Safety

Mirapex (Pramipexole Dihydrochloride) and Mirapex ER (Pramipexole Dihydrochloride) Extended-release Tablets

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

January 2016

Summary View

ADVERSE REACTIONS

Postmarketing Experience
  • …skin reactions (including erythema, rash, pruritus, urticaria)…

 

March 2013

Summary View

ADVERSE REACTIONS

Post Marketing Experience
  • ...inappropriate antidiuretic hormone secretion (SIADH)

  

August 2012

Summary View 

WARNINGS AND PRECAUTIONS

Retinal Pathology
  • Human Data: A two-year open-label, randomized, parallel-group safety study of retinal deterioration and vision compared Mirapex tablets and immediate-release Ropinirole… 

 

Page Last Updated: 02/12/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.