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U.S. Department of Health and Human Services

Safety

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Avelox (Moxifloxacin Hydrochloride) Tablets and Injection

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 Avelox…
 

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 Avelox?
  • 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 Avelox…