Index of reports
> Cases with Off Label Use (18)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Hydrocortisone (Hydrocortisone Topical) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Hydrocortisone side effects in
Reported by a physician from United States on 2012-08-20
Patient:
Reactions: Multi-Organ Failure, Off Label Use, Sepsis, Cerebral Ischaemia
Adverse event resulted in: death
Drug(s) suspected as cause:
Asparaginase
Dosage: 2500 units/m2/dose as 4 weekly doses
Indication: Acute Lymphocytic Leukaemia
Bortezomib
Dosage: 1.3 mg/sq.m/dose on days 1, 4, 8 and 11 combined with vxld
Indication: Acute Lymphocytic Leukaemia
Cytarabine
Dosage: on day 1 for all patients and on days 8, 15, 22 for cns invlovment
Indication: Acute Lymphocytic Leukaemia
Dexamethasone
Dosage: 10 mg/m2/day divided in to 2 doses for 14 consecutive days
Administration route: Oral
Indication: Acute Lymphocytic Leukaemia
Doxorubicin Hydrochloride
Dosage: on day 1 over 15-30 minutes
Indication: Acute Lymphocytic Leukaemia
Hydrocortisone
Dosage: on days 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
Methotrexate
Dosage: 1 dose on day 15 for no cns involvement and on days 8, 15, 22 for cns involvement
Indication: Acute Lymphocytic Leukaemia
Vincristine
Dosage: 1.5 mg/m2/dose, max. 2 mg, by push on days 1, 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
Possible Hydrocortisone side effects in
Reported by a physician from United States on 2012-08-20
Patient:
Reactions: Off Label Use, Zygomycosis
Drug(s) suspected as cause:
Asparaginase
Dosage: 2500 units/m2/dose as 4 weekly doses
Asparaginase
Dosage: 2500 units/m2/dose as 4 weekly doses
Indication: Acute Lymphocytic Leukaemia
Asparaginase
Dosage: 2500 units/m2/dose as 4 weekly doses
Asparaginase
Dosage: 2500 units/m2/dose as 4 weekly doses
Bortezomib
Dosage: 1.3 mg/sq.m/dose on days 1, 4, 8 and 11 combined with vxld
Indication: Acute Lymphocytic Leukaemia
Bortezomib
Dosage: 1.3 mg/sq.m/dose on days 1, 4, 8 and 11 combined with vxld
Bortezomib
Dosage: 1.3 mg/sq.m/dose on days 1, 4, 8 and 11 combined with vxld
Bortezomib
Dosage: 1.3 mg/sq.m/dose on days 1, 4, 8 and 11 combined with vxld
Cytarabine
Dosage: on day 1 for all patients and on days 8, 15,22 for cns invlovment
Indication: Acute Lymphocytic Leukaemia
Cytarabine
Dosage: on day 1 for all patients and on days 8, 15,22 for cns invlovment
Cytarabine
Dosage: on day 1 for all patients and on days 8, 15,22 for cns invlovment
Cytarabine
Dosage: on day 1 for all patients and on days 8, 15,22 for cns invlovment
Dexamethasone
Dosage: 10 mg/m2/day divided in to 2 doses for 24 consecutive days
Administration route: Oral
Dexamethasone
Dosage: 10 mg/m2/day divided in to 2 doses for 24 consecutive days
Administration route: Oral
Dexamethasone
Dosage: 10 mg/m2/day divided in to 2 doses for 24 consecutive days
Administration route: Oral
Indication: Acute Lymphocytic Leukaemia
Dexamethasone
Dosage: 10 mg/m2/day divided in to 2 doses for 24 consecutive days
Administration route: Oral
Doxorubicin Hydrochloride
Dosage: given over 15-30 minutes on day 1
Indication: Acute Lymphocytic Leukaemia
Doxorubicin Hydrochloride
Dosage: given over 15-30 minutes on day 1
Doxorubicin Hydrochloride
Dosage: given over 15-30 minutes on day 1
Doxorubicin Hydrochloride
Dosage: given over 15-30 minutes on day 1
Hydrocortisone
Dosage: on days 8, 15 and 22
Hydrocortisone
Dosage: on days 8, 15 and 22
Hydrocortisone
Dosage: on days 8, 15 and 22
Hydrocortisone
Dosage: on days 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
Methotrexate
Dosage: 1 dose on day 15 for no cns invlovement and on days 8, 15, 22 for cns invlovement
Methotrexate
Dosage: 1 dose on day 15 for no cns invlovement and on days 8, 15, 22 for cns invlovement
Indication: Acute Lymphocytic Leukaemia
Methotrexate
Dosage: 1 dose on day 15 for no cns invlovement and on days 8, 15, 22 for cns invlovement
Methotrexate
Dosage: 1 dose on day 15 for no cns invlovement and on days 8, 15, 22 for cns invlovement
Vincristine
Dosage: 1.5 mg/m2/dose, max. 2 mg, by push on days 1, 8, 15 and 22
Vincristine
Dosage: 1.5 mg/m2/dose, max. 2 mg, by push on days 1, 8, 15 and 22
Vincristine
Dosage: 1.5 mg/m2/dose, max. 2 mg, by push on days 1, 8, 15 and 22
Vincristine
Dosage: 1.5 mg/m2/dose, max. 2 mg, by push on days 1, 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
Possible Hydrocortisone side effects in
Reported by a physician from United States on 2012-08-17
Patient:
Reactions: Off Label Use, Zygomycosis
Drug(s) suspected as cause:
Asparaginase
Dosage: 2500 units/m2/dose as 4 weekly doses
Asparaginase
Dosage: 2500 units/m2/dose as 4 weekly doses
Asparaginase
Dosage: 2500 units/m2/dose as 4 weekly doses
Indication: Acute Lymphocytic Leukaemia
Asparaginase
Dosage: 2500 units/m2/dose as 4 weekly doses
Bortezomib
Dosage: 1.3 mg/sq.m/dose on days 1, 4, 8 and 11 combined with vxld
Bortezomib
Dosage: 1.3 mg/sq.m/dose on days 1, 4, 8 and 11 combined with vxld
Bortezomib
Dosage: 1.3 mg/sq.m/dose on days 1, 4, 8 and 11 combined with vxld
Bortezomib
Dosage: 1.3 mg/sq.m/dose on days 1, 4, 8 and 11 combined with vxld
Indication: Acute Lymphocytic Leukaemia
Cytarabine
Dosage: on day 1 for all patients and on days 8, 15,22 for cns invlovment
Cytarabine
Dosage: on day 1 for all patients and on days 8, 15,22 for cns invlovment
Cytarabine
Dosage: on day 1 for all patients and on days 8, 15,22 for cns invlovment
Indication: Acute Lymphocytic Leukaemia
Cytarabine
Dosage: on day 1 for all patients and on days 8, 15,22 for cns invlovment
Dexamethasone
Dosage: 10 mg/m2/day divided in to 2 doses for 24 consecutive days
Administration route: Oral
Dexamethasone
Dosage: 10 mg/m2/day divided in to 2 doses for 24 consecutive days
Administration route: Oral
Indication: Acute Lymphocytic Leukaemia
Dexamethasone
Dosage: 10 mg/m2/day divided in to 2 doses for 24 consecutive days
Administration route: Oral
Dexamethasone
Dosage: 10 mg/m2/day divided in to 2 doses for 24 consecutive days
Administration route: Oral
Doxorubicin Hydrochloride
Dosage: given over 15-30 minutes on day 1
Doxorubicin Hydrochloride
Dosage: given over 15-30 minutes on day 1
Doxorubicin Hydrochloride
Dosage: given over 15-30 minutes on day 1
Indication: Acute Lymphocytic Leukaemia
Doxorubicin Hydrochloride
Dosage: given over 15-30 minutes on day 1
Hydrocortisone
Dosage: on days 8, 15 and 22
Hydrocortisone
Dosage: on days 8, 15 and 22
Hydrocortisone
Dosage: on days 8, 15 and 22
Hydrocortisone
Dosage: on days 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
Methotrexate
Dosage: 1 dose on day 15 for no cns invlovement and on days 8, 15, 22 for cns invlovement
Indication: Acute Lymphocytic Leukaemia
Methotrexate
Dosage: 1 dose on day 15 for no cns invlovement and on days 8, 15, 22 for cns invlovement
Methotrexate
Dosage: 1 dose on day 15 for no cns invlovement and on days 8, 15, 22 for cns invlovement
Methotrexate
Dosage: 1 dose on day 15 for no cns invlovement and on days 8, 15, 22 for cns invlovement
Vincristine
Dosage: 1.5 mg/m2/dose, max. 2 mg, by push on days 1, 8, 15 and 22
Vincristine
Dosage: 1.5 mg/m2/dose, max. 2 mg, by push on days 1, 8, 15 and 22
Vincristine
Dosage: 1.5 mg/m2/dose, max. 2 mg, by push on days 1, 8, 15 and 22
Vincristine
Dosage: 1.5 mg/m2/dose, max. 2 mg, by push on days 1, 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
Possible Hydrocortisone side effects in
Reported by a physician from United States on 2012-08-17
Patient:
Reactions: Off Label Use, Hypoxia, Pleural Effusion, Bacterial Sepsis
Adverse event resulted in: death
Drug(s) suspected as cause:
Asparaginase
Dosage: (pegylated) 2500 units/ m2/ dose as 4 weekly doses
Indication: Acute Lymphocytic Leukaemia
Bortezomib
Dosage: on days 1, 4, 8 and 11
Indication: Acute Lymphocytic Leukaemia
Cytarabine
Dosage: on day 1 and as cns involvement on days 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
Dexamethasone
Dosage: divided into 2 doses for 14 consecutive days
Administration route: Oral
Indication: Acute Lymphocytic Leukaemia
Doxorubicin Hydrochloride
Dosage: over 15-30 minutes on day 1
Indication: Acute Lymphocytic Leukaemia
Hydrocortisone
Dosage: on days 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
Methotrexate
Dosage: on day 15 and triple therapy on days 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
Vincristine
Dosage: by push day 1, 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
Possible Hydrocortisone side effects in
Reported by a physician from United States on 2012-08-16
Patient:
Reactions: Off Label Use, Hypotension, Hypertension
Drug(s) suspected as cause:
Bortezomib
Dosage: per dose on days 1, 4, 8 and 11
Indication: Acute Lymphocytic Leukaemia
Cytarabine
Dosage: on day 1 or days 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
Dexamethasone
Dosage: per day divided into 2 doses was given orally for 14 consecutive days
Administration route: Oral
Indication: Acute Lymphocytic Leukaemia
Doxorubicin Hydrochloride
Dosage: over 15-30 minutes on day 1
Indication: Acute Lymphocytic Leukaemia
Hydrocortisone
Dosage: on days 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
Methotrexate
Dosage: on day 15 or days 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
PEG-Asparaginase
Dosage: 2500 units/m2/dose was given intramuscularly as 4 weekly doses
Indication: Acute Lymphocytic Leukaemia
Vincristine
Dosage: per dose (2 mg maximum dose) was administered intravenously by push on day 1, 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
Possible Hydrocortisone side effects in
Reported by a physician from United States on 2012-08-16
Patient:
Reactions: Off Label Use, Peripheral Sensorimotor Neuropathy
Drug(s) suspected as cause:
Bortezomib
Dosage: by push per dose on days 1, 4, 8 and 11
Indication: Acute Lymphocytic Leukaemia
Cytarabine
Dosage: on day 1 or days 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
Dexamethasone
Dosage: per day divided into 2 doses was given orally for 14 consecutive days
Administration route: Oral
Indication: Acute Lymphocytic Leukaemia
Doxorubicin Hydrochloride
Dosage: over 15-30 minutes on day 1
Indication: Acute Lymphocytic Leukaemia
Hydrocortisone
Dosage: on days 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
Methotrexate
Dosage: on day 15 or days 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
PEG-Asparaginase
Dosage: 2500 units/m2/dose was given intramuscularly as 4 weekly doses
Indication: Acute Lymphocytic Leukaemia
Vincristine
Dosage: per dose (2 mg maximum dose) was administered intravenously by push on day 1, 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
Possible Hydrocortisone side effects in
Reported by a physician from United States on 2012-08-16
Patient:
Reactions: Off Label Use, Amylase Abnormal, Lipase Abnormal
Drug(s) suspected as cause:
Bortezomib
Dosage: per dose on days 1, 4, 8 and 11
Indication: Acute Lymphocytic Leukaemia
Cytarabine
Dosage: on day 1 or days 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
Dexamethasone
Dosage: divided into 2 doses was given orally for 14 consecutive days
Administration route: Oral
Indication: Acute Lymphocytic Leukaemia
Doxorubicin Hydrochloride
Dosage: over 15-30 minutes on day 1
Indication: Acute Lymphocytic Leukaemia
Hydrocortisone
Dosage: on days 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
Methotrexate
Dosage: on day 15 or days 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
PEG-Asparaginase
Dosage: 2500 units/m2/dose was given intramuscularly as 4 weekly doses
Indication: Acute Lymphocytic Leukaemia
Vincristine
Dosage: per dose (2 mg maximum dose) was administered intravenously by push on day 1, 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
Other drugs received by patient: Voriconazole; Vancomycin; Levofloxacin; Posaconazole
Possible Hydrocortisone side effects in
Reported by a physician from United States on 2012-08-16
Patient:
Reactions: Off Label Use, Coagulopathy, Lower Gastrointestinal Haemorrhage, Escherichia Sepsis
Drug(s) suspected as cause:
Asparaginase
Dosage: 2500 units/m2/dose as 4 weekly doses
Indication: Acute Lymphocytic Leukaemia
Bortezomib
Dosage: 1.3 mg/sq.m/dose on days 1, 4, 8 and 11 combined with vxld
Indication: Acute Lymphocytic Leukaemia
Cytarabine
Dosage: on day 1 for all patients and on days 8, 15, 22 for cns invlovment
Indication: Acute Lymphocytic Leukaemia
Dexamethasone
Dosage: 10 mg/m2/day divided in to 2 doses for 14 consecutive days
Administration route: Oral
Indication: Acute Lymphocytic Leukaemia
Doxorubicin Hydrochloride
Dosage: given over 15-30 minutes on day 1
Indication: Acute Lymphocytic Leukaemia
Hydrocortisone
Dosage: on days 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
Methotrexate
Dosage: 1 dose on day 15 for no cns involvement and on days 8, 15, 22 for cns involvement
Indication: Acute Lymphocytic Leukaemia
Vincristine
Dosage: 1.5 mg/m2/dose, max. 2 mg, by push on days 1, 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
Possible Hydrocortisone side effects in
Reported by a physician from United States on 2012-08-16
Patient:
Reactions: Off Label Use, Amylase Abnormal, Lipase Abnormal
Drug(s) suspected as cause:
Asparaginase
Dosage: 2500 units/m2/dose as 4 weekly doses
Indication: Acute Lymphocytic Leukaemia
Bortezomib
Dosage: 1.3 mg/sq.m/dose on days 1, 4, 8 and 11 combined with vxld
Indication: Acute Lymphocytic Leukaemia
Cytarabine
Dosage: on day 1 for all patients and on days 8, 15, 22 for cns invlovment
Indication: Acute Lymphocytic Leukaemia
Dexamethasone
Dosage: 10 mg/m2/day divided in to 2 doses for 14 consecutive days
Administration route: Oral
Indication: Acute Lymphocytic Leukaemia
Doxorubicin Hydrochloride
Dosage: on day 1 over 15-30 minutes
Indication: Acute Lymphocytic Leukaemia
Hydrocortisone
Dosage: on days 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
Methotrexate
Dosage: 1 dose on day 15 for no cns involvement and on days 8, 15, 22 for cns involvement
Indication: Acute Lymphocytic Leukaemia
Vincristine
Dosage: 1.5 mg/m2/dose, max. 2 mg, by push on days 1, 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
Possible Hydrocortisone side effects in
Reported by a physician from United States on 2012-08-16
Patient:
Reactions: Off Label Use, Encephalopathy, Cerebral Ischaemia
Drug(s) suspected as cause:
Bortezomib
Dosage: per dose on days 1, 4, 8 and 11
Indication: Acute Lymphocytic Leukaemia
Cytarabine
Dosage: on day 1 or days 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
Dexamethasone
Dosage: divided into 2 doses was given orally for 14 consecutive days
Administration route: Oral
Indication: Acute Lymphocytic Leukaemia
Doxorubicin Hydrochloride
Dosage: over 15-30 minutes on day 1
Indication: Acute Lymphocytic Leukaemia
Hydrocortisone
Dosage: on days 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
Methotrexate
Dosage: on day 15 or days 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
PEG-Asparaginase
Dosage: 2500 units/m2/dose was given intramuscularly as 4 weekly doses
Indication: Acute Lymphocytic Leukaemia
Vincristine
Dosage: per dose (2 mg maximum dose) was administered intravenously by push on day 1, 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
Possible Hydrocortisone side effects in
Reported by a physician from United States on 2012-08-14
Patient:
Reactions: Off Label Use, Bacterial Sepsis, Pleural Effusion, Hypoxia
Adverse event resulted in: death
Drug(s) suspected as cause:
Asparaginase
Dosage: (pegylated) 2500 units/ m2/ dose as 4 weekly doses
Indication: Acute Lymphocytic Leukaemia
Bortezomib
Dosage: on days 1, 4, 8 and 11
Indication: Acute Lymphocytic Leukaemia
Cytarabine
Dosage: on day 1 and as cns involvement on days 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
Dexamethasone
Dosage: divided into 2 doses for 14 consecutive days
Administration route: Oral
Indication: Acute Lymphocytic Leukaemia
Doxorubicin Hydrochloride
Dosage: over 15-30 minutes on day 1
Indication: Acute Lymphocytic Leukaemia
Hydrocortisone
Dosage: on days 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
Methotrexate
Dosage: on day 15 and triple therapy on days 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
Vincristine
Dosage: by push day 1, 8, 15 and 22
Indication: Acute Lymphocytic Leukaemia
Possible Hydrocortisone side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-15
Patient: female
Reactions: Off Label Use, Application Site Pain
Drug(s) suspected as cause:
Hydrocortisone
Possible Hydrocortisone 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 Hydrocortisone 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 Hydrocortisone 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 Hydrocortisone 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 Hydrocortisone 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 Hydrocortisone side effects in 43 year old female
Reported by a consumer/non-health professional from United States on 2012-01-30
Patient: 43 year old female
Reactions: Off Label Use, Thermal Burn
Drug(s) suspected as cause:
Benadryl
Administration route: Topical
Indication: Thermal Burn
Start date: 2012-01-01
Hydrocortisone
Administration route: Topical
Indication: Thermal Burn
Start date: 2012-01-01
Other drugs received by patient: Nicorette; Nicorette
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