DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Vancomycin (Vancomycin Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Clinical Trial Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to vancomycin hydrochloride in 260 adult subjects in two Phase 3 clinical trials for the treatment of diarrhea associated with C.   difficile . In both trials, subjects received vancomycin hydrochloride 125 mg orally four times daily.  The mean duration of treatment was 9.4 days.  The median age of patients was 67, ranging between 19 and 96 years of age.  Patients were predominantly Caucasian (93%) and 52% were male.

Adverse reactions occurring in ≥ 5% of vancomycin hydrochloride-treated subjects are shown in Table 1.  The most common adverse reactions associated with vancomycin hydrochloride (≥ 10%) were nausea, abdominal pain, and hypokalemia.

Table 1: Common ( ≥ 5%) Adverse Reactionsa for Vancomycin Hydrochloride Reported in Clinical Trials for Treatment of Diarrhea Associated with C. difficile

System/Organ Class

Adverse Reaction

Vancomycin Hydrochloride % (N=260)

Gastrointestinal disorders

Nausea

Abdominal pain

Vomiting

Diarrhea

Flatulence

17

15

9

9

8

General disorders and administration site conditions

Pyrexia

Edema peripheral

Fatigue

9

6

5

Infections and infestations

Urinary tract infection

8

Metabolism and nutrition disorders

Hypokalemia

13

Musculoskeletal and connective tissue disorders

Back pain

6

Nervous system disorders

Headache

7

a Adverse reaction rates were derived from the incidence of treatment-emergent adverse events.

Nephrotoxicity (e.g., reports of renal failure, renal impairment, blood creatinine increased) occurred in 5% of subjects treated with vancomycin hydrochloride.  Nephrotoxicity following vancomycin hydrochloride typically first occurred within one week after completion of treatment (median day of onset was Day 16).  Nephrotoxicity following vancomycin hydrochloride occurred in 6% of subjects >65 years of age and 3% of subjects ≤65 years of age [see Warnings and Precautions, Nephrotoxicity] .

The incidences of hypokalemia, urinary tract infection, peripheral edema, insomnia, constipation, anemia, depression, vomiting, and hypotension were higher among subjects >65 years of age than in subjects ≤65 years of age [see   Use In Specific Populations, Geriatric Use] .

Discontinuation of study drug due to adverse events occurred in 7% of subjects treated with vancomycin hydrochloride.  The most common adverse events leading to discontinuation of vancomycin hydrochloride were C. difficile colitis (<1%), nausea (<1%), and vomiting (<1%).

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of vancomycin hydrochloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Ototoxicity : Cases of hearing loss associated with intravenously administered vancomycin have been reported. Most of these patients had kidney dysfunction or a pre-existing hearing loss or were receiving concomitant treatment with an ototoxic drug [see   Warnings and Precautions, Ototoxicity ] .  Vertigo, dizziness, and tinnitus have been reported.

Hematopoietic : Reversible neutropenia, usually starting 1 week or more after onset of intravenous therapy with vancomycin or after a total dose of more than 25 g, has been reported for several dozen patients.  Neutropenia appears to be promptly reversible when vancomycin is discontinued.  Thrombocytopenia has been reported.

Miscellaneous: Patients have been reported to have had anaphylaxis, drug fever, chills, nausea, eosinophilia, rashes (including exfoliative dermatitis), Stevens-Johnson syndrome, toxic epidermal necrolysis, and rare cases of vasculitis in association with the administration of vancomycin.

A condition has been reported that is similar to the IV-induced syndrome with symptoms consistent with anaphylactoid reactions, including hypotension, wheezing, dyspnea, urticaria, pruritus, flushing of the upper body (“Red Man Syndrome”), pain and muscle spasm of the chest and back.  These reactions usually resolve within 20 minutes but may persist for several hours.



REPORTS OF SUSPECTED VANCOMYCIN SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Vancomycin. The information is not vetted and should not be considered as verified clinical evidence.

Possible Vancomycin side effects / adverse reactions in 66 year old female

Reported by a health professional (non-physician/pharmacist) from Korea, Republic of on 2011-10-03

Patient: 66 year old female

Reactions: Bronchopulmonary Aspergillosis, Hypotension

Adverse event resulted in: death

Suspect drug(s):
Itraconazole
    Indication: Aspergillosis

Vancomycin
    Indication: Aspergillosis

Voriconazole
    Indication: Aspergillosis

Azithromycin
    Indication: Aspergillosis

Adalimumab
    Indication: Rheumatoid Arthritis

Ceftriaxone
    Indication: Aspergillosis

Other drugs received by patient: Prednisolone; Celecoxib; Methotrexate



Possible Vancomycin side effects / adverse reactions in 88 year old female

Reported by a health professional (non-physician/pharmacist) from Denmark on 2011-10-03

Patient: 88 year old female

Reactions: Face Oedema

Suspect drug(s):
Kadian
    Dosage: sc
    Indication: Product Used FOR Unknown Indication

Vancomycin
    Dosage: iv
    Indication: Product Used FOR Unknown Indication

Metoclopramide
    Dosage: sc
    Indication: Product Used FOR Unknown Indication

Metronidazole
    Dosage: iv
    Indication: Product Used FOR Unknown Indication

Ciprofloxacin
    Dosage: iv
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Trospium Chloride; Polyethylene Glycol; Simvastatin; Cetirizine HCL; Amitriptyline HCL; Lidocaine; Propylthiouracil



Possible Vancomycin side effects / adverse reactions in 88 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-10-03

Patient: 88 year old female

Reactions: Face Oedema

Suspect drug(s):
Morphine Sulfate
    Indication: Product Used FOR Unknown Indication

Vancomycin
    Indication: Product Used FOR Unknown Indication

Metoclopramide
    Indication: Product Used FOR Unknown Indication

Metronidazole IN Plastic Container
    Indication: Product Used FOR Unknown Indication

Ciprofloxacin IN Dextrose
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Amitriptyline HCL; Lidocaine; Trospium Chloride; Cetirizine HCL; Polyethylene Glycol; Simvastatin; Propylthiouracil



See index of all Vancomycin side effect reports >>

Drug label data at the top of this Page last updated: 2012-06-25

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2015