ARAVA

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Arava Adverse Events Reported to the FDA Over Time

How are Arava adverse event reports trending over time?

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

Most Common Arava Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy	610 (2.95%)
Alanine Aminotransferase Increased	528 (2.56%)
Aspartate Aminotransferase Increase...	481 (2.33%)
Diarrhoea	333 (1.61%)
Blood Alkaline Phosphatase Increase...	295 (1.43%)
Pyrexia	279 (1.35%)
Gamma-glutamyltransferase Increased	272 (1.32%)
Blood Lactate Dehydrogenase Increas...	243 (1.18%)
Nausea	211 (1.02%)
Dyspnoea	186 (.9%)
Rash	163 (.79%)
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Vomiting	163 (.79%)
Weight Decreased	160 (.77%)
Liver Function Test Abnormal	146 (.71%)
Anaemia	145 (.7%)
Pneumonia	141 (.68%)
Hepatic Function Abnormal	135 (.65%)
Headache	134 (.65%)
Liver Disorder	129 (.62%)
Interstitial Lung Disease	126 (.61%)
Hepatic Enzyme Increased	123 (.6%)
Hypertension	122 (.59%)
Asthenia	119 (.58%)
Pruritus	115 (.56%)
Blood Bilirubin Increased	112 (.54%)
Respiratory Failure	112 (.54%)
Alopecia	110 (.53%)
Renal Failure	108 (.52%)
Abdominal Pain	107 (.52%)
Haemoglobin Decreased	102 (.49%)
Arthralgia	100 (.48%)
Fatigue	97 (.47%)
Sepsis	97 (.47%)
White Blood Cell Count Decreased	96 (.46%)
Hepatic Failure	93 (.45%)
Cardiac Failure	92 (.45%)
Cough	89 (.43%)
Pancytopenia	89 (.43%)
Anorexia	88 (.43%)
Jaundice	88 (.43%)
Platelet Count Decreased	87 (.42%)
Pleural Effusion	86 (.42%)
Transaminases Increased	86 (.42%)
Abortion Induced	85 (.41%)
Death	82 (.4%)
Malaise	79 (.38%)
Leukopenia	77 (.37%)
Multi-organ Failure	77 (.37%)
Abortion Spontaneous	76 (.37%)
Drug Ineffective	75 (.36%)
Thrombocytopenia	73 (.35%)
Pulmonary Embolism	71 (.34%)
Blood Creatinine Increased	70 (.34%)
Chest Pain	69 (.33%)
Myocardial Infarction	68 (.33%)
General Physical Health Deteriorati...	67 (.32%)
Condition Aggravated	66 (.32%)
Pregnancy	66 (.32%)
Dizziness	63 (.3%)
White Blood Cell Count Increased	63 (.3%)
C-reactive Protein Increased	62 (.3%)
Convulsion	61 (.3%)
Rheumatoid Arthritis	60 (.29%)
Hepatitis	58 (.28%)
Pain	58 (.28%)
Dehydration	57 (.28%)
Renal Failure Acute	57 (.28%)
Infection	56 (.27%)
Off Label Use	56 (.27%)
Pneumonitis	56 (.27%)
Neutropenia	53 (.26%)
Abdominal Pain Upper	52 (.25%)
Blood Urea Increased	52 (.25%)
Medication Error	52 (.25%)
Hypoaesthesia	51 (.25%)
Syncope	51 (.25%)
Hypotension	50 (.24%)
Blood Pressure Increased	48 (.23%)
Pain In Extremity	48 (.23%)
Disseminated Intravascular Coagulat...	46 (.22%)
Fall	46 (.22%)
Hepatotoxicity	46 (.22%)
Septic Shock	46 (.22%)
Drug Interaction	45 (.22%)
Erythema	45 (.22%)
Ascites	44 (.21%)
Decreased Appetite	44 (.21%)
Mouth Ulceration	43 (.21%)
Paraesthesia	43 (.21%)
Pulmonary Oedema	43 (.21%)
Staphylococcal Infection	43 (.21%)
Tachycardia	43 (.21%)
Gastrointestinal Haemorrhage	42 (.2%)
Histiocytosis Haematophagic	42 (.2%)
Stevens-johnson Syndrome	42 (.2%)
Loss Of Consciousness	41 (.2%)
Red Blood Cell Count Decreased	41 (.2%)
Lymphadenopathy	38 (.18%)
Toxic Epidermal Necrolysis	38 (.18%)
Atrial Fibrillation	37 (.18%)
Cardiac Arrest	37 (.18%)

Share/Embed Graph Export Data

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

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

Hepatobiliary	1775 (8.59%)
Hepatic And Hepatobiliary	893 (4.32%)
Epidermal And Dermal Conditions	855 (4.14%)
Infections - Pathogen Unspecified	855 (4.14%)
Hematology Investigations	729 (3.53%)
Chemical Injury And Poisoning	702 (3.4%)
Gastrointestinal Signs	691 (3.34%)
Respiratory	633 (3.06%)
Enzyme	578 (2.8%)
Neurological	488 (2.36%)
Lower Respiratory Tract Disorders	422 (2.04%)
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Gastrointestinal Motility And Defec...	378 (1.83%)
Bacterial Infectious	314 (1.52%)
Anemias Nonhemolytic And Marrow Dep...	303 (1.47%)
Body Temperature Conditions	298 (1.44%)
Joint	280 (1.36%)
Renal Disorders	275 (1.33%)
Cardiac Arrhythmias	257 (1.24%)
Renal And Urinary Tract Investigati...	230 (1.11%)
White Blood Cell	230 (1.11%)
Physical Examination Topics	207 (1%)
Skin Appendage Conditions	189 (.91%)
Therapeutic And Nontherapeutic Effe...	189 (.91%)
Central Nervous System Vascular	179 (.87%)
Appetite And General Nutritional	156 (.76%)
Injuries	153 (.74%)
Pleural	151 (.73%)
Vascular Hypertensive	147 (.71%)
Protein And Chemistry Analyses	144 (.7%)
Headaches	138 (.67%)
Heart Failures	138 (.67%)
Cardiac And Vascular Investigations	134 (.65%)
Oral Soft Tissue Conditions	130 (.63%)
Muscle	129 (.62%)
Decreased And Nonspecific Blood Pre...	122 (.59%)
Gastrointestinal Inflammatory Condi...	121 (.59%)
Gastrointestinal Ulceration And Per...	121 (.59%)
Viral Infectious	119 (.58%)
Coronary Artery	118 (.57%)
Electrolyte And Fluid Balance Condi...	117 (.57%)
Musculoskeletal And Connective Tiss...	112 (.54%)
Obstetric And Gynecological Therape...	112 (.54%)
Gastrointestinal Hemorrhages	108 (.52%)
Medication Errors	103 (.5%)
Pulmonary Vascular	101 (.49%)
Fungal Infectious	100 (.48%)
Platelet	100 (.48%)
Abortions And Stillbirth	98 (.47%)
Seizures	95 (.46%)
Fatal Outcomes	91 (.44%)
Coagulopathies And Bleeding Diathes...	89 (.43%)
Tissue	88 (.43%)
Urinary Tract Signs	88 (.43%)
Myocardial	87 (.42%)
Peripheral Neuropathies	86 (.42%)
Ocular Infections, Irritations And ...	85 (.41%)
Metabolic, Nutritional And Blood Ga...	84 (.41%)
Vision	82 (.4%)
Movement Disorders	81 (.39%)
Therapeutic Procedures And Supporti...	81 (.39%)
Gastrointestinal Neoplasms Malignan...	79 (.38%)
Pregnancy, Labour, Delivery And Pos...	79 (.38%)
Respiratory And Mediastinal Neoplas...	76 (.37%)
Water, Electrolyte And Mineral	76 (.37%)
Peritoneal And Retroperitoneal Cond...	62 (.3%)
Skin Neoplasms Malignant And Unspec...	60 (.29%)
Mycobacterial Infectious	58 (.28%)
Nephropathies	58 (.28%)
Allergic Conditions	57 (.28%)
Deliria	57 (.28%)
Bone And Joint Injuries	56 (.27%)
Bone Disorders	55 (.27%)
Upper Respiratory Tract Disorders	55 (.27%)
Exocrine Pancreas Conditions	54 (.26%)
Skin Vascular Abnormalities	53 (.26%)
Cardiac Disorder Signs	52 (.25%)
Hematopoietic Neoplasms	52 (.25%)
Breast Neoplasms Malignant And Unsp...	51 (.25%)
Investigations, Imaging And Histopa...	51 (.25%)
Procedural And Device Related Injur...	51 (.25%)
Reproductive Neoplasms Female Malig...	51 (.25%)
Immunology And Allergy	50 (.24%)
Leukemias	49 (.24%)
Anxiety Disorders	47 (.23%)
Cardiac Valve	46 (.22%)
Vascular	45 (.22%)
Disturbances In Thinking	44 (.21%)
Spleen, Lymphatic And Reticulendoth...	44 (.21%)
Bronchial Disorders	43 (.21%)
Lipid Analyses	43 (.21%)
Embolism And Thrombosis	42 (.2%)
Skin And Subcutaneous Tissue	41 (.2%)
Gallbladder	40 (.19%)
Psychiatric	40 (.19%)
Microbiology And Serology	39 (.19%)
Vascular Inflammations	38 (.18%)
Ocular Structural Change, Deposit A...	37 (.18%)
Hematological And Lymphoid Tissue T...	35 (.17%)
Pericardial	34 (.16%)
Renal And Urinary Tract Neoplasms M...	34 (.16%)
Lifestyle Issues	33 (.16%)

Share/Embed Graph Export Data

This graph shows the top categories of adverse events submitted to the FDA for Arava, 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 Arava 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 Arava According to Those Reporting Adverse Events

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

Rheumatoid Arthritis	4782
Product Used For Unknown Indication	416
Drug Use For Unknown Indication	361
Arthritis	222
Psoriatic Arthropathy	138
Polyarthritis	67
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Juvenile Arthritis	54
Ankylosing Spondylitis	37
Psoriasis	18
Musculoskeletal Pain	18
Ill-defined Disorder	13
Bk Virus Infection	11
Immunosuppression	9
Spondylitis	8
Systemic Lupus Erythematosus	8
Arthralgia	8
Drug Exposure During Pregnancy	8
Mixed Connective Tissue Disease	8
Osteoarthritis	7
Osteoporosis	7
Prophylaxis	7
Spondyloarthropathy	6
Polymyalgia Rheumatica	6
Behcets Syndrome	5
Sjogrens Syndrome	5
Arthropathy	5
Immune System Disorder	4
Scleroderma	4
Hepatic Function Abnormal	3
Sapho Syndrome	3
Interstitial Lung Disease	3
Musculoskeletal Stiffness	3
Pruritus	3
Accidental Drug Intake By Child	3
Fibromyalgia	2
Inflammatory Pain	2
Renal Transplant	2
Myalgia	2
Sle Arthritis	2
Seronegative Arthritis	2
Transplant	2
Respiratory Disorder	2
Rheumatoid Nodule	2
Polymyositis	2
Inflammation	2
Drug Exposure Before Pregnancy	2
Sarcoidosis	1
Rheumatoid Factor Positive	1
Renal Impairment	1
Dermatomyositis	1
Cardiomyopathy	1

Drug Labels

Label	Labeler	Effective
Arava	sanofi-aventis U.S. LLC	14-NOV-12
Arava	Bryant Ranch Prepack	17-JAN-13

Arava Case Reports

What Arava 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 Arava. 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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