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U.S. Department of Health and Human Services

Safety

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Qvar (beclomethasone dipropionate HFA) Inhalation

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – July 2012

 

Summary View

 

PRECAUTIONS

ADVERSE REACTIONS

  • During postmarketing experience, psychiatric events and behavioral changes such as aggression, depression, sleep disorders, psychomotor hyperactivity, and suicidal ideation have been reported (primarily in children). Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.