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Abelcet (Amphotericin B) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Abelcet (Amphotericin B) 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 (17)
Death (7)
Life Threatening Events (1)
Disability (1)

Reports by Reaction Type

Blood Creatinine Increased (4)Blood Bilirubin Increased (3)Chills (3)Pyrexia (3)Renal Failure (3)Body Temperature Increased (2)Multi-Organ Failure (2)Oxygen Saturation Decreased (2)Autonomic Nervous System Imbalance (2)Renal Impairment (2)Respiratory Failure (2)Obstructive Airways Disorder (2)

Possible Abelcet side effects in 47 year old female

Reported by a health professional (non-physician/pharmacist) from Israel on 2012-07-17

Patient: 47 year old female

Reactions: Respiratory Failure, Coma, Metabolic Disorder, Hypernatraemia, Haemodialysis, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Abelcet

Other drugs received by patient: Omeprazole; Ritonavir; Darunavir Ethanolate; Raltegravir; Lamivudine



Possible Abelcet side effects in 14 year old male

Reported by a physician from United States on 2012-06-15

Patient: 14 year old male, weighing 67.4 kg (148.3 pounds)

Reactions: Blood Fibrinogen Decreased, Stomatitis, Prothrombin Time Prolonged, Caecitis, Hypokalaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Etoposide
    Dosage: unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-05-14
    End date: 2012-05-18

Velcade
    Dosage: 1.3 mg/m2, cyclic
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-05-14
    End date: 2012-05-22

Cytarabine
    Dosage: unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-05-14
    End date: 2012-05-24

Abelcet
    Indication: Product Used FOR Unknown Indication

Daunorubicin Hydrochloride
    Dosage: unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2012-05-14
    End date: 2012-05-18



Possible Abelcet side effects in 54 year old male

Reported by a pharmacist from United States on 2012-03-26

Patient: 54 year old male, weighing 90.6 kg (199.3 pounds)

Reactions: Renal Failure, Respiratory Failure

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

Drug(s) suspected as cause:
Abelcet

Abelcet
    Dosage: 450mg
    Indication: Pneumonia Fungal
    Start date: 2012-03-21
    End date: 2012-03-22

Abelcet
    Dosage: 450mg
    Indication: Febrile Neutropenia
    Start date: 2012-03-21
    End date: 2012-03-22



Possible Abelcet side effects in 22 year old female

Reported by a physician from United States on 2012-03-05

Patient: 22 year old female

Reactions: Immune Reconstitution Syndrome, Cryptococcus Test Positive, Nuclear Magnetic Resonance Imaging Brain Abnormal, Meningitis, Headache, Blood Creatinine Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tacrolimus
    Indication: Immunosuppression

Mycophenolic Acid
    Indication: Immunosuppression

Flucytosine
    Indication: Meningitis

Prednisone
    Indication: Immunosuppression

Abelcet
    Dosage: 5 mg/kg;qd ; 200 mg;qd
    Indication: Meningitis
    Start date: 2008-01-01
    End date: 2008-01-01

Abelcet
    Dosage: 5 mg/kg;qd ; 200 mg;qd
    Indication: Meningitis
    Start date: 2008-01-01
    End date: 2008-01-01

Fluconazole
    Dosage: 200 mg;qd
    Indication: Meningitis



Possible Abelcet side effects in female

Reported by a consumer/non-health professional from United States on 2012-01-02

Patient: female

Reactions: Obstructive Airways Disorder

Drug(s) suspected as cause:
Abelcet
    Start date: 2011-01-01

Tobi
    Dosage: 1 df, qd

Other drugs received by patient: Sodium Chloride Concentrated INJ



Possible Abelcet side effects in 56 year old male

Reported by a physician from United States on 2011-12-27

Patient: 56 year old male

Reactions: Multi-Organ Failure, Blood Bilirubin Increased, Blood Alkaline Phosphatase Increased, Renal Failure, Aspartate Aminotransferase Increased, Acute Respiratory Distress Syndrome

Adverse event resulted in: death

Drug(s) suspected as cause:
Abelcet



Possible Abelcet side effects in

Reported by a physician from United States on 2011-12-27

Patient:

Reactions: Blood Creatinine Increased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Abelcet
    Dosage: 225 mg/kg, qd, iv
    Indication: Fungal Infection
    Start date: 1996-07-04
    End date: 1996-07-08

Abelcet
    Dosage: 225 mg/kg, qd, iv
    Indication: Fungal Infection
    Start date: 1996-07-09

Other drugs received by patient: Cyclosporine; Corticosteroid; Tacrolimus



Possible Abelcet side effects in 59 year old male

Reported by a physician from United States on 2011-12-27

Patient: 59 year old male, weighing 80.0 kg (176.0 pounds)

Reactions: Renal Failure, Blood Disorder, Toxicity To Various Agents

Adverse event resulted in: death

Drug(s) suspected as cause:
Abelcet
    Dosage: 400 mg;qd;iv ; 200 mg;qd;iv
    Indication: Aspergillosis
    Start date: 1996-12-31
    End date: 1997-01-02

Abelcet
    Dosage: 400 mg;qd;iv ; 200 mg;qd;iv
    Indication: Aspergillosis
    Start date: 1997-01-03
    End date: 2007-01-08

Other drugs received by patient: Polymyxin / 00106601 /; Vancomycin; Amphotericin B; Cymevene / 00784201 /



Possible Abelcet side effects in 56 year old female

Reported by a individual with unspecified qualification from United States on 2011-12-27

Patient: 56 year old female, weighing 75.0 kg (165.0 pounds)

Reactions: Brain Mass, Lung Infection, Mental Status Changes, Blood Creatinine Increased

Adverse event resulted in: death

Drug(s) suspected as cause:
Amphotericin B
    Dosage: 20 mg.kg, iv
    Indication: Prophylaxis
    Start date: 1996-09-24
    End date: 1996-10-07

Abelcet
    Dosage: 400 mg, qd, iv
    Indication: Lung Infection
    Start date: 1996-10-07
    End date: 1996-11-23

Other drugs received by patient: Steroid; Cyclosporine



Possible Abelcet side effects in 3 year old female

Reported by a physician from Spain on 2011-12-27

Patient: 3 year old female

Reactions: Disease Complication, Skin Reaction, Cardiac Disorder, Papule

Adverse event resulted in: death

Drug(s) suspected as cause:
Abelcet

Other drugs received by patient: Imipenem; Amikacin



Possible Abelcet side effects in 74 year old female

Reported by a individual with unspecified qualification from United States on 2011-12-27

Patient: 74 year old female, weighing 70.0 kg (154.0 pounds)

Reactions: Blood Bilirubin Increased, Renal Impairment, Laboratory Test Interference, Blood Creatinine Increased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Abelcet
    Dosage: 335 mg, qd, iv
    Indication: Systemic Mycosis
    Start date: 1996-12-03
    End date: 1996-12-10

Amphotericin B
    Dosage: 40 mg, qd, iv
    Indication: Systemic Mycosis
    Start date: 1996-11-28
    End date: 1996-12-01

Other drugs received by patient: Gentamicin; Vancomycin; Cytarabine; Mitoxantrone; Etoposide; Ciprofloxacin; Immunoglobulin Human Normal; Aztreonam



Possible Abelcet side effects in 34 year old female

Reported by a physician from United States on 2011-12-27

Patient: 34 year old female, weighing 52.0 kg (114.4 pounds)

Reactions: Cerebral Aspergillosis, Bronchopulmonary Aspergillosis, Multi-Organ Failure, Tachycardia, Chills, Tachypnoea, Pyrexia

Adverse event resulted in: death

Drug(s) suspected as cause:
Abelcet
    Dosage: 280 mg;x1;iv, 280 mg;x1;iv
    Indication: Aspergillosis
    Start date: 2000-08-14
    End date: 2000-08-14

Abelcet
    Dosage: 280 mg;x1;iv, 280 mg;x1;iv
    Indication: Aspergillosis
    Start date: 2000-08-21
    End date: 2000-08-21

Other drugs received by patient: Zantac; Premarin; Targocid; Zovirax / 00587301 /; Prostine; Ciproxin / 00697201 /; Leucovorin Calcium; Maxipime; Orgametril; Allopurinol



Possible Abelcet side effects in female

Reported by a consumer/non-health professional from United States on 2011-12-09

Patient: female

Reactions: Obstructive Airways Disorder

Drug(s) suspected as cause:
Abelcet
    Dosage: qw;inh
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-01-01

Tobi
    Dosage: qd;inh
    Indication: Product Used FOR Unknown Indication



Possible Abelcet side effects in female

Reported by a physician from United States on 2011-11-15

Patient: female, weighing 57.5 kg (126.5 pounds)

Reactions: Blood Bilirubin Increased, Chest Discomfort, Dyspnoea, Wheezing, Blood Albumin Decreased, Drug Interaction, Pyrexia, Renal Impairment, Oedema Peripheral, Hypoxia, Aspergillosis, Pulmonary Oedema, Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Abelcet

Gleevec
    Dosage: 400 mg, qd
    Administration route: Oral
    Indication: Acute Myeloid Leukaemia
    Start date: 2004-03-14
    End date: 2004-03-23

Cytarabine
    Dosage: unk
    Indication: Acute Myeloid Leukaemia

Daunorubicin HCL
    Dosage: unk
    Indication: Acute Myeloid Leukaemia

Other drugs received by patient possibly interacting with the suspect drug:
Voriconazole

Other drugs received by patient: Hydrea; Acyclovir; Vancomycin; Oxycodone HCL; Zosyn; Gentamicin



Possible Abelcet side effects in 14 year old female

Reported by a physician from United States on 2011-11-14

Patient: 14 year old female, weighing 54.0 kg (118.8 pounds)

Reactions: Autonomic Nervous System Imbalance, Body Temperature Increased, Chills, Respiratory Distress, Oxygen Saturation Decreased

Drug(s) suspected as cause:
Abelcet

Other drugs received by patient: Lanomycin / 00391001 /; Piperacillin and Tazobactam



Possible Abelcet side effects in 15 year old female

Reported by a individual with unspecified qualification from United States on 2011-11-14

Patient: 15 year old female, weighing 63.0 kg (138.6 pounds)

Reactions: Respiratory Disorder, Autonomic Nervous System Imbalance, Body Temperature Increased, Chills, Oxygen Saturation Decreased

Drug(s) suspected as cause:
Abelcet

Other drugs received by patient: Voxin; Piperacillin and Tazobactam; Metrogyl / 00012501 /; Lanomycin / 00391001 /



Possible Abelcet side effects in 55 year old male

Reported by a physician from United States on 2011-10-18

Patient: 55 year old male

Reactions: Pyrexia, Tremor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Abelcet

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