Drug Safety Information for DEFINITY (Perflutren)

FDA Safety-related Labeling Changes for DEFINITY (PERFLUTREN) Rx Drug: Safety Information Link

Adverse Drug Reactions for DEFINITY* (Perflutren)

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 DEFINITY
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Back pain	927
2	Dyspnoea	152
3	Urticaria	149
4	Flushing	124
5	Chest pain	106
6	Headache	97
7	Pruritus	80
8	Muscle spasms	77
9	Pain in extremity	74
10	Nausea	73
11	Dizziness	72
12	Arthralgia	59
13	Hypotension	57
14	Rash	50
15	Hypersensitivity	41
16	Chest discomfort	41
17	Hyperhidrosis	37
18	Neck pain	35
19	Feeling hot	34
20	Pain	33

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

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

	Reason	# of FDA Reports
1	Echocardiogram	1478
2	Stress echocardiogram	668
3	Cardiac stress test	163
4	Ultrasound scan	71
5	Chest pain	54
6	Dyspnoea	47
7	Liver transplant	26
8	Diagnostic procedure	23
9	Cardiovascular evaluation	20
10	Imaging procedure	19

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

Types of Adverse Events for DEFINITY

Total Reports Filed with FDA: 3838

Number of FDA Adverse Event Reports by Patient Age for DEFINITY

Total Reports Filed with FDA: 3838*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Perflutren (Definity)

Charts are based on 3838 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.