Vancocin HCl Pulvules Side Effects
Generic Name: vancomycin
Note: This page contains side effects data for the generic drug vancomycin. It is possible that some of the dosage forms included below may not apply to the brand name Vancocin HCl Pulvules.
It is possible that some side effects of Vancocin HCl Pulvules may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.
For the Consumer
Applies to vancomycin: oral capsule, oral powder for solution, oral powder for suspension
Other dosage forms:
As well as its needed effects, vancomycin (the active ingredient contained in Vancocin HCl Pulvules) may cause unwanted side effects that require medical attention.
If any of the following side effects occur while taking vancomycin, check with your doctor immediately: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
- frequent urge to urinate
- increased thirst
- irregular heartbeat
- loss of appetite
- lower back or side pain
- mood changes
- muscle pain or cramps
- nausea or vomiting
- numbness or tingling in the hands, feet, or lips
- rapid weight gain
- shortness of breath
- unusual tiredness or weakness
- unusual weight gain or loss
- Change in the frequency of urination or amount of urine
- difficulty with breathing
- redness or other discoloration of the skin
- scaling or welting of the skin
- skin rash
- Black, tarry stools
- bleeding gums
- blistering, peeling, or loosening of the skin
- blurred vision
- continuing ringing or buzzing or other unexplained noise in the ears
- 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
- 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
- tightness in the chest
- troubled breathing with exertion
- unusual bleeding or bruising
Some vancomycin side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:More common
- Abdominal or stomach pain
- back pain
- bitter or unpleasant taste
- excess air or gas in the stomach or intestines
- mouth irritation
- passing gas
- difficulty having a bowel movement (stool)
- trouble sleeping
For Healthcare Professionals
Applies to vancomycin: compounding powder, intravenous powder for injection, intravenous solution, oral capsule, oral powder for reconstitution, oral solution
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 (the active ingredient contained in Vancocin HCl Pulvules) 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.[Ref]
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.[Ref]
Nervous system side effects have included ototoxicity presented as tinnitus or sensorineural hearing loss in association with elevated vancomycin (the active ingredient contained in Vancocin HCl Pulvules) 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.[Ref]
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.[Ref]
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 (the active ingredient contained in Vancocin HCl Pulvules) and eosinophilia associated with vancomycin administration have been reported during postmarketing experience.[Ref]
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.[Ref]
Intraperitoneal administration of sterile vancomycin (the active ingredient contained in Vancocin HCl Pulvules) 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%).[Ref]
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.[Ref]
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 (the active ingredient contained in Vancocin HCl Pulvules) 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.[Ref]
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.[Ref]
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 (the active ingredient contained in Vancocin HCl Pulvules) and have included pain, tenderness, and necrosis. Phlebitis (inflammation at the injection site), thrombophlebitis, and nonbullous vancomycin-induced skin necrosis have been reported.[Ref]
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.[Ref]
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.[Ref]
Musculoskeletal side effects have included severe chest, shoulder, and low back pains during intravenous administration of vancomycin (the active ingredient contained in Vancocin HCl Pulvules) in patients undergoing peritoneal dialysis. Back pain (6%) has been reported with the oral formulation.[Ref]
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 (the active ingredient contained in Vancocin HCl Pulvules) during postmarketing experience. Anaphylaxis associated with vancomycin administration has been reported during postmarketing experience.[Ref]
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.[Ref]
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 (the active ingredient contained in Vancocin HCl Pulvules) administration have been reported during postmarketing experience.[Ref]
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.
Psychiatric side effects associated with the oral formulation have included depression.
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 (the active ingredient contained in Vancocin HCl Pulvules) 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.[Ref]
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.[Ref]
Respiratory side effects have included at least one case of interstitial pneumonia.[Ref]
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