Terbinafine Pregnancy Category: Is it Safe? Risks & Guide

Terbinafine is an antifungal medication that comes in both topical and oral forms. It’s often prescribed to treat fungal infections of the nails, skin, and scalp.

If you’re pregnant or planning to become pregnant, you might wonder about the safety of taking this medication. What is the terbinafine pregnancy category? What do we know about its potential effects on a developing baby?

This article will delve into the available data and recommendations regarding terbinafine use during pregnancy and breastfeeding. However, it’s essential to remember that this information is for educational purposes only. Always consult with your healthcare provider for personalized advice regarding any medication use during pregnancy.

Terbinafine: Pregnancy category and what that means

The FDA uses letter categories to describe the risk a medication may pose to a developing baby.

FDA Pregnancy Categories

The FDA has given topical terbinafine a pregnancy category of B. That means that high doses of the drug didn’t cause birth defects when given to animals. However, there haven’t been enough well-designed studies in pregnant women to know for sure.

Terbinafine tablets are generally not recommended during pregnancy. If a pregnant person needs terbinafine, the benefit of using it should clearly outweigh any potential risks to the fetus.

Topical vs. oral terbinafine

Terbinafine cream, gel, spray, and solution are less likely to harm a baby during pregnancy because only a small amount of the medication gets absorbed into the bloodstream.

Oral terbinafine presents a higher potential risk because more of the drug circulates throughout the body.

Some experts recommend waiting until after pregnancy to treat nail fungus (onychomycosis) or ringworm of the scalp (tinea capitis).

Animal studies

Animal studies using high doses of terbinafine given by mouth or injection have not revealed evidence of birth defects.

Giving rats and rabbits doses of terbinafine hydrochloride up to 300 mg/kg/day did not cause birth defects. These doses are much higher than what a person would be exposed to from the recommended dose of topical terbinafine.

Terbinafine and Breastfeeding

A small amount of terbinafine does pass into breast milk.

Research has found that after a 500 mg oral dose, between 0.03 percent and 0.13 percent of the terbinafine ends up in breast milk. That’s between 0.15 mg and 0.65 mg of terbinafine that a baby could ingest.

Topical Application and Breastfeeding

Terbinafine cream, gel, spray, and solution are unlikely to get into breast milk and cause side effects in a baby. When you apply terbinafine to your skin, only a tiny amount is expected to pass into your breast milk.

However, if you are breastfeeding, you should not apply terbinafine to your breasts. Make sure to wash your hands well after you apply topical terbinafine.

Oral Terbinafine and Breastfeeding

There isn’t much data available on how much of a terbinafine tablet passes into breast milk, but the amounts are probably small. If you are breastfeeding and taking terbinafine tablets, you may want to consider using a different antifungal medication.

If you continue to take oral terbinafine, watch the baby for signs of:

  • feeding problems
  • stomach upset
  • jaundice
  • rash

Some experts say that you shouldn’t breastfeed while you’re taking oral terbinafine.

Important Considerations and Recommendations

If you’re pregnant, breastfeeding, or trying to get pregnant, you should always consult with a healthcare professional before taking any medication, including terbinafine. They can help you weigh the risks and benefits in your specific situation and suggest other treatments if needed.

If you do take terbinafine while breastfeeding, keep a close eye on your baby for any potential side effects. The biggest concern is liver toxicity, so watch out for jaundice (yellowing of the skin or eyes), especially in younger babies who are exclusively breastfed.

Ultimately, the decision to use terbinafine while breastfeeding comes down to what’s most important for the mother’s health. The drug company recommends either stopping the medication or stopping breastfeeding, depending on the drug’s importance to the mother’s well-being. Also, while terbinafine probably won’t hurt your fertility, it’s still a good idea to let your doctor know if you’re trying to conceive.

Frequently Asked Questions

What antifungal is pregnancy category B?

Clotrimazole, nystatin (topical), and miconazole are examples of antifungals that are generally considered pregnancy category B. This means animal studies haven’t shown a risk to the fetus, but there aren’t adequate and well-controlled studies in pregnant women. Always consult with your doctor before taking any medication during pregnancy.

Why can’t you take fluconazole when pregnant?

High doses of fluconazole have been linked to birth defects in some studies. While a single, low dose might be considered in specific circumstances, it’s generally avoided, especially during the first trimester. Safer alternatives are usually preferred during pregnancy.

Why was terbinafine discontinued?

Terbinafine hasn’t been discontinued; it’s still available by prescription. However, its use is carefully considered due to potential side effects, including liver issues. It’s important to discuss the risks and benefits with your doctor before taking it, especially if you have pre-existing liver problems.

What is the drug of choice for fungal infection in pregnancy?

The drug of choice depends on the type and location of the fungal infection. For vaginal yeast infections, topical antifungals like clotrimazole or miconazole are often preferred. Systemic antifungals are generally avoided unless absolutely necessary and prescribed by a doctor.

What does group B mean in pregnancy?

This likely refers to Group B Streptococcus (GBS), a type of bacteria that can be present in pregnant women. While usually harmless to the mother, it can sometimes cause infections in newborns. Pregnant women are routinely screened for GBS, and if positive, antibiotics are given during labor to protect the baby.

Final Thoughts

If you’re pregnant or breastfeeding and need to treat a fungal infection, topical terbinafine is generally considered safer than oral terbinafine, but there’s not a lot of data available either way, so you should be cautious.

The most important thing is to talk with a doctor or other qualified health professional before using terbinafine, or other medications such as gentian violet, if you are pregnant or breastfeeding. They can give you medical advice that’s specific to you and your situation.

Remember, the information in this article is for general knowledge only and should not be used in place of advice from a professional.