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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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