Resistance in Clinical
Isolates Adverse Events Evidence Supporting Efficacy
Not reported Minimally absorbed Multiple RCTs; U.S. FDA-Approved
One clinical isolate with
increased MIC
Minimally absorbed Two Phase III RCT comparisons to
vancomcyin; U.S. FDA-Approved
Increased MIC reported
in some studies; hetero-
resistance also reported
Neuropathy, nausea Multiple RCTs
Not reported GI symptoms • Small RCT comparison to
vancomycin and a modest sized RCT
comparison to metronidazole
Reported to develop in
vivo resistance
GI symptoms • Modest-sized RCT comparison to
metronidazole and a small RCT
comparison to vancomycin
Potential for
development of high-
level resistance
Minimally absorbed • 1 small RCT comparison to
vancomycin for primary treatment
• Case series and 1 RCT pilot study
show promise for use as a post-
vancomycin 'chaser' strateg y in
management of recurrent CDAD
Not reported GI symptoms Case reports and small case series
Increasing resistance
noted
Minimally
absorbed, poor taste
Two small RCT comparisons to
vancomycin
Among pa ents receiving DIFICID, 33 (5.9%) withdrew from trials as a result of adverse reac ons.
Vomi ng was the primary adverse reac on leading to discon nua on of dosing (incidence of 0.5%
for both DIFICID and vancomycin pa ents).
The safety and effec veness of DIFICID in pa ents < 18 years of age have not been established.
