Prilosec Side Effects & Drug Interactions

HealthCentral.com

Drug Library
Prilosec - Side Effects & Drug Interactions [Omeprazole]

A 78-week mouse carcinogenicity study of omeprazole did not show increased tumor occurrence, but the study was not conclusive. A 26-week p53+/-transgenic mouse carcinogenicity study was not positive. Omeprazole was not mutagenic in an in vitro Ames Salmonella typhimurium assay, an in vitro mouse lymphoma cell assay and an in vivo rat liver DNA damage assay. A mouse micronucleus test at 625 and 6250 times the human dose gave a borderline result, as did an in vivo bone marrow chromosome aberration test. A second mouse micronucleus study at 2000 times the human dose, but with different (suboptimal) sampling times, was negative.

In a rat fertility and general reproductive performance test, omeprazole in a dose range of 13.8 to 138.0 mg/ kg/ day (approximately 35 to 345 times
the human dose) was not toxic or deleterious to the reproductive performance of parental animals.

Pregnancy Omeprazole

Pregnancy Category C

Teratology studies conducted in pregnant rats at doses up to 138 mg/ kg/ day (approximately 345 times the human dose) and in pregnant rabbits at doses up to 69 mg/ kg/ day (approximately 172 times the human dose) did not disclose any evidence for a teratogenic potential of omeprazole.

In rabbits, omeprazole in a dose range of 6.9 to 69.1 mg/ kg/ day (approximately 17 to 172 times the human dose) produced dose-related increases in embryo-lethality, fetal resorptions and pregnancy disruptions. In rats, dose-related embryo/ fetal toxicity and postnatal developmental toxicity were observed in offspring resulting from parents treated with omeprazole 13.8 to 138.0 mg/ kg/ day (approximately 35 to 345 times the human dose). There are no adequate or well-controlled studies in pregnant women. Sporadic reports have been received of congenital abnormalities occurring in infants born to women who have received omeprazole during pregnancy. Omeprazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.