Note: This document contains side effect information about bupivacaine. Some dosage forms listed on this page may not apply to the brand name Marcaine Spinal.

Applies to bupivacaine: implantation implant. Other dosage forms:

• injection solution

Serious side effects of Marcaine Spinal

Along with its needed effects, bupivacaine (the active ingredient contained in Marcaine Spinal) 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

• Fever
• headache
• shakiness in the legs, arms, hands, or feet
• swelling or discharge where the implant is placed

Incidence not known

• Anxiety
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain or discomfort
• chills
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, slow, pounding, or irregular heartbeat or pulse
• flushing, redness of the skin
• lightheadedness, dizziness, or fainting
• nausea
• no blood pressure or pulse
• palpitations
• restlessness
• skin rash, itching, hives, or welts
• sweating
• unconsciousness
• unusual tiredness or weakness
• unusually warm skin
• vomiting

Other side effects of Marcaine Spinal

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

• Change in taste
• loss of taste
• numbness in the mouth

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]