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Aricept (Donepezil) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Aricept (Donepezil) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (397)
Death (71)
Life Threatening Events (42)
Disability (18)

Reports by Reaction Type

Syncope (31)Electrocardiogram QT Prolonged (26)Convulsion (25)Drug Interaction (24)Fall (22)Altered State of Consciousness (21)Bradycardia (20)Dementia (19)Vomiting (19)Loss of Consciousness (18)Malaise (18)Decreased Appetite (18)

Below are a few examples of reports where side effects / adverse reactions may be related to Aricept (Donepezil). For a complete list or a specific selection of reports, please use the links above.

Possible Aricept side effects in 83 year old male

Reported by a physician from Japan on 2012-08-27

Patient: 83 year old male

Reactions: Pancytopenia

Drug(s) suspected as cause:
Aricept



Possible Aricept side effects in 59 year old female

Reported by a physician from China on 2012-08-27

Patient: 59 year old female, weighing 55.0 kg (121.0 pounds)

Reactions: Speech Disorder, Akinesia, Parkinsonism

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aricept
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2012-08-08
    End date: 2012-08-17

Aricept
    Indication: Dementia

Other drugs received by patient: Amantadine HCL; Levodopa and Benserazide; Pramipexole Dihychloride



Possible Aricept side effects in male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-20

Patient: male, weighing 41.0 kg (90.2 pounds)

Reactions: Status Epilepticus

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Aricept
    Dosage: 10 mg
    Start date: 2012-05-10
    End date: 2012-05-13

Aricept
    Dosage: 5 mg
    Administration route: Oral
    Indication: Dementia
    Start date: 2012-04-06
    End date: 2012-05-09

Memantine HCL
    Dosage: 15 mg
    Administration route: Oral
    Start date: 2012-05-10
    End date: 2012-05-13

Memantine HCL
    Dosage: 10 mg
    Administration route: Oral
    Indication: Dementia
    Start date: 2012-04-28
    End date: 2012-05-09

Other drugs received by patient: Lantus; Gramalil; Glimicron; Urso 250; Rebamipide; Nocbin



Possible Aricept side effects in 76 year old female

Reported by a pharmacist from Japan on 2012-08-17

Patient: 76 year old female

Reactions: Large Intestine Perforation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aricept
    Administration route: Oral

Aricept
    Administration route: Oral

Other drugs received by patient: Cinacalcet Hydrochloride; Depas; Bisoprolol Fumarate; Toledomin; Zetia; Warfarin Sodium; Rabeprazole Sodium; Exforge; Alfarol; Levothyroxine Sodium



Possible Aricept side effects in female

Reported by a pharmacist from Japan on 2012-08-16

Patient: female

Reactions: Delirium, Somnolence

Drug(s) suspected as cause:
Aricept
    Administration route: Oral

Aricept
    Administration route: Oral



Possible Aricept side effects in male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-16

Patient: male

Reactions: TIC

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aricept
    Dosage: 10 mg
    Administration route: Oral
    Indication: Dementia Alzheimer's Type
    Start date: 2009-05-29
    End date: 2012-07-18

Memantine HCL
    Dosage: 20 mg
    Administration route: Oral
    Indication: Dementia Alzheimer's Type
    End date: 2012-07-18

Other drugs received by patient: Ticlopidine HCL; Januvia; Losartan Potassium



Possible Aricept side effects in 83 year old male

Reported by a physician from Japan on 2012-08-14

Patient: 83 year old male

Reactions: Pancytopenia

Drug(s) suspected as cause:
Aricept



Possible Aricept side effects in 83 year old female

Reported by a physician from Norway on 2012-08-14

Patient: 83 year old female

Reactions: Renal Failure, Drug Interaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aricept

Other drugs received by patient possibly interacting with the suspect drug:
Ramipril
    Dosage: 2.5 mg, 1x/day
    Administration route: Oral
    Indication: Hypertension
    End date: 2012-07-10

Other drugs received by patient: Nitroglycerin; Clotrimazole; Afipran



Possible Aricept side effects in 81 year old female

Reported by a physician from Japan on 2012-08-14

Patient: 81 year old female

Reactions: Agitation, Delirium

Drug(s) suspected as cause:
Aricept

Other drugs received by patient: Quetiapine; Blonanserin; Blonanserin; Blonanserin; Yokukan-SAN; Blonanserin; Blonanserin; Quetiapine; Blonanserin



Possible Aricept side effects in female

Reported by a physician from Norway on 2012-08-08

Patient: female

Reactions: Renal Failure, Drug Interaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aricept

Other drugs received by patient possibly interacting with the suspect drug:
Ramipril
    Administration route: Oral
    Indication: Hypertension
    End date: 2012-07-10

Other drugs received by patient: Nitroglycerin; Clotrimazole; Afipran



Possible Aricept side effects in 85 year old female

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: 85 year old female

Reactions: Rash, Stevens-Johnson Syndrome

Adverse event resulted in: death

Drug(s) suspected as cause:
Aricept
    Dosage: unk
    Administration route: Oral
    Start date: 2012-01-01

Aricept
    Dosage: unk
    Administration route: Oral
    Indication: Dementia Alzheimer's Type
    Start date: 2012-01-01
    End date: 2012-01-01

Azithromycin
    Dosage: unk



Possible Aricept side effects in 85 year old female

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: 85 year old female

Reactions: Rash, Stevens-Johnson Syndrome

Adverse event resulted in: death

Drug(s) suspected as cause:
Aricept
    Dosage: unknown
    Administration route: Oral
    Start date: 2012-01-01
    End date: 2012-01-01

Aricept
    Dosage: unknown
    Administration route: Oral
    Start date: 2012-01-01

Azithromycin
    Dosage: unknown
    Start date: 2012-01-01



Possible Aricept side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-03

Patient: female

Reactions: Confusional State, Drug Screen Positive, Tremor

Drug(s) suspected as cause:
Aricept
    Dosage: unk
    Administration route: Oral

Cyclobenzaprine
    Dosage: unk
    Administration route: Oral

Gabapentin
    Dosage: unk
    Administration route: Oral

Ibuprofen (Advil)
    Dosage: unk
    Administration route: Oral

Lisinopril
    Dosage: unk
    Administration route: Oral

Nabumetone
    Dosage: unk
    Administration route: Oral

Namenda
    Dosage: unk
    Administration route: Oral

Remeron
    Dosage: unk
    Administration route: Oral

Tramadol HCL
    Dosage: unk
    Administration route: Oral



Possible Aricept side effects in 83 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-02

Patient: 83 year old female

Reactions: Asthma, Electrocardiogram QT Prolonged, Malaise, Bradycardia, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Alprazolam
    Dosage: unk
    Administration route: Oral
    Indication: Depression

Aricept
    Dosage: unk
    Administration route: Oral
    Indication: Dementia Alzheimer's Type
    Start date: 2010-02-01

Athymil
    Dosage: unk
    Administration route: Oral
    Indication: Depression

Atorvastatin
    Dosage: unk
    Administration route: Oral
    Indication: Hypercholesterolaemia

Perindopril Erbumine
    Dosage: unk
    Administration route: Oral
    Indication: Hypertension

Pulmicort
    Dosage: unk
    Administration route: Oral
    Indication: Asthma
    Start date: 2012-04-01

Zolpidem
    Dosage: unk
    Administration route: Oral
    Indication: Depression



Possible Aricept side effects in 84 year old female

Reported by a physician from Japan on 2012-08-02

Patient: 84 year old female

Reactions: Rhabdomyolysis, Cardiac Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aricept

Other drugs received by patient: Cefazolin Sodium; Lamisil; Sitagliptin Phosphate; Micamlo; Lysozyme Hydrochloride; Betamethasone Sodium Phosphate; Resplen; Acetaminophen; Aldactone; Zithromax; Micardis; Vitaneurin; Actos; Amlodipine; Januvia



Possible Aricept side effects in male

Reported by a pharmacist from Japan on 2012-07-31

Patient: male

Reactions: Suicide Attempt

Drug(s) suspected as cause:
Aricept



Possible Aricept side effects in 83 year old female

Reported by a pharmacist from United States on 2012-07-27

Patient: 83 year old female, weighing 75.0 kg (165.0 pounds)

Reactions: Syncope, Bradycardia, Gastritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aricept

Other drugs received by patient: Remeron; Glycolax; Vitamin B-12; Dulcolax; Nitrofurantoin; Clonazepam; Tylenol; Ergocalciferol; Aspirin; Docusate



Possible Aricept side effects in female

Reported by a physician from France on 2012-07-26

Patient: female

Reactions: Electrocardiogram QT Prolonged

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Alprazolam
    Dosage: unknown
    Administration route: Oral

Aricept
    Dosage: unknown
    Administration route: Oral
    Indication: Dementia Alzheimer's Type
    Start date: 2010-02-01

Athymil
    Dosage: unknown
    Administration route: Oral

Atorvastatin
    Dosage: unknown
    Administration route: Oral

Perindopril Erbumine
    Dosage: unknown
    Administration route: Oral

Pulmicort
    Dosage: unknown
    Administration route: Oral
    Indication: Asthma
    Start date: 2012-04-01

Zolpidem
    Dosage: unknown
    Administration route: Oral



Possible Aricept side effects in 83 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-26

Patient: 83 year old female

Reactions: Electrocardiogram QT Prolonged, Asthma, Presyncope, Condition Aggravated, Bradycardia, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aceon
    Dosage: oral
    Administration route: Oral
    Indication: Hypertension

Alprazolam
    Dosage: oral
    Administration route: Oral
    Indication: Depression

Aricept
    Dosage: oral
    Administration route: Oral
    Indication: Dementia Alzheimer's Type
    Start date: 2010-02-01

Athymil (Mianserin Hydrochloride)
    Dosage: oral
    Administration route: Oral
    Indication: Depression

Atorvastatin Calcium
    Dosage: oral
    Administration route: Oral

Pulmicort
    Indication: Asthma
    Start date: 2012-04-01

Zolpidem
    Dosage: oral
    Administration route: Oral
    Indication: Depression



Possible Aricept side effects in 83 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-26

Patient: 83 year old female

Reactions: Electrocardiogram QT Prolonged, Malaise, Bradycardia, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Alprazolam
    Dosage: unk
    Administration route: Oral
    Indication: Depression

Aricept
    Dosage: unk
    Administration route: Oral
    Indication: Dementia Alzheimer's Type
    Start date: 2010-02-01

Athymil
    Dosage: unk
    Administration route: Oral
    Indication: Depression

Atorvastatin
    Dosage: unk
    Administration route: Oral
    Indication: Hypercholesterolaemia

Perindopril Erbumine
    Dosage: unk
    Administration route: Oral
    Indication: Hypertension

Pulmicort
    Dosage: unk
    Indication: Asthma
    Start date: 2012-04-01

Zolpidem
    Dosage: unk
    Administration route: Oral
    Indication: Depression



Possible Aricept side effects in female

Reported by a physician from France on 2012-07-26

Patient: female

Reactions: Electrocardiogram QT Prolonged, Malaise, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Alprazolam
    Administration route: Oral
    Indication: Depression

Aricept
    Administration route: Oral
    Indication: Dementia Alzheimer's Type
    Start date: 2010-02-01

Athymil
    Administration route: Oral
    Indication: Depression

Atorvastatin
    Administration route: Oral
    Indication: Hypercholesterolaemia

Perindopril Erbumine
    Administration route: Oral
    Indication: Hypertension

Pulmicort
    Indication: Asthma
    Start date: 2012-04-01

Zolpidem
    Administration route: Oral
    Indication: Depression

Other drugs received by patient: Fluticasone Propionate / Salmeterol



Possible Aricept side effects in 83 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-24

Patient: 83 year old female

Reactions: Electrocardiogram QT Prolonged, Malaise, Bradycardia, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Alprazolam
    Dosage: unk
    Administration route: Oral
    Indication: Depression

Aricept
    Dosage: unk
    Administration route: Oral
    Start date: 2010-02-01

Athymil
    Dosage: unk
    Administration route: Oral
    Indication: Depression

Atorvastatin
    Dosage: unk
    Administration route: Oral
    Indication: Hypercholesterolaemia

Perindopril Erbumine
    Dosage: unk
    Administration route: Oral
    Indication: Hypertension

Pulmicort
    Dosage: unk
    Indication: Asthma
    Start date: 2012-04-01

Zolpidem
    Dosage: unk
    Administration route: Oral
    Indication: Depression



Possible Aricept side effects in 80 year old female

Reported by a pharmacist from Japan on 2012-07-23

Patient: 80 year old female

Reactions: Rhabdomyolysis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aricept
    Administration route: Oral
    Indication: Dementia
    Start date: 2012-04-19
    End date: 2012-07-01

Crestor
    Dosage: unknown
    Administration route: Oral
    Indication: Diabetes Mellitus
    End date: 2012-07-01

Other drugs received by patient: Tegretol; Celebrex; Mucosta; Coniel; Nipolazin



Possible Aricept side effects in 65 year old female

Reported by a physician from United States on 2012-07-23

Patient: 65 year old female

Reactions: Urinary Incontinence, Dementia, Drug Interaction

Drug(s) suspected as cause:
Aricept

Other drugs received by patient possibly interacting with the suspect drug:
Detrol
    Dosage: unk
    Indication: Urinary Incontinence



Possible Aricept side effects in female

Reported by a pharmacist from Belgium on 2012-07-23

Patient: female, weighing 68.0 kg (149.6 pounds)

Reactions: Confusional State, Atrial Fibrillation, Withdrawal Syndrome, Cardiac Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aricept
    Dosage: unknown
    Administration route: Oral
    Start date: 2012-06-01

Aricept
    Administration route: Oral
    Start date: 2011-12-15
    End date: 2012-06-01



Possible Aricept side effects in 72 year old male

Reported by a consumer/non-health professional from Greece on 2012-07-23

Patient: 72 year old male

Reactions: Amylase Increased, Pancreatic Enzymes Increased, Lipase Increased, Hepatic Enzyme Increased

Drug(s) suspected as cause:
Aricept
    Dosage: 5 mg, 1x/day
    Administration route: Oral
    Start date: 2012-01-01

Lipitor
    Dosage: 20 mg, 1x/day
    Administration route: Oral
    Indication: Hypercholesterolaemia
    End date: 2012-05-01

Other drugs received by patient: Calcioral D3



Possible Aricept side effects in female

Reported by a physician from France on 2012-07-20

Patient: female

Reactions: Electrocardiogram QT Prolonged

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aricept

Other drugs received by patient: Fluticasone + Salmelerol; Zolpidem; Perindopril Erbumine; Atrovastatine; Mianserine; Alprazolam



Possible Aricept side effects in 89 year old male

Reported by a physician from Japan on 2012-07-19

Patient: 89 year old male

Reactions: Miosis, Convulsion

Drug(s) suspected as cause:
Aricept

Other drugs received by patient: Symmetrel; Polyful; Loperamide Hydrochloride; Ferotym; Aspara Potassium; Seftac; Urosulol; Flenied



Possible Aricept side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-18

Patient:

Reactions: Drug Screen Positive

Drug(s) suspected as cause:
Advil
    Dosage: unk

Aricept
    Dosage: unk

Cyclobenzaprine
    Dosage: unk

Gabapentin
    Dosage: unk

Lisinopril
    Dosage: unk

Nabumetone
    Dosage: unk

Namenda
    Dosage: unk

Remeron
    Dosage: unk

Tramadol HCL
    Dosage: unk



Possible Aricept side effects in female

Reported by a physician from United States on 2012-07-16

Patient: female, weighing 61.2 kg (134.7 pounds)

Reactions: Headache

Drug(s) suspected as cause:
Aricept

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