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Sortis Adverse Events Reported to the FDA Over Time

How are Sortis adverse event reports trending over time?

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

Most Common Sortis Adverse Events Reported to the FDA

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

Myalgia
76 (2.89%)
Blood Creatine Phosphokinase Increa...
70 (2.66%)
Rhabdomyolysis
70 (2.66%)
Drug Interaction
57 (2.16%)
Muscle Spasms
32 (1.22%)
Muscle Atrophy
24 (.91%)
Aspartate Aminotransferase Increase...
23 (.87%)
Asthenia
23 (.87%)
Gamma-glutamyltransferase Increased
23 (.87%)
Muscular Weakness
23 (.87%)
Alanine Aminotransferase Increased
21 (.8%)
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Hepatocellular Injury
21 (.8%)
Myocardial Infarction
19 (.72%)
Nausea
18 (.68%)
Tendon Rupture
18 (.68%)
C-reactive Protein Increased
17 (.65%)
Renal Failure Acute
17 (.65%)
Arthralgia
16 (.61%)
Pruritus
16 (.61%)
Blood Creatinine Increased
15 (.57%)
Dyspnoea
15 (.57%)
Hepatitis
15 (.57%)
Polyneuropathy
15 (.57%)
Renal Failure
15 (.57%)
Transaminases Increased
15 (.57%)
Weight Decreased
15 (.57%)
Blood Creatine Phosphokinase Mb Inc...
14 (.53%)
Blood Lactate Dehydrogenase Increas...
14 (.53%)
International Normalised Ratio Incr...
14 (.53%)
Oedema Peripheral
14 (.53%)
Condition Aggravated
13 (.49%)
Gait Disturbance
13 (.49%)
Myopathy
13 (.49%)
Blood Triglycerides Increased
12 (.46%)
Depression
12 (.46%)
Fall
12 (.46%)
Hypertension
12 (.46%)
Paraesthesia
12 (.46%)
Dialysis
11 (.42%)
Drug Exposure During Pregnancy
11 (.42%)
Red Blood Cell Sedimentation Rate I...
11 (.42%)
Tendonitis
11 (.42%)
Fatigue
10 (.38%)
Hyperhidrosis
10 (.38%)
Jaundice
10 (.38%)
Muscle Disorder
10 (.38%)
Myoglobin Blood Increased
10 (.38%)
Myositis
10 (.38%)
Pain In Extremity
10 (.38%)
Stent Occlusion
10 (.38%)
Acute Coronary Syndrome
9 (.34%)
Amyotrophic Lateral Sclerosis
9 (.34%)
Blister
9 (.34%)
Dizziness
9 (.34%)
Drug Ineffective
9 (.34%)
Haemoglobin Decreased
9 (.34%)
Hypotension
9 (.34%)
Thrombosis
9 (.34%)
Blood Cholesterol Increased
8 (.3%)
Blood Urea Increased
8 (.3%)
Dermatitis Bullous
8 (.3%)
Diarrhoea
8 (.3%)
Liver Disorder
8 (.3%)
Liver Injury
8 (.3%)
Malaise
8 (.3%)
Musculoskeletal Stiffness
8 (.3%)
Nephrotic Syndrome
8 (.3%)
Psoriasis
8 (.3%)
Pyrexia
8 (.3%)
Vomiting
8 (.3%)
Abdominal Pain
7 (.27%)
Angina Pectoris
7 (.27%)
Angioedema
7 (.27%)
Confusional State
7 (.27%)
Decreased Appetite
7 (.27%)
Disturbance In Attention
7 (.27%)
Hyperkalaemia
7 (.27%)
Liver Function Test Abnormal
7 (.27%)
Neuropathy Peripheral
7 (.27%)
Overdose
7 (.27%)
Pain
7 (.27%)
Parosmia
7 (.27%)
Polymyalgia Rheumatica
7 (.27%)
Rash
7 (.27%)
Urticaria
7 (.27%)
Abortion Induced
6 (.23%)
Blood Alkaline Phosphatase Increase...
6 (.23%)
Blood Bilirubin Increased
6 (.23%)
Bursitis
6 (.23%)
Eyelid Oedema
6 (.23%)
Gastrointestinal Haemorrhage
6 (.23%)
General Physical Health Deteriorati...
6 (.23%)
Hepatic Enzyme Increased
6 (.23%)
Hepatic Failure
6 (.23%)
Hepatic Necrosis
6 (.23%)
Hepatitis Cholestatic
6 (.23%)
Hypoaesthesia
6 (.23%)
Insomnia
6 (.23%)
Lipase Increased
6 (.23%)
Loss Of Consciousness
6 (.23%)
Low Density Lipoprotein Increased
6 (.23%)

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

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

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

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

Hypercholesterolaemia
207
Hyperlipidaemia
173
Ill-defined Disorder
62
Drug Use For Unknown Indication
46
Coronary Artery Disease
31
Dyslipidaemia
28
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Blood Cholesterol Increased
26
Product Used For Unknown Indication
25
Lipid Metabolism Disorder
17
Myocardial Infarction
14
Prophylaxis
14
Type Iia Hyperlipidaemia
13
Angina Pectoris
6
Blood Triglycerides Increased
6
Hypertension
6
Cerebral Infarction
5
Lipids Increased
4
Myocardial Ischaemia
4
Carotid Artery Stenosis
3
Hypertriglyceridaemia
3
Cardiovascular Event Prophylaxis
3
Acute Myocardial Infarction
3
Metabolic Disorder
3
Mixed Hyperlipidaemia
3
Diabetes Mellitus
3
Low Density Lipoprotein Increased
2
Acute Coronary Syndrome
2
Cardiac Disorder
2
Drug Therapy
2
Arteriosclerosis
2
Carotid Arteriosclerosis
2
Ischaemic Cardiomyopathy
2
Arterial Occlusive Disease
2
Stent Placement
2
Arteriosclerosis Coronary Artery
2
Lipoprotein Deficiency
2
Coronary Artery Surgery
2
Cardiovascular Evaluation
1
Hypocholesterolaemia
1
Angina Unstable
1
Peripheral Arterial Occlusive Disea...
1
Coronary Arterial Stent Insertion
1
Vascular Graft
1
Vascular Calcification
1
Arterial Repair
1
Brain Stem Stroke
1
Blood Cholesterol Abnormal
1
Cerebral Arteriosclerosis
1
Ischaemic Heart Disease Prophylaxis
1
Metabolic Syndrome
1
Cardiovascular Disorder
1

Sortis Case Reports

What Sortis 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 Sortis. 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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