Tazarotene

The Basics

What is Tazarotene?

Used to treat acne.

Brand names for Tazarotene

Tazorac

How Tazarotene is classified

Dermatologic Agents, Keratolytic Agents

Tazarotene During Pregnancy

Tazarotene 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 Tazarotene while pregnant

Based on data from animal reproduction studies, retinoid pharmacology, and the potential for systemic absorption, TAZORAC Gel may cause fetal harm when administered to a pregnant female and is contraindicated during pregnancy. Safety in pregnant females has not been established. The potential risk to the fetus outweighs the potential benefit to the mother from TAZORAC Gel during pregnancy; therefore, TAZORAC Gel should be discontinued as soon as pregnancy is recognized [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY]. Limited case reports of pregnancy in females enrolled in clinical trials for TAZORAC Gel have not established a clear association with tazarotene and major birth defects or miscarriage risk. Because the exact timing and extent of exposure in relation to the gestational age are not certain, the significance of these findings is unknown. In animal reproduction studies with pregnant rats, tazarotene dosed topically during organogenesis at 0.5 times the maximum systemic exposure in subjects treated with the maximum recommended human dose (MRHD) of tazarotene gel, 0.1% resulted in reduced fetal body weights and reduced skeletal ossification. In animal reproduction studies with pregnant rabbits dosed topically with tazarotene gel at 7 times the maximum systemic exposure in subjects treated with the MRHD of tazarotene gel, 0.1%, there were single incidences of known retinoid malformations, including spina bifida, hydrocephaly, and heart anomalies. In animal reproduction studies with pregnant rats and rabbits, tazarotene dosed orally during organogenesis at 0.5 and 13 times, respectively, the maximum systemic exposure in subjects treated with the MRHD of tazarotene gel, 0.1% resulted in malformations, fetal toxicity, developmental delays, and/or behavioral delays. In pregnant rats, tazarotene dosed orally prior to mating through early gestation resulted in decreased litter size, decreased numbers of live fetuses, decreased fetal body weights, and increased malformations at doses approximately 2 times higher than the maximum systemic exposure in subjects treated with the MRHD of tazarotene gel, 0.1% . The background risk of major birth defects and miscarriage for the indicated population is unknown. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. 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.

Taking Tazarotene While Breastfeeding

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

Topical tazarotene has not been studied during breastfeeding. Some experts feel it should not be used on greater than 20% of the body surface area while nursing because of possible absorption.[1] If tazarotene is used, ensure that the infant’s skin does not come into direct contact with the areas of maternal skin that have been treated and the infant does not ingest the product from the mother’s skin.

Maternal / infant drug levels

Topical tazarotene has not been studied during breastfeeding. Some experts feel it should not be used on greater than 20% of the body surface area while nursing because of possible absorption.[1] If tazarotene is used, ensure that the infant’s skin does not come into direct contact with the areas of maternal skin that have been treated and the infant does not ingest the product from the mother’s skin.

Possible effects of Tazarotene on milk supply

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

Possible alternatives to Tazarotene

(Psoriasis) Adalimumab, Etanercept, Infliximab, Phototherapy, Tretinoin.