Vancomycin Side Effects
Some side effects of vancomycin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to vancomycin: oral capsule, oral solution
Get emergency medical help if you have any of these signs of an allergic reaction while taking vancomycin: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using vancomycin and call your doctor at once if you have any of these serious side effects:
hearing loss, ringing in your ears;
urinating less than usual or not at all;
fever, chills, body aches, flu symptoms;
feeling light-headed, fainting;
skin rash, redness, bruising, severe tingling, numbness, pain, muscle weakness;
severe stomach pain, diarrhea that is watery or bloody;
low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or
severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Less serious side effects of vancomycin may include:
back pain; or
muscle pain or tightness.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to vancomycin: intravenous powder for injection, intravenous solution, oral capsule, oral powder for reconstitution, oral solution
Nephrotoxicity occurred more frequently with an older, previously marketed formulation of vancomycin. The potential for nephrotoxicity appears to be much lower with the current formulation.
Unusual cases of acute interstitial nephritis have been reported, often associated with rash, eosinophilia, and fever. Acute tubulointerstitial nephritis associated with fatal toxic epidermal necrolysis has also been reported.
In general, nephrotoxicity following oral vancomycin was first reported within one week after therapy completion (median day of onset was Day 16). Nephrotoxicity following oral vancomycin was reported in 6% of patients older than 65 years of age and 3% of patients 65 years of age or younger.
Renal side effects have included nephrotoxicity (primarily characterized by increased serum creatinine and BUN concentrations), especially with large doses. Rare cases of renal failure, interstitial nephritis, and tubulointerstitial nephritis have been reported. Abnormal renal function and azotemia have also been reported. The risk of nephrotoxicity has been associated with vancomycin trough levels exceeding 10 mcg/mL. Nephrotoxicity (e.g., renal failure, renal impairment, increased blood creatinine) has been reported in 5% of patients treated with the oral formulation.
Ototoxicity occurred more frequently with an older, previously marketed formulation of vancomycin. The potential for ototoxicity appears to be much lower with the current formulation.
Severe, irreversible, bilateral sensorineural hearing loss was reported in a 63-year-old male following administration of two 5 mg intrathecal doses of vancomycin in addition to intravenous vancomycin. The patient also experienced headaches, dizziness, orthostatic syncope, and lethargy.
The incidence of insomnia associated with the oral formulation was higher in patients older than 65 years of age than in patients 65 years of age or younger.
Nervous system side effects have included ototoxicity presented as tinnitus or sensorineural hearing loss in association with elevated vancomycin serum concentrations. The hearing loss may be irreversible. Lethargy, headache, dizziness, orthostatic syncope, confusion, and at least one case of neuralgic amyotrophy have been reported. A case of mononeuritis multiplex associated with vancomycin therapy has been reported. Headache (7%) and insomnia have been reported with the oral formulation. Cases of hearing loss associated with intravenous vancomycin have been reported during postmarketing experience, mostly in patients with kidney dysfunction or a preexisting hearing loss or who were receiving concurrent treatment with an ototoxic drug. Vertigo, dizziness, and tinnitus have been reported during postmarketing experience.
Reversible neutropenia usually developed 1 week or more after the onset of intravenous vancomycin therapy or after a total dose of more than 25 g. Neutropenia appeared to be promptly reversible when vancomycin was discontinued.
Vancomycin may induce antineutrophilic antibodies. A 48-year-old male developed neutropenia and positive antineutrophilic antibodies after 16 days of vancomycin. His WBC decreased to 600 cells/mm3 but recovered after discontinuation of vancomycin and initiation of granulocyte-colony stimulating factor.
Thrombocytopenia with a positive rechallenge occurred in a 58-year-old male treated for chronic osteomyelitis due to methicillin-resistant Staphylococcus aureus. Vancomycin was initiated at 1 g intravenously every 12 hours and titrated to 1.75 g intravenously every 24 hours by hospital day 9. Platelet count fell from 397,000/mm3 two days before initiation of vancomycin to 22,000/mm3 after 9 days of therapy (hospital day 14). Vancomycin was discontinued and platelets increased to 310,000/mm3 by day 19. Rechallenge with vancomycin on day 22 resulted in a prompt decrease in platelet count to 77,000/mm3 after just 2 days. Platelet count returned to normal a couple days after discontinuation of vancomycin. The patient was subsequently treated with surgery, followed by trimethoprim/sulfamethoxazole and eventually discharged. The mechanism of vancomycin-induced thrombocytopenia was thought to be immune-mediated rather than via a direct toxic effect. Other concurrent medications were ruled out as causative agents.
There were 119 spontaneous reports of thrombocytopenia possibly associated with vancomycin submitted to the manufacturer between 1983 and 1997. In one study (n=285), thrombocytopenia (platelets less than 150 x 10(9)/L) occurred in 7.7% of patients and severe thrombocytopenia (platelets less than 50 x 10(9)/L) occurred in 0.3% receiving vancomycin for more than 5 days.
The incidence of anemia associated with the oral formulation was higher in patients older than 65 years of age than in patients 65 years of age or younger.
Hematologic side effects have included reversible neutropenia and rare cases of thrombocytopenia, anemia, and reversible agranulocytosis (granulocytes less than 500/mm3). Leukopenia has also been reported. Anemia has been reported with the oral formulation. Thrombocytopenia, reversible neutropenia associated with intravenous vancomycin, and eosinophilia associated with vancomycin administration have been reported during postmarketing experience.
Gastrointestinal side effects associated with the injectable formulation have included Clostridium difficile associated diarrhea, chemical peritonitis (following intraperitoneal administration), and pseudomembranous colitis. Nausea (17%), abdominal pain (15%), vomiting (9%), diarrhea (9%), flatulence (8%), constipation, and Clostridium difficile colitis have been reported with the oral formulation. Nausea associated with vancomycin administration has been reported during postmarketing experience.
Intraperitoneal administration of sterile vancomycin during continuous ambulatory peritoneal dialysis has been associated with chemical peritonitis, characterized by cloudy dialysate with or without abdominal pain and fever. It was reversible upon discontinuation of intraperitoneal vancomycin.
The incidences of vomiting and constipation associated with the oral formulation were higher in patients older than 65 years of age than in patients 65 years of age or younger.
The most common side effects leading to discontinuation of oral vancomycin were nausea (less than 1%), vomiting (less than 1%), and Clostridium difficile colitis (less than 1%).
Other side effects have included infusion-related events, drug-induced fever, chills, and red man syndrome. Infusion-related events have occurred during or soon after rapid infusion of vancomycin, and symptoms have included anaphylactoid reactions, including hypotension, wheezing, dyspnea, urticaria, pruritus, flushing of the upper body ("red neck"), and/or pain and muscle spasm of the chest and back. Pyrexia (9%), peripheral edema (6%), and fatigue (5%) have been reported with the oral formulation. A condition similar to the intravenous-induced syndrome has been reported during postmarketing experience with oral vancomycin. Symptoms were also consistent with anaphylactoid reactions, including hypotension, wheezing, dyspnea, urticaria, pruritus, flushing of the upper body ("red man syndrome"), and pain and muscle spasm of the chest and back. Drug fever and chills associated with vancomycin administration have been reported during postmarketing experience.
Infusion of vancomycin over less than 60 minutes has been associated with an increased incidence of red man syndrome. Slowing the infusion rate has generally decreased or eliminated the syndrome, and pretreatment with antihistamines has increased patient tolerance. Red man syndrome is caused by a nonspecific release of histamine rather than an allergic reaction.
The anaphylactoid reactions usually resolved within 20 minutes but have persisted for several hours.
The incidence of peripheral edema associated with the oral formulation was higher in patients older than 65 years of age than in patients 65 years of age or younger.
The incidence of hypokalemia associated with the oral formulation was higher in patients older than 65 years of age than in patients 65 years of age or younger.
Metabolic side effects associated with the oral formulation have included hypokalemia (13%).
Local side effects generally have been associated with extravasation of intravenously administered vancomycin and have included pain, tenderness, and necrosis. Phlebitis (inflammation at the injection site), thrombophlebitis, and nonbullous vancomycin-induced skin necrosis have been reported.
The incidence of hypotension associated with the oral formulation was higher in patients older than 65 years of age than in patients 65 years of age or younger.
Cardiovascular side effects have included phlebitis and vasculitis. Rare cases of dose-dependent hypotension, lupus-like vasculitis, and a leukocytoclastic vasculitis have been reported. A case of cardiac arrest associated with rapid infusion of vancomycin therapy (1 g intravenously given over 2 minutes) has been reported. Hypotension has been reported with the oral formulation. Vasculitis associated with vancomycin administration has been reported during postmarketing experience.
Musculoskeletal side effects have included severe chest, shoulder, and low back pains during intravenous administration of vancomycin in patients undergoing peritoneal dialysis. Back pain (6%) has been reported with the oral formulation.
Hypersensitivity side effects have included erythema multiforme, exfoliative dermatitis, linear IgA bullous dermatosis, Stevens-Johnson syndrome, and anaphylaxis. Drug rash with eosinophilia and systemic symptoms (DRESS syndrome) has been reported with intravenous vancomycin during postmarketing experience. Anaphylaxis associated with vancomycin administration has been reported during postmarketing experience.
A 74-year-old male developed an erythematous rash after 4 days of treatment with vancomycin, piperacillin, tazobactam, and ciprofloxacin. The rash progressed to bullae and skin sloughing that involved 90% of his body, including the oral mucosa, palms, soles, genitals, and conjunctiva, and he became septicemic and died 22 days after onset. Skin biopsies and direct immunofluorescence were consistent with a diagnosis of linear IgA bullous dermatosis.
Six of twenty reported cases of vancomycin-associated linear IgA bullous dermatosis have involved the mucosa and two have involved the conjunctiva.
Dermatologic side effects have included rash, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and bullous skin disease. Fatalities have been reported. At least one case of acute tubulointerstitial nephritis associated with fatal toxic epidermal necrolysis has been reported. Rashes (including exfoliative dermatitis), Stevens-Johnson syndrome, and toxic epidermal necrolysis associated with vancomycin administration have been reported during postmarketing experience.
Psychiatric side effects associated with the oral formulation have included depression.
The incidence of depression associated with the oral formulation was higher in patients older than 65 years of age than in patients 65 years of age or younger.
Genitourinary side effects associated with the oral formulation have included urinary tract infection (8%).
The incidence of urinary tract infection associated with the oral formulation was higher in patients older than 65 years of age than in patients 65 years of age or younger.
A 57-year-old male with Clostridium difficile-associated enterocolitis was started on oral vancomycin because diarrhea failed to resolve with metronidazole. The patient's diarrhea improved but did not resolve; however, by day 6 of oral vancomycin treatment, the patient's ALT and AST became abnormally high and vancomycin was stopped. Within 3 days of vancomycin discontinuation, the patient's ALT and AST levels returned to normal. The patient received a total of 5 courses of oral vancomycin because his diarrhea improved but did not resolve. During each course of oral vancomycin, the patient's ALT and AST levels increased and then returned to normal following discontinuation of the drug. Following the discontinuation of the final course of oral vancomycin, the patient's C difficile-associated enterocolitis resolved and his liver enzyme levels returned to normal.
Hepatic side effects have included elevated aspartate transaminase (AST) and alanine transaminase (ALT) with oral vancomycin in at least one case report. Abnormal liver function has been reported during intravenous administration.
Respiratory side effects have included at least one case of interstitial pneumonia.
More vancomycin resources
- vancomycin Concise Consumer Information (Cerner Multum)
- vancomycin MedFacts Consumer Leaflet (Wolters Kluwer)
- vancomycin Advanced Consumer (Micromedex) - Includes Dosage Information
- Vancomycin Professional Patient Advice (Wolters Kluwer)
- Vancocin Prescribing Information (FDA)
- Vancocin Monograph (AHFS DI)
- Vancocin HCl Advanced Consumer (Micromedex) - Includes Dosage Information
Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.