Zantac Side Effects
The link between Zantac and cancer goes back decades. Our firm represents
people from across the country with the following Zantac side effects:
- Bladder cancer
- Breast cancer
- Esophageal/nasal/throat cancer
- Kidney cancer
- Liver cancer
- Lung cancer (for non-smokers)
- Pancreatic cancer
- Prostate cancer
- Stomach cancer
- Thyroid cancer
“We have an epidemic of cancer in our society. For years we have
been trying to figure out what’s behind it. Our firm has done a
lot of work exposing the causes of non-Hodgkin lymphoma in our Monsanto
Roundup litigation. Now we have another source of cancer – it appears
that for decades, Zantac has been causing cancer, and we’re only
now just seeing it. People from all across the country have cancer today
because they took Zantac. That is a wrong that we will fight to make right.”
R. Brent Wisner
Common Zantac Brands
Below are some of the most common Zantac brands and generic ranitidine
- Zantac 150 Tablets
- Zantac 150 Maximum Strength
- Zantac 150 Maximum Strength Cool Mint
- Zantac 75 Tablets
- Wal-Zan 150
- Wal-Zan 75
- Heartburn Relief (ranitidine)
- Acid Reducer (ranitidine)
- Acid Control (ranitidine)
Zantac NDMA Cancer Risks
Central to the Zantac cancer risk issue is the known carcinogen NDMA. N-Nitrosodimethylamine
(NDMA) is a water-soluble organic (containing the element carbon) chemical
and appears as a yellow liquid with little or no obvious taste or odor.
NDMA was once used to make rocket fuel, but today is made only for research
purposes. It can also be produced as a byproduct of manufacturing processes.
Humans can be exposed to NDMA in relatively small amounts through various
products, including tobacco, foods (cured meat, fish, cheese, beer), shampoos,
cleansers, and pesticides.
NDMA is carcinogenic even in minimal doses. The FDA’s acceptable
daily intake of NDMA is 96 nanograms (ng), or 96 billionths of a gram.
Researchers have reported NDMA levels in food ranging from 14 ng per 100 grams (about 3.5 ounces) in whole milk to 10,900
ng per 100 grams in sausage. Studies show that NDMA exposure as little as
179 ng per 100 grams per day is associated with elevated cancer risks.
The International Agency for Cancer Research (IARC), the most recognized
cancer research institution in the world, studied over 200 research papers
on NDMA and the NDMA cancer risk. IARC placed the chemical in the “Group
2A” category, meaning substances that are “probably carcinogenic
to humans.” The agency found that NDMA is “carcinogenic in
all animal species tested” and noted that the metabolism of NDMA
by humans and animals is similar.
NDMA caused malignant tumor growth in several organs, in multiple species,
via numerous routes of exposure (oral, inhalation, subcutaneous (under
the skin), injections), with dose-response relationships appearing in
several studies. Scientists are also gaining detailed knowledge of the
body's biochemical mechanisms to repair NDMA DNA damage and how those
mechanisms play a role in the progression towards cancer.
NDMA in Zantac
In 2019, Valisure, an online pharmacy, and Emery Pharma, a contract laboratory,
found unacceptably high levels of NDMA in ranitidine during batch testing.
Both companies sounded the alarm on NDMA in Zantac, reporting that one
ranitidine 150 mg tablet produced 304,500 ng of NDMA, which is roughly
1,700 times the exposure level found to be carcinogenic in some studies. Valisure and Emery Pharma filed citizen’s petitions with the FDA,
urging the agency to suspend sales and issue a Zantac recall.
After receiving the petitions,
the FDA announced that it was investigating the Zantac NDMA risks. Countless people who
now have cancer after taking Zantac are turning to the courts and filing
a Zantac lawsuit to hold the various manufacturers accountable, such as
Sanofi Boehringer Ingelheim, Chattem, Pfizer and GlaxoSmithKline (GSK)
for their reckless disregard for human health and willingness to put profit
Zantac Recall Update
On April 1, 2020, the FDA issued a Zantac recall announcement, calling
for the immediate market withdrawal request of all Zantac (ranitidine)
products. The FDA reported that NDMA in “some ranitidine products
increases over time and when stored at higher than room temperatures and
may result in consumer exposure to unacceptable levels…”
Before the FDA Zantac recall announcement, numerous manufacturers issued generic Zantac recall announcements on
their own, including Apotex, Sandoz (Novartis), and GlaxoSmithKline (GSK).
Canada, the United Kingdom (UK), and the European Union (EU) have also
issued recalls on Zantac.
The following companies issued Zantac voluntary (ranitidine) recall announcements:
- American Health Packaging
- Amneal Pharmaceuticals
- Aurobindo Pharma USA
- Apotex Corp. (this includes over-the-counter ranitidine tablets 75 mg and
150 mg, labeled by Walgreens, Walmart, and Rite-Aid)
- Appco Pharma
- Denton Pharma (dba Northwind Pharmaceuticals)
- Reddy’s Laboratories (this includes Zantac over-the-counter OTC medicines
labeled by retailers such as Walgreens, Walmart, CVS, Target, and Kroger)
- GlaxoSmithKline (GSK)
- Glenmark Pharmaceuticals
- Golden State Medical Supply
- Lannett Company
- Novitium Pharma
- Perrigo Company
- Precision Dose
To stay updated on Zantac (ranitidine) recall announcements, we advise
you to consult the
FDA’s Recalls, Market Withdrawals, & Safety Alerts page. The FDA alerts consumers with the recall reason and lists Zantac recall
lot numbers, if applicable.
Zantac Replacement – What are the FDA Recommended Zantac Alternatives?
Deciding on a safe alternative to Zantac is something you should discuss
with your doctor. The U.S. Food and Drug Administration’s (FDA)
recommends the following Zantac replacement options:
Prilosec (omeprazole) – A proton pump inhibitor (PPI) medication commonly used to treat stomach
acid-related conditions, including gastroesophageal reflux disease (GERD).
Nexium (esomeprazole) – A proton pump inhibitor (PPI) that reduces stomach acid production and
treats GERD, ulcers, and other conditions.
Prevacid (lansoprazole) – A proton pump inhibitor (PPI) recommended for short-term ulcer and acid
Pepcid (famotidine) – An H2 blocker that treats ulcers, GERD, and conditions that cause excess
Tagamet (cimetidine) – An H2 blocker that reduces acid in the stomach to treat ulcers and acid reflux.
Zantac Cancer Study – Does the Research Confirm Cancer Link?
Numerous studies have found that the NDMA in Zantac causes breast cancer,
prostate cancer, and other forms of cancer. Below we highlight some of
the most important research on Zantac.
2019 Valisure Study: How Zantac (Ranitidine) Produces NDMA
In 2019, Valisure conducted batch testing for Zantac (ranitidine) using
FDA-recommended protocols. Valisure found NDMA levels as high as 3,267,968
ng (nanograms) per Zantac tablet, more than 34,000 times higher than the
FDA limit of 96 ng or .096 mcg (micrograms).
Wondering if the increased heat of the testing process may have contributed
to these results, Valisure decided to test ranitidine under conditions
that simulated those found in the stomach (simulated gastric fluid with
sodium nitrite). NDMA levels, while not as high, were still extraordinary,
ranging from 23,600 ng to 304,500 ng, over 3,100 times the FDA’s
“Valisure’s testing reveals NDMA levels so high that the nitroso
for NDMA likely comes from no other source than the ranitidine molecule
itself.” [Nitroso refers to an atomic grouping of nitrogen and oxygen,
such as found in the nitrite group of NDMA.]
Valisure Citizen Petition on Ranitidine, September 9, 2019
Valisure also points to a third mechanism that could lead to NDMA production
after Zantac is ingested – an enzyme, dimethylarginine dimethylaminohydrolase
(DDAH), that can react with ranitidine to “liberate” DMA from
ranitidine, making it available to combine with nitrite from the ranitidine
molecule, nitrite circulating in the body, or “other potential pathways
particularly in weak acidic conditions such as that in the kidney or bladder.”
This mechanism, according to Valisure, could generate millions of nanograms
of NDMA throughout the body.
2021 Valisure Study on Zantac (Ranitidine)
Valisure Zantac study analyzed NDMA production “under simulated physiologic gastric states.”
What does this mean exactly? Researchers conducted the study by mimicking
the human stomach ingesting a Zantac tablet across a broad range of pH
concentrations, ranitidine concentrations, and nitrite concentrations.
The study used FDA-recommended protocols for determining nitrosamines
in ranitidine tablets.
The study found that Zantac “may be a significant source of NDMA
under a range of physiologically relevant conditions.” Under numerous
conditions meant to simulate the human stomach, Zantac NDMA levels increased
with increasing nitrite levels and decreasing pH levels
up to three orders of magnitude beyond established limits. The authors cautioned, “these data support recent regulatory actions
to limit ranitidine availability.”
Study on Zantac Published in
Cancers published a study on Zantac in December of 2020. Researchers looked at data from the FDA’s Adverse
Events Reporting System (FAERS), searching adverse event reports of cancer
stemming from primary and secondary use of proton pump inhibitors (PPIs)
and H2 antagonists, the group of drugs to which Zantac belongs.
The study found elevated incidences of esophageal cancer, pharyngeal cancer,
liver cancer, and pancreatic cancer, and stomach cancer, among others. The
Cancers study provides “support for the assertion that NDMA contaminated
ranitidine is associated with the occurrence of gastrointestinal cancer.
This assertion was bolstered by an abundance of evidence demonstrating
that NDMA exposure is associated with an increased risk of cancer in humans
as well as animals.”
This research is similar to
data from a 2000 study, which investigated the association between prescription ranitidine use
and specific cancers. In the 2000 study, researchers found a statistically
2.4-fold increased risk for stomach cancer and esophageal cancer.
Sloan Kettering Study Finds Association Between Ranitidine and Cancer
Researchers from the Sloan Kettering Cancer Center conducted the study,
‘Ranitidine use, N-Nitrosodimethylamine (NDMA) production and variations
in cancer diagnoses’. The study used similar methods to the 2021 Valisure study above.
The Sloan Kettering study analyzed ranitidine NDMA production under various
simulated gastric conditions. Researchers also conducted an epidemiologic
analysis to evaluate potential associations between ranitidine and several
forms of cancer.
According to the authors, Zantac produces increasing amounts of NDMA over
time (up to, and likely beyond four hours) and with increasing sodium
The study found positive associations for bladder cancer, breast cancer,
prostate cancer, and thyroid cancer.
Epidemiological Studies of Zantac and Cancer
Very few epidemiological studies of patients taking Zantac have been conducted.
In a study conducted by the National Cancer Institute, adult male health
professionals with peptic ulcers were followed for 14 years (1986 –
2000). The subjects of the study were asked if they used either Tagamet
or Zantac as a treatment. The authors of the study reported that use of
either drug was associated with an increased risk of bladder cancer, though
the increase fell short of statistical significance.
Other Zantac Studies
A true Zantac cancer study in humans—where humans are deliberately
given Zantac to ingest to observe the results—has not been conducted
and never will, as it would be unethical. However, a 1983 study of ranitidine
in rodents found that it produced several “genotoxic effects,”
including DNA fragmentation in the liver and gastric mucosa (the mucous
membrane that lines the stomach). Significantly, studies of Tagamet (cimetidine),
another antacid in Zantac’s class (H2 blockers), did not show DNA damage.
Genetic damage is known to be at the root of all cancers. A 2013 meta-analysis
of studies that examined the relationship between various acid-suppressing
drugs and gastric cancer concluded that that “acid suppressive drugs
are associated with an increased risk of gastric cancer.”
These studies support three important points underlying the danger posed
NDMA has not been directly tested in humans. The cancer risk is too high.
However, we know from years of research that humans are regularly exposed
to NDMA via many foods and beverages. This has provided a means of testing
NDMA’s carcinogenic potential—and by extension the carcinogenicity
of Zantac—in humans indirectly.
- NDMA is carcinogenic in humans in exceedingly small amounts.
- Levels of NDMA produced by Zantac are extremely high.
- The problem with Zantac is not an “impurity” in the drug, but
rather the design of the drug itself and how that design makes Zantac
itself a carcinogen.
Contact us today at (855) 948-5098 for more information on how we can assist you
with filing a Zantac lawsuit.