Top 20 Adverse Events Reported to FDA between 2004 and 2012

FDA Adverse Events Summary for NUVARING* (Ethinyl estradiol; etonogestrel) between 2004 and 2012

Less than 10% of all adverse events are ever reported to the FDA

These charts and graphs provide data on adverse effects and events attributed to NUVARING. They are based on FDA Adverse Event reports received through the FDA Adverse Event Reporting System (FAERS) program.

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

  Side Effect # of FDA Reports
1 Pulmonary embolism 1364
2 Deep vein thrombosis 921
3 Metrorrhagia 524
4 Headache* 514
5 Nausea* 438
6 Thrombosis 390
7 Depression* 349
8 Anxiety 320
9 Migraine 307
10 Pain 298
11 Chest pain 294
12 Abdominal pain 293
13 Dyspnoea 271
14 Device expulsion 265
15 Dizziness 262
16 Pain in extremity 259
17 Vomiting 257
18 Fatigue 246
19 Hypercoagulation 241
20 Cerebrovascular accident 239

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

(based on 39034 reports filed with the FDA between 2004 and 2012)

Top 20 Adverse Events report to FDA

Adverse Event Reports are submitted 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). 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.

Source: (last accessed 4/9/2014