Bupivacaine liposome Side Effects

Not all side effects for bupivacaine liposome may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to bupivacaine liposome: injection suspension

In addition to its needed effects, some unwanted effects may be caused by bupivacaine liposome. In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking bupivacaine liposome, check with your doctor or nurse immediately:

More common
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred vision
  • confusion
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast, pounding, or irregular heartbeat or pulse
  • fever
  • pale skin
  • rapid weight gain
  • sweating
  • tingling of the hands or feet
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss
Less common
  • Bleeding from the anus
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain or discomfort
  • fainting
  • lightheadedness, dizziness, or fainting
  • painful defecation
  • shortness of breath
  • slow or irregular heartbeat
  • swelling at the surgical site
Less common or rare
  • Chills
  • decrease in the frequency of urination
  • decrease in the urine volume
  • difficult or troubled breathing
  • difficulty in passing urine (dribbling)
  • extra heart beat
  • headache
  • hives
  • hoarseness
  • irregular, fast or slow, or shallow breathing
  • irritation
  • itching
  • joint pain, stiffness, or swelling
  • nervousness
  • not breathing
  • painful urination
  • pale or blue lips, fingernails, or skin
  • pounding in the ears
  • rash
  • redness of the skin
  • shakiness in the legs, arms, hands, or feet
  • shortness of breath
  • swelling at the incision site
  • tightness in the chest
  • troubled breathing or swallowing
  • weakness
  • wheezing

Some of the side effects that can occur with bupivacaine liposome may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Back pain
  • muscle spasm
  • nausea
  • sleepiness or unusual drowsiness
  • sleeplessness
  • trouble sleeping
  • unable to sleep
  • vomiting
Less common
  • Decreased appetite
  • itching in the genital or other skin areas
  • scaling
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
Less common or rare
  • Agitation
  • cold sweats
  • hives or welts
  • increased sweating
  • muscle weakness
  • pain in the neck
  • paleness of the skin
  • restlessness

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.[Ref]

Dermatologic

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

Gastrointestinal

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

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.[Ref]

Genitourinary

Genitourinary side effects have included urinary retention and urinary incontinence.[Ref]

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%).[Ref]

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).[Ref]

Immunologic

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

Local

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

Metabolic

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

Musculoskeletal

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

Nervous system

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

Ocular

Ocular side effects have included blurred vision.[Ref]

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.[Ref]

Psychiatric

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

Respiratory

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

References

1. "Product Information. Exparel (bupivacaine liposome)." Pacira Pharmaceuticals Inc, San Diego, CA.

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