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Hydrocortisone (Hydrocortisone Topical) - Sepsis - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Sepsis (15)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Hydrocortisone (Hydrocortisone Topical) where reactions include sepsis. 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 2012-08-14

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 18 month old male

Reported by a physician from United States on 2012-07-06

Patient: 18 month old male, weighing 11.4 kg (25.1 pounds)

Reactions: Sepsis, Febrile Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Asparaginase
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-04-18

Cyclophosphamide
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-04-18

Dexamethasone Sodium Phosphate
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-04-18

Dexamethasone Sodium Phosphate

Etoposide
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-04-18

Hydrocortisone
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-04-18

Lestaurtinib
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-04-18

Lestaurtinib

Mercaptopurine

Mercaptopurine
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-04-18

Methotrexate
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-04-18

Methotrexate

Vincristine

Vincristine
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-04-18



Possible Hydrocortisone side effects in 10 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-21

Patient: 10 year old female

Reactions: Small Intestinal Obstruction, Renal Failure, Sepsis, Febrile Neutropenia, Hypertension, Abdominal Compartment Syndrome

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: six doses as part of copadm1 and six doses as part of dose-reduced copadm2

Cyclophosphamide
    Dosage: 300 mg/m2 as part of cop
    Indication: Burkitt's Lymphoma Stage III

Cytarabine
    Dosage: continuous infusion of 100 mg/m2 daily for 5 days
    Indication: Burkitt's Lymphoma Stage III

Cytarabine
    Dosage: administered once with hydrocortisone as part of cym1

Doxorubicin HCL
    Dosage: as part of copadm1
    Indication: Burkitt's Lymphoma Stage III

Doxorubicin HCL
    Dosage: as part of copadm2

Hydrocortisone
    Dosage: administered once with cytarabine as part of cym1

Hydrocortisone
    Dosage: administered with methotrexate
    Indication: Burkitt's Lymphoma Stage III

Methotrexate
    Dosage: as part of copadm2 and cym1

Methotrexate
    Dosage: administered with hydrocortisone
    Indication: Burkitt's Lymphoma Stage III

Methotrexate
    Dosage: as part of copadm1

Prednisolone
    Dosage: 60 mg/m2/day for 7 days as part of cop
    Indication: Burkitt's Lymphoma Stage III

Prednisolone
    Dosage: 60 mg/m2/day for 5 days, then tapered over 3 days as part of copadm1 and copadm2

Rituximab
    Dosage: five total doses; cumulative dose of 1875 mg/m2
    Indication: Burkitt's Lymphoma Stage III

Vincristine
    Dosage: as part of copadm2

Vincristine
    Dosage: as part of copadm1

Vincristine
    Dosage: as part of cop
    Indication: Burkitt's Lymphoma Stage III



Possible Hydrocortisone side effects in 10 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-21

Patient: 10 year old female

Reactions: Small Intestinal Obstruction, Renal Failure, Sepsis, Febrile Neutropenia, Hypertension, Abdominal Compartment Syndrome

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: six doses as part of copadm1 and six doses as part of dose-reduced copadm2

Cyclophosphamide
    Dosage: 300 mg/m2 as part of cop
    Indication: Burkitt's Lymphoma Stage III

Cytarabine
    Dosage: continuous infusion of 100 mg/m2 daily for 5 days
    Indication: Burkitt's Lymphoma Stage III

Cytarabine
    Dosage: administered once with hydrocortisone as part of cym1

Doxorubicin HCL
    Dosage: as part of copadm1
    Indication: Burkitt's Lymphoma Stage III

Doxorubicin HCL
    Dosage: as part of copadm2

Hydrocortisone
    Dosage: administered with methotrexate
    Indication: Burkitt's Lymphoma Stage III

Hydrocortisone
    Dosage: administered once with cytarabine as part of cym1

Methotrexate
    Dosage: 3000 mg/m2; administered with hydrocortisone
    Indication: Burkitt's Lymphoma Stage III

Methotrexate
    Dosage: as part of copadm1

Methotrexate
    Dosage: as part of copadm2 and cym1

Prednisolone
    Dosage: 60 mg/m2/day for 5 days, then tapered over 3 days as part of copadm1 and copadm2

Prednisolone
    Dosage: 60 mg/m2/day for 7 days as part of cop
    Indication: Burkitt's Lymphoma Stage III

Rituximab
    Dosage: five total doses; cumulative dose of 1875 mg/m2
    Indication: Burkitt's Lymphoma Stage III

Vincristine
    Dosage: as part of copadm1

Vincristine
    Dosage: as part of copadm2

Vincristine
    Dosage: as part of cop
    Indication: Burkitt's Lymphoma Stage III



Possible Hydrocortisone side effects in 10 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-21

Patient: 10 year old female

Reactions: Small Intestinal Obstruction, Renal Failure, Sepsis, Febrile Neutropenia, Hypertension, Abdominal Compartment Syndrome

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: 300 mg/m2 as part of cop
    Indication: Burkitt's Lymphoma Stage III

Cyclophosphamide
    Dosage: six doses as part of copadm1 and six doses as part of dose-reduced copadm2

Cytarabine
    Dosage: continuous infusion of 100 mg/m2 daily for 5 days
    Indication: Burkitt's Lymphoma Stage III

Cytarabine
    Dosage: administered once with hydrocortisone as part of cym1

Doxorubicin HCL
    Dosage: as part of copadm1
    Indication: Burkitt's Lymphoma Stage III

Doxorubicin HCL
    Dosage: as part of copadm2

Hydrocortisone
    Dosage: administered once with cytarabine as part of cym1

Hydrocortisone
    Dosage: administered with methotrexate
    Indication: Burkitt's Lymphoma Stage III

Methotrexate
    Dosage: as part of copadm1

Methotrexate
    Dosage: as part of copadm2 and cym1

Methotrexate
    Dosage: administered with hydrocortisone
    Indication: Burkitt's Lymphoma Stage III

Prednisolone
    Dosage: 60 mg/m2/day for 5 days, then tapered over 3 days as part of copadm1 and copadm2

Prednisolone
    Dosage: 60 mg/m2/day for 7 days as part of cop
    Indication: Burkitt's Lymphoma Stage III

Rituximab
    Dosage: five total doses; cumulative dose of 1875 mg/m2
    Indication: Burkitt's Lymphoma Stage III

Vincristine
    Dosage: as part of copadm2

Vincristine
    Dosage: as part of cop
    Indication: Burkitt's Lymphoma Stage III

Vincristine
    Dosage: as part of copadm1



Possible Hydrocortisone side effects in 10 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-20

Patient: 10 year old female

Reactions: Small Intestinal Obstruction, Renal Failure, Sepsis, Pancytopenia, Febrile Neutropenia, Hypertension, Abdominal Compartment Syndrome

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: 250 mg/m2, bid for 6 doses

Cyclophosphamide
    Dosage: 250 mg/m2, bid for 6 doses

Cyclophosphamide
    Dosage: 300 mg/m2, unk
    Indication: Burkitt's Lymphoma Stage III

Cytarabine
    Dosage: 100 mg/m2, for 5 days
    Indication: Burkitt's Lymphoma Stage III

Cytarabine
    Dosage: unknown

Doxorubicin HCL
    Dosage: 30 mg/m2, unk

Doxorubicin HCL
    Dosage: 60 mg/m2, unk
    Indication: Burkitt's Lymphoma Stage III

Hydrocortisone
    Indication: Burkitt's Lymphoma Stage III

Hydrocortisone
    Dosage: intrathecally twice

Hydrocortisone

Hydrocortisone
    Dosage: intrathecally twice

Hydrocortisone
    Dosage: unknwon

Methotrexate
    Dosage: 1500 mg/m2, unk

Methotrexate
    Indication: Burkitt's Lymphoma Stage III

Methotrexate
    Dosage: intrathecally twice

Methotrexate
    Dosage: intrathecally twice

Methotrexate
    Dosage: 1500 mg/m2, unk

Methotrexate
    Dosage: 30000 mg/m2, unk

Methotrexate

Prednisolone
    Dosage: 60 mg/m2, for 5 days, then taper over 3 days

Prednisolone
    Dosage: 60 mg/m2, for 5 days then taper over 3 days

Prednisolone
    Dosage: 60 mg/m2, per day for 7 days
    Indication: Burkitt's Lymphoma Stage III

Rituximab
    Dosage: every 2-4 weeks for 5 total doses with cumulative dose of 1875 mg/m2
    Indication: Burkitt's Lymphoma Stage III

Rituximab
    Dosage: cumulative dose of 1875 mg/m2

Vincristine
    Dosage: 2 mg/m2, unk

Vincristine
    Dosage: 1 mg/m2, unk
    Indication: Burkitt's Lymphoma Stage III

Vincristine
    Dosage: 1 mg/m2, unk



Possible Hydrocortisone side effects in 18 year old male

Reported by a physician from United States on 2012-05-10

Patient: 18 year old male, weighing 126.4 kg (278.1 pounds)

Reactions: Abdominal Pain, White Blood Cell Count Decreased, Hypotension, Hyponatraemia, Acidosis, Capillary Leak Syndrome, Sepsis, Platelet Count Decreased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Cytarabine
    Dosage: 70 mg, cyclic
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2012-02-24

Doxorubicin HCL
    Dosage: 60 mg/m2, cyclic
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2012-02-24
    End date: 2012-02-24

Hydrocortisone
    Dosage: unk
    Indication: B Precursor Type Acute Leukaemia

Methotrexate
    Dosage: unk
    Indication: B Precursor Type Acute Leukaemia

Pegaspargase
    Dosage: 2500 iu, cyclic
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2012-02-25
    End date: 2012-03-02

Prednisone TAB
    Dosage: 50 mg, bid
    Administration route: Oral
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2012-02-24
    End date: 2012-03-04

Velcade
    Dosage: 1.3 mg/m2, cyclic
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2012-02-24
    End date: 2012-03-02

Vincristine
    Dosage: 2 mg, cyclic
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2012-02-24
    End date: 2012-03-02



Possible Hydrocortisone side effects in 10 year old female

Reported by a individual with unspecified qualification from United States on 2012-04-26

Patient: 10 year old female

Reactions: Renal Failure, Sepsis, Febrile Neutropenia, Hypertension, Abdominal Compartment Syndrome

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: regimen copadm1, for 6 doses

Cyclophosphamide
    Dosage: regimen cop
    Indication: Burkitt's Lymphoma

Cyclophosphamide
    Dosage: regimen copadm2, for 6 doses

Cytarabine
    Dosage: regimen cym1,continuous infusion daily for 5 days
    Indication: Burkitt's Lymphoma

Doxorubicin HCL
    Dosage: regimen copadm2

Doxorubicin HCL
    Dosage: regimen copadm1
    Indication: Burkitt's Lymphoma

Hydrocortisone
    Dosage: regimen cym1, methotrexate/hydrocortisone once and cytarabine/hydrocortisone once

Hydrocortisone
    Dosage: regimen copadm2, methotrexate/hydrocortisone twice

Hydrocortisone
    Dosage: regimen cop, methotrexate/hydrocortisone
    Indication: Burkitt's Lymphoma

Hydrocortisone
    Dosage: regimen copadm1, methotrexate/hydrocortisone twice

Methotrexate
    Dosage: regimen copadm2

Methotrexate
    Dosage: regimen copadm1,
    Indication: Burkitt's Lymphoma

Methotrexate
    Dosage: regimen cym1

Prednisolone
    Dosage: regimen copadm1, for 5 days then taper over 3 days

Prednisolone
    Dosage: regimen copadm2, for 5 days then taper over 3 days

Prednisolone
    Dosage: regimen cop, for 7 days
    Indication: Burkitt's Lymphoma

Rituximab
    Dosage: every 2-4 weeks for 5 total doses, starting between copadm1 and copadm2
    Indication: Burkitt's Lymphoma

Vincristine
    Dosage: regimen copadm1

Vincristine
    Dosage: regimen cop
    Indication: Burkitt's Lymphoma

Vincristine
    Dosage: regimen copadm2



Possible Hydrocortisone side effects in 18 year old male

Reported by a consumer/non-health professional from United States on 2012-04-13

Patient: 18 year old male, weighing 126.4 kg (278.1 pounds)

Reactions: Abdominal Pain, White Blood Cell Count Decreased, Hypotension, Hyponatraemia, Acidosis, Capillary Leak Syndrome, Sepsis, Platelet Count Decreased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Cytarabine
    Dosage: 70 mg, cyclic
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2012-02-24

Doxorubicin HCL
    Dosage: 60 mg/m2, cyclic
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2012-02-24
    End date: 2012-02-24

Hydrocortisone
    Dosage: unk
    Indication: B Precursor Type Acute Leukaemia

Methotrexate
    Dosage: unk
    Indication: B Precursor Type Acute Leukaemia

Pegaspargase
    Dosage: 2500 iu, cyclic
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2012-02-25
    End date: 2012-03-02

Prednisone TAB
    Dosage: 50 mg, bid
    Administration route: Oral
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2012-02-24
    End date: 2012-03-04

Velcade
    Dosage: 1.3 mg/m2, cyclic
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2012-02-24
    End date: 2012-03-02

Vincristine
    Dosage: 2 mg, cyclic
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2012-02-24
    End date: 2012-03-02



Possible Hydrocortisone side effects in 18 year old male

Reported by a consumer/non-health professional from United States on 2012-03-13

Patient: 18 year old male, weighing 126.4 kg (278.1 pounds)

Reactions: Abdominal Pain, White Blood Cell Count Decreased, Hypotension, Hyponatraemia, Acidosis, Capillary Leak Syndrome, Sepsis, Platelet Count Decreased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Cytarabine
    Dosage: 70 mg, cyclic
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2012-02-24

Doxorubicin HCL
    Dosage: 60 mg/m2, cyclic
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2012-02-24
    End date: 2012-02-24

Hydrocortisone
    Dosage: unk
    Indication: B Precursor Type Acute Leukaemia

Methotrexate
    Dosage: unk
    Indication: B Precursor Type Acute Leukaemia

Pegaspargase
    Dosage: 2500 iu, cyclic
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2012-02-24
    End date: 2012-03-02

Prednisone TAB
    Dosage: 20 mg/m2, cyclic
    Administration route: Oral
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2012-02-24
    End date: 2012-03-04

Velcade
    Dosage: 1.3 mg/m2, cyclic
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2012-02-24
    End date: 2012-03-02

Vincristine
    Dosage: 1.5 mg/m2, cyclic
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2012-02-24
    End date: 2012-03-02



Possible Hydrocortisone side effects in 10 year old female

Reported by a consumer/non-health professional from United States on 2012-03-09

Patient: 10 year old female, weighing 20.8 kg (45.8 pounds)

Reactions: Abdominal Pain, Confusional State, Lung Infection, Headache, Peripheral Sensory Neuropathy, Caecitis, Hypokalaemia, Fungaemia, Hypoxia, Clostridial Infection, Back Pain, Rash Pustular, Vomiting, Nausea, Pain in Extremity, Lung Neoplasm, Hypotension, Febrile Neutropenia, Pancytopenia, Hyponatraemia, Hypophosphataemia, Diarrhoea, NO Therapeutic Response, Sepsis, Hypophagia, Respiratory Tract Infection, Enterocolitis Infectious, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cytarabine
    Dosage: unk
    Indication: B Precursor Type Acute Leukaemia
    End date: 2011-12-29

Doxorubicin HCL
    Dosage: 60 mg/m2, cyclic
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2011-12-14
    End date: 2011-12-14

Hydrocortisone
    Dosage: unk
    Indication: B Precursor Type Acute Leukaemia
    End date: 2011-12-29

Methotrexate
    Dosage: unk
    Indication: B Precursor Type Acute Leukaemia
    End date: 2011-12-29

Pegaspargase
    Dosage: unk
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2011-12-15
    End date: 2011-12-29

Prednisone
    Dosage: 20 mg/m2, cyclic
    Administration route: Oral
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2011-12-14
    End date: 2011-12-27

Velcade
    Dosage: 1.3 mg/m2, cyclic
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2011-12-14
    End date: 2011-12-17

Vincristine
    Dosage: 1.5 mg/m2, cyclic
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2011-12-14
    End date: 2011-12-29



Possible Hydrocortisone side effects in 35 year old

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-10-28

Patient: 35 year old

Reactions: Hypophosphataemia, Rhabdomyolysis, Hyperkalaemia, Staphylococcal Infection, Sepsis, Acidosis, Renal Failure Acute

Drug(s) suspected as cause:
Gabapentin
    Dosage: unk ukn, unk

H2 Antagonist
    Dosage: unk ukn, unk

Hydrocortisone
    Dosage: unk ukn, unk

Morphine
    Dosage: unk ukn, unk

Propofol
    Dosage: unk ukn, unk



Possible Hydrocortisone side effects in 17 year old

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-07

Patient: 17 year old

Reactions: Epidural Lipomatosis, Sepsis, Acute Myeloid Leukaemia Recurrent

Drug(s) suspected as cause:
Hydrocortisone

Other drugs received by patient: (Chemotherapeutics)



Possible Hydrocortisone side effects in 90 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-04

Patient: 90 year old male

Reactions: Orthostatic Hypotension, Death, Haematocrit Decreased, Pleural Effusion, Drug Administration Error, Hypoxia, Blood Creatinine Increased, Blood Glucose Increased, Hydronephrosis, Dyspnoea, Urinary Tract Infection, Renal Failure, Sepsis, Dehydration, Gait Disturbance, Asthenia

Adverse event resulted in: death

Drug(s) suspected as cause:
Doxazosin Mesylate
    Indication: Bladder Disorder

Hydrocortisone
    Indication: Prostate Cancer

Other drugs received by patient: Carvedilol; Ketoconazole

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