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Cubicin (Daptomycin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Cubicin (Daptomycin) 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 (532)
Death (149)
Life Threatening Events (55)
Disability (8)

Reports by Reaction Type

Death (57)Eosinophilic Pneumonia (49)Blood Creatine Phosphokinase Increased (38)Rhabdomyolysis (29)Blood Creatinine Increased (21)Endocarditis (19)Sepsis (19)Drug Ineffective (18)Renal Failure Acute (17)Drug Interaction (14)Antimicrobial Susceptibility Test Resistant (13)Hypotension (13)

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

Possible Cubicin side effects in 72 year old male

Reported by a physician from Germany on 2012-08-27

Patient: 72 year old male, weighing 90.0 kg (198.0 pounds)

Reactions: Blood Creatinine Increased

Drug(s) suspected as cause:
Cubicin
    End date: 2011-08-23

Cubicin
    Indication: Bacteraemia
    Start date: 2011-08-14

Cubicin
    End date: 2011-08-23

Cubicin
    Indication: Postoperative Wound Infection
    Start date: 2011-08-14

Other drugs received by patient: Antibiotics; Levofloxacin



Possible Cubicin side effects in 84 year old male

Reported by a pharmacist from Japan on 2012-08-27

Patient: 84 year old male

Reactions: Renal Impairment, Henoch-Schonlein Purpura, Eosinophil Count Increased

Drug(s) suspected as cause:
Cubicin

Other drugs received by patient: Vancomycin



Possible Cubicin side effects in male

Reported by a pharmacist from United States on 2012-08-27

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Cubicin



Possible Cubicin side effects in 73 year old female

Reported by a physician from Germany on 2012-08-27

Patient: 73 year old female, weighing 87.0 kg (191.4 pounds)

Reactions: Body Temperature Fluctuation, Respiratory Rate Increased, White Blood Cell Disorder, Urine Output Decreased, Hypotension

Drug(s) suspected as cause:
Cubicin

Other drugs received by patient: Ampicillin; Ceftazidime



Possible Cubicin side effects in 77 year old male

Reported by a physician from United States on 2012-08-24

Patient: 77 year old male

Reactions: Cardiac Valve Abscess, Cardiac Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cubicin



Possible Cubicin side effects in female

Reported by a pharmacist from United Kingdom on 2012-08-22

Patient: female

Reactions: Creatinine Renal Clearance Decreased, Drug Ineffective, Inflammatory Marker Increased

Drug(s) suspected as cause:
Cubicin



Possible Cubicin side effects in 46 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22

Patient: 46 year old male

Reactions: Depressed Level of Consciousness, Somnolence, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cubicin
    Indication: Product Used FOR Unknown Indication

Cubicin

Other drugs received by patient: Fluconazole; Itraconazole; Tazobactam; Doxycycline HCL; Anidulafungin; Ciprofloxacin; Fluconazole; Cefazolin; Vancomycin; Anidulafungin; Voriconazole; Piperacillin



Possible Cubicin side effects in 75 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-20

Patient: 75 year old female

Reactions: Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Cubicin
    Indication: Treatment Failure

Cubicin
    Indication: Staphylococcal Infection

Other drugs received by patient: Gentamicin; Flucloxacillin; Rifampicin



Possible Cubicin side effects in 76 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-20

Patient: 76 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Cubicin
    Indication: Treatment Failure

Cubicin
    Indication: Staphylococcal Infection

Other drugs received by patient: Rifampicin; Vancomycin



Possible Cubicin side effects in 72 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-20

Patient: 72 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Cubicin
    Indication: Treatment Failure

Cubicin
    Indication: Staphylococcal Infection

Other drugs received by patient: Flucloxacillin; Rifampicin



Possible Cubicin side effects in 78 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-20

Patient: 78 year old female

Reactions: Device Breakage

Adverse event resulted in: death

Drug(s) suspected as cause:
Cubicin
    Indication: Staphylococcal Infection

Cubicin
    Indication: Treatment Failure

Other drugs received by patient: Rifampicin; Vancomycin; Gentamicin



Possible Cubicin side effects in

Reported by a pharmacist from United States on 2012-08-20

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Cubicin



Possible Cubicin side effects in 72 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-20

Patient: 72 year old female

Reactions: Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Cubicin
    Indication: Drug Therapy Changed

Cubicin
    Indication: Staphylococcal Infection

Other drugs received by patient: Gentamicin; Vancomycin; Rifampicin



Possible Cubicin side effects in 61 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-20

Patient: 61 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Cubicin
    Indication: Staphylococcal Infection

Cubicin
    Indication: Treatment Failure

Other drugs received by patient: Linezolid; Flucloxacillin; Gentamicin; Rifampicin



Possible Cubicin side effects in 7 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: 7 year old male

Reactions: Convulsion

Drug(s) suspected as cause:
Cubicin



Possible Cubicin side effects in 70 year old male

Reported by a physician from United States on 2012-08-17

Patient: 70 year old male

Reactions: Coma

Drug(s) suspected as cause:
Cubicin



Possible Cubicin side effects in 67 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-17

Patient: 67 year old male

Reactions: Vasculitic Rash

Drug(s) suspected as cause:
Cubicin
    Indication: Renal Failure Acute

Cubicin
    Indication: Staphylococcal Infection

Rifampicin
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Vancomycin; Gentamicin



Possible Cubicin side effects in 59 year old female

Reported by a physician from United Kingdom on 2012-08-17

Patient: 59 year old female

Reactions: Hyperparathyroidism

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

Drug(s) suspected as cause:
Cubicin

Other drugs received by patient: Vitamin A+D; Clindamycin



Possible Cubicin side effects in 43 year old male

Reported by a physician on 2012-08-10

Patient: 43 year old male, weighing 98.0 kg (215.6 pounds)

Reactions: Blood Creatine Phosphokinase Increased, Cardiac Failure, Pain, Hypertension

Drug(s) suspected as cause:
Cubicin

Other drugs received by patient: Meropenem



Possible Cubicin side effects in 69 year old female

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

Patient: 69 year old female, weighing 93.0 kg (204.6 pounds)

Reactions: Haemothorax, Haemoglobin Decreased, Disseminated Intravascular Coagulation, Shock Haemorrhagic, Pneumothorax, Subcutaneous Haematoma, Small Intestinal Haemorrhage

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Cubicin

Other drugs received by patient: Ceftazidime; Cancidas; Garamycin



Possible Cubicin side effects in 66 year old

Reported by a health professional (non-physician/pharmacist) from Switzerland on 2012-08-09

Patient: 66 year old , weighing 112.0 kg (246.4 pounds)

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Cubicin
    Indication: Enterococcal Infection

Cubicin



Possible Cubicin side effects in 43 year old

Reported by a health professional (non-physician/pharmacist) from Switzerland on 2012-08-09

Patient: 43 year old

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Cubicin
    Indication: Enterococcal Infection

Cubicin



Possible Cubicin side effects in 57 year old

Reported by a health professional (non-physician/pharmacist) from Switzerland on 2012-08-09

Patient: 57 year old , weighing 56.0 kg (123.2 pounds)

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Cubicin
    Indication: Staphylococcal Infection

Cubicin



Possible Cubicin side effects in 63 year old male

Reported by a physician on 2012-08-06

Patient: 63 year old male

Reactions: Rhabdomyolysis, Blood Creatine Phosphokinase Increased, Refractory Anaemia, Haemorrhage, Hypotension, Aspartate Aminotransferase Increased, Drug Interaction

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Cubicin
    Start date: 2012-05-02
    End date: 2012-05-02

Cubicin
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-30
    End date: 2012-04-30

Rosuvastatin
    Administration route: Oral
    Start date: 2012-04-19
    End date: 2012-04-19

Rosuvastatin
    Administration route: Oral
    Start date: 2012-04-20
    End date: 2012-05-30

Other drugs received by patient: Levalbuterol Hydrochloride; Vancomycin; Meropenem; Chlorothiazide; Lactulose; Ferrous Sulfate TAB; Caspofungin Acetate; Flagyl; Albumin (Human); Atrovent; Levofloxacin



Possible Cubicin side effects in 63 year old male

Reported by a physician from United States on 2012-08-06

Patient: 63 year old male

Reactions: Rhabdomyolysis, Blood Creatine Phosphokinase Increased, Aspartate Aminotransferase Increased, Drug Interaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Crestor
    Administration route: Oral
    Indication: Acute Respiratory Distress Syndrome
    Start date: 2012-04-19
    End date: 2012-04-19

Crestor
    Administration route: Oral
    Indication: Sepsis
    Start date: 2012-04-19
    End date: 2012-04-19

Crestor
    Administration route: Oral
    Start date: 2012-04-20
    End date: 2012-05-01

Crestor
    Administration route: Oral
    Start date: 2012-04-20
    End date: 2012-05-01

Cubicin
    Dosage: 200ml/hour, 580mg
    Start date: 2012-05-02
    End date: 2012-05-02

Cubicin
    Dosage: 200ml/hour, 580mg
    Start date: 2012-04-30
    End date: 2012-04-30

Other drugs received by patient: Lactulose; Albumin (Human); Diuril; Flagyl; Vancomycin; Meropenem; Ferrous Sulfate and Folic Acid; Casofungin; Atrovent; Levlbuterol; Levofloxacin



Possible Cubicin side effects in male

Reported by a individual with unspecified qualification from Japan on 2012-08-03

Patient: male

Reactions: Hepatic Function Abnormal

Drug(s) suspected as cause:
Cubicin

Other drugs received by patient: Vancomycin



Possible Cubicin side effects in 54 year old male

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

Patient: 54 year old male

Reactions: Sepsis

Adverse event resulted in: death

Drug(s) suspected as cause:
Cubicin
    Indication: Bacteraemia

Cubicin

Other drugs received by patient: Vancomycin



Possible Cubicin side effects in 59 year old female

Reported by a physician from United Kingdom on 2012-08-03

Patient: 59 year old female

Reactions: Hyperparathyroidism

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

Drug(s) suspected as cause:
Cubicin

Other drugs received by patient: Clindamycin HCL



Possible Cubicin side effects in 61 year old male

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

Patient: 61 year old male

Reactions: Multi-Organ Failure, Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Cubicin
    Indication: Bacteraemia

Cubicin
    Indication: Haemodialysis

Cubicin
    Indication: Renal Failure

Cubicin
    Indication: Hepatic Failure

Other drugs received by patient: Meropenem



Possible Cubicin side effects in 75 year old male

Reported by a physician from United States on 2012-08-03

Patient: 75 year old male

Reactions: Bronchopneumonia, Septic Shock

Adverse event resulted in: death

Drug(s) suspected as cause:
Caspofungin Acetate
    Indication: Candidiasis

Cubicin
    Indication: Product Used FOR Unknown Indication

Meropenem
    Indication: Product Used FOR Unknown Indication

Posaconazole
    Indication: Candidiasis

Other drugs received by patient: Cytarabine; Valtrex; Fluconazole; Fludarabine Phosphate; Levofloxacin; Voriconazole

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