GLIADEL

Gliadel Adverse Events Reported to the FDA Over Time

How are Gliadel adverse event reports trending over time?

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

Most Common Gliadel Adverse Events Reported to the FDA

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

Convulsion	35 (2.76%)
Brain Oedema	34 (2.68%)
Deep Vein Thrombosis	32 (2.52%)
Intracranial Hypotension	29 (2.29%)
Pulmonary Embolism	25 (1.97%)
Pyrexia	23 (1.81%)
Headache	22 (1.74%)
Hydrocephalus	22 (1.74%)
Post Procedural Complication	22 (1.74%)
Disease Progression	17 (1.34%)
Mental Status Changes	17 (1.34%)
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Thrombocytopenia	17 (1.34%)
Brain Abscess	16 (1.26%)
Staphylococcal Infection	15 (1.18%)
Hyponatraemia	13 (1.03%)
Asthenia	12 (.95%)
Cognitive Disorder	12 (.95%)
Dehydration	12 (.95%)
Somnolence	12 (.95%)
Postoperative Wound Infection	11 (.87%)
Cerebral Haemorrhage	10 (.79%)
Fatigue	10 (.79%)
Intracranial Pressure Increased	10 (.79%)
Muscular Weakness	10 (.79%)
Coma	9 (.71%)
Confusional State	9 (.71%)
Hemiparesis	9 (.71%)
Vomiting	9 (.71%)
Fall	8 (.63%)
Hypotension	8 (.63%)
Infection	8 (.63%)
Meningitis	8 (.63%)
Nausea	8 (.63%)
Sepsis	8 (.63%)
Drug Administration Error	7 (.55%)
Extradural Haematoma	7 (.55%)
Hyperglycaemia	7 (.55%)
Oedema	7 (.55%)
Pseudomeningocele	7 (.55%)
Respiratory Failure	7 (.55%)
Urinary Tract Infection	7 (.55%)
Wound Infection	7 (.55%)
Anaemia	6 (.47%)
Depressed Level Of Consciousness	6 (.47%)
Drug Toxicity	6 (.47%)
Incision Site Complication	6 (.47%)
Inflammation	6 (.47%)
Lethargy	6 (.47%)
Leukopenia	6 (.47%)
Off Label Use	6 (.47%)
Pneumocephalus	6 (.47%)
Pneumonia	6 (.47%)
Wound Dehiscence	6 (.47%)
Arachnoiditis	5 (.39%)
Back Pain	5 (.39%)
Depression	5 (.39%)
General Physical Health Deteriorati...	5 (.39%)
Haematoma	5 (.39%)
Haemoglobin Abnormal	5 (.39%)
Head Injury	5 (.39%)
Implant Site Necrosis	5 (.39%)
Loss Of Consciousness	5 (.39%)
Malignant Neoplasm Progression	5 (.39%)
Metastases To Lung	5 (.39%)
Neoplasm Recurrence	5 (.39%)
Non-small Cell Lung Cancer	5 (.39%)
Pupil Fixed	5 (.39%)
Subdural Haematoma	5 (.39%)
Wound Infection Staphylococcal	5 (.39%)
Wound Secretion	5 (.39%)
Agitation	4 (.32%)
Bacterial Infection	4 (.32%)
Balance Disorder	4 (.32%)
Brain Herniation	4 (.32%)
Brain Mass	4 (.32%)
Cerebral Cyst	4 (.32%)
Computerised Tomogram Abnormal	4 (.32%)
Drug Level Decreased	4 (.32%)
Encephalitis	4 (.32%)
Haemorrhage	4 (.32%)
Hallucination	4 (.32%)
Hypokalaemia	4 (.32%)
Implant Site Reaction	4 (.32%)
Necrosis	4 (.32%)
Neoplasm Progression	4 (.32%)
Neurological Symptom	4 (.32%)
Nuclear Magnetic Resonance Imaging ...	4 (.32%)
Osteitis	4 (.32%)
Partial Seizures	4 (.32%)
Pneumonia Aspiration	4 (.32%)
Postictal State	4 (.32%)
Propionibacterium Infection	4 (.32%)
Visual Acuity Reduced	4 (.32%)
Anxiety	3 (.24%)
Candidiasis	3 (.24%)
Central Nervous System Infection	3 (.24%)
Cerebral Haematoma	3 (.24%)
Cerebral Ischaemia	3 (.24%)
Cerebral Ventricle Dilatation	3 (.24%)
Chest Pain	3 (.24%)
Chills	3 (.24%)

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

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

Neurological	106 (8.36%)
Infections - Pathogen Unspecified	102 (8.04%)
Increased Intracranial Pressure And...	66 (5.21%)
Procedural And Device Related Injur...	60 (4.73%)
Seizures	48 (3.79%)
Injuries	43 (3.39%)
Bacterial Infectious	39 (3.08%)
Embolism And Thrombosis	37 (2.92%)
Electrolyte And Fluid Balance Condi...	30 (2.37%)
Central Nervous System Vascular	28 (2.21%)
Pulmonary Vascular	25 (1.97%)
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Body Temperature Conditions	24 (1.89%)
Gastrointestinal Signs	23 (1.81%)
Hematology Investigations	23 (1.81%)
Headaches	22 (1.74%)
Respiratory	22 (1.74%)
Miscellaneous And Site Unspecified ...	18 (1.42%)
Platelet	17 (1.34%)
Psychiatric	17 (1.34%)
Administration Site Reactions	14 (1.1%)
Central Nervous System Infections A...	12 (.95%)
Mental Impairment	12 (.95%)
Muscle	12 (.95%)
Neurological, Special Senses And Ps...	12 (.95%)
Ocular Neuromuscular	12 (.95%)
Anemias Nonhemolytic And Marrow Dep...	11 (.87%)
Chemical Injury And Poisoning	11 (.87%)
Movement Disorders	11 (.87%)
Musculoskeletal And Connective Tiss...	11 (.87%)
Structural Brain	11 (.87%)
Deliria	10 (.79%)
Microbiology And Serology	10 (.79%)
Therapeutic Procedures And Supporti...	10 (.79%)
Vascular Hemorrhagic	10 (.79%)
Vision	10 (.79%)
White Blood Cell	10 (.79%)
Decreased And Nonspecific Blood Pre...	9 (.71%)
Metastases	9 (.71%)
Water, Electrolyte And Mineral	9 (.71%)
Cardiac Arrhythmias	8 (.63%)
Investigations, Imaging And Histopa...	8 (.63%)
Respiratory And Mediastinal Neoplas...	8 (.63%)
Anxiety Disorders	7 (.55%)
Glucose Metabolism Disorders	7 (.55%)
Medication Errors	7 (.55%)
Nervous System Neoplasms Malignant ...	7 (.55%)
Toxicology And Therapeutic Drug Mon...	7 (.55%)
Epidermal And Dermal Conditions	6 (.47%)
Gastrointestinal Motility And Defec...	6 (.47%)
Lower Respiratory Tract Disorders	6 (.47%)
Metabolic, Nutritional And Blood Ga...	6 (.47%)
Neoplasm Related Morbidities	6 (.47%)
Nervous System Neoplasms Benign	6 (.47%)
Therapeutic And Nontherapeutic Effe...	6 (.47%)
Tissue	6 (.47%)
Depressed Mood Disorders	5 (.39%)
Disturbances In Thinking	5 (.39%)
Hepatobiliary	5 (.39%)
Renal Disorders	5 (.39%)
Appetite And General Nutritional	4 (.32%)
Bone Disorders	4 (.32%)
Blood And Lymphatic System Disorder...	3 (.24%)
Encephalopathies	3 (.24%)
Enzyme	3 (.24%)
Fatal Outcomes	3 (.24%)
Fungal Infectious	3 (.24%)
Gastrointestinal Ulceration And Per...	3 (.24%)
Neuromuscular	3 (.24%)
Peritoneal And Retroperitoneal Cond...	3 (.24%)
Physical Examination Topics	3 (.24%)
Pleural	3 (.24%)
Protein And Amino Acid Metabolism	3 (.24%)
Schizophrenia And Other Psychotic	3 (.24%)
Arteriosclerosis, Stenosis, Vascula...	2 (.16%)
Bone, Calcium, Magnesium And Phosph...	2 (.16%)
Cardiac And Vascular Investigations	2 (.16%)
Cardiac Valve	2 (.16%)
Coagulopathies And Bleeding Diathes...	2 (.16%)
Gastrointestinal	2 (.16%)
Hematological	2 (.16%)
Injuries By Physical Agents	2 (.16%)
Personality Disorders	2 (.16%)
Protein And Chemistry Analyses	2 (.16%)
Renal And Urinary Tract Investigati...	2 (.16%)
Skin Appendage Conditions	2 (.16%)
Thyroid Gland	2 (.16%)
Urinary Tract Signs	2 (.16%)
Viral Infectious	2 (.16%)
Abdominal Hernias And Other Abdomin...	1 (.08%)
Cognitive And Attention Disorders	1 (.08%)
Communication Disorders	1 (.08%)
Eating Disorders	1 (.08%)
Gastrointestinal Hemorrhages	1 (.08%)
Gastrointestinal Inflammatory Condi...	1 (.08%)
Gastrointestinal Stenosis And Obstr...	1 (.08%)
Hepatic And Hepatobiliary	1 (.08%)
Inner Ear And Viiith Cranial Nerve	1 (.08%)
Joint	1 (.08%)
Leukemias	1 (.08%)
Lifestyle Issues	1 (.08%)
Mood Disorders	1 (.08%)

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