Tretinoin

Pregnancy

Tretinoin should not be used during the first trimester of pregnancy because of the risk of harm to the fetus. If acne treatment is needed during pregnancy, it is preferable to use other agents.

This is based on studies done on pregnant animals and some case reports of pregnant women however a direct causal association has not been established.

Category: C

Category A

Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).

Category B

Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Category C

Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Category D

There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Category X

Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Breastfeeding

Excretion into human milk: Unknown

There are no adequate studies to determine the risk of tretinoin during breastfeeding. 

When tretinoin is applied topically, only a small amount enters the bloodstream, so the risk to the infant is considered to be low. Even so, to minimize tretinoin absorption into the bloodstream, avoid applying tretinoin over large areas of skin and leaving it on for long periods of time.   

Use tretinoin cream or gel instead of tretinoin ointments to reduce the risk of the infant’s exposure to paraffins in the medication through breastfeeding.

Furthermore, do not apply tretinoin to the nipple area and make sure the infant’s skin does not come into contact with the areas of skin that have been treated with tretinoin. Make sure to wash hands after application of tretinoin.