Label Changes for:

Stromectol (ivermectin) 3 mg Tablets

June 2009

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) -- June 2009

ADVERSE REACTIONS 

Post-Marketing experience 

The following adverse reactions have been reported since the drug was registered overseas: 

  • Onchocerciasis:  Conjunctival hemorrhage 
  • All Indications:  hepatitis
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