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Exelon (Rivastigmine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Exelon (Rivastigmine) 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 (1516)
Death (610)
Life Threatening Events (45)
Disability (28)

Reports by Reaction Type

Death (309)Fall (124)Vomiting (86)Pneumonia (78)Cerebrovascular Accident (69)Malaise (63)Dementia Alzheimer's Type (63)Nausea (61)Somnolence (60)Confusional State (57)Agitation (54)Application Site Erythema (54)

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

Possible Exelon side effects in

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

Patient:

Reactions: Cerebral Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Exelon



Possible Exelon side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-08-27

Patient: male, weighing 75.0 kg (165.0 pounds)

Reactions: Defaecation Urgency, Vomiting, Coma, Cerebrovascular Accident, Asphyxia, Aggression, Convulsion, Hypertension

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Exelon

Other drugs received by patient: Lyrica; Aloin; Risperidone



Possible Exelon side effects in male

Reported by a pharmacist from United Kingdom on 2012-08-27

Patient: male

Reactions: Dysphagia, Cerebrovascular Accident

Drug(s) suspected as cause:
Exelon



Possible Exelon side effects in male

Reported by a consumer/non-health professional from Canada on 2012-08-27

Patient: male

Reactions: Cellulitis, Skin Exfoliation, Animal Bite

Drug(s) suspected as cause:
Exelon
    Dosage: 9.5 mg/24 hours
    Indication: Dementia Alzheimer's Type
    Start date: 2012-05-24

Exelon



Possible Exelon side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-08-27

Patient: male

Reactions: Cerebrovascular Accident

Drug(s) suspected as cause:
Exelon
    Dosage: 3 mg, daily
    Administration route: Oral
    Indication: Depression

Exelon
    Indication: Central Nervous System Lesion



Possible Exelon side effects in 58 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 58 year old male

Reactions: Staphylococcal Infection, Drug Administration Error, Blood Glucose Abnormal

Drug(s) suspected as cause:
Exelon
    Dosage: 4.6 mg, unk

Exelon
    Dosage: 2 df (4.6mg), unk



Possible Exelon side effects in male

Reported by a consumer/non-health professional from Mexico on 2012-08-27

Patient: male

Reactions: Lung Disorder, Respiratory Arrest, Asthenia

Adverse event resulted in: death

Drug(s) suspected as cause:
Exelon



Possible Exelon side effects in female

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

Patient: female

Reactions: Drug Eruption, Agitation, Peripheral Coldness, Pruritus, Pyrexia, Generalised Erythema, Skin Discolouration, Cyanosis, Oedema Peripheral, Papule, Blood Glucose Increased, Blood Pressure Increased, Restlessness, Toxic Epidermal Necrolysis, Skin Oedema, Rash, Application Site Rash, Diarrhoea

Drug(s) suspected as cause:
Exelon
    Dosage: 18 mg, daily
    Start date: 2012-03-21
    End date: 2012-05-18

Exelon
    Dosage: 4.5 mg, daily
    Indication: Dementia Alzheimer's Type
    Start date: 2012-01-04
    End date: 2012-01-29

Exelon
    Dosage: 9 mg, daily
    Start date: 2012-01-30
    End date: 2012-02-23

Exelon
    Dosage: 13.5 mg, daily
    Start date: 2012-02-24
    End date: 2012-03-20

Tegretol
    Dosage: 100 mg, daily
    Administration route: Oral
    Indication: Restlessness
    Start date: 2012-04-05
    End date: 2012-04-17

Tegretol
    Dosage: 200 mg, daily
    Administration route: Oral
    Start date: 2012-04-18
    End date: 2012-05-28

Other drugs received by patient: Yokukan-SAN; Calcium Antagonists; Atelec



Possible Exelon side effects in 84 year old male

Reported by a physician from Japan on 2012-08-26

Patient: 84 year old male

Reactions: Syncope

Drug(s) suspected as cause:
Exelon

Other drugs received by patient: Depas; Aspirin



Possible Exelon side effects in 87 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 87 year old female

Reactions: Carotid Artery Stenosis, Dysphagia, Hemiplegia, Cerebrovascular Accident

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Exelon



Possible Exelon side effects in male

Reported by a consumer/non-health professional from Mexico on 2012-08-24

Patient: male

Reactions: Application Site Rash, Application Site Pruritus, Cardiac Disorder, Application Site Irritation

Drug(s) suspected as cause:
Exelon
    Dosage: 9.5 mg (10 cm2), unk
    Start date: 2012-06-01

Exelon
    Dosage: 4.6 mg, one patch daily
    Indication: Dementia Alzheimer's Type
    Start date: 2011-01-01

Exelon
    Dosage: 9.5 mg, qod
    Start date: 2012-07-01

Other drugs received by patient: Nexium; Corticosteroid NOS; Diuretics



Possible Exelon side effects in female

Reported by a consumer/non-health professional from Argentina on 2012-08-24

Patient: female

Reactions: Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Exelon



Possible Exelon side effects in 75 year old male

Reported by a consumer/non-health professional from Brazil on 2012-08-24

Patient: 75 year old male

Reactions: Vomiting, Nausea, Haemoptysis, Urinary Tract Infection, Ulcer, Pallor, Apathy, Malaise, Dizziness

Drug(s) suspected as cause:
Exelon
    Dosage: 6 mg, bid

Exelon
    Dosage: 0.04 mg/ml, unk

Exelon
    Dosage: 3 mg, bid
    Indication: Dementia Alzheimer's Type

Other drugs received by patient: Hormones; Amlodipine



Possible Exelon side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-24

Patient: female, weighing 50.0 kg (110.0 pounds)

Reactions: Pelvic Fracture, Haemorrhage, Drug Ineffective, Blood Count Abnormal, Multiple Fractures, Road Traffic Accident, Cardio-Respiratory Arrest, Injury

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Exelon
    Dosage: 9.5 mg daily

Exelon
    Dosage: 4.6 mg daily
    Indication: Memory Impairment

Other drugs received by patient: Prolopa; Simvastatin



Possible Exelon side effects in female

Reported by a consumer/non-health professional from Mexico on 2012-08-24

Patient: female

Reactions: Pneumonia, Arthropathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Exelon



Possible Exelon side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-08-23

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Exelon



Possible Exelon side effects in 88 year old male

Reported by a health professional (non-physician/pharmacist) from Brazil on 2012-08-23

Patient: 88 year old male

Reactions: Pruritus, Application Site Burn, Application Site Hypersensitivity

Drug(s) suspected as cause:
Exelon
    Dosage: 4.6 mg/ 24 hrs
    Indication: Dementia Alzheimer's Type

Exelon
    Dosage: 9.5 mg/ 24 hrs



Possible Exelon side effects in

Reported by a consumer/non-health professional from Argentina on 2012-08-23

Patient:

Reactions: Cardio-Respiratory Arrest, Chest Pain, Feeling Abnormal

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Exelon



Possible Exelon side effects in 75 year old male

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 75 year old male

Reactions: Drug Ineffective, Mental Disorder, Deafness, Memory Impairment

Drug(s) suspected as cause:
Exelon



Possible Exelon side effects in 75 year old male

Reported by a consumer/non-health professional from Brazil on 2012-08-22

Patient: 75 year old male

Reactions: Ulcer

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Exelon

Other drugs received by patient: Amlodipine



Possible Exelon side effects in female

Reported by a consumer/non-health professional from India on 2012-08-22

Patient: female

Reactions: Sepsis

Adverse event resulted in: death

Drug(s) suspected as cause:
Exelon



Possible Exelon side effects in

Reported by a pharmacist from Germany on 2012-08-22

Patient: , weighing 82.0 kg (180.4 pounds)

Reactions: Blood Pressure Increased, Confusional State, Overdose, Nausea, Pallor

Drug(s) suspected as cause:
Exelon
    Dosage: 6 mg, bid
    Administration route: Oral
    Start date: 2012-08-02
    End date: 2012-08-03

Exelon
    Dosage: 2 df, unk
    Administration route: Oral
    Indication: Parkinson's Disease

Exelon
    Dosage: 6 mg, unk
    Administration route: Oral
    Start date: 2012-08-05

Exelon
    Dosage: 4 capsules of 3 mg, once/single
    Administration route: Oral

Other drugs received by patient: Domperidone; Midodrine Hydrochloride; Levodopa



Possible Exelon side effects in female

Reported by a consumer/non-health professional from Canada on 2012-08-22

Patient: female

Reactions: Dementia Alzheimer's Type

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Clozaril
    Dosage: 300 mg
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 1998-10-12

Exelon
    Dosage: 6 mg, bid
    Administration route: Oral

Other drugs received by patient: Calcium; Aspirin; Atenolol; Vitamin D; Glyburide; Metformin; Synthroid



Possible Exelon side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-22

Patient: female

Reactions: Glomerular Filtration Rate Decreased, Urinary Tract Infection, International Normalised Ratio Increased, Drug Interaction, Pyrexia, Prothrombin Time Ratio Decreased, Klebsiella Infection, C-Reactive Protein Increased, Atrioventricular Block, Bradycardia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Exelon

Other drugs received by patient possibly interacting with the suspect drug:
Cordarone
    Dosage: 200 mg, unk
    Indication: Atrial Fibrillation
    Start date: 2012-01-01

Other drugs received by patient: Zoloft; Previscan; Nitroglycerin; Atacand



Possible Exelon side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: male

Reactions: Withdrawal Syndrome

Drug(s) suspected as cause:
Exelon

Other drugs received by patient: Amlodipine; Pravastatin; Seroquel; Meclizine; Oxycodone HCL; Naproxen; Zantac; Citalopram Hydrobromide



Possible Exelon side effects in male

Reported by a consumer/non-health professional from India on 2012-08-21

Patient: male

Reactions: Death, Dementia

Adverse event resulted in: death

Drug(s) suspected as cause:
Exelon



Possible Exelon side effects in 88 year old male

Reported by a health professional (non-physician/pharmacist) from Brazil on 2012-08-21

Patient: 88 year old male

Reactions: Hypersensitivity, Pruritus, Application Site Burn

Drug(s) suspected as cause:
Exelon
    Dosage: 4.6 mg/ 24 hrs
    Indication: Dementia Alzheimer's Type

Exelon
    Dosage: 9.5 mg/ 24 hrs



Possible Exelon side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-21

Patient: male

Reactions: Abnormal Behaviour, Aggression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakote
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2011-10-24

Equanil
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2011-10-24

Exelon
    Indication: Product Used FOR Unknown Indication
    End date: 2011-01-01

Tiapridal
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Trimeprazine Tartrate
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2011-10-24

Xanax
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Polyethylene Glycol; Digoxin



Possible Exelon side effects in male

Reported by a physician from Taiwan, Province of China on 2012-08-21

Patient: male, weighing 68.0 kg (149.6 pounds)

Reactions: Road Traffic Accident, Subdural Haematoma, Hemiparesis

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Exelon

Other drugs received by patient: Sennapur; Norvasc



Possible Exelon side effects in 90 year old male

Reported by a consumer/non-health professional from India on 2012-08-21

Patient: 90 year old male

Reactions: Myocardial Infarction

Adverse event resulted in: death

Drug(s) suspected as cause:
Exelon

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