Vancocin HCl Pulvules Side Effects

Generic Name: vancomycin

Please note - some side effects for Vancocin HCl Pulvules may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects by Body System - for Healthcare Professionals

Renal

Renal side effects have included nephrotoxicity, which has been reported in approximately 5% of patients treated with vancomycin and characterized by increased serum creatinine and BUN concentrations. Rare cases of renal failure, interstitial nephritis, and tubulointerstitial nephritis have been reported. Abnormal renal function has also been reported. The risk of nephrotoxicity has been associated with vancomycin trough levels exceeding 10 mcg/mL.

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.

Nervous system

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.

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.

Hematologic

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.

Hematologic side effects have included reversible neutropenia (2% to 3%) and rare cases of thrombocytopenia, anemia, and agranulocytosis. Leukopenia has also been reported.

Gastrointestinal

Gastrointestinal side effects have included nausea and rare cases of diarrhea, peritonitis, and pseudomembranous colitis.

Rare cases of peritonitis associated with intraperitoneal vancomycin therapy have been reported, but may have been due to chemical impurities in the drug formulation used.

Intraperitoneal administration of vancomycin to patients on continuous ambulatory peritoneal dialysis has been associated with chemical peritonitis, characterized by cloudy dialysate with or without abdominal pain or fever. It is reversible upon discontinuation of intraperitoneal vancomycin.

Other

Other side effects have included drug-induced fever, chills, and red man syndrome.

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. Symptoms similar to those of the IV-induced syndrome have also occurred during oral vancomycin therapy. Red man syndrome is caused by a nonspecific release of histamine rather than an allergic reaction.

Local

Local side effects generally have been associated with extravasation of intravenously administered vancomycin and have included pain, tenderness, and necrosis. Thrombophlebitis and nonbullous vancomycin-induced skin necrosis have been reported.

Cardiovascular

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 gram intravenously given over 2 minutes) has been reported.

Musculoskeletal

Musculoskeletal side effects have included severe chest, shoulder, and low back pains during intravenous administration of vancomycin in patients undergoing peritoneal dialysis.

Hypersensitivity

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.

Hypersensitivity side effects have included erythema multiforme, exfoliative dermatitis, linear IgA bullous dermatosis, Stevens-Johnson syndrome, and anaphylaxis. At least one case of acute tubulointerstitial nephritis associated with fatal toxic epidermal necrolysis has been reported. Drug rash with eosinophilia and systemic symptoms (DRESS syndrome) has been reported during postmarketing experience.

Dermatologic

Dermatologic side effects have included rash, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and bullous skin disease. Fatalities have been reported.

Hepatic

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

Respiratory side effects have included at least one case of interstitial pneumonia.

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