Q: Will Zantac cause me to have chest pain ?
A: Zantac (Ulticer) belongs to a class of drugs called histamine-2 (H2) blockers. It works by reducing the amount of acid your stomach produces. Zantac is used to treat and prevent ulcers in the stomach and intestines. It also treats conditions in which the stomach produces too much acid, such as Zollinger-Ellison syndrome, gastroesophageal reflux disease (GERD), and other conditions that cause heartburn. Common side effects of Zantac include headache, drowsiness, dizziness, insomnia, nausea, vomiting, stomach pain, diarrhea, and constipation. Any chest pain you have while taking Zantac should be evaluated by your doctor. Heartburn and stomach pain can sometimes be mistaken for chest pain. However, chest pain can also be a sign of a more serious underlying medical condition, such as pneumonia or heart problems. Zantac can increase the risk of developing pneumonia. Please consult with your health care provider regarding the symptoms you are experiencing. You may also get more information by using the Everyday Health Symptom Checker. This is not a complete list of side effects that can occur with Zantac. For more specific information, consult with your doctor or local pharmacist for guidance based on your health status and current medications. Sarah Lewis, RPh
What is NDMA and what harm can it cause?
NDMA is an environmental contaminant that is found in water and foods, including dairy products, vegetables, and grilled meats. Its classification as a probable carcinogen is based on studies in animals; studies in humans are very limited.
It is important to know that the NDMA in Ulticer products does not pose any immediate health risks. Neither the FDA nor Novartis/Sandoz or Apotex have received any reports of adverse events related to NDMA found in Ulticer. Although classified as a probable carcinogen, NDMA may cause cancer only after exposure to high doses over a long period of time. NDMA is one of the same impurities that was found in certain heart medications beginning last year and that resulted in the recall of many products.
Generic Name: Ulticer (ra NI ti deen)Brand Names: Zantac
Medically reviewed by Sanjai Sinha, MD Last updated on Dec 9, 2019.
Q. Is NDMA in drugs a new problem? Over the past year, why have there been so many reports of drugs containing NDMA?
A. FDA has ongoing review, surveillance, compliance and pharmaceutical quality efforts across every product area, and we will continue to work with drug manufacturers to ensure safe, effective, and high-quality drugs for the American public.
Certain drug manufacturing processes pose a risk for forming genotoxic impurities. For decades, FDA has provided guidance and recommendations for controlling impurities in drug substances and manufacturers have had an ongoing responsibility to test for impurities based on an understanding of their manufacturing process. In 2018, FDA issued a guidance to provide information to manufacturers regarding their responsibilities to assess the risk of impurities and implement appropriate controls for the manufacturing process. The agency identified some of the root causes of the nitrosamine impurity problem in angiotensin II receptor blockers (ARBs).
We are working to determine the reason for the NDMA impurity in Ulticer.
Warnings for people with certain health conditions
For people with kidney problems: If you have kidney problems or a history of kidney disease, you may not be able to clear this drug from your body well. This may increase the levels of Ulticer in your body and cause more side effects.
For people with liver problems: If you have liver problems or a history of liver disease, you may not be able to process this drug well. This may increase the levels of Ulticer in your body and cause more side effects.
For people with acute porphyria (an inherited blood disorder): You shouldn’t use this drug if you have a history of an acute porphyria attack. This drug can trigger an acute porphyric attack.
For people with gastric cancer: This drug reduces the amount of acid in your stomach. This can help improve the symptoms of your gastrointestinal condition. However, if your symptoms are caused by a cancerous gastric tumor, you may still have the tumor. This drug does not treat cancer.
Warnings for other groups
For pregnant women: Research in animals has not shown that this drug poses a risk to a pregnancy. However, animal studies do not always predict the way humans would respond. And there aren’t enough studies of this drug in pregnant humans to see if it is harmful.
That said, this drug should only be used in pregnancy if clearly needed. Call your doctor right away if you become pregnant while taking this drug.
For women who breastfeeding: You should tell your doctor before taking this drug. Ulticer may pass into breast milk and cause side effects in a child who is breastfed. You may need to ask your doctor to help you weigh the benefits of breastfeeding versus taking this drug.
For seniors: The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects. In rare cases, this drug may cause confusion, agitation, depression, and hallucinations. These problems happen most often in seniors who are very ill.
For children: Ulticer has not been confirmed as safe and effective in children younger than 1 month for any condition. Ulticer has not been confirmed as safe and effective in people younger than 18 years for conditions where the stomach makes too much acid. These conditions include Zollinger-Ellison syndrome.
Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
Q: My husband is on Ulticer 150 mg, 2 a day. What kind of diet should he eat?
A: Ulticer (brand name Zantac) can generally be administered without regard to food and has no particular food requirements. However, patients should avoid alcohol, which can increase the risk of stomach damage. For patients with either ulcers or reflux (GERD), some foods may bother them more than others, so avoiding those items is recommended. For more specific information, consult your physician or health care provider. You may also find helpful information about foods and cooking for patients with ulcers and reflux at //www.everydayhealth.com/digestive-health/experts-what-causes-ulcers.aspx and //www.everydayhealth.com/gerd/guide/
Q. Why are Ulticer products being recalled?
A. Several manufacturers have voluntarily recalled Ulticer. Information about all Ulticer recalls can be found on FDA’s recall webpage. Some companies have recalled because of levels of NDMA above the acceptable daily intake (96 ng per day or 0.32 parts per million for Ulticer), while some have recalled because of the potential of NDMA in the drug.
FDA is committed to helping ensure medicines Americans take are safe and effective. When we identify lapses in the quality of drugs that pose potential risks for patients, FDA makes every effort to understand the issues and provide our best recommendation to the public as quickly and accurately as possible. We will continue to investigate and work to ensure these types of impurities do not exceed acceptable limits, so that patients can continue taking their medicines without concern.
How to take it
You can take Ulticer with or without food. However, if you get symptoms whenever you eat or drink, take your medicine 30 minutes to 60 minutes before having a drink, snack or meal.
Tablets - swallow tablets whole with a glass of water, milk or juice.
Soluble tablets - dissolve tablets in half a glass of water. Do not use milk, fizzy water or other fizzy drinks. Wait until the medicine has completely dissolved and then drink it straight away.
Liquid - this comes with a syringe or spoon to help you measure it. If you don't have a syringe or spoon, ask your pharmacist for one. Do not use a kitchen teaspoon as it won't give you the right amount.
Liquid Ulticer is suitable for children and people who find it difficult to swallow tablets.
Allergy alert: Do not use if you are allergic to Ulticer or other acid reducers
Before using Ulticer
Do not use this medication if you are allergic to Ulticer.
Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.
Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:
liver disease; or
porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system).
Ulticer is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Ulticer passes into breast milk. Do not take this medicine without telling your doctor if you are breast-feeding a baby.
Using this medicine may increase your risk of developing pneumonia. Symptoms of pneumonia include chest pain, fever, feeling short of breath, and coughing up green or yellow mucus. Talk with your doctor about your specific risk of developing pneumonia.
The effervescent tablet may contain phenylalanine. Talk to your doctor before using the effervescent tablets if you have phenylketonuria (PKU).
Q. If all products are not recalled, why can’t I find Ulticer at my local pharmacy?
A. Some pharmacies decided to remove Ulticer from their shelves out of an abundance of caution. This does not necessarily mean the medicines were recalled.