ZIDOVUDINE

Zidovudine Adverse Events Reported to the FDA Over Time

How are Zidovudine adverse event reports trending over time?

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

Most Common Zidovudine Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy	1113 (5.64%)
Immune Reconstitution Syndrome	326 (1.65%)
Anaemia	320 (1.62%)
Premature Baby	293 (1.49%)
Maternal Drugs Affecting Foetus	292 (1.48%)
Pyrexia	237 (1.2%)
Cardiac Murmur	178 (.9%)
Congenital Anomaly	173 (.88%)
Neutropenia	172 (.87%)
Vomiting	167 (.85%)
Caesarean Section	163 (.83%)
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Diarrhoea	154 (.78%)
Stillbirth	150 (.76%)
Pregnancy	129 (.65%)
Abdominal Distension	122 (.62%)
Hiv Infection	122 (.62%)
Lactic Acidosis	110 (.56%)
Drug Ineffective	109 (.55%)
Lipodystrophy Acquired	109 (.55%)
Nausea	103 (.52%)
Death	96 (.49%)
Lymphadenopathy	96 (.49%)
Rash	96 (.49%)
Pancytopenia	93 (.47%)
Portal Hypertension	93 (.47%)
Mitochondrial Toxicity	92 (.47%)
Ventricular Septal Defect	92 (.47%)
Cryptorchism	91 (.46%)
Alanine Aminotransferase Increased	87 (.44%)
Drug Toxicity	83 (.42%)
Cough	82 (.42%)
Eyelid Ptosis	82 (.42%)
Sepsis	82 (.42%)
Abdominal Hernia	81 (.41%)
Drug Interaction	81 (.41%)
Drug Resistance	81 (.41%)
Pneumonia	81 (.41%)
Sudden Infant Death Syndrome	79 (.4%)
Abortion Spontaneous	78 (.4%)
Small For Dates Baby	78 (.4%)
Aspartate Aminotransferase Increase...	75 (.38%)
Weight Decreased	74 (.38%)
Fatigue	73 (.37%)
Thrombocytopenia	73 (.37%)
Trisomy 21	72 (.37%)
Ventricular Hypertrophy	70 (.36%)
Headache	69 (.35%)
Hepatotoxicity	69 (.35%)
Abdominal Pain	68 (.34%)
Dyspnoea	67 (.34%)
Jaundice	67 (.34%)
Renal Failure Acute	67 (.34%)
Diplopia	64 (.32%)
Intra-uterine Death	64 (.32%)
Haemoglobin Decreased	63 (.32%)
Hepatomegaly	63 (.32%)
Neonatal Disorder	63 (.32%)
Hypertension	62 (.31%)
Pallor	61 (.31%)
Progressive External Ophthalmoplegi...	60 (.3%)
Respiratory Distress	60 (.3%)
Asthenia	59 (.3%)
Atrial Septal Defect	59 (.3%)
Congenital Heart Valve Disorder	59 (.3%)
Convulsion	59 (.3%)
Renal Impairment	58 (.29%)
Metabolic Acidosis	57 (.29%)
Gastroenteritis	56 (.28%)
Polydactyly	56 (.28%)
Dehydration	55 (.28%)
Hepatic Function Abnormal	55 (.28%)
Death Neonatal	54 (.27%)
Apnoea	53 (.27%)
Hyperlactacidaemia	53 (.27%)
Malaise	53 (.27%)
Hyperlipidaemia	52 (.26%)
Myopathy	51 (.26%)
Ascites	50 (.25%)
Cholestasis	50 (.25%)
Hepatitis	50 (.25%)
Pancreatitis	50 (.25%)
Viral Mutation Identified	50 (.25%)
Hepatic Encephalopathy	48 (.24%)
Splenomegaly	48 (.24%)
Gastrointestinal Disorder	47 (.24%)
Hydrocephalus	47 (.24%)
Liver Function Test Abnormal	47 (.24%)
Cachexia	46 (.23%)
Acute Hepatic Failure	45 (.23%)
Atrioventricular Block Complete	44 (.22%)
Liver Disorder	44 (.22%)
Foetal Growth Retardation	43 (.22%)
Lipoatrophy	43 (.22%)
Abortion Induced	42 (.21%)
Tuberculosis	42 (.21%)
Hepatic Failure	41 (.21%)
Premature Labour	41 (.21%)
Premature Rupture Of Membranes	41 (.21%)
Pulmonary Hypertension	41 (.21%)
Blood Alkaline Phosphatase Increase...	40 (.2%)
Condition Aggravated	40 (.2%)

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

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

Chemical Injury And Poisoning	1501 (7.61%)
Hepatic And Hepatobiliary	863 (4.38%)
Infections - Pathogen Unspecified	592 (3%)
Gastrointestinal Signs	546 (2.77%)
Anemias Nonhemolytic And Marrow Dep...	522 (2.65%)
Respiratory	518 (2.63%)
Neonatal And Perinatal Conditions	498 (2.53%)
Cardiac And Vascular Disorders Cong...	420 (2.13%)
Therapeutic And Nontherapeutic Effe...	373 (1.89%)
Neurological	353 (1.79%)
Hepatobiliary	346 (1.75%)
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Immunodeficiency Syndromes	335 (1.7%)
Viral Infectious	300 (1.52%)
Abortions And Stillbirth	299 (1.52%)
Epidermal And Dermal Conditions	281 (1.43%)
White Blood Cell	278 (1.41%)
Body Temperature Conditions	251 (1.27%)
Hematology Investigations	247 (1.25%)
Acid-base	246 (1.25%)
Cardiac Arrhythmias	240 (1.22%)
Fatal Outcomes	236 (1.2%)
Musculoskeletal And Connective Tiss...	232 (1.18%)
Cardiac And Vascular Investigations	227 (1.15%)
Renal Disorders	225 (1.14%)
Congenital And Hereditary	216 (1.1%)
Obstetric And Gynecological Therape...	206 (1.04%)
Pregnancy, Labour, Delivery And Pos...	195 (.99%)
Spleen, Lymphatic And Reticulendoth...	190 (.96%)
Appetite And General Nutritional	182 (.92%)
Gastrointestinal Motility And Defec...	177 (.9%)
Myocardial	176 (.89%)
Skin And Subcutaneous Tissue	169 (.86%)
Muscle	152 (.77%)
Mycobacterial Infectious	150 (.76%)
Microbiology And Serology	147 (.75%)
Fetal Complications	142 (.72%)
Reproductive Tract And Breast Disor...	141 (.72%)
Electrolyte And Fluid Balance Condi...	137 (.69%)
Ocular Neuromuscular	128 (.65%)
Physical Examination Topics	127 (.64%)
Fungal Infectious	125 (.63%)
Bacterial Infectious	120 (.61%)
Gastrointestinal Tract Disorders Co...	119 (.6%)
Movement Disorders	119 (.6%)
Medication Errors	118 (.6%)
Neonatal Respiratory	116 (.59%)
Chromosomal Abnormalities And Abnor...	110 (.56%)
Lipid Metabolism	110 (.56%)
Metabolism	109 (.55%)
Gastrointestinal Hemorrhages	103 (.52%)
Cardiac Valve	102 (.52%)
Abdominal Hernias And Other Abdomin...	99 (.5%)
Placental, Amniotic And Cavity Diso...	99 (.5%)
Encephalopathies	98 (.5%)
Glucose Metabolism Disorders	97 (.49%)
Maternal Complications Of Labour An...	96 (.49%)
Vision	96 (.49%)
Gastrointestinal Inflammatory Condi...	92 (.47%)
Enzyme	91 (.46%)
Seizures	86 (.44%)
Platelet	85 (.43%)
Increased Intracranial Pressure And...	75 (.38%)
Water, Electrolyte And Mineral	75 (.38%)
Headaches	73 (.37%)
Cytoplasmic Disorders Congenital	72 (.37%)
Protein And Chemistry Analyses	72 (.37%)
Vascular	72 (.37%)
Neurological Disorders Congenital	71 (.36%)
Exocrine Pancreas Conditions	68 (.34%)
Vascular Hypertensive	68 (.34%)
Gastrointestinal Conditions	65 (.33%)
Heart Failures	65 (.33%)
Respiratory Disorders Congenital	65 (.33%)
Ancillary Infectious Topics	63 (.32%)
Neuromuscular	63 (.32%)
Allergic Conditions	62 (.31%)
Gastrointestinal	62 (.31%)
Pulmonary Vascular	62 (.31%)
Lower Respiratory Tract Disorders	61 (.31%)
Renal And Urinary Tract Investigati...	61 (.31%)
Bone Disorders	59 (.3%)
Metabolic, Nutritional And Blood Ga...	59 (.3%)
Ocular Infections, Irritations And ...	59 (.3%)
Peritoneal And Retroperitoneal Cond...	59 (.3%)
Embolism And Thrombosis	57 (.29%)
Maternal Complications Of Pregnancy	57 (.29%)
Procedural And Device Related Injur...	56 (.28%)
Injuries	55 (.28%)
Peripheral Neuropathies	55 (.28%)
Eye	53 (.27%)
Gastrointestinal Stenosis And Obstr...	53 (.27%)
Joint	52 (.26%)
Mental Impairment	52 (.26%)
Urinary Tract Signs	51 (.26%)
Musculoskeletal And Connective Tiss...	50 (.25%)
Immune	49 (.25%)
Pleural	47 (.24%)
Renal And Urinary Tract Disorders C...	47 (.24%)
Deliria	46 (.23%)
Immunology And Allergy	45 (.23%)
Lipid Analyses	45 (.23%)

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