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Amphotericin B (Amphotericin B) - Life Threatening Events - Suspected Cause - Side Effect Reports

 
 



Index of reports > Life Threatening Events (14)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Amphotericin B life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Amphotericin B side effects in 48 year old male

Reported by a physician from United States on 2012-08-16

Patient: 48 year old male, weighing 80.0 kg (176.0 pounds)

Reactions: Pneumonia Cryptococcal, Anaphylactic Reaction

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Prednisone TAB
    Administration route: Oral
    Start date: 2012-01-08
    End date: 2012-01-28

Prednisone TAB
    Indication: Kidney Transplant Rejection

Cellcept
    Administration route: Oral
    Indication: Renal Transplant
    Start date: 2010-02-14

Cellcept
    Administration route: Oral

Prednisone TAB
    Start date: 2011-08-18

Sirolimus
    Administration route: Oral
    Indication: Prophylaxis Against Transplant Rejection
    Start date: 2010-06-25
    End date: 2012-01-31

Amphotericin B
    Indication: Pneumonia Cryptococcal
    Start date: 2012-01-08
    End date: 2012-01-28

Cellcept
    Administration route: Oral
    Start date: 2012-01-31

Other drugs received by patient: Humalog; Amlodipine; Lantus; Aspirin; Moxifloxacin; Pantoprazole; Lantus



Possible Amphotericin B side effects in 33 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01

Patient: 33 year old male, weighing 93.0 kg (204.6 pounds)

Reactions: Lactobacillus Infection, Blood PH Increased, Tachycardia, Blood PH Decreased, Device Related Infection, Scleral Haemorrhage, Bacterial Sepsis, Acute Respiratory Distress Syndrome, Bone Marrow Failure, Blood Bicarbonate Increased, Acute Respiratory Failure, Renal Failure Acute, Febrile Neutropenia, Haemodialysis, Alopecia, Treatment Failure, Base Excess Decreased

Adverse event resulted in: life threatening event, hospitalization

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

Daunorubicin HCL
    Dosage: see image
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-03-30
    End date: 2012-04-01

Daunorubicin HCL
    Dosage: see image
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-04-14
    End date: 2012-04-16

Imipenem and Cilastatin
    Dosage: 1000 mg, q8 hours intravenous (not otherwise specified)
    Indication: Infection
    Start date: 2012-05-07
    End date: 2012-05-28

Caspofungin Acetate
    Dosage: see image
    Indication: Infection
    Start date: 2012-04-09

Caspofungin Acetate
    Dosage: see image
    Indication: Infection
    Start date: 2012-04-08
    End date: 2012-04-08

Caspofungin Acetate
    Dosage: see image
    Indication: Infection
    Start date: 2012-05-20
    End date: 2012-05-22

Voriconazole
    Dosage: 522 mg, q12 hours, intravenous (not otherwise specified)
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-05-08
    End date: 2012-05-08

Penicillin G
    Dosage: 24000000 u, q24 hrs intravenous (not otherwise specified)
    Indication: Infection
    Start date: 2012-05-04
    End date: 2012-05-09

Amphotericin B
    Dosage: 450 mg, uid/qd, intravenous (not otherwise specified)
    Indication: Fungal Infection
    Start date: 2012-05-06
    End date: 2012-05-08

Amphotericin B
    Dosage: 450 mg, uid/qd, intravenous (not otherwise specified)
    Indication: Infection Prophylaxis
    Start date: 2012-05-06
    End date: 2012-05-08

Aztreonam
    Dosage: see image
    Indication: Bacterial Infection
    Start date: 2012-05-06
    End date: 2012-05-07

Aztreonam
    Dosage: see image
    Indication: Bacterial Infection
    Start date: 2012-04-09
    End date: 2012-04-10

Cefepime
    Dosage: 2 g, q8 hours, intravenous (not otherwise specified) ; intravenous (not otherwise specified)
    Indication: Infection
    Start date: 2012-03-29
    End date: 2012-04-10

Cefepime
    Dosage: 2 g, q8 hours, intravenous (not otherwise specified) ; intravenous (not otherwise specified)
    Indication: Infection
    Start date: 2012-06-02
    End date: 2012-06-05

(Investigational Drug)
    Dosage: 60 mg, uid/qd, oral ; 60 mg, uid/qd, oral
    Administration route: Oral
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-04-17
    End date: 2012-04-23

(Investigational Drug)
    Dosage: 60 mg, uid/qd, oral ; 60 mg, uid/qd, oral
    Administration route: Oral
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-04-02
    End date: 2012-04-08

Cytarabine
    Dosage: see image
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-04-14
    End date: 2012-04-20

Cytarabine
    Dosage: see image
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-03-30
    End date: 2012-04-05

Other drugs received by patient: Ondansetron; Seroquel; Percocet; Nystatin; Zyloprim; Acetaminophen; Calcium Carbonate; Lorazepam; Xanax; Allopurinol; Calcium Gluconate; Ibuprofen; Hydroxyzine Pamoate; Celexa



Possible Amphotericin B side effects in 47 year old female

Reported by a health professional (non-physician/pharmacist) from Brazil on 2012-05-30

Patient: 47 year old female, weighing 68.0 kg (149.6 pounds)

Reactions: Hepatomegaly, Respiratory Disorder, Respiratory Tract Haemorrhage, Candidiasis, Renal Failure Acute

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

Drug(s) suspected as cause:
Tretinoin
    Dosage: 40 mg/m2/day continuously
    Administration route: Oral
    Indication: Acute Promyelocytic Leukaemia

Metamizole
    Dosage: 500 mg
    Administration route: Oral
    Indication: Febrile Neutropenia

Fluconazole
    Dosage: 200 mg/day
    Administration route: Oral
    Indication: Candidiasis

Mitoxantrone
    Dosage: 20 mg/m2/day
    Indication: Acute Promyelocytic Leukaemia

Amphotericin B
    Dosage: 30 mg/day, 6 hours of infusion
    Indication: Candidiasis

Cytarabine
    Dosage: 370 mg/m2/day
    Indication: Acute Promyelocytic Leukaemia

Cefepime
    Dosage: 2 g, every eight hours
    Indication: Febrile Neutropenia

Other drugs received by patient: Meropenem; Methotrexate; Tretinoin



Possible Amphotericin B side effects in 43 year old female

Reported by a physician from Korea, Republic of on 2012-04-02

Patient: 43 year old female

Reactions: Bronchopulmonary Aspergillosis, Renal Impairment, Pneumonia, Lymphangioleiomyomatosis, Aspergillosis, Asphyxia

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Deflazacort
    Indication: Lung Transplant

Tacrolimus
    Indication: Immunosuppressant Drug Therapy

Amphotericin B
    Indication: Bronchopulmonary Aspergillosis

Voriconazole
    Indication: Bronchopulmonary Aspergillosis

Mycophenolate Mofetil
    Indication: Immunosuppressant Drug Therapy

Itraconazole
    Dosage: 400 mg
    Indication: Aspergillosis

Fluconazole
    Dosage: 50 mg
    Indication: Prophylaxis

Mycophenolate Mofetil
    Indication: Lung Transplant

Cotrim
    Indication: Antibiotic Prophylaxis

Valganciclovir
    Indication: Antibiotic Prophylaxis

Voriconazole
    Dosage: 150 mg
    Indication: Pneumonia

Deflazacort
    Dosage: 24 mg
    Indication: Immunosuppressant Drug Therapy

Tacrolimus
    Indication: Lung Transplant

Amphotericin B
    Dosage: 35 mg
    Indication: Pneumonia



Possible Amphotericin B side effects in 47 year old female

Reported by a health professional (non-physician/pharmacist) from Brazil on 2012-03-09

Patient: 47 year old female, weighing 69.0 kg (151.8 pounds)

Reactions: Pneumonia Klebsiella, Hepatomegaly, Diarrhoea, Drug Interaction, Renal Failure Acute

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Cytarabine
    Dosage: for 7 days
    Administration route: Oral

Mitoxantrone
    Dosage: for 3 days
    Administration route: Oral

Amphotericin B
    Dosage: 6:0 on day13,stopped on day 21

Other drugs received by patient possibly interacting with the suspect drug:
Cefepime
    Dosage: every 8:0,emperic therapy
    Indication: Anaemia

Tretinoin
    Dosage: continued until day 16,restarted from day 37 20mg/m2
    Administration route: Oral

Cefepime
    Dosage: every 8:0,emperic therapy
    Indication: Thrombocytopenia

Fluconazole
    Administration route: Oral

Cefepime
    Dosage: every 8:0,emperic therapy
    Indication: Febrile Neutropenia

Other drugs received by patient: Dipyrone TAB; Dipyrone TAB; Methotrexate; Dexamethasone; Dipyrone TAB



Possible Amphotericin B side effects in 47 year old female

Reported by a health professional (non-physician/pharmacist) from Brazil on 2012-03-07

Patient: 47 year old female

Reactions: Dyspnoea, Hepatomegaly, Respiratory Tract Haemorrhage, Candidiasis, Renal Failure Acute

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tretinoin
    Dosage: unk
    Administration route: Oral
    Indication: Acute Promyelocytic Leukaemia

Mitoxantrone
    Dosage: unk
    Indication: Acute Promyelocytic Leukaemia

Fluconazole
    Dosage: 200 mg/day
    Administration route: Oral
    Indication: Candidiasis

Metamizole
    Dosage: unk
    Indication: Acute Promyelocytic Leukaemia

Amphotericin B
    Dosage: 30 mg/day 6:0
    Indication: Product Used FOR Unknown Indication

Cefepime
    Dosage: 2 g, every 8:0
    Indication: Acute Promyelocytic Leukaemia

Cytarabine
    Dosage: unk
    Indication: Acute Promyelocytic Leukaemia

Other drugs received by patient: Meropenem; Methotrexate; Tretinoin



Possible Amphotericin B side effects in 67 year old female

Reported by a physician from United States on 2012-01-27

Patient: 67 year old female

Reactions: Bronchopulmonary Aspergillosis, Aspergillosis, Pleural Effusion, Condition Aggravated, Cerebral Ischaemia

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Sirolimus
    Dosage: 1 mg
    Indication: Immunosuppressant Drug Therapy

Amphotericin B
    Indication: Aspergillosis

Amphotericin B
    Indication: Bronchopulmonary Aspergillosis

Prednisone TAB
    Dosage: 7.5 mg
    Indication: Immunosuppressant Drug Therapy

Tacrolimus
    Dosage: 1.5 mg

Voriconazole
    Administration route: Oral
    Indication: Aspergillosis

Tacrolimus
    Dosage: 4 mg
    Indication: Immunosuppressant Drug Therapy

Voriconazole
    Indication: Bronchopulmonary Aspergillosis



Possible Amphotericin B side effects in male

Reported by a health professional (non-physician/pharmacist) from Austria on 2012-01-17

Patient: male

Reactions: Toxic Epidermal Necrolysis

Adverse event resulted in: death, life threatening event

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

Anidulafungin
    Dosage: on day 1
    Indication: Fungal Infection

Metronidazole
    Indication: Product Used FOR Unknown Indication

Amphotericin B
    Indication: Product Used FOR Unknown Indication

Anidulafungin
    Dosage: infusion

Cefotaxime
    Indication: Product Used FOR Unknown Indication

Tigecycline
    Indication: Product Used FOR Unknown Indication



Possible Amphotericin B side effects in 36 year old male

Reported by a pharmacist from United States on 2011-12-19

Patient: 36 year old male

Reactions: Drug Ineffective

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

Drug(s) suspected as cause:
Amphotericin B
    Indication: Lung Infection
    Start date: 2011-10-13

Noxafil
    Dosage: 200 mg;q6h
    Indication: Lung Infection
    Start date: 2011-10-13

Noxafil
    Dosage: 200 mg;q6h
    Indication: Pneumonia
    Start date: 2011-10-13



Possible Amphotericin B side effects in 54 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2011-12-15

Patient: 54 year old female

Reactions: Zygomycosis, Renal Failure, Anaemia, Neutropenia, Sinusitis

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Mycophenolate Mofetil
    Dosage: 1000 mg
    Indication: Immunosuppressant Drug Therapy
    End date: 2009-02-13

Advagraft
    Dosage: 4.5 mg
    Administration route: Oral
    Indication: Immunosuppressant Drug Therapy
    End date: 2009-02-06

Advagraft
    Dosage: 2 mg
    Administration route: Oral
    Start date: 2009-02-06
    End date: 2009-02-13

Amphotericin B
    Administration route: Oral
    Indication: Fungal Oesophagitis

Tazocillin
    Start date: 2009-01-26

Prograf
    Indication: Immunosuppressant Drug Therapy

Ciprofloxacin
    Start date: 2009-01-26

Prednisone TAB
    Dosage: 5 mg
    Indication: Immunosuppressant Drug Therapy

Valganciclovir
    Dosage: 450 mg
    Indication: Antiviral Prophylaxis

Amphotericin B
    Start date: 2009-02-06

Posaconazole
    Dosage: 800 mg
    Indication: Prophylaxis Against Transplant Rejection
    Start date: 2009-02-13
    End date: 2009-02-26

Fluindione
    Dosage: 20 mg
    Administration route: Oral
    Indication: Graft Thrombosis

Amlodipine
    Dosage: 5 mg
    Indication: Hypertension

Celiprolol
    Dosage: 200 mg
    Indication: Hypertension

Repaglinide
    Dosage: 3 mg
    Indication: Diabetes Mellitus

Amoxicillin
    Indication: Antibiotic Therapy
    Start date: 2009-01-20
    End date: 2009-01-26



Possible Amphotericin B side effects in 5 year old female

Reported by a physician from Greece on 2011-12-09

Patient: 5 year old female

Reactions: Grand MAL Convulsion, Acinetobacter Infection, Central Nervous System Infection, Stenotrophomonas Infection, Aspergillosis, Hydrocephalus, Cardiac Arrest, CNS Ventriculitis

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Levetiracetam
    Indication: Epilepsy

Ceftazidime
    Indication: Stenotrophomonas Infection

Isoniazid
    Indication: Tuberculosis of Central Nervous System

Amphotericin B Deoxycholate
    Dosage: 5 mg
    Indication: CNS Ventriculitis

Ceftazidime
    Indication: Acinetobacter Infection

Levetiracetam

Pyrazinamide
    Indication: Tuberculosis of Central Nervous System

Levofloxacin
    Indication: Tuberculosis of Central Nervous System

Voriconazole
    Indication: CNS Ventriculitis

Meropenem
    Indication: Inflammation

Colistin
    Indication: Acinetobacter Infection

Dexamethasone Tablets Usp, 1.5 MG
    Indication: Tuberculosis of Central Nervous System

Rifampin
    Indication: Tuberculosis of Central Nervous System

Streptomycin
    Indication: Tuberculosis of Central Nervous System

Meropenem
    Indication: Acinetobacter Infection

Amphotericin B Deoxycholate

Pyrazinamide

Meropenem
    Indication: Stenotrophomonas Infection

Colistin
    Indication: Stenotrophomonas Infection

Dexamethasone Tablets Usp, 1.5 MG

Dexamethasone Tablets Usp, 1.5 MG

Amphotericin B
    Indication: Aspergillosis



Possible Amphotericin B side effects in 50 year old male

Reported by a consumer/non-health professional from United States on 2011-11-15

Patient: 50 year old male, weighing 55.0 kg (121.0 pounds)

Reactions: Neutropenia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Fluconazole
    Administration route: Oral
    Indication: Meningitis Cryptococcal
    Start date: 2011-07-22
    End date: 2011-08-03

Amphotericin B
    Dosage: reg 2, 35mg, 3 per 1 wk 5aug11-11aug11
    Indication: Meningitis Cryptococcal
    Start date: 2011-08-05
    End date: 2011-09-09

Other drugs received by patient: Bactrim; Flucytosine



Possible Amphotericin B side effects in 34 year old male

Reported by a health professional (non-physician/pharmacist) from Korea, Republic of on 2011-10-31

Patient: 34 year old male

Reactions: Bronchopulmonary Aspergillosis, Post Procedural Bile Leak, Nephropathy Toxic, Transplant Rejection, Biloma, Hepatic Enzyme Increased

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Fluconazole
    Indication: Immunosuppressant Drug Therapy

Methylprednisolone
    Dosage: 500 mg
    Indication: Immunosuppressant Drug Therapy

Voriconazole
    Indication: Bronchopulmonary Aspergillosis

Mycophenolate Mofetil
    Indication: Immunosuppressant Drug Therapy

Amphotericin B
    Indication: Bronchopulmonary Aspergillosis



Possible Amphotericin B side effects in 50 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-28

Patient: 50 year old male, weighing 55.0 kg (121.0 pounds)

Reactions: Neutropenia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Fluconazole
    Administration route: Oral
    Indication: Meningitis Cryptococcal
    Start date: 2011-07-22
    End date: 2011-08-03

Amphotericin B
    Dosage: reg 2, 35mg, 3 per 1 wk 5aug11-11aug11
    Indication: Meningitis Cryptococcal
    Start date: 2011-08-05
    End date: 2011-09-09

Other drugs received by patient: Bactrim; Flucytosine

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