Ciprofloxacin - Adverse Effects

Adverse Effects

The safety of fluoroquinolones is similar to that of other antibiotics. In most, adverse reactions are mild to moderate; however, occasionally serious adverse effects occur.

According to the FDA-approved package insert, 49,038 patients received courses of ciprofloxacin in pre-approval clinical trials. Most of the adverse events reported were described as only mild or moderate in severity, abated soon after the drug was discontinued, and required no treatment. Ciprofloxacin was discontinued because of an adverse event in 1% of orally treated patients.

The most frequently reported drug related events, from clinical trials of all formulations, all dosages, all drug-therapy durations, and for all indications of ciprofloxacin therapy were nausea (2.5%), diarrhea (1.6%), liver function tests abnormal (1.3%), vomiting (1%), and rash (1%). Other adverse events occurred at rates of <1%.

There have been a number of regulatory actions taken as a result of such adverse reactions, which included published warnings, additional warnings and safety information added to the package inserts together with the issuance of "Dear Doctor Letters" concerning the recent addition of Black Box Warnings.