Drug Safety Information for NUVARING (Ethinyl estradiol; etonogestrel)

Safety-related Labeling Changes for NUVARING (ETHINYL ASTADIOL; ETONOGESTREL) Rx Drug: FDA Link

Adverse Drug Reactions for NUVARING* (Ethinyl estradiol; etonogestrel)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with NUVARING
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pulmonary embolism3707
2Deep vein thrombosis2608
3Inappropriate schedule of drug administration1240
4Headache*939
5Metrorrhagia892
6Depression*788
7Device expulsion783
8Nausea*734
9Anxiety*717
10Migraine664
11Thrombosis659
12Unintended pregnancy580
13Off label use561
14Chest pain548
15Menorrhagia483
16Pain482
17Pain in extremity481
18Cerebrovascular accident480
19Incorrect drug administration duration478
20Dyspnoea466

* This side effect also appears in "Top 10 Side Effects of NUVARING " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking NUVARING
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Contraception*44366
2Product used for unknown indication4728
3Menstruation irregular*2989
4Menstrual cycle management2902
5Endometriosis*1141
6Menstrual disorder828
7Ovarian cyst767
8Menorrhagia*649
9Dysmenorrhoea*346
10Hormone replacement therapy309

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for NUVARING

Total Reports Filed with FDA: 72941


Number of FDA Adverse Event Reports by Patient Age for NUVARING

Total Reports Filed with FDA: 72941*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ethinyl estradiol; etonogestrel (Nuvaring)

Charts are based on 72941 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and NUVARING Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.