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The following adverse events have been identified during postapproval use of Lamisil TabletsBecause these events are reported voluntarily from a population of uncertain sizeit is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The results of a variety of in vitromutations in Ecoli and StyphimuriumDNA repair in rat hepatocytesmutagenicity in Chinese hamster fibroblastschromosome aberrationand sister chromatid exchanges in Chinese hamster lung cellsand in vivochromosome aberration in Chinese hamstersmicronucleus test in micegenotoxicity tests gave no evidence of a mutagenic or clastogenic potential.
InvestigationsAltered prothrombin timeprolongation and reductionin patients concomitantly treated with warfarin and increased blood creatine phosphokinase have been reported.
The most frequently reported adverse events observed in the 3 US/Canadian placebo-controlled trials are listed in the table belowThe adverse events reported encompass gastrointestinal symptomsincluding diarrheadyspepsiaand abdominal painliver test abnormalitiesrashesurticariapruritusand taste disturbancesChanges in the ocular lens and retina have been reported following the use of Lamisil Tablets in controlled trialsThe clinical significance of these changes is unknownIn generalthe adverse events were mildtransientand did not lead to discontinuation from study participation.
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