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Sporanox (Itraconazole) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Sporanox (Itraconazole) 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 (92)
Death (10)
Life Threatening Events (3)
Disability (4)

Reports by Reaction Type

Erythema (7)Oedema Peripheral (7)Headache (6)Drug Ineffective (5)Cardiac Failure Congestive (5)Self Injurious Behaviour (5)Diarrhoea (5)Pruritus (4)Diabetes Mellitus (4)Erectile Dysfunction (4)Hyperhidrosis (4)Death (4)

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

Possible Sporanox side effects in female

Reported by a consumer/non-health professional from China on 2012-08-27

Patient: female

Reactions: Cholecystitis, Headache, Pyrexia, Hyperhidrosis

Drug(s) suspected as cause:
Sporanox
    Administration route: Oral
    Indication: Onychomycosis
    Start date: 2012-08-14
    End date: 2012-08-15

Sporanox
    Administration route: Oral
    Start date: 2012-08-18

Sporanox
    Administration route: Oral
    Start date: 2012-08-11
    End date: 2012-08-13

Sporanox
    Administration route: Oral
    Start date: 2012-08-16
    End date: 2012-08-17



Possible Sporanox side effects in female

Reported by a consumer/non-health professional from China on 2012-08-24

Patient: female

Reactions: Cholecystitis, Pyrexia, Headache, Hyperhidrosis

Drug(s) suspected as cause:
Sporanox
    Administration route: Oral
    Start date: 2012-08-16
    End date: 2012-08-17

Sporanox
    Administration route: Oral
    Indication: Onychomycosis
    Start date: 2012-08-14
    End date: 2012-08-15

Sporanox
    Administration route: Oral
    Start date: 2012-08-18

Sporanox
    Administration route: Oral
    Start date: 2012-08-11
    End date: 2012-08-13



Possible Sporanox side effects in

Reported by a physician from China on 2012-08-22

Patient:

Reactions: Jaundice, Vomiting, Nausea, Drug Ineffective, Headache, Pyrexia, Rash

Drug(s) suspected as cause:
Itraconazole
    Administration route: Oral
    Indication: Pulmonary Mycosis

Sporanox

Sporanox
    Indication: Pulmonary Mycosis



Possible Sporanox side effects in

Reported by a physician from Germany on 2012-07-26

Patient:

Reactions: Cardiac Arrest

Drug(s) suspected as cause:
Chemotherapy
    Indication: Myeloid Leukaemia

Chemotherapy
    Indication: Myelodysplastic Syndrome

Itraconazole
    Indication: Antifungal Prophylaxis

Sporanox
    Administration route: Oral
    Indication: Antifungal Prophylaxis



Possible Sporanox side effects in

Reported by a physician from Germany on 2012-07-26

Patient:

Reactions: Alanine Aminotransferase Increased

Drug(s) suspected as cause:
Chemotherapy
    Indication: Myeloid Leukaemia

Chemotherapy
    Indication: Myelodysplastic Syndrome

Sporanox
    Administration route: Oral
    Indication: Antifungal Prophylaxis

Sporanox



Possible Sporanox side effects in

Reported by a physician from Germany on 2012-07-26

Patient:

Reactions: Cardio-Respiratory Arrest

Drug(s) suspected as cause:
Chemotherapy
    Indication: Myelodysplastic Syndrome

Chemotherapy
    Indication: Myeloid Leukaemia

Itraconazole
    Dosage: for 3 days
    Indication: Antifungal Prophylaxis

Sporanox
    Administration route: Oral
    Indication: Antifungal Prophylaxis



Possible Sporanox side effects in

Reported by a physician from Germany on 2012-07-25

Patient:

Reactions: Pneumocystis Jiroveci Pneumonia

Drug(s) suspected as cause:
Chemotherapy
    Indication: Myelodysplastic Syndrome

Chemotherapy
    Indication: Myeloid Leukaemia

Sporanox
    Administration route: Oral
    Indication: Antifungal Prophylaxis

Sporanox



Possible Sporanox side effects in

Reported by a physician from Germany on 2012-07-25

Patient:

Reactions: Atrial Fibrillation

Drug(s) suspected as cause:
Chemotherapy
    Indication: Myelodysplastic Syndrome

Chemotherapy
    Indication: Myeloid Leukaemia

Sporanox
    Administration route: Oral
    Indication: Antifungal Prophylaxis

Sporanox



Possible Sporanox side effects in

Reported by a physician from Germany on 2012-07-25

Patient:

Reactions: Atrial Fibrillation

Drug(s) suspected as cause:
Chemotherapy
    Indication: Myelodysplastic Syndrome

Chemotherapy
    Indication: Myeloid Leukaemia

Sporanox

Sporanox
    Administration route: Oral
    Indication: Antifungal Prophylaxis



Possible Sporanox side effects in

Reported by a physician from Germany on 2012-07-25

Patient:

Reactions: Hyperbilirubinaemia

Drug(s) suspected as cause:
Chemotherapy
    Indication: Myeloid Leukaemia

Chemotherapy
    Indication: Myelodysplastic Syndrome

Sporanox

Sporanox
    Administration route: Oral
    Indication: Antifungal Prophylaxis



Possible Sporanox side effects in

Reported by a physician from Germany on 2012-07-25

Patient:

Reactions: Gastrointestinal Haemorrhage

Drug(s) suspected as cause:
Chemotherapy
    Indication: Myelodysplastic Syndrome

Chemotherapy
    Indication: Myeloid Leukaemia

Sporanox

Sporanox
    Administration route: Oral
    Indication: Antifungal Prophylaxis



Possible Sporanox side effects in

Reported by a physician from Germany on 2012-07-24

Patient:

Reactions: Hyperbilirubinaemia

Drug(s) suspected as cause:
Chemotherapy
    Indication: Myeloid Leukaemia

Chemotherapy
    Indication: Myelodysplastic Syndrome

Sporanox
    Administration route: Oral
    Indication: Antifungal Prophylaxis



Possible Sporanox side effects in 51 year old female

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-07-19

Patient: 51 year old female, weighing 70.0 kg (154.0 pounds)

Reactions: Multiple Drug Overdose Intentional, Self Injurious Behaviour

Drug(s) suspected as cause:
Dopaminergic Agents
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-28
    End date: 2012-06-28

Sporanox
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-28
    End date: 2012-06-28

Tramadol Hydrochloride and Acetaminophen
    Dosage: 37.5mg/ 325 mg
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-28
    End date: 2012-06-28



Possible Sporanox side effects in 47 year old male

Reported by a consumer/non-health professional from China on 2012-07-05

Patient: 47 year old male

Reactions: Nerve Injury

Drug(s) suspected as cause:
Sporanox
    Dosage: 2nd stoss therapy
    Administration route: Oral

Sporanox
    Dosage: 1st stoss therapy
    Administration route: Oral
    Start date: 2011-05-01

Sporanox
    Dosage: 3rd stoss therapy
    Administration route: Oral
    Indication: Onychomycosis



Possible Sporanox side effects in 51 year old female

Reported by a physician from Italy on 2012-07-05

Patient: 51 year old female, weighing 70.0 kg (154.0 pounds)

Reactions: Multiple Drug Overdose Intentional, Self Injurious Behaviour

Drug(s) suspected as cause:
Dopaminergic Agents
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-28
    End date: 2012-06-28

Sporanox
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-28
    End date: 2012-06-28

Tramadol Hydrochloride and Acetaminophen
    Dosage: 37.5mg/ 325 mg
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-28
    End date: 2012-06-28



Possible Sporanox side effects in male

Reported by a consumer/non-health professional from China on 2012-06-12

Patient: male, weighing 60.0 kg (132.0 pounds)

Reactions: Abdominal Pain, Palpitations, Diarrhoea, Heart Rate Increased, Dizziness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sporanox
    Administration route: Oral
    Start date: 2011-08-23

Sporanox
    Administration route: Oral
    Start date: 2011-07-28
    End date: 2011-08-21

Sporanox
    Administration route: Oral
    Indication: Upper Respiratory Fungal Infection
    Start date: 2011-07-06
    End date: 2011-07-21



Possible Sporanox side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-08

Patient: female

Reactions: Confusional State, Cerebral Small Vessel Ischaemic Disease, Renal Failure, Respiratory Acidosis, Cytolytic Hepatitis, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sporanox

Other drugs received by patient: Fluindione; Cordarone; Koretic; Furosemide



Possible Sporanox side effects in

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

Patient:

Reactions: Pneumonia Fungal, Fungal Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Itraconazole
    Dosage: for 4-6 weeks
    Administration route: Oral
    Indication: Oral Fungal Infection

Sporanox
    Dosage: 4-6 weeks
    Administration route: Oral
    Indication: Oral Fungal Infection



Possible Sporanox side effects in male

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

Patient: male, weighing 133.8 kg (294.4 pounds)

Reactions: Drug Ineffective, Depression, Hyperhidrosis

Drug(s) suspected as cause:
Prozac
    Indication: Depression

Prozac

Prozac

Sporanox
    Administration route: Oral
    Indication: Exposure To Mould
    Start date: 2012-03-01

Other drugs received by patient: Multiple Vitamin



Possible Sporanox side effects in 65 year old

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

Patient: 65 year old

Reactions: Myalgia, Balance Disorder, Arthralgia, Neck Pain, Headache, Infertility

Drug(s) suspected as cause:
Sporanox
    Administration route: Oral

Sporanox
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Corticosteroids; Fungizone



Possible Sporanox side effects in female

Reported by a physician from China on 2012-05-25

Patient: female, weighing 65.0 kg (143.0 pounds)

Reactions: Roseola, Erythema

Drug(s) suspected as cause:
Sporanox



Possible Sporanox side effects in male

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

Patient: male, weighing 60.0 kg (132.0 pounds)

Reactions: Weight Increased, Diarrhoea, Liver Function Test Abnormal, LOW Density Lipoprotein Decreased, Platelet Count Decreased, Generalised Oedema, Blood Cholesterol Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sporanox
    Administration route: Oral
    Start date: 2011-07-12
    End date: 2011-07-18

Sporanox
    Administration route: Oral
    Indication: Onychomycosis
    Start date: 2011-06-01
    End date: 2011-06-08



Possible Sporanox side effects in 55 year old male

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

Patient: 55 year old male, weighing 60.0 kg (132.0 pounds)

Reactions: Extravasation, Oedema Peripheral, Erythema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sporanox



Possible Sporanox side effects in male

Reported by a consumer/non-health professional from China on 2012-05-24

Patient: male, weighing 60.0 kg (132.0 pounds)

Reactions: Priapism

Drug(s) suspected as cause:
Sporanox



Possible Sporanox side effects in 37 year old male

Reported by a consumer/non-health professional from China on 2012-05-18

Patient: 37 year old male

Reactions: Erectile Dysfunction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sporanox



Possible Sporanox side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-18

Patient: male, weighing 40.4 kg (88.8 pounds)

Reactions: Spinal Compression Fracture, Osteoporosis, Bone Density Decreased, Fall

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Sporanox



Possible Sporanox side effects in

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

Patient:

Reactions: Death, Encephalitis Viral, Encephalitis Fungal

Adverse event resulted in: death

Drug(s) suspected as cause:
Acyclovir
    Indication: Antiviral Treatment

Sporanox
    Indication: Antifungal Prophylaxis

Valacyclovir Hydrochloride
    Indication: Antiviral Treatment



Possible Sporanox side effects in male

Reported by a physician from China on 2012-05-11

Patient: male, weighing 60.0 kg (132.0 pounds)

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Sporanox
    Indication: Pneumonia Fungal
    Start date: 2011-07-06
    End date: 2011-07-06

Sporanox
    Indication: Pulmonary Mycosis
    Start date: 2011-07-06
    End date: 2011-07-06



Possible Sporanox side effects in 67 year old male

Reported by a consumer/non-health professional from Australia on 2012-05-11

Patient: 67 year old male

Reactions: Liver Injury, Renal Injury, Spleen Disorder

Drug(s) suspected as cause:
Sporanox



Possible Sporanox side effects in male

Reported by a physician from China on 2012-05-10

Patient: male, weighing 60.0 kg (132.0 pounds)

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Sporanox
    Indication: Pneumonia Fungal
    Start date: 2011-07-06
    End date: 2011-07-06

Sporanox
    Indication: Pulmonary Mycosis
    Start date: 2011-07-06
    End date: 2011-07-06

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