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Label Changes for:

Nucynta (tapentadol) Immediate-release Oral Tablets

November 2010

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) – November 2010


Postmarketing Experience
  • Nervous system disorders: headache
  • Psychiatric disorders: hallucination