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Entecavir Adverse Events Reported to the FDA Over Time

How are Entecavir adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Entecavir, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Entecavir is flagged as the suspect drug causing the adverse event.

Most Common Entecavir Adverse Events Reported to the FDA

What are the most common Entecavir adverse events reported to the FDA?

Drug Resistance
42 (5.05%)
Blood Hiv Rna Decreased
28 (3.37%)
Lactic Acidosis
28 (3.37%)
Alanine Aminotransferase Increased
25 (3.01%)
Hepatic Neoplasm Malignant
23 (2.77%)
Hepatic Encephalopathy
21 (2.53%)
Blood Bilirubin Increased
20 (2.41%)
Hepatitis B
19 (2.29%)
Hepatic Failure
16 (1.93%)
Blood Creatine Phosphokinase Increa...
12 (1.44%)
Pancreatitis
11 (1.32%)
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Ascites
10 (1.2%)
Hepatic Function Abnormal
9 (1.08%)
Renal Impairment
9 (1.08%)
Vomiting
9 (1.08%)
Diplopia
8 (.96%)
Hepatitis B Dna Increased
8 (.96%)
Prothrombin Time Prolonged
8 (.96%)
Abortion Spontaneous
7 (.84%)
Activated Partial Thromboplastin Ti...
7 (.84%)
Aspartate Aminotransferase Increase...
7 (.84%)
Blood Amylase Increased
7 (.84%)
Hepatic Cirrhosis
7 (.84%)
Hyperlipidaemia
7 (.84%)
Lung Adenocarcinoma
7 (.84%)
Rash Maculo-papular
7 (.84%)
Viral Load Increased
7 (.84%)
Acanthosis
6 (.72%)
Drug Ineffective
6 (.72%)
Hyponatraemia
6 (.72%)
Listeria Encephalitis
6 (.72%)
Liver Transplant
6 (.72%)
Pancreatitis Acute
6 (.72%)
Renal Failure
6 (.72%)
Seborrhoeic Dermatitis
6 (.72%)
Squamous Cell Carcinoma
6 (.72%)
Transaminases Increased
6 (.72%)
Asthenia
5 (.6%)
Blood Bicarbonate Decreased
5 (.6%)
Dizziness
5 (.6%)
Encephalopathy
5 (.6%)
Hyperkalaemia
5 (.6%)
Jaundice
5 (.6%)
Leukoplakia
5 (.6%)
Liver Injury
5 (.6%)
Pain In Extremity
5 (.6%)
Pharyngeal Oedema
5 (.6%)
Pneumonia
5 (.6%)
Pregnancy
5 (.6%)
Rash
5 (.6%)
Acidosis
4 (.48%)
Acute Hepatic Failure
4 (.48%)
Anaemia
4 (.48%)
Central Nervous System Lymphoma
4 (.48%)
Death
4 (.48%)
Dermatitis Allergic
4 (.48%)
Diabetes Mellitus
4 (.48%)
Gastric Cancer
4 (.48%)
Headache
4 (.48%)
Hepatitis
4 (.48%)
Laryngeal Erythema
4 (.48%)
Laryngeal Oedema
4 (.48%)
Laryngospasm
4 (.48%)
Platelet Count Decreased
4 (.48%)
Pruritus
4 (.48%)
Pyrexia
4 (.48%)
Tachycardia
4 (.48%)
Therapeutic Response Decreased
4 (.48%)
Ataxia
3 (.36%)
Blood Creatinine Increased
3 (.36%)
Cardiac Failure
3 (.36%)
Cerebellar Syndrome
3 (.36%)
Cytolytic Hepatitis
3 (.36%)
Drug Exposure During Pregnancy
3 (.36%)
Drug Interaction
3 (.36%)
Lipase Increased
3 (.36%)
Memory Impairment
3 (.36%)
Musculoskeletal Pain
3 (.36%)
Nausea
3 (.36%)
Paraesthesia
3 (.36%)
Skin Exfoliation
3 (.36%)
Thermal Burn
3 (.36%)
Urinary Tract Infection
3 (.36%)
Viral Mutation Identified
3 (.36%)
Viral Myocarditis
3 (.36%)
Wrist Fracture
3 (.36%)
Abdominal Pain Upper
2 (.24%)
Alanine Aminotransferase Abnormal
2 (.24%)
Alopecia
2 (.24%)
Alpha 1 Foetoprotein Increased
2 (.24%)
Anal Haemorrhage
2 (.24%)
Aspergillosis
2 (.24%)
Atrioventricular Septal Defect
2 (.24%)
Basal Cell Carcinoma
2 (.24%)
Bile Duct Obstruction
2 (.24%)
Bradycardia
2 (.24%)
Breast Cancer
2 (.24%)
Bronchopulmonary Aspergillosis
2 (.24%)
Cardio-respiratory Arrest
2 (.24%)
Cerebral Infarction
2 (.24%)
Cholangitis Acute
2 (.24%)

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This graph shows the top adverse events submitted to the FDA for Entecavir, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Entecavir is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Entecavir

What are the most common Entecavir adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Entecavir, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Entecavir is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Entecavir According to Those Reporting Adverse Events

Why are people taking Entecavir, according to those reporting adverse events to the FDA?

Hepatitis B
328
Product Used For Unknown Indication
27
Drug Use For Unknown Indication
22
Hepatitis
12
Hepatic Failure
12
Antiviral Prophylaxis
9
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Hepatitis B Virus Test
9
Hiv Infection
9
Hepatitis B Virus
8
Hepatic Cirrhosis
6
Prophylaxis
6
Herpes Zoster
5
Antiretroviral Therapy
4
Hepatitis B Surface Antigen Positiv...
4
Antiviral Treatment
3
Aplastic Anaemia
3
Chronic Hepatitis
2
Hepatitis Fulminant
2
Hepatitis D
2
Hepatitis B Surface Antibody Positi...
1
Hepatitis B Positive
1
Viral Hepatitis Carrier
1
Liver Disorder
1

Drug Labels

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BaracludeE.R. Squibb & Sons, L.L.C.12-OCT-12

Entecavir Case Reports

What Entecavir safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Entecavir. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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