PregnancyRisk SummaryThere are no available data on TYRVAYA use in pregnant women to inform any drug associatedrisks. In animal reproduction studies, varenicline did not produce malformations at clinicallyrelevant doses.All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US generalpopulation, the estimated background risk of major birth defects and miscarriage in clinicallyrecognized pregnancies is 2% to 4% and 15% to 20%, respectively.