Kaopectate Side Effects

Generic Name: bismuth subsalicylate

Please note - some side effects for Kaopectate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Kaopectate - for the Consumer

Kaopectate

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Kaopectate:

Temporary and harmless darkening of the tongue or stool.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fever; hearing loss; nausea; ringing in the ears; severe constipation; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Kaopectate Suspension

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Kaopectate Suspension:

Temporary and harmless darkening of the tongue or stool.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; bloody or dark urine; fever; hearing loss; nausea; ringing in the ears; severe constipation; unusual bruising or bleeding; vomiting that may or may not look like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

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. 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.

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