A Reappraisal of Ciprofloxacin Use in Infants and Children

Marcia L. Buck, PharmD, FCCP, FPPAG, BCPPS


Pediatr Pharm. 2018;24(8) 

In This Article

Pediatric Adverse Reaction Data

The safety profile of ciprofloxacin was studied by Bayer in an international multicenter trial.[4] A total of 684 children (mean age 6 + 4 years, range 1 to 17 years) with a complicated UTI or pyelonephritis were enrolled; 335 received ciprofloxacin and 349 were given a comparator cephalosporin for a mean duration of 11 days (range 1–88 days). The presence of musculoskeletal or neurologic adverse reactions was assessed at 6 weeks and 1 year after treatment and reviewed by an independent pediatric safety committee.

Musculoskeletal adverse reactions included arthralgia, abnormal gait, abnormal joint exam, joint sprains, leg, arm, or back pain, bone pain, myalgia, or decreased range of motion in an ankle, knee, hip, wrist, elbow, or shoulder. The rates of musculoskeletal adverse reactions reported within 6 weeks after the initiation of treatment were 9.3% (31/335) in the ciprofloxacin group and 6% (21/349) in the comparator group (95% CI −0.8%, 7.2%). All signs and symptoms in these patients resolved, most within 1 month of the report. The rates of musculoskeletal adverse effects reported at any point up to 1 year after initiation of treatment were 13.7% (46/337) in the ciprofloxacin group and 9.5% (33/349) in the comparators (95% CI −0.6%, 9.1%). The study was designed to demonstrate that the rate of musculoskeletal adverse reactions for ciprofloxacin did not exceed that of the comparator by more than 6%. At both 6-week and 1-year assessments, it could not be concluded that the ciprofloxacin group had findings similar to the comparator group.

The incidence of neurologic adverse reactions at the 6-week assessment was 3% (9/355) in the ciprofloxacin group and 2% (7/349) in the comparator group. The reactions reported included dizziness, nervousness, insomnia, and somnolence. Overall, the incidence of adverse reactions was 41% in the ciprofloxacin group and 31% in the comparator group, with the most common reactions being gastrointestinal (15% and 9%, respectively). Serious adverse reactions were uncommon, occurring in 7.5% and 5.7% of patients.

Additional adverse reaction data were obtained from a randomized, double-blind trial of 129 patients (6–17 years of age) with cystic fibrosis having an acute pulmonary exacerbation. Patients received either ciprofloxacin or the combination of ceftazidime and tobramycin intravenously for 10–21 days. Symptoms were evaluated for an average of 23 days after completing therapy (range 0–93 days). Musculoskeletal adverse reactions were reported in 22% of the patients in the ciprofloxacin group and 21% of the comparator group.

Several other case reports and case series have described fluoroquinolone adverse effects in children and young adults. Moffett and colleagues described two cases of ciprofloxacin-associated renal insufficiency.[18] Both patients had cystic fibrosis and were being treated for a pulmonary exacerbation. Symptoms began at 10 days and 3 weeks, with a rise in creatinine and blood urea nitrogen. Renal function improved rapidly after discontinuation, with complete resolution within 3 weeks. In the study by Sideri describing ciprofloxacin use in 18 critically ill children, the authors reported two cases of diarrhea, one case of vomiting, and one case of transient supraventricular tachycardia attributed to treatment.[8] The authors found no cases of QT prolongation. In contrast, the authors of the systematic review of ciprofloxacin use in neonates described earlier found no reports of serious adverse effects, but noted that the focus of most of the papers reviewed was on clinical cure and included only limited follow-up.[9]

In a paper just released on-line in The Journal of Pediatrics, Shah and Ong described an 8-year-old child who developed an erythematous rash and superficial venous thrombophlebitis after being given a single IV ciprofloxacin dose for nephrostomy tube replacement.[19] His symptoms resolved within a few hours. This was felt to be a local reaction and he was subsequently given a 10-day course of oral ciprofloxacin without adverse effects.