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Zinacef (Cefuroxime) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Zinacef (Cefuroxime) 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 (20)
Death (1)
Life Threatening Events (11)

Reports by Reaction Type

Cholestatic Liver Injury (6)Condition Aggravated (6)Pyrexia (5)Leukocytoclastic Vasculitis (4)Renal Failure Acute (3)Anaphylactic Shock (2)Skin Discolouration (2)Diarrhoea Haemorrhagic (2)Endocarditis (2)Blood Creatinine Increased (2)Blister (2)Blood Urea Increased (2)

Possible Zinacef side effects in 70 year old male

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

Patient: 70 year old male, weighing 77.0 kg (169.4 pounds)

Reactions: Drug Interaction, Renal Failure Acute

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Zinacef
    Dosage: 1.5-3 g daily
    Indication: Endocarditis
    Start date: 2011-01-13
    End date: 2011-01-19

Ramipril
    Dosage: 2.5 mg, qd
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-02-01
    End date: 2011-01-19

Gentamicin
    Dosage: unk
    Indication: Endocarditis
    Start date: 2011-01-03
    End date: 2011-01-19

Other drugs received by patient: Fraxiparin, 0.3 ML, Amp, GSK; Fenistil, 1 MG, Novartis; Midazolam, AMP; Sobelin, 600 MG, Amp, Pfizer; Protaphane, Amp, Novo Nordisk



Possible Zinacef side effects in female

Reported by a pharmacist from Finland on 2012-07-16

Patient: female

Reactions: Urticaria, Anaphylactic Shock, Erythema, Cardiac Arrest, Pulseless Electrical Activity

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Zinacef



Possible Zinacef side effects in male

Reported by a physician from Finland on 2012-07-03

Patient: male

Reactions: Hepatic Necrosis, C-Reactive Protein Increased, Alanine Aminotransferase Increased, Pleural Effusion, Pyrexia, Ascites, Abdominal Pain Upper

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zinacef
    Indication: Urinary Tract Infection
    Start date: 2012-05-23
    End date: 2012-05-28

Ketoprofen
    Indication: Calculus Urinary
    Start date: 2012-05-20
    End date: 2012-05-20

Other drugs received by patient: Atacand



Possible Zinacef side effects in male

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-06-18

Patient: male

Reactions: Cholestatic Liver Injury, Condition Aggravated

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Enoxaparin Sodium
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-01
    End date: 2012-02-28

Acetaminophen
    Administration route: Oral
    Indication: Pain
    Start date: 2011-09-01
    End date: 2012-01-01

Rocephin
    Indication: Bacterial Infection
    Start date: 2011-09-01
    End date: 2012-01-01

Imipenem and Cilastatin Sodium
    Administration route: Oral
    Indication: Bacterial Infection
    Start date: 2011-09-01
    End date: 2012-02-28

Citalopram Hydrobromide
    Administration route: Oral
    Indication: Depression
    Start date: 2011-09-01
    End date: 2012-01-01

Tasigna
    Administration route: Oral
    Indication: Myeloid Leukaemia
    Start date: 2010-10-01

Zinacef
    Indication: Bacterial Infection
    Start date: 2011-09-01

Nexium
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Lantus; Lyrica; Lorazepam; Primperan TAB; Oxazepam



Possible Zinacef side effects in male

Reported by a lawyer from Denmark on 2012-06-18

Patient: male

Reactions: Fatigue, Arthralgia, Drug Hypersensitivity, Anaphylactic Shock, Endotracheal Intubation, Blood Pressure Decreased, Oxygen Saturation Decreased, Cardiac Disorder

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Zinacef



Possible Zinacef side effects in 63 year old male

Reported by a physician from Switzerland on 2012-06-14

Patient: 63 year old male

Reactions: Cholestatic Liver Injury, Condition Aggravated

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Citalopram Hydrobromide
    Administration route: Oral
    Indication: Depression
    Start date: 2011-09-01
    End date: 2012-01-01

Rocephin
    Indication: Bacterial Infection
    Start date: 2011-09-01
    End date: 2012-01-01

Acetaminophen
    Administration route: Oral
    Indication: Pain
    Start date: 2011-09-01
    End date: 2012-01-01

Zinacef
    Indication: Bacterial Infection
    Start date: 2011-09-01

Nexium
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Imipenem and Cilastatin Sodium
    Administration route: Oral
    Indication: Bacterial Infection
    Start date: 2011-09-01
    End date: 2012-02-28

Tasigna
    Administration route: Oral
    Indication: Myeloid Leukaemia
    Start date: 2010-10-01

Enoxaparin Sodium
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-01
    End date: 2012-02-28

Other drugs received by patient: Primperan (Switzerland); Lorazepam; Oxazepam; Lyrica; Lantus



Possible Zinacef side effects in 63 year old male

Reported by a physician from Switzerland on 2012-06-12

Patient: 63 year old male

Reactions: Cholestatic Liver Injury, Condition Aggravated

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Tasigna
    Administration route: Oral
    Indication: Myeloid Leukaemia
    Start date: 2010-10-01

Enoxaparin Sodium
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-01
    End date: 2012-02-28

Imipenem and Cilastatin Sodium
    Administration route: Oral
    Indication: Bacterial Infection
    Start date: 2011-09-01
    End date: 2012-02-28

Citalopram Hydrobromide
    Administration route: Oral
    Indication: Depression
    Start date: 2011-09-01
    End date: 2012-01-01

Zinacef
    Indication: Bacterial Infection
    End date: 2011-09-01

Rocephin
    Indication: Bacterial Infection
    Start date: 2011-09-01
    End date: 2012-01-01

Acetaminophen
    Administration route: Oral
    Indication: Pain
    Start date: 2011-09-01
    End date: 2012-01-01

Nexium
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Lorazepam; Primperan TAB; Lyrica; Oxazepam; Lantus



Possible Zinacef side effects in 63 year old male

Reported by a physician from Switzerland on 2012-06-06

Patient: 63 year old male

Reactions: Blood Alkaline Phosphatase Increased, Cholestatic Liver Injury, Gamma-Glutamyltransferase Increased, Pyrexia, Bilirubin Conjugated Increased

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Zinacef
    Dosage: unk
    Indication: Bacterial Infection
    Start date: 2011-09-01

Enoxaparin Sodium
    Dosage: unk
    Start date: 2011-09-01
    End date: 2012-02-28

Tasigna
    Dosage: unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2010-10-01

Acetaminophen
    Dosage: unk
    Indication: Pain
    Start date: 2011-09-01
    End date: 2012-01-01

Rocephin
    Dosage: unk
    Indication: Bacterial Infection
    Start date: 2011-09-01
    End date: 2012-01-01

Imipenem and Cilastatin Sodium
    Dosage: unk
    Indication: Bacterial Infection
    Start date: 2011-09-01
    End date: 2012-02-28

Citalopram Hydrobromide
    Dosage: unk
    Indication: Depression
    Start date: 2011-09-01
    End date: 2012-01-01

Nexium

Other drugs received by patient: Lantus; Aspirin; Lorazepam; Primperan TAB; Oxazepam; Lyrica



Possible Zinacef side effects in 63 year old male

Reported by a health professional (non-physician/pharmacist) from Switzerland on 2012-06-06

Patient: 63 year old male

Reactions: Cholestatic Liver Injury, Condition Aggravated

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Primaxin
    Administration route: Oral
    Indication: Bacterial Infection
    Start date: 2011-09-01
    End date: 2012-02-28

Tasigna
    Administration route: Oral
    Indication: Myeloid Leukaemia
    Start date: 2010-10-01

Nexium
    Administration route: Oral

Citalopram Hydrobromide
    Administration route: Oral
    Indication: Depression
    Start date: 2011-09-01
    End date: 2012-01-01

Rocephin
    Indication: Bacterial Infection
    Start date: 2011-09-01
    End date: 2012-01-01

Zinacef
    Indication: Bacterial Infection
    Start date: 2011-09-01

Enoxaparin Sodium
    Start date: 2011-09-01
    End date: 2012-02-28

Acetaminophen
    Administration route: Oral
    Indication: Pain
    Start date: 2011-09-01
    End date: 2012-01-01

Other drugs received by patient: Lantus; Lorazepam; Oxazepam; Lyrica; Primperan TAB



Possible Zinacef side effects in 63 year old male

Reported by a physician from Switzerland on 2012-06-05

Patient: 63 year old male

Reactions: Cholestatic Liver Injury, Condition Aggravated

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Imipenem and Cilastatin Sodium
    Administration route: Oral
    Indication: Bacterial Infection
    Start date: 2011-09-01

Rocephin
    Indication: Bacterial Infection
    Start date: 2011-09-01
    End date: 2012-01-01

Citalopram Hydrobromide
    Administration route: Oral
    Indication: Depression
    Start date: 2011-09-01
    End date: 2012-01-01

Nexium
    Administration route: Oral

Tasigna
    Administration route: Oral
    Indication: Myeloid Leukaemia
    Start date: 2010-10-01

Acetaminophen
    Administration route: Oral
    Indication: Pain
    Start date: 2011-09-01
    End date: 2012-01-01

Zinacef
    Indication: Bacterial Infection
    Start date: 2011-09-01

Enoxaparin Sodium
    Start date: 2011-09-01

Other drugs received by patient: Lyrica; Lantus; Primperan TAB; Oxazepam; Lorazepam



Possible Zinacef side effects in 70 year old male

Reported by a physician from Germany on 2011-12-22

Patient: 70 year old male, weighing 77.0 kg (169.4 pounds)

Reactions: Blood Urea Increased, Glomerular Filtration Rate Decreased, Endocarditis, Empyema, Blood Creatinine Increased, Renal Failure Acute

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Gentamicin
    Dosage: 240 mg, 1x/day
    Indication: Endocarditis
    Start date: 2011-01-05
    End date: 2011-01-19

Zinacef
    Dosage: 1.5-3 g, qd
    Indication: Endocarditis
    Start date: 2011-01-13
    End date: 2011-01-19

Ramipril
    Dosage: 2.5 mg, 1x/day
    Administration route: Oral
    Start date: 2010-02-01
    End date: 2011-01-19

Gentamicin
    Dosage: 80 mg, 1x/day
    Start date: 2011-01-03
    End date: 2011-01-03

Gentamicin
    Dosage: 160 mg, 1x/day
    Start date: 2011-01-04
    End date: 2011-01-04

Other drugs received by patient: Fenistil; Fraxiparin; Fraxiparin; Midazolam; Midazolam; Protaphan; Fenistil; Clindamycin HCL



Possible Zinacef side effects in 70 year old male

Reported by a physician from Germany on 2011-12-07

Patient: 70 year old male, weighing 77.0 kg (169.4 pounds)

Reactions: Blood Urea Increased, Glomerular Filtration Rate Decreased, Endocarditis, Empyema, Blood Creatinine Increased, Renal Failure Acute

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Gentamicin
    Dosage: 240 mg, 1x/day
    Indication: Endocarditis
    Start date: 2011-01-05
    End date: 2011-01-19

Gentamicin
    Dosage: 160 mg, 1x/day
    Start date: 2011-01-04
    End date: 2011-01-04

Zinacef
    Dosage: 1.5-3 g, qd
    Indication: Endocarditis
    Start date: 2011-01-13
    End date: 2011-01-19

Gentamicin
    Dosage: 80 mg, 1x/day
    Start date: 2011-01-03
    End date: 2011-01-03

Ramipril
    Dosage: 2.5 mg, 1x/day
    Administration route: Oral
    Start date: 2010-02-01
    End date: 2011-01-19

Other drugs received by patient: Fraxiparin; Clindamycin HCL; Fraxiparin; Protaphan; Midazolam; Fenistil; Midazolam; Fenistil



Possible Zinacef side effects in 3 year old male

Reported by a physician from Czech Republic on 2011-11-28

Patient: 3 year old male

Reactions: Pneumonia Streptococcal, Diarrhoea Haemorrhagic, Condition Aggravated, Pyrexia, Leukocytosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zinacef

Other drugs received by patient: Corticosteroids



Possible Zinacef side effects in 4 year old male

Reported by a physician from Czech Republic on 2011-11-28

Patient: 4 year old male

Reactions: Haematochezia, Diarrhoea, Colitis, Mucous Stools, Pseudomembranous Colitis, Pyrexia, Haematemesis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zinacef

Other drugs received by patient: Gentamicin; Corticoid; Metronidazole; Oxygen; Penicillin



Possible Zinacef side effects in 3 year old male

Reported by a physician from Czech Republic on 2011-11-17

Patient: 3 year old male

Reactions: Diarrhoea Haemorrhagic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zinacef



Possible Zinacef side effects in female

Reported by a health professional (non-physician/pharmacist) from Denmark on 2011-11-10

Patient: female

Reactions: Blood Pressure Increased, Drug Ineffective, Rash, Leukocytoclastic Vasculitis, Arthropathy, Skin Discolouration, Staphylococcal Infection, Vasculitis, Gait Disturbance, Blister

Drug(s) suspected as cause:
Keflex
    Indication: Antibiotic Therapy
    Start date: 2008-05-01

Gentamicin
    Indication: Antibiotic Therapy
    Start date: 2008-05-01

Clindamycin
    Indication: Antibiotic Therapy
    Start date: 2008-05-01

Zinacef
    Indication: Antibiotic Therapy
    Start date: 2008-01-01

Dicloxacillin
    Indication: Antibiotic Therapy
    Start date: 2008-01-01

Meropenem
    Indication: Antibiotic Therapy
    Start date: 2008-05-01



Possible Zinacef side effects in female

Reported by a lawyer from Denmark on 2011-11-10

Patient: female

Reactions: Leukocytoclastic Vasculitis, Skin Discolouration, Skin Necrosis, Rash, Wound Infection Staphylococcal, Blister

Drug(s) suspected as cause:
Meropenem
    Indication: Antibiotic Therapy
    Start date: 2008-05-01

Keflex
    Indication: Antibiotic Therapy
    Start date: 2008-05-01

Gentamicin
    Indication: Antibiotic Therapy
    Start date: 2008-05-01

Clindamycin
    Indication: Antibiotic Therapy
    Start date: 2008-05-01

Zinacef
    Indication: Antibiotic Therapy
    Start date: 2008-01-01

Dicloxacillin
    Indication: Antibiotic Therapy
    Start date: 2008-01-01

Other drugs received by patient: Unknown Medication



Possible Zinacef side effects in 739 month old female

Reported by a lawyer from Denmark on 2011-11-09

Patient: 739 month old female

Reactions: Leukocytoclastic Vasculitis

Drug(s) suspected as cause:
Clindamycin
    Indication: Antibiotic Therapy
    Start date: 2008-05-01

Keflex
    Indication: Antibiotic Therapy
    Start date: 2008-05-01

Zinacef
    Dosage: single dose
    Indication: Antibiotic Therapy
    Start date: 2008-01-11

Dicloxacillin
    Indication: Antibiotic Therapy
    Start date: 2008-01-01

Meropenem
    Indication: Antibiotic Therapy
    Start date: 2008-05-01

Gentamicin
    Indication: Antibiotic Therapy
    Start date: 2008-05-01



Possible Zinacef side effects in male

Reported by a physician from Malaysia on 2011-11-09

Patient: male

Reactions: Chills, Tachycardia, Pyrexia

Drug(s) suspected as cause:
Zinacef

Other drugs received by patient: Hydrocortisone; Ventolin; Atrovent



Possible Zinacef side effects in 61 year old female

Reported by a lawyer from Denmark on 2011-11-04

Patient: 61 year old female

Reactions: Leukocytoclastic Vasculitis

Drug(s) suspected as cause:
Gentamicin
    Indication: Antibiotic Therapy
    Start date: 2008-05-01

Meropenem
    Indication: Antibiotic Therapy
    Start date: 2008-05-01

Dicloxacillin
    Indication: Antibiotic Therapy
    Start date: 2008-01-01

Clindamycin Phosphate
    Dosage: unk
    Indication: Antibiotic Therapy
    Start date: 2008-05-01

Keflex
    Indication: Antibiotic Therapy
    Start date: 2008-05-01

Zinacef
    Indication: Antibiotic Therapy
    Start date: 2008-01-01

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