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Zantac (Ranitidine) Side Effects | NDMA Contamination

What are the side effects of Zantac (ranitidine)?. Zantac made with ranitidine is no longer available on the U.S. market. Common side effects include headaches. diarrhea and nausea. Rare. serious side effects include liver failure. acute porphyria attacks and pneumonia.

Common Side Effects of Zantac (Ranitidine)

The most common side effects of Zantac are mild and infrequent. They also don’t last very long. Because ranitidine is no longer available on the market, there is no new information on Zantac made with ranitidine and its side effects.

Zantac side effects may include:

  • Stomach pain
  • Constipation
  • Diarrhea
  • Headache
  • Drowsiness
  • Fatigue
  • Dizziness
  • Insomnia
  • Nausea
  • Vomiting
  • Rash
  • Dark urine
  • Shortness of breath
  • Chest pain
  • Jaundice
  • Fever

In clinical trials, the rate of Zantac side effects was very similar to those reported by people who took a placebo, or an inactive medicine, according to French researchers who published their work in Drug Safety. Researchers in another study by Glaxo Wellcome looked at data from controlled clinical trials with more than 26,000 patients who took the drug for four weeks or more. They also looked at postmarketing surveillance studies and adverse event reports. Researchers “confirmed the excellent safety profile of ranitidine.”

But after the Valisure pharmacy alerted the FDA that batches of ranitidine contained high levels of N-nitrosodimethylamine, or NDMA, several manufacturers voluntarily recalled their ranitidine products.

On April 1, 2020, the FDA requested manufacturers immediately withdraw all prescription and over-the-counter ranitidine drugs from the market. While initial FDA testing found NDMA in ranitidine in low levels, new FDA testing confirmed that NDMA levels increase in ranitidine over time.

Headache as the Most Common Side Effect

Headache is the most common ranitidine side effect reported in clinical trials.

Serious and Rare Zantac Side Effects

According to the drug’s insert, serious Zantac side effects are rare. If you suffer any of the following side effects, talk to your health care provider.

Serious side effects of Zantac (ranitidine) include:

  • Clay-colored stools
  • Coughing up mucus
  • Dark urine
  • Easy bruising or bleeding
  • Irregular heartbeat
  • Loss of appetite
  • Severe blistering, peeling, and red skin rash with headache
  • Vision problems
  • Weakness
  • Yellowing of the eyes or skin

Central Nervous System Side Effects

Rare cases of mental confusion, depression, agitation and hallucinations and reversible blurred vision have been reported. These mental issues have been reported most often in severely ill, elderly patients. Some people also reported vertigo, dizziness and involuntary motor disturbances.

Cardiovascular Side Effects

Cardiovascular issues with Zantac are extremely rare but have occurred. French researcher T. Vial and colleagues reported the risk was about 1 in 1 million patients.

These include abnormal heart rhythms that mostly occur during rapid intravenous treatment with ranitidine. They usually subside after stopping the drug. Other cardiac events include hypertension and premature ventricular beats.

Gastrointestinal Issues

Along with constipation, diarrhea and abdominal pain, researchers also received rare reports of pancreatitis.

Liver Failure and Hepatitis

People have reported rare instances of liver failure and hepatitis. Some of these people also suffered jaundice. If this happens, discontinue Zantac immediately and speak to a health care professional. According to the drug’s label, these conditions are usually reversible. In rare cases, people died because of liver injury.

Blood Disorders

Some people who took Zantac suffered blood count changes including low white blood cells and low platelets. Rare cases of low red blood cell counts, with or without bone marrow problems, and very rare cases of acquired immune hemolytic anemia have been reported.

Gynecomastia, Impotence and Decreased Sex Drive

According to the drug’s label, controlled studies in animals and humans didn’t show that Zantac caused impotence or abnormal enlargement of the breasts called gynecomastia. But men taking the drug have reported cases of impotence and decreased sex drive when taking Zantac.