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Baraclude (Entecavir) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Baraclude (Entecavir) 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 (25)
Life Threatening Events (8)
Disability (4)

Reports by Reaction Type

Hepatic Neoplasm Malignant (36)Pregnancy (21)Death (17)Renal Impairment (9)Blood Creatine Phosphokinase Increased (7)Drug Ineffective (7)Hepatic Failure (6)Exposure VIA Father (6)Fatigue (6)Pruritus (5)Myalgia (5)Abortion Induced (5)

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

Possible Baraclude side effects in

Reported by a physician from Taiwan, Province of China on 2012-08-27

Patient:

Reactions: Hepatic Neoplasm Malignant

Drug(s) suspected as cause:
Baraclude



Possible Baraclude side effects in

Reported by a physician from Taiwan, Province of China on 2012-08-27

Patient:

Reactions: Hepatic Neoplasm Malignant

Drug(s) suspected as cause:
Baraclude



Possible Baraclude side effects in

Reported by a consumer/non-health professional from Taiwan, Province of China on 2012-08-27

Patient:

Reactions: Hepatic Neoplasm Malignant

Drug(s) suspected as cause:
Baraclude



Possible Baraclude side effects in

Reported by a physician from Taiwan, Province of China on 2012-08-27

Patient:

Reactions: Hepatic Neoplasm Malignant

Drug(s) suspected as cause:
Baraclude



Possible Baraclude side effects in 75 year old male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 75 year old male

Reactions: Hepatic Neoplasm Malignant

Adverse event resulted in: death

Drug(s) suspected as cause:
Baraclude



Possible Baraclude side effects in male

Reported by a consumer/non-health professional from Germany on 2012-08-24

Patient: male

Reactions: Obesity

Drug(s) suspected as cause:
Baraclude



Possible Baraclude side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: male

Reactions: Therapeutic Embolisation

Drug(s) suspected as cause:
Baraclude



Possible Baraclude side effects in 48 year old male

Reported by a consumer/non-health professional from Portugal on 2012-08-21

Patient: 48 year old male

Reactions: Encephalopathy, Hepatic Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Baraclude

Other drugs received by patient: Ibuprofen



Possible Baraclude side effects in 60 year old female

Reported by a physician from United Kingdom on 2012-08-17

Patient: 60 year old female

Reactions: Lactic Acidosis

Drug(s) suspected as cause:
Baraclude



Possible Baraclude side effects in 69 year old male

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

Patient: 69 year old male

Reactions: Liver Abscess, Septic Shock

Adverse event resulted in: death

Drug(s) suspected as cause:
Baraclude
    Dosage: 0.5 mg, qd
    Administration route: Oral
    Indication: Hepatitis B

Nexavar
    Dosage: 400 mg, qd
    Administration route: Oral
    Indication: Hepatic Neoplasm Malignant
    Start date: 2012-05-11
    End date: 2012-06-26



Possible Baraclude side effects in

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient:

Reactions: Renal Disorder

Drug(s) suspected as cause:
Baraclude



Possible Baraclude side effects in 65 year old male

Reported by a physician from Australia on 2012-08-09

Patient: 65 year old male

Reactions: Salivary Gland Cancer

Adverse event resulted in: death

Drug(s) suspected as cause:
Baraclude



Possible Baraclude side effects in 32 year old male

Reported by a consumer/non-health professional from China on 2012-08-08

Patient: 32 year old male

Reactions: Muscular Weakness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Baraclude



Possible Baraclude side effects in

Reported by a consumer/non-health professional from Germany on 2012-08-08

Patient:

Reactions: Surgery

Drug(s) suspected as cause:
Baraclude



Possible Baraclude side effects in 49 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-07

Patient: 49 year old female

Reactions: Myalgia

Drug(s) suspected as cause:
Adefovir
    Indication: Hepatitis B
    Start date: 2009-08-17

Baraclude
    Administration route: Oral

Other drugs received by patient: Levosulpiride; Synthroid



Possible Baraclude side effects in female

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

Patient: female

Reactions: Blood Creatine Phosphokinase Increased, Arthralgia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Baraclude
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2012-02-01
    End date: 2012-06-20

Cyclophosphamide
    Administration route: Oral
    Start date: 2012-03-05

Cyclophosphamide
    Administration route: Oral
    Start date: 2012-04-02

Cyclophosphamide
    Administration route: Oral
    Start date: 2012-01-23

Cyclophosphamide
    Administration route: Oral
    Start date: 2012-04-24

Cyclophosphamide
    Administration route: Oral
    Start date: 2012-02-20

Cyclophosphamide
    Administration route: Oral
    Start date: 2012-02-06

Cyclophosphamide
    Administration route: Oral
    Start date: 2012-03-19

Cyclophosphamide
    Administration route: Oral
    Start date: 2012-05-23
    End date: 2012-05-23

Other drugs received by patient: Novorapid; Potassium Chloride; Prednisone TAB; Valacyclovir Hydrochloride; Humulin N; Cacit D3; Glucophage; Atarax; Bactrim



Possible Baraclude side effects in

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient:

Reactions: Pulmonary Artery Atresia, Asplenia, Atrioventricular Septal Defect

Drug(s) suspected as cause:
Baraclude



Possible Baraclude side effects in 48 year old male

Reported by a consumer/non-health professional from Portugal on 2012-08-01

Patient: 48 year old male

Reactions: Encephalopathy, Hepatic Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Baraclude

Other drugs received by patient: Ibuprofen



Possible Baraclude side effects in 64 year old male

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient: 64 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Baraclude



Possible Baraclude side effects in 72 year old male

Reported by a consumer/non-health professional from Korea, Republic of on 2012-07-25

Patient: 72 year old male

Reactions: Hepatic Neoplasm Malignant, Abdominal Pain Upper

Drug(s) suspected as cause:
Baraclude

Other drugs received by patient: Ursa; Vitamin B Complex CAP



Possible Baraclude side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-25

Patient: male

Reactions: Maternal Drugs Affecting Foetus, Heart Disease Congenital

Drug(s) suspected as cause:
Baraclude



Possible Baraclude side effects in 49 year old male

Reported by a consumer/non-health professional from China on 2012-07-25

Patient: 49 year old male, weighing 66.0 kg (145.2 pounds)

Reactions: Blood Creatine Phosphokinase Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Baraclude



Possible Baraclude side effects in

Reported by a consumer/non-health professional from Japan on 2012-07-23

Patient:

Reactions: Generalised Oedema

Drug(s) suspected as cause:
Baraclude



Possible Baraclude side effects in 90 year old male

Reported by a physician from Japan on 2012-07-23

Patient: 90 year old male

Reactions: Hepatic Neoplasm Malignant

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Baraclude



Possible Baraclude side effects in 35 year old male

Reported by a physician from France on 2012-07-23

Patient: 35 year old male, weighing 72.0 kg (158.4 pounds)

Reactions: Neuropathy Peripheral, Myopathy

Drug(s) suspected as cause:
Baraclude



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

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

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

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

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

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

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

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

Carboplatin
    Dosage: 250 mg/m2, unk
    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

Cyclophosphamide
    Dosage: 350 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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



Possible Baraclude side effects in female

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

Patient: female

Reactions: Breast Cancer

Drug(s) suspected as cause:
Baraclude



Possible Baraclude side effects in 36 year old male

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

Patient: 36 year old male

Reactions: Infertility

Drug(s) suspected as cause:
Baraclude



Possible Baraclude side effects in 69 year old male

Reported by a consumer/non-health professional from Japan on 2012-07-20

Patient: 69 year old male, weighing 75.0 kg (165.0 pounds)

Reactions: Hepatic Neoplasm Malignant

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Baraclude

Other drugs received by patient: Hepsera; Urso 250



Possible Baraclude side effects in 75 year old male

Reported by a consumer/non-health professional from Japan on 2012-07-18

Patient: 75 year old male

Reactions: Glomerular Filtration Rate Decreased, Diarrhoea

Drug(s) suspected as cause:
Baraclude

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