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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