Zyrtec

THE SAFETY OF XYZAL (LEVOCETIRIZINE) 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 CAN CAUSE HARM TO YOUR BABY:

Levocetirizine should only be used during pregnancy if medically necessary, as determined by your doctor. No adequate or well-controlled studies have looked at the use of levocetirizine during pregnancy. Due to the lack of data, some expert sources recommend treatment with alternative antihistamines that have been studied more thoroughly in pregnancy. Additionally, taking levocetirizine during the last 2 weeks of pregnancy may increase the risk of abnormal eye development in your baby, which could lead to blindness.

What is Xyzal (levocetirizine)?

Xyzal is a second generation antihystamine medication that is taken to relieve symptoms caused by allergies. It contains the active ingredient levocetirizine and is available as oral tablets or liquid. Xyzal only needs to be taken once daily. This medication can be purchased without a prescription. Always check with your doctor first before using any product containing levocetirizine.

What is Xyzal (levocetirizine) used to treat?

Levocetirizine can temporarily reduce symptoms of sneezing, runny nose, itchy nose or throat, and red, itchy, or watery eyes caused by indoor and outdoor allergies to dust, mold, pollen, pet dander, or other substances. It can be used to treat seasonal or perennial allergies. People with seasonal allergies only develop symptoms during certain times of the year, while those with perennial allergies have symptoms year-round. Levocetirizine only needs to be taken once daily and can help prevent symptoms throughout the day. This medication can also be used to treat prolonged cases of hives.

How does Xyzal (levocetirizine) work?

Levocetirizine is an antihistamine, meaning that it blocks some of the effects of histamine. Histamine is a chemical that is produced in your body when you are exposed to an allergen, such as pollen, mold, or dust. Sneezing, runny nose, itchy eyes, and other symptoms associated with allergies are caused by histamine. By reducing the effects of histamine, levocetirizine can improve allergy symptoms.

If I am taking Xyzal (levocetirizine), can it harm my baby?

Levocetirizine should only be taken during pregnancy if medically necessary, as determined by your doctor. It is unknown if levocetirizine can cross the placenta to reach the developing baby. Animal studies have not associated levocetirizine with a higher risk of birth defects, and only one small study in humans has looked at the safety of levocetirizine during pregnancy. The study found that the use of cetirizine (an antihistamine that is similar to levocetirizine) or levocetirizine during pregnancy was not associated with an increased risk of birth defects. However, very few of the expecting moms were taking levocetirizine (144 took cetirizine, and 6 took levocetirizine). The authors concluded that more studies are needed to determine the risks associated with these medications during pregnancy. Due to the lack of data, some experts recommend using an alternative antihistamine to treat expecting moms. 

Additionally, a study found that taking any antihistamine during the last 2 weeks of pregnancy could harm your baby. The study found a higher risk of retrolental fibroplasia (a condition causing abnormal eye development, which could lead to blindness) in expecting moms who took any antihistamine during the last 2 weeks of pregnancy.

Bottom line: Levocetirizine should only be used during pregnancy if medically necessary, as determined by your doctor. No adequate or well-controlled human studies have looked at the use of levocetirizine in pregnancy, and the effects of this medication on your growing baby are unknown. Taking any antihistamine during the last 2 weeks of pregnancy may increase the risk of abnormal eye development in your baby.

If I am taking Xyzal (levocetirizine) and become pregnant, what should I do?

If you become pregnant while taking levocetirizine, you should contact your doctor immediately. Your doctor will determine if levocetirizine is medically necessary, or if it should be discontinued until after the birth of your baby.

If I am taking Xyzal (levocetirizine), can I safely breastfeed my baby?

The use of levocetirizine while breastfeeding is not recommended. However, your doctor will evaluate the potential risks of levocetirizine to your baby and determine if this medication is medically necessary. No human or animal studies have looked at the safety of levocetirizine while breastfeeding. This medication is expected to pass into breast milk and could cause side effects, including sleepiness or irritability, in the breastfed baby. Despite these possible risks, levocetirizine has a lower likelihood of causing sleepiness than some other antihistamines and may be preferred by your doctor. Although some expert sources consider occasional low doses of levocetirizine to be probably acceptable while breastfeeding, higher doses or those taken for longer time periods may cause sleepiness or other effects in the breastfed baby. 

Bottom line: The use of levocetirizine is not recommended while breastfeeding. There have been no studies of the effects of levocetirizine on the breastfed baby. Levocetirizine is expected to pass into breast milk and could cause sleepiness or irritability in your baby.

If I am taking Xyzal (levocetirizine), will it be more difficult to get pregnant?

No human studies have looked at the effects of levocetirizine on fertility. Animal studies have found that levocetirizine did not affect fertility. 

If I am taking Xyzal (levocetirizine), what should I know?

Levocetirizine should only be used during pregnancy if medically necessary, as determined by your doctor. The limited data available on the use of levocetirizine in pregnancy consists of 6 expecting moms. More studies are needed to determine the potential effects of levocetirizine on the developing baby. Due to the lack of data, some expert sources recommend using an alternative antihistamine. Additionally, taking any antihistamine within the last 2 weeks of pregnancy could increase the risk of abnormal eye development in your baby.

The use of levocetirizine is not recommended in breastfeeding moms. This medication is expected to pass into breast milk and could cause sleepiness or other side effects in the breastfed baby.

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

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

You may find Pregistry's expert report about allergic rhinitis here, reports about various other health conditions as well as the individual medications used to treat allergies and other conditions here.   Additional information can also be found in the resources below. 

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

Xyzal.com: Xyzal Allergy 24Hr 

WebMD: What are Histamines?

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.