Applies to vancomycin: oral capsule, oral powder for solution

Other dosage forms:

• intravenous powder for solution

Along with its needed effects, vancomycin 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 immediately if any of the following side effects occur while taking vancomycin:

More common

• Bladder pain
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody or cloudy urine
• decreased urine
• difficult, burning, or painful urination
• dry mouth
• fever
• frequent urge to urinate
• increased thirst
• irregular heartbeat
• loss of appetite
• lower back or side pain
• mood changes
• muscle pain or cramps
• nausea
• numbness or tingling in the hands, feet, or lips
• rapid weight gain
• seizures
• unusual tiredness or weakness
• unusual weight gain or loss
• vomiting

Less common

• Change in the frequency of urination or amount of urine
• difficulty with breathing
• drowsiness
• weakness

Rare

• Hives
• redness or other discoloration of the skin
• scaling or welting of the skin
• skin rash

Incidence not known

• Black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• blurred vision
• chills
• confusion
• continuing ringing or buzzing or other unexplained noise in the ears
• cough
• diarrhea
• difficulty with swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast heartbeat
• feeling of constant movement of self or surroundings
• feeling of fullness in the ears
• hearing loss
• itching
• joint or muscle pain
• loss of balance
• lower back or side pain
• pale skin
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• ringing or buzzing in the ears
• sensation of spinning
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• sweating
• tightness in the chest
• troubled breathing with exertion
• unusual bleeding or bruising

Some side effects of vancomycin 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

• Back pain
• bitter or unpleasant taste
• excess air or gas in the stomach or bowels
• headache
• mouth irritation
• passing gas
• stomach pain

Incidence not known

• Depression
• difficulty having a bowel movement
• trouble sleeping

Applies to vancomycin: compounding powder, intravenous powder for injection, intravenous solution, oral capsule, oral powder for reconstitution, oral solution

The most commonly reported side effects include nausea, abdominal pain, and hypokalemia.

Chemical peritonitis occurred with intraperitoneal administration.

Mild gastrointestinal tract disturbances occurred with oral administration.

Very common (10% or more): Nausea (up to 17%), abdominal pain (up to 15%)

Common (1% to 10%): Vomiting, diarrhea, flatulence

Uncommon (0.1% to 1%): Mild gastrointestinal tract disturbances

Very rare (less than 0.01%): Pseudomembranous enterocolitis/colitis

Frequency not reported: Chemical peritonitis, constipation, indigestion, stomachache

Very common (10% or more): Hypokalemia (up to 13%)

Common (1% to 10%): Exanthema, pruritus, red man syndrome, redness of the face/upper arms, urticaria

Uncommon (0.1% to 1%): Erythema, itch

Rare (0.01% to 0.1%): Toxic epidermal necrolysis

Very rare (less than 0.01%): Exfoliative dermatitis, linear IgA bullous dermatosis, Lyell's syndrome, Stevens-Johnson syndrome

Frequency not reported: Acute generalized exanthematous pustulosis (AGEP), erythematous macular rash with intense pruritus over face/neck/upper body, rash, red neck

Common (1% to 10%): Decrease in blood pressure, flushing of the upper body, peripheral edema, phlebitis

Uncommon (0.1% to 1%): Thrombophlebitis

Rare (0.01% to 0.1%): Vasculitis

Very rare (less than 0.01%): Cardiac arrest

Frequency not reported: Bradycardia, cardiogenic shock, generalized flushing, hypotension, palpitations, substernal pressure, tachycardia

Postmarketing reports: Chest pain

Hypotension, bradycardia, cardiogenic shock, and cardiac arrest have occurred with rapid bolus administration.

Renal failure was most commonly characterized by increased serum creatinine levels or BUN concentrations.

Azotemia usually resolved upon discontinuation of treatment.

Common (1% to 10%): Increased serum creatinine, increased serum urea, nephrotoxicity, renal insufficiency

Rare (0.01% to 0.1%): Acute renal failure, interstitial nephritis

Frequency not reported: Acute kidney injury, Acute tubular necrosis, azotemia, blood urea nitrogen (BUN) concentrations increased, uremia, transient increased urea

Common (1% to 10%): Fatigue, mucosal inflammation, pyrexia

Uncommon (0.1% to 1%): Chills, fever, pain, permanent hearing loss, transient hearing loss

Rare (0.01% to 0.1%): Drug fever, ototoxicity, rigors, shivering, tinnitus

Common (1% to 10%): Dyspnea, stridor

Frequency not reported: Wheezing

Common (1% to 10%): Back pain

Rare (0.01% to 0.1%): Back and chest muscle pain and spasm

Common (1% to 10%): Headache

Rare (0.01% to 0.1%): Dizziness, vertigo

Common (1% to 10%): Urinary tract infection

Frequency not reported: Granular urinary casts

Uncommon (0.1% to 1%): Eosinophilia,

Rare (0.01% to 0.1%): Agranulocytosis, leukopenia, pancytopenia, reversible agranulocytosis, reversible neutropenia, thrombocytopenia

Frequency not reported: Anemia

Rare (0.01% to 0.1%): Anaphylactic reactions, anaphylaxis, hypersensitivity reactions

Frequency not reported: Anaphylactoid reaction

Rare (0.01% to 0.1%): Superinfection

Frequency not reported: Drug rash with eosinophilia and systemic symptoms (DRESS), non-susceptible organism overgrowth

Frequency not reported: Injection site inflammation, injection site pruritus, necrosis, tissue irritation

HORV occurred in patients given this drug via intracameral or intravitreal route during/after cataract surgery.

Frequency not reported: Hemorrhagic occlusive retinal vasculitis (HORV), permanent vision loss

Frequency not reported: Depression, insomnia

Frequency not reported: Transaminase elevations