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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)  

 

August 2013

Summary View

 

WARNINGS AND PRECAUTIONS

Peripheral Neuropathy
  • Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones, including Noroxin…
 

ADVERSE REACTIONS

Serious and Otherwise Important Adverse Reactions
  • Peripheral Neuropathy that may be irreversible
Postmarketing Experience
Nervous Disorders
  • Peripheral neuropathy (that may be irreversible)
 

MEDICATION GUIDE

What are the possible side effects of Noroxin?
  • Changes in sensation and nerve damage (Peripheral Neuropathy) - Damage to the nerves in arms, hands, legs, or feet can happen in people taking fluoroquinolones, including Noroxin…

 

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.