The sources use different wording. A generic tretinoin cream 0.05% label says tretinoin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, while the Renova (tretinoin cream) 0.02% label says it should not be used during pregnancy. The patient instructions in the Retin-A cream and gel label say to consult your physician before using the medication if you are pregnant, think you are pregnant, or are nursing a baby.
What four product labels say about pregnancy
Each row names the product the label is for. The wording is not the same across them.
| Question | What the source says |
|---|---|
| What does the generic tretinoin cream 0.05% label (for acne) say? | There are no adequate and well-controlled studies in pregnant women. Tretinoin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. |
| What does the Renova (tretinoin cream) 0.02% label say? | There are no adequate and well-controlled studies in pregnant women. Renova 0.02% should not be used during pregnancy. |
| What does the Retin-A cream and gel label say? | Thirty human cases of temporally associated congenital malformations have been reported during two decades of clinical use. The label says no definite pattern of teratogenicity and no causal association have been established from these cases. Five of the reports describe what the label calls the rare birth defect category holoprosencephaly (defects associated with incomplete midline development of the forebrain). The label says the significance of these spontaneous reports in terms of risk to the fetus is not known. |
| What does the Retin-A Micro (tretinoin gel microsphere) label say? | Available data from published prospective observational studies and retrospective cohort studies over decades of use of topical tretinoin in pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. |
Limits on the human data
The same Retin-A Micro label says the available studies have methodologic limitations, including potential misclassification of exposure, small sample size and in some cases, lack of physical exam by an expert in birth defects. The studies it describes are observational and cohort studies, and observational studies cannot show cause and effect.
What the meta-analysis found
A systematic review and meta-analysis of first-trimester exposure to topical retinoids (Br J Dermatol 2015) included a total of 654 pregnant women exposed to topical retinoids and 1375 unexposed control pregnant women. It did not detect significant increases in rates of major congenital malformations. The abstract text used here refers to topical retinoids as a group. It does not give results for tretinoin alone or for any strength.
The authors also commented on their own result. They wrote that it "may be used primarily in reassuring women who were inadvertently exposed to topical retinoids during their pregnancy." They added: "However, the statistical power is not adequate to justify the use of topical retinoids during pregnancy."
Breastfeeding
The generic tretinoin cream 0.05% label says it is not known whether the drug is excreted in human milk. It adds that, because many drugs are excreted in human milk, caution should be exercised when tretinoin is administered to a nursing woman. This guide reports nursing wording only from this label and from the Retin-A patient instructions below.
The patient instructions in the Retin-A cream and gel label say that if you are pregnant, think you are pregnant, or are nursing a baby, consult your physician before using this medication. The information for patients in the Renova (tretinoin cream) 0.02% label says not to use Renova 0.02% if you are pregnant or attempting to become pregnant, and that if you become pregnant while using it, please contact your physician immediately.
What this does not tell you
These sources do not show that tretinoin cream carries no risk in pregnancy, and they do not show that it causes harm. The label wording differs by product, and this guide does not choose between the labels. The human data described by the Retin-A Micro label are observational, and the meta-analysis authors say its statistical power is not adequate to justify the use of topical retinoids during pregnancy.
Each label describes its own named product. None describes a compounded cream. FDA says: "Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed." This guide does not say how any label's wording applies to a compounded cream. Decisions about an individual's situation are for a licensed provider.