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Apokyn Adverse Events Reported to the FDA Over Time

How are Apokyn adverse event reports trending over time?

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

Most Common Apokyn Adverse Events Reported to the FDA

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

Death
93 (2.72%)
Fall
91 (2.67%)
Somnolence
87 (2.55%)
Nausea
69 (2.02%)
Drug Ineffective
62 (1.82%)
Hallucination
59 (1.73%)
Condition Aggravated
51 (1.49%)
Dizziness
43 (1.26%)
Hypotension
43 (1.26%)
Confusional State
38 (1.11%)
Dyskinesia
34 (1%)
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General Physical Health Deteriorati...
34 (1%)
Loss Of Consciousness
33 (.97%)
Vomiting
30 (.88%)
Aggression
29 (.85%)
Asthenia
29 (.85%)
Muscle Rigidity
28 (.82%)
Dyspnoea
27 (.79%)
Oedema Peripheral
26 (.76%)
Blood Pressure Increased
25 (.73%)
Headache
25 (.73%)
Haemolytic Anaemia
24 (.7%)
Hyperhidrosis
24 (.7%)
Psychotic Disorder
24 (.7%)
Hallucination, Visual
23 (.67%)
Nodule
23 (.67%)
Blood Pressure Decreased
22 (.64%)
Dysstasia
22 (.64%)
Paranoia
22 (.64%)
Tremor
22 (.64%)
Fatigue
21 (.62%)
Muscle Spasms
21 (.62%)
Pain
21 (.62%)
Abasia
20 (.59%)
Malaise
20 (.59%)
Anxiety
19 (.56%)
Depression
19 (.56%)
Drug Effect Decreased
19 (.56%)
Inflammation
18 (.53%)
Syncope
18 (.53%)
Abnormal Behaviour
17 (.5%)
Pneumonia
17 (.5%)
Agitation
16 (.47%)
Insomnia
16 (.47%)
Myocardial Infarction
16 (.47%)
Urinary Tract Infection
15 (.44%)
Feeling Abnormal
14 (.41%)
Hyperkinesia
14 (.41%)
Hypertension
14 (.41%)
Incorrect Dose Administered
14 (.41%)
Infusion Site Mass
14 (.41%)
Sleep Disorder
14 (.41%)
Cerebrovascular Accident
13 (.38%)
No Therapeutic Response
13 (.38%)
Pain In Extremity
13 (.38%)
Rash
13 (.38%)
Thrombocytopenia
13 (.38%)
Cough
12 (.35%)
Disease Progression
12 (.35%)
Flushing
12 (.35%)
Haemoglobin Decreased
12 (.35%)
Cardiac Disorder
11 (.32%)
Chest Pain
11 (.32%)
Contusion
11 (.32%)
Diarrhoea
11 (.32%)
Hip Fracture
11 (.32%)
Infusion Site Necrosis
11 (.32%)
Injection Site Nodule
11 (.32%)
Unresponsive To Stimuli
11 (.32%)
Erythema
10 (.29%)
Gait Disturbance
10 (.29%)
Hypersexuality
10 (.29%)
Immobile
10 (.29%)
Infection
10 (.29%)
Injection Site Erythema
10 (.29%)
Pallor
10 (.29%)
Suicide Attempt
10 (.29%)
Vision Blurred
10 (.29%)
Anaemia
9 (.26%)
Anaemia Haemolytic Autoimmune
9 (.26%)
Cellulitis
9 (.26%)
Joint Swelling
9 (.26%)
Mobility Decreased
9 (.26%)
Musculoskeletal Stiffness
9 (.26%)
Panic Attack
9 (.26%)
Pyrexia
9 (.26%)
Rotavirus Test Positive
9 (.26%)
Anorexia
8 (.23%)
Atrial Fibrillation
8 (.23%)
Cardiac Failure Congestive
8 (.23%)
Completed Suicide
8 (.23%)
Dementia
8 (.23%)
Disturbance In Attention
8 (.23%)
Dysgeusia
8 (.23%)
Hospitalisation
8 (.23%)
Infusion Site Inflammation
8 (.23%)
Palpitations
8 (.23%)
Pruritus
8 (.23%)
Spinal Fracture
8 (.23%)
Weight Decreased
8 (.23%)
Arthritis
7 (.21%)

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

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

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

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

Parkinsons Disease
600
Product Used For Unknown Indication
177
Drug Use For Unknown Indication
121
Parkinsonism
15
On And Off Phenomenon
12
Restless Legs Syndrome
5
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Dystonia
4
Akinesia
2
Erectile Dysfunction
2
Dyskinesia
2
Muscle Rigidity
2
Nervous System Disorder
1
Freezing Phenomenon
1
Depressed Level Of Consciousness
1
Musculoskeletal Stiffness
1
Metal Poisoning
1
Mobility Decreased
1
Migraine
1
Movement Disorder
1

Drug Labels

LabelLabelerEffective
ApokynTercica, Inc.12-JAN-11
ApokynUS WorldMeds, LLC11-JUN-12

Apokyn Case Reports

What Apokyn 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 Apokyn. 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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