Drugs
Haloperidol (marketed as Haldol, Haldol Decanoate, and Haldol Lactate) Information
FDA ALERT [9/2007]: This Alert highlights revisions to the labeling for haloperidol (marketed as Haldol, Haldol Decanoate and Haldol Lactate). The updated labeling includes WARNINGS stating that Torsades de Pointes and QT prolongation have been observed in patients receiving haloperidol, especially when the drug is administered intravenously or in higher doses than recommended. Haloperidol is not approved for intravenous use.
This information reflects FDA’s current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.
To report any unexpected adverse or serious events associated with the use of this drug, please contact the FDA MedWatch program either online, by regular mail or by fax, using the contact information at the bottom of this page.
Related Information
FDA Drug Safety Communication: Antipsychotic drug labels updated on use during pregnancy and risk of abnormal muscle movements and withdrawal symptoms in newborns
2/22/2011Information for Healthcare Professionals: Haloperidol (marketed as Haldol, Haldol Decanoate and Haldol Lactate)
9/2007Information on Conventional Antipsychotics Information for Healthcare Professionals: Conventional Antipsychotics
6/16/2008FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs
FDA press release (6/16/2008)
Labeling and Regulatory History and Labeling from Drugs@FDA
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