Index of reports
> Cases with Rhabdomyolysis (12)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Ketoconazole (Ketoconazole Topical) where reactions include rhabdomyolysis. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Ketoconazole side effects in 77 year old male
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-06-27
Patient: 77 year old male, weighing 90.0 kg (198.0 pounds)
Reactions: Cholelithiasis, Rhabdomyolysis, Oral Candidiasis, Drug Interaction, Hypothyroidism, Renal Failure Acute
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Ketoconazole
Administration route: Oral
Indication: Prostate Cancer Metastatic
Start date: 2011-11-01
Zocor
Administration route: Oral
Indication: Coronary Artery Disease
End date: 2011-11-01
Possible Ketoconazole side effects in 77 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-24
Patient: 77 year old male
Reactions: Rhabdomyolysis, Medication Error, Drug Interaction, Hepatitis
Drug(s) suspected as cause:
Hydrocortisone
Indication: Product Used FOR Unknown Indication
Ketoconazole
Indication: Product Used FOR Unknown Indication
Other drugs received by patient possibly interacting with the suspect drug: Simvastatin
Indication: Product Used FOR Unknown Indication
Possible Ketoconazole side effects in 70 year old female
Reported by a health professional (non-physician/pharmacist) from Portugal on 2012-02-07
Patient: 70 year old female
Reactions: Neurotoxicity, Rhabdomyolysis, Hepatotoxicity, Drug Interaction, Renal Failure Acute
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Simvastatin
Indication: Product Used FOR Unknown Indication
Ketoconazole
Indication: Skin Lesion
Cyclosporine
Indication: Skin Lesion
Possible Ketoconazole side effects in 70 year old female
Reported by a health professional (non-physician/pharmacist) from Portugal on 2011-12-27
Patient: 70 year old female
Reactions: Neurotoxicity, Confusional State, Rhabdomyolysis, Hepatotoxicity, Drug Interaction, Renal Failure Acute, Convulsion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Simvastatin
Dosage: unk
Indication: Hypercholesterolaemia
Ketoconazole
Dosage: unk
Indication: Skin Lesion
Cyclosporine
Dosage: unk
Indication: Skin Lesion
Possible Ketoconazole side effects in 70 year old female
Reported by a health professional (non-physician/pharmacist) from Portugal on 2011-12-13
Patient: 70 year old female
Reactions: Neurotoxicity, Rhabdomyolysis, Hepatotoxicity, Drug Interaction, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cyclosporine
Indication: Skin Lesion
Simvastatin
Indication: Product Used FOR Unknown Indication
Ketoconazole
Indication: Skin Lesion
Possible Ketoconazole side effects in 70 year old female
Reported by a physician from Portugal on 2011-12-12
Patient: 70 year old female
Reactions: Confusional State, Rhabdomyolysis, Nephropathy Toxic, Abasia, Drug Interaction, Headache, Tremor, Convulsion, Myalgia, Neurotoxicity, Malaise, Hepatotoxicity, Asthenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Simvastatin
Dosage: unk
Indication: Product Used FOR Unknown Indication
Ketoconazole
Dosage: unk
Indication: Skin Lesion
Cyclophosphamide
Dosage: unk
Indication: Skin Lesion
Possible Ketoconazole side effects in 70 year old female
Reported by a health professional (non-physician/pharmacist) from Portugal on 2011-12-06
Patient: 70 year old female
Reactions: Neurotoxicity, Rhabdomyolysis, Drug Interaction, Renal Failure Acute, Liver Disorder
Drug(s) suspected as cause:
Ketoconazole
Other drugs received by patient possibly interacting with the suspect drug: Cyclosporine
Indication: Skin Lesion
Simvastatin
Possible Ketoconazole side effects in 70 year old female
Reported by a health professional (non-physician/pharmacist) from Portugal on 2011-11-23
Patient: 70 year old female
Reactions: Confusional State, Rhabdomyolysis, Abasia, Drug Interaction, Headache, Convulsion, Tremor, Liver Disorder, Myalgia, Neurotoxicity, Malaise, Asthenia, Renal Failure Acute
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Ketoconazole
Other drugs received by patient possibly interacting with the suspect drug: Cyclosporine
Indication: Skin Lesion
Simvastatin
Indication: Skin Lesion
Possible Ketoconazole side effects in 70 year old female
Reported by a physician from Portugal on 2011-11-18
Patient: 70 year old female
Reactions: Confusional State, Rhabdomyolysis, Abasia, Drug Interaction, Headache, Convulsion, Tremor, Liver Disorder, Myalgia, Neurotoxicity, Malaise, Asthenia, Renal Failure Acute
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Ketoconazole
Cyclosporine
Zocor
Possible Ketoconazole side effects in 70 year old female
Reported by a health professional (non-physician/pharmacist) from Portugal on 2011-11-09
Patient: 70 year old female
Reactions: Confusional State, Rhabdomyolysis, Abasia, Drug Interaction, Headache, Tremor, Liver Disorder, Convulsion, Neurotoxicity, Myalgia, Malaise, Asthenia, Renal Failure Acute
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Ketoconazole
Other drugs received by patient possibly interacting with the suspect drug: Simvastatin
Indication: Skin Lesion
Cyclosporine
Indication: Skin Lesion
Possible Ketoconazole side effects in 70 year old female
Reported by a health professional (non-physician/pharmacist) from Portugal on 2011-11-09
Patient: 70 year old female
Reactions: Confusional State, Rhabdomyolysis, Headache, Convulsion, Liver Disorder, Tremor, Myalgia, Malaise, Skin Lesion, Asthenia, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Simvastatin
Dosage: 20 mg (20 mg, 1 in 1 d),
Indication: Product Used FOR Unknown Indication
Cyclosporine
Dosage: 200 mg (100 mg, 2 in 1 d),
Indication: Skin Lesion
Ketoconazole
Dosage: 200 mg (200 mg, 1 in 1 d),
Indication: Skin Lesion
Other drugs received by patient: Omeprazole; Bisoprolol; Valsartan / Hydrochloride (CO-Diovan); Alprazolam; Acetylsalicylic Acid SRT
Possible Ketoconazole side effects in 70 year old female
Reported by a physician from Portugal on 2011-10-26
Patient: 70 year old female
Reactions: Confusional State, Rhabdomyolysis, Drug Interaction, Headache, Tremor, Convulsion, Liver Disorder, Myalgia, Malaise, Asthenia, Renal Failure Acute
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Zocor
Ketoconazole
Cyclosporine
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