KIOVIG

Adverse Events

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Kiovig Adverse Events Reported to the FDA Over Time

How are Kiovig adverse event reports trending over time?

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

Most Common Kiovig Adverse Events Reported to the FDA

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

Chills	46 (6.62%)
Pyrexia	31 (4.46%)
Headache	22 (3.17%)
Nausea	21 (3.02%)
Blood Pressure Decreased	14 (2.01%)
Chest Pain	13 (1.87%)
Erythema	12 (1.73%)
Tachycardia	12 (1.73%)
Flank Pain	11 (1.58%)
Haemoglobin Decreased	10 (1.44%)
Hypertension	10 (1.44%)
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Malaise	10 (1.44%)
Body Temperature Increased	9 (1.29%)
Cardiac Arrest	9 (1.29%)
Drug Ineffective	9 (1.29%)
Dyspnoea	9 (1.29%)
Hypersensitivity	9 (1.29%)
Neutropenia	9 (1.29%)
Acute Pulmonary Oedema	8 (1.15%)
Cold Sweat	8 (1.15%)
Epilepsy	8 (1.15%)
Eye Pain	8 (1.15%)
Multiple Myeloma	8 (1.15%)
Photophobia	8 (1.15%)
Vomiting	7 (1.01%)
Abdominal Pain	6 (.86%)
Back Pain	6 (.86%)
Blood Pressure Increased	6 (.86%)
Chest Discomfort	6 (.86%)
Cyanosis	6 (.86%)
Oxygen Saturation Decreased	6 (.86%)
Procedural Nausea	6 (.86%)
Pruritus Generalised	6 (.86%)
Thrombocytopenia	6 (.86%)
Vertigo	6 (.86%)
Bradycardia	5 (.72%)
Haemolysis	5 (.72%)
Hypotension	5 (.72%)
Migraine	5 (.72%)
Anaphylactic Reaction	4 (.58%)
Angina Pectoris	4 (.58%)
Anxiety	4 (.58%)
Aortic Aneurysm	4 (.58%)
Coombs Direct Test Positive	4 (.58%)
Dizziness	4 (.58%)
Feeling Hot	4 (.58%)
Feeling Of Body Temperature Change	4 (.58%)
Flushing	4 (.58%)
Heart Rate Increased	4 (.58%)
Hepatitis B Antigen	4 (.58%)
Hepatitis B Antigen Positive	4 (.58%)
Hepatitis B Dna Assay Positive	4 (.58%)
Hyperhidrosis	4 (.58%)
Meningitis Aseptic	4 (.58%)
Multiple Sclerosis	4 (.58%)
Myasthenia Gravis	4 (.58%)
Pain	4 (.58%)
Peripheral Artery Aneurysm	4 (.58%)
Peripheral Embolism	4 (.58%)
Rash	4 (.58%)
Respiratory Disorder	4 (.58%)
Respiratory Tract Infection	4 (.58%)
Upper Respiratory Tract Infection	4 (.58%)
Urticaria	4 (.58%)
Yellow Skin	4 (.58%)
Abdominal Distension	3 (.43%)
Anaphylactic Shock	3 (.43%)
Brain Hypoxia	3 (.43%)
Deep Vein Thrombosis	3 (.43%)
Disease Progression	3 (.43%)
Drug Intolerance	3 (.43%)
Eczema	3 (.43%)
Feeling Abnormal	3 (.43%)
Hyperkeratosis Palmaris And Plantar...	3 (.43%)
Lip Swelling	3 (.43%)
Loss Of Consciousness	3 (.43%)
Nail Disorder	3 (.43%)
Nephrotic Syndrome	3 (.43%)
Pneumonia	3 (.43%)
Pulmonary Embolism	3 (.43%)
Respiratory Arrest	3 (.43%)
Somnolence	3 (.43%)
Tachypnoea	3 (.43%)
Unresponsive To Stimuli	3 (.43%)
Abortion Induced	2 (.29%)
Acute Sinusitis	2 (.29%)
Anal Haemorrhage	2 (.29%)
Anti-erythrocyte Antibody Positive	2 (.29%)
Aphagia	2 (.29%)
Application Site Pruritus	2 (.29%)
Application Site Reaction	2 (.29%)
Asthenia	2 (.29%)
Body Temperature Decreased	2 (.29%)
Bronchial Carcinoma	2 (.29%)
Bronchitis	2 (.29%)
Cardio-respiratory Arrest	2 (.29%)
Circulatory Collapse	2 (.29%)
Colonic Polyp	2 (.29%)
Contusion	2 (.29%)
Diarrhoea Haemorrhagic	2 (.29%)
Disseminated Intravascular Coagulat...	2 (.29%)

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

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

Gastrointestinal Signs	44 (6.33%)
Epidermal And Dermal Conditions	33 (4.75%)
Body Temperature Conditions	31 (4.46%)
Cardiac Arrhythmias	28 (4.03%)
Respiratory	28 (4.03%)
Headaches	27 (3.88%)
Cardiac And Vascular Investigations	25 (3.6%)
Infections - Pathogen Unspecified	20 (2.88%)
Musculoskeletal And Connective Tiss...	20 (2.88%)
Microbiology And Serology	19 (2.73%)
Allergic Conditions	18 (2.59%)
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Neurological	15 (2.16%)
Skin Appendage Conditions	15 (2.16%)
Hematology Investigations	14 (2.01%)
Physical Examination Topics	14 (2.01%)
Therapeutic And Nontherapeutic Effe...	14 (2.01%)
Decreased And Nonspecific Blood Pre...	10 (1.44%)
Eye	10 (1.44%)
Vascular Hypertensive	10 (1.44%)
Ocular Sensory Symptoms	9 (1.29%)
White Blood Cell	9 (1.29%)
Aneurysms And Artery Dissections	8 (1.15%)
Cardiac Disorder Signs	8 (1.15%)
Embolism And Thrombosis	8 (1.15%)
Inner Ear And Viiith Cranial Nerve	8 (1.15%)
Lower Respiratory Tract Disorders	8 (1.15%)
Plasma Cell Neoplasms	8 (1.15%)
Seizures	8 (1.15%)
Administration Site Reactions	7 (1.01%)
Metabolic, Nutritional And Blood Ga...	6 (.86%)
Platelet	6 (.86%)
Procedural And Device Related Injur...	6 (.86%)
Renal Disorders	6 (.86%)
Hemolyses And Related Conditions	5 (.72%)
Oral Soft Tissue Conditions	5 (.72%)
Angiedema And Urticaria	4 (.58%)
Anxiety Disorders	4 (.58%)
Coronary Artery	4 (.58%)
Demyelinating	4 (.58%)
Injuries	4 (.58%)
Neuromuscular	4 (.58%)
Vascular	4 (.58%)
Coagulopathies And Bleeding Diathes...	3 (.43%)
Cornification And Dystrophic Skin	3 (.43%)
Cranial Nerve Disorders	3 (.43%)
Immunology And Allergy	3 (.43%)
Nephropathies	3 (.43%)
Pulmonary Vascular	3 (.43%)
Urinary Tract Signs	3 (.43%)
Benign Neoplasms Gastrointestinal	2 (.29%)
Gastrointestinal Hemorrhages	2 (.29%)
Gastrointestinal Inflammatory Condi...	2 (.29%)
Gastrointestinal Motility And Defec...	2 (.29%)
Movement Disorders	2 (.29%)
Obstetric And Gynecological Therape...	2 (.29%)
Renal And Urinary Tract Investigati...	2 (.29%)
Respiratory And Mediastinal Neoplas...	2 (.29%)
Tongue Conditions	2 (.29%)
Anemias Nonhemolytic And Marrow Dep...	1 (.14%)
Arteriosclerosis, Stenosis, Vascula...	1 (.14%)
Eating Disorders	1 (.14%)
Electrolyte And Fluid Balance Condi...	1 (.14%)
Gallbladder	1 (.14%)
Gastrointestinal Neoplasms Malignan...	1 (.14%)
Joint	1 (.14%)
Leukemias	1 (.14%)
Maternal Complications Of Labour An...	1 (.14%)
Muscle	1 (.14%)
Neonatal And Perinatal Conditions	1 (.14%)
Protein And Chemistry Analyses	1 (.14%)
Skin Vascular Abnormalities	1 (.14%)
Therapeutic Procedures And Supporti...	1 (.14%)
Urolithiases	1 (.14%)
Vision	1 (.14%)

Share/Embed Graph Export Data

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

Common Uses of Kiovig According to Those Reporting Adverse Events

Why are people taking Kiovig, according to those reporting adverse events to the FDA?

Multiple Sclerosis	10
Kawasakis Disease	7
Primary Immunodeficiency Syndrome	6
Polyneuropathy	6
Immunodeficiency Common Variable	6
Thrombocytopenia	6
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Guillain-barre Syndrome	5
Idiopathic Thrombocytopenic Purpura	5
Drug Use For Unknown Indication	4
Demyelinating Polyneuropathy	4
Myasthenia Gravis	4
Off Label Use	4
Product Used For Unknown Indication	3
Hypogammaglobulinaemia	3
Immunoglobulins Decreased	3
Dermatomyositis	3
Blood Immunoglobulin G Decreased	2
Secondary Immunodeficiency	2
Panel-reactive Antibody	2
Lewis-sumner Syndrome	2
Intentional Drug Misuse	2
Renal Transplant	2
Immunodeficiency	2
Prophylaxis	2
Immunoglobulin Therapy	2
Hiv Infection	2
Autonomic Neuropathy	2
Burkitts Lymphoma	2
Respiratory Tract Infection	1
Systemic Lupus Erythematosus	1
Infection Prophylaxis	1
Pemphigus	1
Chronic Lymphocytic Leukaemia	1
Allogenic Bone Marrow Transplantati...	1
Mixed Connective Tissue Disease	1
Dementia Alzheimers Type	1
Infertility	1
Cerebral Sarcoidosis	1
Cystitis Haemorrhagic	1
Aplasia Pure Red Cell	1
Wiskott-aldrich Syndrome	1
Immunodeficiency Congenital	1

Kiovig Case Reports

What Kiovig safety concerns are being reported by doctors and researchers in the medical literature?

About Results

This report contains aggregated drug side effects and adverse events for Kiovig. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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