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 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 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 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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