Fluoroquinolones (FQs) are second line antimicrobial agents. Once the decision to prescribe
an antimicrobial is made, its choice should be based on both the benefits and harms. This
systematic review quantifies the occurrence of common adverse events (AEs) related to FQs
in relation to any other antimicrobial for any indication in primary care.
We searched randomized controlled trials from Embase, PubMed, Cochrane Central Register
of Controlled Trials and CINHAL. FQs had to be administered orally, for any indication, to
adults and in primary care. Data were extracted independently in standard forms in
“Covidence”. Pooled estimates of the intervention effects for AEs were determined by the Peto
odds ratios (ORs) and 95% confidence intervals in Revman.
Of the 39 studies selected, the most commonly reported AEs were nausea, vomiting,
diarrhoea, headache, dizziness, and rash. A meta-analysis of 28 studies reporting AEs
showed central nervous system (CNS) (OR 1.40 (1.12-1.75) p=0.003, heterogeneity (I2
) = 0%)
and gastrointestinal (GI) related AEs (OR 1.20 (1.06-1.36) p=0.005, I2=80%) were significantly
associated with FQs use compared to other antimicrobials. Compared to FQs, co-amoxiclav
showed significantly more total AEs (OR 0.70 (0.54-0.90) p=0.006, I2=78%) and GI-related
AEs (OR 0.69(0.52-0.91) p=0.008, I2=94%). Withdrawal and/or discontinuation due to drugrelated
AEs were higher for FQs (OR 1.19 (1.00-1.42) p=0.05, I2=5%). Sensitivity analyses
did not change these results.
FQs are associated with more CNS and GI-related AEs compared to other types of
antimicrobial. This information is relevant to support decision making in relation to