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Ampicillin and Sulbactam (Ampicillin / Sulbactam) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Ampicillin and Sulbactam (Ampicillin / Sulbactam) 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 (59)
Death (3)
Life Threatening Events (5)

Reports by Reaction Type

Enterocolitis Haemorrhagic (14)Culture Stool Positive (9)Klebsiella Infection (6)Urinary Tract Infection (6)Benign Prostatic Hyperplasia (6)Diarrhoea (6)Klebsiella Test Positive (6)Phimosis (5)Rash (5)Pyrexia (4)Diarrhoea Haemorrhagic (4)Rash Morbilliform (4)

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

Possible Ampicillin and Sulbactam side effects in 66 year old male

Reported by a physician from Germany on 2012-08-13

Patient: 66 year old male, weighing 90.0 kg (198.0 pounds)

Reactions: Supraventricular Tachycardia

Drug(s) suspected as cause:
Ampicillin and Sulbactam



Possible Ampicillin and Sulbactam side effects in 25 year old male

Reported by a physician from Turkey on 2012-08-11

Patient: 25 year old male

Reactions: Enterocolitis Haemorrhagic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ampicillin and Sulbactam



Possible Ampicillin and Sulbactam side effects in 27 year old female

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

Patient: 27 year old female

Reactions: Enterocolitis Haemorrhagic, Culture Stool Positive, Klebsiella Test Positive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ampicillin and Sulbactam



Possible Ampicillin and Sulbactam side effects in 22 year old male

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

Patient: 22 year old male

Reactions: Enterocolitis Haemorrhagic, Klebsiella Infection, Diarrhoea Haemorrhagic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ampicillin and Sulbactam



Possible Ampicillin and Sulbactam side effects in 51 year old male

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

Patient: 51 year old male

Reactions: Enterocolitis Haemorrhagic, Clostridium Test Positive, Culture Stool Positive, Klebsiella Test Positive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ampicillin and Sulbactam



Possible Ampicillin and Sulbactam side effects in 46 year old female

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

Patient: 46 year old female

Reactions: Klebsiella Infection, Enterocolitis Haemorrhagic, Diarrhoea Haemorrhagic, Culture Stool Positive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ampicillin and Sulbactam



Possible Ampicillin and Sulbactam side effects in 43 year old female

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

Patient: 43 year old female

Reactions: Klebsiella Infection, Enterocolitis Haemorrhagic, Clostridial Infection, Culture Stool Positive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ampicillin and Sulbactam



Possible Ampicillin and Sulbactam side effects in 20 year old female

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

Patient: 20 year old female

Reactions: Enterocolitis Haemorrhagic, Klebsiella Infection, Clostridial Infection, Culture Stool Positive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ampicillin and Sulbactam



Possible Ampicillin and Sulbactam side effects in 36 year old female

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

Patient: 36 year old female

Reactions: Klebsiella Infection, Enterocolitis Haemorrhagic, Clostridial Infection, Culture Stool Positive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ampicillin and Sulbactam



Possible Ampicillin and Sulbactam side effects in 41 year old male

Reported by a physician from Turkey on 2012-08-02

Patient: 41 year old male

Reactions: Enterocolitis Haemorrhagic, Clostridium Test Positive, Klebsiella Test Positive, Culture Stool Positive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ampicillin and Sulbactam



Possible Ampicillin and Sulbactam side effects in

Reported by a physician from Turkey on 2012-08-02

Patient:

Reactions: Haematochezia, Diarrhoea

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ampicillin and Sulbactam



Possible Ampicillin and Sulbactam side effects in 22 year old male

Reported by a physician from Turkey on 2012-08-02

Patient: 22 year old male

Reactions: Enterocolitis Haemorrhagic, Clostridium Test Positive, Klebsiella Test Positive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ampicillin and Sulbactam



Possible Ampicillin and Sulbactam side effects in 27 year old female

Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-08-02

Patient: 27 year old female

Reactions: Enterocolitis Haemorrhagic, Klebsiella Test Positive, Culture Stool Positive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ampicillin and Sulbactam



Possible Ampicillin and Sulbactam side effects in

Reported by a physician from Turkey on 2012-08-02

Patient:

Reactions: Haematochezia, Diarrhoea

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ampicillin and Sulbactam



Possible Ampicillin and Sulbactam side effects in 28 year old female

Reported by a physician from Turkey on 2012-08-02

Patient: 28 year old female

Reactions: Klebsiella Infection, Enterocolitis Haemorrhagic, Diarrhoea, Diarrhoea Haemorrhagic, Clostridial Infection, Culture Stool Positive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ampicillin and Sulbactam

Other drugs received by patient: NON-Steroidal Anti-Inflammatory Drug



Possible Ampicillin and Sulbactam side effects in

Reported by a physician from Turkey on 2012-08-02

Patient:

Reactions: Haematochezia, Diarrhoea

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ampicillin and Sulbactam



Possible Ampicillin and Sulbactam side effects in 49 year old male

Reported by a physician from Turkey on 2012-08-02

Patient: 49 year old male

Reactions: Enterocolitis Haemorrhagic, Diarrhoea, Diarrhoea Haemorrhagic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ampicillin and Sulbactam

Other drugs received by patient: Nonsteroidal Anti-Inflammatory Drug (Nsaid)



Possible Ampicillin and Sulbactam side effects in 46 year old female

Reported by a physician from Turkey on 2012-08-02

Patient: 46 year old female

Reactions: Enterocolitis Haemorrhagic, Klebsiella Test Positive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ampicillin and Sulbactam



Possible Ampicillin and Sulbactam side effects in 73 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-30

Patient: 73 year old male

Reactions: Fungaemia, Bacterial Translocation

Drug(s) suspected as cause:
Ampicillin and Sulbactam
    Indication: Pneumonia Aspiration

Meropenem



Possible Ampicillin and Sulbactam side effects in 3 month old male

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

Patient: 3 month old male, weighing 4.7 kg (10.3 pounds)

Reactions: Overdose, Hypopnoea

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Ampicillin and Sulbactam
    Dosage: at 450 mg
    Indication: Infection
    Start date: 2012-05-22
    End date: 2012-05-24

Ceftazidime
    Dosage: at 450 mg
    Indication: Infection
    Start date: 2012-05-22
    End date: 2012-05-24

Other drugs received by patient: Mictonetten; Diflucan; Colecalciferol; Calcium Carbonate; Paracetamol; Sodium Chloride; Ferro; Sodium Polystyrene Sulfonate; SAB Simplex; Neorecormon ^roche^



Possible Ampicillin and Sulbactam side effects in 74 year old female

Reported by a health professional (non-physician/pharmacist) from Chile on 2012-06-14

Patient: 74 year old female

Reactions: Linear IGA Disease

Drug(s) suspected as cause:
Ampicillin and Sulbactam

Other drugs received by patient: Vancomycin; Ceftriaxone; Levetiracetam; Phenytoin; Topiramate



Possible Ampicillin and Sulbactam side effects in 47 year old female

Reported by a physician from Turkey on 2012-06-11

Patient: 47 year old female

Reactions: Vomiting, Nausea, Hepatitis Toxic, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ampicillin and Sulbactam

Other drugs received by patient: Levothyroxine Sodium



Possible Ampicillin and Sulbactam side effects in 74 year old female

Reported by a physician from Chile on 2012-06-08

Patient: 74 year old female

Reactions: Meningitis Pneumococcal, Pneumonia, Status Epilepticus, Cerebral Haemorrhage, Nervous System Disorder, Vasculitis, Myocardial Infarction, Rash Maculo-Papular, Septic Shock, Blister

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ampicillin and Sulbactam

Other drugs received by patient: Phenytoin; Topiramate; Vancomycin; Ceftriaxone; Levetiracetam



Possible Ampicillin and Sulbactam side effects in male

Reported by a physician from Germany on 2012-06-01

Patient: male, weighing 77.0 kg (169.4 pounds)

Reactions: Urinary Tract Infection, Benign Prostatic Hyperplasia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ampicillin and Sulbactam
    Dosage: 1500 mg
    Administration route: Oral
    Indication: Urinary Tract Infection
    Start date: 2011-07-21
    End date: 2011-07-24

Blind (BI 1356)
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-06-15

Ciprofloxacin
    Dosage: 500 mg
    Administration route: Oral
    Indication: Urinary Tract Infection
    Start date: 2011-07-25
    End date: 2011-07-28

Surgery OF Prostat Hypertrophy
    Indication: Benign Prostatic Hyperplasia
    Start date: 2011-07-27
    End date: 2011-07-27

Tamsulosin HCL
    Dosage: 40 mg
    Administration route: Oral
    Indication: Benign Prostatic Hyperplasia
    Start date: 2011-07-01
    End date: 2011-07-27

Other drugs received by patient: Surgery OF Phimose



Possible Ampicillin and Sulbactam side effects in 61 year old male

Reported by a physician from Germany on 2012-05-30

Patient: 61 year old male, weighing 90.0 kg (198.0 pounds)

Reactions: Drug Eruption, Acute Generalised Exanthematous Pustulosis

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Ampicillin and Sulbactam

Other drugs received by patient: Aspirin; Staphylex; Clopidogrel



Possible Ampicillin and Sulbactam side effects in 84 year old male

Reported by a physician from Germany on 2012-04-27

Patient: 84 year old male, weighing 74.0 kg (162.8 pounds)

Reactions: Hepatitis Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ampicillin and Sulbactam
    Dosage: 1500 mg, 3x/day
    Indication: Pneumonia
    Start date: 2007-11-27
    End date: 2007-12-05

Ampicillin and Sulbactam
    Dosage: 1500 mg, 1x/day
    Start date: 2007-12-06
    End date: 2007-12-06

Pantoprazole
    Dosage: 40 mg, 2x/day
    Start date: 2007-11-27
    End date: 2007-11-27

Pantoprazole
    Dosage: 40 mg, 1x/day
    Start date: 2007-11-28
    End date: 2007-12-03

Other drugs received by patient: Biotin; Dobutamine; Enalapril Maleate; Beriplex HS; Furosemid ^dak^; Nitroglycerin; Propofol; Riboflavin; Thiamine; Allopurinol; Calcium; Cyanocobalamin; Fentanyl; Fentanyl; Fentanyl; Marcumar; Calcium; Fentanyl; Flumazenil; Digimerck; Fentanyl; Folic Acid; Metoclopramide Hydrochloride; Konakion; Aspisol; Ascorbic Acid; Metoprolol Succinate; Pyridoxine; Heparin; Lactose; Beloc; Metoprolol Tartrate; Midazolam; Dormicum Tablet ^roche^; Morphine; Nicotinamide; Pantothenic Acid; RED Blood Cells, Concentrated; Sucrose; Factor II / Factor IX CH / Factor VII / Factor X; Plasma Protein Fraction (Human); Zoldem; Amphotericin B; Enalapril Maleate



Possible Ampicillin and Sulbactam side effects in 84 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-04-25

Patient: 84 year old male

Reactions: Hepatitis Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ampicillin and Sulbactam
    Dosage: 1500 mg, 1x/day
    Start date: 2007-12-06
    End date: 2007-12-06

Ampicillin and Sulbactam
    Dosage: 1500 mg, 3x/day
    Indication: Pneumonia
    Start date: 2007-11-27
    End date: 2007-12-05

Pantoprazole
    Dosage: 40.0 mg, 2x/day
    Start date: 2007-11-27
    End date: 2007-11-27

Pantoprazole
    Dosage: 40.0 mg, 1x/day
    Start date: 2007-11-28
    End date: 2007-12-03

Other drugs received by patient: Aspisol; Dobutamine; Fentanyl; Flumazenil; Beloc; Midazolam; Morphine; Konakion; Pyridoxine; Ascorbic Acid; Biotin; Marcumar; Konakion; RED Blood Cells, Concentrated; Amphotericin B; Digimerck; Nitroglycerin; Konakion; Propofol; Allopurinol; Amphotericin B; Enalapril Maleate; Enalapril Maleate; Metoprolol Tartrate; Plasma Protein Fraction (Human); Propofol; Calcium; Cyanocobalamin; Metoprolol Tartrate; Midazolam; Midazolam; Propofol; Zolpidem Tartrate; Calcium; Dobutamine; Beriplex HS; Fentanyl; Metoclopramide Hydrochloride; Metoprolol Succinate; Beloc; Beloc; Metoprolol Tartrate; Riboflavin; Factor II / Factor IX CH / Factor VII / Factor X; Furosemid ^dak^; Heparin; Lactose; Metoprolol Succinate; Dormicum Tablet ^roche^; Nicotinamide; Thiamine; Fentanyl; Fentanyl; Fentanyl; Folic Acid; Metoprolol Succinate; Midazolam; Midazolam; Pantothenic Acid; Konakion; Sucrose



Possible Ampicillin and Sulbactam side effects in 80 year old male

Reported by a pharmacist from United States on 2012-04-20

Patient: 80 year old male, weighing 80.8 kg (177.8 pounds)

Reactions: Pyrexia, Rash

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ampicillin and Sulbactam



Possible Ampicillin and Sulbactam side effects in 74 year old female

Reported by a health professional (non-physician/pharmacist) from Chile on 2012-04-17

Patient: 74 year old female

Reactions: Linear IGA Disease, Rash Macular, Blister

Drug(s) suspected as cause:
Ampicillin and Sulbactam

Other drugs received by patient: Cetriaxone (Ceftriaxone); Vancomycin



Possible Ampicillin and Sulbactam side effects in 41 year old male

Reported by a physician from Germany on 2012-04-16

Patient: 41 year old male, weighing 104.0 kg (228.8 pounds)

Reactions: LIP Swelling, Dysarthria, Rash, Swollen Tongue

Drug(s) suspected as cause:
Ampicillin and Sulbactam
    Dosage: 1.5 g, 3x/day
    Indication: Diverticulitis
    Start date: 2011-10-09
    End date: 2011-10-10

Ciprofloxacin HCL
    Dosage: 500 mg, unk
    Administration route: Oral
    Indication: Drug Rash With Eosinophilia and Systemic Symptoms
    Start date: 2011-10-11
    End date: 2011-10-12

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