Medications containing promethazine hydrochloride (HCl) should not be used for children less than two years of age because of the potential for fatal respiratory depression. This includes promethazine HCl in any form: syrups, suppositories, tablets, or injectables. Cases of respiratory depression including fatalities have been reported with use of promethazine HCl in children less than two years of age. Caution should also be exercised when administering promethazine HCl in any form to pediatric patients two years of age and older. The labeling on all products, brand name and generic, has been changed to reflect these strengthened warnings. One manufacturer of suppositories and tablets has notified healthcare professionals of the changed label. The FDA is issuing this safety alert to make sure that healthcare professionals, other caregivers, and patients realize that the warnings apply to promethazine HCl syrups as well.

This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.