Drug Safety Information for CRYSELLE (Ethinyl estradiol; norgestrel)

Safety-related Labeling Changes for LO/OVRAL (ETHINYL ESTRADIOL; NORGESTREL) Rx Drug: FDA Link

Safety-related Labeling Changes for LO/OVRAL-28 (ETHINYL ESTRADIOL; NORGESTREL) Rx Drug: FDA Link

Adverse Drug Reactions for CRYSELLE* (Ethinyl estradiol; norgestrel)

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 CRYSELLE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective153
2Product quality issue147
3Unintended pregnancy132
12Deep vein thrombosis30
13Pulmonary embolism30
16Abdominal pain28
19Emotional distress22
20Cholecystitis chronic21

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

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

Reason # of FDA Reports
2Product used for unknown indication193
3Oral contraception144
7Menstruation irregular33
8Off label use27
9Menstrual cycle management26
10Polycystic ovaries21

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

Types of Adverse Events for CRYSELLE

Total Reports Filed with FDA: 3735

Number of FDA Adverse Event Reports by Patient Age for CRYSELLE

Total Reports Filed with FDA: 3735*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ethinyl estradiol; norgestrel (Ogestrel 0.5/50-28, Low-ogestrel-28, Elinest, Low-ogestrel-21, Cryselle, Lo/ovral-28, Ogestrel 0.5/50-21, Ovral-28, Ovral, Lo/ovral)

Charts are based on 3735 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 CRYSELLE Reviews and Review Summary .

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.

Visit   DrugInformer.com more on CRYSELLE's side effects.