Ranitidine bismuth citrate Side Effects

Some side effects of ranitidine bismuth citrate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to ranitidine bismuth citrate: oral tablet

Stop taking ranitidine bismuth citrate and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take ranitidine bismuth citrate and talk to your doctor if you experience

• changes in taste;

• headache or dizziness;

• diarrhea, nausea, or constipation; or

• tremor (shaking).

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

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.

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.

Nervous system

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

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

Other

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

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.

Dermatologic

Dermatological side effects have included pruritus (3%).

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