NEOPROFEN

Neoprofen Adverse Events Reported to the FDA Over Time

How are Neoprofen adverse event reports trending over time?

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

Most Common Neoprofen Adverse Events Reported to the FDA

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

Bronchopulmonary Dysplasia	96 (23.88%)
Completed Suicide	27 (6.72%)
Necrotising Colitis	18 (4.48%)
Intestinal Perforation	17 (4.23%)
Pulmonary Hypertension	17 (4.23%)
Death	15 (3.73%)
Stevens-johnson Syndrome	10 (2.49%)
Gastrointestinal Perforation	8 (1.99%)
Neonatal Disorder	8 (1.99%)
Necrotising Enterocolitis Neonatal	7 (1.74%)
Neonatal Hypotension	5 (1.24%)
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Abdominal Abscess	4 (1%)
Cardiac Arrest	4 (1%)
Haemorrhage Intracranial	4 (1%)
Haemorrhage Neonatal	4 (1%)
Ileal Perforation	4 (1%)
Abdominal Distension	3 (.75%)
Death Neonatal	3 (.75%)
Erythema Multiforme	3 (.75%)
Intraventricular Haemorrhage	3 (.75%)
Large Intestine Perforation	3 (.75%)
Peritonitis	3 (.75%)
Renal Failure Neonatal	3 (.75%)
Retinopathy Of Prematurity	3 (.75%)
Sepsis Neonatal	3 (.75%)
Anuria	2 (.5%)
Aspiration	2 (.5%)
Condition Aggravated	2 (.5%)
Erythema	2 (.5%)
Fungal Infection	2 (.5%)
Gastric Perforation	2 (.5%)
Gastrointestinal Necrosis	2 (.5%)
Hepatic Haemorrhage	2 (.5%)
Intentional Self-injury	2 (.5%)
Medication Error	2 (.5%)
Neutropenia	2 (.5%)
No Therapeutic Response	2 (.5%)
Patent Ductus Arteriosus	2 (.5%)
Peritoneal Fluid Analysis Abnormal	2 (.5%)
Pneumoperitoneum	2 (.5%)
Product Quality Issue	2 (.5%)
Renal Failure	2 (.5%)
Renal Failure Acute	2 (.5%)
Respiratory Arrest	2 (.5%)
Skin Discolouration	2 (.5%)
Skin Haemorrhage	2 (.5%)
Small Intestinal Perforation	2 (.5%)
Substance Abuse	2 (.5%)
Toxic Epidermal Necrolysis	2 (.5%)
Urine Output Decreased	2 (.5%)
Vascular Resistance Pulmonary Incre...	2 (.5%)
Agitation	1 (.25%)
Anaemia Neonatal	1 (.25%)
Apnoea	1 (.25%)
Arrhythmia	1 (.25%)
Bacteraemia	1 (.25%)
Bilirubin Conjugated Increased	1 (.25%)
Blood Creatinine Decreased	1 (.25%)
Blood Potassium Increased	1 (.25%)
Blood Pressure Decreased	1 (.25%)
Bradycardia Neonatal	1 (.25%)
Chorioamnionitis	1 (.25%)
Corneal Oedema	1 (.25%)
Dehydration	1 (.25%)
Depressed Level Of Consciousness	1 (.25%)
Developmental Delay	1 (.25%)
Dilatation Ventricular	1 (.25%)
Discomfort	1 (.25%)
Drug Abuser	1 (.25%)
Drug Interaction	1 (.25%)
Drug Screen Positive	1 (.25%)
Dyskinesia	1 (.25%)
Euthyroid Sick Syndrome	1 (.25%)
Failure To Thrive	1 (.25%)
Feeding Disorder Neonatal	1 (.25%)
Gastrointestinal Anastomotic Leak	1 (.25%)
Gastrointestinal Disorder	1 (.25%)
Gastrointestinal Haemorrhage	1 (.25%)
Generalised Oedema	1 (.25%)
Haemorrhage	1 (.25%)
Hepatitis C	1 (.25%)
Hyperbilirubinaemia	1 (.25%)
Hypokinesia Neonatal	1 (.25%)
Hypothyroidism	1 (.25%)
Hypoxia	1 (.25%)
Incorrect Dose Administered	1 (.25%)
Incorrect Drug Administration Durat...	1 (.25%)
Incorrect Route Of Drug Administrat...	1 (.25%)
Infection	1 (.25%)
Intentional Drug Misuse	1 (.25%)
Intercepted Drug Dispensing Error	1 (.25%)
Intra-abdominal Haemorrhage	1 (.25%)
Intraventricular Haemorrhage Neonat...	1 (.25%)
Late Metabolic Acidosis Of Newborn	1 (.25%)
Lung Disorder	1 (.25%)
Meconium Increased	1 (.25%)
Neonatal Anuria	1 (.25%)
Neonatal Cholestasis	1 (.25%)
Neonatal Hypoxia	1 (.25%)
Neonatal Infection	1 (.25%)
Oedema Neonatal	1 (.25%)

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

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

Neonatal Respiratory	98 (24.38%)
Gastrointestinal Ulceration And Per...	36 (8.96%)
Suicidal And Self-injurious Behavio...	29 (7.21%)
Gastrointestinal Inflammatory Condi...	25 (6.22%)
Epidermal And Dermal Conditions	19 (4.73%)
Fatal Outcomes	18 (4.48%)
Pulmonary Vascular	17 (4.23%)
Infections - Pathogen Unspecified	11 (2.74%)
Neonatal And Perinatal Conditions	10 (2.49%)
Renal Disorders	10 (2.49%)
Respiratory	9 (2.24%)
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Central Nervous System Vascular	8 (1.99%)
Cardiac Arrhythmias	6 (1.49%)
Medication Errors	6 (1.49%)
Procedural And Device Related Injur...	6 (1.49%)
Decreased And Nonspecific Blood Pre...	5 (1.24%)
Peritoneal And Retroperitoneal Cond...	5 (1.24%)
Vascular Hemorrhagic	5 (1.24%)
Cardiac And Vascular Investigations	4 (1%)
Hepatic And Hepatobiliary	4 (1%)
Gastrointestinal Signs	3 (.75%)
Hematology Investigations	3 (.75%)
Myocardial	3 (.75%)
Ocular Structural Change, Deposit A...	3 (.75%)
Psychiatric	3 (.75%)
Renal And Urinary Tract Investigati...	3 (.75%)
Therapeutic And Nontherapeutic Effe...	3 (.75%)
Appetite And General Nutritional	2 (.5%)
Cardiac And Vascular Disorders Cong...	2 (.5%)
Fungal Infectious	2 (.5%)
Gastrointestinal	2 (.5%)
Gastrointestinal Hemorrhages	2 (.5%)
Gastrointestinal Vascular Condition...	2 (.5%)
Lifestyle Issues	2 (.5%)
Movement Disorders	2 (.5%)
Product Quality Issues	2 (.5%)
Skin Vascular Abnormalities	2 (.5%)
Thyroid Gland	2 (.5%)
White Blood Cell	2 (.5%)
Acid-base	1 (.25%)
Anemias Nonhemolytic And Marrow Dep...	1 (.25%)
Anxiety Disorders	1 (.25%)
Bacterial Infectious	1 (.25%)
Cardiac Valve	1 (.25%)
Electrolyte And Fluid Balance Condi...	1 (.25%)
Gastrointestinal Conditions	1 (.25%)
Hepatobiliary	1 (.25%)
Legal Issues	1 (.25%)
Metabolic, Nutritional And Blood Ga...	1 (.25%)
Neurological	1 (.25%)
Ocular Infections, Irritations And ...	1 (.25%)
Ocular Neuromuscular	1 (.25%)
Physical Examination Topics	1 (.25%)
Placental, Amniotic And Cavity Diso...	1 (.25%)
Platelet	1 (.25%)
Therapeutic Procedures And Supporti...	1 (.25%)
Toxicology And Therapeutic Drug Mon...	1 (.25%)
Viral Infectious	1 (.25%)
Water, Electrolyte And Mineral	1 (.25%)

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