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Label Changes for:

alli (orlistat) Capsules

May 2016

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

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

May 2016

WARNINGS (addition)

Ask a Doctor or Pharmacist Before Use If You Are Taking….

  • Amiodarone (heart medicine)


June 2014

Drug Facts Label

Ask a doctor or pharmacist before use if you are

  • Taking medicine for seizures

Stop use and ask a doctor if

  • You are taking medicine for seizures and your seizures happen more often or get worse 


September 2010


Stop use and ask a doctor if:
  • you develop itching
  • yellow eyes or skin
  • dark urine or loss of appetite
  • There have been rare reports of liver injury in people taking orlistat