Tolnaftate has not been formally assigned a pregnancy safety category by the FDA, and no definitive human studies confirm it is safe during pregnancy. It is generally recommended only when the benefit outweighs the risk. Because better-studied alternatives exist, most providers steer pregnant patients toward those options instead.
What the Research Actually Shows
No controlled studies have been published on tolnaftate’s effects during human pregnancy. The one meaningful piece of evidence comes from a large Hungarian surveillance study that tracked over 22,000 newborns with birth defects and 38,000 matched controls between 1980 and 1996. Among this enormous dataset, only 13 mothers in each group had used tolnaftate spray during pregnancy, making the sample extremely small.
Within that small group, four cases of heart-related birth defects appeared among the tolnaftate-exposed group, producing a roughly threefold increase in risk compared to controls. However, the heart defects were all different types, and the number of cases was so low that researchers could not draw firm conclusions. They described the finding as a “signal” worth investigating further, not proof of harm. No follow-up studies have been published since.
That leaves pregnant women in an uncomfortable gray zone: there is no clear evidence of harm, but also no reassuring evidence of safety. The lack of data is the core issue, not a confirmed danger.
Why the Formulation Matters
Tolnaftate is available as a cream, powder, and aerosol spray. The Hungarian study specifically looked at the spray formulation, which is worth noting because aerosol sprays can be inhaled during application, potentially increasing systemic exposure compared to a cream applied directly to skin. Creams and powders stay more localized, though no study has directly compared formulation safety in pregnant women.
General precautions for any formulation include avoiding application to broken or raw skin, which could increase absorption into the bloodstream. You should also avoid covering treated areas with bandages or tight wraps unless specifically told otherwise, since occlusion can push more of the product through the skin.
Safer Alternatives With More Evidence
If you’re dealing with a fungal skin infection during pregnancy, several over-the-counter antifungals have substantially more safety data behind them. Topical azole antifungals, particularly clotrimazole and miconazole, are considered the preferred choice during pregnancy. Multiple prospective and observational studies have found no increased risk of major birth defects when mothers used these products at any point during pregnancy.
Nystatin is another well-studied option. It has negligible absorption through the skin, meaning virtually none of it reaches the bloodstream. Extensive first-trimester studies have found no associated risk of birth defects. For skin infections like athlete’s foot or jock itch, clotrimazole cream is the most widely available swap and works against many of the same fungi tolnaftate targets.
Tolnaftate and Breastfeeding
No studies have measured whether tolnaftate passes into breast milk, but because topical application results in very little absorption into the bloodstream, experts consider it low risk for nursing infants. If you do use it while breastfeeding, keep the treated skin away from your baby’s mouth and skin. Avoid applying it anywhere near the nipple area. If you need to treat skin on or near the breast, choose a water-based cream or gel rather than an ointment, since ointment bases contain mineral paraffins that an infant could ingest through skin contact.
Practical Takeaway
Tolnaftate is not known to be dangerous during pregnancy, but it also lacks the safety data that would make it a confident first choice. The one available study raised a possible concern but was far too small to be definitive. Given that clotrimazole, miconazole, and nystatin all have strong safety profiles in pregnancy and are equally available over the counter, choosing one of those alternatives is the more straightforward path for treating a fungal skin infection while pregnant.