LAMIVUDINE

Lamivudine Adverse Events Reported to the FDA Over Time

How are Lamivudine adverse event reports trending over time?

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

Most Common Lamivudine Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy	859 (3.05%)
Immune Reconstitution Syndrome	630 (2.24%)
Pyrexia	393 (1.4%)
Vomiting	302 (1.07%)
Anaemia	301 (1.07%)
Nausea	251 (.89%)
Premature Baby	240 (.85%)
Alanine Aminotransferase Increased	231 (.82%)
Diarrhoea	216 (.77%)
Lactic Acidosis	215 (.76%)
Drug Ineffective	204 (.73%)
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Abortion Spontaneous	192 (.68%)
Maternal Drugs Affecting Foetus	170 (.6%)
Rash	169 (.6%)
Drug Resistance	166 (.59%)
Neutropenia	160 (.57%)
Lipodystrophy Acquired	159 (.57%)
Pregnancy	158 (.56%)
Aspartate Aminotransferase Increase...	157 (.56%)
Stillbirth	148 (.53%)
Jaundice	147 (.52%)
Lymphadenopathy	142 (.5%)
Drug Interaction	140 (.5%)
Abdominal Pain	138 (.49%)
Malaise	138 (.49%)
Headache	136 (.48%)
Death	134 (.48%)
Dyspnoea	133 (.47%)
Renal Impairment	133 (.47%)
Sepsis	129 (.46%)
Weight Decreased	129 (.46%)
Blood Bilirubin Increased	127 (.45%)
Fatigue	126 (.45%)
Cough	125 (.44%)
Hepatic Failure	122 (.43%)
Abdominal Distension	118 (.42%)
Hepatitis B	117 (.42%)
Asthenia	114 (.41%)
Renal Failure Acute	113 (.4%)
Mitochondrial Toxicity	111 (.39%)
Renal Failure	106 (.38%)
Blood Alkaline Phosphatase Increase...	105 (.37%)
Confusional State	103 (.37%)
Congenital Anomaly	101 (.36%)
Pneumonia	100 (.36%)
Hepatitis	99 (.35%)
Hepatic Function Abnormal	97 (.34%)
Haemoglobin Decreased	96 (.34%)
Portal Hypertension	96 (.34%)
Hepatotoxicity	95 (.34%)
Ascites	94 (.33%)
Tuberculosis	92 (.33%)
Drug Toxicity	91 (.32%)
Hepatomegaly	91 (.32%)
Hiv Infection	91 (.32%)
Hyperlipidaemia	91 (.32%)
Abortion Induced	90 (.32%)
Metabolic Acidosis	90 (.32%)
Condition Aggravated	87 (.31%)
Eyelid Ptosis	87 (.31%)
Pancytopenia	85 (.3%)
Myalgia	82 (.29%)
Hypertension	81 (.29%)
Hyperlactacidaemia	80 (.28%)
Convulsion	79 (.28%)
General Physical Health Deteriorati...	79 (.28%)
Thrombocytopenia	79 (.28%)
Liver Disorder	78 (.28%)
Cholestasis	77 (.27%)
Neuropathy Peripheral	77 (.27%)
Blood Creatinine Increased	74 (.26%)
Liver Function Test Abnormal	74 (.26%)
Viral Mutation Identified	74 (.26%)
Caesarean Section	73 (.26%)
Hepatic Encephalopathy	73 (.26%)
Hypersensitivity	72 (.26%)
Cardiac Murmur	69 (.25%)
Intra-uterine Death	69 (.25%)
Cachexia	68 (.24%)
Diplopia	68 (.24%)
Pancreatitis	68 (.24%)
Splenomegaly	68 (.24%)
Acute Hepatic Failure	67 (.24%)
Dehydration	67 (.24%)
Platelet Count Decreased	67 (.24%)
Leukopenia	66 (.23%)
Arthralgia	65 (.23%)
Diabetes Mellitus	64 (.23%)
Gamma-glutamyltransferase Increased	62 (.22%)
Osteonecrosis	62 (.22%)
Progressive External Ophthalmoplegi...	62 (.22%)
Ventricular Septal Defect	62 (.22%)
Cd4 Lymphocytes Decreased	61 (.22%)
Lipoatrophy	61 (.22%)
Pain	61 (.22%)
Decreased Appetite	60 (.21%)
Disease Recurrence	60 (.21%)
Myopathy	60 (.21%)
Pruritus	60 (.21%)
Respiratory Distress	60 (.21%)
Small For Dates Baby	60 (.21%)

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

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

Hepatic And Hepatobiliary	1501 (5.34%)
Chemical Injury And Poisoning	1132 (4.02%)
Gastrointestinal Signs	959 (3.41%)
Hepatobiliary	838 (2.98%)
Epidermal And Dermal Conditions	770 (2.74%)
Infections - Pathogen Unspecified	757 (2.69%)
Therapeutic And Nontherapeutic Effe...	682 (2.42%)
Immunodeficiency Syndromes	649 (2.31%)
Respiratory	596 (2.12%)
Neurological	595 (2.11%)
Viral Infectious	531 (1.89%)
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Anemias Nonhemolytic And Marrow Dep...	493 (1.75%)
Renal Disorders	463 (1.65%)
Abortions And Stillbirth	434 (1.54%)
Body Temperature Conditions	421 (1.5%)
Hematology Investigations	412 (1.46%)
Acid-base	407 (1.45%)
Neonatal And Perinatal Conditions	401 (1.43%)
Mycobacterial Infectious	302 (1.07%)
White Blood Cell	298 (1.06%)
Cardiac Arrhythmias	296 (1.05%)
Microbiology And Serology	296 (1.05%)
Muscle	282 (1%)
Spleen, Lymphatic And Reticulendoth...	275 (.98%)
Gastrointestinal Motility And Defec...	268 (.95%)
Skin And Subcutaneous Tissue	251 (.89%)
Fungal Infectious	248 (.88%)
Musculoskeletal And Connective Tiss...	229 (.81%)
Physical Examination Topics	219 (.78%)
Appetite And General Nutritional	215 (.76%)
Enzyme	215 (.76%)
Pregnancy, Labour, Delivery And Pos...	213 (.76%)
Movement Disorders	208 (.74%)
Cardiac And Vascular Disorders Cong...	206 (.73%)
Bacterial Infectious	196 (.7%)
Electrolyte And Fluid Balance Condi...	196 (.7%)
Renal And Urinary Tract Investigati...	194 (.69%)
Cardiac And Vascular Investigations	193 (.69%)
Glucose Metabolism Disorders	189 (.67%)
Musculoskeletal And Connective Tiss...	183 (.65%)
Fatal Outcomes	175 (.62%)
Lipid Metabolism	175 (.62%)
Obstetric And Gynecological Therape...	167 (.59%)
Urinary Tract Signs	164 (.58%)
Myocardial	161 (.57%)
Metabolism	157 (.56%)
Bone Disorders	155 (.55%)
Gastrointestinal Hemorrhages	154 (.55%)
Metabolic, Nutritional And Blood Ga...	149 (.53%)
Deliria	147 (.52%)
Headaches	143 (.51%)
Vision	143 (.51%)
Allergic Conditions	141 (.5%)
Water, Electrolyte And Mineral	135 (.48%)
Peripheral Neuropathies	130 (.46%)
Congenital And Hereditary	126 (.45%)
Ocular Neuromuscular	126 (.45%)
Gastrointestinal Inflammatory Condi...	125 (.44%)
Seizures	125 (.44%)
Gastrointestinal Tract Disorders Co...	122 (.43%)
Coronary Artery	121 (.43%)
Encephalopathies	121 (.43%)
Nephropathies	121 (.43%)
Peritoneal And Retroperitoneal Cond...	116 (.41%)
Protein And Chemistry Analyses	115 (.41%)
Exocrine Pancreas Conditions	112 (.4%)
Joint	112 (.4%)
Ocular Infections, Irritations And ...	106 (.38%)
Reproductive Tract And Breast Disor...	103 (.37%)
Fetal Complications	102 (.36%)
Bone And Joint Injuries	99 (.35%)
Injuries	97 (.34%)
Medication Errors	96 (.34%)
Platelet	96 (.34%)
Heart Failures	95 (.34%)
Placental, Amniotic And Cavity Diso...	95 (.34%)
Chromosomal Abnormalities And Abnor...	93 (.33%)
Lower Respiratory Tract Disorders	91 (.32%)
Procedural And Device Related Injur...	91 (.32%)
Central Nervous System Vascular	89 (.32%)
Vascular Hypertensive	89 (.32%)
Depressed Mood Disorders	87 (.31%)
Pleural	86 (.31%)
Lipid Analyses	83 (.3%)
Protozoal Infectious	83 (.3%)
Anxiety Disorders	81 (.29%)
Embolism And Thrombosis	79 (.28%)
Cytoplasmic Disorders Congenital	77 (.27%)
Gastrointestinal Conditions	77 (.27%)
Maternal Complications Of Labour An...	76 (.27%)
Decreased And Nonspecific Blood Pre...	75 (.27%)
Neuromuscular	74 (.26%)
Increased Intracranial Pressure And...	73 (.26%)
Renal And Urinary Tract Disorders C...	73 (.26%)
Bone, Calcium, Magnesium And Phosph...	71 (.25%)
Neurological Disorders Congenital	71 (.25%)
Oral Soft Tissue Conditions	70 (.25%)
Abdominal Hernias And Other Abdomin...	69 (.25%)
Urolithiases	67 (.24%)
Eye	65 (.23%)
Gastrointestinal Vascular Condition...	65 (.23%)

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This graph shows the top categories of adverse events submitted to the FDA for Lamivudine, 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 Lamivudine 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.