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Noxafil (Posaconazole) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Noxafil (Posaconazole) 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 (72)
Death (16)
Life Threatening Events (15)
Disability (5)

Reports by Reaction Type

Drug Interaction (14)Sinoatrial Block (7)Atrioventricular Block Second Degree (6)Myositis (6)Nodal Arrhythmia (5)Septic Shock (5)Sinus Tachycardia (5)Sinus Bradycardia (4)Diabetes Mellitus (3)Overdose (3)Neuropathy Peripheral (3)Thrombocytopenia (3)

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

Possible Noxafil side effects in

Reported by a physician from United States on 2012-08-23

Patient:

Reactions: Malabsorption, Overdose, Drug Interaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Noxafil

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

Noxafil
    Dosage: 1500 mg qd

Noxafil
    Dosage: 120-300 mg/kg/day

Noxafil
    Dosage: 3000 mg/kg/day

Pantoprazole

Sucralfate

Other drugs received by patient: Amphotericin B (+) L-(Alpha)-Dimyristoylphosphatidylcholine (+) L-(Alp; Amphotericin B (+) L-(Alpha)-Dimyristoylphosphatidylcholine (+) L-(Alp; Amphotericin B (+) L-(Alpha)-Dimyristoylphosphatidylcholine (+) L-(Alp; Amphotericin B; Micafungin; Amphotericin B (+) L-(Alpha)-Dimyristoylphosphatidylcholine (+) L-(Alp



Possible Noxafil side effects in

Reported by a physician from Austria on 2012-08-23

Patient:

Reactions: Multi-Organ Failure, Diarrhoea, Graft Versus Host Disease

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Noxafil

Other drugs received by patient: Corticosteroids (Unspecified); Mycophenolate Mefetil; Itraconazole; Amphotericin B; Methylprednisolone; Remicade; Voriconazole; Caspofungin Acetate



Possible Noxafil side effects in

Reported by a health professional (non-physician/pharmacist) from Switzerland on 2012-08-23

Patient:

Reactions: Hepatotoxicity, Drug-Induced Liver Injury

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acetaminophen
    Dosage: 1000 mg, tid
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-30
    End date: 2012-02-01

Noxafil
    Dosage: 200 mg, qid
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2012-01-25
    End date: 2012-02-02

Other drugs received by patient: Fosamax; Urso Falk; Calcimagon D3; Nexium; Ciprofloxacin; Valtrex; Meticorten



Possible Noxafil side effects in

Reported by a physician from United States on 2012-08-23

Patient:

Reactions: Malabsorption, Overdose, Vomiting, Nausea, Drug Interaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Noxafil

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

Famotidine
    Dosage: unk

Nifedipine

Noxafil
    Dosage: 800 mg, q6h
    Administration route: Oral

Noxafil
    Dosage: 600 mg, q6h

Noxafil
    Dosage: 400 mg, q4h

Pantoprazole
    Dosage: unk

Phenytoin
    Dosage: unk
    Indication: Convulsion Prophylaxis

Sirolimus

Sucralfate
    Dosage: unk
    Administration route: Oral

Sucralfate
    Dosage: unk

Other drugs received by patient: Micafungin



Possible Noxafil side effects in

Reported by a consumer/non-health professional from Germany on 2012-08-10

Patient:

Reactions: Congestive Cardiomyopathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Noxafil

Other drugs received by patient: Sulfamethoxazole and Trimethoprim



Possible Noxafil side effects in

Reported by a physician from United States on 2012-08-09

Patient:

Reactions: Fusarium Infection

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Noxafil



Possible Noxafil side effects in

Reported by a physician from United States on 2012-08-09

Patient:

Reactions: Abdominal Pain, Agitation, Abasia, Drug Interaction, Muscular Weakness, Hyponatraemia, Constipation, Paraesthesia, Convulsion, Neurotoxicity, Peroneal Nerve Palsy, Inappropriate Antidiuretic Hormone Secretion, Areflexia, Brain Oedema

Drug(s) suspected as cause:
Noxafil

Other drugs received by patient possibly interacting with the suspect drug:
Vincristine Sulfate
    Indication: Prophylaxis



Possible Noxafil side effects in

Reported by a individual with unspecified qualification from United States on 2012-08-07

Patient:

Reactions: Disease Progression

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Noxafil

Other drugs received by patient: Amphotericin B



Possible Noxafil side effects in

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

Patient:

Reactions: Congestive Cardiomyopathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Noxafil

Other drugs received by patient: Sulfamethoxazole and Trimethoprim



Possible Noxafil side effects in

Reported by a physician from Denmark on 2012-07-30

Patient:

Reactions: Neurotoxicity, Hypokinesia, Pain in Extremity, Drug Interaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Noxafil

Other drugs received by patient possibly interacting with the suspect drug:
Oncovin
    Dosage: 2 mg, qw
    Start date: 2012-04-17
    End date: 2012-05-01

Other drugs received by patient: Prednisolone; Vancomycin; Imatinib Mesylate; Meropenem



Possible Noxafil side effects in

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

Patient:

Reactions: Pancreatitis Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Noxafil
    Dosage: 200 mg, tid
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-12
    End date: 2012-01-30

Tazobactam
    Dosage: 4 g, tid
    Indication: Pyrexia
    Start date: 2012-01-20
    End date: 2012-02-10

Other drugs received by patient: Furosemide; Polaramine; Acetaminophen; Vancomycin; Idarubicin Hydrochloride; Vesanoid; Lutenyl; Cytarabine; Fungizone; Zolpidem Tartrate



Possible Noxafil side effects in

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

Patient:

Reactions: Acute Hepatic Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ciprofloxacin
    Dosage: 500 mg, bid
    Administration route: Oral
    Indication: Antibiotic Prophylaxis
    Start date: 2011-12-13
    End date: 2012-01-05

Exjade
    Dosage: 125 mg, bid
    Administration route: Oral
    Indication: Transfusion Reaction
    Start date: 2011-12-20
    End date: 2012-01-05

Noxafil
    Dosage: 400 mg, bid
    Administration route: Oral
    Indication: Antifungal Prophylaxis
    Start date: 2011-12-20
    End date: 2011-12-27

Other drugs received by patient: Acyclovir; Atacand; Cotrim DS; Pantoprazole



Possible Noxafil side effects in

Reported by a physician from United States on 2012-07-20

Patient:

Reactions: Fusarium Infection

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Noxafil



Possible Noxafil side effects in

Reported by a physician from Spain on 2012-07-18

Patient:

Reactions: Overdose

Drug(s) suspected as cause:
Noxafil
    Administration route: Oral
    Indication: Fungal Infection

Posaconazole
    Dosage: unk
    Indication: Fungal Infection
    Start date: 2012-06-30



Possible Noxafil side effects in

Reported by a consumer/non-health professional from United States on 2012-07-16

Patient:

Reactions: Arthralgia

Drug(s) suspected as cause:
Noxafil



Possible Noxafil side effects in

Reported by a individual with unspecified qualification from United States on 2012-07-10

Patient:

Reactions: Disease Progression

Adverse event resulted in: death, disablity

Drug(s) suspected as cause:
Noxafil

Other drugs received by patient: Amphotericin B



Possible Noxafil side effects in male

Reported by a pharmacist from United Kingdom on 2012-07-05

Patient: male

Reactions: Malaise

Drug(s) suspected as cause:
Noxafil



Possible Noxafil side effects in male

Reported by a physician from United Kingdom on 2012-06-27

Patient: male

Reactions: Neuropathy Peripheral, Neoplasm Malignant

Drug(s) suspected as cause:
Noxafil

Other drugs received by patient: Acyclovir; Septra



Possible Noxafil side effects in female

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

Patient: female

Reactions: Fungal Infection

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Noxafil
    Dosage: 600 mg;qd;po
    Administration route: Oral
    Indication: Fungal Infection

Noxafil
    Dosage: 600 mg;qd;po
    Administration route: Oral
    Indication: Prophylaxis



Possible Noxafil side effects in 22 year old male

Reported by a physician from France on 2012-06-21

Patient: 22 year old male

Reactions: Intentional Overdose, Urticaria, Purpura

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Noxafil



Possible Noxafil side effects in 62 year old female

Reported by a consumer/non-health professional from United States on 2012-06-14

Patient: 62 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Noxafil



Possible Noxafil side effects in 42 year old male

Reported by a physician from Thailand on 2012-06-04

Patient: 42 year old male

Reactions: Septic Shock

Adverse event resulted in: death

Drug(s) suspected as cause:
Noxafil



Possible Noxafil side effects in male

Reported by a physician from United States on 2012-06-01

Patient: male

Reactions: Drug Level Changed, Fusarium Infection

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Noxafil



Possible Noxafil side effects in 42 year old male

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

Patient: 42 year old male

Reactions: Septic Shock

Adverse event resulted in: death

Drug(s) suspected as cause:
Noxafil



Possible Noxafil side effects in 43 year old male

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

Patient: 43 year old male

Reactions: Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Noxafil



Possible Noxafil side effects in male

Reported by a physician from Thailand on 2012-05-29

Patient: male

Reactions: Septic Shock

Adverse event resulted in: death

Drug(s) suspected as cause:
Noxafil



Possible Noxafil side effects in 18 year old female

Reported by a physician from Thailand on 2012-05-16

Patient: 18 year old female

Reactions: Leukaemia Recurrent

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Noxafil

Other drugs received by patient: Bactrim



Possible Noxafil side effects in 42 year old male

Reported by a physician from Thailand on 2012-05-15

Patient: 42 year old male

Reactions: Septic Shock

Adverse event resulted in: death

Drug(s) suspected as cause:
Noxafil



Possible Noxafil side effects in 18 year old female

Reported by a physician from Thailand on 2012-05-15

Patient: 18 year old female

Reactions: Leukaemia Recurrent

Adverse event resulted in: death

Drug(s) suspected as cause:
Noxafil



Possible Noxafil side effects in 43 year old male

Reported by a physician from Thailand on 2012-05-15

Patient: 43 year old male

Reactions: Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Noxafil

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