ranitidine

WARNING

In 2020, the Food and Drug Administration (FDA) removed all prescription and over-the-counter (OTC) ranitidine products off the market after tests showed the heartburn drug ranitidine (previously marketed as Zantac) may break down into the carcinogen n-nitrosodimethylamine (NDMA). If you have been taking the drug, you should stop taking it now. If you still have any ranitidine products at home, you should properly dispose of them.

Zantac has been reformulated as Zantac 360 to contain another H2 blocker, famotidine, and does not contain NDMA.

Other medications are available to treat heartburn, which do not contain NDMA, such as famotidine (Pepcid AC), cimetidine (Tagamet HB), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec). 

Drug information on ranitidine (discontinued)

• Ranitidine was previously used for the treatment and prevention of stomach and duodenum ulcers, and the treatment of heartburn, inflammation of the esophagus, and Zollinger-Ellison syndrome.
• Ranitidine is an oral drug that blocks the production of acid by acid-producing cells in the stomach. It belongs to a class of drugs called H2 (histamine-2) blockers that also includes cimetidine (Tagamet HB), and famotidine (Pepcid AC).
• Histamine is a naturally occurring chemical that stimulates cells in the stomach (parietal cells) to produce acid. H2-blockers inhibit the action of histamine on the cells, thus reducing the production of acid by the stomach. Since excessive stomach acid can damage the esophagus, stomach, and duodenum and lead to inflammation and ulceration, reducing stomach acid prevents and heals acid-induced inflammation and ulcers. 

Based on the prescription drug labeling information available prior to being pulled from the market, the potential side effects of ranitidine include those listed below.

Minor side effects occur and these are:

• constipation,
• diarrhea,
• fatigue,
• headache,
• insomnia,
• muscle pain,
• nausea, and
• vomiting.

Other important, but rare, side effects include:

• agitation,
• anemia,
• confusion,
• depression,
• easy bruising or bleeding,
• hallucinations,
• hair loss,
• irregular heartbeat,
• rash,
• visual changes,
• and yellowing of the skin or eyes.

Prior to its recall, ranitidine could be taken with or without food.

• Usual oral doses for treating ulcers and GERD are 150 mg twice daily or 300 mg at bedtime. The maintenance dose is 150 mg daily.
• Erosive esophagitis is treated with 150 mg 4 times daily.
• Zollinger-Ellison syndrome may be treated with as much as 6 g daily.
• Heartburn is treated with 75 mg or 150 mg once or twice daily 30-60 minutes before consuming meals or beverages that cause heartburn.

Self-medication should not last longer than 2 weeks unless advised by a physician.

Ranitidine, like other drugs that reduce stomach acid, may interfere with the absorption of drugs that require acid for adequate absorption. Examples include iron salts (for example iron sulphate), itraconazole (Sporanox), and ketoconazole (Extina, Xolegel, Kuric).

Because ranitidine has been withdrawn from the market, do not take the drug, especially if you are pregnant or breastfeeding.

As with any other medication you may take while pregnant or nursing, please consult with your doctor on what drugs you may be able to take for your symptoms.