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Vancomycin (Vancomycin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Vancomycin and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (681)
Death (104)
Life Threatening Events (78)
Disability (13)

Reports by Reaction Type

Drug Rash With Eosinophilia and Systemic Symptoms (104)Renal Failure Acute (100)Pyrexia (62)Renal Failure (45)Hypotension (35)Septic Shock (35)Toxic Epidermal Necrolysis (34)Thrombocytopenia (31)Stevens-Johnson Syndrome (31)Renal Impairment (28)Tubulointerstitial Nephritis (25)Tachycardia (23)

Below are a few examples of reports where side effects / adverse reactions may be related to Vancomycin. For a complete list or a specific selection of reports, please use the links above.

Possible Vancomycin side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: female, weighing 61.0 kg (134.2 pounds)

Reactions: Dyspnoea, Pneumonia, Tachycardia, Pyrexia, Multi-Organ Failure, Oedema, Hypoxia, Urosepsis, Asthenia, Escherichia Infection, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Afinitor
    Dosage: unk
    Administration route: Oral
    Indication: Breast Cancer Metastatic
    Start date: 2010-12-23
    End date: 2011-03-18

Comparator Trastuzumab
    Dosage: 137 mg
    Indication: Breast Cancer Metastatic
    Start date: 2010-12-23
    End date: 2011-03-10

Paclitaxel
    Dosage: 142 mg
    Indication: Breast Cancer Metastatic
    Start date: 2010-12-23
    End date: 2011-03-03

Vancomycin
    Dosage: 1 g, q12h
    Start date: 2011-03-16

Other drugs received by patient: Duoneb; Lovenox; Xanax; Benadryl; Metoprolol Tartrate; Vicodin; Protonix



Possible Vancomycin side effects in 76 year old female

Reported by a physician from France on 2012-08-23

Patient: 76 year old female

Reactions: Drug Rash With Eosinophilia and Systemic Symptoms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ciprofloxacin HCL
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Ticarcillin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Vancomycin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication



Possible Vancomycin side effects in 52 year old female

Reported by a physician from France on 2012-08-23

Patient: 52 year old female

Reactions: Drug Rash With Eosinophilia and Systemic Symptoms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gabapentin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Trimethoprim + Sulfamethoxazole
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Vancomycin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication



Possible Vancomycin side effects in 57 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-23

Patient: 57 year old female

Reactions: Shock, Rash Pruritic, Hypokalaemia, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ciprofloxacin Hydrochloride
    Indication: Infection
    Start date: 2011-07-11
    End date: 2011-07-19

Vancomycin
    Indication: Infection
    Start date: 2011-07-11
    End date: 2011-07-19

Other drugs received by patient: Tegretol; Depakene; Aspirin; Bisoprolol Fumarate; Calciparine; Levothyroxine Sodium



Possible Vancomycin side effects in

Reported by a physician from France on 2012-08-22

Patient:

Reactions: Drug Rash With Eosinophilia and Systemic Symptoms

Drug(s) suspected as cause:
Ciprofloxacin HCL
    Dosage: unk, unknown
    Indication: Product Used FOR Unknown Indication

Ticarcillin
    Dosage: unk, unknown
    Indication: Product Used FOR Unknown Indication

Vancomycin
    Dosage: unk, unknown
    Indication: Product Used FOR Unknown Indication



Possible Vancomycin side effects in 65 year old female

Reported by a health professional (non-physician/pharmacist) from Korea, Republic of on 2012-08-22

Patient: 65 year old female

Reactions: Drug Resistance, Deafness

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Ampicillin
    Indication: Meningitis Pneumococcal

Rocephin
    Indication: Meningitis Pneumococcal

Vancomycin
    Indication: Meningitis Pneumococcal



Possible Vancomycin side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22

Patient: female

Reactions: Blood Pressure Increased, Dyspnoea, Flatulence, Peritoneal Dialysis Complication, Weight Increased, Abdominal Distension, Umbilical Hernia, Feeling Abnormal, Cardiac Arrest

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dianeal
    Start date: 2009-07-19
    End date: 2009-07-28

Dianeal
    Indication: Peritoneal Dialysis

Dianeal LOW Calcium W / Dextrose 1.5%
    Indication: Peritoneal Dialysis

Heparin

Vancomycin



Possible Vancomycin side effects in 65 year old male

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 65 year old male

Reactions: Multi-Organ Failure, Metabolic Acidosis, Rash, Rash Morbilliform, Drug Rash With Eosinophilia and Systemic Symptoms, Eosinophilia, Rash Pruritic

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Fluconazole
    Indication: Evidence Based Treatment

Levofloxacin
    Indication: Evidence Based Treatment

Metronidazole
    Indication: Evidence Based Treatment

Vancomycin
    Indication: Evidence Based Treatment



Possible Vancomycin side effects in 52 year old female

Reported by a consumer/non-health professional from Israel on 2012-08-21

Patient: 52 year old female

Reactions: Histiocytosis Haematophagic, Drug Rash With Eosinophilia and Systemic Symptoms

Drug(s) suspected as cause:
Gabapentin
    Indication: Product Used FOR Unknown Indication

Immune Globulin (Human)
    Dosage: 200 mg/kg/day
    Indication: Drug Rash With Eosinophilia and Systemic Symptoms

Sulfamethoxazole and Trimethoprim
    Indication: Product Used FOR Unknown Indication

Vancomycin
    Indication: Product Used FOR Unknown Indication



Possible Vancomycin side effects in 18 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient: 18 year old male

Reactions: Dysgeusia, Pruritus Generalised, Blood Creatine Phosphokinase Increased, Bone Marrow Failure, Neutropenia, Decreased Appetite, Leukopenia

Drug(s) suspected as cause:
Daptomycin
    Indication: Staphylococcal Osteomyelitis

Telavancin Hydrochloride
    Dosage: approximately 10 mg/kg/day
    Indication: Staphylococcal Osteomyelitis

Vancomycin
    Dosage: 13 mg/kg
    Indication: Staphylococcal Osteomyelitis

Vancomycin
    Dosage: 19 mg/kg

Other drugs received by patient: Rifampicin; Ciprofloxacin; Meropenem



Possible Vancomycin side effects in 62 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-21

Patient: 62 year old male

Reactions: Pancytopenia, Condition Aggravated

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bactrim
    Start date: 2012-05-29
    End date: 2012-06-12

Ceftriaxone
    Start date: 2012-05-16
    End date: 2012-05-29

Vancomycin
    Start date: 2012-03-22
    End date: 2012-05-29

Other drugs received by patient: Clindamycin HCL; Levofloxacin



Possible Vancomycin side effects in 52 year old female

Reported by a health professional (non-physician/pharmacist) from Israel on 2012-08-21

Patient: 52 year old female

Reactions: Histiocytosis Haematophagic, Drug Rash With Eosinophilia and Systemic Symptoms

Drug(s) suspected as cause:
Gabapentin
    Indication: Product Used FOR Unknown Indication

Immune Globulin (Human)
    Dosage: 200 mg/kg/day
    Indication: Drug Rash With Eosinophilia and Systemic Symptoms

Sulfamethoxazole and Trimethoprim
    Indication: Product Used FOR Unknown Indication

Vancomycin
    Indication: Product Used FOR Unknown Indication



Possible Vancomycin side effects in 59 year old male

Reported by a pharmacist from United States on 2012-08-21

Patient: 59 year old male, weighing 76.3 kg (167.8 pounds)

Reactions: Angioedema, Diabetic Neuropathic Ulcer, Osteomyelitis, TOE Amputation

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Lisinopril
    Dosage: 40 mg, every day, po
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-08-10
    End date: 2012-07-16

Vancomycin
    Dosage: 1500 mg
    Indication: Infection Prophylaxis
    Start date: 2012-06-15
    End date: 2012-06-17

Vancomycin
    Dosage: 1500 mg
    Indication: Surgery
    Start date: 2012-06-15
    End date: 2012-06-17



Possible Vancomycin side effects in 74 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-21

Patient: 74 year old male, weighing 59.0 kg (129.8 pounds)

Reactions: Pneumonia, Renal Failure, Respiratory Disorder

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Vancomycin

Other drugs received by patient: Doripenem Monohydrate; Humulin R



Possible Vancomycin side effects in male

Reported by a physician from Ireland on 2012-08-20

Patient: male

Reactions: Malaise, Rash, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sodium Chloride 0.9%
    End date: 2012-08-02

Vancomycin
    Indication: Infection
    End date: 2012-08-02

Other drugs received by patient: Celebrex; Metronidazole; Oxycontin; Oxycodone Hydrochloride; Lyrica



Possible Vancomycin side effects in 65 year old male

Reported by a physician from United States on 2012-08-20

Patient: 65 year old male

Reactions: Metabolic Acidosis, Oedema Mucosal, Mental Status Changes, Drug Rash With Eosinophilia and Systemic Symptoms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Levofloxacin
    Indication: Evidence Based Treatment

Vancomycin
    Indication: Evidence Based Treatment

Other drugs received by patient: Metronidazole; Fluconazole



Possible Vancomycin side effects in 65 year old male

Reported by a physician from United States on 2012-08-20

Patient: 65 year old male

Reactions: Metabolic Acidosis, Oedema Mucosal, Mental Status Changes, Drug Rash With Eosinophilia and Systemic Symptoms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Levofloxacin
    Indication: Evidence Based Treatment

Vancomycin
    Indication: Evidence Based Treatment

Other drugs received by patient: Metronidazole; Fluconazole



Possible Vancomycin side effects in 65 year old male

Reported by a physician from United States on 2012-08-17

Patient: 65 year old male

Reactions: Metabolic Acidosis, Oedema Mucosal, Mental Status Changes, Swollen Tongue, Drug Rash With Eosinophilia and Systemic Symptoms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Levofloxacin (Levaquin)
    Indication: Evidence Based Treatment

Vancomycin
    Indication: Evidence Based Treatment

Other drugs received by patient: Metronidazole; Fluconazole



Possible Vancomycin side effects in 20 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: 20 year old male, weighing 89.4 kg (196.7 pounds)

Reactions: Pruritus

Drug(s) suspected as cause:
Vancomycin



Possible Vancomycin side effects in 18 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: 18 year old male

Reactions: Pruritus Generalised, Malaise, Fatigue, Chills, Bone Marrow Failure, Neutropenia, Pyrexia, Leukopenia

Drug(s) suspected as cause:
Vancomycin
    Dosage: 1 g, q12h

Vancomycin
    Dosage: 1.5 g, q12h

Other drugs received by patient: Amoxicillin; Rifampin; Ertapenem; Telavancin Hydrochloride; Minocycline HCL; Daptomycin; Meropenem



Possible Vancomycin side effects in 70 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-17

Patient: 70 year old male

Reactions: Confusional State, Disorientation, Aggression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ciprofloxacin Hydrochloride
    Indication: Septic Shock
    Start date: 2012-06-17
    End date: 2012-06-19

Fungizone
    Indication: Candidiasis
    Start date: 2012-06-18

Ranitidine
    Start date: 2012-06-17

Tazobactam
    Start date: 2012-06-17

Vancomycin
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-17
    End date: 2012-06-17



Possible Vancomycin side effects in male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-17

Patient: male, weighing 72.6 kg (159.7 pounds)

Reactions: Acute Myeloid Leukaemia, Renal Failure Acute

Adverse event resulted in: death

Drug(s) suspected as cause:
Clofarabine
    Dosage: 37 mg, qd
    Start date: 2012-02-02
    End date: 2012-02-05

Clofarabine
    Dosage: 37 mg, qd
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-01-30
    End date: 2012-01-30

Mozobil
    Dosage: 17.4 mg, qd
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-01-30
    End date: 2012-01-30

Mozobil
    Dosage: 17.4 mg, qd
    Start date: 2012-02-01
    End date: 2012-02-04

Vancomycin
    Dosage: 1 g, bid
    Indication: Sepsis
    Start date: 2012-02-05
    End date: 2012-02-07

Other drugs received by patient: Daunorubicin HCL; Potassium Chloride; Nicotine; Fluticasone Propionate / Salmeterol; Acetaminophen and Codeine Phosphate; Ondansetron; Potassium Chloride; Allopurinol; Daunorubicin HCL; Cyclizine; Furosemide; Ipratropium Bromide; Chlordiazepoxide; Itraconazole; Acyclovir; Meropenem; Meropenem; Acetaminophen and Codeine Phosphate; Calcium Carbonate; Daunorubicin HCL



Possible Vancomycin side effects in 2 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-17

Patient: 2 year old female

Reactions: Blood Alkaline Phosphatase Increased, Gamma-Glutamyltransferase Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amikacin
    Dosage: unk
    Indication: Bronchitis
    Start date: 2012-07-10
    End date: 2012-07-18

Augmentin '500'
    Dosage: unk
    Indication: Pharyngeal Abscess
    Start date: 2012-06-30
    End date: 2012-07-10

Tazobactam
    Dosage: unk
    Indication: Bronchitis
    Start date: 2012-07-10
    End date: 2012-07-11

Vancomycin
    Dosage: unk
    Indication: Bronchitis
    Start date: 2012-07-12
    End date: 2012-07-18

Other drugs received by patient: Claforan; Solu-Medrol; Amoxicillin; Fosfocine; Clarithromycin



Possible Vancomycin side effects in female

Reported by a physician from Korea, Republic of on 2012-08-16

Patient: female

Reactions: Pneumonia, Sepsis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Doripenem Monohydrate
    Indication: Pneumonia
    Start date: 2012-07-21
    End date: 2012-07-22

Vancomycin
    Indication: Pneumonia
    Start date: 2012-07-19
    End date: 2012-07-22

Other drugs received by patient: Verapamil; Lasix; Solu-Medrol; Anti Arrhythmic



Possible Vancomycin side effects in 76 year old female

Reported by a physician from France on 2012-08-16

Patient: 76 year old female

Reactions: Drug Rash With Eosinophilia and Systemic Symptoms, Hepatitis

Drug(s) suspected as cause:
Ciprofloxacin

Ticarcillin

Vancomycin



Possible Vancomycin side effects in

Reported by a consumer/non-health professional from Netherlands on 2012-08-15

Patient:

Reactions: Hyperkalaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cancidas
    Dosage: 50 mg, qd
    Start date: 2010-01-28
    End date: 2010-02-16

Cancidas
    Dosage: 70 mg, qd
    Indication: Infection Prophylaxis
    Start date: 2010-01-27
    End date: 2010-01-27

Tacrolimus
    Indication: Liver Transplant
    Start date: 2009-05-25
    End date: 2010-01-27

Tacrolimus
    Indication: Immunosuppression
    Start date: 2010-01-29
    End date: 2010-03-09

Tacrolimus
    Start date: 2010-03-10
    End date: 2010-03-14

Tacrolimus
    Start date: 2010-03-17

Vancomycin
    Indication: Localised Intraabdominal Fluid Collection
    Start date: 2010-01-26
    End date: 2010-02-04

Vancomycin
    Indication: Staphylococcal Infection

Other drugs received by patient: Norfloxacin; Esomeprazole; Albumin (Human); Methylprednisolone; Insulin; Ipratropium Bromide; Plasma Protein Fraction (Human); Plasma Protein Fraction (Human); Sulfamethoxazole and Trimethoprim; Mycophenolate Mofetil; Terlipressin; Insulin; Meropenem; Blood Cells, RED; Omeprazole; Omeprazole; Heparin; Insulin; Dextrose; Duovent; Ceftriaxone Sodium; Ursodiol; Methylprednisolone; Acyclovir; Duovent; Mycophenolate Mofetil; Esomeprazole; Magnesium Sulfate; Lactitol; Albumin (Human); Ampicillin; Norepinephrine; Tramadol Hydrochloride; Heparin



Possible Vancomycin side effects in 78 year old male

Reported by a pharmacist from United States on 2012-08-15

Patient: 78 year old male, weighing 56.7 kg (124.7 pounds)

Reactions: Nephropathy Toxic, Blood Creatinine Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vancomycin
    Dosage: 1250mg qid po
    Administration route: Oral
    Indication: Clostridium Difficile Colitis
    Start date: 2012-04-05
    End date: 2012-04-09

Vancomycin
    Dosage: 750mg q12h iv
    Start date: 2012-03-29
    End date: 2012-04-09

Other drugs received by patient: NPH Insulin; Esomeprazole Sodium; Collagenase Topically; Metoprolol Tartrate; Heparin; Citalopram Hydrobromide; Simvastatin; D5ns IVF; Hydromorphone HCL; Insulin Aspart Sliding Scale; Sinemet; Amlodipine; Senna; Ferrous Sulfate TAB; Docusate



Possible Vancomycin side effects in 76 year old female

Reported by a physician from France on 2012-08-15

Patient: 76 year old female

Reactions: Drug Rash With Eosinophilia and Systemic Symptoms

Drug(s) suspected as cause:
Ciprofloxacin HCL

Ticarcillin

Vancomycin



Possible Vancomycin side effects in 76 year old female

Reported by a physician from France on 2012-08-15

Patient: 76 year old female

Reactions: Drug Rash With Eosinophilia and Systemic Symptoms

Drug(s) suspected as cause:
Ciprofloxacin

Ticarcillin

Vancomycin



Possible Vancomycin side effects in 82 year old male

Reported by a physician from Australia on 2012-08-14

Patient: 82 year old male

Reactions: Bacteraemia, Staphylococcal Infection, Treatment Failure

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Gentamicin
    Indication: Device Related Infection

Metronidazole
    Indication: Device Related Infection

Timentin
    Indication: Device Related Infection

Vancomycin
    Indication: Device Related Infection

Vancomycin
    Indication: Antibiotic Prophylaxis

Other drugs received by patient: Warfarin Sodium

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