Label Changes for:

Lumigan (bimatoprost ophthalmic solution)

March 2012

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) – March 2012

 

 

ADVERSE REACTIONS

Postmarketing Experience
  • The following reactions have been identified during postmarketing use of Lumigan 0.01% and 0.03% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to Lumigan or a combination of these factors, include: dizziness, eyelid edema, hypertension, nausea, and periorbital and lid changes associated with a deepening of the eyelid sulcus
     
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