Zantac (Ranitidine) Side Effects | NDMA Contamination
What are the common side effects of Zantac (ranitidine)? What serious and rare side effects can occur with Zantac? Find out about the potential side effects and safety issues related to the NDMA contamination of Zantac.
Zantac (Ranitidine) Side Effects
Zantac (ranitidine) was a commonly used medication for treating acid reflux, heartburn, and ulcers. However, in 2019, the U.S. Food and Drug Administration (FDA) requested the withdrawal of all prescription and over-the-counter ranitidine drugs from the market due to the presence of a potentially cancer-causing impurity called N-Nitrosodimethylamine (NDMA).
While Zantac made with ranitidine is no longer available, it’s important to understand the potential side effects associated with the drug. This article will provide an overview of the common, serious, and rare side effects of Zantac (ranitidine).
Common Side Effects of Zantac (Ranitidine)
The most common side effects of Zantac (ranitidine) were generally mild and temporary. According to clinical trials, the rate of Zantac side effects was very similar to those reported by people who took a placebo (an inactive medication). The common side effects of Zantac (ranitidine) included:
- Stomach pain
- Constipation
- Diarrhea
- Headache
- Drowsiness
- Fatigue
- Dizziness
- Insomnia
- Nausea
- Vomiting
- Rash
- Dark urine
- Shortness of breath
- Chest pain
- Jaundice
- Fever
Serious and Rare Zantac Side Effects
While the common side effects of Zantac (ranitidine) were generally mild, there were also some more serious and rare side effects that could occur. These include:
Central Nervous System Effects
Rare cases of mental confusion, depression, agitation, hallucinations, and reversible blurred vision have been reported, particularly in severely ill, elderly patients. Some people also reported vertigo, dizziness, and involuntary motor disturbances.
Cardiovascular Effects
Cardiovascular issues with Zantac are extremely rare but have occurred. These include abnormal heart rhythms, hypertension, and premature ventricular beats.
Gastrointestinal Issues
In addition to the common gastrointestinal side effects, researchers have also received rare reports of pancreatitis.
Liver Failure and Hepatitis
Rare instances of liver failure and hepatitis, sometimes accompanied by jaundice, have been reported. These conditions are usually reversible, but in rare cases, people have died due to liver injury.
Blood Disorders
Some people who took Zantac suffered changes in their blood counts, including low white blood cells, low platelets, low red blood cell counts, and very rare cases of acquired immune hemolytic anemia.
Gynecomastia, Impotence, and Decreased Sex Drive
While controlled studies did not show that Zantac caused impotence or abnormal breast enlargement (gynecomastia), some men taking the drug have reported cases of impotence and decreased sex drive.
NDMA Contamination and Zantac Recall
In September 2019, the FDA announced that it had detected low levels of NDMA in some ranitidine medications, including Zantac. NDMA is a probable human carcinogen, meaning it may cause cancer. As a result, several manufacturers voluntarily recalled their ranitidine products, and the FDA eventually requested the withdrawal of all prescription and over-the-counter ranitidine drugs from the market.
The FDA’s testing confirmed that NDMA levels in ranitidine can increase over time, particularly when stored at higher temperatures. This raised concerns about the long-term safety of Zantac (ranitidine) and led to its market withdrawal.
Alternatives to Zantac
After the Zantac recall, patients who previously took the medication for acid reflux, heartburn, or ulcers may need to explore alternative treatment options. Some common alternatives to Zantac include:
- Other H2 blockers, such as famotidine (Pepcid) or nizatidine
- Proton pump inhibitors (PPIs) like omeprazole (Prilosec) or esomeprazole (Nexium)
- Antacids like Tums, Rolaids, or Maalox
- Lifestyle changes, such as avoiding trigger foods, losing weight, and elevating the head of the bed
It’s important to discuss any changes in medication with your healthcare provider to ensure the safest and most effective treatment plan for your individual needs.
Conclusion
While Zantac (ranitidine) was a commonly used medication, it has been removed from the market due to concerns about NDMA contamination and potential cancer risks. The common side effects of Zantac were generally mild, but there were also more serious and rare side effects that could occur, including central nervous system, cardiovascular, gastrointestinal, liver, and blood-related issues. If you previously took Zantac, be sure to work with your healthcare provider to explore safe and effective alternative treatment options.