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DONEPEZIL

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Donepezil Adverse Events Reported to the FDA Over Time

How are Donepezil adverse event reports trending over time?

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

Most Common Donepezil Adverse Events Reported to the FDA

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

Fall
348 (1.92%)
Bradycardia
330 (1.82%)
Drug Interaction
275 (1.51%)
Syncope
257 (1.41%)
Vomiting
238 (1.31%)
Nausea
217 (1.19%)
Convulsion
216 (1.19%)
Diarrhoea
211 (1.16%)
Confusional State
197 (1.08%)
Rhabdomyolysis
189 (1.04%)
Somnolence
160 (.88%)
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Dizziness
158 (.87%)
Loss Of Consciousness
156 (.86%)
Depressed Level Of Consciousness
155 (.85%)
Electrocardiogram Qt Prolonged
153 (.84%)
Dehydration
138 (.76%)
Hallucination
137 (.75%)
Tremor
135 (.74%)
Malaise
133 (.73%)
Asthenia
130 (.72%)
Delirium
124 (.68%)
Condition Aggravated
122 (.67%)
Pneumonia
120 (.66%)
Agitation
116 (.64%)
Arrhythmia
111 (.61%)
Cardiac Arrest
110 (.61%)
Dementia
107 (.59%)
Hypotension
104 (.57%)
Insomnia
101 (.56%)
Decreased Appetite
100 (.55%)
General Physical Health Deteriorati...
100 (.55%)
Overdose
99 (.54%)
Pyrexia
99 (.54%)
Weight Decreased
98 (.54%)
Altered State Of Consciousness
95 (.52%)
Gait Disturbance
89 (.49%)
Memory Impairment
89 (.49%)
Headache
86 (.47%)
Anorexia
85 (.47%)
Atrial Fibrillation
81 (.45%)
Blood Pressure Decreased
81 (.45%)
Abnormal Behaviour
78 (.43%)
Disorientation
78 (.43%)
Neuroleptic Malignant Syndrome
77 (.42%)
Sinus Bradycardia
76 (.42%)
Aggression
74 (.41%)
Cerebrovascular Accident
74 (.41%)
Depression
74 (.41%)
Cardiac Failure
73 (.4%)
Dysphagia
73 (.4%)
Dyspnoea
73 (.4%)
Sick Sinus Syndrome
72 (.4%)
Sudden Death
72 (.4%)
Pneumonia Aspiration
71 (.39%)
Renal Failure Acute
70 (.39%)
Ventricular Tachycardia
70 (.39%)
Anaemia
65 (.36%)
Urinary Tract Infection
65 (.36%)
Torsade De Pointes
64 (.35%)
Cardio-respiratory Arrest
63 (.35%)
Coma
63 (.35%)
Death
62 (.34%)
Extrapyramidal Disorder
61 (.34%)
Fatigue
60 (.33%)
Hallucination, Visual
60 (.33%)
Myocardial Infarction
59 (.32%)
Parkinsonism
59 (.32%)
Feeling Abnormal
55 (.3%)
Psychotic Disorder
55 (.3%)
Atrioventricular Block Complete
54 (.3%)
Cognitive Disorder
54 (.3%)
Hyperhidrosis
53 (.29%)
Anxiety
52 (.29%)
Atrioventricular Block
51 (.28%)
Constipation
51 (.28%)
Hyponatraemia
51 (.28%)
Muscle Spasms
51 (.28%)
Cerebral Haemorrhage
50 (.28%)
Miosis
50 (.28%)
Renal Failure
50 (.28%)
Shock
50 (.28%)
Gastrointestinal Haemorrhage
49 (.27%)
Restlessness
49 (.27%)
Blood Creatine Phosphokinase Increa...
48 (.26%)
Dyskinesia
48 (.26%)
Urinary Incontinence
47 (.26%)
Drug Ineffective
46 (.25%)
Blood Glucose Increased
45 (.25%)
Abdominal Pain
44 (.24%)
Aspartate Aminotransferase Increase...
44 (.24%)
Balance Disorder
44 (.24%)
Chest Pain
44 (.24%)
Alanine Aminotransferase Increased
43 (.24%)
Epilepsy
43 (.24%)
Speech Disorder
43 (.24%)
Hypoxia
42 (.23%)
Heart Rate Decreased
41 (.23%)
Nightmare
41 (.23%)
Amnesia
40 (.22%)
Cardiac Disorder
40 (.22%)
Oedema Peripheral
40 (.22%)

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

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

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

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

Dementia Alzheimers Type
2234
Dementia
1170
Drug Use For Unknown Indication
393
Product Used For Unknown Indication
296
Memory Impairment
244
Amnesia
171
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Cognitive Disorder
123
Vascular Dementia
105
Ill-defined Disorder
84
Parkinsons Disease
82
Dementia With Lewy Bodies
57
Senile Dementia
28
Prophylaxis
16
Confusional State
12
Pain
10
Psychiatric Symptom
10
Hypertension
8
Dementia Of The Alzheimers Type, Un...
8
Disturbance In Attention
8
Multiple Sclerosis
8
Depression
7
Diabetes Mellitus
7
Presenile Dementia
6
Delusion
6
Restlessness
4
Schizoaffective Disorder Bipolar Ty...
4
Cerebral Haemorrhage
4
Off Label Use
4
Agitation
4
Frontotemporal Dementia
4
Nervous System Disorder
4
Mental Disorder
4
Dependence
4
Cerebral Infarction
3
Psychotic Disorder
3
Anxiety
3
Hallucination, Visual
3
Cerebral Autosomal Dominant Arterio...
3
Mental Impairment
3
Central Nervous System Lymphoma
3
Tremor
3
Abnormal Behaviour
3
Impaired Self-care
2
Accidental Exposure
2
Quality Of Life Decreased
2
Anaemia
2
Schizophrenia
2
Cerebral Atrophy
2
Drug Therapy
2
Convulsion
2
Brain Injury
2

Drug Labels

LabelLabelerEffective
AriceptPhysicians Total Care, Inc.03-NOV-10
AriceptPD-Rx Pharmaceuticals, Inc.03-NOV-10
Donepezil Hydrochloride OdtGreenstone LLC30-NOV-10
Donepezil HydrochlorideodtUDL Laboratories, Inc.30-NOV-10
Donepezil HydrochlorideGreenstone LLC30-NOV-10
Donepezil HydrochloridePhysicians Total Care, Inc.17-DEC-10
Donepezil HydrochlorideSandoz Inc11-JAN-11
Donepezil HydrochlorideNCS HealthCare of KY, Inc dba Vangard Labs17-JAN-11
Donepezil HydrochlorideActavis Inc.28-JAN-11
Donepezil HydrochlorideContract Pharmacy Services-PA31-JAN-11
Donepezil HydrochlorideAmerican Health Packaging01-FEB-11
Donepezil HydrochlorideWOCKHARDT LIMITED19-APR-11
Donepezil HydrochlorideWOCKHARDT USA LLC19-APR-11
Donepezil HydrochlorideHikma Pharmaceutical02-MAY-11
Donepezil HydrochlorideZydus Pharmaceuticals (USA) Inc.11-MAY-11
Donepezil HydrochlorideCadila Healthcare Limited11-MAY-11
Donepezil HydrochlorideZydus Pharmaceuticals (USA) Inc.20-MAY-11
Donepezil HydrochlorideCadila Healthcare Limited20-MAY-11
Donepezil HydrochlorideUnit Dose Services31-MAY-11
Donepezil HydrochlorideUnit Dose Services31-MAY-11
Donepezil HydrochlorideSandoz Inc31-MAY-11
Donepezil HydrochlorideSun Pharmaceutical Industries Limited 01-JUN-11
Donepezil HydrochlorideINDICUS PHARMA LLC07-JUL-11
Donepezil HydrochlorideTorrent Pharmaceuticals Limited10-AUG-11
Donepezil HydrochlorideAccord Healthcare, Inc.01-SEP-11
Donepezil HydrochlorideContract Pharmacy Services-PA04-OCT-11
Donepezil HydrochlorideSolco Healthcare US LLC16-OCT-11
AriceptEisai Inc.29-FEB-12
AriceptodtEisai Inc.29-FEB-12
Donepezil HydrochlorideNCS HealthCare of KY, Inc dba Vangard Labs15-MAR-12
AriceptCardinal Health26-APR-12
Donepezil Hydrochloride Jubilant Cadista Pharmaceuticals Inc.25-JUN-12
Donepezil HydrochlorideAurobindo Pharma Limited02-JUL-12
Donepezil HydrochlorideMajor Pharmaceuticals23-JUL-12
Donepezil HydrochloridePreferred Pharmaceuticals, Inc.06-SEP-12
Donepezil HydrochlorideWest-ward Pharmaceutical Corp19-SEP-12
Donepezil HydrochlorideRebel Distributors Corp26-SEP-12
Donepezil HydrochlorideDr. Reddys Laboratories Limited02-NOV-12
Donepezil HydrochlorideRanbaxy Pharmaceuticals Inc.09-NOV-12
Donepezil HydrochlorideMylan Pharmaceuticals Inc.13-DEC-12
Donepezil HydrochlorideMacleods Pharmaceuticals Limited04-JAN-13
Donepezil HydrochlorideMacleods Pharmaceuticals Limited09-JAN-13
AriceptBryant Ranch Prepack17-JAN-13
Donepezil HydrochlorideBryant Ranch Prepack21-JAN-13
Donepezil HydrochlorideTeva Pharmaceuticals USA Inc14-FEB-13
Donepezil HydrochlorideMcKesson Packaging Services a business unit of McKesson Corporation26-FEB-13
Donepezil HydrochlorideMcKesson Packaging Services a business unit of McKesson Corporation05-MAR-13
Donepezil HydrochlorideCardinal Health08-MAR-13
Donepezil Hydrochloride5 MgNorthStar RxLLC26-MAR-13
Donepezil Hydrochloride10 MgNorthStar RxLLC26-MAR-13
Donepezil HydrochlorideMcKesson Contract Packaging10-APR-13

Donepezil Case Reports

What Donepezil 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 Donepezil. 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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