Drug Safety Information for ESTARYLLA (Ethinyl estradiol; norgestimate)
Safety-related Labeling Changes for ORTHO CYCLEN-21 (ETHINYL ESTRADIOL; NORGESTIMATE) Rx Drug: FDA Link
Safety-related Labeling Changes for ORTHO TRI-CYCLEN (ETHINYL ESTRADIOL; NORGESTIMATE; NORGESTIMATE; NORGESTIMATE) Rx Drug: FDA Link
Safety-related Labeling Changes for ORTHO TRI-CYCLEN LO (ETHINYL ESTRADIOL; NORGESTIMATE) Rx Drug: FDA Link
Adverse Drug Reactions for ESTARYLLA* (Ethinyl estradiol; norgestimate)
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 ESTARYLLA
(reported in FDA Medwatch/FAERS Reports)
Side Effect | # of FDA Reports | |
---|---|---|
1 | Pregnancy on oral contraceptive | 406 |
2 | Nausea* | 356 |
3 | Pain | 277 |
4 | Depression* | 258 |
5 | Headache* | 243 |
6 | Anxiety | 234 |
7 | Metrorrhagia | 231 |
8 | Vomiting | 205 |
9 | Pulmonary embolism | 202 |
10 | Fatigue | 181 |
11 | Injury | 174 |
12 | Abdominal pain | 172 |
13 | Dizziness | 166 |
14 | Drug ineffective | 165 |
15 | Deep vein thrombosis | 148 |
16 | Cholecystitis chronic | 140 |
17 | Menstruation irregular | 140 |
18 | Dyspnoea | 137 |
19 | Product quality issue | 136 |
20 | Inflammatory bowel disease | 129 |
* This side effect also appears in "Top 10 Side Effects of ESTARYLLA " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking ESTARYLLA
(associated with FDA Medwatch/FAERS Reports)
Reason | # of FDA Reports | |
---|---|---|
1 | Contraception* | 4906 |
2 | Product used for unknown indication | 1111 |
3 | Oral contraception* | 442 |
4 | Menstruation irregular* | 281 |
5 | Acne* | 189 |
6 | Dysmenorrhoea* | 95 |
7 | Ovarian cyst | 82 |
8 | Menopausal symptoms* | 67 |
9 | Hormone replacement therapy | 65 |
10 | Polycystic ovaries | 52 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for ESTARYLLA
Total Reports Filed with FDA: 17559
Number of FDA Adverse Event Reports by Patient Age for ESTARYLLA
Total Reports Filed with FDA: 17559*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ethinyl estradiol; norgestimate (Tri-previfem, Previfem, Tri-lo-estarylla, Tri-estarylla, Mono-linyah, Tri-linyah, Sprintec, Ortho cyclen-28, Tri lo sprintec, Tri-sprintec, Estarylla, Ortho tri-cyclen lo, Ortho tri-cyclen, Ortho cyclen-21)
Charts are based on 17559 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 ESTARYLLA 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.