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Mycamine (Micafungin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Mycamine (Micafungin) 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 (38)
Death (22)
Life Threatening Events (2)
Disability (1)

Reports by Reaction Type

Death (12)Off Label Use (6)Drug Ineffective (5)Multi-Organ Failure (4)Candidiasis (3)Rash (3)Sepsis (3)Abdominal Pain (2)Graft Versus Host Disease (2)Chills (2)Chest Pain (2)Metastases To Lung (2)

Below are a few examples of reports where side effects / adverse reactions may be related to Mycamine (Micafungin). For a complete list or a specific selection of reports, please use the links above.

Possible Mycamine side effects in female

Reported by a pharmacist from United States on 2012-08-01

Patient: female

Reactions: Chest Pain, Metastases To Lung

Drug(s) suspected as cause:
Mycamine



Possible Mycamine side effects in female

Reported by a pharmacist from United States on 2012-07-18

Patient: female

Reactions: Chest Pain, Metastases To Lung

Drug(s) suspected as cause:
Mycamine



Possible Mycamine side effects in female

Reported by a physician from United States on 2012-07-17

Patient: female

Reactions: Off Label Use, Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Mycamine



Possible Mycamine side effects in male

Reported by a physician from United States on 2012-06-22

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Mycamine

Other drugs received by patient: Levalbuterol HCL; Propofol; Sodium Bicarbonate; Levophed; Norepinephrine Bitartrate; Morphine; Sodium Chloride



Possible Mycamine side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-20

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Mycamine



Possible Mycamine side effects in female

Reported by a physician from Italy on 2012-05-30

Patient: female

Reactions: Angioedema, Rash

Drug(s) suspected as cause:
Folina
    Dosage: 5 mg, unknown/d
    Administration route: Oral
    Indication: Anaemia
    Start date: 2011-10-04
    End date: 2011-10-26

Merrem
    Dosage: 6 g, unknown/d
    Indication: Pyrexia
    Start date: 2011-10-23
    End date: 2011-11-07

Acyclovir
    Dosage: 2 g, unknown/d
    Indication: Antiviral Prophylaxis
    Start date: 2011-10-04
    End date: 2011-11-21

Mycamine
    Dosage: 50 mg, unknown/d
    Indication: Antifungal Prophylaxis
    Start date: 2011-10-04
    End date: 2011-11-07

Vancomycin
    Dosage: 2 g, unknown/d
    Indication: Antibiotic Prophylaxis
    Start date: 2011-10-04
    End date: 2011-11-02

Becozym
    Dosage: 10 mg, unknown/d
    Administration route: Oral
    Indication: Anaemia
    Start date: 2011-10-04
    End date: 2011-10-26



Possible Mycamine side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-30

Patient: male

Reactions: Off Label Use, Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Mycamine



Possible Mycamine side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-29

Patient: male, weighing 93.0 kg (204.6 pounds)

Reactions: Off Label Use, Graft Versus Host Disease, Device Related Infection, Infection

Drug(s) suspected as cause:
Prograf
    Dosage: 13 mg, uid/qd
    Administration route: Oral
    Indication: Stem Cell Transplant
    Start date: 2009-06-09

Mycamine
    Dosage: unk
    Indication: Antifungal Prophylaxis
    Start date: 2009-08-01

Other drugs received by patient: Insulin; Antihypertensives; Actigall; Metrol; Vitamin D; Norvasc; Corticosteroids; Folic Acid



Possible Mycamine side effects in

Reported by a consumer/non-health professional from United States on 2012-05-25

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Mycamine



Possible Mycamine side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-16

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Mycamine



Possible Mycamine side effects in female

Reported by a physician from France on 2012-04-30

Patient: female, weighing 5.0 kg (11.0 pounds)

Reactions: Multi-Organ Failure, Renal Failure, Drug Ineffective, Incorrect Dose Administered, Rash, Thrombocytopenia

Adverse event resulted in: death

Drug(s) suspected as cause:
Mycamine
    Dosage: 4 mg/kg, unknown/d
    Indication: Fungaemia
    Start date: 2012-01-19
    End date: 2012-01-27

Mycamine
    Dosage: 12.5 mg/kg, unknown/d
    Start date: 2012-02-10
    End date: 2012-03-04

Mycamine
    Dosage: 2 mg/kg, unknown/d
    Indication: Systemic Candida

Mycamine
    Dosage: 12 mg/kg, unknown/d
    Start date: 2012-01-27
    End date: 2012-02-02

Mycamine
    Dosage: 10 mg/kg, unknown/d
    Start date: 2012-02-04
    End date: 2012-02-09

Other drugs received by patient: Sufentanil Citrate; Bactrim; Noradrenalin; Midazolam HCL



Possible Mycamine side effects in male

Reported by a physician from United States on 2012-04-23

Patient: male, weighing 99.0 kg (217.8 pounds)

Reactions: Small Intestinal Obstruction, Multi-Organ Failure, Fungaemia, Urinary Tract Infection Enterococcal, Bacteraemia, Escherichia Urinary Tract Infection, Sepsis

Adverse event resulted in: death

Drug(s) suspected as cause:
Prograf
    Dosage: 1 mg, tid
    Administration route: Oral
    Indication: Liver Transplant
    Start date: 2006-10-28
    End date: 2012-03-30

Mycamine
    Dosage: 100 mg, uid/qd
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Ursodiol; Norepinephrine Bitartrate; Daptomycin; Methylprednisolone; Lansoprazole; Doripenem; Ribavirin; Calcium Chloride; Gentamicin



Possible Mycamine side effects in

Reported by a physician from Germany on 2012-04-20

Patient:

Reactions: END Stage AIDS

Adverse event resulted in: death

Drug(s) suspected as cause:
Mycamine



Possible Mycamine side effects in

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-04-10

Patient:

Reactions: Multi-Organ Failure, Drug Ineffective, Sepsis, Candidiasis

Adverse event resulted in: death

Drug(s) suspected as cause:
Mycamine



Possible Mycamine side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-09

Patient: male, weighing 99.0 kg (217.8 pounds)

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Prograf
    Dosage: 1 mg, tid
    Administration route: Oral
    Indication: Liver Transplant
    Start date: 2006-10-28
    End date: 2012-03-30

Mycamine
    Dosage: 100 mg, uid/qd
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Methylprednisolone; Gentamicin; Calcium Chloride; Lansoprazole; Ribavirin; Doripenem; Norepinephrine Bitartrate; Ursodiol; Daptomycin



Possible Mycamine side effects in 79 year old female

Reported by a consumer/non-health professional from United States on 2012-03-15

Patient: 79 year old female

Reactions: Death, Renal Failure, Contusion, Blood Lactate Dehydrogenase Increased, Thrombotic Thrombocytopenic Purpura

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Mycamine



Possible Mycamine side effects in 59 year old female

Reported by a consumer/non-health professional from United States on 2012-02-21

Patient: 59 year old female

Reactions: Blood Bilirubin Increased, Neutropenia, Cardiac Arrest

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Mycamine
    Dosage: 100 mg, unknown/d
    Indication: Fungal Test Positive
    Start date: 2012-02-05

Mycamine
    Dosage: unk
    End date: 2012-02-12

Mycamine
    Dosage: 1/2 dose
    Start date: 2012-02-09



Possible Mycamine side effects in 65 year old female

Reported by a physician from United States on 2012-02-13

Patient: 65 year old female

Reactions: Off Label Use, Cellulitis, Gout

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Voriconazole
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Mycamine
    Dosage: 125 mg, uid/qd
    Indication: Aspergillosis
    Start date: 2011-12-20
    End date: 2012-01-01



Possible Mycamine side effects in 51 year old male

Reported by a physician from Spain on 2012-02-08

Patient: 51 year old male, weighing 68.0 kg (149.6 pounds)

Reactions: Drug Ineffective, Septic Shock, Candidiasis

Adverse event resulted in: death

Drug(s) suspected as cause:
Mycamine



Possible Mycamine side effects in male

Reported by a physician from Italy on 2012-01-18

Patient: male

Reactions: Urinary Retention

Drug(s) suspected as cause:
Mycamine



Possible Mycamine side effects in male

Reported by a consumer/non-health professional from United States on 2012-01-18

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Mycamine



Possible Mycamine side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-17

Patient: female

Reactions: Multi-Organ Failure, Abdominal Pain, Drug Ineffective, Chills, Acute Respiratory Distress Syndrome, Infusion Related Reaction

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Ambisome
    Dosage: 400 mg, uid/qd
    Indication: Fungaemia
    Start date: 2011-05-25
    End date: 2011-05-25

Mycamine
    Dosage: 2000 mg, total dose
    Indication: Systemic Candida
    Start date: 2011-05-23
    End date: 2011-06-22

Other drugs received by patient: Invanz; Doripenem Monohydrate; Fluconazole



Possible Mycamine side effects in 1 month old female

Reported by a physician from Brazil on 2012-01-11

Patient: 1 month old female

Reactions: Off Label Use, Overdose, Neonatal Cholestasis

Drug(s) suspected as cause:
Mycamine

Other drugs received by patient: Teicoplanin; Meropenem; Vancomycin



Possible Mycamine side effects in 80 year old female

Reported by a pharmacist from United States on 2011-12-22

Patient: 80 year old female

Reactions: Respiratory Failure, Blood Culture Positive, Sepsis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mycamine

Other drugs received by patient: Caspofungin Acetate



Possible Mycamine side effects in 51 year old male

Reported by a physician from Spain on 2011-12-21

Patient: 51 year old male

Reactions: Drug Ineffective

Adverse event resulted in: death

Drug(s) suspected as cause:
Mycamine



Possible Mycamine side effects in 40 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2011-12-21

Patient: 40 year old male

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Mycamine



Possible Mycamine side effects in male

Reported by a physician from United States on 2011-12-20

Patient: male, weighing 56.0 kg (123.2 pounds)

Reactions: Bone Marrow Transplant

Drug(s) suspected as cause:
Mycamine



Possible Mycamine side effects in female

Reported by a physician from France on 2011-12-06

Patient: female

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Mycamine
    Dosage: unk
    Indication: Acute Myeloid Leukaemia

Caspofungin Acetate
    Dosage: unk
    Indication: Acute Myeloid Leukaemia



Possible Mycamine side effects in female

Reported by a consumer/non-health professional from United States on 2011-12-06

Patient: female, weighing 68.0 kg (149.6 pounds)

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Mycamine

Other drugs received by patient: Ativan; Sodium Chloride; Morphine; Dopamine HCL; Calcium Chloride; Tygacil; Guaifenesin; Lortab; Vasopressin



Possible Mycamine side effects in 1 month old female

Reported by a consumer/non-health professional from Brazil on 2011-12-01

Patient: 1 month old female

Reactions: Off Label Use, Neonatal Cholestasis, Incorrect Dose Administered

Drug(s) suspected as cause:
Mycamine

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