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A long-term carcinogenicity study was performed in rats (dosing duration of 104 weeks) at doses up to and including 75 mg/kg/day (450 mg/m2) for male rats and 100 mg/kg/day

(600 mg/m2) for female rats. These doses are approximately 1.8-fold and 2.4-fold higher than the maximum daily human dosage of 246 mg/m2. No evidence of carcinogenicity was observed with tramadol in male or female rats. A carcinogenicity study was also conducted in p53(+/-)-heterozygous mice (dosing duration of 26 weeks) at doses up to and including 150 mg/kg/day (450 mg/m2) for male and female mice. This dose is approximately 1.8-fold higher than the maximum daily human dosage of 246 mg/m2. No evidence of carcinogenicity was observed in male or female mice.

Source: FDA [Internet]. U.S. Food and Drug Administration. Available from: http://www.fda.gov/

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