EFALIZUMAB

Efalizumab Adverse Events Reported to the FDA Over Time

How are Efalizumab adverse event reports trending over time?

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

Most Common Efalizumab Adverse Events Reported to the FDA

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

Psoriasis	47 (2.49%)
Condition Aggravated	34 (1.8%)
Pyrexia	32 (1.7%)
Pneumonia	26 (1.38%)
Weight Decreased	26 (1.38%)
Arthralgia	25 (1.33%)
Lymphadenopathy	25 (1.33%)
Headache	20 (1.06%)
Anaemia	18 (.96%)
Vomiting	18 (.96%)
Alanine Aminotransferase Increased	16 (.85%)
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Aspartate Aminotransferase Increase...	16 (.85%)
Death	16 (.85%)
Oedema Peripheral	16 (.85%)
Malaise	15 (.8%)
Nausea	15 (.8%)
Sepsis	14 (.74%)
Back Pain	13 (.69%)
Drug Ineffective	13 (.69%)
Respiratory Failure	13 (.69%)
Asthenia	12 (.64%)
Dermatitis Exfoliative	12 (.64%)
Bladder Cancer	11 (.58%)
Blood Alkaline Phosphatase Increase...	11 (.58%)
Diarrhoea	11 (.58%)
Myalgia	11 (.58%)
Psoriatic Arthropathy	11 (.58%)
Pulmonary Embolism	11 (.58%)
Sinusitis	11 (.58%)
Blood Potassium Increased	10 (.53%)
Pulmonary Oedema	10 (.53%)
Anorexia	9 (.48%)
Chills	9 (.48%)
Myocarditis	9 (.48%)
Splenomegaly	9 (.48%)
White Blood Cell Count Increased	9 (.48%)
Blood Creatinine Increased	8 (.42%)
Dermatitis	8 (.42%)
Influenza Like Illness	8 (.42%)
Lupus-like Syndrome	8 (.42%)
Lymphocytosis	8 (.42%)
Pancreatitis	8 (.42%)
Peripheral T-cell Lymphoma Unspecif...	8 (.42%)
Rash	8 (.42%)
Renal Failure Acute	8 (.42%)
Staphylococcal Infection	8 (.42%)
Abdominal Pain	7 (.37%)
Appendicitis	7 (.37%)
Chest X-ray Abnormal	7 (.37%)
Encephalitis	7 (.37%)
Erythrodermic Psoriasis	7 (.37%)
Hepatic Neoplasm Malignant	7 (.37%)
Hepatitis B	7 (.37%)
Hypertension	7 (.37%)
Leukocytosis	7 (.37%)
Lipoma	7 (.37%)
Pruritus	7 (.37%)
Arthritis	6 (.32%)
Asthma	6 (.32%)
Blood Glucose Increased	6 (.32%)
Cerebral Aspergillosis	6 (.32%)
Completed Suicide	6 (.32%)
Cough	6 (.32%)
Deep Vein Thrombosis	6 (.32%)
Depression	6 (.32%)
Dizziness	6 (.32%)
Eosinophil Count Increased	6 (.32%)
Haemoglobin Decreased	6 (.32%)
Hepatic Enzyme Increased	6 (.32%)
Hyperkeratosis	6 (.32%)
Hypotension	6 (.32%)
Inflammation	6 (.32%)
Intracranial Pressure Increased	6 (.32%)
Meningitis Viral	6 (.32%)
Papilloedema	6 (.32%)
Pneumonia Bacterial	6 (.32%)
Progressive Multifocal Leukoencepha...	6 (.32%)
Pulmonary Congestion	6 (.32%)
Viral Infection	6 (.32%)
Visual Impairment	6 (.32%)
Alopecia	5 (.27%)
Angina Pectoris	5 (.27%)
Blood Cholesterol Increased	5 (.27%)
Cardiac Failure	5 (.27%)
Clostridium Difficile Colitis	5 (.27%)
Dyspnoea	5 (.27%)
Erectile Dysfunction	5 (.27%)
Fatigue	5 (.27%)
Herpes Zoster	5 (.27%)
Hyperpyrexia	5 (.27%)
Joint Swelling	5 (.27%)
Lymphoma	5 (.27%)
Meningitis	5 (.27%)
Muscular Weakness	5 (.27%)
Night Sweats	5 (.27%)
Oedema	5 (.27%)
Pain In Extremity	5 (.27%)
Parakeratosis	5 (.27%)
Pemphigoid	5 (.27%)
Pneumonia Fungal	5 (.27%)
Rash Erythematous	5 (.27%)

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

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

Epidermal And Dermal Conditions	153 (8.12%)
Infections - Pathogen Unspecified	109 (5.79%)
Hematology Investigations	56 (2.97%)
Joint	52 (2.76%)
Hepatobiliary	47 (2.49%)
Viral Infectious	47 (2.49%)
Neurological	44 (2.34%)
Gastrointestinal Signs	43 (2.28%)
Spleen, Lymphatic And Reticulendoth...	42 (2.23%)
Respiratory	40 (2.12%)
Bacterial Infectious	38 (2.02%)
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Body Temperature Conditions	38 (2.02%)
Anemias Nonhemolytic And Marrow Dep...	31 (1.65%)
Physical Examination Topics	30 (1.59%)
Musculoskeletal And Connective Tiss...	27 (1.43%)
Lower Respiratory Tract Disorders	26 (1.38%)
Water, Electrolyte And Mineral	26 (1.38%)
Fungal Infectious	24 (1.27%)
Muscle	23 (1.22%)
Therapeutic And Nontherapeutic Effe...	22 (1.17%)
Cardiac And Vascular Investigations	21 (1.11%)
Fatal Outcomes	20 (1.06%)
Headaches	20 (1.06%)
Microbiology And Serology	19 (1.01%)
Renal And Urinary Tract Investigati...	19 (1.01%)
White Blood Cell	19 (1.01%)
Hepatic And Hepatobiliary	18 (.96%)
Metabolic, Nutritional And Blood Ga...	18 (.96%)
Renal Disorders	17 (.9%)
Enzyme	15 (.8%)
Cardiac Arrhythmias	14 (.74%)
Coronary Artery	14 (.74%)
Lipid Analyses	14 (.74%)
Gastrointestinal Motility And Defec...	13 (.69%)
Myocardial	13 (.69%)
Lymphomas Non-hodgkins T-cell	12 (.64%)
Pulmonary Vascular	12 (.64%)
Renal And Urinary Tract Neoplasms M...	12 (.64%)
Skin Appendage Conditions	12 (.64%)
Appetite And General Nutritional	11 (.58%)
Metastases	11 (.58%)
Central Nervous System Infections A...	10 (.53%)
Central Nervous System Vascular	10 (.53%)
Increased Intracranial Pressure And...	10 (.53%)
Respiratory And Pulmonary Investiga...	10 (.53%)
Skin And Subcutaneous Tissue	10 (.53%)
Vision	10 (.53%)
Inner Ear And Viiith Cranial Nerve	9 (.48%)
Movement Disorders	9 (.48%)
Neurological, Special Senses And Ps...	9 (.48%)
Suicidal And Self-injurious Behavio...	9 (.48%)
Connective Tissue Disorders	8 (.42%)
Exocrine Pancreas Conditions	8 (.42%)
Injuries	8 (.42%)
Vitamin Related	8 (.42%)
Anxiety Disorders	7 (.37%)
Electrolyte And Fluid Balance Condi...	7 (.37%)
Gastrointestinal Vascular Condition...	7 (.37%)
Heart Failures	7 (.37%)
Hepatobiliary Neoplasms Malignant A...	7 (.37%)
Immunology And Allergy	7 (.37%)
Investigations, Imaging And Histopa...	7 (.37%)
Reproductive Neoplasms Male Maligna...	7 (.37%)
Soft Tissue Neoplasms Benign	7 (.37%)
Tissue	7 (.37%)
Vascular Hypertensive	7 (.37%)
Bronchial Disorders	6 (.32%)
Cornification And Dystrophic Skin	6 (.32%)
Decreased And Nonspecific Blood Pre...	6 (.32%)
Depressed Mood Disorders	6 (.32%)
Embolism And Thrombosis	6 (.32%)
Gallbladder	6 (.32%)
Lifestyle Issues	6 (.32%)
Ocular Structural Change, Deposit A...	6 (.32%)
Chemical Injury And Poisoning	5 (.27%)
Diverticular	5 (.27%)
Gastrointestinal Hemorrhages	5 (.27%)
Hematopoietic Neoplasms	5 (.27%)
Lymphomas	5 (.27%)
Mycobacterial Infectious	5 (.27%)
Peritoneal And Retroperitoneal Cond...	5 (.27%)
Platelet	5 (.27%)
Reproductive Neoplasms Female Malig...	5 (.27%)
Sexual Function And Fertility	5 (.27%)
Urinary Tract Signs	5 (.27%)
Adrenal Gland	4 (.21%)
Breast Neoplasms Malignant And Unsp...	4 (.21%)
Deliria	4 (.21%)
Diabetic Complications	4 (.21%)
Disturbances In Thinking	4 (.21%)
Gastrointestinal Stenosis And Obstr...	4 (.21%)
Glucose Metabolism Disorders	4 (.21%)
Hematological	4 (.21%)
Hematological And Lymphoid Tissue T...	4 (.21%)
Peripheral Neuropathies	4 (.21%)
Pleural	4 (.21%)
Psychiatric And Behavioural Symptom...	4 (.21%)
Respiratory And Mediastinal Neoplas...	4 (.21%)
Seizures	4 (.21%)
Vascular	4 (.21%)
Abortions And Stillbirth	3 (.16%)

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