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U.S. Department of Health and Human Services

Safety

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Noroxin (norfloxacin) tablets

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

 

 

March 2013

Summary View

ADVERSE REACTIONS

Postmarketing Experience
  • muscle spasms

 

 

June 2012 

Summary View

 

ADVERSE REACTIONS

Post-marketing
  • DRESS (drug rash with eosinophilia and systemic symptoms) syndrome
 

MEDICATION GUIDE

What are the possible side effects of Noroxin?
  • Serious allergic reactions- Skin rash accompanied by fever and feeling unwell

 

February 2012

Summary View

 

ADVERSE REACTIONS

Post-Marketing
  • Skin: leukocytoclastic vasculitis

 

October 2011

Summary View

 

WARNINGS

Central Nervous System Effects/ Disorders:
  • added......Convulsions have been reported in patients receiving norfloxacin. Convulsions, increased intracranial pressure (including pseudotumor cerebri), and toxic psychoses have been reported in patients receiving drugs in this class.

 

September 2011

Summary View

MEDICATION GUIDE

  • increased risk of tendon rupture or swelling of the tendon (tendinitis) from the use of fluoroquinolones.

 

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