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Baraclude (Entecavir) - Life Threatening Events - Suspected Cause - Side Effect Reports

 
 



Index of reports > Life Threatening Events (8)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Baraclude (Entecavir) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Baraclude side effects in 66 year old male

Reported by a physician from Japan on 2012-07-20

Patient: 66 year old male

Reactions: Pneumonia, Interstitial Lung Disease

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Adriamycin PFS
    Dosage: 40 mg/m2, unk
    Start date: 2010-12-22
    End date: 2010-12-22

Zovirax
    Dosage: unk
    Start date: 2011-06-30
    End date: 2011-07-08

Adriamycin PFS
    Dosage: 30 mg/m2, unk
    Start date: 2010-10-14
    End date: 2010-10-14

Allopurinol
    Dosage: 100 mg, 3x/day
    Administration route: Oral
    Start date: 2011-07-05
    End date: 2011-07-19

Adriamycin PFS
    Dosage: 30 mg/m2, unk
    Start date: 2010-11-24
    End date: 2010-11-24

Adriamycin PFS
    Dosage: 30 mg/m2, unk
    Start date: 2010-12-29
    End date: 2010-12-29

Vancomycin
    Dosage: 0.5 g, 2x/day
    Start date: 2011-01-07
    End date: 2011-01-17

Cymerin
    Dosage: 60 mg/m2, unk
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-10-14
    End date: 2010-12-29

Carboplatin
    Dosage: 250 mg/m2, unk
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-10-26
    End date: 2010-12-08

Sulfamethoxazole and Trimethoprim
    Dosage: 1 df, 1x/day
    Administration route: Oral
    Start date: 2011-07-15

Pantosin
    Dosage: unk
    Administration route: Oral
    Indication: Constipation
    Start date: 2011-01-07
    End date: 2011-01-10

Adriamycin PFS
    Dosage: 40 mg/m2, unk
    Start date: 2010-11-16
    End date: 2010-11-16

Methotrexate Sodium
    Dosage: 15 mg, daily
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-11-18
    End date: 2010-11-18

KW-0761
    Dosage: 1 mg/kg, unk
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-10-08
    End date: 2010-12-21

Lansoprazole
    Dosage: 15 mg, 1x/day
    Administration route: Oral
    Start date: 2011-05-26
    End date: 2011-07-19

Allopurinol
    Dosage: 100 mg, 1x/day
    Administration route: Oral
    Indication: Hyperuricaemia
    End date: 2011-01-20

Lyrica
    Dosage: 75 mg, 1x/day
    Administration route: Oral
    Indication: Pain
    Start date: 2011-06-29
    End date: 2011-07-19

Sulfamethoxazole and Trimethoprim
    Dosage: 1 df, 1x/day
    Administration route: Oral
    Indication: Antifungal Prophylaxis
    End date: 2011-01-28

Fentanyl
    Dosage: unk
    Indication: Stomatitis
    Start date: 2011-01-02
    End date: 2011-01-19

Magmitt
    Dosage: unk
    Administration route: Oral
    Indication: Constipation
    Start date: 2011-01-07
    End date: 2011-01-10

Adriamycin PFS
    Dosage: 40 mg/m2, unk
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-10-07
    End date: 2010-10-07

Diflucan
    Dosage: 100 mg, 1x/day
    Administration route: Oral
    Indication: Antifungal Prophylaxis
    End date: 2011-01-11

Prednisolone
    Dosage: 40 mg/m2, unk
    Administration route: Oral
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-10-07
    End date: 2010-12-29

Zovirax
    Dosage: 200 mg, 1x/day
    Administration route: Oral
    Indication: Prophylaxis
    End date: 2011-01-28

Zovirax
    Dosage: 200 mg, 1x/day
    Administration route: Oral
    Start date: 2011-07-12
    End date: 2011-07-19

Lipidil
    Dosage: 100 df, 1x/day
    Administration route: Oral
    Indication: Hyperlipidaemia
    End date: 2011-01-26

Meropenem
    Dosage: 0.5 g, 2x/day
    Indication: Pneumonia
    Start date: 2011-01-07
    End date: 2011-01-24

Baraclude
    Dosage: 0.5 mg, 1/2day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2010-06-29
    End date: 2011-07-19

Amlodipine
    Dosage: 5 mg, 1x/day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-10-08
    End date: 2011-02-17

Oncovin
    Dosage: 1 mg/m2, unk
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-10-07
    End date: 2010-12-22

Etoposide
    Dosage: 100 mg/m2, 3x/day
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-10-26
    End date: 2010-12-08

Cefazolin Sodium
    Dosage: unk
    Administration route: Oral
    Indication: Proctitis
    Start date: 2010-10-22
    End date: 2011-02-17

Diflucan
    Dosage: unk
    Start date: 2011-01-19
    End date: 2011-01-28

Cyclophosphamide
    Dosage: 350 mg/m2, unk
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-10-07
    End date: 2010-12-22

Fildesin
    Dosage: 2.4 mg/m2, unk
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-10-26
    End date: 2010-12-08

Cytarabine
    Dosage: 40 mg, daily
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-11-18
    End date: 2010-11-18

Prednisolone
    Dosage: 10 mg, daily
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-11-18
    End date: 2010-11-18

Lansoprazole
    Dosage: 15 mg, 1x/day
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    End date: 2011-02-17

Meropenem
    Dosage: 1 g, 3x/day
    Start date: 2011-07-04
    End date: 2011-07-15

Other drugs received by patient: Vfend; Targocid; Slow-K; Ciprofloxacin HCL



Possible Baraclude side effects in 61 year old male

Reported by a consumer/non-health professional from Japan on 2012-05-23

Patient: 61 year old male

Reactions: Hepatic Neoplasm Malignant

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Baraclude



Possible Baraclude side effects in 61 year old male

Reported by a consumer/non-health professional from Japan on 2012-05-21

Patient: 61 year old male

Reactions: Hepatic Neoplasm Malignant

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Baraclude



Possible Baraclude side effects in 71 year old female

Reported by a physician from Japan on 2012-03-15

Patient: 71 year old female, weighing 45.0 kg (99.0 pounds)

Reactions: Hepatitis Fulminant

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Decadron
    Administration route: Oral
    Indication: Chemotherapy
    Start date: 2011-09-22

Baraclude
    Administration route: Oral
    Indication: Viral Hepatitis Carrier
    Start date: 2011-01-06
    End date: 2012-02-02

Januvia
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2011-12-22
    End date: 2012-02-02

Promacta
    Administration route: Oral
    Indication: Chemotherapy
    Start date: 2011-12-22
    End date: 2012-02-02

Other drugs received by patient: Gemcitabine



Possible Baraclude side effects in 60 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-12-07

Patient: 60 year old male

Reactions: Hepatic Neoplasm Malignant

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Baraclude

Other drugs received by patient: Losartan Potassium; Vitamedin; Lendormin; Amlodipine; Intron A; Selbex; Urso 250; Feron



Possible Baraclude side effects in

Reported by a pharmacist from United States on 2011-11-02

Patient:

Reactions: Pneumonia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Baraclude
    Indication: Hepatitis B

Reyataz
    Indication: HIV Infection

Other drugs received by patient: Efavirenz; Isentress



Possible Baraclude side effects in male

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-11-01

Patient: male

Reactions: Pneumonia, Renal Disorder, Interstitial Lung Disease, Platelet Count Decreased, Herpes Zoster

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Diflucan
    Administration route: Oral
    Indication: Antifungal Prophylaxis
    End date: 2011-01-11

Prednisolone
    Dosage: 10 milligram/sq.meter
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-11-18
    End date: 2010-11-18

Zovirax
    Administration route: Oral
    Indication: Prophylaxis
    End date: 2011-01-28

Oncovin
    Dosage: 1 milligram/sq.meter
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-10-07
    End date: 2010-12-22

Cyclophosphamide
    Dosage: 350 milligram/sq.meter
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-10-07
    End date: 2010-12-22

Cymerin
    Dosage: 60 milligram/sq.meter
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-10-14
    End date: 2010-12-29

Doxorubicin Hydrochloride
    Dosage: 30 milligram/sq.meter
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-12-29
    End date: 2010-12-29

Doxorubicin Hydrochloride
    Dosage: 40 milligram/sq.meter
    Start date: 2010-11-16
    End date: 2010-11-16

Zovirax
    Administration route: Oral
    Start date: 2011-07-12
    End date: 2011-07-19

Lyrica
    Administration route: Oral
    Indication: Pain
    Start date: 2011-06-29
    End date: 2011-07-19

Doxorubicin Hydrochloride
    Dosage: 30 milligram/sq.meter
    Start date: 2010-10-14
    End date: 2010-10-14

Doxorubicin Hydrochloride
    Dosage: 30 milligram/sq.meter
    Start date: 2010-11-24
    End date: 2010-11-24

Allopurinol
    Administration route: Oral
    Indication: Prophylaxis
    End date: 2011-01-20

Other Antitumor Agents
    Dosage: 1 milligram/kilogram
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-10-08
    End date: 2010-12-21

Cefazolin Sodium
    Indication: Proctitis
    Start date: 2010-10-22
    End date: 2011-02-17

Fildesin
    Dosage: 2.4 milligram/sq.meter
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-10-26
    End date: 2010-12-08

Etoposide
    Dosage: 100 milligram/sq.meter
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-10-26
    End date: 2010-12-08

Doxorubicin Hydrochloride
    Dosage: 40 milligram/sq.meter
    Start date: 2010-12-22
    End date: 2010-12-22

Doxorubicin Hydrochloride
    Dosage: 40 milligram/sq.meter
    Start date: 2010-10-07
    End date: 2010-10-07

Meropenem
    Indication: Pneumonia
    Start date: 2011-01-07
    End date: 2011-01-24

Meropenem
    Start date: 2011-07-04
    End date: 2011-07-15

Vancomycin Hychloride
    Indication: Pneumonia
    Start date: 2011-01-07
    End date: 2011-01-17

Allopurinol
    Administration route: Oral
    Start date: 2011-07-05
    End date: 2011-07-19

Carboplatin
    Dosage: 250 milligram/sq.meter
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-10-26
    End date: 2010-12-08

Methotrexate
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-11-18
    End date: 2010-11-18

Cytarabine
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-11-18
    End date: 2010-11-18

Pantosin
    Administration route: Oral
    Indication: Constipation
    Start date: 2011-01-07
    End date: 2011-01-10

Fentanyl Citrate
    Indication: Stomatitis
    Start date: 2011-01-02
    End date: 2011-01-19

Lansoprazole
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    End date: 2011-02-17

Lipidil
    Administration route: Oral
    Indication: Hyperlipidaemia
    End date: 2011-01-26

Prednisolone
    Dosage: 40 milligram/sq.meter
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-10-07
    End date: 2010-12-29

Magmitt
    Administration route: Oral
    Indication: Constipation
    Start date: 2011-01-07
    End date: 2011-01-10

Baraclude
    Indication: Hepatitis B
    Start date: 2011-06-29
    End date: 2011-07-19

Amlodipine
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-10-08
    End date: 2011-02-17

Lansoprazole
    Administration route: Oral
    Start date: 2011-05-26
    End date: 2011-07-19

Sulfamethoxazole
    Administration route: Oral
    Indication: Antifungal Prophylaxis
    End date: 2011-01-28

Sulfamethoxazole
    Administration route: Oral
    Start date: 2011-07-15

Other drugs received by patient: Targocid; Vfend; Slow-K; Ciprofloxacin HCL



Possible Baraclude side effects in 66 year old male

Reported by a physician from Japan on 2011-10-24

Patient: 66 year old male

Reactions: Pneumonia, Interstitial Lung Disease

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Cytarabine
    Dosage: 40 mg, daily
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-11-18
    End date: 2010-11-18

Sulfamethoxazole
    Dosage: 1 df, 1x/day
    Administration route: Oral
    Start date: 2011-07-15

Zovirax
    Dosage: 200 mg, 1x/day
    Administration route: Oral
    Start date: 2011-07-12
    End date: 2011-07-19

Meropenem
    Dosage: 1 g, 3x/day
    Start date: 2011-07-04
    End date: 2011-07-15

Doxorubicin Hydrochloride
    Dosage: 30 mg/m2, unk
    Start date: 2010-11-24
    End date: 2010-11-24

Sulfamethoxazole
    Dosage: 1 df, 1x/day
    Administration route: Oral
    Indication: Antifungal Prophylaxis
    End date: 2011-01-28

Allopurinol
    Dosage: 100 mg, 3x/day
    Administration route: Oral
    Start date: 2011-07-05
    End date: 2011-07-19

Fentanyl
    Dosage: unk
    Indication: Stomatitis
    Start date: 2011-01-02
    End date: 2011-01-19

Magmitt
    Dosage: unk
    Administration route: Oral
    Indication: Constipation
    Start date: 2011-01-07
    End date: 2011-01-10

Prednisolone
    Dosage: 10 mg, daily
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-11-18
    End date: 2010-11-18

Lansoprazole
    Dosage: 15 mg, 1x/day
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    End date: 2011-02-17

Cefazolin Sodium
    Dosage: unk
    Administration route: Oral
    Indication: Proctitis
    Start date: 2010-10-22
    End date: 2011-02-17

Baraclude
    Dosage: 0.5 mg, 1/2day
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2010-06-29
    End date: 2011-07-19

Oncovin
    Dosage: 1 mg/m2, unk
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-10-07
    End date: 2010-12-22

Cymerin
    Dosage: 60 mg/m2, unk
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-10-14
    End date: 2010-12-29

Etoposide
    Dosage: 100 mg/m2, 3x/day
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-10-26
    End date: 2010-12-08

Allopurinol
    Dosage: 100 mg, 1x/day
    Administration route: Oral
    Indication: Hyperuricaemia
    End date: 2011-01-20

Pantosin
    Dosage: unk
    Administration route: Oral
    Indication: Constipation
    Start date: 2011-01-07
    End date: 2011-01-10

Doxorubicin Hydrochloride
    Dosage: 30 mg/m2, unk
    Start date: 2010-12-29
    End date: 2010-12-29

Prednisolone
    Dosage: 40 mg/m2, unk
    Administration route: Oral
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-10-07
    End date: 2010-12-29

Fildesin
    Dosage: 2.4 mg/m2, unk
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-10-26
    End date: 2010-12-08

Doxorubicin Hydrochloride
    Dosage: 30 mg/m2, unk
    Start date: 2010-10-14
    End date: 2010-10-14

Doxorubicin Hydrochloride
    Dosage: 40 mg/m2, unk
    Start date: 2010-12-22
    End date: 2010-12-22

Methotrexate Sodium
    Dosage: 15 mg, daily
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-11-18
    End date: 2010-11-18

Amlodipine
    Dosage: 5 mg, 1x/day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-10-08
    End date: 2011-02-17

Diflucan
    Dosage: 100 mg, 1x/day
    Administration route: Oral
    Indication: Antifungal Prophylaxis
    End date: 2011-01-11

KW-0761
    Dosage: 1 mg/kg, unk
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-10-08
    End date: 2010-12-21

Cyclophosphamide
    Dosage: 350 mg/m2, unk
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-10-07
    End date: 2010-12-22

Lansoprazole
    Dosage: 15 mg, 1x/day
    Administration route: Oral
    Start date: 2011-05-26
    End date: 2011-07-19

Doxorubicin Hydrochloride
    Dosage: 40 mg/m2, unk
    Start date: 2010-11-16
    End date: 2010-11-16

Diflucan
    Dosage: unk
    Start date: 2011-01-19
    End date: 2011-01-28

Vancomycin
    Dosage: 0.5 g, 2x/day
    Start date: 2011-01-07
    End date: 2011-01-17

Lyrica
    Dosage: 75 mg, 1x/day
    Administration route: Oral
    Indication: Pain
    Start date: 2011-06-29
    End date: 2011-07-19

Carboplatin
    Dosage: 250 mg/m2, unk
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-10-26
    End date: 2010-12-08

Zovirax
    Dosage: unk
    Start date: 2011-06-30
    End date: 2011-07-08

Lipidil
    Dosage: 100 df, 1x/day
    Administration route: Oral
    Indication: Hyperlipidaemia
    End date: 2011-01-26

Meropenem
    Dosage: 0.5 g, 2x/day
    Indication: Pneumonia
    Start date: 2011-01-07
    End date: 2011-01-24

Doxorubicin Hydrochloride
    Dosage: 40 mg/m2, unk
    Indication: Adult T-Cell Lymphoma / Leukaemia
    Start date: 2010-10-07
    End date: 2010-10-07

Zovirax
    Dosage: 200 mg, 1x/day
    Administration route: Oral
    Indication: Prophylaxis
    End date: 2011-01-28

Other drugs received by patient: Ciprofloxacin HCL; Vfend; Slow-K; Targocid

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