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

 
 



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, 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 2012-08-17

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 2012-08-16

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 2012-08-16

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 2012-08-14

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, 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 2012-04-30

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 2012-02-03

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, 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 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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