What is Ulcaid and which products are affected?
Ulcaid (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 Ulcaid 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. Ulcaid distributed by other companies remains on store shelves.
Health Canada, a federal department within the Canadian government, has asked all companies to stop distributing Ulcaid drugs there, indicating that “current evidence suggests that NDMA may be present in Ulcaid, regardless of the manufacturer.” France has taken the step of recalling all Ulcaid products.
Q. Why are Ulcaid products being recalled?
A. Several manufacturers have voluntarily recalled Ulcaid. Information about all Ulcaid 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 Ulcaid), 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.
What is the most important information I should know about Ulcaid?
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.
Do not use this medication if you are allergic to Ulcaid.
Ask a doctor or pharmacist if it is safe for you to take this medicine if you have kidney disease, liver disease, or porphyria.
Using Ulcaid 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.
Ulcaid granules and effervescent tablets must be dissolved in water before you take them.
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.
Avoid drinking alcohol. It can increase the risk of damage to your stomach.
It may take up to 8 weeks of using this medicine before your ulcer heals. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 6 weeks of treatment.
COMMON BRAND(S): Zantac
GENERIC NAME(S): Ulcaid Hcl
Ulcaid is used to treat ulcers of the stomach and intestines and prevent them from coming back after they have healed. This medication is also used to treat certain stomach and throat (esophagus) problems (such as erosive esophagitis, gastroesophageal reflux disease-GERD, 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. Ulcaid belongs to a class of drugs known as H2 blockers.
This medication is also available without a prescription. It is used to prevent and treat heartburn and other symptoms caused by too much acid in the stomach (acid indigestion). If you are taking this medication for self-treatment, it is important to read the manufacturer's package instructions carefully so you know when to consult your doctor or pharmacist.
What do we know so far?
On September 13, 2019, the FDA announced that preliminary tests found low levels of N-nitrosodimethylamine (NDMA) in Ulcaid, 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 Ulcaid products sold in the US.
These announcements came after a Connecticut-based online pharmacy informed the FDA that it had detected NDMA in multiple Ulcaid 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 Ulcaid from their shelves. You can get FDA updates here.
Supplies of Ulcaid are currently very limited. This is due to a possible risk with the ingredients.
Try to speak to your doctor before your Ulcaid runs out. There are similar medicines they can prescribe for you if you still need it. In the meantime, keep taking your medicine as usual.
If you have any concerns, speak to your pharmacist or doctor.
Ulcaid reduces the amount of acid your stomach makes.
It's used for indigestion and heartburn and acid reflux. It is also used for gastro-oesophageal reflux disease (GORD) - this is when you keep getting acid reflux. Ulcaid is also taken to prevent and treat stomach ulcers.
Sometimes, Ulcaid is taken for a rare illness caused by a tumour in the pancreas or gut called Zollinger-Ellison syndrome.
Ulcaid comes as tablets, soluble (dispersible) tablets that dissolve in water to make a drink, or as a liquid that you drink.
All types of Ulcaid are available on prescription. You can also buy the lowest strength 75mg tablets from pharmacies and supermarkets.
What to do about:
- stomach pains - try to rest and relax. It can help to eat and drink slowly and have smaller and more frequent meals. Putting a heat pad or covered hot water bottle on your stomach may also help. If you are in a lot of pain, speak to your pharmacist or doctor.
- constipation - eat more high-fibre foods such as fresh fruit and vegetables and cereals, and drink plenty of water. Try to exercise, for example, by going for a daily walk or run. If this doesn't help, talk to your pharmacist or doctor.
- feeling sick - it may help if you don't eat rich or spicy food while you're taking Ulcaid.
What Other Drugs Interact with Ulcaid?
If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.
There are no severe interactions with Ulcaid.
Serious Interactions of Ulcaid include:
Ulcaid has moderate interactions with at least 51 different drugs.
Mild Interactions of Ulcaid include:
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.
What other drugs will affect Ulcaid?
Before taking Ulcaid, tell your doctor if you are taking triazolam (Halcion). You may not be able to use Ulcaid, or you may need dosage adjustments or special tests during treatment.
There may be other drugs that can interact with Ulcaid. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Generic Name: Ulcaid (ra NI ti deen)Brand Names: Zantac
Medically reviewed by Sanjai Sinha, MD Last updated on Dec 9, 2019.
Q: Will Zantac cause me to have chest pain ?
A: Zantac (Ulcaid) 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 Ulcaid, and how does it work (mechanism of action)?
Ulcaid is an oral drug that blocks the production of acid by acid-producing cells in the stomach. It belongs to a class of drugs called H2 (histamine-2) blockers that also includes cimetidine (Tagamet), nizatidine (Axid), and famotidine (Pepcid). Histamine is a naturally occurring chemical that stimulates cells in the stomach (parietal cells) to produce acid. H2-blockers inhibit the action of histamine on the cells, thus reducing the production of acid by the stomach. Since excessive stomach acid can damage the esophagus, stomach, and duodenum and lead to inflammation and ulceration, reducing stomach acid prevents and heals acid-induced inflammation and ulcers. The FDA approved Ulcaid in October 1984.