Drug Safety Information for XULANE (Ethinyl estradiol; norelgestromin)

Safety-related Labeling Changes for ORTHO EVRA (ETHINYL ESTRADIOL; NORELGESTROMIN) Rx Drug: FDA Link

Adverse Drug Reactions for XULANE* (Ethinyl estradiol; norelgestromin)

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 XULANE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Metrorrhagia3208
2Nausea*1341
3Application site reaction1232
4Pulmonary embolism1099
5Deep vein thrombosis849
6Headache*747
7Unintended pregnancy730
8Product quality issue663
9Inappropriate schedule of drug administration614
10Vomiting487
11Oligomenorrhoea464
12Thrombosis464
13Breast tenderness*456
14Menorrhagia453
15Drug dose omission446
16Abdominal pain422
17Wrong technique in drug usage process384
18Dizziness333
19Injury320
20Vaginal haemorrhage311

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

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

Reason # of FDA Reports
1Contraception*24273
2Product used for unknown indication3941
3Menstruation irregular*770
4Menstrual disorder363
5Endometriosis173
6Ovarian cyst144
7Dysmenorrhoea141
8Menopausal symptoms137
9Menorrhagia*129
10Hormone level abnormal*91

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


Types of Adverse Events for XULANE

Total Reports Filed with FDA: 32769


Number of FDA Adverse Event Reports by Patient Age for XULANE

Total Reports Filed with FDA: 32769*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ethinyl estradiol; norelgestromin (Xulane, Ortho evra)

Charts are based on 32769 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 XULANE 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.