Robitussin

THE SAFETY OF DEXTROMETHORPHAN DURING PREGNANCY OR BREASTFEEDING

The information provided below is for readers based in the United States of America. Readers outside of the United States of America should seek the information from local sources.

THIS MEDICATION IS UNLIKELY TO CAUSE HARM TO YOUR BABY:

Despite a limited number of studies in humans, dextromethorphan at recommended over-the-counter doses is generally considered safe during pregnancy or while breastfeeding. Formulations containing ethanol should not be used while pregnant or breastfeeding. It is important to talk to your doctor before using dextromethorphan during pregnancy.

What is dextromethorphan?

Dextromethorphan is a cough suppressant or antitussive medication currently available as a generic or brand name medication (Robitussin™, Delsym™). Dextromethorphan is available as a capsule, lozenge, oral solution, or in combination formulations. Combination formulations may contain ethanol, a type of alcohol, and these formulations should be avoided during pregnancy. It is important not to exceed the recommended number of doses per day (see product labeling). Dextromethorphan is available over-the-counter or by prescription. 

What is dextromethorphan used to treat?

Dextromethorphan is used to treat cough in children over 4 years old, adolescents, and adults. Studies suggest that dextromethorphan is one of the more commonly used over-the-counter medications during pregnancy. Many over-the-counter cough and cold medications contain dextromethorphan. While many cough and cold medications are considered relatively safe for short-term use during pregnancy, it is important to speak with your doctor before using any of these medications while you are pregnant. 

How does dextromethorphan work?

Dextromethorphan works by decreasing the sensitivity of cough receptors in the throat and suppressing the cough center in the brain. 

You can find information on the use of over-the-counter cough and cold medications during pregnancy here. Additional information on treating coughs during pregnancy is located here.

If I am taking dextromethorphan, can it harm my baby?

There are limited human studies evaluating the safety of dextromethorphan in human pregnancy. However, the popularity of dextromethorphan and a lack of reports of birth defects provide support for the medication’s safety during pregnancy. Dextromethorphan is generally considered safe during pregnancy when used at recommended doses. Use of this medication during pregnancy should be limited to women who have significant need for this medication. Contact your doctor before using this medication during pregnancy. 

Evidence from animal studies with dextromethorphan:

Unpublished studies in pregnant rats and rabbits have reported no harm to the offspring associated with dextromethorphan exposure at 20 and 100 times the recommended human dose. One published study exposed chicken embryos to dextromethorphan, finding increased embryo death and embryo defects at the highest doses used. However, results from this animal study have been heavily criticized due to the study design and chicken embryos serving as a poor model to equate to humans.

Evidence for the risks of dextromethorphan in human babies:

The use of dextromethorphan has not been associated with an increased risk of birth defects. The Collaborative Perinatal Project found no evidence of a link between dextromethorphan exposure during the first trimester and birth defects in 300 infants. Additional surveillance studies have reported no link between dextromethorphan exposure during pregnancy and birth defects. The Spanish Collaborative Study of Congenital Malformations found no increase in birth defects in babies exposed in utero to cough medications containing dextromethorphan. A 2001 study in 184 women compared women exposed to dextromethorphan in the first trimester to women not exposed to the medication during the same time period, finding no difference in outcomes such as birth defects, stillbirths, or birth weight. 

Formulations of dextromethorphan containing ethanol should not be used during pregnancy. A case report from 1981 described a baby born with facial deformities and symptoms of irritability and muscle tension that are consistent with fetal alcohol syndrome due to in utero exposure to dextromethorphan with ethanol. There have been case reports describing a pattern of birth defects affecting the genitals and urinary tract in infants exposure to dextromethorphan and doxylamine in utero. Subsequent analysis found no genetic basis for these birth defects, and the defects were thought to be caused by doxylamine exposure. Studies suggest individuals may metabolize or breakdown dextromethorphan differently. Therefore, there is a potential for unmetabolized dextromethorphan to build up in both the mother's and baby's circulation.

Bottom line: There is limited safety information on the use of dextromethorphan during pregnancy. Recommended doses of over-the-counter dextromethorphan are expected to be safe in pregnant women; however, consult your doctor before using this medication during pregnancy. It may be recommended to avoid formulations containing ethanol and dextromethorphan during pregnancy.

If I am taking dextromethorphan and become pregnant, what should I do?

If you are using dextromethorphan and become pregnant, you should contact your doctor immediately. Your doctor will determine if your medication is medically necessary, or if it should be discontinued until after the birth of your baby.

If I am taking dextromethorphan, can I safely breastfeed my baby?

Dextromethorphan is expected to pass into human breast milk. Formulations of dextromethorphan containing ethanol should not be used while breastfeeding. However, formulations without ethanol are considered safe during breastfeeding.

Bottom line: There is no evidence on the safety of dextromethorphan exposure in nursing infants, but it is expected to be safe to use while breastfeeding. Formulations containing dextromethorphan and ethanol should not be used while breastfeeding.

If I am taking dextromethorphan, will it be more difficult to get pregnant?

There is no information available on the impact of dextromethorphan on fertility.

If I am taking dextromethorphan, what should I know?

There is a lack of human studies evaluating the safety of dextromethorphan during pregnancy or breastfeeding; however, recommended over-the-counter doses of dextromethorphan (without ethanol) are generally considered safe during pregnancy and while breastfeeding. It is important to talk to your doctor before using this medication during pregnancy.

If I am taking any medication, what should I know?

This report provides a summary of the available information about the use of dextromethorphan during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.

You may find Pregistry's expert reports about the individual medications used to treat cough and cold symptoms here, and a report on having a cough during pregnancy here.   Additional information can also be found in the resources below. 

For more information about dextromethorphan during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following links:

National Center for Biotechnology Information:Dextromethorphan 

UCSF: Acute upper respiratory tract infection (cold)

Read the whole report
General information

It is very common for women to worry about having a miscarriage or giving birth to a child with a birth defect while they are pregnant. Many decisions that women make about their health during pregnancy are made with these concerns in mind.

For many women these concerns are very real. As many as 1 in 5 pregnancies end in a miscarriage, and 1 in 33 babies are born with a birth defect. These rates are considered the background population risk, which means they do not take into consideration anything about the health of the mom, the medications she is taking, or the family history of the mom or the baby’s dad. A number of different things can increase these risks, including taking certain medications during pregnancy.

It is known that most medications, including over-the-counter medications, taken during pregnancy do get passed on to the baby. Fortunately, most medicines are not harmful to the baby and can be safely taken during pregnancy. But there are some that are known to be harmful to a baby’s normal development and growth, especially when they are taken during certain times of the pregnancy. Because of this, it is important to talk with your doctor or midwife about any medications you are taking, ideally before you even try to get pregnant.

If a doctor other than the one caring for your pregnancy recommends that you start a new medicine while you are pregnant, it is important that you let them know you are pregnant.

If you do need to take a new medication while pregnant, it is important to discuss the possible risks the medicine may pose on your pregnancy with your doctor or midwife. They can help you understand the benefits and the risks of taking the medicine.

Ultimately, the decision to start, stop, or change medications during pregnancy is up to you to make, along with input from your doctor or midwife. If you do take medications during pregnancy, be sure to keep track of all the medications you are taking.