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ART 50

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Art 50 Adverse Events Reported to the FDA Over Time

How are Art 50 adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Art 50, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Art 50 is flagged as the suspect drug causing the adverse event.

Most Common Art 50 Adverse Events Reported to the FDA

What are the most common Art 50 adverse events reported to the FDA?

Cytolytic Hepatitis
7 (3.5%)
Haemoglobin Decreased
6 (3%)
Sudden Death
6 (3%)
Dyspnoea
5 (2.5%)
Mitral Valve Disease
5 (2.5%)
Mitral Valve Incompetence
5 (2.5%)
Pleural Effusion
5 (2.5%)
Renal Failure
5 (2.5%)
Abdominal Pain
4 (2%)
Agranulocytosis
4 (2%)
Anorexia
4 (2%)
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C-reactive Protein Increased
4 (2%)
Chromaturia
4 (2%)
Hyponatraemia
4 (2%)
Pancreatitis Acute
4 (2%)
Thrombocytopenia
4 (2%)
Weight Decreased
4 (2%)
Diarrhoea
3 (1.5%)
General Physical Health Deteriorati...
3 (1.5%)
Lung Disorder
3 (1.5%)
Oedema Peripheral
3 (1.5%)
Pyrexia
3 (1.5%)
Sepsis
3 (1.5%)
Alanine Aminotransferase Increased
2 (1%)
Aortic Valve Incompetence
2 (1%)
Ascites
2 (1%)
Aspartate Aminotransferase Increase...
2 (1%)
Cardio-respiratory Arrest
2 (1%)
Cholestasis
2 (1%)
Drug Interaction
2 (1%)
Erythema
2 (1%)
Hepatitis
2 (1%)
Hepatojugular Reflux
2 (1%)
Mitral Valve Stenosis
2 (1%)
Osteonecrosis
2 (1%)
Pain
2 (1%)
Pemphigoid
2 (1%)
Pruritus
2 (1%)
Venous Insufficiency
2 (1%)
Abdominal Discomfort
1 (.5%)
Abdominal Pain Upper
1 (.5%)
Anaemia
1 (.5%)
Anuria
1 (.5%)
Aortic Bruit
1 (.5%)
Apathy
1 (.5%)
Asthenia
1 (.5%)
Biopsy Bone Marrow Abnormal
1 (.5%)
Blood Alkaline Phosphatase Increase...
1 (.5%)
Blood Bilirubin Increased
1 (.5%)
Bronchiolitis
1 (.5%)
Carbon Monoxide Diffusing Capacity ...
1 (.5%)
Cardiac Arrest
1 (.5%)
Cholelithiasis Obstructive
1 (.5%)
Condition Aggravated
1 (.5%)
Constipation
1 (.5%)
Diastolic Dysfunction
1 (.5%)
Dysgeusia
1 (.5%)
Dyspnoea Exertional
1 (.5%)
Eczema
1 (.5%)
Endoscopy Gastrointestinal Abnormal
1 (.5%)
Faeces Discoloured
1 (.5%)
Flatulence
1 (.5%)
Gamma-glutamyltransferase Increased
1 (.5%)
Gastritis
1 (.5%)
Gastrointestinal Haemorrhage
1 (.5%)
Haematemesis
1 (.5%)
Hepatic Enzyme Increased
1 (.5%)
Hepatic Steatosis
1 (.5%)
Hepatocellular Injury
1 (.5%)
Herpes Zoster
1 (.5%)
Inflammation
1 (.5%)
International Normalised Ratio Incr...
1 (.5%)
Knee Arthroplasty
1 (.5%)
Left Atrial Dilatation
1 (.5%)
Left Ventricular Failure
1 (.5%)
Left Ventricular Hypertrophy
1 (.5%)
Leukopenia
1 (.5%)
Lipase Increased
1 (.5%)
Muscle Spasms
1 (.5%)
Myalgia
1 (.5%)
Myeloid Maturation Arrest
1 (.5%)
Nausea
1 (.5%)
Neutrophil Count Increased
1 (.5%)
Normochromic Normocytic Anaemia
1 (.5%)
Oedema
1 (.5%)
Overdose
1 (.5%)
Overweight
1 (.5%)
Pancreatic Necrosis
1 (.5%)
Pancreatitis Necrotising
1 (.5%)
Paraesthesia
1 (.5%)
Pneumonia
1 (.5%)
Pruritus Generalised
1 (.5%)
Pulmonary Arterial Hypertension
1 (.5%)
Pulmonary Arterial Pressure Increas...
1 (.5%)
Pulmonary Embolism
1 (.5%)
Pulse Abnormal
1 (.5%)
Purpura
1 (.5%)
Qrs Axis Abnormal
1 (.5%)
Rash
1 (.5%)
Rash Maculo-papular
1 (.5%)
Red Blood Cell Sedimentation Rate I...
1 (.5%)

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This graph shows the top adverse events submitted to the FDA for Art 50, 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 Art 50 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 Art 50

What are the most common Art 50 adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Art 50, 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 Art 50 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 Art 50 According to Those Reporting Adverse Events

Why are people taking Art 50, according to those reporting adverse events to the FDA?

Osteoarthritis
25
Drug Use For Unknown Indication
21
Arthralgia
4
Product Used For Unknown Indication
2
Prostatic Specific Antigen
1
Musculoskeletal Pain
1
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Arthritis
1
Unevaluable Event
1
Arthropathy
1

Art 50 Case Reports

What Art 50 safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Art 50. 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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