THIS MEDICATION CAN CAUSE HARM TO YOUR BABY:
Zantac (ranitidine) should only be used during pregnancy if medically necessary, as determined by your doctor. Several studies have found that the use of ranitidine during pregnancy did not increase the risk of birth defects. However, ranitidine may increase the risk of premature delivery and that your baby will develop childhood asthma.
IMPORTANT NOTICE: Apotex Corp., the manufacturer of ranitidine (the active ingredient in Zantac), is voluntarily recalling Ranitidine Tablets 75mg and 150mg (All pack sizes and Formats) to the Retail level. Apotex has learned from the U.S. Food and Drug Administration and other Global regulators that some ranitidine medicines including brand and generic formulations of ranitidine regardless of the manufacturer, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA), which is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. Please, consult with your doctor immediately if you are using any product containing ranitidine.
What is Zantac (ranitidine)?
Zantac is a medication that is taken to reduce stomach acid associated with heartburn. Heartburn is a burning sensation in your throat or chest that usually occurs after eating.This burning is caused by stomach acid. People with heartburn may also experience a sour or acidic taste. Some people experience heartburn occasionally after eating certain foods or drinking caffeinated beverages or alcohol. Other people experience heartburn more frequently and may have gastroesophageal reflux disease (GERD). Zantac contains the active ingredient ranitidine. Ranitidine is available as oral tablets, capsules, syrup, and an injectable solution that is given intravenously (into a vein in your arm) by a healthcare professional. Some forms of ranitidine are available without a prescription from your doctor. Always check with your doctor before using any product containing ranitidine.
What is Zantac (ranitidine) used to treat?
Ranitidine is taken to relieve heartburn associated with acid indigestion and sour stomach. It is used to treat gastroesophageal reflux disease (GERD) and conditions that cause too much stomach acid production. Ranitidine can also be used as part of a treatment plan to heal stomach ulcers and damage to the esophagus caused by long-term exposure to stomach acid.
What is GERD?
In GERD, the muscle separating your esophagus from your stomach does not work properly. This causes stomach acid to flow into your esophagus (acid reflux). If you have acid reflux, you may experience heartburn or have a sour taste in the back of your throat. People with GERD have acid reflux that occurs at least twice per week and lasts for several weeks. GERD can produce more serious symptoms, such as difficulty swallowing, coughing, vomiting, pain in the upper chest, and lung problems. The esophagus can also become injured because it is continuously being exposed to stomach acid. During pregnancy, changes in your body’s hormones can increase the likelihood that you will develop GERD. You can read more about GERD during pregnancy here.
How does Zantac (ranitidine) work?
Ranitidine is called an H2-blocker because it blocks some of the effects of histamine in your stomach cells. Histamine is a natural chemical that promotes the release of stomach acid. By blocking the effects of histamine in stomach cells, stomach acid is reduced.
If I am taking Zantac (ranitidine), can it harm my baby?
Ranitidine should only be used during pregnancy if medically necessary, as determined by your doctor. This medication crosses the human placenta to reach the developing baby. Although many studies have found no increased risk of birth defects or other birth complications with the use of ranitidine during pregnancy, one study found that this medication increased the risk of premature birth. In addition, some studies have shown that taking an H2-blocker while pregnant can increase the risk that your baby will develop childhood asthma. Despite potential risks, some experts consider ranitidine to be compatible with pregnancy since it has not been associated with a higher risk of birth defects.
EVIDENCE:
Birth Defects and Birth Outcomes
A large study that looked at 2,398 babies who were exposed to an H2-blocker during pregnancy found that H2-blockers were not associated with a higher risk of birth defects. They also found no increased risk of premature birth, miscarriage, or intrauterine growth restriction (when babies are born smaller than normal for their age) in expecting moms who used an H2-blocker. The study concluded that H2-blockers can be used safely in pregnancy to manage heartburn and GERD.
Another study looked at 178 expecting moms who took an H2-blocker (71% of whom took ranitidine) during the first trimester of pregnancy compared to expecting moms who were not exposed to an H2-blocker. No increased rate of birth defects was observed. The study also observed no significant differences in birth weight, age at birth, or number of miscarriages or stillbirths.
Several other studies have not associated the use of ranitidine with a higher risk of birth defects, including studies that looked at pregnancy outcomes for: 156 expecting moms who took ranitidine early in pregnancy; 322 expecting moms who took ranitidine; and 276 expecting moms who took ranitidine during the first trimester of pregnancy.
Although many studies have not associated ranitidine with birth defects, one study found that ranitidine may have increased the risk of premature birth. The study found a higher number of premature deliveries among 335 expecting moms who took ranitidine. No increased risk of birth defects was observed.
Administering ranitidine during labor may also cause severe reactions that could harm your baby. Severe, life-threatening allergic reactions were observed in 4 expecting moms who received ranitidine intravenously (by injection into a vein) during labor. Of these, 2 babies developed low heart rate, which normalized before birth, and the third baby was normal at delivery. The fourth expecting mom developed severe low blood pressure and required emergency cesarean section. The baby had a low heart rate and suffered from seizure-like movement, which required treatment with a prescription medication.
Allergic Disease
Researchers have recently discovered that taking a medication that reduces stomach acid during pregnancy may increase the likelihood that your baby will develop allergic diseases as a child. One study looked at 1613 children whose moms had taken an H2-blocker while pregnant and found that exposure to an H2-blocker during pregnancy increased the risk of childhood asthma by 41%.
Bottom line: Ranitidine should only be used during pregnancy if medically necessary, as determined by your doctor. This medication crosses the placenta and could expose your baby to its effects. Based on current data, several studies have not associated ranitidine with a higher risk of birth defects. However, taking ranitidine during pregnancy may increase the chances of premature birth and that your baby will develop childhood asthma.
If I am taking Zantac (ranitidine) and become pregnant, what should I do?
If you are taking ranitidine and become pregnant, you should contact your doctor immediately. Your doctor will determine if ranitidine is medically necessary, or if it should be discontinued until after the birth of your baby.
If I am taking Zantac (ranitidine), can I safely breastfeed my baby?
Caution should be used if ranitidine is taken by breastfeeding moms. This medication passes into breast milk. Ranitidine is occasionally prescribed to newborn babies, and the amount of ranitidine in breast milk is less than the dose prescribed to a newborn. Ranitidine is not expected to cause
side effects in breastfed babies. There is very little data available on the safety of ranitidine while breastfeeding. One report described a breastfeeding mom who took ranitidine twice daily for 2 days. No side effects were observed in the breastfed baby. Ranitidine lowers stomach acid, and it is unknown if long-term exposure to ranitidine from breast milk could have effects on the breastfed baby. Your doctor will evaluate the possible risks of ranitidine to your baby and determine if treatment is medically necessary.
Bottom line: Caution should be used in breastfeeding moms who are taking ranitidine. Ranitidine passes into breast milk, and there is very little data available on its effects in the breastfed baby.
If I am taking Zantac (ranitidine), will it be more difficult to get pregnant?
Very little data is available on the effects of ranitidine on fertility. Some animal studies have shown that H2-blockers have anti-fertility properties and can prevent implantation of a fertilized egg in females. In addition to the effects observed in female animals, ranitidine may impair fertility in men. A study found that cimetidine, another H2-blocker, negatively affected semen quality and could potentially impair fertility in men. However, the effects of ranitidine on semen quality were unclear. Ranitidine can also cause loss of sexual function in men.
If I am taking Zantac (ranitidine), what should I know?
Always ask your doctor before taking ranitidine if you are pregnant or breastfeeding.
Ranitidine should only be used during pregnancy if medically necessary, as determined by your doctor. Many studies have found that taking ranitidine during pregnancy was not associated with a higher risk of birth defects, but it may increase the risk of premature birth and childhood asthma.
Caution should be used if ranitidine is taken by breastfeeding moms. This medication passes into breast milk, and the long-term effects of ranitidine exposure to the breastfed baby are unknown.
If I am taking any medication, what should I know?
This report provides a summary of available information about the use of Zantac (ranitidine) during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.
You may find Pregistry's expert report about GERD here, and reports about the various medications used for digestive system disorders here. Additional information can also be found in the resources below.
For more information about Zantac (ranitidine), heartburn, and GERD during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following links:
U.S. National Library of Medicine: Heartburn
Mayo Clinic (2018). Gastroesophageal reflux disease (GERD)
U.S. Department of Health and Human Services: Symptoms & Causes of GER & GERD
Lexicomp: Ranitidine: Drug Information
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.