Varenicline

The Basics

What is Varenicline?

Helps people stop smoking.

Brand names for Varenicline

Chantix, Champix

How Varenicline is classified

Nicotinic Agonists

Varenicline During Pregnancy

Varenicline pregnancy category

Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Varenicline while pregnant

Available human data on the use of CHANTIX in pregnant women are not sufficient to inform a drug associated risk. Smoking during pregnancy is associated with maternal, fetal, and neonatal risks [see Clinical Considerations]. In animal studies, varenicline did not result in major malformations but caused decreased fetal weights in rabbits when dosed during organogenesis at exposures equivalent to 50 times the exposure at the maximum recommended human dose (MRHD). Additionally, administration of varenicline to pregnant rats during organogenesis through lactation produced developmental toxicity in offspring at maternal exposures equivalent to 36 times human exposure at the MRHD . The estimated background risk of oral clefts is increased by approximately 30% in infants of women who smoke during pregnancy, compared to pregnant women who do not smoke. The background risk of other major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Clinical Considerations Disease-Associated Maternal And/Or Embryo/Fetal Risk Smoking during pregnancy causes increased risks of orofacial clefts, premature rupture of membranes, placenta previa, placental abruption, ectopic pregnancy, fetal growth restriction and low birth weight, stillbirth, preterm delivery and shortened gestation, neonatal death, sudden infant death syndrome and reduction of lung function in infants. It is not known whether quitting smoking with CHANTIX during pregnancy reduces these risks.

Taking Varenicline While Breastfeeding

What are recommendations for lactation if you're taking Varenicline?

Varenicline is a partial nicotine agonist used to assist smoking cessation. One researcher points out that based on animal data on nicotine, varenicline might interfere with normal infant lung development and recommends against its use in nursing mothers.[1] Because no information is available on the use of varenicline during breastfeeding, an alternate drug is preferred, especially while nursing a newborn or preterm infant.[2] If a mother chooses to breastfeed while taking varenicline, she should monitor her infant for seizures and excessive vomiting.

Maternal / infant drug levels

Varenicline is a partial nicotine agonist used to assist smoking cessation. One researcher points out that based on animal data on nicotine, varenicline might interfere with normal infant lung development and recommends against its use in nursing mothers.[1] Because no information is available on the use of varenicline during breastfeeding, an alternate drug is preferred, especially while nursing a newborn or preterm infant.[2] If a mother chooses to breastfeed while taking varenicline, she should monitor her infant for seizures and excessive vomiting.

Possible effects of Varenicline on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Varenicline

(Smoking Cessation) Bupropion.