INOMAX

Adverse Events

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Inomax Adverse Events Reported to the FDA Over Time

How are Inomax adverse event reports trending over time?

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

Most Common Inomax Adverse Events Reported to the FDA

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

Oxygen Saturation Decreased	79 (7.5%)
Device Failure	55 (5.22%)
Cardio-respiratory Arrest	34 (3.23%)
Neonatal Disorder	33 (3.13%)
Device Malfunction	27 (2.56%)
Intraventricular Haemorrhage Neonat...	27 (2.56%)
Patent Ductus Arteriosus	27 (2.56%)
Cardiac Arrest	18 (1.71%)
General Physical Health Deteriorati...	17 (1.61%)
Heart Rate Decreased	17 (1.61%)
Blood Pressure Decreased	16 (1.52%)
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Bradycardia	14 (1.33%)
Medical Device Complication	14 (1.33%)
Pneumothorax	14 (1.33%)
Hypotension	13 (1.23%)
Acidosis	12 (1.14%)
Pulmonary Haemorrhage	12 (1.14%)
Anaemia Neonatal	10 (.95%)
Bradycardia Neonatal	10 (.95%)
Death	10 (.95%)
Intestinal Perforation	10 (.95%)
Hypoxia	9 (.85%)
Multi-organ Failure	9 (.85%)
Pulmonary Hypertension	9 (.85%)
Sepsis Neonatal	9 (.85%)
Medication Error	8 (.76%)
Neonatal Hypotension	8 (.76%)
Death Neonatal	7 (.66%)
Device Misuse	7 (.66%)
Disseminated Intravascular Coagulat...	7 (.66%)
Metabolic Acidosis	7 (.66%)
Necrotising Enterocolitis Neonatal	7 (.66%)
No Therapeutic Response	7 (.66%)
Off Label Use	7 (.66%)
Respiratory Failure	7 (.66%)
Right Ventricular Failure	7 (.66%)
Post Procedural Complication	6 (.57%)
Shock	6 (.57%)
Acute Chest Syndrome	5 (.47%)
Cerebral Haemorrhage	5 (.47%)
Hyperglycaemia	5 (.47%)
Neonatal Hypoxia	5 (.47%)
Neonatal Respiratory Distress Syndr...	5 (.47%)
Premature Baby	5 (.47%)
Pulmonary Embolism	5 (.47%)
Pulmonary Oedema	5 (.47%)
Renal Failure	5 (.47%)
Respiratory Disorder Neonatal	5 (.47%)
Sepsis	5 (.47%)
Ventricular Fibrillation	5 (.47%)
Abdominal Distension	4 (.38%)
C-reactive Protein Increased	4 (.38%)
Cardiac Arrest Neonatal	4 (.38%)
Condition Aggravated	4 (.38%)
Haemoglobin Decreased	4 (.38%)
Haemorrhage Intracranial	4 (.38%)
Klebsiella Infection	4 (.38%)
Oliguria	4 (.38%)
Platelet Count Decreased	4 (.38%)
Pulmonary Arterial Pressure Increas...	4 (.38%)
Skin Discolouration	4 (.38%)
Staphylococcal Infection	4 (.38%)
Thrombocytopenia Neonatal	4 (.38%)
Accidental Exposure	3 (.28%)
Anaemia	3 (.28%)
Atrial Fibrillation	3 (.28%)
Coagulopathy	3 (.28%)
Device Leakage	3 (.28%)
Dilatation Ventricular	3 (.28%)
Drug Ineffective	3 (.28%)
Endocarditis	3 (.28%)
Generalised Oedema	3 (.28%)
Hypercapnia	3 (.28%)
Intraventricular Haemorrhage	3 (.28%)
Lung Consolidation	3 (.28%)
Necrotising Colitis	3 (.28%)
Neonatal Respiratory Acidosis	3 (.28%)
Peritonitis	3 (.28%)
Pleural Effusion	3 (.28%)
Pneumatosis Intestinalis	3 (.28%)
Pneumonia	3 (.28%)
Procedural Complication	3 (.28%)
Pulmonary Interstitial Emphysema Sy...	3 (.28%)
Tricuspid Valve Incompetence	3 (.28%)
Wrong Drug Administered	3 (.28%)
Aspiration	2 (.19%)
Atelectasis Neonatal	2 (.19%)
Blood Glucose Increased	2 (.19%)
Blood Ph Decreased	2 (.19%)
Blood Pressure Increased	2 (.19%)
Brain Death	2 (.19%)
Brain Oedema	2 (.19%)
Bronchial Secretion Retention	2 (.19%)
Candida Sepsis	2 (.19%)
Capillary Leak Syndrome	2 (.19%)
Cardiac Index Decreased	2 (.19%)
Cardiac Murmur	2 (.19%)
Cardio-respiratory Arrest Neonatal	2 (.19%)
Cardiovascular Disorder	2 (.19%)
Central Venous Pressure Increased	2 (.19%)
Cerebral Ventricle Dilatation	2 (.19%)

Share/Embed Graph Export Data

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

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

Procedural And Device Related Injur...	131 (12.44%)
Cardiac Arrhythmias	93 (8.83%)
Metabolic, Nutritional And Blood Ga...	87 (8.26%)
Cardiac And Vascular Investigations	52 (4.94%)
Respiratory	44 (4.18%)
Central Nervous System Vascular	43 (4.08%)
Neonatal And Perinatal Conditions	39 (3.7%)
Cardiac And Vascular Disorders Cong...	31 (2.94%)
Decreased And Nonspecific Blood Pre...	30 (2.85%)
Infections - Pathogen Unspecified	30 (2.85%)
Neonatal Respiratory	26 (2.47%)
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Acid-base	22 (2.09%)
Fatal Outcomes	19 (1.8%)
Medication Errors	19 (1.8%)
Lower Respiratory Tract Disorders	18 (1.71%)
Hematology Investigations	17 (1.61%)
Pleural	17 (1.61%)
Pulmonary Vascular	16 (1.52%)
Bacterial Infectious	14 (1.33%)
Gastrointestinal Ulceration And Per...	14 (1.33%)
Renal Disorders	14 (1.33%)
Anemias Nonhemolytic And Marrow Dep...	13 (1.23%)
Myocardial	13 (1.23%)
Therapeutic And Nontherapeutic Effe...	12 (1.14%)
Therapeutic Procedures And Supporti...	12 (1.14%)
Gastrointestinal Inflammatory Condi...	11 (1.04%)
Coagulopathies And Bleeding Diathes...	10 (.95%)
Gastrointestinal Signs	9 (.85%)
Heart Failures	9 (.85%)
Glucose Metabolism Disorders	6 (.57%)
Platelet	6 (.57%)
Vascular	6 (.57%)
Hemoglobinopathies	5 (.47%)
Bronchial Disorders	4 (.38%)
Cardiac Disorder Signs	4 (.38%)
Cardiac Valve	4 (.38%)
Chemical Injury And Poisoning	4 (.38%)
Epidermal And Dermal Conditions	4 (.38%)
Hematological And Lymphoid Tissue T...	4 (.38%)
Hepatic And Hepatobiliary	4 (.38%)
Increased Intracranial Pressure And...	4 (.38%)
Injuries	4 (.38%)
Neurological	4 (.38%)
Peritoneal And Retroperitoneal Cond...	4 (.38%)
Protein And Chemistry Analyses	4 (.38%)
Renal And Urinary Tract Disorders C...	4 (.38%)
Body Temperature Conditions	3 (.28%)
Electrolyte And Fluid Balance Condi...	3 (.28%)
Fungal Infectious	3 (.28%)
Movement Disorders	3 (.28%)
Respiratory Disorders Congenital	3 (.28%)
Water, Electrolyte And Mineral	3 (.28%)
Appetite And General Nutritional	2 (.19%)
Encephalopathies	2 (.19%)
Fetal Complications	2 (.19%)
Gastrointestinal Stenosis And Obstr...	2 (.19%)
Muscle	2 (.19%)
Physical Examination Topics	2 (.19%)
Placental, Amniotic And Cavity Diso...	2 (.19%)
Red Blood Cell	2 (.19%)
Renal And Urinary Tract Investigati...	2 (.19%)
Spleen, Lymphatic And Reticulendoth...	2 (.19%)
Structural Brain	2 (.19%)
Thoracic Disorders	2 (.19%)
Upper Respiratory Tract Disorders	2 (.19%)
Vascular Hemorrhagic	2 (.19%)
Blood And Lymphatic System Disorder...	1 (.09%)
Changes In Physical Activity	1 (.09%)
Deliria	1 (.09%)
Gastrointestinal	1 (.09%)
Gastrointestinal Conditions	1 (.09%)
Gastrointestinal Hemorrhages	1 (.09%)
Gastrointestinal Vascular Condition...	1 (.09%)
Headaches	1 (.09%)
Joint	1 (.09%)
Microbiology And Serology	1 (.09%)
Miscellaneous And Site Unspecified ...	1 (.09%)
Musculoskeletal And Connective Tiss...	1 (.09%)
Mycoplasmal Infectious	1 (.09%)
Neurological, Special Senses And Ps...	1 (.09%)
Obstetric And Gynecological Therape...	1 (.09%)
Pericardial	1 (.09%)
Product Quality Issues	1 (.09%)
Respiratory And Pulmonary Investiga...	1 (.09%)
Seizures	1 (.09%)
Tissue	1 (.09%)
Toxicology And Therapeutic Drug Mon...	1 (.09%)
Urinary Tract Signs	1 (.09%)
Vascular Therapeutic Procedures	1 (.09%)
White Blood Cell	1 (.09%)

Share/Embed Graph Export Data

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

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

Prophylaxis	71
Lung Disorder	70
Pulmonary Hypertension	51
Hypoxia	12
Acute Respiratory Distress Syndrome	12
Product Used For Unknown Indication	10
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Persistent Foetal Circulation	10
Oxygen Saturation Decreased	8
Neonatal Respiratory Distress Syndr...	8
Vasodilation Procedure	7
Respiratory Failure	5
Sickle Cell Anaemia	5
Bronchopulmonary Dysplasia	5
Pulmonary Arterial Hypertension	4
Pulmonary Arterial Pressure Increas...	4
Medical Device Implantation	3
Ventricular Assist Device Insertion	3
Myocardial Infarction	2
Respiratory Disorder	2
Oxygen Saturation Abnormal	2
Premature Baby	2
Acute Respiratory Failure	2
Neonatal Aspiration	2
Right Ventricular Failure	1
H1n1 Influenza	1
Mechanical Ventilation	1
Ventilation Perfusion Mismatch	1
Cardiac Operation	1
Endotracheal Intubation	1
Lung Transplant	1
Venous Oxygen Saturation	1
Mean Arterial Pressure Decreased	1
Chronic Left Ventricular Failure	1
Oxygen Saturation Increased	1
Accidental Exposure	1
Oxygen Supplementation	1
Diagnostic Procedure	1
Oxygen Saturation	1
Pollution	1
Drug Use For Unknown Indication	1
Heart Transplant	1
Pulmonary Arterial Pressure	1
Vascular Test	1
Pneumonia	1
Pleural Effusion	1
Cardiopulmonary Failure	1
Pulmonary Fibrosis	1
Lung Injury	1
Pulmonary Haemorrhage	1
Sickle Cell Anaemia With Crisis	1
Congenital Cardiovascular Anomaly	1

Drug Labels

Label	Labeler	Effective
Inomax	INO Therapeutics	09-JUL-11

Inomax Case Reports

What Inomax 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 Inomax. 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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