Label Changes for:
Oracea (doxycycline) Capsules
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)
- 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.