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Ketoconazole (Ketoconazole Topical) - Off Label Use - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Off Label Use (15)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Ketoconazole (Ketoconazole Topical) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Ketoconazole side effects in male

Reported by a health professional (non-physician/pharmacist) from Taiwan, Province of China on 2012-08-01

Patient: male

Reactions: Off Label Use, Prostatic Specific Antigen Decreased

Drug(s) suspected as cause:
Ketoconazole

Other drugs received by patient: Prednisolone



Possible Ketoconazole side effects in 83 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-12

Patient: 83 year old female

Reactions: Off Label Use, Atrioventricular Block, Mental Status Changes, Drug Interaction

Drug(s) suspected as cause:
Ketoconazole
    Administration route: Oral
    Indication: Cushing's Syndrome

Ketoconazole
    Dosage: for 2 days
    Administration route: Oral

Potassium Chloride
    Administration route: Oral
    Indication: Hypokalaemia

Other drugs received by patient possibly interacting with the suspect drug:
Verapamil
    Indication: Hypertension



Possible Ketoconazole side effects in 50 year old male

Reported by a physician from United States on 2012-06-04

Patient: 50 year old male

Reactions: Off Label Use, Hyperkalaemia, Adrenocortical Insufficiency Acute, Hypoglycaemia, Hypotension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ketoconazole
    Dosage: 200 mg;
    Indication: Hypercorticoidism

Ketoconazole
    Dosage: 200 mg;
    Indication: Off Label Use



Possible Ketoconazole side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-04

Patient: male

Reactions: Off Label Use, Thrombocytopenia

Drug(s) suspected as cause:
Ketoconazole



Possible Ketoconazole side effects in 38 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-05-04

Patient: 38 year old male

Reactions: Off Label Use, Eczema, Rash Pruritic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ketoconazole

Other drugs received by patient: Herbal OIL NOS



Possible Ketoconazole side effects in male

Reported by a physician from United States on 2012-04-30

Patient: male

Reactions: Off Label Use, Decreased Appetite

Drug(s) suspected as cause:
Hydrocortisone
    Indication: Prostate Cancer Metastatic

Hydrocortisone
    Dosage: tapering dose after 3 weeks

Ketoconazole
    Administration route: Oral
    Indication: Prostate Cancer Metastatic

Other drugs received by patient: Gonadotropin-Releasing Hormone Agonist



Possible Ketoconazole side effects in male

Reported by a physician from United States on 2012-04-30

Patient: male

Reactions: Off Label Use, Hyperglycaemia

Drug(s) suspected as cause:
Hydrocortisone
    Indication: Prostate Cancer Metastatic

Hydrocortisone
    Dosage: tapering dose after 3 weeks

Ketoconazole
    Administration route: Oral
    Indication: Prostate Cancer Metastatic

Other drugs received by patient: Gonadotropin-Releasing Hormone Agonist



Possible Ketoconazole side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-25

Patient: male

Reactions: Off Label Use, Thrombocytopenia

Drug(s) suspected as cause:
Ketoconazole



Possible Ketoconazole side effects in male

Reported by a consumer/non-health professional from United States on 2012-03-28

Patient: male, weighing 99.8 kg (219.5 pounds)

Reactions: Off Label Use, Prostatic Specific Antigen Increased, Rhinorrhoea, Nasal Congestion

Drug(s) suspected as cause:
Ketoconazole

Other drugs received by patient: Lisinopril; Hydrocortisone; Warfarin Sodium



Possible Ketoconazole side effects in male

Reported by a physician from United States on 2012-02-03

Patient: male

Reactions: Off Label Use, Hyperglycaemia

Drug(s) suspected as cause:
Hydrocortisone
    Dosage: tapering dose after 3 weeks

Hydrocortisone
    Indication: Prostate Cancer Metastatic

Ketoconazole
    Administration route: Oral
    Indication: Prostate Cancer Metastatic

Other drugs received by patient: Gonadotropin-Releasing Hormone Agonist



Possible Ketoconazole side effects in male

Reported by a physician from United States on 2012-01-31

Patient: male

Reactions: Off Label Use, Decreased Appetite

Drug(s) suspected as cause:
Hydrocortisone
    Dosage: tapering dose after 3 weeks

Hydrocortisone
    Indication: Prostate Cancer Metastatic

Ketoconazole
    Administration route: Oral
    Indication: Prostate Cancer Metastatic

Other drugs received by patient: Gonadotropin-Releasing Hormone Agonist



Possible Ketoconazole side effects in male

Reported by a physician from United States on 2012-01-31

Patient: male

Reactions: Off Label Use, Hyperglycaemia

Drug(s) suspected as cause:
Hydrocortisone
    Dosage: tapering dose after 3 weeks

Hydrocortisone
    Indication: Prostate Cancer Metastatic

Ketoconazole
    Administration route: Oral
    Indication: Prostate Cancer Metastatic

Other drugs received by patient: Gonadotropin-Releasing Hormone Agonist



Possible Ketoconazole side effects in female

Reported by a consumer/non-health professional from Canada on 2012-01-16

Patient: female

Reactions: Inappropriate Schedule of Drug Administration, Hypersensitivity, Pruritus, Skin Exfoliation, Skin Burning Sensation, Sensory Loss, Rash, DRY Skin, Erythema, Suicidal Ideation, Off Label Use, Dermatitis, Alopecia, Melanocytic Naevus

Drug(s) suspected as cause:
Ketoconazole
    Administration route: Topical

Ketoconazole
    Administration route: Topical
    Indication: Tinea Infection



Possible Ketoconazole side effects in female

Reported by a consumer/non-health professional from Canada on 2011-12-02

Patient: female

Reactions: Inappropriate Schedule of Drug Administration, Pruritus, Skin Exfoliation, Skin Burning Sensation, Sensory Loss, DRY Skin, Rash, Erythema, Suicidal Ideation, Off Label Use, Dermatitis, Alopecia

Drug(s) suspected as cause:
Ketoconazole
    Administration route: Topical

Ketoconazole
    Administration route: Topical
    Indication: Tinea Infection



Possible Ketoconazole side effects in male

Reported by a consumer/non-health professional from United States on 2011-10-28

Patient: male, weighing 99.8 kg (219.5 pounds)

Reactions: Off Label Use, Prostatic Specific Antigen Increased, Rhinorrhoea, Nasal Congestion

Drug(s) suspected as cause:
Ketoconazole

Other drugs received by patient: Warfarin Sodium; Hydrocortisone; Lisinopril

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