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Does Zantac Cause Cancer?

In April 2020, the U.S. Food and Drug Administration asked all manufacturers to withdraw Zantac (ranitidine) products from the market because the drug may contain unacceptable levels of N-Nitrosodimethylamine (NDMA). NDMA is a probable human carcinogen linked to several types of cancer in animals. Some studies have linked the drug to increased cancer risk cancer, while others have not.

So far, there are over 500 federal Zantac lawsuits filed in Florida federal court against the makers of the anti-acid drug. These lawsuits claim Zantac caused several types of cancer and drug makers failed to warn the public.

Unfortunately, the science regarding Zantac and cancer in humans hasn’t shown a definitive answer.

Some studies as far back as the 1980s hinted at a link between the drug and NDMA formation. But one study that looked at the records of 65 million people found people who took ranitidine had less of a cancer risk than those who took another H2 blocker, famotidine.

What Is in Zantac That Causes Cancer?

NDMA is the main chemical in Zantac that is known to cause cancer in animals and probably in humans.

Zantac’s relationship with NDMA is unique. Out of all the drugs that FDA has found to be contaminated with NDMA — including valsartan, losartan and metformin — ranitidine has been the only medication in which levels of the carcinogen may actually increase over time as the drug sits on the shelf.

“FDA has found N-nitrosodimethylamine (NDMA) levels in some ranitidine products increase with time and temperature posing a risk to consumers, and therefore the agency has requested the withdrawal of all ranitidine products from the U.S. market.”

Source: U.S. Food and Drug Administration

The pharmacy Valisure first brought the problem to the FDA’s attention in June 2019, and it filed a citizen’s petition in September 2019 requesting that the FDA recall all ranitidine products.

The pharmacy’s research found that ranitidine was unstable and could generate very high levels of NDMA. Ranitidine contains a dimethylamine (“DMA”) and a nitrite, chemicals that combine to form NDMA.

Studies performed by Stanford University and other academic groups revealed NDMA levels far above the FDA’s current daily acceptable intake limit of 96 ng. In fact, the Stanford study suspected that ranitidine could form millions of ng of NDMA.

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What Are the Chances of Getting Cancer?

So far, there is only limited evidence that NDMA in ranitidine causes cancer, and scientists haven’t come up with an absolute risk value.

A study under review conducted by researchers at Memorial Sloan Kettering Cancer Center found an increased risk in the odds of developing certain cancers, according to a 2020 article by Richard H. Adamson and Bruce A. Chabner in The Oncologist.

The European Medicines Agency estimated that the cancer risk for valsartan, another medication contaminated with NDMA, ranges from 12 to almost 30 cases per 100,000 people for those taking 320 mg of valsartan with 3.7 micrograms of NDEA and 24.1 micrograms of NDMA every day for four years, according to Adamson and Chabner.

“NDMA contamination poses a potential carcinogenic risk of undetermined effect at present for those taking ranitidine, valsartan, or related medications on a regular basis.”

Source: Richard H. Adamson, Ph.D. and Bruce A. Chabner, M.D.

But scientists haven’t come up with a risk for ranitidine, though authors said, “the risk from NDMA in ranitidine and in its over‐the‐counter version, Zantac, is more problematic and may be greater.”

Not all studies agree that ranitidine poses a risk compared to other drugs. For example, Dr. Nabeeha Mohyuddin, an internal medicine resident at Allegheny Health Network in Pittsburgh, and colleagues collected the data of 1.62 million people who used ranitidine, 3.37 users of famotidine and 59.63 million people who didn’t use either H2 blocker.

The rates of cancer were lower with ranitidine than with famotidine, an H2 blocker not contaminated with NDMA. The chance of getting cancer from ranitidine was 26.4 percent versus 31.1 percent for people who took famotidine. Limitations of the study included incorrect records and lack of reported data on the extent of ranitidine and famotidine use.

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What Types of Cancer Does Zantac Cause?

Because NDMA can cause a wide variety of cancers, Zantac could potentially cause many types of cancer. It’s important to know that the research on this topic is still new and scientists haven’t found solid evidence that says Zantac causes any type of cancer. But they cannot rule out the drug’s cancer causing potential either.

According to lawyers accepting Zantac cancer cases, many people who developed cancer after taking ranitidine didn’t have a family history of cancer or genetic markers for the disease. Their treating physicians stressed that the cancer was caused by something environmental. NDMA is an environmental contaminant.

Most common cancers in Zantac lawsuits include:
  • Bladder cancer and bladder removal
  • Colon cancer
  • Prostate cancer
  • Kidney cancer and kidney removal
  • Liver cancer
  • Stomach cancer
  • Breast cancer

Other potential cancers include stomach, colorectal, esophageal, bladder, breast, liver, prostate, pancreatic, ovarian and melanoma.

In at least two studies, one in 2004 by the National Cancer Institute and another in 2016 by Teng Zeng and William A. Mitch of Stanford University, researchers found potential links between ranitidine and bladder cancer, according to Valisure. But they didn’t find proof of causation.

A survey of 24,000 patients at Memorial Sloan Kettering Cancer Center found that ranitidine use was associated with an increased chance of presenting with breast, testicular, thyroid and kidney cancer, according to Adamson and Chabner.

What To Do If You’ve Been Diagnosed with Cancer

If you’ve been diagnosed with cancer after taking Zantac, tell your doctor about your history with ranitidine. It may help them determine your diagnosis and treatment recommendations.

Make sure to keep your doctor’s notes and medical records. You may qualify to file a Zantac lawsuit and be eligible for compensation from Zantac’s makers.

If you are interested in finding out more about your legal options, contact a Zantac lawyer right away because there may be time limits on your case.

Please seek the advice of a medical professional before making health care decisions.

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Michelle Llamas, Senior Content Writer
Written By Michelle Llamas Senior Writer

Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for nearly a decade. She focuses on various medical conditions, health policy, COVID-19, LGBTQ health, mental health and women’s health issues. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

  • Member of American Medical Writers Association (AMWA) and former Engage Committee and Membership Committee member
  • Centers for Disease Control and Prevention (CDC) Health Literacy certificates
  • Original works published or cited in The Lancet, British Journal of Clinical Pharmacology and the Journal for Palliative Medicine
Edited By

11 Cited Research Articles

Drugwatch.com writers follow rigorous sourcing guidelines and cite only trustworthy sources of information, including peer-reviewed journals, court records, academic organizations, highly regarded nonprofit organizations, government reports and interviews with qualified experts. Review our editorial policy to learn more about our process for producing accurate, current and balanced content.

  1. Adamson, R.H. & Chabner, B.A. (2020). The Finding of N‐Nitrosodimethylamine in Common Medicines. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7288647/#onco13312-bib-0017
  2. Gever, J. (2020, August 23). Ranitidine Cancer Risk: Health Records Offer Reassurance. Retrieved from https://www.medpagetoday.com/meetingcoverage/ddw/86314
  3. Michaud, D.A. et al. (2004). Peptic ulcer disease and the risk of bladder cancer in a prospective study of male health professionals. Retrieved from https://pubmed.ncbi.nlm.nih.gov/14973090/
  4. O’Neal v. Boehringer Ingelheim Pharmaceuticals et al. (2020, January 10). Complaint and Demand for Jury Trial. Retrieved from https://aboutlawsuits-wpengine.netdna-ssl.com/wp-content/uploads/2020-1-10-zantac-oneal-complaint.pdf
  5. U.S. Food and Drug Administration. (2020, April 1). FDA Requests Removal of All Ranitidine Products (Zantac) from the Market. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market
  6. U.S. Food and Drug Administration. (2020, April 1). Questions and Answers: NDMA impurities in ranitidine (commonly known as Zantac). Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/questions-and-answers-ndma-impurities-ranitidine-commonly-known-zantac
  7. Valisure. (2019). Ranitidine Investigation Summary. Retrieved from https://www.valisure.com/wp-content/uploads/SUMMARY-of-Ranitidine-investigation-v1.8.pdf
  8. Valisure. (2019, September 9). Valisure Citizen Petition on Ranitidine. Retrieved from https://www.valisure.com/wp-content/uploads/Valisure-Ranitidine-FDA-Citizen-Petition-v4.12.pdf
  9. Valisure. (n.d.). Valisure Detects NDMA in Ranitidine. Retrieved from https://www.valisure.com/blog/valisure-news/detection-of-ndma-in-raniditine/
  10. Young, K.D. (2020, May 12). Ranitidine did not show higher cancer risk than famotidine in study. Retrieved from https://www.mdedge.com/clinicianreviews/article/222118/gastroenterology/ranitidine-did-not-show-higher-cancer-risk
  11. Zeng, T. & Mitch, W.A. (2016, March 18). Oral intake of ranitidine increases urinary excretion of N-nitrosodimethylamine. Retrieved from https://academic.oup.com/carcin/article/37/6/625/1744630
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