TABLE 3

Adverse Drug Experiences (All Spontaneous Safety Reports)

AEListed*UnlistedTotal
No. of serious events022
Serious events
 Blood sodium decreasedx1
 Epilepsyx1
No. of nonserious events181432
Nonserious events
 Injection site painx8
 Altered biodistributionx6
 Hypersensitivityx4
 Headachex3
 Nauseax2
 Syncopex2
 Anxietyx1
 Cold sweatx1
 Dysgeusiax1
 Epistaxisx1
 Facial painx1
 Influenzalike illnessx1
 Sense of oppressionx1
  • * Included in current reference safety information (listed)—that is, European Summary of Product Characteristics (March 2013) or U.S. prescribing information (April 2011).

  • Added in 2002.

  • Added in 2011.

  • Approximately half a million doses of DaTscan dispensed in 13-y period. x indicates whether event is currently mentioned in reference safety information (listed) or not (unlisted).