943
- Unintended pregnancy5%928
- Depressionlow mood4.3%795
- Nauseafeeling sick4%743
- Migrainemigraine3.9%727
- Anxietyanxiety3.8%705
- Menorrhagiaheavy periods3.2%593
- Thrombosis3.2%592
- Off label useused for a purpose or in a way not on the label3.2%591
- Product quality issuea problem with the product itself3%568
- Vaginal haemorrhagevaginal bleeding2.5%473
- Chest painchest pain2.5%468
- Pain in extremitypain in an arm or leg2.4%450
- Cerebrovascular accidentstroke2.3%437
- Painpain, site not specified2.3%427
- Urinary tract infectionbladder or urinary infection2.3%427
- Abdominal painstomach or belly pain2.3%426
- Muscle spasmsmuscle cramps2.2%413
- Fatiguetiredness2.2%412
- Dyspnoeashortness of breath2.1%400
- Hypertensionhigh blood pressure2.1%390
Top 30 of 1,929 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 25 drugs in the estrogen class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 127,523 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 81.7% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Contraception | 9,863 | 52.9% |
| Menstrual cycle management | 232 | 1.2% |
| Menstruation irregular | 182 | 1% |
| Menorrhagia | 131 | 0.7% |
| Endometriosis | 78 | 0.4% |
| Dysmenorrhoea | 77 | 0.4% |
The indication field is filled in by the reporter and is often blank; shares are of all 18,643 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Nuvaring reports |
|---|---|---|
| Ibuprofen | 199 | 1.1% |
| Zoloft | 132 | 0.7% |
| Synthroid | 130 | 0.7% |
| Lexapro | 115 | 0.6% |
| Tylenol | 110 | 0.6% |
| Albuterol | 100 | 0.5% |
| Topamax | 95 | 0.5% |
| Bupropion hydrochloride | 91 | 0.5% |
| Zyrtec | 82 | 0.4% |
| Singulair | 75 | 0.4% |
Other products listed in reports where Nuvaring is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Nuvaring | Estrogen | All reports |
|---|---|---|---|
| Reports as suspect product | 18,643 | 127,523 | 20,646,523 |
| Share of that pool | — | 14.6% | 0.1% |
| Reports, latest 12 months | 55 | — | 1,332,454 |
| Marked serious | 49.2% | 57.2% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 14 | 17 | 91 |
| Hospitalisation recorded, per 1,000 reports | 299 | 105 | 213 |
| Consumer-filed share | 50% | 49% | 45.8% |
| Top term, share of reports | Pulmonary embolism 21% | median 0.2% | 0.5% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the estrogen class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Premarin | brand | 34,401 | 158 | 77.8% |
| Prempro | brand | 19,832 | 36 | 90.4% |
| Estradiol | generic | 15,479 | 2,777 | 43% |
| Estradiol Transdermal System | brand | 5,989 | 1,308 | 3.2% |
| Estrace | brand | 4,649 | 25 | 58.9% |
| Estring | brand | 3,813 | 115 | 30.5% |
| CombiPatch (estradiol/norethindrone acetate transdermal system) | brand | 3,608 | 384 | 19.5% |
| Climara | brand | 3,146 | 37 | 25.9% |
| Minivelle | brand | 2,823 | 33 | 4% |
| Climara Pro | brand | 1,949 | 115 | 11% |
| Xulane | brand | 1,537 | 65 | 10.3% |
| Vivelle-Dot | brand | 1,488 | 62 | 32.1% |
| EstroGel | brand | 1,312 | 94 | 74.9% |
| Conjugated estrogens | generic | 1,167 | 12 | 98.7% |
| Twirla | brand | 1,014 | 96 | 2.1% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Nuvaring reports
How many adverse event reports has FDA received for Nuvaring?
18,643 reports list Nuvaring as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 55 of them arrived in the latest 12 months. Another 2,527 list it only as a concomitant medication.
What reactions are recorded in Nuvaring reports?
pulmonary embolism (21%), deep vein thrombosis (14.1%), inappropriate schedule of drug administration (11.8%), device expulsion (7.2%) and no adverse event (6.3%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Nuvaring was responsible.
How serious are the reports?
49.2% are marked serious by the reporter. Among the outcomes recorded, 1.4% of reports include death and 29.9% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (50%), physician (16.8%) and not given (10.6%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Nuvaring rising?
55 reports in the 12 months to June 2026, down 21% from 70 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Nuvaring was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Nuvaring?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Nuvaring as a suspect or interacting product; reports listing it only as a concomitant medication (2,527) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.