ROACTEMRA

Roactemra Adverse Events Reported to the FDA Over Time

How are Roactemra adverse event reports trending over time?

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

Most Common Roactemra Adverse Events Reported to the FDA

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

Pyrexia	26 (1.7%)
Pneumonia	25 (1.64%)
Rash	22 (1.44%)
Septic Shock	19 (1.24%)
Asthenia	17 (1.11%)
Thrombocytopenia	17 (1.11%)
Dizziness	15 (.98%)
Myocardial Infarction	15 (.98%)
Sepsis	15 (.98%)
Cytolytic Hepatitis	14 (.92%)
Diarrhoea	14 (.92%)
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Diverticulitis	14 (.92%)
Pruritus	13 (.85%)
Tachycardia	13 (.85%)
Arthralgia	12 (.79%)
Neutropenia	12 (.79%)
Peritonitis	12 (.79%)
Abdominal Pain	11 (.72%)
Cerebrovascular Accident	11 (.72%)
Hypertension	11 (.72%)
Malaise	11 (.72%)
Nausea	11 (.72%)
Pleural Effusion	11 (.72%)
Dyspnoea	10 (.65%)
Vasculitis	10 (.65%)
Anaemia	9 (.59%)
Demyelinating Polyneuropathy	9 (.59%)
Drug Ineffective	9 (.59%)
Face Oedema	9 (.59%)
Fatigue	9 (.59%)
Flushing	9 (.59%)
Headache	9 (.59%)
Hepatic Enzyme Increased	9 (.59%)
Lung Disorder	9 (.59%)
Myelodysplastic Syndrome	9 (.59%)
Oedema Peripheral	9 (.59%)
Catheter Site Pain	8 (.52%)
Cerebral Infarction	8 (.52%)
Chills	8 (.52%)
Cough	8 (.52%)
Hyperlipidaemia	8 (.52%)
Multi-organ Failure	8 (.52%)
Pancytopenia	8 (.52%)
White Blood Cell Count Decreased	8 (.52%)
Abscess	7 (.46%)
Acute Myocardial Infarction	7 (.46%)
Bursitis	7 (.46%)
Conjunctivitis	7 (.46%)
Herpes Zoster	7 (.46%)
Leukopenia	7 (.46%)
Transient Ischaemic Attack	7 (.46%)
Tremor	7 (.46%)
Urinary Tract Infection	7 (.46%)
Vomiting	7 (.46%)
Abdominal Abscess	6 (.39%)
Blood Pressure Increased	6 (.39%)
Cholecystitis Acute	6 (.39%)
Death	6 (.39%)
Deep Vein Thrombosis	6 (.39%)
Fall	6 (.39%)
Infection	6 (.39%)
Renal Failure Acute	6 (.39%)
Septic Arthritis Streptococcal	6 (.39%)
Sudden Death	6 (.39%)
Agranulocytosis	5 (.33%)
C-reactive Protein Increased	5 (.33%)
Cardiac Arrest	5 (.33%)
Cardiac Disorder	5 (.33%)
Circulatory Collapse	5 (.33%)
Decreased Appetite	5 (.33%)
Depression	5 (.33%)
Disease Progression	5 (.33%)
Duodenitis	5 (.33%)
Erysipelas	5 (.33%)
Eye Swelling	5 (.33%)
Haematoma	5 (.33%)
Haemorrhagic Stroke	5 (.33%)
Hepatic Cirrhosis	5 (.33%)
Liver Function Test Abnormal	5 (.33%)
Metrorrhagia	5 (.33%)
Myalgia	5 (.33%)
Post Herpetic Neuralgia	5 (.33%)
Pulmonary Embolism	5 (.33%)
Pulmonary Oedema	5 (.33%)
Rectal Haemorrhage	5 (.33%)
Skin Exfoliation	5 (.33%)
Urosepsis	5 (.33%)
Urticaria	5 (.33%)
Abortion Spontaneous	4 (.26%)
Alanine Aminotransferase Increased	4 (.26%)
Anaemia Macrocytic	4 (.26%)
Aortic Dissection	4 (.26%)
Arthritis	4 (.26%)
Aspartate Aminotransferase Increase...	4 (.26%)
Basilar Artery Thrombosis	4 (.26%)
Blindness	4 (.26%)
C-reactive Protein Decreased	4 (.26%)
Cardiac Failure	4 (.26%)
Cellulitis	4 (.26%)
Chest Discomfort	4 (.26%)
Chest Pain	4 (.26%)

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

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

Infections - Pathogen Unspecified	171 (11.19%)
Epidermal And Dermal Conditions	71 (4.65%)
Respiratory	48 (3.14%)
Central Nervous System Vascular	47 (3.08%)
Neurological	39 (2.55%)
Bacterial Infectious	35 (2.29%)
Gastrointestinal Signs	31 (2.03%)
White Blood Cell	31 (2.03%)
Hepatobiliary	30 (1.96%)
Coronary Artery	28 (1.83%)
Hematology Investigations	28 (1.83%)
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Body Temperature Conditions	26 (1.7%)
Cardiac Arrhythmias	26 (1.7%)
Joint	26 (1.7%)
Hepatic And Hepatobiliary	25 (1.64%)
Anemias Nonhemolytic And Marrow Dep...	24 (1.57%)
Gastrointestinal Motility And Defec...	21 (1.37%)
Ocular Infections, Irritations And ...	19 (1.24%)
Platelet	19 (1.24%)
Viral Infectious	18 (1.18%)
Peritoneal And Retroperitoneal Cond...	17 (1.11%)
Eye	16 (1.05%)
Lower Respiratory Tract Disorders	16 (1.05%)
Pleural	16 (1.05%)
Embolism And Thrombosis	15 (.98%)
Bone And Joint Injuries	14 (.92%)
Headaches	14 (.92%)
Muscle	14 (.92%)
Therapeutic And Nontherapeutic Effe...	14 (.92%)
Gastrointestinal Ulceration And Per...	13 (.85%)
Cardiac Disorder Signs	12 (.79%)
Fatal Outcomes	12 (.79%)
Lipid Metabolism	12 (.79%)
Gastrointestinal Hemorrhages	11 (.72%)
Injuries	11 (.72%)
Peripheral Neuropathies	11 (.72%)
Vascular	11 (.72%)
Vascular Hypertensive	11 (.72%)
Vascular Inflammations	11 (.72%)
Administration Site Reactions	10 (.65%)
Hearing	10 (.65%)
Leukemias	10 (.65%)
Movement Disorders	10 (.65%)
Synovial And Bursal	10 (.65%)
Vision	10 (.65%)
Decreased And Nonspecific Blood Pre...	9 (.59%)
Musculoskeletal And Connective Tiss...	9 (.59%)
Protein And Chemistry Analyses	9 (.59%)
Renal Disorders	9 (.59%)
Skin Appendage Conditions	9 (.59%)
Allergic Conditions	8 (.52%)
Cranial Nerve Disorders	8 (.52%)
Gallbladder	8 (.52%)
Gastrointestinal Inflammatory Condi...	8 (.52%)
Neuromuscular	8 (.52%)
Angiedema And Urticaria	7 (.46%)
Bone Disorders	7 (.46%)
Cardiac And Vascular Investigations	7 (.46%)
Heart Failures	7 (.46%)
Respiratory And Mediastinal Neoplas...	7 (.46%)
Aneurysms And Artery Dissections	6 (.39%)
Coagulopathies And Bleeding Diathes...	6 (.39%)
Menstrual Cycle And Uterine Bleedin...	6 (.39%)
Mycobacterial Infectious	6 (.39%)
Pericardial	6 (.39%)
Pulmonary Vascular	6 (.39%)
Skin And Subcutaneous Tissue	6 (.39%)
Upper Respiratory Tract Disorders	6 (.39%)
Appetite And General Nutritional	5 (.33%)
Arteriosclerosis, Stenosis, Vascula...	5 (.33%)
Depressed Mood Disorders	5 (.33%)
Oral Soft Tissue Conditions	5 (.33%)
Skin Neoplasms Malignant And Unspec...	5 (.33%)
Tissue	5 (.33%)
Vascular Hemorrhagic	5 (.33%)
Water, Electrolyte And Mineral	5 (.33%)
Abortions And Stillbirth	4 (.26%)
Bile Duct	4 (.26%)
Breast Neoplasms Malignant And Unsp...	4 (.26%)
Bronchial Disorders	4 (.26%)
Deliria	4 (.26%)
Gastrointestinal Neoplasms Malignan...	4 (.26%)
Immunodeficiency Syndromes	4 (.26%)
Reproductive Tract	4 (.26%)
Seizures	4 (.26%)
Sleep Disorders	4 (.26%)
Therapeutic Procedures And Supporti...	4 (.26%)
Urinary Tract Signs	4 (.26%)
Electrolyte And Fluid Balance Condi...	3 (.2%)
Glucose Metabolism Disorders	3 (.2%)
Inner Ear And Viiith Cranial Nerve	3 (.2%)
Lipid Analyses	3 (.2%)
Neurological, Special Senses And Ps...	3 (.2%)
Procedural And Device Related Injur...	3 (.2%)
Skin Vascular Abnormalities	3 (.2%)
Anal And Rectal Conditions	2 (.13%)
Anxiety Disorders	2 (.13%)
Benign Neoplasms Gastrointestinal	2 (.13%)
Dental And Gingival Conditions	2 (.13%)
Diverticular	2 (.13%)
Endocrine Neoplasms Malignant And U...	2 (.13%)

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