In 2018, doctors wrote over 15 million prescriptions for ranitidine, the generic name for the heartburn drug, Zantac. Several millions more have purchased Zantac over the counter. But sales figures for Zantac in 2019 and 2020 will likely take a steep nose dive. That’s because Zantac was recalled from the market on April 1, 2020 by the FDA, over concerns that an ingredient in the popular acid reflux remedy contains unsafe levels of a carcinogenic substance.
The recall applies to both prescription and OTC formats. Sanofi SA, the French pharmaceutical manufacturer of Zantac, posted a net loss of $11 million for the last quarter of 2019 [SOURCE]. Despite the recall, however, consumers are still able to purchase Zantac online.
If you’re still taking a prescription ranitidine, you should consult with your doctor about alternatives. And if you’re self-prescribing with an OTC, you may want to consider these natural alternatives, which may prevent leaky gut, a condition that antacids may worsen.
Zantac Side Effects
In September 2019, some manufacturers voluntarily removed their products containing ranitidine, after it was discovered that the active ingredient contains the substance, N-nitrosodimethylamine (NDMA). NDMA has been linked to several types of cancers, including:
According to updates and press announcements by the FDA, Zantac was found to contain unacceptable levels of NDMA. The acceptable daily intake of ranitidine, according to FDA should not exceed 96 nanograms per day or 0.32 parts per million.
Even without taking Zantac, you’re most likely consuming NDMA. That’s because the compound is in tap water and many foods. However, through lab testing, the FDA found that the level of NDMA increases significantly when Zantac is stored at higher temperatures. This includes when the product was exposed to high heat in storage or during transportation.
Tests conducted by FDA also revealed that the older the Zantac was manufactured, the greater the level of NDMA. “These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit,” says the FDA in this press announcement.
Even more concerning, more recent lab testing concludes that NDMA levels increase in ranitidine even under normal storage conditions.
[Want to dispose of your Zantac? Follow these safe disposal tips recommended by FDA.]
To lower your exposure to NDMA, in addition to no longer taking ranitidine drugs, avoid eating cured meats and fish, and any foods that contain sodium nitrite. Sodium nitrite is a preservative that can form high levels of NDMA.
#2: Gastrointestinal Distress
According to the product monograph for Zantac tablets (75 mg and extra strength, 150 mg), H2-blockers such as Zantac may mask symptoms associated with stomach cancer. As a result, if you do have stomach cancer that hasn’t been diagnosed, taking Zantac may prevent a doctor from being able to diagnose it.
If you feel (or have previously felt) abdominal discomfort for two weeks or longer and have not been diagnosed with stomach cancer, consult with your doctor and share this concern.
Another concern about taking H2 blockers is that they can cause an overgrowth of harmful bacteria in the GI tract. This is a side effect of the drug’s ability to reduce stomach acid.
#3: Red Blood Cell Disorder
Although it’s a rare side effect of taking Zantac, the condition known as porphyria has been reported. This condition is characterized by an overproduction of porphyrin. Porphyrin is a protein that carries oxygen in the blood. When an acute attack of porphyria occurs, the urine may turn purple. Abdominal pain, chest pain, and vomiting, are just a few of the symptoms of acute porphyria.
In people with chronic obstructive pulmonary lung disease (COPD), diabetes, or any other condition which may compromise the immune system, there “may be an increased risk of developing community-acquired pneumonia,” reads the product monograph.
If you have weak kidney function, the levels of NDMA in your body will likely be higher than someone with normal kidney function with a history of Zantac usage. This is because ranitidine is excreted through the urine via the kidneys. With severe renal impairment, blood levels of ranitidine are increased and it takes the kidneys longer to eliminate the carcinogen. According to the product insert, “In elderly patients with renal impairment, interrupt treatment if a state of mental confusion arises.”
#6: Central Nervous System Imbalances And Vision Problems
Zantac’s product insert lists the following possible adverse drug reactions:
- Headache (sometimes severe)
- Muscle spasms
- Blurred vision
In addition, rare cases of tremors, or involuntary eye movements have been reported, although these disturbances are reversible.
#7: Low Vitamin B12 Levels
If you have taken Zantac for many years, the drug may interfere with your body’s ability to absorb cyanocobalamin (vitamin B12).
Zantac Side Effects Conclusion
As with all other prescription drugs, there are several other potential side effects of taking Zantac. You can read about them here, as well as ranitidine interactions with other drugs.
Remember, do not stop taking a Zantac prescription without first consulting with your doctor. But by all means, considering the FDA has recalled Zantac because of the fact that its main active ingredient may cause cancer, you should share this concern with your doctor right away.