EPITOMAX

Epitomax Adverse Events Reported to the FDA Over Time

How are Epitomax adverse event reports trending over time?

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

Most Common Epitomax Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy	65 (5.06%)
Paraesthesia	24 (1.87%)
Weight Decreased	22 (1.71%)
Premature Baby	21 (1.64%)
Convulsion	19 (1.48%)
Condition Aggravated	16 (1.25%)
Epilepsy	14 (1.09%)
Metabolic Acidosis	14 (1.09%)
Pyrexia	14 (1.09%)
Caesarean Section	13 (1.01%)
Irritability	12 (.93%)
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Overdose	12 (.93%)
Diarrhoea	11 (.86%)
Premature Labour	11 (.86%)
Abortion Spontaneous	10 (.78%)
Hypotonia	10 (.78%)
Off Label Use	10 (.78%)
Vomiting	10 (.78%)
Cerebral Haemorrhage	9 (.7%)
Cytolytic Hepatitis	9 (.7%)
Decreased Appetite	9 (.7%)
Neutropenia	9 (.7%)
Premature Rupture Of Membranes	9 (.7%)
Renal Failure Acute	9 (.7%)
Status Epilepticus	9 (.7%)
Electroencephalogram Abnormal	8 (.62%)
Pulmonary Embolism	8 (.62%)
Abdominal Pain	7 (.55%)
Balance Disorder	7 (.55%)
Cholestasis	7 (.55%)
Coma	7 (.55%)
Diaphragmatic Hernia	7 (.55%)
Foetal Growth Retardation	7 (.55%)
Insomnia	7 (.55%)
Malnutrition	7 (.55%)
Maternal Drugs Affecting Foetus	7 (.55%)
Pulmonary Arterial Hypertension	7 (.55%)
Pulmonary Hypertension	7 (.55%)
Ventricular Septal Defect	7 (.55%)
Cough	6 (.47%)
Depression	6 (.47%)
Drug Interaction	6 (.47%)
Drug Withdrawal Syndrome	6 (.47%)
Dysmorphism	6 (.47%)
Hepatitis Cholestatic	6 (.47%)
Leukopenia	6 (.47%)
Nausea	6 (.47%)
Pain	6 (.47%)
Somnolence	6 (.47%)
Speech Disorder	6 (.47%)
Visual Acuity Reduced	6 (.47%)
Agitation	5 (.39%)
Aspartate Aminotransferase Increase...	5 (.39%)
Asthenia	5 (.39%)
Bradycardia	5 (.39%)
Cataract	5 (.39%)
Delirium	5 (.39%)
Disseminated Intravascular Coagulat...	5 (.39%)
Dyspnoea	5 (.39%)
Escherichia Infection	5 (.39%)
Fat Necrosis	5 (.39%)
Gamma-glutamyltransferase Increased	5 (.39%)
Hypotonia Neonatal	5 (.39%)
Limb Malformation	5 (.39%)
Malaise	5 (.39%)
Osteonecrosis	5 (.39%)
Oxygen Saturation Decreased	5 (.39%)
Pancreatic Atrophy	5 (.39%)
Plagiocephaly	5 (.39%)
Prothrombin Level Decreased	5 (.39%)
Pruritus	5 (.39%)
Respiratory Distress	5 (.39%)
Tremor	5 (.39%)
Affective Disorder	4 (.31%)
Alcohol Intolerance	4 (.31%)
Anorexia	4 (.31%)
Anuria	4 (.31%)
Areflexia	4 (.31%)
Arthralgia	4 (.31%)
Blood Creatinine Increased	4 (.31%)
Bronchitis	4 (.31%)
Cardiac Arrest	4 (.31%)
Congenital Diaphragmatic Anomaly	4 (.31%)
Congenital Diaphragmatic Hernia	4 (.31%)
Congenital Torticollis	4 (.31%)
Death	4 (.31%)
Diplopia	4 (.31%)
Drug Dose Omission	4 (.31%)
Dysaesthesia	4 (.31%)
Fatigue	4 (.31%)
Feeling Drunk	4 (.31%)
Gastrointestinal Disorder	4 (.31%)
Headache	4 (.31%)
Hypertonia	4 (.31%)
Inflammation	4 (.31%)
Intra-uterine Death	4 (.31%)
Middle Insomnia	4 (.31%)
Musculoskeletal Pain	4 (.31%)
Pulmonary Hypoplasia	4 (.31%)
Retrognathia	4 (.31%)
Shock	4 (.31%)

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

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

Chemical Injury And Poisoning	75 (5.84%)
Neurological	72 (5.61%)
Seizures	47 (3.66%)
Hepatic And Hepatobiliary	37 (2.88%)
Musculoskeletal And Connective Tiss...	37 (2.88%)
Neonatal And Perinatal Conditions	31 (2.41%)
Respiratory	29 (2.26%)
Physical Examination Topics	24 (1.87%)
Gastrointestinal Signs	23 (1.79%)
Maternal Complications Of Labour An...	22 (1.71%)
Pulmonary Vascular	22 (1.71%)
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Appetite And General Nutritional	21 (1.64%)
Medication Errors	21 (1.64%)
Vision	21 (1.64%)
Body Temperature Conditions	19 (1.48%)
Cardiac Arrhythmias	18 (1.4%)
Epidermal And Dermal Conditions	18 (1.4%)
Therapeutic And Nontherapeutic Effe...	18 (1.4%)
Cardiac And Vascular Disorders Cong...	17 (1.32%)
White Blood Cell	17 (1.32%)
Acid-base	16 (1.25%)
Hematology Investigations	15 (1.17%)
Obstetric And Gynecological Therape...	15 (1.17%)
Renal Disorders	15 (1.17%)
Abortions And Stillbirth	14 (1.09%)
Central Nervous System Vascular	14 (1.09%)
Hepatobiliary	14 (1.09%)
Neuromuscular	14 (1.09%)
Respiratory Disorders Congenital	14 (1.09%)
Anxiety Disorders	13 (1.01%)
Gastrointestinal Motility And Defec...	13 (1.01%)
Infections - Pathogen Unspecified	13 (1.01%)
Sleep Disorders	12 (.93%)
Fetal Complications	11 (.86%)
Metabolic, Nutritional And Blood Ga...	11 (.86%)
Urinary Tract Signs	11 (.86%)
Movement Disorders	10 (.78%)
Neurological, Special Senses And Ps...	10 (.78%)
Renal And Urinary Tract Investigati...	10 (.78%)
Therapeutic Procedures And Supporti...	10 (.78%)
Electrolyte And Fluid Balance Condi...	9 (.7%)
Muscle	9 (.7%)
Musculoskeletal And Connective Tiss...	9 (.7%)
Bacterial Infectious	8 (.62%)
Bone Disorders	8 (.62%)
Decreased And Nonspecific Blood Pre...	7 (.55%)
Exocrine Pancreas Conditions	7 (.55%)
Neonatal Respiratory	7 (.55%)
Thoracic Disorders	7 (.55%)
Tissue	7 (.55%)
Anterior Eye Structural Change, Dep...	6 (.47%)
Cardiac And Vascular Investigations	6 (.47%)
Depressed Mood Disorders	6 (.47%)
Ear And Labyrinthine Disorders Cong...	6 (.47%)
Embolism And Thrombosis	6 (.47%)
Glaucoma And Ocular Hypertension	6 (.47%)
Joint	6 (.47%)
Mental Impairment	6 (.47%)
Red Blood Cell	6 (.47%)
Skin Appendage Conditions	6 (.47%)
Upper Respiratory Tract Disorders	6 (.47%)
Coagulopathies And Bleeding Diathes...	5 (.39%)
Congenital And Hereditary	5 (.39%)
Deliria	5 (.39%)
Encephalopathies	5 (.39%)
Maternal Complications Of Pregnancy	5 (.39%)
Neurological Disorders Congenital	5 (.39%)
Pregnancy, Labour, Delivery And Pos...	5 (.39%)
Bone And Joint Injuries	4 (.31%)
Bronchial Disorders	4 (.31%)
Fatal Outcomes	4 (.31%)
Food Intolerance Syndromes	4 (.31%)
Gastrointestinal Conditions	4 (.31%)
Glucose Metabolism Disorders	4 (.31%)
Headaches	4 (.31%)
Injuries	4 (.31%)
Lower Respiratory Tract Disorders	4 (.31%)
Mood Disorders	4 (.31%)
Musculoskeletal And Connective Tiss...	4 (.31%)
Ocular Neuromuscular	4 (.31%)
Ocular Structural Change, Deposit A...	4 (.31%)
Platelet	4 (.31%)
Suicidal And Self-injurious Behavio...	4 (.31%)
External Ear Disorders	3 (.23%)
Gastrointestinal Hemorrhages	3 (.23%)
Gastrointestinal Stenosis And Obstr...	3 (.23%)
Hemolyses And Related Conditions	3 (.23%)
Increased Intracranial Pressure And...	3 (.23%)
Injuries By Physical Agents	3 (.23%)
Microbiology And Serology	3 (.23%)
Myocardial	3 (.23%)
Neurological Disorders Of The Eye	3 (.23%)
Ocular Infections, Irritations And ...	3 (.23%)
Skin Vascular Abnormalities	3 (.23%)
Allergic Conditions	2 (.16%)
Autoimmune	2 (.16%)
Bladder And Bladder Neck Disorders	2 (.16%)
Blood And Lymphatic System Disorder...	2 (.16%)
Cardiac Disorder Signs	2 (.16%)
Changes In Physical Activity	2 (.16%)
Dental And Gingival Conditions	2 (.16%)

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