Ranitidine hydrochloride, sold under the brand name Zantac and others, is a popular drug used to treat heartburn, acid reflux and ulcers. The FDA ordered a full market withdrawal of ranitidine products in April 2020 after NDMA, a probable human carcinogen, was detected.
Ranitidine, sold under the brand name Zantac and others, is a popular drug used to treat various gastrointestinal issues. Ranitidine products work by decreasing stomach acid production, helping to prevent or temporarily relieve heartburn, acid reflux, ulcers, and other similar ailments.
It was discovered in England in 1977, came into commercial use in 1981, and went on to become one of the most commonly prescribed medications in the country. By 2019, there were over 13 million active ranitidine prescriptions in the United States alone. Certain preparations of ranitidine products also became available over the counter (OTC). For example, in the U.S., consumers could purchase 75 and 150-mg tablets OTC from their local drug stores until the FDA ordered a full market withdrawal of ranitidine products in April 2020.
Zantac is the most common brand name for the drug ranitidine hydrochloride, or ranitidine HCL. It was manufactured and sold by Sanofi in the United States. Before the FDA recalled all ranitidine products, generic ranitidine hydrochloride products were widely available from other manufacturers, including Apotex and Sandoz.
Zantac (ranitidine) was given in various forms, including capsules, tablets and syrups, as well as injectables. Prescription Zantac oral tablets and capsules could be taken once or twice daily, with or without food as directed by a doctor. Some patients were instructed to take Zantac up to 4 times a day. Ultimately, the exact dosage was based on the patient’s condition and responsiveness to treatment.
Patients who used nonprescription Zantac to treat symptoms of indigestion or heartburn took 1 tablet by mouth with a glass of water as needed. To prevent heartburn, patients could take 1 tablet by mouth 30-60 minutes before a meal. Zantac’s label directions warned not to take more than 2 tablets in a 24-hour period or for more than 14 days in a row, unless instructed by a doctor.
Common side effects of Zantac include diarrhea, constipation and headache. Some patients reported dizziness, skin rash, nausea, vomiting, stomach cramps and drowsiness. In rare circumstances, especially among the elderly or those who were especially ill, there were reports of central nervous system issues (including depression and hallucinations), cardiovascular trouble (such as tachycardia), and issues impacting the liver and lungs.
Overdosing on Zantac or other ranitidine products is very rare, but not impossible. Taking much more than the recommended dosage of prescription or OTC Zantac could build up dangerous levels of the drug in the body. Symptoms of a Zantac overdose typically include trouble walking and low blood pressure that results in dizziness or fainting.
Because ranitidine products like Zantac work by decreasing the amount of acid your stomach produces, it should not be taken with other drugs that need stomach acid to help the body properly absorb them. This could include certain azole antifungals (like itraconazole), atazanavir, delaviridine, pazopanid and dasatinib, among others. Importantly, Zantac shouldn’t be taken with other products that contain ranitidine or other H2 blockers, including cimetidine, famotidine and nizatidine.
In September 2019, a probable carcinogen (a substance that could cause cancer) called NDMA was detected in ranitidine products, including Zantac. The FDA asked manufacturers to recall the drug and its generic forms pending investigation and urged consumers to seek other OTC alternatives. NDMA is commonly ingested in food and water, but not in levels expected to lead to an increased risk of cancer. In the instance of Zantac and other ranitidine products, the FDA was concerned about the impact of sustained, higher levels of exposure to the impurity.
Additional testing confirmed that NDMA levels in ranitidine drugs like Zantac can increase over time, especially when stored at higher temperatures. Ultimately, it was determined that NDMA impurities present in Zantac and other ranitidine products exceeded acceptable levels. In April 2020, the FDA requested a full market withdrawal of all ranitidine products in the United States.
At the height of its popularity, Zantac became one of the world’s first ever drugs to top $1 billion in annual sales. By 2019, before the drug was recalled by the FDA, there were over 13 million active prescriptions in the United States alone. This suggests that doctors considered Zantac and its generic forms an extremely viable treatment for heartburn and gastrointestinal issues. However, once the probable carcinogen NDMA was linked to ranitidine products, prescriptions and over the counter availability of the drugs abruptly halted.
Alternative Remedies for Heartburn & Acid Reflux
There are many other ways to treat and prevent acid reflux, heartburn and other conditions that Zantac was used to address. For example, lifestyle changes can go a long way. Stop smoking and drinking, as that decreases the esophagus’s ability to function properly. Proper diet and weight management are also key.
Patients may also prevent issues by avoiding large meals, eating meals earlier, or cutting out triggering foods altogether. Some people find relief by waiting at least 3 hours before lying down after a meal, and elevating the head of their bed if they experience heartburn at night. Loose-fitting clothing can also help improve symptoms as tighter clothes can put pressure on your abdomen.
Scores of people who were diagnosed with cancer after taking Zantac and ranitidine products are coming forward with their stories. A class action suit against Zantac manufacturers in California is the first to schedule an official trial, slated for October 2022—the first in a series of bellweather cases that will set the future of Zantac litigation in full motion. A multidistrict litigation is also moving forward in Florida, where over 800 cases are pending. Cases in an array of other states, including New York, Oregon, Texas and Tennessee, could also be scheduled to begin before the California trial.
These are just a few examples. The revelations about ranitidine products containing NDMA are recent. Litigation is just beginning, but it’s moving full steam ahead. There have been no settlements yet, but the bellweather cases mentioned above may be used to anticipate future settlement amounts.
For more information on Zantac, its recall by the FDA, and NDMA, visit these trusted resources: