Xaracoll Side Effects

Generic name: bupivacaine

Medically reviewed by Drugs.com. Last updated on Jun 1, 2024.

Note: This document provides detailed information about Xaracoll Side Effects associated with bupivacaine. Some dosage forms listed on this page may not apply specifically to the brand name Xaracoll.

Applies to bupivacaine: injection solution.

Other dosage forms:

• implantation implant

Important warnings This medicine can cause some serious health issues

Injection route (solution)

There have been reports of cardiac arrest with difficult resuscitation or death during use of bupivacaine for epidural anesthesia in obstetrical patients.

In most cases, this has followed use of the 0.75% (7.5 mg/mL) concentration.

Resuscitation has been difficult or impossible despite apparently adequate preparation and appropriate management.

Cardiac arrest has occurred after convulsions resulting from systemic toxicity, presumably following unintentional intravascular injection.

The 0.75% (7.5 mg/mL) concentration of bupivacaine hydrochloride injection is not recommended for obstetrical anesthesia and should be reserved for surgical procedures where a high degree of muscle relaxation and prolonged effect are necessary.

Serious side effects of Xaracoll

Along with its needed effects, bupivacaine (the active ingredient contained in Xaracoll) 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:

More common

• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change or loss of taste
• chest pain or discomfort
• continuing ringing or buzzing or other unexplained noise in the ears
• decrease in the frequency and amount of urine
• diarrhea
• difficult or painful urination
• dizziness
• dry mouth
• fever
• headache
• hearing loss
• increased thirst
• loss of appetite
• mood changes
• muscle pain or cramps
• nausea or vomiting
• seizures
• sleepiness or unusual drowsiness
• slow or irregular heartbeat
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness

Less common

• arm, leg, back, or jaw pain
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blurred vision
• body aches or pain
• chills
• cough or hoarseness
• cramps
• difficulty in moving
• dry throat
• ear congestion
• fast or pounding heartbeat or pulse
• increased blinking
• loss of voice
• muscle stiffness or twitching
• nervousness
• pain, cramps, or heavy menstrual bleeding
• pain, swelling, or redness in the joints
• pounding in the ears
• runny or stuffy nose
• sneezing
• sore throat
• swelling of the testes
• tightness in the chest
• twitching of the eyelids
• unusual weight gain or loss

Incidence not known

• anxiety
• cold, clammy, pale skin
• confusion
• difficulty swallowing
• discouragement
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• excitement
• false or unusual sense of well-being
• feeling sad or empty
• general feeling of illness
• hives, itching, skin rash
• irritability
• loss of interest or pleasure
• puffiness or swelling of the eyelids or around the eyes, lips, or tongue
• restlessness
• shivering
• slowing of labor
• stiff neck or back
• sweating
• trouble concentrating
• trouble sleeping
• weakness of the muscles in your face

Other side effects of Xaracoll

Some side effects of bupivacaine 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

• acid or sour stomach
• belching
• bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• constipation
• excess air or gas in the stomach or intestines
• full feeling
• heartburn
• indigestion
• passing gas
• stomach discomfort, upset, or pain

Incidence not known

• abnormal ejaculation
• decreased sexual performance or desire
• loss of bladder and bowel control
• loss of genital sensation and sexual function
• no sensation in the legs
• numbness
• unable to move the legs

For healthcare professionals

Applies to bupivacaine: compounding powder, injectable kit, injectable solution, intrathecal solution, intravenous solution, parenteral implant.

General

The most frequently reported side effects are acute adverse experiences which demand immediate countermeasures are related to the central nervous system and the cardiovascular system. A major cause of adverse reactions is excessive plasma levels, which may be due to overdose, unintentional intravascular injection, or slow metabolic degradation. It is also difficult to distinguish adverse reactions caused by the drug per se from the physiological effects of the nerve block (e.g. decrease in blood pressure, bradycardia, temporary urinary retention), events caused directly (e.g. spinal hematoma) or indirectly (e.g. meningitis, epidural abscess) by needle puncture or events associated to cerebrospinal leakage (e.g. postdural puncture headache).^[Ref]

Cardiovascular

• Very common (10% or more): Hypotension, bradycardia
• Common (1% to 10%): Hypertension
• Rare (less than 0.1%): Cardiac arrest, cardiac arrhythmia
• Frequency not reported: Cardiac output decreased, heart block, ventricular tachycardia, ventricular fibrillation, myocardium depression, cardiovascular collapse, maternal hypotension^[Ref]

Nervous system

• Common (1% to 10%): Paresthesia, postdural puncture headache, dizziness
• Uncommon (0.1% to 1%): Paresis, dysesthesia, convulsion, circumoral paresthesia, unconsciousness, tremor, lightheadedness, dysarthria
• Rare (less than 0.1%): Paraplegia, paralysis, neuropathy, arachnoiditis, total unintentional spinal block, peripheral nerve injury
• Frequency not reported: Loss of sphincter control, meningismus, cranial nerve palsies, syncope, high/total spinal block, slurred speech, drowsiness, spinal hematoma^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea
• Common (1% to 10%): Vomiting
• Frequency not reported: Fecal incontinence, swallowing difficult, numbness of tongue^[Ref]

Local

• Frequency not reported: Persistent anesthesia^[Ref]

Genitourinary

• Common (1% to 10%): Urinary retention, urinary incontinence
• Frequency not reported: Loss of perineal sensation, loss of sexual function^[Ref]

Respiratory

• Rare (less than 0.1%): Respiratory depression
• Frequency not reported: Respiratory arrest, laryngeal edema, sneezing, respiratory paralysis, hypoxia, hypercarbia^[Ref]

Other

• Uncommon (0.1% to 1%): Hyperacusis, tinnitus
• Frequency not reported: Alkaline phosphatase increased, bilirubin increased, chills, weakness, septic meningitis, labor delayed, temperature elevated, forceps delivery increased, sensation of heat, cold/numbness^[Ref]

Immunologic

• Rare (less than 0.1%): Allergic reaction, anaphylactic shock
• Frequency not reported: Anaphylaxis^[Ref]

Ocular

• Uncommon (0.1% to 1%): Vision disturbed
• Rare (less than 0.1%): Diplopia
• Frequency not reported: Blurred vision, pupils constricted^[Ref]

Psychiatric

• Frequency not reported: Restlessness, anxiety, depression, agitation, nervousness, apprehension, euphoria, confusion^[Ref]

Hepatic

• Frequency not reported: Hepatic dysfunction, ALT increased, AST increased^[Ref]

Dermatologic

• Frequency not reported: Urticaria, pruritus, erythema, angioedema, excessive sweating, cutaneous lesion^[Ref]

Musculoskeletal

• Uncommon (0.1% to 1%): Muscle weakness, back pain, muscle twitching
• Frequency not reported: Joint pain, stiffness, loss of motion
• Postmarketing reports: Chondrolysis^[Ref]

Further information

Xaracoll side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer