Drug Safety Information for LUNELLE (Estradiol cypionate; medroxyprogesterone acetate)

Adverse Drug Reactions for LUNELLE* (Estradiol cypionate; medroxyprogesterone acetate)

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 LUNELLE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Diabetes mellitus3
2Abdominal pain2
3Pregnancy2
4Flatulence1
5Secretion discharge1
6Vascular graft1
7Fear1
8Ectopic pregnancy1
9Toe amputation1
10Gestational diabetes1
11Burning sensation1
12Pyrexia1
13Somnolence1
14Pain*1
15Diabetic ketoacidosis1
16Weight increased*1
17Hyperinsulinism1
18Swelling face1
19Dizziness1
20Abortion missed1

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

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

Reason # of FDA Reports
1Oral contraception5
2Contraception*2

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


Types of Adverse Events for LUNELLE

Total Reports Filed with FDA: 63


Number of FDA Adverse Event Reports by Patient Age for LUNELLE

Total Reports Filed with FDA: 63*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Estradiol cypionate; medroxyprogesterone acetate (Lunelle)

Charts are based on 63 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 LUNELLE 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.