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Eraxis (Anidulafungin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Eraxis (Anidulafungin) 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 (12)
Death (8)

Reports by Reaction Type

Drug Ineffective (3)Death (3)Blood Bilirubin Increased (2)Coagulopathy (2)Hypokalaemia (2)Abdominal Pain (1)Systemic Candida (1)Heparin-Induced Thrombocytopenia (1)Pyrexia (1)Paraplegia (1)Heart Rate Irregular (1)Electrolyte Imbalance (1)

Possible Eraxis side effects in 14 year old male

Reported by a physician from Australia on 2012-08-10

Patient: 14 year old male

Reactions: Liver Function Test Abnormal, Aspergillosis

Adverse event resulted in: death

Drug(s) suspected as cause:
Fluconazole

Eraxis
    Indication: Aspergillosis



Possible Eraxis side effects in 14 year old male

Reported by a pharmacist from Australia on 2012-07-20

Patient: 14 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Eraxis



Possible Eraxis side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-18

Patient:

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Eraxis



Possible Eraxis side effects in 60 year old female

Reported by a physician from Australia on 2012-04-25

Patient: 60 year old female

Reactions: Blood Bilirubin Increased, Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Ambisome
    Indication: Candidiasis

Cancidas

Eraxis
    Indication: Candidiasis

Other drugs received by patient: Aspirin; Pentoxifylline; Iron (Unspecified)



Possible Eraxis side effects in male

Reported by a physician from Australia on 2012-03-29

Patient: male

Reactions: Systemic Candida, Respiratory Failure, Cardiac Failure, Drug Ineffective

Adverse event resulted in: death

Drug(s) suspected as cause:
Fluconazole

Eraxis
    Indication: Candidiasis



Possible Eraxis side effects in male

Reported by a physician from Australia on 2012-03-13

Patient: male

Reactions: Death, Drug Ineffective

Adverse event resulted in: death

Drug(s) suspected as cause:
Eraxis
    Indication: Candidiasis

Fluconazole



Possible Eraxis side effects in male

Reported by a physician from Malaysia on 2012-02-14

Patient: male

Reactions: Electrolyte Imbalance, Heart Rate Irregular, Hypokalaemia

Adverse event resulted in: death

Drug(s) suspected as cause:
Eraxis



Possible Eraxis side effects in male

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

Patient: male

Reactions: Hypokalaemia

Adverse event resulted in: death

Drug(s) suspected as cause:
Eraxis



Possible Eraxis side effects in 60 year old female

Reported by a physician from Australia on 2012-02-06

Patient: 60 year old female

Reactions: Blood Bilirubin Increased

Adverse event resulted in: death

Drug(s) suspected as cause:
Eraxis
    Indication: Endocarditis Candida

Ambisome
    Indication: Endocarditis Candida

Caspofungin
    Dosage: unk
    Indication: Endocarditis Candida

Other drugs received by patient: Acetylsalicylic Acid; Iron; Oxypentifylline



Possible Eraxis side effects in male

Reported by a pharmacist from United States on 2012-02-03

Patient: male, weighing 113.0 kg (248.6 pounds)

Reactions: Coagulopathy, Hypofibrinogenaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Eraxis

Other drugs received by patient: Vancomycin; Hydromorphone HCL; Eraxis; Atorvastatin; Esomeprazole; Tobramycin; Aspirin; Ezetimibe; Diphenhydramine HCL; Insulin Lispro; Metoprolol; Ferrous Sulfate TAB; Zosyn; Acetaminophen



Possible Eraxis side effects in male

Reported by a pharmacist from United States on 2012-01-23

Patient: male, weighing 64.0 kg (140.8 pounds)

Reactions: Renal Failure, Heparin-Induced Thrombocytopenia, International Normalised Ratio Increased, Laboratory Test Interference, Coagulopathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Eraxis

Other drugs received by patient: Chlorhexidine Gluconate; Vancomycin; Aspirin; Metronidazole; Ipratropium Bromide; Ciprofloxacin; Heparin; Albuterol; Zosyn



Possible Eraxis side effects in 16 year old male

Reported by a physician from Israel on 2011-11-03

Patient: 16 year old male

Reactions: Paraplegia, Abdominal Pain, Pyrexia, Rash

Drug(s) suspected as cause:
Eraxis

Other drugs received by patient: Nystatin; Amikacin; Piperacillin and Tazobactam; Neupogen; Resprim; Vancomycin

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