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Atgam (Equine Thymocyte Immune Globulin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Atgam (Equine Thymocyte Immune Globulin) 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 (22)
Death (9)
Life Threatening Events (1)

Reports by Reaction Type

Urticaria (6)Renal Failure Acute (6)Generalised Oedema (5)Bone Marrow Failure (5)Bronchopulmonary Aspergillosis (5)Cytolytic Hepatitis (5)Hypersensitivity (4)Drug Interaction (4)Hepatic Failure (4)Pyrexia (4)Multiple Drug Overdose (4)Infusion Related Reaction (4)

Possible Atgam side effects in 49 year old female

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

Patient: 49 year old female, weighing 59.0 kg (129.8 pounds)

Reactions: Cytolytic Hepatitis

Drug(s) suspected as cause:
Atgam

Other drugs received by patient: Neoral; Neoral; Prednisolone



Possible Atgam side effects in 30 year old female

Reported by a physician from France on 2012-08-03

Patient: 30 year old female, weighing 55.0 kg (121.0 pounds)

Reactions: Urticaria, Cerebral Venous Thrombosis, Infusion Related Reaction

Drug(s) suspected as cause:
Atgam

Other drugs received by patient: Prednisolone; Neoral



Possible Atgam side effects in 15 year old female

Reported by a pharmacist from France on 2012-07-30

Patient: 15 year old female, weighing 55.0 kg (121.0 pounds)

Reactions: Bronchopulmonary Aspergillosis, Dyspnoea, Haemoptysis, Urticaria, Hypotension, Anaphylactic Shock, Haemodynamic Instability, Chest Pain, Tachypnoea

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

Drug(s) suspected as cause:
Atgam

Other drugs received by patient: Solu-Medrol; Bactrim; Polaramine; Fungizone



Possible Atgam side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-26

Patient: female

Reactions: Bronchopulmonary Aspergillosis, Hypersensitivity, Hepatic Failure, Drug Interaction, Respiratory Distress, Generalised Oedema, Immunosuppressant Drug Level Decreased, Renal Impairment, Bone Marrow Failure, Multiple Drug Overdose, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Atgam
    Dosage: 40 mg/kg, unk
    Start date: 2012-04-25
    End date: 2012-04-27

Atgam
    Dosage: 40 mg/kg, unk
    Start date: 2012-04-23

Bactrim
    Dosage: 1 df, qw3
    Indication: Prophylaxis
    Start date: 2012-04-01

Cancidas
    Start date: 2012-05-28
    End date: 2012-05-30

Ciprofloxacin
    Start date: 2012-05-28
    End date: 2012-06-06

Clavulanate Potassium
    Dosage: unk
    Start date: 2012-06-04

Clavulanate Potassium
    Dosage: 1 df, tid
    Start date: 2012-05-28
    End date: 2012-06-01

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

Neoral
    Dosage: 1 df, bid
    Administration route: Oral
    Start date: 2012-04-23

Vancomycin
    Dosage: 1 g, bid
    Start date: 2012-05-22

Vancomycin
    Dosage: 2000 mg, unk
    Start date: 2012-05-25

Vancomycin
    Dosage: 1800 mg, unk
    Start date: 2012-06-06

Vancomycin
    Dosage: 2250 mg, unk
    Start date: 2012-05-31

Vancomycin
    Dosage: 2000 mg, unk
    Start date: 2012-06-04

Vfend
    Administration route: Oral

Vfend
    Dosage: 1 df, bid
    Indication: Bronchopulmonary Aspergillosis
    Start date: 2012-05-14
    End date: 2012-05-31

Other drugs received by patient: Colistin; Neupogen



Possible Atgam side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-26

Patient: female

Reactions: Bronchopulmonary Aspergillosis, Hypersensitivity, Drug Interaction, Hepatic Failure, Respiratory Distress, Generalised Oedema, Immunosuppressant Drug Level Decreased, Renal Impairment, Bone Marrow Failure, Multiple Drug Overdose, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Atgam
    Dosage: 40 mg/kg, unk
    Start date: 2012-04-25
    End date: 2012-04-27

Atgam
    Dosage: 40 mg/kg, unk
    Start date: 2012-04-23

Bactrim
    Dosage: 1 df, qw3
    Indication: Prophylaxis
    Start date: 2012-04-01

Cancidas
    Start date: 2012-05-28
    End date: 2012-05-30

Ciproflaxacin
    Start date: 2012-05-28
    End date: 2012-06-06

Clavulanate Potassium
    Dosage: 1 df, tid
    Start date: 2012-05-28
    End date: 2012-06-01

Clavulanate Potassium
    Dosage: unk
    Start date: 2012-06-04

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

Neoral
    Dosage: 1 df, bid
    Administration route: Oral
    Start date: 2012-04-23

Vancomycin
    Dosage: 1 g, bid
    Start date: 2012-05-22

Vancomycin
    Dosage: 2250 mg, unk
    Start date: 2012-05-31

Vancomycin
    Dosage: 1800 mg, unk
    Start date: 2012-06-06

Vancomycin
    Dosage: 2000 mg, unk
    Start date: 2012-06-04

Vancomycin
    Dosage: 2000 mg, unk
    Start date: 2012-05-25

Vfend
    Administration route: Oral

Vfend
    Dosage: 1 df, bid
    Indication: Bronchopulmonary Aspergillosis
    Start date: 2012-05-14
    End date: 2012-05-31

Other drugs received by patient: Colistin; Neupogen



Possible Atgam side effects in 24 year old female

Reported by a physician from France on 2012-07-25

Patient: 24 year old female, weighing 64.0 kg (140.8 pounds)

Reactions: Urticaria, Cytolytic Hepatitis, Tonsillitis, Cholestasis, Pyrexia, Infusion Related Reaction

Drug(s) suspected as cause:
Atgam

Other drugs received by patient: Ciclosporin; Atovaquone; Solu-Medrol; Valacyclovir Hydrochloride; Zarzio



Possible Atgam side effects in 24 year old female

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

Patient: 24 year old female, weighing 64.0 kg (140.8 pounds)

Reactions: Cytolytic Hepatitis, Urticaria, Tonsillitis, Cholestasis, Pyrexia, Infusion Related Reaction

Drug(s) suspected as cause:
Atgam

Other drugs received by patient: Zarzio; Solu-Medrol; Atovaquone; Ciclosporin; Valacyclovir Hydrochloride



Possible Atgam side effects in female

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

Patient: female

Reactions: Bronchopulmonary Aspergillosis, Hypersensitivity, Drug Interaction, Hepatic Failure, Generalised Oedema, Immunosuppressant Drug Level Decreased, Renal Impairment, Bone Marrow Failure, Multiple Drug Overdose, Renal Failure Acute

Adverse event resulted in: death

Drug(s) suspected as cause:
Atgam
    Dosage: 40 mg/kg, unk
    Start date: 2012-04-23

Atgam
    Dosage: 40 mg/kg, unk
    Start date: 2012-04-25
    End date: 2012-04-27

Bactrim
    Dosage: 1 df, qw3
    Indication: Prophylaxis
    Start date: 2012-04-01

Cancidas
    Start date: 2012-05-28
    End date: 2012-05-30

Ciprofloxacin
    Start date: 2012-05-28
    End date: 2012-06-06

Clavulanate Potassium
    Dosage: 1 df, tid
    Start date: 2012-05-28
    End date: 2012-06-01

Clavulanate Potassium
    Dosage: unk
    Start date: 2012-06-04

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

Neoral
    Dosage: 1 df, bid
    Administration route: Oral
    Start date: 2012-04-23

Vancomycin
    Dosage: 1 g, bid
    Start date: 2012-05-22

Vancomycin
    Dosage: 2000 mg, unk
    Start date: 2012-05-25

Vancomycin
    Dosage: 2250 mg, unk
    Start date: 2012-05-31

Vancomycin
    Dosage: 1800 mg, unk
    Start date: 2012-06-06

Vancomycin
    Dosage: 2000 mg, unk
    Start date: 2012-06-04

Vfend
    Administration route: Oral

Vfend
    Dosage: 1 df, bid
    Indication: Bronchopulmonary Aspergillosis
    Start date: 2012-05-14
    End date: 2012-05-31

Other drugs received by patient: Colistin; Neupogen



Possible Atgam side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-16

Patient: female

Reactions: Bronchopulmonary Aspergillosis, Hypersensitivity, Drug Interaction, Hepatic Failure, Generalised Oedema, Immunosuppressant Drug Level Decreased, Renal Impairment, Bone Marrow Failure, Multiple Drug Overdose, Renal Failure Acute

Adverse event resulted in: death

Drug(s) suspected as cause:
Atgam
    Dosage: 40 mg/kg, unk
    Start date: 2012-04-23

Atgam
    Dosage: 40 mg/kg, unk
    Start date: 2012-04-25
    End date: 2012-04-27

Bactrim
    Dosage: 1 df, qw3
    Indication: Prophylaxis
    Start date: 2012-04-01

Cancidas
    Start date: 2012-05-28
    End date: 2012-05-30

Ciprofloxacin
    Start date: 2012-05-28
    End date: 2012-06-06

Clavulanate Potassium
    Dosage: unk
    Start date: 2012-06-04

Clavulanate Potassium
    Dosage: 1 df, tid
    Start date: 2012-05-28
    End date: 2012-06-01

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

Neoral
    Dosage: 1 df, bid
    Administration route: Oral
    Start date: 2012-04-23

Vancomycin
    Dosage: 1800 mg, unk
    Start date: 2012-06-06

Vancomycin
    Dosage: 2000 mg, unk
    Start date: 2012-06-04

Vancomycin
    Dosage: 2000 mg, unk
    Start date: 2012-05-25

Vancomycin
    Dosage: 2250 mg, unk
    Start date: 2012-05-31

Vancomycin
    Dosage: 1 g, bid
    Start date: 2012-05-22

Vfend
    Dosage: 1 df, bid
    Indication: Bronchopulmonary Aspergillosis
    Start date: 2012-05-14
    End date: 2012-05-31

Vfend
    Administration route: Oral

Other drugs received by patient: Colistin; Neupogen



Possible Atgam side effects in male

Reported by a physician from France on 2012-07-13

Patient: male

Reactions: Cerebral Venous Thrombosis, Cytolytic Hepatitis

Drug(s) suspected as cause:
Atgam



Possible Atgam side effects in 37 year old male

Reported by a physician from France on 2012-07-02

Patient: 37 year old male, weighing 75.0 kg (165.0 pounds)

Reactions: Rotavirus Infection, Clostridium Test Positive, Cystitis Klebsiella

Drug(s) suspected as cause:
Atgam

Other drugs received by patient: Prednisone TAB; Ciclosporin



Possible Atgam side effects in 36 year old male

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

Patient: 36 year old male, weighing 65.0 kg (143.0 pounds)

Reactions: Bacterial Sepsis, Disease Progression

Adverse event resulted in: death

Drug(s) suspected as cause:
Atgam

Other drugs received by patient: Cyclosporine; Solu-Medrol



Possible Atgam side effects in male

Reported by a consumer/non-health professional from France on 2012-06-25

Patient: male

Reactions: Urticaria, Hypertension, Decreased Appetite, Renal Failure Acute

Drug(s) suspected as cause:
Atgam
    Dosage: 2 g, daily
    Indication: Bone Marrow Failure
    Start date: 2011-12-28
    End date: 2011-12-31

Neoral
    Indication: Bone Marrow Failure
    End date: 2011-12-28

Sandimmune
    Dosage: 2 df
    Start date: 2011-12-28

Other drugs received by patient: Polaramine; Acetaminophen; Valacyclovir Hydrochloride; Solu-Medrol; Bactrim



Possible Atgam side effects in 4 year old male

Reported by a physician from Israel on 2012-06-14

Patient: 4 year old male

Reactions: Generalised Oedema, Polyserositis, Pericardial Effusion, Ascites, Periorbital Oedema, Weight Increased, Oedema Peripheral, Pleural Effusion

Drug(s) suspected as cause:
Atgam
    Indication: Prophylaxis Against Transplant Rejection

Busulfan
    Indication: Prophylaxis Against Transplant Rejection

Cyclophosphamide
    Indication: Prophylaxis Against Transplant Rejection

Fludarabine Phosphate
    Indication: Prophylaxis Against Transplant Rejection

Thiotepa
    Indication: Prophylaxis Against Transplant Rejection



Possible Atgam side effects in female

Reported by a pharmacist from United States on 2012-04-30

Patient: female

Reactions: Hepatic Enzyme Increased

Drug(s) suspected as cause:
Atgam



Possible Atgam side effects in

Reported by a pharmacist from United States on 2012-04-13

Patient:

Reactions: Throat Irritation, Urticaria, Hypotension, Pyrexia

Drug(s) suspected as cause:
Atgam



Possible Atgam side effects in male

Reported by a consumer/non-health professional from United States on 2012-03-30

Patient: male, weighing 90.7 kg (199.5 pounds)

Reactions: Back Pain, Pain in Extremity, Rash, Headache, Feeling Cold, Myalgia, Irritability, Arthralgia, RED Blood Cell Count Decreased, Heart Rate Increased, Pulmonary Oedema, Bone Marrow Failure, Gait Disturbance

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Atgam
    Dosage: unk
    Indication: Aplastic Anaemia

Prednisone TAB
    Dosage: unk



Possible Atgam side effects in 58 year old male

Reported by a physician from India on 2012-03-05

Patient: 58 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Atgam



Possible Atgam side effects in 68 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-02-29

Patient: 68 year old male

Reactions: Cytolytic Hepatitis, Serum Sickness, Pyrexia, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atgam

Other drugs received by patient: Tamsulosin; Pravastatin Sodium



Possible Atgam side effects in

Reported by a pharmacist from United States on 2012-01-31

Patient:

Reactions: Drug Intolerance, Infusion Related Reaction

Drug(s) suspected as cause:
Atgam

Other drugs received by patient: Platelets, Human Blood



Possible Atgam side effects in male

Reported by a pharmacist from United States on 2011-11-02

Patient: male, weighing 74.4 kg (163.6 pounds)

Reactions: Anaphylactic Reaction

Drug(s) suspected as cause:
Atgam

Other drugs received by patient: Valtrex



Possible Atgam side effects in

Reported by a pharmacist from Germany on 2011-10-03

Patient:

Reactions: Escherichia Sepsis

Adverse event resulted in: death

Drug(s) suspected as cause:
Atgam

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