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Zosyn (Piperacillin / Tazobactam) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Zosyn (Piperacillin / Tazobactam) 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 (195)
Death (45)
Life Threatening Events (40)
Disability (5)

Reports by Reaction Type

Hepatic Function Abnormal (16)Pyrexia (14)Interstitial Lung Disease (14)Drug Interaction (11)Renal Failure Acute (11)Liver Disorder (10)Rash (10)Diarrhoea (10)Renal Impairment (9)Alopecia (9)Pneumonia Aspiration (8)Skin Exfoliation (8)

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

Possible Zosyn side effects in 38 year old female

Reported by a physician from Japan on 2012-08-27

Patient: 38 year old female, weighing 72.0 kg (158.4 pounds)

Reactions: Interstitial Lung Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zosyn

Other drugs received by patient: Metformin HCL; Mucodyne; Humalog; Lantus; Astomin



Possible Zosyn side effects in 63 year old male

Reported by a physician from Japan on 2012-08-24

Patient: 63 year old male

Reactions: Lung Infection Pseudomonal

Adverse event resulted in: death

Drug(s) suspected as cause:
Meropenem
    Dosage: 3 g, 1x/day
    Indication: Febrile Neutropenia

Zosyn
    Dosage: 4.5 g, 3x/day

Zosyn
    Dosage: 4.5 g, 3x/day
    Indication: Febrile Neutropenia

Other drugs received by patient: Fluconazole; Daunorubicin HCL; Novantrone; Etoposide; Cytarabine; Teicoplanin; Vfend



Possible Zosyn side effects in 73 year old male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 73 year old male, weighing 70.3 kg (154.6 pounds)

Reactions: Dyspnoea, Diarrhoea, Clostridium Difficile Colitis, Gallbladder Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zosyn



Possible Zosyn side effects in 61 year old male

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

Patient: 61 year old male, weighing 88.0 kg (193.6 pounds)

Reactions: LIP Swelling, Pruritus, Vomiting, Nausea, Anaphylactic Reaction, Rash

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Zosyn

Other drugs received by patient: Ciprofloxacin; Enalapril Maleate; Cyanocobalamin; Nifedipine; Insulin; Esomeprazole Sodium; Hydralazine HCL; Ferrous Sulfate TAB



Possible Zosyn side effects in 83 year old female

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

Patient: 83 year old female

Reactions: Haemorrhagic Diathesis, Drug Interaction, Prothrombin Time Prolonged

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zosyn

Other drugs received by patient possibly interacting with the suspect drug:
Warfarin Sodium
    Dosage: 1 mg, 1x/day
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2012-05-09
    End date: 2012-05-19

Other drugs received by patient: Aspirin; Amobantes; Tulobuterol



Possible Zosyn side effects in 84 year old male

Reported by a physician from Japan on 2012-08-10

Patient: 84 year old male

Reactions: Anaphylactic Shock

Adverse event resulted in: death

Drug(s) suspected as cause:
Zosyn

Other drugs received by patient: Montelukast Sodium; Famotidine; Mucodyne; Fluticasone Propionate; Coniel; Magnesium Oxide; Uniphyl; Tamsulosin HCL; Neophyllin; Losartan Potassium and Hydrochlorothiazide



Possible Zosyn side effects in 66 year old female

Reported by a pharmacist from Japan on 2012-08-03

Patient: 66 year old female, weighing 47.0 kg (103.4 pounds)

Reactions: Ocular Hyperaemia, Rhinorrhoea, Nasal Congestion, Oropharyngeal Discomfort

Drug(s) suspected as cause:
Zosyn



Possible Zosyn side effects in 66 year old female

Reported by a pharmacist from Japan on 2012-07-31

Patient: 66 year old female, weighing 47.0 kg (103.4 pounds)

Reactions: Ocular Hyperaemia, Rhinorrhoea, Nasal Congestion, Oropharyngeal Discomfort

Drug(s) suspected as cause:
Zosyn



Possible Zosyn side effects in

Reported by a pharmacist from United States on 2012-07-25

Patient:

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Zosyn



Possible Zosyn side effects in 1 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-25

Patient: 1 year old male, weighing 18.0 kg (39.6 pounds)

Reactions: Pneumonia Fungal, Electrocardiogram QT Prolonged, Renal Disorder, Malnutrition, Disseminated Intravascular Coagulation, Clostridium Colitis, Gastric Ulcer, Pneumonia Cytomegaloviral, Liver Disorder, Hypokalaemia, Pneumocystis Jiroveci Pneumonia, Pneumonia Bacterial, Pancreatitis, Acute Respiratory Distress Syndrome

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Ambisome
    Dosage: uncertainty

Bactrim
    Dosage: unk

Cellcept
    Dosage: uncertainty
    Administration route: Oral

Cyclosporine
    Dosage: uncertainty

Decadron
    Dosage: 12 mg, unk
    Administration route: Oral
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2011-05-20
    End date: 2011-06-17

Funguard
    Dosage: uncertainty

Meropenem
    Dosage: unk
    Indication: Prophylaxis

Rituxan

Romiplostim
    Dosage: 1 mg/kg, qwk
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2011-06-01
    End date: 2011-06-08

Romiplostim
    Dosage: 2 mg/kg, qwk
    Start date: 2011-06-15
    End date: 2011-06-15

Romiplostim
    Dosage: 3 mg/kg, qwk
    Start date: 2011-06-24
    End date: 2012-06-24

Romiplostim
    Dosage: 5 mg/kg, qwk
    Start date: 2011-08-09
    End date: 2011-08-09

Romiplostim
    Dosage: 5 mg/kg, qwk
    Start date: 2011-07-21
    End date: 2011-08-06

Romiplostim
    Dosage: 10 mg/kg, qwk
    Start date: 2011-10-17

Romiplostim
    Dosage: 9 mg/kg, qwk
    Start date: 2011-09-08
    End date: 2011-09-08

Romiplostim
    Dosage: 4 mg/kg, qwk
    Start date: 2011-07-11
    End date: 2011-07-11

Romiplostim
    Dosage: 8 mg/kg, qwk
    Start date: 2011-09-01
    End date: 2011-09-01

Romiplostim
    Dosage: 3 mg/kg, qwk
    Start date: 2012-06-21
    End date: 2012-06-21

Romiplostim
    Dosage: 6 mg/kg, qwk
    Start date: 2011-08-16
    End date: 2011-08-16

Romiplostim
    Dosage: 7 mg/kg, qwk
    Start date: 2011-08-24
    End date: 2011-08-24

Romiplostim
    Dosage: 10 mg/kg, qwk
    Start date: 2011-09-15
    End date: 2011-10-13

Zosyn
    Dosage: unk

Other drugs received by patient: Prednisolone; Prednisolone; Fungizone; Prednisolone; Prednisolone; Prednisolone; Famotidine; Danazol; Danazol; Immune Globulin (Human); Cefazolin Sodium; Prednisolone; Prednisolone; Prednisolone; Prednisolone



Possible Zosyn side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-24

Patient: male

Reactions: Jaundice, Weight Decreased, Deafness, Drug Withdrawal Syndrome Neonatal, Constipation, Failure To Thrive, Speech Disorder, Tethered Cord Syndrome, Type 1 Diabetes Mellitus, Gastrooesophageal Reflux Disease, Spina Bifida, Ear Infection, Meningomyelocele, Anxiety, Feeding Disorder Neonatal, Attention Deficit / Hyperactivity Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dexamethasone
    Indication: Foetal Exposure During Pregnancy

Januvia
    Indication: Foetal Exposure During Pregnancy

Lantus
    Indication: Foetal Exposure During Pregnancy

Metformin Hydrochloride
    Indication: Foetal Exposure During Pregnancy

Novolog
    Indication: Foetal Exposure During Pregnancy

Prozac
    Indication: Foetal Exposure During Pregnancy

Seroquel
    Indication: Foetal Exposure During Pregnancy

Terbutaline
    Indication: Foetal Exposure During Pregnancy

Topamax
    Indication: Foetal Exposure During Pregnancy
    Start date: 2006-08-03
    End date: 2006-10-06

Zoloft
    Indication: Foetal Exposure During Pregnancy

Zosyn
    Indication: Foetal Exposure During Pregnancy

Other drugs received by patient: Multi-Vitamins



Possible Zosyn side effects in

Reported by a pharmacist from United States on 2012-07-24

Patient:

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Zosyn



Possible Zosyn side effects in 91 year old male

Reported by a physician from Japan on 2012-07-20

Patient: 91 year old male, weighing 50.0 kg (110.0 pounds)

Reactions: Renal Disorder, Liver Disorder

Drug(s) suspected as cause:
Zosyn
    Dosage: 2.25 g, 3x/day
    End date: 2011-03-22

Zosyn
    Dosage: 4.5 g, 3x/day
    Indication: Pneumonia
    Start date: 2011-03-12

Other drugs received by patient: Clarithromycin



Possible Zosyn side effects in 57 year old female

Reported by a pharmacist from United States on 2012-07-19

Patient: 57 year old female

Reactions: Renal Impairment

Drug(s) suspected as cause:
Carboplatin
    Indication: Neoplasm Malignant
    Start date: 2012-06-26

Taxol
    Indication: Neoplasm Malignant
    Start date: 2012-06-26

Vancomycin
    Indication: Neoplasm Malignant
    Start date: 2012-06-29

Zosyn
    Indication: Neoplasm Malignant
    Start date: 2012-06-20



Possible Zosyn side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-18

Patient: female, weighing 94.8 kg (208.5 pounds)

Reactions: Back Pain, Pruritus, Skin Exfoliation, Alopecia, Blister, Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zosyn

Other drugs received by patient: Vancomycin; Insulin; Diflucan; Tobramycin; Dilantin



Possible Zosyn side effects in 38 year old female

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

Patient: 38 year old female, weighing 72.0 kg (158.4 pounds)

Reactions: Lung Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zosyn

Other drugs received by patient: Mucodyne; Astomin; Lantus; Humalog; Metformin HCL



Possible Zosyn side effects in 1 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-13

Patient: 1 year old male, weighing 18.0 kg (39.6 pounds)

Reactions: Electrocardiogram QT Prolonged, Pneumonia Fungal, Renal Disorder, Disseminated Intravascular Coagulation, Malnutrition, Gastric Ulcer, Clostridium Colitis, Pneumonia Cytomegaloviral, Hypokalaemia, Liver Disorder, Pneumocystis Jiroveci Pneumonia, Pneumonia Bacterial, Pancreatitis, Acute Respiratory Distress Syndrome

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Ambisome
    Dosage: uncertainty

Bactrim
    Dosage: unk

Cellcept
    Dosage: uncertainty
    Administration route: Oral

Cyclosporine
    Dosage: uncertainty

Decadron
    Dosage: 12 mg, unk
    Administration route: Oral
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2011-05-20
    End date: 2011-06-17

Funguard
    Dosage: uncertainty

Meropenem
    Dosage: unk
    Indication: Prophylaxis

Rituxan

Romiplostim
    Dosage: 3 mg/kg, qwk
    Start date: 2011-06-24
    End date: 2012-06-24

Romiplostim
    Dosage: 10 mg/kg, qwk
    Start date: 2011-09-15
    End date: 2011-10-13

Romiplostim
    Dosage: 2 mg/kg, qwk
    Start date: 2011-06-15
    End date: 2011-06-15

Romiplostim
    Dosage: 5 mg/kg, qwk
    Start date: 2011-07-21
    End date: 2011-08-06

Romiplostim
    Dosage: 6 mg/kg, qwk
    Start date: 2011-08-16
    End date: 2011-08-16

Romiplostim
    Dosage: 5 mg/kg, qwk
    Start date: 2011-08-09
    End date: 2011-08-09

Romiplostim
    Dosage: 10 mg/kg, qwk
    Start date: 2011-10-17

Romiplostim
    Dosage: 8 mg/kg, qwk
    Start date: 2011-09-01
    End date: 2011-09-01

Romiplostim
    Dosage: 9 mg/kg, qwk
    Start date: 2011-09-08
    End date: 2011-09-08

Romiplostim
    Dosage: 4 mg/kg, qwk
    Start date: 2011-07-11
    End date: 2011-07-11

Romiplostim
    Dosage: 1 mg/kg, qwk
    Indication: Idiopathic Thrombocytopenic Purpura
    Start date: 2011-06-01
    End date: 2011-06-08

Romiplostim
    Dosage: 3 mg/kg, qwk
    Start date: 2012-06-21
    End date: 2012-06-21

Romiplostim
    Dosage: 7 mg/kg, qwk
    Start date: 2011-08-24
    End date: 2011-08-24

Zosyn
    Dosage: unk

Other drugs received by patient: Danazol; Famotidine; Prednisolone; Prednisolone; Danazol; Prednisolone; Cefazolin Sodium; Prednisolone; Immune Globulin (Human); Prednisolone; Fungizone; Prednisolone; Prednisolone; Prednisolone; Prednisolone



Possible Zosyn side effects in female

Reported by a physician from United States on 2012-07-11

Patient: female, weighing 94.8 kg (208.5 pounds)

Reactions: Back Pain, Pruritus, Skin Exfoliation, Alopecia, Blister, Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zosyn

Other drugs received by patient: Insulin; Dilantin; Diflucan; Tobramycin; Vancomycin



Possible Zosyn side effects in

Reported by a pharmacist from United States on 2012-07-11

Patient:

Reactions: Malaise, Circumstance or Information Capable of Leading To Medication Error

Drug(s) suspected as cause:
Zosyn



Possible Zosyn side effects in 63 year old male

Reported by a physician from Japan on 2012-07-11

Patient: 63 year old male

Reactions: Lung Infection Pseudomonal

Adverse event resulted in: death

Drug(s) suspected as cause:
Meropenem
    Dosage: 3 g, 1x/day
    Indication: Febrile Neutropenia

Zosyn
    Dosage: 4.5 g, 3x/day
    Indication: Febrile Neutropenia

Zosyn
    Dosage: 4.5 g, 3x/day

Other drugs received by patient: Etoposide; Vfend; Fluconazole; Novantrone; Teicoplanin; Cytarabine; Daunorubicin HCL



Possible Zosyn side effects in male

Reported by a pharmacist from United States on 2012-07-03

Patient: male

Reactions: Renal Impairment, Nephropathy Toxic, Drug Interaction

Drug(s) suspected as cause:
Zosyn

Other drugs received by patient possibly interacting with the suspect drug:
Vancomycin Hychloride
    Dosage: unk



Possible Zosyn side effects in female

Reported by a pharmacist from United States on 2012-07-03

Patient: female

Reactions: Renal Impairment, Nephropathy Toxic, Drug Interaction

Drug(s) suspected as cause:
Zosyn

Other drugs received by patient possibly interacting with the suspect drug:
Vancomycin Hychloride
    Dosage: unk
    Indication: Subcutaneous Abscess



Possible Zosyn side effects in 35 year old female

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

Patient: 35 year old female, weighing 75.0 kg (165.0 pounds)

Reactions: Tubulointerstitial Nephritis

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Flurbiprofen
    Dosage: 50 mg/ day
    Indication: Febrile Neutropenia
    Start date: 2011-10-21
    End date: 2011-10-21

Loxoprofen
    Dosage: 60-120 mg/ day
    Administration route: Oral
    Indication: Febrile Neutropenia
    Start date: 2011-10-22
    End date: 2011-10-31

Meropenem
    Dosage: 2-3 g/ day
    Indication: Febrile Neutropenia
    Start date: 2011-10-26
    End date: 2011-11-03

Vancomycin
    Dosage: 2 g/ day
    Indication: Febrile Neutropenia
    Start date: 2011-10-27
    End date: 2011-11-04

Zosyn
    Dosage: unk
    Start date: 2011-11-05
    End date: 2011-11-07

Zosyn
    Dosage: 4.5 g, 3x/day
    Indication: Device Related Infection
    Start date: 2011-10-17
    End date: 2011-10-21

Other drugs received by patient: Norgestrel and Ethinyl Estradiol; Prednisolone Sodium Succinate INJ; Cytarabine; Maxipime; Amikacin; Ambisome; Funguard



Possible Zosyn side effects in female

Reported by a pharmacist from United States on 2012-07-03

Patient: female

Reactions: Renal Impairment, Nephropathy Toxic, Drug Interaction

Drug(s) suspected as cause:
Zosyn

Other drugs received by patient possibly interacting with the suspect drug:
Vancomycin Hychloride
    Dosage: unk



Possible Zosyn side effects in 88 year old female

Reported by a physician from Japan on 2012-06-29

Patient: 88 year old female, weighing 46.0 kg (101.2 pounds)

Reactions: Hepatic Function Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zosyn
    Dosage: 9 g, unk
    Indication: Pneumonia
    Start date: 2012-04-03
    End date: 2012-04-04

Zosyn
    Dosage: 13.5 g, unk
    Indication: Urinary Tract Infection
    Start date: 2012-04-05
    End date: 2012-04-17

Other drugs received by patient: Famotidine; Silvinol; Equa; Furosemide; Diart; Nicorandil; Lacb R



Possible Zosyn side effects in 63 year old male

Reported by a physician from Japan on 2012-06-27

Patient: 63 year old male

Reactions: Lung Infection Pseudomonal

Adverse event resulted in: death

Drug(s) suspected as cause:
Zosyn
    Dosage: 4.5 g, 3x/day
    Indication: Febrile Neutropenia

Zosyn
    Dosage: 4.5 g, 3x/day

Other drugs received by patient: Daunorubicin HCL; Meropenem; Vfend; Fluconazole; Novantrone; Vfend; Cytarabine; Etoposide; Teicoplanin



Possible Zosyn side effects in 75 year old female

Reported by a physician from Japan on 2012-06-22

Patient: 75 year old female, weighing 37.0 kg (81.4 pounds)

Reactions: Interstitial Lung Disease, Hypokalaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zosyn

Other drugs received by patient: Lansoprazole; Amlodipine; Zolpidem; Ketoprofen; Magmitt; Alosenn; Loxonin; Olmesartan Medoxomil



Possible Zosyn side effects in 14 year old female

Reported by a physician from United States on 2012-06-21

Patient: 14 year old female

Reactions: Anaemia, Pyrexia, Thrombocytopenia, Leukopenia

Drug(s) suspected as cause:
Zosyn
    Dosage: 2.25 g, every 8 hours
    Start date: 2012-04-12
    End date: 2012-04-17

Zosyn
    Dosage: 3.375 g, every 6 hours
    Start date: 2012-04-17
    End date: 2012-04-24



Possible Zosyn side effects in 76 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-06-20

Patient: 76 year old male, weighing 53.0 kg (116.6 pounds)

Reactions: Pruritus Generalised, Oedema, Anaphylactic Shock, Erythema, Cough

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Lactec
    Dosage: unk
    Start date: 2012-02-16
    End date: 2012-02-16

Zosyn
    Dosage: 4.5 g, unk
    Indication: Antibiotic Prophylaxis
    Start date: 2012-02-16
    End date: 2012-02-16



Possible Zosyn side effects in male

Reported by a pharmacist from United States on 2012-06-20

Patient: male

Reactions: Injection Site Erythema, Injection Site Extravasation, Injection Site Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zosyn

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