Maalox Total Relief Side Effects

Generic name: bismuth subsalicylate

Note: This document contains side effect information about bismuth subsalicylate. Some of the dosage forms listed on this page may not apply to the brand name Maalox Total Relief.

Some side effects of Maalox Total Relief 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 bismuth subsalicylate: oral suspension, oral tablet, oral tablet chewable

Get emergency medical help if you have any of these signs of an allergic reaction while taking bismuth subsalicylate (the active ingredient contained in Maalox Total Relief) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking this medicine and call your doctor at once if you have a serious side effect such as:

• hearing loss or ringing in your ears;

• diarrhea lasting longer than 2 days; or

• worsened stomach symptoms.

Less serious side effects include:

• constipation;

• dark colored stools; or

• black or darkened tongue.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to bismuth subsalicylate: compounding powder, oral suspension, oral tablet, oral tablet chewable

Nervous system

Nervous system side effects have included weakness, fatigue, depression, anxiety, irritability, insomnia, unsteady gait, motor incoordination, loss of memory, jerky movements, mental confusion, disorientation, difficulty in walking and speaking, tremor, myoclonic jerks, and incontinence. Myoclonic encephalopathy has occurred rarely. It should be noted that nervous system side effects have been the most common feature of bismuth toxicity.

Nervous system toxicity is a common feature of bismuth toxicity. Bismuth toxicity is characterized by the insidious onset of weakness and fatigue, depression, anxiety, irritability, insomnia, unsteady gait, motor incoordination, loss of memory, and jerky movements. Acute toxicity may result in the development of mental confusion, disorientation, difficulty in walking and speaking, tremor, myoclonic jerks, and incontinence.

Myoclonic encephalopathy has occurred in patients who have ingested bismuth for several months to years, but the incidence is very rare. Recovery of patients from bismuth encephalopathy may take several months following discontinuation of use. Bismuth encephalopathy has generally been reported in patients ingesting salts other than subsalicylate.

Other

Salicylism has been reported in patients who chronically ingest bismuth subsalicylate (the active ingredient contained in Maalox Total Relief) Common complaints include vertigo, diminished hearing, lethargy, CNS dysfunction, confusion, tinnitus, vomiting, and abdominal pain. Patients may present with respiratory alkalosis and metabolic acidosis, azotemia, and hypoprothrombinemia and platelet dysfunction. The elderly may be particularly vulnerable to the development of salicylism.

Other side effects have included salicylism.

Gastrointestinal

Gastrointestinal side effects have included darkening of the tongue or stool. These effects have been temporary in the majority of cases.