Bupivacaine Side Effects

Some side effects of bupivacaine 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 bupivacaine: injectable kit, injectable solution, intrathecal solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking bupivacaine: hives, red rash, itching; sneezing, difficulty breathing; severe dizziness, vomiting; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have any of these serious side effects:

• feeling anxious, restless, confused, or like you might pass out;

• problems with speech or vision;

• ringing in the ears, metallic taste, numbness or tingling around your mouth, or tremors;

• seizure (convulsions);

• weak or shallow breathing;

• fast heart rate, gasping, feeling unusually hot;

• slow heart rate, weak pulse;

• urinating less than usual or not at all.

Less serious side effects include:

• nausea, vomiting;

• chills or shivering;

• headache; or

• back pain.

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 bupivacaine: compounding powder, injectable kit, injectable solution, intrathecal solution

General

In general, reactions to bupivacaine are typical of those associated with other amide-type local anesthetics. A major cause of adverse reactions to these drugs is high plasma levels, which may be due to overdosage, rapid absorption from injection site, diminished tolerance, accidental intravascular injection, or slow metabolic degradation.

The most common side effects that require immediate countermeasures are related to the central nervous system and the cardiovascular system. These reactions are generally dose related and due to excessive plasma levels. Accidental subarachnoid injection may result in underventilation or apnea. Hypotension caused by loss of sympathetic tone and respiratory paralysis or underventilation caused by cephalad extension of the motor level of anesthesia may occur and may lead to cardiac arrest if untreated. Elderly patients over 65 years of age, especially those with hypertension, may be at higher risk of hypotensive effects. Factors influencing plasma protein binding, such as acidosis, altered protein production due to systemic diseases, or competition with other drugs for protein binding sites, may decrease tolerance.

Nervous system

Nervous system side effects following epidural or caudal anesthesia have included spinal block (including high or total spinal block); hypotension secondary to spinal block; urinary retention; fecal and urinary incontinence; loss of perineal sensation and sexual function; persistent anesthesia, paresthesia, weakness, paralysis of the lower extremities and loss of sphincter control all of which may have slow, incomplete, or no recovery; headache; backache; septic meningitis; meningismus; arachnoiditis; slowing of labor; increased incidence of forceps delivery; shivering; and cranial nerve palsies due to traction on nerves from loss of cerebrospinal fluid. Neurologic effects following other procedures or routes of administration may include persistent anesthesia, paresthesia, weakness, paralysis, all of which may have slow, incomplete, or no recovery. Central nervous system side effects have included excitation and/or depression, restlessness, anxiety, dizziness, tinnitus, blurred vision, tremors, convulsions, drowsiness, unconsciousness, respiratory arrest, nausea, vomiting, chills, and pupil constriction.

Cardiovascular

Cardiovascular side effects have included myocardial depression, decreased cardiac output, heart block, hypotension, bradycardia, ventricular arrhythmias (including ventricular tachycardia and ventricular fibrillation), and cardiac arrest.

Respiratory

Respiratory side effects have included respiratory paralysis or underventilation (due to upward extension of the level of spinal anesthesia) and may lead to secondary hypoxic cardiac arrest if not treated.

Other

Other side effects have included a high spinal (characterized by paralysis of the legs, loss of consciousness, respiratory paralysis, and bradycardia) following accidental subarachnoid injection.

Hypersensitivity

Hypersensitivity side effects have included allergic-type reactions including signs such as urticaria, pruritus, erythema, angioneurotic edema (including laryngeal edema), tachycardia, sneezing, nausea, vomiting, dizziness, syncope, excessive sweating, elevated temperature, and possibly, anaphylactoid-like symptomatology (including severe hypotension).

Gastrointestinal

Gastrointestinal side effects have included nausea and vomiting during spinal anesthesia.

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