Is Ranitidine (Ranitidine) available and does it cause cancer as a side effect?

From the Guidelines

Ranitidine is not recommended due to concerns about potential cancer risk associated with N-nitrosodimethylamine (NDMA) contamination, and alternative medications like famotidine or proton pump inhibitors should be considered instead. The availability of ranitidine has been impacted by its withdrawal from the market in 2020 due to these concerns. Although ranitidine itself does not directly cause cancer, the potential for NDMA formation during storage led to its removal as a precautionary measure 1. It is essential to note that the FDA has not concluded that all ranitidine products definitely cause cancer, but the risk associated with NDMA contamination is a significant concern.

Key Points to Consider

• Ranitidine was withdrawn from the market in 2020 due to concerns about NDMA contamination 1.
• Alternative medications like famotidine (Pepcid), cimetidine (Tagamet), or proton pump inhibitors like omeprazole are available and do not have the same NDMA concerns.
• The FDA has not concluded that all ranitidine products definitely cause cancer, but removed them as a precautionary measure.
• Some manufacturers have reformulated their products to address these concerns, and limited ranitidine products may be returning to some markets with additional safeguards.

Recommendations for Patients

• If you need an acid-reducing medication, consult with your healthcare provider about alternative options like famotidine or proton pump inhibitors.
• Do not take ranitidine without consulting your healthcare provider, as the risks associated with NDMA contamination are a significant concern.
• Always follow the guidance of your healthcare provider when starting or switching medications.

From the FDA Drug Label

Carcinogenesis, Mutagenesis, Impairment of Fertility: There was no indication of tumorigenic or carcinogenic effects in life-span studies in mice and rats at dosages up to 2,000 mg/kg per day. The FDA drug label does not answer the question about Ranitidine causing cancer as a side effect in humans, but it does indicate that no carcinogenic effects were found in animal studies.

• Ranitidine availability is not explicitly addressed in terms of current market status, but the label provides information on its use and interactions. Based on the label, Ranitidine has been studied for its effects on other drugs and has several interactions, but the information on carcinogenic effects is limited to animal studies 2.

From the Research

Availability of Ranitidine

• Ranitidine is a histamine H2-receptor antagonist that has been used to treat peptic ulcer disease and other allied diseases 3, 4.
• It is available in various forms, including oral tablets and injectable solutions.

Cancer Risk Associated with Ranitidine

• The discovery of N-nitrosodimethylamine (NDMA), a suspected human carcinogen, in ranitidine products raised concerns about its potential carcinogenic effects 5.
• However, a large prospective study using high-quality prescription and cancer incidence data found no consistent evidence of increased risk of upper gastrointestinal cancers associated with ranitidine use 6.
• The study compared ranitidine users with users of other histamine-2 receptor blockers (H2RB) and proton pump inhibitors (PPI) and found no excess 10-year cumulative risk of esophageal, stomach, liver, or pancreatic cancers.
• Another study investigated the root cause of NDMA presence in ranitidine hydrochloride and found that certain impurities in the drug can produce NDMA at different rates 7.
• The study suggested that strict control of these impurities during manufacturing and storage can help mitigate the risk of NDMA formation.

Safety Profile of Ranitidine

• Ranitidine has been shown to be well tolerated and safe for use in various patient populations, including obstetric patients, children, the elderly, and patients with renal impairment 3, 4.
• The drug has a favorable efficacy and tolerability profile, making it a first-line agent for the treatment and prevention of gastrointestinal disorders associated with gastric acid secretion 3.