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Hydrocortisone (Hydrocortisone Topical) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Hydrocortisone (Hydrocortisone Topical) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (269)
Death (51)
Life Threatening Events (13)
Disability (12)

Reports by Reaction Type

Rhabdomyolysis (21)Abdominal Pain (20)Hypotension (19)Off Label Use (18)Hypertension (17)Tendonitis (16)Hyponatraemia (16)Decreased Appetite (15)Sepsis (15)Epidural Lipomatosis (14)Headache (13)Nausea (13)

Below are a few examples of reports where side effects / adverse reactions may be related to Hydrocortisone (Hydrocortisone Topical). For a complete list or a specific selection of reports, please use the links above.

Possible Hydrocortisone side effects in

Reported by a physician from United States on 2012-08-22

Patient:

Reactions: Abdominal Pain, Thrombosis, Hyperkalaemia, Coagulopathy, Hypoglycaemia, Hypocalcaemia, Hypoxia, Hiccups, Alanine Aminotransferase Abnormal, Pneumonitis, Cough, Pain in Extremity, Hypotension, Hyperglycaemia, External Ear Pain, Haematotoxicity, Dehydration, Lower Gastrointestinal Haemorrhage, Hypofibrinogenaemia, Aspartate Aminotransferase Abnormal, Hypokalaemia, Blood Bilirubin Abnormal, Pleural Effusion, Decreased Appetite, Gamma-Glutamyltransferase Abnormal, Hyponatraemia, Hypercalcaemia, Hypophosphataemia, Diarrhoea, Hypoalbuminaemia, Hypertension, Infection

Adverse event resulted in: hospitalization

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 HCL
    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 Sodium
    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

Other drugs received by patient: Vancomycin; Posaconazole; Voriconazole; Levofloxacin



Possible Hydrocortisone side effects in

Reported by a physician from United States on 2012-08-20

Patient:

Reactions: Gastrointestinal Haemorrhage, Coagulopathy, Escherichia Sepsis

Drug(s) suspected as cause:
Cytarabine
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia

Dexamethasone
    Dosage: 10 mg/m2, cyclic
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia

Doxorubicin Hydrochloride
    Dosage: 60 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia

Hydrocortisone
    Indication: Acute Lymphocytic Leukaemia

Methotrexate
    Indication: Acute Lymphocytic Leukaemia

PEG-Asparaginase
    Dosage: unk, cyclic
    Indication: Acute Lymphocytic Leukaemia

Velcade
    Dosage: 1.3 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia

Vincristine
    Dosage: 1.5 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia



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: Adrenal Insufficiency, Encephalopathy

Drug(s) suspected as cause:
Cytarabine
    Dosage: unk unk, cyclic
    Indication: Acute Lymphocytic Leukaemia

Dexamethasone
    Dosage: 10 mg/m2, cyclic
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia

Doxorubicin Hydrochloride
    Dosage: 60 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia

Hydrocortisone
    Dosage: unk, cyclic
    Indication: Acute Lymphocytic Leukaemia

Methotrexate
    Dosage: unk, cyclic
    Indication: Acute Lymphocytic Leukaemia

PEG-Asparaginase
    Dosage: unk, cyclic
    Indication: Acute Lymphocytic Leukaemia

Velcade
    Dosage: 1.3 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia

Vincristine
    Dosage: 1.5 mg/m2, cyclic
    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 2012-08-20

Patient:

Reactions: Abdominal Pain, Thrombosis, Hyperkalaemia, Hypoglycaemia, Coagulopathy, Hypokalaemia, Blood Bilirubin Abnormal, Hiccups, Pleural Effusion, Hypoxia, Hypocalcaemia, Alanine Aminotransferase Abnormal, Cough, Pneumonitis, Decreased Appetite, Pain in Extremity, Hypotension, Hyperglycaemia, Gamma-Glutamyltransferase Abnormal, Hyponatraemia, External Ear Pain, Hypercalcaemia, Haematotoxicity, Hypophosphataemia, Diarrhoea, Dehydration, Hypoalbuminaemia, Lower Gastrointestinal Haemorrhage, Hypertension, Hypofibrinogenaemia, Aspartate Aminotransferase Abnormal, Infection

Adverse event resulted in: hospitalization

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

Other drugs received by patient: Levofloxacin; Voriconazole; Posaconazole; Vancomycin



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 47 year old female

Reported by a physician from France on 2012-08-17

Patient: 47 year old female, weighing 44.0 kg (96.8 pounds)

Reactions: Peliosis Hepatis, Gamma-Glutamyltransferase Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hydrocortisone
    Administration route: Oral
    Start date: 2011-09-01

Lysodren
    Administration route: Oral
    Indication: Adrenocortical Carcinoma
    Start date: 2011-09-01
    End date: 2012-05-10

Other drugs received by patient: Lutenyl; Folic Acid; Amlodipine Besylate



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, 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 2012-08-16

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 2012-08-15

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Cytarabine
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia

Dexamethasone
    Dosage: 10 mg/m2, cyclic
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia

Doxorubicin Hydrochloride
    Dosage: 60 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia

Hydrocortisone
    Indication: Acute Lymphocytic Leukaemia

Methotrexate
    Dosage: unk, cyclic
    Indication: Acute Lymphocytic Leukaemia

PEG-Asparaginase
    Dosage: unk, cyclic
    Indication: Acute Lymphocytic Leukaemia

Velcade
    Dosage: 1.3 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia

Vincristine
    Dosage: 1.5 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia



Possible Hydrocortisone side effects in

Reported by a physician from United States on 2012-08-15

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Cytarabine
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia

Decadron
    Dosage: 10 mg/m2, cyclic
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia

Doxorubicin Hydrochloride
    Dosage: 60 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia

Hydrocortisone
    Indication: Acute Lymphocytic Leukaemia

Methotrexate
    Dosage: unk, cyclic
    Indication: Acute Lymphocytic Leukaemia

Oncaspar
    Dosage: unk, cyclic
    Indication: Acute Lymphocytic Leukaemia

Velcade
    Dosage: 1.3 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia

Vincristine
    Dosage: 1.5 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia



Possible Hydrocortisone side effects in

Reported by a physician from United States on 2012-08-15

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Cytarabine
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia

Dexamethasone
    Dosage: 10 mg/m2, cyclic
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia

Doxorubicin Hydrochloride
    Dosage: 60 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia

Hydrocortisone
    Indication: Acute Lymphocytic Leukaemia

Methotrexate
    Dosage: unk, cyclic
    Indication: Acute Lymphocytic Leukaemia

PEG-Asparaginase
    Dosage: unk, cyclic
    Indication: Acute Lymphocytic Leukaemia

Velcade
    Dosage: 1.3 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia

Vincristine
    Dosage: 1.5 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia



Possible Hydrocortisone side effects in

Reported by a physician from United States on 2012-08-15

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Cytarabine
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia

Decadron
    Dosage: 10 mg/m2, cyclic
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia

Doxorubicin Hydrochloride
    Dosage: 60 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia

Hydrocortisone
    Indication: Acute Lymphocytic Leukaemia

Methotrexate
    Dosage: unk, cyclic
    Indication: Acute Lymphocytic Leukaemia

Oncaspar
    Dosage: unk, cyclic
    Indication: Acute Lymphocytic Leukaemia

Velcade
    Dosage: 1.3 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia

Vincristine
    Dosage: 1.5 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia



Possible Hydrocortisone side effects in

Reported by a physician from United States on 2012-08-15

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Cytarabine
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia

Decadron
    Dosage: 10 mg/m2, cyclic
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia

Doxorubicin Hydrochloride
    Dosage: 60 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia

Hydrocortisone
    Indication: Acute Lymphocytic Leukaemia

Methotrexate
    Dosage: unk, cyclic
    Indication: Acute Lymphocytic Leukaemia

Oncaspar
    Dosage: unk, cyclic
    Indication: Acute Lymphocytic Leukaemia

Velcade
    Dosage: 1.3 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia

Vincristine
    Dosage: 1.5 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia



Possible Hydrocortisone side effects in

Reported by a physician from United States on 2012-08-15

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Cytarabine
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia

Dexamethasone
    Dosage: 10 mg/m2, cyclic
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia

Doxorubicin Hydrochloride
    Dosage: 60 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia

Hydrocortisone
    Indication: Acute Lymphocytic Leukaemia

Methotrexate
    Dosage: unk, cyclic
    Indication: Acute Lymphocytic Leukaemia

PEG-Asparaginase
    Dosage: unk, cyclic
    Indication: Acute Lymphocytic Leukaemia

Velcade
    Dosage: 1.3 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia

Vincristine
    Dosage: 1.5 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia



Possible Hydrocortisone side effects in

Reported by a physician from United States on 2012-08-15

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Cytarabine
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia

Decadron
    Dosage: 10 mg/m2, cyclic
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia

Doxorubicin Hydrochloride
    Dosage: 60 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia

Hydrocortisone
    Indication: Acute Lymphocytic Leukaemia

Methotrexate
    Dosage: unk, cyclic
    Indication: Acute Lymphocytic Leukaemia

Oncaspar
    Dosage: unk, cyclic
    Indication: Acute Lymphocytic Leukaemia

Velcade
    Dosage: 1.3 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia

Vincristine
    Dosage: 1.5 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia



Possible Hydrocortisone side effects in

Reported by a physician from United States on 2012-08-14

Patient:

Reactions: Thrombosis, Abdominal Pain, Hyperkalaemia, Hypoglycaemia, Coagulopathy, Hypoxia, Hypocalcaemia, Hiccups, Alanine Aminotransferase Abnormal, Cough, Pneumonitis, Pain in Extremity, Hyperglycaemia, Hypotension, External Ear Pain, Haematotoxicity, Dehydration, Lower Gastrointestinal Haemorrhage, Hypofibrinogenaemia, Aspartate Aminotransferase Abnormal, Hypokalaemia, Neuropathy Peripheral, Blood Bilirubin Abnormal, Pleural Effusion, Decreased Appetite, Hyponatraemia, Gamma-Glutamyltransferase Abnormal, Hypercalcaemia, Hypophosphataemia, Diarrhoea, Hypoalbuminaemia, Hypertension, Infection

Adverse event resulted in: hospitalization

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

Other drugs received by patient: Levofloxacin; Vancomycin; Posaconazole; Voriconazole



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

Reported by a physician from United States on 2012-08-14

Patient:

Reactions: Multi-Organ Failure, 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 2012-08-14

Patient:

Reactions: 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

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

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 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

Dexamethasone
    Dosage: 10 mg/m2/day divided in to 2 doses for 24 consecutive days
    Administration route: Oral
    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
    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

Hydrocortisone
    Dosage: on days 8, 15 and 22

Hydrocortisone
    Dosage: on days 8, 15 and 22
    Indication: Acute Lymphocytic Leukaemia

Hydrocortisone
    Dosage: on days 8, 15 and 22

Hydrocortisone
    Dosage: on days 8, 15 and 22

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
    Indication: Acute Lymphocytic Leukaemia

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
    Indication: Acute Lymphocytic Leukaemia

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



Possible Hydrocortisone side effects in female

Reported by a physician from Germany on 2012-08-10

Patient: female

Reactions: Cellulitis, C-Reactive Protein Increased, Necrosis, Lymphangitis, Aplastic Anaemia, Skin Necrosis, Empyema, Thermal Burn, White Blood Cell Count Increased

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Humira
    Indication: Rheumatoid Arthritis
    Start date: 2005-12-01
    End date: 2006-12-01

Hydrocortisone
    Indication: Rheumatoid Arthritis

Methotrexate
    Administration route: Oral
    Start date: 2007-06-19

Methotrexate
    Indication: Rheumatoid Arthritis
    Start date: 2005-12-01
    End date: 2006-12-01

Other drugs received by patient: Prednisolone; Etanercept



Possible Hydrocortisone side effects in 10 month old male

Reported by a physician from United States on 2012-08-10

Patient: 10 month old male, weighing 10.6 kg (23.3 pounds)

Reactions: Skin Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Indication: Acute Lymphocytic Leukaemia
    End date: 2012-07-02

Cytarabine
    Indication: Acute Lymphocytic Leukaemia
    End date: 2012-07-11

Daunorubicin HCL
    Indication: Acute Lymphocytic Leukaemia
    End date: 2012-06-29

Dexamethasone
    Dosage: 140 milligram daily; 2.5 mg bid day 1-7 + 15-21
    Indication: Acute Lymphocytic Leukaemia
    End date: 2012-07-18

Hydrocortisone
    Indication: Acute Lymphocytic Leukaemia
    End date: 2012-07-11

Lestaurtinib
    Dosage: 50 milligram daily; 5mg/kg/day;day5-day20;25mg bid
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-04-02
    End date: 2012-07-17

Methotrexate
    Indication: Acute Lymphocytic Leukaemia
    End date: 2012-07-11

Pegaspargase
    Indication: Acute Lymphocytic Leukaemia
    End date: 2012-07-01

Vincristine
    Dosage: wk#10-0.5 mg;#11-0.3 mg;#12-0.5 mg
    Indication: Acute Lymphocytic Leukaemia
    End date: 2012-07-11



Possible Hydrocortisone side effects in 65 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-06

Patient: 65 year old male

Reactions: Pancreatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Hydrocortisone
    Dosage: 50 mg, 4x/day
    Start date: 2012-06-09
    End date: 2012-06-14

Lasix
    Dosage: 20 mg, 3x/day
    Start date: 2012-06-12
    End date: 2012-06-14

Vfend
    Dosage: 400 mg daily
    Indication: Aspergillosis
    Start date: 2012-06-11
    End date: 2012-06-14

Other drugs received by patient: Bactrim; Amikacin; Methylprednisolone; Bactrim; Captopril; Cell Cept; Piperacillin and Tazobactam; Terbutaline; Cell Cept



Possible Hydrocortisone side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-02

Patient: female, weighing 91.0 kg (200.2 pounds)

Reactions: Lyme Disease

Drug(s) suspected as cause:
Cortef
    Dosage: 20 mg in morning, 5mg at 2pm
    Administration route: Oral
    Indication: Hypopituitarism
    Start date: 2009-01-01

Hydrocortisone
    Dosage: 20 mg in morning and 5mg at 2pm
    Administration route: Oral
    Indication: Hypopituitarism
    Start date: 2009-01-01

Levothyroxine Sodium
    Dosage: 50 ug, 1x/day
    Administration route: Oral
    Indication: Hypothyroidism
    Start date: 2009-01-01

Synthroid
    Dosage: 50 ug, 1x/day
    Administration route: Oral
    Indication: Hypothyroidism
    Start date: 2009-01-01

Other drugs received by patient: Calcium Carbonate / Ergocalciferol; Albuterol; Theophylline; Zyrtec; Fluticasone Propionate; Alpha Lipoic Acid; Iron; Coenzyme Q10; Lactobacillus Acidophilus; Diflucan

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