Drug Safety Information for CETROTIDE (Cetrorelix)

FDA Safety-related Labeling Changes for CETROTIDE (CETRORELIX) Rx Drug: Safety Information Link

Adverse Drug Reactions for CETROTIDE* (Cetrorelix)

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 CETROTIDE
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Ovarian hyperstimulation syndrome	49
2	Drug ineffective	21
3	Abortion spontaneous	17
4	Ascites	14
5	Abdominal pain*	13
6	Caesarean section	11
7	Hypersensitivity	11
8	Ovarian disorder	11
9	Dyspnoea	9
10	Ectopic pregnancy	8
11	Pregnancy	8
12	Anaphylactic reaction	7
13	Blood luteinising hormone increased	7
14	Maternal exposure before pregnancy	7
15	Twin pregnancy	7
16	Nausea	7
17	Premature labour	6
18	Loss of consciousness	6
19	Vomiting	6
20	Injection site erythema	6

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

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

	Reason	# of FDA Reports
1	In vitro fertilisation	147
2	Ovulation induction	95
3	Product used for unknown indication	70
4	Assisted fertilisation	50
5	Infertility	49
6	Prevention of premature ovulation	14
7	Blood follicle stimulating hormone	12
8	Ovarian hyperstimulation syndrome	10
9	Oocyte donor	9
10	Infertility female	9

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

Types of Adverse Events for CETROTIDE

Total Reports Filed with FDA: 608

Number of FDA Adverse Event Reports by Patient Age for CETROTIDE

Total Reports Filed with FDA: 608*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Cetrorelix (Cetrorelix acetate, Cetrotide)

Charts are based on 608 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.

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.