One of the global challenges in the area of  health  is  antimicrobial  resistance,  and  it  is  urgent  to  rethink  the  use  of  antimicrobial  drugs. The use of clinical and epidemiological methods to analyze the potential benefits and risks of drug therapy  has now become  a  requirement  for  the  rational use of drugs. Off-label use is the term  utilized  for  the  use  of  a  drug  other  than  that  recommended  and  listed  in  the  product  registration  and  package  insert. High rates  of  off-label  use  of  these  drugs  in  adult and  paediatric patients have been reported. The objective  of  this study  was  to  describe  the  off-label  use  of  antibacterial  in  prescriptions  for  hospitalized  adult  patients  as  per  the  drug regulatory agency was studied and  it was observed that off-label use of drugs is a frequent practice in the studied environment, and in the face of a dramatic scenario of increased antibacterial resistance.

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