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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