Applies to bupivacaine liposome: injection suspension.

Serious side effects

Along with its needed effects, bupivacaine liposome may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking bupivacaine liposome:

More common

• Blurred vision
• chills
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, pounding, or irregular heartbeat or pulse
• fever
• sweating

Less common

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain or discomfort
• collection of blood under the skin
• decrease in frequency of urination
• decrease in urine volume
• deep, dark purple bruise
• difficulty in passing urine (dribbling)
• dry mouth
• headache
• increased thirst
• irregular heartbeat
• itching, pain, redness, or swelling
• loss of appetite
• mood changes
• muscle pain, cramp, spasm, or twitching
• nausea
• nervousness
• painful urination
• pale skin
• pounding in the ears
• rapid weight gain
• seizures
• slow or fast heartbeat
• tingling of the hands or feet
• trouble breathing
• unusual bleeding or bruising
• unusual weight gain or loss
• vomiting

Incidence not known

• Loss of consciousness
• no blood pressure or pulse
• stopping of the heart
• weakness of the muscles in your face

Other side effects

Some side effects of bupivacaine liposome may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Motor dysfunction
• trouble sleeping

Less common

• Anxiety
• belching
• change in taste
• constipation
• decreased appetite
• falls
• feeling hot
• heartburn
• hiccups
• indigestion
• itching in the genitals or other skin areas
• loss of taste
• scaling
• seeing double
• sensory loss
• stomach discomfort, upset, or pain
• swelling at the surgical site

Rare

• Increased sweating

For Healthcare Professionals

Applies to bupivacaine liposome: injectable suspension.

General

The most common adverse reactions reported when administration was via infiltration were nausea, vomiting, and dizziness; when administration was via nerve block, common adverse reactions have included nausea, pyrexia, and constipation.^[Ref]

Nervous system

Very common (10% or more): Dizziness (up to 11.3%), motor dysfunction (14.9%)

Common (1% to 10%): Headache, somnolence, hypoesthesia, syncope, dysgeusia, sensory loss

Frequency not reported: Tremor, dizziness postural, paresthesia, syncope, tinnitus, sedation, somnolence, convulsions^[Ref]

Convulsions have been reported following accidental intravascular injection of this drug and other amide-containing products.^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 40.2%), vomiting (up to 27.8%), constipation (up to 22%)

Common (1% to 10%): Anal hemorrhage, painful defecation, rectal discharge, hypoesthesia oral

Frequency not reported: Procedural nausea^[Ref]

Dermatologic

Very common (10% or more): Pruritus (up to 15%)

Common (1% to 10%): Pruritus generalized, hyperhidrosis,

Frequency not reported: Erythema, rash pruritic, cold sweat, urticaria, cellulitis, wound dehiscence, wound secretion, blister, drug eruption, erythema, rash, hematoma^[Ref]

Psychiatric

Common (1% to 10%): Insomnia, confusional state

Frequency not reported: Anxiety, depression, agitation, restlessness^[Ref]

Cardiovascular

Common (1% to 10%): Hypotension, tachycardia, sinus tachycardia, bradycardia, peripheral edema, hypertension

Frequency not reported: Bradycardia, procedural hypertension, procedural hypotension, palpitations, sinus bradycardia, supraventricular extrasystoles, ventricular extrasystoles, ventricular tachycardia, blood pressure increased, blood pressure decreased, pallor, arrhythmia, atrial fibrillation, atrioventricular block first degree, bundle branch block left, bundle branch block right, cardiac arrest, deep vein thrombosis, orthostatic hypotension, electrocardiogram QT prolonged, presyncope, syncope^[Ref]

Cardiac arrest has been reported following accidental intravascular injection of this drug and other amide-containing products.^[Ref]

Hypersensitivity

Rare (less than 0.1%): Allergic-type reactions^[Ref]

Other

Very common (10% or more): Pyrexia (up to 23.3%)

Common (1% to 10%): Procedural pain, lethargy, body temperature increased, feeling hot, post-procedural swelling, fatigue, fall

Frequency not reported: Chills, pain, edema, hearing impaired, asthenia^[Ref]

Hematologic

Common (1% to 10%): Anemia, anemia postoperative, hemorrhagic anemia, postprocedural hematoma

Frequency not reported: White blood cell count increased^[Ref]

Hepatic

Common (1% to 10%): Alanine aminotransferase increased, aspartate aminotransferase increased, increased hepatic enzyme

Musculoskeletal

Common (1% to 10%): Muscle spasms, back pain, muscle twitching

Frequency not reported: Muscular weakness, neck pain, arthralgia, back pain, joint swelling, mobility decreased, muscle spasms, muscular weakness, musculoskeletal pain^[Ref]

Immunologic

Common (1% to 10%): Fungal infection^[Ref]

Metabolic

Common (1% to 10%): Appetite decreased

Frequency not reported: Oxygen saturation decreased, hypokalemia^[Ref]

Renal

Common (1% to 10%): Blood creatinine increased^[Ref]

Respiratory

Common (1% to 10%): Hiccups, hypoxia

Frequency not reported: Laryngospasm, apnea, respiratory depression, respiratory failure, lung infection, pneumonia, cough, dyspnea, lung infiltration, atelectasis^[Ref]

Genitourinary

Frequency not reported: Urinary retention, urinary incontinence, dysuria^[Ref]

Local

Frequency not reported: Incision site edema^[Ref]

Ocular

Frequency not reported: Vision blurred, visual impairment^[Ref]