Butisol Side Effects

Please note - some side effects for Butisol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Butisol - for the consumer

Butisol Sodium

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 Butisol Sodium:

Clumsiness; dizziness; excessive daytime drowsiness; lightheadedness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal thoughts or behavior; confusion; fainting; fever; hallucinations; mental or mood changes; nausea or vomiting; new or worsening trouble sleeping; severe dizziness; shortness of breath; swelling or tightness of the throat; very slow breathing.

Butisol Sodium Elixir

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 Butisol Sodium Elixir:

Clumsiness; dizziness; excessive daytime drowsiness; lightheadedness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal thoughts or behavior; confusion; fainting; fever; hallucinations; mental or mood changes; nausea or vomiting; new or worsening trouble sleeping; severe dizziness; shortness of breath; swelling or tightness of the throat; very slow breathing.

For the professional

Butisol

The following adverse reactions have been observed with the use of barbiturates in hospitalized patients. Because such patients may be less aware of certain of the milder adverse effects of barbiturates, the incidence of these reactions may be somewhat higher in fully ambulatory patients.

More than 1 in 100 patients. The most common adverse reaction, somnolence, is estimated to occur at a rate of 1 to 3 patients per 100.

Less than 1 in 100 patients. The most common adverse reactions estimated to occur at a rate of less than 1 in 100 patients listed below, grouped by organ system, and by decreasing order of occurrence are:

Central nervous system/psychiatric: Agitation, confusion, hyperkinesia, ataxia, CNS depression, nightmares, nervousness, psychiatric disturbance, hallucinations, insomnia, anxiety, dizziness, thinking abnormality.

Respiratory: Hypoventilation, apnea.

Cardiovascular: Bradycardia, hypotension, syncope.

Gastrointestinal: Nausea, vomiting, constipation.

Other reported reactions: Headache, hypersensitivity (angioedema, skin rashes, exfoliative dermatitis), fever, liver damage.

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