Bupivacaine liposome Side Effects

Some side effects of bupivacaine liposome 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 liposome: injectable suspension

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

You will be watched closely after receiving bupivacaine liposome, to make sure you do not have a reaction to the medication. Tell your caregivers at once if you have any of these signs of a serious side effect:

• ringing in your ears;

• feeling restless or anxious;

• feeling like you might pass out;

• speech or vision problems, a metallic taste in your mouth;

• numbness or tingling around your mouth;

• tremors, twitching, mood changes;

• fast heart rate, feeling short of breath, feeling unusually hot or cold;

• numbness, weakness, or loss of movement where the injection was given; or

• if you still feel numb several hours after your surgery.

Less serious side effects include:

• mild dizziness or drowsiness;

• nausea, vomiting;

• constipation;

• itching;

• headache, back pain; or

• swelling in your hands or feet.

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 bupivacaine liposome: injectable suspension

Cardiovascular

Cardiovascular side effects have included hypertension, hypotension, tachycardia, bradycardia, palpitations, sinus bradycardia, supraventricular extrasystoles, ventricular extrasystoles, procedural hypertension, procedural hypotension, and ventricular tachycardia.

Dermatologic

Dermatologic side effects have included pruritus, rash, cold sweat, and urticaria.

Gastrointestinal

Gastrointestinal side effects have included nausea (10%), constipation (10%), vomiting (10%), anal hemorrhage, painful defecation, and rectal discharge.

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.

Genitourinary

Genitourinary side effects have included urinary retention and urinary incontinence.

Hematologic

Hematologic side effects have included anemia, postoperative anemia, hemorrhagic anemia, alanine aminotransferase (ALT) increased (4%), aspartate aminotransferase (AST) increased (3%), and blood creatinine increased (2%).

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).

Immunologic

Immunologic side effects have included fungal infection (2%).

Local

Local side effects have included procedural pain and incision site edema (2%).

Metabolic

Metabolic side effects have included decreased appetite and metabolism and nutrition disorders (2%).

Musculoskeletal

Musculoskeletal side effects have included muscle spasms, back pain, and muscular weakness.

Nervous system

Nervous system side effects have included dizziness, headache, somnolence, pallor, syncope, insomnia, pain, chills, paresthesia, tremors, and increased body temperature.

Ocular

Ocular side effects have included blurred vision.

Other

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

Psychiatric

Psychiatric side effects have included anxiety, confused state, depression, agitation, and restlessness.

Respiratory

Respiratory side effects have included hypoxia, laryngospasm, apnea, respiratory depression, respiratory failure, and decreased oxygen saturation.

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