UMEM Educational Pearls

Category: Pharmacology & Therapeutics

Title: Fluoroquinolones and risk of tendon rupture

Keywords: fluoroquinolone, tendon rupture (PubMed Search)

Posted: 7/1/2016 by Michelle Hines, PharmD (Emailed: 7/2/2016) (Updated: 7/2/2016)
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Fluoroquinolone antibiotics are used to treat a wide range of infections and as prophylaxis against infection in certain immune compromised patients. In 2008 the FDA issued a boxed warning for tendonitis and tendon rupture for the fluoroquinolone antibiotic class, and in May 2016 a statement recommending the use of alternate therapies for uncomplicated UTIs and upper respiratory infections was issued. The mechanism by which fluoroquinolones causes tendon injury has not been elucidated, but may be related to oxidative stress caused by the overproduction of reactive oxygen species in tenocytes.

Adverse event reporting to the FDA is performed voluntarily by healthcare professionals and consumers through MedWatch. An analysis of tendon rupture events associated with fluoroquinolone use reported to the FDA’s Adverse Event Reporting System (FAERS) database was recently published.

What they found:

  • 2495 reported cases of tendon rupture associated with fluoroquinolones
  • Most cases involved levofloxacin (n=1555), ciprofloxacin (n=606), or moxifloxacin (n=230).
  • Concomitant corticosteroids were administered in 21.2% of cases.
  • The mean age was approximately 60 +/- 5 years.
  • The ratio of men:women was 1.16:1.
  • Renal function was not reported in this study.

Application to clinical practice:

  • There is a risk of tendonitis/tendon rupture with administration of fluoroquinolone antibiotics.
  • Risk factors for fluoroquinolone-associated tendinopathies may include advanced age, impaired renal function, and use of concomitant corticosteroids.
  • Alternatives to fluoroquinolone antibiotics should be considered for patients with tendinopathy risk factors.
  • When indicated, fluoroquinolones should be used at the lowest effective dose for the shortest possible time period to minimize exposure.


  1. Arabyat RM, et al. Fluoroquinolone-associated tendon-rupture: a summary of reports in the Food and Drug Administration’s adverse event reporting system. Expert Opin Drug Saf 2015; 14:1653-60. (PMID 26393387)

  2. FDA Drug Safety Communication from 5/12/2016:


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