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Review Rivastigmine Safety Reports submitted to FDA

Total Rivastigmine reports: 15.
Rivastigmine FDA safety alerts: 2001 .
Reported deaths: 1    Reported hospitalizations: 8.
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FDA Reported Rivastigmine Side Effects: vertigo, meniere's disease, gait disturbance, balance disorder, accidental exposure, abnormal behaviour, fall, gait deviation, dystonia, death, pyrexia.
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Rivastigmine Side Effects Report #5657672-3
Consumer or non-health professional from UNITED STATES reported RIVASTIGMINE problem on Feb 28, 2008. Male patient, 58 years of age, was treated with RIVASTIGMINE. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, blood creatine phosphokinase increased, blood pressure decreased, body temperature increased, gait disturbance, hyperhidrosis, mental impairment, muscle rigidity. RIVASTIGMINE dosage: 3 MG, BID. During the same period patient was treated with OLANZAPINE, BISACODYL, HYDROCHLOROTHIAZIDE, BROMOCRIPTINE MESYLATE. Patient was hospitalized. Patient recovered.

Rivastigmine Side Effects Report #5635934-3
RIVASTIGMINE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Feb 21, 2008. Male patient, 67 years of age, weighting 132.3 lb, was diagnosed with dementia, parkinson's disease, depression and was treated with RIVASTIGMINE. After drug was administered, patient experienced the following problems/side effects: circulatory collapse. RIVASTIGMINE dosage: 3 MG, UNK. During the same period patient was treated with ENTACAPONE, MADOPAR, MIRTAZAPINE. Patient recovered.

Rivastigmine Side Effects Report #5591088-3
Health Professional from UNITED STATES reported RIVASTIGMINE problem on Jan 07, 2008. Female patient, 61 years of age, was diagnosed with dementia alzheimer's type, anxiety, depressive symptom, bipolar ii disorder, reflux oesophagitis, hypothyroidism, insomnia and was treated with RIVASTIGMINE. After drug was administered, patient experienced the following problems/side effects: anxiety, chest discomfort, dyspnoea, dystonia. RIVASTIGMINE dosage: 3 MG, BID. During the same period patient was treated with CLONAZEPAM, DEXTROAMPHETAMINE, LAMOTRIGINE, LANSOPRAZOLE, LEVOTHYROXINE, MEMANTINE, QUETIAPINE, RISPERIDONE. Patient was hospitalized. Patient recovered.

Rivastigmine Side Effects Report #5536932-0
RIVASTIGMINE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Dec 04, 2007. Male patient, 83 years of age, was diagnosed with dementia alzheimer's type, insomnia, thrombosis prophylaxis, blood cholesterol increased, diabetes mellitus, hypertension and was treated with RIVASTIGMINE. After drug was administered, patient experienced the following problems/side effects: confusional state, dizziness, fall, syncope. RIVASTIGMINE dosage: 4 MG, BID. During the same period patient was treated with ZOPICLONE, ASPIRIN, ATORVASTATIN, GLICLAZIDE, RAMIPRIL. Patient was hospitalized. Patient recovered.


Rivastigmine Side Effects Report #5574728-4
Pharmacist from UNITED STATES reported RIVASTIGMINE problem on Dec 21, 2007. Female patient, 92 years of age, weighting 100.0 lb, was diagnosed with memory impairment and was treated with RIVASTIGMINE. After drug was administered, patient experienced the following problems/side effects: back pain, muscle spasms, muscular weakness, tremor. RIVASTIGMINE dosage: 1.5 MG BID PO FEW DAYS. Patient was hospitalized. Patient recovered.

Rivastigmine Side Effects Report #5441336-5
RIVASTIGMINE problem was reported by a Health Professional from FRANCE on Aug 27, 2007. Male patient, 79 years of age, was diagnosed with dementia alzheimer's type and was treated with RIVASTIGMINE. After drug was administered, patient experienced the following problems/side effects: dystonia, gait deviation. RIVASTIGMINE dosage: unknown. Patient died on 01/01/2005.

Rivastigmine Side Effects Report #5401106-0
Health Professional from UNITED KINGDOM reported RIVASTIGMINE problem on July 23, 2007. Male patient, 64 years of age, was diagnosed with parkinson's disease, depression and was treated with RIVASTIGMINE. After drug was administered, patient experienced the following problems/side effects: blood pressure increased, fall, immobile, pyrexia. RIVASTIGMINE dosage: 1.5 MG, BID. During the same period patient was treated with SINEMET CR, LOFEPRAMINE. Patient recovered.

Rivastigmine Side Effects Report #5401106-0
RIVASTIGMINE problem was reported by a Health Professional from UNITED KINGDOM on July 23, 2007. Male patient, 64 years of age, was diagnosed with parkinson's disease, depression and was treated with RIVASTIGMINE. After drug was administered, patient experienced the following problems/side effects: blood pressure increased, fall, immobile, pyrexia. RIVASTIGMINE dosage: 1.5 MG, BID. During the same period patient was treated with SINEMET CR, LOFEPRAMINE. Patient recovered.

Rivastigmine Side Effects Report #5767825-1
Health Professional from AUSTRALIA reported RIVASTIGMINE problem on May 30, 2008. Male patient, 87 years of age, was diagnosed with dementia alzheimer's type and was treated with RIVASTIGMINE. After drug was administered, patient experienced the following problems/side effects: activities of daily living impaired, anticholinergic syndrome, apathy, diarrhoea, fall, nausea, social avoidant behaviour. RIVASTIGMINE dosage: 4.5 MG, BID. During the same period patient was treated with RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE. Patient was hospitalized. Patient recovered.


Rivastigmine Side Effects Report #5771429-4
RIVASTIGMINE problem was reported by a Health Professional from AUSTRALIA on May 30, 2008. Male patient, 87 years of age, was diagnosed with dementia alzheimer's type and was treated with RIVASTIGMINE. After drug was administered, patient experienced the following problems/side effects: activities of daily living impaired, anticholinergic syndrome, apathy, diarrhoea, fall, nausea, social avoidant behaviour. RIVASTIGMINE dosage: 4.5 MG, BID. During the same period patient was treated with RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE. Patient was hospitalized. Patient recovered.

Rivastigmine Side Effects Report #5731660-0
Health Professional from UNITED KINGDOM reported RIVASTIGMINE problem on Apr 29, 2008. Female patient was treated with RIVASTIGMINE. After drug was administered, patient experienced the following problems/side effects: freezing phenomenon. RIVASTIGMINE dosage: 9.5 MG/24 HRS. Patient recovered.

Rivastigmine Side Effects Report #5710876-3
RIVASTIGMINE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Apr 10, 2008. Male patient, 71 years of age, was diagnosed with dementia, parkinson's disease and was treated with RIVASTIGMINE. After drug was administered, patient experienced the following problems/side effects: asthenia, asthenopia, confusional state, mobility decreased. RIVASTIGMINE dosage: 1.5MG. During the same period patient was treated with ENTACAPONE, SINEMET. Patient recovered.

Rivastigmine Side Effects Report #5710923-9
Physician from SPAIN reported RIVASTIGMINE problem on Apr 10, 2008. Female patient, 80 years of age, was diagnosed with dementia alzheimer's type and was treated with RIVASTIGMINE. After drug was administered, patient experienced the following problems/side effects: hepatitis toxic. RIVASTIGMINE dosage: 3 MG/DAILY. During the same period patient was treated with RIVASTIGMINE TARTRATE. Patient recovered.

Rivastigmine Side Effects Report #5317415-X
RIVASTIGMINE problem was reported by a Physician from NETHERLANDS on Apr 23, 2007. Female patient, 71 years of age, weighting 165.3 lb, was diagnosed with dementia alzheimer's type, pain and was treated with RIVASTIGMINE. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, accidental exposure, balance disorder, gait disturbance, meniere's disease, vertigo. RIVASTIGMINE dosage: unknown. During the same period patient was treated with REMINYL, ACETYLSALICYLIC ACID SRT, IRON SUPPLEMENTS. Patient recovered.


Rivastigmine Side Effects Report #5323417-X
Consumer or non-health professional from NETHERLANDS reported RIVASTIGMINE problem on May 03, 2007. Female patient, 71 years of age, weighting 165.3 lb, was diagnosed with dementia alzheimer's type, pain and was treated with RIVASTIGMINE. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, accidental exposure, balance disorder, gait disturbance, meniere's disease, overdose, vertigo. RIVASTIGMINE dosage: unknown. During the same period patient was treated with REMINYL, ACETYLSALICYLIC ACID SRT, IRON SUPPLEMENTS. Patient recovered.


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