Drug Safety Information for EMEND (Fosaprepitant dimeglumine)

FDA Safety-related Labeling Changes for EMEND (APREPITANT) Rx Drug: Safety Information Link

Required post-approval safety study:

Deferred pediatric study under PREA for the treatment of post-operative nausea and vomiting pediatric patients ages 0 to less than 17 years of age. Due Date: 2020-01-31

Original FDA Drug Approval Date for EMEND: 2003-03-26

Adverse Drug Reactions for EMEND* (Fosaprepitant dimeglumine)

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 EMEND
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Nausea	545
2	Vomiting	408
3	Dyspnoea	338
4	Diarrhoea	321
5	Pyrexia	259
6	Febrile neutropenia	258
7	Death	251
8	Neutropenia	220
9	Fatigue	202
10	Dehydration	201
11	Decreased appetite	182
12	Abdominal pain	178
13	Anaemia	174
14	White blood cell count decreased	162
15	Thrombocytopenia	158
16	Asthenia	157
17	Flushing	148
18	Rash	147
19	Renal failure acute	144
20	Constipation	143

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

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

	Reason	# of FDA Reports
1	Prophylaxis of nausea and vomiting	3528
2	Product used for unknown indication	1303
3	Nausea	1123
4	Premedication	858
5	Prophylaxis	627
6	Chemotherapy	375
7	Vomiting	338
8	Antiemetic supportive care	243
9	Breast cancer	100
10	Prophylactic chemotherapy	72

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

Types of Adverse Events for EMEND

Total Reports Filed with FDA: 19882

Number of FDA Adverse Event Reports by Patient Age for EMEND

Total Reports Filed with FDA: 19882*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Fosaprepitant dimeglumine (Aprepitant, Fosaprepitant, Emend)

Charts are based on 19882 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.