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SIFROL

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Sifrol Adverse Events Reported to the FDA Over Time

How are Sifrol adverse event reports trending over time?

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

Most Common Sifrol Adverse Events Reported to the FDA

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

Hallucination
92 (2.51%)
Somnolence
88 (2.4%)
Fall
68 (1.85%)
Oedema Peripheral
63 (1.72%)
Neuroleptic Malignant Syndrome
59 (1.61%)
Sudden Onset Of Sleep
56 (1.53%)
Confusional State
50 (1.36%)
Delirium
50 (1.36%)
Death
43 (1.17%)
Road Traffic Accident
41 (1.12%)
Pathological Gambling
40 (1.09%)
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Pneumonia
40 (1.09%)
Pyrexia
40 (1.09%)
Suicide Attempt
39 (1.06%)
Nausea
37 (1.01%)
Tremor
37 (1.01%)
Depression
32 (.87%)
Dizziness
31 (.84%)
Overdose
31 (.84%)
Posture Abnormal
30 (.82%)
Cardiac Failure
29 (.79%)
Vomiting
29 (.79%)
Dyskinesia
28 (.76%)
Abnormal Behaviour
27 (.74%)
Hallucination, Visual
27 (.74%)
Pneumonia Aspiration
26 (.71%)
Condition Aggravated
25 (.68%)
Constipation
24 (.65%)
Hyponatraemia
24 (.65%)
Medication Error
24 (.65%)
Inappropriate Antidiuretic Hormone ...
23 (.63%)
Loss Of Consciousness
23 (.63%)
Weight Increased
23 (.63%)
Delusion
22 (.6%)
Drug Interaction
22 (.6%)
Dehydration
21 (.57%)
Interstitial Lung Disease
21 (.57%)
Hypotension
19 (.52%)
Insomnia
19 (.52%)
Fatigue
18 (.49%)
General Physical Health Deteriorati...
18 (.49%)
Restlessness
18 (.49%)
Sleep Attacks
18 (.49%)
Sleep Disorder
18 (.49%)
Agitation
17 (.46%)
Liver Disorder
17 (.46%)
Pain
17 (.46%)
Anaemia
16 (.44%)
Headache
16 (.44%)
Syncope
16 (.44%)
Aggression
15 (.41%)
Anxiety
15 (.41%)
Blood Pressure Increased
15 (.41%)
Drug Abuse
15 (.41%)
Pain In Extremity
15 (.41%)
Blood Creatine Phosphokinase Increa...
14 (.38%)
Disseminated Intravascular Coagulat...
14 (.38%)
Femur Fracture
14 (.38%)
Libido Increased
14 (.38%)
Pulmonary Embolism
14 (.38%)
Altered State Of Consciousness
13 (.35%)
Anorexia
13 (.35%)
Coma
13 (.35%)
Depressed Level Of Consciousness
13 (.35%)
Drug Ineffective
13 (.35%)
Hypersexuality
13 (.35%)
Pleural Effusion
13 (.35%)
Completed Suicide
12 (.33%)
Drug Abuser
12 (.33%)
Dysphagia
12 (.33%)
Pleurisy
12 (.33%)
Blood Pressure Fluctuation
11 (.3%)
Bradycardia
11 (.3%)
Contusion
11 (.3%)
Movement Disorder
11 (.3%)
Muscle Spasms
11 (.3%)
Renal Failure
11 (.3%)
Aspartate Aminotransferase Increase...
10 (.27%)
Circulatory Collapse
10 (.27%)
Dyspnoea Exertional
10 (.27%)
Gait Disturbance
10 (.27%)
Gambling
10 (.27%)
Nightmare
10 (.27%)
Personality Change
10 (.27%)
Renal Failure Acute
10 (.27%)
Shock
10 (.27%)
Suicidal Ideation
10 (.27%)
Abdominal Pain
9 (.25%)
Angina Pectoris
9 (.25%)
Back Pain
9 (.25%)
Cardio-respiratory Arrest
9 (.25%)
Cholelithiasis
9 (.25%)
Convulsion
9 (.25%)
Decreased Appetite
9 (.25%)
Drowning
9 (.25%)
Economic Problem
9 (.25%)
Fracture
9 (.25%)
Hepatic Function Abnormal
9 (.25%)
Hypoaesthesia
9 (.25%)
Impulse-control Disorder
9 (.25%)
Myocardial Infarction
9 (.25%)

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

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

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

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

Parkinsons Disease
855
Restless Legs Syndrome
196
Parkinsonism
42
Drug Use For Unknown Indication
13
Polyneuropathy Alcoholic
12
Tremor
11
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Extrapyramidal Disorder
8
Product Used For Unknown Indication
8
Psychotic Disorder
4
Muscle Spasms
3
Multiple System Atrophy
2
Restlessness
2
Rapid Eye Movements Sleep Abnormal
2
Neurodegenerative Disorder
2
Dementia
2
Paraesthesia
2
Pain
2
Progressive Supranuclear Palsy
2
Bartters Syndrome
1
Central Pontine Myelinolysis
1
Depression
1
Poor Quality Sleep
1
Muscle Contractions Involuntary
1
Freezing Phenomenon
1
Endoscopic Retrograde Cholangiopanc...
1
Hypokinesia
1
Cerebral Infarction
1
Movement Disorder
1
Accidental Exposure
1

Sifrol Case Reports

What Sifrol 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 Sifrol. 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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