• Fluoroquinolones, including levofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all age groups. This risk is further increased in older adults (usually those >60 years of age), individuals receiving concomitant corticosteroids, and kidney, heart, or lung transplant recipients. (See Tendinopathy and Tendon Rupture under Cautions.)

REMS:

FDA approved a REMS for levofloxacin to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of levofloxacin and consists of the following: medication guide. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).