AE | Listed* | Unlisted | Total |
No. of serious events | 0 | 2 | 2 |
Serious events | |||
Blood sodium decreased | x | 1 | |
Epilepsy | x | 1 | |
No. of nonserious events | 18 | 14 | 32 |
Nonserious events | |||
Injection site pain† | x | 8 | |
Altered biodistribution | x | 6 | |
Hypersensitivity‡ | x | 4 | |
Headache | x | 3 | |
Nausea‡ | x | 2 | |
Syncope | x | 2 | |
Anxiety | x | 1 | |
Cold sweat | x | 1 | |
Dysgeusia‡ | x | 1 | |
Epistaxis | x | 1 | |
Facial pain | x | 1 | |
Influenzalike illness | x | 1 | |
Sense of oppression | x | 1 |
↵* 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).