Butisol Sodium Side Effects

Generic name: butabarbital

Note: This document contains side effect information about butabarbital. Some of the dosage forms listed on this page may not apply to the brand name Butisol Sodium.

Some side effects of Butisol Sodium 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 butabarbital: oral elixir, oral tablet

Butabarbital may cause a severe allergic reaction. Stop taking butabarbital (the active ingredient contained in Butisol Sodium) and Get emergency medical help if you have any of these signs of an allergic reaction while taking butabarbital: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• feeling like you might pass out;

• a fever or a sore throat;

• sores in your mouth;

• easy bruising or bleeding; or

• trouble breathing or swallowing.

Less serious side effects may be more likely to occur, such as:

• drowsiness or dizziness;

• problems with memory or concentration;

• excitement (especially in children or older adults);

• joint or muscle pain;

• nausea, vomiting, upset stomach, constipation; or

• nightmares or increased dreaming.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to butabarbital: oral elixir, oral tablet

Nervous system

Nervous system side effects have included somnolence, headache, confusion, hyperkinesias, ataxia, and dizziness.

Cardiovascular

Cardiovascular side effects have included bradycardia, hypotension, and syncope.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, and constipation.

Hypersensitivity

Hypersensitivity reactions have included angioedema, skin rash, and exfoliative dermatitis.

Oncologic

Oncologic side effects have included a possible increased frequency of malignancy (particularly liver cancer and brain tumors) following use of phenobarbital and other barbiturates.

Other

Other side effects have included physical and psychological dependence. Withdrawal symptoms have been reported when butabarbital (the active ingredient contained in Butisol Sodium) therapy has been discontinued suddenly.

Psychiatric

Psychiatric side effects have included agitation, nightmares, nervousness, psychiatric disturbance, hallucinations, insomnia, anxiety, and abnormal thinking.

Respiratory

Respiratory side effects have included hypoventilation and apnea.

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