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U.S. Department of Health and Human Services

Safety

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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) –

 

 

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…