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: 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 2012-07-26
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 2012-07-25
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 2012-07-25
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 2012-07-24
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 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 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 2012-05-24
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 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 2012-05-11
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 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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