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Label Changes for:

Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets Aplenzin (bupropion hydrobromide) Extended-Release Tablets

July 2011

Changes have been made to the PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – July 2011



Drug Interactions
  • information regarding drug-drug interactions between bupropion and drugs that inhibit or induce CYP2B6, such as ritonavir or efavirenz
  • information about potential interactions between bupropion and drugs which require metabolic activation by CYP2D6 in order to be effective (e.g., tamoxifen)
Drug-Laboratory Test Interactions
  • False-positive urine immunoassay screening tests for amphetamines have been reported in patients taking bupropion. This is due to.....


  • added.......content re: false positive test results for amphetamines