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THE SAFETY OF METRONIDAZOLE VAGINAL GEL 0.75% (VANDAZOLE) 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:

The use of metronidazole vaginal gel during pregnancy or breastfeeding should be limited only to women requiring this medication. First trimester use should be avoided.

What is metronidazole vaginal gel?

Metronidazole vaginal gel is an antibiotic medication applied inside the vagina. 

What is metronidazole vaginal gel used to treat?

Metronidazole vaginal gel is used to treat bacterial vaginosis, an infection of the vagina, in non-pregnant women. 

How does metronidazole vaginal gel work?

Metronidazole interferes with protein and DNA development in bacteria, killing bacteria that cause the infection.

If I am using metronidazole vaginal gel, can it harm my baby?

Metronidazole crosses the human placenta to reach the developing baby. Evidence on the safety of metronidazole during pregnancy confilcts between different studies. Some studies have identified an increased risk of birth defects or certain types of cancer in infants exposed in utero to metronidazole, while other studies have found no association between metronidazole and birth defects or cancer. Topical application of metronidazole is not expected to absorb as readily as oral forms of the medication. The manufacturer of metronidazole vaginal gel states that this medication should not be used during pregnancy; however, bacterial vaginosis during pregnancy can cause negative effects for mother and baby. The Centers for Disease Control and Prevention recommend vaginal metronidazole for bacterial vaginosis during pregnancy. Metronidazole for vaginosis should be avoided during the first trimester of pregnancy, but the medication may be used to treat vaginosis during the second or third trimester if no other treatment options are available.

If I am using metronidazole vaginal gel and become pregnant, what should I do?

Women who are trying to become pregnant or discover they are pregnant should speak with their doctor before using vaginal metronidazole. Alternative treatment options may be available. Metronidazole is not recommended during the first trimester of pregnancy.

If I am using metronidazole vaginal gel, can I safely breastfeed my baby?

Metronidazole does pass into breast milk. Exposure of nursing infants to metronidazole should be limited to avoid any negative side effects. Topical and vaginal metronidazole are not expected to pose a high risk for nursing infants. Oral metronidazole may require discontinuation of breastfeeding for several hours (12-24 hours) to allow for elimination from the body before breastfeeding can be resumed. The manufacturer of this medication recommends either discontinuing this medication or discontinuing breastfeeding while taking this medication. Breastfeeding is not recommended in women on long-term metronidazole therapy.

If I am using metronidazole vaginal gel, will it be more difficult to get pregnant?

Metronidazole is not expected to negatively affect female fertility, but there is a possible risk of negative effects on male fertility.

If I am using metronidazole vaginal gel, what should I know?

It is important to speak with your doctor to discuss the safety of vaginal metronidazole exposure during pregnancy or breastfeeding. Limited information is available on the safety of vaginal metronidazole during pregnancy. Women using vaginal metronidazole should have clear indications for its use, with no other alternatives available. Breastfeeding is not recommended in women using long-term metronidazole.

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

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

You may find Pregistry's expert reports about infections here,  and reports about the individual medications used to treat infections here, and a report about bacterial vaginosis here.   Additional information can also be found in the resources below. 

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

Centers for Disease Control and Prevention: Bacterial Vaginosis

U.S. Food and Drug Administration:  Vandazole Prescribing Information

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.