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More than 15 million people are prescribed Zantac or generic brands of ranitidine every year to treat heartburn, GERD, peptic ulcers, and other acid-related digestive disorders. Millions of others use over-the-counter versions of Zantac.

In September 2019, the U.S. Food & Drug Administration (FDA) warned that some Zantac samples had tested positive for N-nitrosodimethylamine (NDMA), a probable human carcinogen.

Zantac: Background

Zantac (ranitidine) belongs to a class of acid-reducing medications called H2 (histamine-2) blockers.

Prescription versions are approved to treat a number of acid-related disorders, including:

• Short-term treatment of duodenal ulcer.
• Maintenance therapy of duodenal ulcer, after healing and at reduced dosage.
• Pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis).
• Short-term treatment of active, benign gastric ulcer.
• Maintenance therapy of benign gastric ulcer, after healing and at reduced dosage.
• Treatment and maintenance of erosive esophagitis
• Treatment of GERD.

Zantac came to market in 1981, and was the world’s best-selling prescription drug by 1987. However, its popularity would eventually be surpassed by another class of heartburn drugs called proton pump inhibitors.

Prescription versions inlcude 150mg and 300mg tablets, 25mg and 150mg effervescent tablets, and an oral syrup. In addition to oral forms, the drug may be administered as an intramuscular injection or an intravenous infusion.

Consumers can now purchase ranitidine over-the-counter in 75mg and 150mg dosages for the relief of heartburn.

Boehringer Ingelheim Pharmaceuticals marketed name-brand Zantac in the United States from October 2006 through January 2017. Sanofi-Aventis currently holds the marketing license.

Zantac Side Effects

Zantac can increase the risk of developing pneumonia.

Some people may also experience an allergic reaction to ranitidine. For this reason, those using Zantac should seek immediate emergency medical attention if they experience any sign of an allergic reaction, including hives, difficulty breathing, or swelling of the face, lips, tongue, or throat.

Patients should stop using ranitidine and call their doctor if they experience any of the following Zantac side effects:

• Stomach pain, loss of appetite.
• Dark urine, jaundice (yellowing of the skin or eyes).
• Fever, chills, cough with mucus, chest pain, feeling short of breath.
• Fast or slow heart rate.
• Easy bruising or bleeding.
• Problems with your skin or hair.

Other possible side effects include:

• Headache (may be severe).
• Drowsiness, dizziness.
• Sleep problems (insomnia).
• Decreased libido, impotence, or difficulty having an orgasm.
• Swollen or tender breasts (in men)
• Nausea, vomiting, stomach pain.
• Diarrhea or constipation.

Before taking ranitidine, patients should let their doctor know if they have kidney disease, liver disease, or porphyria.

People taking triazolam (Halcion) should also tell before beginning treatment. These patients may not be able to use ranitidine, or they may need a dosage adjustment or special tests during treatment.

Zantac and NDMA

On September 13, 2019, the FDA warned that traces of NDMA had been detected in samples of Zantac and ranitidine, including over-the-counter versions. An online pharmacy company called Valisure conducted the tests, and claimed to have found NDMA in every sample.

The U.S. Environmental Protection Agency classifies NDMA as a probable human carcinogen. Animal studies have linked exposure to various cancers, including liver cancer, kidney cancer, breast cancer, and gastrointestinal cancers. Research also suggests exposure to NDMA may result in non-cancerous liver damage or internal bleeding and death.

The FDA’s warnings came more than year after NDMA turned up in generic versions of valsartan, an angiotensin II receptor blocker (ARB) used to treat heart failure and high-blood pressure. NDMA and other potentially cancer-causing nitrosamines were eventually detected in several generic ARBs, resulting in dozens of drug recalls in the United States and 22 other counties.

The FDA did not order a Zantac recall, insisting that the levels of NDMA found in the samples were low. However, the agency also urged people taking over-the-counter versions to consider switching to another antacid. Those taking prescription versions should not stop treatment without speaking with their doctor, as doing so could worsen their condition.

Within days of the FDA’s announcement, consumers began filing Zantac lawsuits in courts throughout the United States. Plaintiffs claim that Zantac and ranitidine may contain levels of NDMA anywhere from 3,000 to 26,000 times higher than the legally allowable limit.