NOVORAPID FLEXPEN

Novorapid Flexpen Adverse Events Reported to the FDA Over Time

How are Novorapid Flexpen adverse event reports trending over time?

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

Most Common Novorapid Flexpen Adverse Events Reported to the FDA

What are the most common Novorapid Flexpen adverse events reported to the FDA?

Hypoglycaemia	90 (6.75%)
Blood Glucose Increased	37 (2.77%)
Intentional Overdose	28 (2.1%)
Drug Exposure During Pregnancy	27 (2.02%)
Loss Of Consciousness	25 (1.87%)
Fall	18 (1.35%)
Road Traffic Accident	18 (1.35%)
Diabetic Ketoacidosis	17 (1.27%)
Hypoglycaemic Coma	17 (1.27%)
Premature Baby	17 (1.27%)
Suicide Attempt	17 (1.27%)
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Hyperglycaemia	16 (1.2%)
Hypoglycaemic Unconsciousness	16 (1.2%)
Death	15 (1.12%)
Vomiting	15 (1.12%)
Blood Glucose Fluctuation	13 (.97%)
Blood Glucose Decreased	12 (.9%)
Device Failure	12 (.9%)
Drug Ineffective	12 (.9%)
Headache	12 (.9%)
Hypoglycaemic Seizure	12 (.9%)
Acute Stress Disorder	11 (.82%)
Convulsion	11 (.82%)
Diabetes Mellitus Inadequate Contro...	11 (.82%)
Dyspnoea	11 (.82%)
Glioblastoma	10 (.75%)
Hyperhidrosis	10 (.75%)
Hyperosmolar State	10 (.75%)
Hypovolaemia	10 (.75%)
Nausea	10 (.75%)
Coma	9 (.67%)
Myocardial Infarction	9 (.67%)
Sudden Death	9 (.67%)
Cardiac Failure	8 (.6%)
Cerebral Haemorrhage	8 (.6%)
Diarrhoea	8 (.6%)
Malaise	8 (.6%)
Myalgia	8 (.6%)
Pain In Extremity	8 (.6%)
Skull Fracture	8 (.6%)
Anaphylactic Shock	7 (.52%)
Angina Pectoris	7 (.52%)
Asthenia	7 (.52%)
Completed Suicide	7 (.52%)
Device Malfunction	7 (.52%)
Dysphagia	7 (.52%)
Fatigue	7 (.52%)
Intra-uterine Death	7 (.52%)
Muscle Spasms	7 (.52%)
Petit Mal Epilepsy	7 (.52%)
Pregnancy	7 (.52%)
Syncope	7 (.52%)
Visual Impairment	7 (.52%)
Caesarean Section	6 (.45%)
Cardiac Failure Congestive	6 (.45%)
Carpal Tunnel Syndrome	6 (.45%)
Condition Aggravated	6 (.45%)
Oedema Peripheral	6 (.45%)
Pollakiuria	6 (.45%)
Pre-eclampsia	6 (.45%)
Weight Decreased	6 (.45%)
Agitation	5 (.37%)
Atrial Septal Defect	5 (.37%)
Circulatory Collapse	5 (.37%)
Dehydration	5 (.37%)
Hypertension	5 (.37%)
Incorrect Product Storage	5 (.37%)
Intentional Drug Misuse	5 (.37%)
Neonatal Respiratory Distress Syndr...	5 (.37%)
Pain	5 (.37%)
Placental Disorder	5 (.37%)
Ventricular Septal Defect	5 (.37%)
Wrong Drug Administered	5 (.37%)
Abdominal Pain	4 (.3%)
Angioedema	4 (.3%)
Arteriosclerosis	4 (.3%)
B-cell Lymphoma Stage I	4 (.3%)
Brain Neoplasm	4 (.3%)
Cellulitis	4 (.3%)
Cerebrovascular Accident	4 (.3%)
Dermatitis Allergic	4 (.3%)
Diabetic Gangrene	4 (.3%)
Face Injury	4 (.3%)
Foetal Distress Syndrome	4 (.3%)
Gallbladder Cancer Metastatic	4 (.3%)
Gastroenteritis	4 (.3%)
Hepatic Cancer Metastatic	4 (.3%)
Hypersensitivity	4 (.3%)
Hypophagia	4 (.3%)
Hypotension	4 (.3%)
Infection	4 (.3%)
Jaundice	4 (.3%)
Ketosis	4 (.3%)
Lung Cancer Metastatic	4 (.3%)
Overdose	4 (.3%)
Pelvic Fracture	4 (.3%)
Pleural Effusion	4 (.3%)
Pneumonia	4 (.3%)
Pruritus Generalised	4 (.3%)
Pyelonephritis	4 (.3%)
Radius Fracture	4 (.3%)

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

What are the most common Novorapid Flexpen adverse events reported to the FDA?

Glucose Metabolism Disorders	146 (10.94%)
Neurological	87 (6.52%)
Metabolic, Nutritional And Blood Ga...	70 (5.25%)
Injuries	47 (3.52%)
Gastrointestinal Signs	45 (3.37%)
Medication Errors	42 (3.15%)
Infections - Pathogen Unspecified	33 (2.47%)
Chemical Injury And Poisoning	31 (2.32%)
Electrolyte And Fluid Balance Condi...	29 (2.17%)
Bone And Joint Injuries	26 (1.95%)
Epidermal And Dermal Conditions	25 (1.87%)
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Fatal Outcomes	24 (1.8%)
Suicidal And Self-injurious Behavio...	24 (1.8%)
Procedural And Device Related Injur...	22 (1.65%)
Coronary Artery	20 (1.5%)
Neonatal And Perinatal Conditions	20 (1.5%)
Seizures	20 (1.5%)
Cardiac And Vascular Disorders Cong...	18 (1.35%)
Diabetic Complications	18 (1.35%)
Anxiety Disorders	17 (1.27%)
Bacterial Infectious	17 (1.27%)
Muscle	17 (1.27%)
Respiratory	17 (1.27%)
Heart Failures	16 (1.2%)
Cardiac Arrhythmias	15 (1.12%)
Central Nervous System Vascular	15 (1.12%)
Nervous System Neoplasms Malignant ...	14 (1.05%)
Allergic Conditions	13 (.97%)
Hepatobiliary Neoplasms Malignant A...	13 (.97%)
Therapeutic And Nontherapeutic Effe...	13 (.97%)
Headaches	12 (.9%)
Hepatic And Hepatobiliary	12 (.9%)
Abortions And Stillbirth	11 (.82%)
Gastrointestinal Motility And Defec...	11 (.82%)
Musculoskeletal And Connective Tiss...	11 (.82%)
Peripheral Neuropathies	10 (.75%)
Skin Appendage Conditions	10 (.75%)
Vision	10 (.75%)
Arteriosclerosis, Stenosis, Vascula...	9 (.67%)
Decreased And Nonspecific Blood Pre...	9 (.67%)
Maternal Complications Of Pregnancy	9 (.67%)
Placental, Amniotic And Cavity Diso...	9 (.67%)
Urinary Tract Signs	9 (.67%)
Gastrointestinal Neoplasms Malignan...	8 (.6%)
Administration Site Reactions	7 (.52%)
Physical Examination Topics	7 (.52%)
Pregnancy, Labour, Delivery And Pos...	7 (.52%)
Acid-base	6 (.45%)
Fetal Complications	6 (.45%)
Lifestyle Issues	6 (.45%)
Maternal Complications Of Labour An...	6 (.45%)
Obstetric And Gynecological Therape...	6 (.45%)
Pleural	6 (.45%)
Cardiac And Vascular Investigations	5 (.37%)
Hepatobiliary	5 (.37%)
Neonatal Respiratory	5 (.37%)
Product Quality Issues	5 (.37%)
Psychiatric	5 (.37%)
Respiratory And Mediastinal Neoplas...	5 (.37%)
Vascular Hypertensive	5 (.37%)
Angiedema And Urticaria	4 (.3%)
Appetite And General Nutritional	4 (.3%)
Cardiac Valve	4 (.3%)
Joint	4 (.3%)
Lower Respiratory Tract Disorders	4 (.3%)
Lymphomas Non-hodgkins B-cell	4 (.3%)
Mental Impairment	4 (.3%)
Movement Disorders	4 (.3%)
Sleep Disorders	4 (.3%)
Cardiac Disorder Signs	3 (.22%)
Disturbances In Thinking	3 (.22%)
Encephalopathies	3 (.22%)
Exocrine Pancreas Conditions	3 (.22%)
Lipid Metabolism	3 (.22%)
Nephropathies	3 (.22%)
Neuromuscular	3 (.22%)
Oral Soft Tissue Conditions	3 (.22%)
Retina, Choroid And Vitreous Hemorr...	3 (.22%)
Tendon, Ligament And Cartilage	3 (.22%)
Therapeutic Procedures And Supporti...	3 (.22%)
Upper Respiratory Tract Disorders	3 (.22%)
Bronchial Disorders	2 (.15%)
Communication Disorders	2 (.15%)
Cutaneous Neoplasms Benign	2 (.15%)
Deliria	2 (.15%)
Endocrine Disorders Congenital	2 (.15%)
Endocrine Neoplasms Malignant And U...	2 (.15%)
Fetal And Neonatal	2 (.15%)
Gallbladder	2 (.15%)
Gastrointestinal Conditions	2 (.15%)
Immunology And Allergy	2 (.15%)
Leukemias	2 (.15%)
Metabolism	2 (.15%)
Musculoskeletal And Connective Tiss...	2 (.15%)
Neurological, Special Senses And Ps...	2 (.15%)
Ocular Neuromuscular	2 (.15%)
Personality Disorders	2 (.15%)
Pulmonary Vascular	2 (.15%)
Renal And Urinary Tract Investigati...	2 (.15%)
Reproductive Tract And Breast Disor...	2 (.15%)
Skin And Subcutaneous Tissue	2 (.15%)

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