"The U.S. Food and Drug Administration today announced its intention to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products (known as otic products) labeled to relieve ear "...
Because clinical studies are conducted under widely varying conditions, adverse drug reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.
In a randomized, active-controlled clinical trial, approximately 300 patients with clinical signs and symptoms of otitis externa were treated with CETRAXAL (ciprofloxacin otic solution) . The most frequently reported adverse reactions were application site pain, ear pruritus, fungal ear superinfection, and headache, each reported in approximately 2-3% of patients.
Read the Cetraxal (ciprofloxacin otic solution) Side Effects Center for a complete guide to possible side effects
No information provided.
Last reviewed on RxList: 5/26/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Cetraxal Information
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