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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