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Ranitidine bismuth citrate Side Effects

Applies to ranitidine bismuth citrate: oral tablet

General

In general, ranitidine bismuth citrate is well tolerated with minimal adverse effects. The more common side effects may include darkening of the tongue and stools, diarrhea, headache and disturbance of taste. These effects could possibly be due to the addition of clarithromycin.[Ref]

Gastrointestinal

Gastrointestinal side effects have included diarrhea, nausea, vomiting, and constipation in 3% to 8% of patients receiving ranitidine bismuth citrate plus clarithromycin and these side effects appear to be associated primarily to clarithromycin.[Ref]

Nervous system

Bismuth salt intoxication has been very rarely linked with neurotoxic symptoms and encephalopathy.[Ref]

Nervous system side effects have included headaches, which occurred in approximately 5% of patients during clinical trials.[Ref]

Other

Other side effects have included disturbance in taste (10%), sleep disorders (2%), nonspecific chest symptoms (2%) and black tongue and/or stools.[Ref]

The disturbance in taste appears to be primarily related to clarithromycin. Black tongue and/or stools may occur due to colonic conversion of bismuth into bismuth sulfide. Both effects are harmless, and dark stools should not be confused with melena.[Ref]

Dermatologic

Dermatological side effects have included pruritus (3%).[Ref]

References

1. Lacey LF, Frazer NM, Keene ON, Smith JT "Comparative pharmacokinetics of bismuth from ranitidine bismuth citrate (GR122311X), a novel anti-ulcerant and tripotassium dicitrato bismuthate (TDB)." Eur J Clin Pharmacol 47 (1994): 177-80

2. "Product Information. Tritec (ranitidine bismuth citrate)." Glaxo Wellcome, Research Triangle Park, NC.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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