NORDITROPIN SIMPLEXX

Norditropin Simplexx Adverse Events Reported to the FDA Over Time

How are Norditropin Simplexx adverse event reports trending over time?

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

Most Common Norditropin Simplexx Adverse Events Reported to the FDA

What are the most common Norditropin Simplexx adverse events reported to the FDA?

Headache	15 (2.32%)
Condition Aggravated	14 (2.17%)
Malaise	13 (2.01%)
Pyrexia	13 (2.01%)
Disease Recurrence	12 (1.86%)
Sleep Apnoea Syndrome	9 (1.39%)
Pruritus	8 (1.24%)
Vomiting	8 (1.24%)
Nausea	7 (1.08%)
Anaphylactic Shock	6 (.93%)
Blood Thyroid Stimulating Hormone D...	6 (.93%)
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Fatigue	6 (.93%)
Joint Dislocation	6 (.93%)
Kyphoscoliosis	6 (.93%)
Neck Pain	6 (.93%)
Pain In Extremity	6 (.93%)
Paraesthesia	6 (.93%)
Torticollis	6 (.93%)
Weight Decreased	6 (.93%)
Back Pain	5 (.77%)
Convulsion	5 (.77%)
Dehydration	5 (.77%)
Drug Exposure During Pregnancy	5 (.77%)
Hot Flush	5 (.77%)
Inflammation	5 (.77%)
Loss Of Consciousness	5 (.77%)
Lymphadenopathy	5 (.77%)
Myokymia	5 (.77%)
Osteochondrosis	5 (.77%)
Palpitations	5 (.77%)
Sinus Tachycardia	5 (.77%)
Upper Respiratory Tract Infection	5 (.77%)
Anxiety	4 (.62%)
Appendicitis	4 (.62%)
Diarrhoea	4 (.62%)
Gastroenteritis	4 (.62%)
Hypertension	4 (.62%)
Hypertrophic Cardiomyopathy	4 (.62%)
Hypotension	4 (.62%)
Hypoventilation	4 (.62%)
Medulloblastoma	4 (.62%)
Meningitis Viral	4 (.62%)
Meningorrhagia	4 (.62%)
Parosmia	4 (.62%)
Petechiae	4 (.62%)
Prosthesis Implantation	4 (.62%)
Respiratory Distress	4 (.62%)
Strabismus	4 (.62%)
Thrombocytopenia	4 (.62%)
Abortion Spontaneous	3 (.46%)
Abscess Oral	3 (.46%)
Arthralgia	3 (.46%)
Asthenia	3 (.46%)
Asthma	3 (.46%)
Astrocytoma	3 (.46%)
Blood Immunoglobulin E Increased	3 (.46%)
Brain Neoplasm	3 (.46%)
Brain Scan Abnormal	3 (.46%)
C-reactive Protein Increased	3 (.46%)
Chromosome Analysis Abnormal	3 (.46%)
Decreased Appetite	3 (.46%)
Dizziness	3 (.46%)
Epistaxis	3 (.46%)
Erysipelas	3 (.46%)
Eye Oedema	3 (.46%)
Germ Cell Cancer	3 (.46%)
Glomerulonephritis Proliferative	3 (.46%)
Hypersomnia	3 (.46%)
Musculoskeletal Stiffness	3 (.46%)
Myalgia	3 (.46%)
Nasopharyngitis	3 (.46%)
Neuroendocrine Carcinoma Of The Ski...	3 (.46%)
Osteoarthritis	3 (.46%)
Osteonecrosis	3 (.46%)
Pallor	3 (.46%)
Renal Failure	3 (.46%)
Spinal Osteoarthritis	3 (.46%)
Wolff-parkinson-white Syndrome	3 (.46%)
Wrist Fracture	3 (.46%)
Abdominal Pain Lower	2 (.31%)
Acromegaly	2 (.31%)
Adenoidal Disorder	2 (.31%)
Alanine Aminotransferase Increased	2 (.31%)
Anaemia	2 (.31%)
Aspartate Aminotransferase Increase...	2 (.31%)
Blood Creatine Phosphokinase Increa...	2 (.31%)
Blood Test Abnormal	2 (.31%)
Breast Cancer Stage Ii	2 (.31%)
Caesarean Section	2 (.31%)
Cardiomyopathy	2 (.31%)
Carpal Tunnel Syndrome	2 (.31%)
Colon Cancer Metastatic	2 (.31%)
Death	2 (.31%)
Depression	2 (.31%)
Developmental Glaucoma	2 (.31%)
Diabetes Mellitus	2 (.31%)
Diplopia	2 (.31%)
Drug Hypersensitivity	2 (.31%)
Electromyogram Abnormal	2 (.31%)
Erythema	2 (.31%)
Foetal Heart Rate Disorder	2 (.31%)

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

What are the most common Norditropin Simplexx adverse events reported to the FDA?

Infections - Pathogen Unspecified	32 (4.95%)
Neurological	24 (3.72%)
Musculoskeletal And Connective Tiss...	22 (3.41%)
Respiratory	22 (3.41%)
Gastrointestinal Signs	19 (2.94%)
Muscle	18 (2.79%)
Headaches	17 (2.63%)
Epidermal And Dermal Conditions	15 (2.32%)
Body Temperature Conditions	13 (2.01%)
Nervous System Neoplasms Malignant ...	11 (1.7%)
Viral Infectious	11 (1.7%)
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Allergic Conditions	10 (1.55%)
Cardiac Arrhythmias	10 (1.55%)
Endocrine Investigations	10 (1.55%)
Joint	10 (1.55%)
Bone And Joint Injuries	9 (1.39%)
Seizures	9 (1.39%)
Vascular	9 (1.39%)
Miscellaneous And Site Unspecified ...	8 (1.24%)
Musculoskeletal And Connective Tiss...	8 (1.24%)
Myocardial	8 (1.24%)
Anemias Nonhemolytic And Marrow Dep...	7 (1.08%)
Central Nervous System Vascular	7 (1.08%)
Electrolyte And Fluid Balance Condi...	7 (1.08%)
Renal Disorders	7 (1.08%)
Upper Respiratory Tract Disorders	7 (1.08%)
White Blood Cell	7 (1.08%)
Bacterial Infectious	6 (.93%)
Cardiac Disorder Signs	6 (.93%)
Chemical Injury And Poisoning	6 (.93%)
Cranial Nerve Disorders	6 (.93%)
Neurological, Special Senses And Ps...	6 (.93%)
Peripheral Neuropathies	6 (.93%)
Physical Examination Topics	6 (.93%)
Procedural And Device Related Injur...	6 (.93%)
Skin Vascular Abnormalities	6 (.93%)
Immunology And Allergy	5 (.77%)
Spleen, Lymphatic And Reticulendoth...	5 (.77%)
Tendon, Ligament And Cartilage	5 (.77%)
Therapeutic Procedures And Supporti...	5 (.77%)
Anxiety Disorders	4 (.62%)
Appetite And General Nutritional	4 (.62%)
Decreased And Nonspecific Blood Pre...	4 (.62%)
Gastrointestinal Motility And Defec...	4 (.62%)
Hematology Investigations	4 (.62%)
Hepatobiliary	4 (.62%)
Movement Disorders	4 (.62%)
Nephropathies	4 (.62%)
Ocular Neuromuscular	4 (.62%)
Platelet	4 (.62%)
Protein And Chemistry Analyses	4 (.62%)
Skin Neoplasms Malignant And Unspec...	4 (.62%)
Vascular Hypertensive	4 (.62%)
Abortions And Stillbirth	3 (.46%)
Bone Disorders	3 (.46%)
Breast Neoplasms Malignant And Unsp...	3 (.46%)
Bronchial Disorders	3 (.46%)
Cytogenetic	3 (.46%)
Eye	3 (.46%)
Fatal Outcomes	3 (.46%)
Hematological And Lymphoid Tissue T...	3 (.46%)
Hypothalamus And Pituitary Gland	3 (.46%)
Increased Intracranial Pressure And...	3 (.46%)
Investigations, Imaging And Histopa...	3 (.46%)
Medication Errors	3 (.46%)
Metabolic, Nutritional And Blood Ga...	3 (.46%)
Musculoskeletal And Connective Tiss...	3 (.46%)
Neonatal And Perinatal Conditions	3 (.46%)
Renal And Urinary Tract Neoplasms M...	3 (.46%)
Sleep Disturbances	3 (.46%)
Acid-base	2 (.31%)
Cardiac And Vascular Investigations	2 (.31%)
Changes In Physical Activity	2 (.31%)
Depressed Mood Disorders	2 (.31%)
Enzyme	2 (.31%)
Eye Disorders Congenital	2 (.31%)
Gastrointestinal Neoplasms Malignan...	2 (.31%)
Glucose Metabolism Disorders	2 (.31%)
Head And Neck Therapeutic Procedure...	2 (.31%)
Lipid Analyses	2 (.31%)
Metastases	2 (.31%)
Obstetric And Gynecological Therape...	2 (.31%)
Ocular Structural Change, Deposit A...	2 (.31%)
Ovarian And Fallopian Tube	2 (.31%)
Parathyroid Gland	2 (.31%)
Placental, Amniotic And Cavity Diso...	2 (.31%)
Urethral Disorders	2 (.31%)
Urinary Tract Signs	2 (.31%)
Vision	2 (.31%)
Abdominal Hernias And Other Abdomin...	1 (.15%)
Administration Site Reactions	1 (.15%)
Adrenal Gland	1 (.15%)
Aural	1 (.15%)
Autoimmune	1 (.15%)
Blood And Lymphatic System Disorder...	1 (.15%)
Bone And Joint Therapeutic Procedur...	1 (.15%)
Breast	1 (.15%)
Central Nervous System Infections A...	1 (.15%)
Congenital And Hereditary	1 (.15%)
Diabetic Complications	1 (.15%)
Endocrine Neoplasms Malignant And U...	1 (.15%)

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