EPIVIR

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Epivir Adverse Events Reported to the FDA Over Time

How are Epivir adverse event reports trending over time?

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

Most Common Epivir Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy	345 (3.53%)
Immune Reconstitution Syndrome	159 (1.63%)
Pyrexia	154 (1.58%)
Abortion Spontaneous	129 (1.32%)
Vomiting	112 (1.15%)
Anaemia	99 (1.01%)
Renal Failure Acute	97 (.99%)
Nausea	88 (.9%)
Alanine Aminotransferase Increased	81 (.83%)
Lactic Acidosis	77 (.79%)
Aspartate Aminotransferase Increase...	72 (.74%)
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Pregnancy	72 (.74%)
Diarrhoea	70 (.72%)
Rash	67 (.69%)
Premature Baby	64 (.65%)
Asthenia	62 (.63%)
Blood Alkaline Phosphatase Increase...	62 (.63%)
Weight Decreased	62 (.63%)
Dyspnoea	60 (.61%)
Pancytopenia	60 (.61%)
Renal Impairment	59 (.6%)
General Physical Health Deteriorati...	52 (.53%)
Drug Resistance	50 (.51%)
Gamma-glutamyltransferase Increased	50 (.51%)
Hepatic Failure	50 (.51%)
Abdominal Pain	49 (.5%)
Death	48 (.49%)
Thrombocytopenia	48 (.49%)
Fatigue	47 (.48%)
Headache	47 (.48%)
Malaise	47 (.48%)
Abortion Induced	43 (.44%)
Condition Aggravated	43 (.44%)
Hepatitis	43 (.44%)
Depression	42 (.43%)
Lipodystrophy Acquired	42 (.43%)
Hepatic Function Abnormal	41 (.42%)
Renal Failure	41 (.42%)
Platelet Count Decreased	40 (.41%)
Diabetes Mellitus	39 (.4%)
Hepatic Cirrhosis	39 (.4%)
Pruritus	39 (.4%)
Stillbirth	39 (.4%)
Caesarean Section	38 (.39%)
Neutropenia	38 (.39%)
Convulsion	37 (.38%)
Hepatitis B	37 (.38%)
Hypoaesthesia	37 (.38%)
Blood Creatinine Increased	36 (.37%)
Pancreatitis	36 (.37%)
Blood Bilirubin Increased	34 (.35%)
Blood Creatine Phosphokinase Increa...	34 (.35%)
Bone Marrow Failure	34 (.35%)
Hypertension	34 (.35%)
Jaundice	34 (.35%)
Liver Disorder	34 (.35%)
Depressed Level Of Consciousness	33 (.34%)
Intra-uterine Death	32 (.33%)
Myalgia	32 (.33%)
Arthralgia	31 (.32%)
Drug Interaction	31 (.32%)
Hepatic Steatosis	31 (.32%)
Mycobacterium Avium Complex Infecti...	31 (.32%)
Blood Lactate Dehydrogenase Increas...	30 (.31%)
Blood Lactic Acid Increased	30 (.31%)
Mitochondrial Cytopathy	30 (.31%)
Maternal Drugs Affecting Foetus	29 (.3%)
Oedema Peripheral	29 (.3%)
White Blood Cell Count Decreased	29 (.3%)
Chest Pain	28 (.29%)
Cough	28 (.29%)
Hyperbilirubinaemia	27 (.28%)
Myocardial Infarction	27 (.28%)
Pneumocystis Jiroveci Pneumonia	27 (.28%)
Sepsis	27 (.28%)
Ascites	26 (.27%)
Neuropathy Peripheral	26 (.27%)
Pneumonia	26 (.27%)
Hepatic Enzyme Increased	25 (.26%)
Premature Labour	25 (.26%)
Dehydration	24 (.25%)
Drug Rash With Eosinophilia And Sys...	24 (.25%)
Hepatitis Fulminant	24 (.25%)
Hepatotoxicity	24 (.25%)
Lymphadenopathy	24 (.25%)
Osteonecrosis	24 (.25%)
Transaminases Increased	24 (.25%)
Abdominal Distension	23 (.24%)
Inflammation	23 (.24%)
Nephrolithiasis	23 (.24%)
Pleural Effusion	22 (.23%)
Renal Disorder	22 (.23%)
Atrial Septal Defect	21 (.21%)
Haemoglobin Decreased	21 (.21%)
Hypertriglyceridaemia	21 (.21%)
Osteomalacia	21 (.21%)
Splenomegaly	21 (.21%)
Umbilical Cord Abnormality	21 (.21%)
Cholestasis	20 (.2%)
Insomnia	20 (.2%)
Metabolic Acidosis	20 (.2%)

Share/Embed Graph Export Data

This graph shows the top adverse events submitted to the FDA for Epivir, 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 Epivir 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 Epivir

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

Hepatic And Hepatobiliary	494 (5.05%)
Chemical Injury And Poisoning	393 (4.02%)
Gastrointestinal Signs	344 (3.52%)
Epidermal And Dermal Conditions	314 (3.21%)
Hepatobiliary	305 (3.12%)
Renal Disorders	263 (2.69%)
Anemias Nonhemolytic And Marrow Dep...	238 (2.44%)
Neurological	219 (2.24%)
Infections - Pathogen Unspecified	216 (2.21%)
Abortions And Stillbirth	211 (2.16%)
Respiratory	200 (2.05%)
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Viral Infectious	172 (1.76%)
Hematology Investigations	169 (1.73%)
Body Temperature Conditions	162 (1.66%)
Immunodeficiency Syndromes	159 (1.63%)
Enzyme	132 (1.35%)
Therapeutic And Nontherapeutic Effe...	132 (1.35%)
Acid-base	115 (1.18%)
Neonatal And Perinatal Conditions	112 (1.15%)
Mycobacterial Infectious	101 (1.03%)
Renal And Urinary Tract Investigati...	101 (1.03%)
White Blood Cell	95 (.97%)
Pregnancy, Labour, Delivery And Pos...	94 (.96%)
Muscle	90 (.92%)
Gastrointestinal Motility And Defec...	89 (.91%)
Physical Examination Topics	89 (.91%)
Glucose Metabolism Disorders	86 (.88%)
Cardiac Arrhythmias	85 (.87%)
Obstetric And Gynecological Therape...	85 (.87%)
Electrolyte And Fluid Balance Condi...	81 (.83%)
Metabolic, Nutritional And Blood Ga...	77 (.79%)
Skin And Subcutaneous Tissue	77 (.79%)
Fungal Infectious	68 (.7%)
Appetite And General Nutritional	65 (.67%)
Bacterial Infectious	65 (.67%)
Spleen, Lymphatic And Reticulendoth...	65 (.67%)
Coronary Artery	64 (.65%)
Medication Errors	63 (.64%)
Movement Disorders	63 (.64%)
Central Nervous System Vascular	62 (.63%)
Musculoskeletal And Connective Tiss...	62 (.63%)
Fatal Outcomes	59 (.6%)
Microbiology And Serology	59 (.6%)
Exocrine Pancreas Conditions	58 (.59%)
Seizures	56 (.57%)
Urinary Tract Signs	56 (.57%)
Platelet	55 (.56%)
Bone Disorders	54 (.55%)
Joint	54 (.55%)
Musculoskeletal And Connective Tiss...	54 (.55%)
Cardiac And Vascular Investigations	52 (.53%)
Lipid Metabolism	50 (.51%)
Headaches	49 (.5%)
Maternal Complications Of Labour An...	48 (.49%)
Nephropathies	48 (.49%)
Lower Respiratory Tract Disorders	47 (.48%)
Skin Appendage Conditions	47 (.48%)
Injuries	45 (.46%)
Depressed Mood Disorders	44 (.45%)
Metabolism	44 (.45%)
Placental, Amniotic And Cavity Diso...	43 (.44%)
Cardiac And Vascular Disorders Cong...	40 (.41%)
Ocular Infections, Irritations And ...	39 (.4%)
Peripheral Neuropathies	39 (.4%)
Gastrointestinal Hemorrhages	36 (.37%)
Myocardial	36 (.37%)
Urolithiases	36 (.37%)
Vascular Hypertensive	36 (.37%)
Gastrointestinal Tract Disorders Co...	34 (.35%)
Water, Electrolyte And Mineral	34 (.35%)
Sleep Disorders	33 (.34%)
Deliria	31 (.32%)
Lipid Analyses	31 (.32%)
Spinal Cord And Nerve Root	31 (.32%)
Allergic Conditions	30 (.31%)
Bone And Joint Injuries	29 (.3%)
Embolism And Thrombosis	29 (.3%)
Pulmonary Vascular	29 (.3%)
Anxiety Disorders	28 (.29%)
Neurological, Special Senses And Ps...	28 (.29%)
Bone, Calcium, Magnesium And Phosph...	27 (.28%)
Decreased And Nonspecific Blood Pre...	27 (.28%)
Renal And Urinary Tract Disorders C...	27 (.28%)
Suicidal And Self-injurious Behavio...	27 (.28%)
Gastrointestinal Inflammatory Condi...	26 (.27%)
Peritoneal And Retroperitoneal Cond...	26 (.27%)
Pleural	26 (.27%)
Encephalopathies	25 (.26%)
Eye	24 (.25%)
Gastrointestinal	24 (.25%)
Ocular Neuromuscular	24 (.25%)
Maternal Complications Of Pregnancy	23 (.24%)
Miscellaneous And Site Unspecified ...	22 (.23%)
Protein And Chemistry Analyses	22 (.23%)
Tissue	22 (.23%)
Coagulopathies And Bleeding Diathes...	21 (.21%)
Fetal Complications	21 (.21%)
Gastrointestinal Vascular Condition...	21 (.21%)
Increased Intracranial Pressure And...	21 (.21%)
Personality Disorders	21 (.21%)
Protozoal Infectious	21 (.21%)

Share/Embed Graph Export Data

This graph shows the top categories of adverse events submitted to the FDA for Epivir, 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 Epivir 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 Epivir According to Those Reporting Adverse Events

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

Hiv Infection	2736
Acquired Immunodeficiency Syndrome	205
Hepatitis B	135
Antiretroviral Therapy	121
Product Used For Unknown Indication	107
Drug Use For Unknown Indication	105
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Antiviral Treatment	60
Antiviral Prophylaxis	54
Hiv Test Positive	46
Retroviral Infection	30
Drug Exposure During Pregnancy	27
Maternal Exposure During Pregnancy	15
Systemic Antiviral Treatment	15
Prophylaxis Against Hiv Infection	13
Ill-defined Disorder	12
Prophylaxis	10
Maternal Exposure Timing Unspecifie...	9
Hepatic Cirrhosis	9
Malaria Prophylaxis	8
Hepatitis	6
Hepatitis B Virus	6
Human Immunodeficiency Virus Transm...	4
Infection Prophylaxis	4
Kaposis Sarcoma Aids Related	3
Lipodystrophy Acquired	3
Accidental Needle Stick	3
Infection	2
Antiviral Drug Level	2
Hepatitis C	2
Foetal Exposure During Pregnancy	2
Hepatitis B Immunisation	2
Hepatitis Chronic Active	2
Congenital Hiv Infection	2
Vertical Infection Transmission	2
Asymptomatic Hiv Infection	1
Hepatitis D	1
Cd4 Lymphocytes Decreased	1
Hepatic Neoplasm Malignant	1
Hepatitis B Virus Test	1
Liver Disorder	1
Chronic Hepatitis	1
Kaposis Sarcoma	1
Intentional Self-injury	1
Hiv Infection Cdc Group Iv Subgroup...	1
Hepatitis B Surface Antigen Positiv...	1
Hepatic Encephalopathy	1
Hepatitis B Surface Antigen	1
Acute Hiv Infection	1
Hiv Antibody	1

Drug Labels

Label	Labeler	Effective
Epivir	State of Florida DOH Central Pharmacy	13-APR-10
Epivir	Physicians Total Care, Inc.	14-APR-10
Epivir	Rebel Distributors Corp	24-SEP-10
Epivir	GlaxoSmithKline LLC	11-JAN-11
Epivir	KAISER FOUNDATION HOSPITALS	31-MAR-11
Epivir	REMEDYREPACK INC.	13-JUL-11
Epivir	REMEDYREPACK INC.	30-AUG-11
Epivir	REMEDYREPACK INC.	13-SEP-11
Epivirhbv	GlaxoSmithKline LLC	13-DEC-11
Epivir	Bryant Ranch Prepack	12-OCT-12
Epivir	ViiV Healthcare Company	23-JAN-13
Epivir	REMEDYREPACK INC.	15-MAR-13

Epivir Case Reports

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

About Results

This report contains aggregated drug side effects and adverse events for Epivir. 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.

Comments

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