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 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
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 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 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 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 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 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 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
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 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 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 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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