Label Changes for:

Oracea (doxycycline) Capsules

July 2013

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

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

 

July 2013

ADVERSE REACTIONS

Postmarketing Experience
  • Because these reactions 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. The following adverse reactions have been identified during post approval use of ORACEA.
  • Nervous system: Pseudotumor cerebri (benign intracranial hypertension), headache.
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