• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail

Cipro (ciprofloxacin hydrochloride)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 2009 and October 2011


October 2011

Summary View


Ciprofloxacin Tablets

Ciprofloxacin IV for Inusion Vial

Ciprofloxacin 0.2 % Solution in 5% Dextrose

Ciprofloxacin Oral Suspension

Cipro XR Tablet



Central Nervous System Effects/ Disorders
  • ... Increased intracranial pressure (including pseudotumor cerebri)


The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.
April 2009


Summary View


Brand (Generic) Name

Sections Modified

Cipro (ciprofloxacin hydrochloride) Tablets


Cipro IV (ciprofloxacin) 1% Solution in Vials


Cipro IV (ciprofloxacin) 0.2% Solution in 5% Dextrose


Cipro (ciprofloxacin) Oral 


Cipro XR (ciprofloxacin extended-release tablets)


“new safety information” with the use of Cipro, particularly the increased risks of tendonitis and tendon rupture.

  • What is the most important information I should know about Cipro?
    • Tendon rupture or swelling of the tendon (tendinitis)