Famotidine: summary of preclinical safety assessment

Extensive preclinical safety studies with famotidine were performed or sponsored by Yamanouchi Phamaceutical Co, Ltd, Tokyo, Japan, and Merck, Sharp & Dohme Research Laboratories, West Point, Pennsylvania, USA. These studies were performed in dogs, rats, mice and rabbits, receiving oral and intravenous administration of the compound. Minimal toxicologic effects (after acute, subacute, or chronic administration) have been observed even at extremely high dosage levels (4,000 mg/kg/day) and for extended periods of administration (2,000 mg/kg/day for 105 weeks). No evidence of teratogenic, mutagenic, or carcinogenic effects or alterations of reproductive function have been seen. Based on these data, there are no contraindications for administration of this compound to humans.