Home Valsartan NDMA & Cancer Risk

NDMA-Contaminated Valsartan and Cancer Risk

The U.S. Food and Drug Administration recalled some batches of valsartan contaminated with the potentially cancer-causing agent N-nitrosodimethylamine (NDMA). The agency estimates that for every 8,000 people that took the highest dose of valsartan for four years there may be one additional case of cancer. NDMA is a known environmental contaminant found in water and foods.

This is an active lawsuit

See If You Qualify for a Valsartan Lawsuit

If you developed cancer or liver damage after taking valsartan, you may be entitled to compensation. Get a free case review today.

  • A+BBB Rating
  • 4.9 StarGoogle Reviews

We value your privacy. By clicking REVIEW MY CASE, you agree to our privacy policy and disclaimer. After submitting, you will be contacted by one or more of Drugwatch's trusted legal partners (including autodialed and prerecorded calls or text/SMS messages). Msg. and data rates apply. Your consent to text messaging is not required for a case review and you may opt out of text messages at any time by texting STOP. This is legal advertising.

  • A+BBB Rating
  • 4.9 StarGoogle Reviews
Last Modified: January 24, 2024
Fact Checked
Medically Reviewed

Board-certified physicians medically review Drugwatch.com content to ensure its accuracy and quality.

Drugwatch.com partners with Physicians’ Review Network Inc. to enlist specialists. PRN is a nationally recognized leader in providing independent medical reviews.

Reviewer specialties include internal medicine, gastroenterology, oncology, orthopedic surgery and psychiatry.

Why Trust DrugWatch?

Drugwatch.com has been empowering patients for more than a decade

Drugwatch.com has provided reliable, trusted information about medications, medical devices and general health since 2008. We’ve also connected thousands of people injured by drugs and medical devices with top-ranked national law firms to take action against negligent corporations.

Our team includes experienced medical writers, award-winning journalists, researchers and certified medical and legal experts. Drugwatch.com is HONCode (Health On the Net Foundation) certified. This means the high-quality information we provide comes from credible sources, such as peer-reviewed medical journals and expert interviews.

The information on Drugwatch.com has been medically and legally reviewed by more than 30 expert contributors, including doctors, pharmacists, lawyers, patient advocates and other health care professionals. Our writers are members of professional associations, including American Medical Writers Association, American Bar Association, The Alliance of Professional Health Advocates and International Society for Medical Publication Professionals.

About Drugwatch.com

  • Assisting patients and their families since 2008.
  • Helped more than 12,000 people find legal help.
  • A+ rating from the Better Business Bureau.
  • 5-star reviewed medical and legal information site.
Learn More About Us


"Drugwatch opened my eyes to the realities of big pharmacy. Having a family member with major depression and anxiety, I was looking for information on her medications. I found information that was very helpful, that her psychiatrist never told her."
Marianne Zahren Patient’s Family Member
  • Google Business Rating
  • BBB A+ Rating Logo

People who took batches of valsartan contaminated with N-nitrosodimethylamine (NDMA), a toxic chemical contaminant, may be at an increased risk for developing cancer. Studies compiled in a report published by the World Health Organization showed that NDMA exposure has resulted in the development of tumors in animals. The report noted that the International Agency for Research on Cancer (IARC) had upgraded NDMA from “possibly carcinogenic to humans” to “probably carcinogenic to humans” based on available evidence.

A 2018 Danish study in the BMJ did not show an increase in the short-term risk of cancer in people who took the tainted valsartan. But it provides short-term reassurance only, experts say.

“There hasn't been long enough follow-up to really see a [cancer] signal. So while I'm reassured that they didn't find one, I don't think it means that patients are completely out of the woods.”

Millions of Americans take valsartan to treat high blood pressure or other heart problems. The U.S. Food and Drug Administration announced a recall of half of the supply of valsartan in the U.S. because of NDMA contamination. Cancer is not a typical side effect of valsartan, but people exposed to contaminated drugs may have a higher risk of developing cancer from NDMA exposure.

In September 2018, the FDA, European Medicines Agency and Health Canada announced it found a second cancer-causing chemical in the same family as NDMA called N-nitrosodiethylamine (NDEA).

As of 2022, lawyers are filing valsartan lawsuits for people who suffered digestive tract cancers after taking valsartan. These include liver, stomach, colorectal, bladder and pancreatic cancer.

See if You Qualify for a Lawsuit Our Partners

Our Trusted Legal Partners

Drugwatch partners with trusted law firms to help you take legal action. After submitting the form, one of Drugwatch's partners will contact you for a free case review.

simmons hanly conroy law firm logo weitz and luxenberg logo sokolove law firm logo levin papantonio rafferty law firm logo nigh goldenberg raso and vaughn law firm logo morgan & morgan logo the ferraro law firm logo meirowitz & wasserberg law firm logo

How Much NDMA Is in Valsartan?

The average NDMA levels detected in contaminated valsartan products from one supplier, Zhejiang Huahai Pharmaceuticals, was 60 parts per million (ppm). This is more than 1,000 times the amount most people consume in drinking water daily.

The Agency for Toxic Substances & Disease Registry released a public health statement in 2015 claiming that animals who suffered liver disease, cancer and death had consumed water containing 5 to 50 ppm of NDMA and food containing 5 to 100 ppm.

Zhejiang Huahai, the Chinese valsartan manufacturer, believes the NDMA contamination occurred after it changed its manufacturing process in 2012.

Registered Nurse Amy Keller explains valsartan's link to NDMA and cancer.

Cancer Risk After Exposure

The FDA estimated that there would be one extra case of cancer for every 8,000 patients taking the highest dose (320 mg) of contaminated valsartan every day for four years. The European Medicines Agency offered a similar calculation of 1 in 5,000 for people treated with 320 mg daily for seven years.

Valsartan Study Fact
Danish researchers found contaminated valsartan slightly increased the risk for colorectal and uterine cancer.
Source: 2018 BMJ study

The 2018 Danish study found a low short-term risk of cancer. It followed 5,150 people with no history of cancer who started taking valsartan between Jan. 1, 2012, and June 30, 2017.

Researchers found 104 cancers in people not exposed to NDMA and 198 cancers in people exposed to tainted valsartan. But authors said researchers need more studies to determine long-term risk.

Types of Cancer Caused by Contaminated Valsartan

Exposure to NDMA can cause cancer in animals and in humans, but the EPA says there are no reports of cancer in humans. However, a study published in Occupational and Environmental Medicine found that rubber workers exposed to NDMA in factories had an increase in cancer of the esophagus, oral cavity and pharynx.

Lawyer Daniel Nigh explains types of cancer that may be caused by valsartan contaminated with NDMA.

In animals, NDMA caused tumors in the liver, respiratory tract, kidneys and blood vessels. Animals exposed to NDMA suffered liver damage and cancer often leading to internal bleeding and death. Treatment for each type of cancer depends on its location and how far it has spread.

Cancers that may be associated with NDMA include:
Please seek the advice of a medical professional before making health care decisions.