Drug Safety Information for OVIDREL (Choriogonadotropin alfa)

Adverse Drug Reactions for OVIDREL* (Choriogonadotropin alfa)

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 OVIDREL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Ovarian hyperstimulation syndrome34
2Abortion spontaneous24
3Nausea11
4Off label use10
5Ectopic pregnancy9
6Pregnancy9
7Abdominal pain9
8Multiple pregnancy9
9Twin pregnancy8
10Pain*7
11Maternal exposure before pregnancy7
12Ovarian enlargement7
13Ascites7
14Caesarean section7
15Dizziness6
16Vaginal haemorrhage6
17Dyspnoea6
18Palpitations6
19Headache6
20Haemorrhage5

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

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

Reason # of FDA Reports
1In vitro fertilisation142
2Infertility female115
3Infertility*80
4Product used for unknown indication66
5Ovulation induction55
6Assisted fertilisation21
7Ischaemic stroke13
8Pregnancy12
9Ovarian disorder9
10Off label use8

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


Types of Adverse Events for OVIDREL

Total Reports Filed with FDA: 708


Number of FDA Adverse Event Reports by Patient Age for OVIDREL

Total Reports Filed with FDA: 708*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Choriogonadotropin alfa (Novarel, Ovidrel)

Charts are based on 708 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 OVIDREL 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.