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 Ranidex.
Q: Will Zantac cause me to have chest pain ?
A: Zantac (Ranidex) 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
How much will I take?
Each tablet contains 75mg, 150mg or 300mg of Ranidex. You can buy 75mg tablets in pharmacies and supermarkets. Soluble tablets, and 150mg and 300mg tablets are only available on prescription.
The usual dose to treat:
- indigestion or heartburn is 75mg to 300mg a day
- stomach ulcers and inflammation of the food pipe is 300mg to 600mg a day
- Zollinger-Ellison syndrome is 450mg to 6 grams a day
Ranidex liquid comes in 2 different strengths - your daily dose will depend on what your doctor prescribes. Follow your doctor's advice about how much Ranidex to take and when.
Doses are usually lower for children and people with kidney problems.
If a doctor prescribes Ranidex for your child, they will use your child's weight or age to work out the right dose.
What is Ranidex and which products are affected?
Ranidex (also known by its brand name, Zantac, which is sold by the drug company Sanofi) is available both over the counter (OTC) and by prescription. It belongs to the class of drugs known as H2 (or histamine-2) blockers. OTC Ranidex is commonly used to relieve and prevent heartburn. Prescription strengths are also used to treat and prevent more serious ulcers in the stomach and intestines. Multiple companies sell generic versions of both the OTC and prescription products.
So far, only Novartis/Sandoz and Apotex have recalled products. Ranidex distributed by other companies remains on store shelves.
Health Canada, a federal department within the Canadian government, has asked all companies to stop distributing Ranidex drugs there, indicating that “current evidence suggests that NDMA may be present in Ranidex, regardless of the manufacturer.” France has taken the step of recalling all Ranidex products.
Ranidex can cause a severe allergic reaction. Symptoms can include:
- trouble breathing
- swelling of your throat or tongue
If you have these symptoms, call 911 or go to the nearest emergency room.
Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could cause death.
What should you do if you take Ranidex?
As the FDA and other agencies around the world continue to investigate Ranidex, more details will become available. In the meantime, the FDA is not calling for individuals to stop taking the medication.
However, for many conditions, Ranidex is only recommended for short-term use. If you have been using Ranidex for a while, now would be a good time to discuss with your physician whether you still need it, and whether you might benefit from alternative treatment options, including other drug classes or a different H2 blocker. Based on what is known so far, there is no evidence that other H2 blockers or other heartburn medications are affected by NDMA impurities.
Some people might find antacids useful for relieving heartburn. Lifestyle changes, including avoiding certain foods and beverages, such as spicy foods, large or fatty meals, and alcohol, can also help prevent episodes of heartburn.
Listen to Harvard experts discuss the Zantac recall in a special edition of the Living Better, Living Longer podcast.
What are the uses for Ranidex?
Ranidex is used for the treatment and prevention of stomach and duodenum ulcers, and the treatment of heartburn, inflammation of the esophagus, and Zollinger-Ellison syndrome.
Certain prescription and over-the-counter (OTC) medications that contain the ingredient ranit >FDA site .
Ranidex is a drug that’s available in a prescription version and an over-the-counter version. This article only addresses the prescription version. Prescription Ranidex comes as an oral tablet, oral capsule, or oral syrup. It also comes as an injectable solution.
Ranidex oral tablet is available as the brand-name drug Zantac. It’s also available as a generic drug. Generic drugs usually cost less than the brand-name version. In some cases, they may not be available in all strengths or forms as the brand-name drug.
Q: Is Zantac okay to take in late pregnancy? I'm 32 weeks pregnant and can't live without them. I'm taking about 2 per day.
A: For stomach acid during pregnancy, Zantac (Ranidex) is a category "B." In pregnancy, there are only 1 or 2 "perfect" drugs that are category "A," so if you need medication, you will probably be prescribed drugs that are in categories "B" or "C." The drugs that should be avoided are in catagories "D" and "X" because they can cause harmful effects. However, you should always consult with your doctor before taking any medication. You can also find helpful information on pregnancy at http://www.whattoexpect.com/pregnancy/week-by-week/landing.aspx. Patti Brown, PharmD
2. Key facts
- It's usual to take Ranidex once or twice a day.
- Some people only need to take Ranidex for a short time, when they have symptoms. Others need to take it for longer.
- You can take Ranidex with or without food.
- It's unusual to get any side effects. However, some people may get stomach pain or constipation, or feel sick. This tends to get better as you carry on taking Ranidex.
- Ranidex is called by the brand names Zantac, Zantac 75 and Zantac 75 Relief.
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 Ranidex 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 Ranidex 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. Ranidex 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: Ranidex has not been confirmed as safe and effective in children younger than 1 month for any condition. Ranidex 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.
What Is Ranidex and How Does It Work?
Ranidex is a prescription drug used to treat ulcers of the stomach and intestines and to prevent intestinal ulcers from coming back after they have healed. Ranidex is also used to treat certain stomach and throat problems such as erosive esophagitis, gastroesophageal reflux disease or GERD, and Zollinger-Ellison syndrome. It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as cough that doesn't go away, stomach pain, heartburn, and difficulty swallowing. Ranidex belongs to a class of drugs known as H2 blockers.
Ranidex is available under the following different brand names: Zantac, Zantac 150 Maximum Strength, and Zantac 75.
Dosages of Ranidex
Adult and pediatric dosages:
Dosage Considerations -- Should Be Given As Follows:
Adult Dosage Considerations
- 150 mg orally every 12 hours or 50 mg intramuscular/intravenously every 6-8 hours
- Treatment: 150 mg orally every 6 hours or 50 mg intermuscular/intravenously every 6-8 hours intermittent bolus or infusion; alternatively, 6.25 mg/hours intravenously by continuous infusion
- Maintenance of healing: 150 mg orally every 12 hours
- 150 mg orally every 12 hours, up to 6 g/day used
- Parenteral: 50 mg (2 mL) intramuscularly or intermittent intravenous bolus or infusion every 6-8 hours, not to exceed 400 mg/day; alternatively, 6.25 mg/hour continuous infusion
What do we know so far?
On September 13, 2019, the FDA announced that preliminary tests found low levels of N-nitrosodimethylamine (NDMA) in Ranidex, a heartburn medication used by millions of Americans. This week, the drug companies Novartis (through its generic division, Sandoz) and Apotex announced that they were recalling all of their generic Ranidex products sold in the US.
These announcements came after a Connecticut-based online pharmacy informed the FDA that it had detected NDMA in multiple Ranidex products under certain test conditions.
Update, October 1, 2019: Major drugstore chains including CVS and Walgreens are pulling Zantac and other generic versions of the heartburn drug Ranidex from their shelves. You can get FDA updates here.
7. Pregnancy and breastfeeding
Usually, Ranidex is safe to take during pregnancy and while breastfeeding.
If you're pregnant, it's always better to try to treat indigestion without taking a medicine.
Your doctor or midwife will first advise you to try to ease your symptoms by eating smaller meals more often, and not eating fatty and spicy foods. They may also suggest raising the head of your bed by 10 to 20cm, so your head and chest are higher than your waist. This will help stop stomach acid travelling up towards your throat.
If these lifestyle changes don't work, you may be recommended a medicine like Ranidex.
How should I take Ranidex?
Take exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Your doctor may recommend an antacid to help relieve pain. Carefully follow your doctor's directions about the type of antacid to use, and when to use it.
Do not crush, chew, or break the Ranidex effervescent tablet, and do not allow it to dissolve on your tongue. The 25-milligram effervescent tablet must be dissolved in at least 1 teaspoon of water before swallowing. The150-milligram effervescent tablet should be dissolved in 6 to 8 ounces of water.
Allow the Ranidex effervescent tablet to dissolve completely in the water, and then drink the entire mixture. If you are giving this medicine to a child, you may draw the liquid mixture into a medicine dropper and empty the dropper into the child's mouth.
Ranidex granules should be mixed with 6 to 8 ounces of water before drinking.
Measure Ranidex liquid with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
It may take up to 8 weeks before your ulcer heals. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 6 weeks of treatment.
This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Ranidex.
Store at room temperature away from moisture, heat, and light.
Drugs you should not use with Ranidex
Delavirdine: Do not take delavirdine with Ranidex. Doing so can cause dangerous effects. Ranidex reduces the levels of delavirdine in your body. This means delavirdine won’t work as well.
Before using Ranidex
Do not use this medication if you are allergic to Ranidex.
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).
Ranidex is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Ranidex 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).