HIGHLIGHTS OF PRESCRIBING INFORMATION |
These highlights do not include all the information needed to use BOTOX® safely and effectively. See full prescribing information for BOTOX.
BOTOX (onabotulinumtoxinA)
Initial U.S. Approval: 1989 |
WARNING: Distant Spread of Toxin Effect
See full prescribing information for complete boxed warning.
The effects of BOTOX and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms.
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