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Review Mirapexin Safety Reports submitted to FDA

Total Mirapexin reports: 7.
Mirapexin FDA safety alerts: No.
   Reported hospitalizations: 1.
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FDA Reported Mirapexin Side Effects: sudden onset of sleep, road traffic accident, somnolence, hyponatraemia, vomiting, nausea, ocular hyperaemia, eye abscess, hallucination, delusion, anxiety.
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Mirapexin Side Effects Report #5533713-9
Physician from reported MIRAPEXIN problem on Nov 30, 2007. Female patient, 76 years of age, was diagnosed with parkinson's disease, vascular encephalopathy, diabetes mellitus, depression, constipation and was treated with MIRAPEXIN. After drug was administered, patient experienced the following problems/side effects: coordination abnormal, hallucination, speech disorder, vascular encephalopathy. MIRAPEXIN dosage: unknown. During the same period patient was treated with SOMAZINA, INSULATARD FLEXPEN, NOBRITOL, OMEPRAZOLE, PLANTABEN. Patient recovered.

Mirapexin Side Effects Report #5512100-3
MIRAPEXIN problem was reported by a Physician from on Nov 06, 2007. Female patient, 73 years of age, was diagnosed with parkinson's disease, hypertension, type 1 diabetes mellitus and was treated with MIRAPEXIN. After drug was administered, patient experienced the following problems/side effects: blood glucose increased. MIRAPEXIN dosage: unknown. During the same period patient was treated with ACE INHIBITOR, INSULIN. Patient recovered.

Mirapexin Side Effects Report #5788114-5
Physician from reported MIRAPEXIN problem on June 20, 2008. Male patient, 51 years of age, was diagnosed with hepatic cirrhosis and was treated with MIRAPEXIN. After drug was administered, patient experienced the following problems/side effects: constipation, hepatic encephalopathy. MIRAPEXIN dosage: unknown. During the same period patient was treated with ALDACTONE, OMEPRAZOLE, DACORTIN, URSOBILANE. Patient recovered.

Mirapexin Side Effects Report #5754417-3
MIRAPEXIN problem was reported by a Physician from on May 22, 2008. Male patient, 78 years of age, was diagnosed with restless legs syndrome and was treated with MIRAPEXIN. After drug was administered, patient experienced the following problems/side effects: confusional state, dysarthria, hemiparesis. MIRAPEXIN dosage: unknown. Patient recovered.

Mirapexin Side Effects Report #5716897-9
Physician from reported MIRAPEXIN problem on Apr 22, 2008. Female patient, 85 years of age, was diagnosed with restless legs syndrome and was treated with MIRAPEXIN. After drug was administered, patient experienced the following problems/side effects: confusional state, somnolence. MIRAPEXIN dosage: unknown. Patient was hospitalized. Patient recovered.

Mirapexin Side Effects Report #5339159-0
MIRAPEXIN problem was reported by a Physician from ITALY on May 28, 2007. Male patient, weighting 238.1 lb, was diagnosed with parkinson's disease, atrial fibrillation, hypertension and was treated with MIRAPEXIN. After drug was administered, patient experienced the following problems/side effects: road traffic accident, sudden onset of sleep. MIRAPEXIN dosage: unknown. During the same period patient was treated with AMIODAR, CARDIRENE, VASERETIC, CARDURA, LANOXIN, MADOPAR. Patient recovered.

Mirapexin Side Effects Report #5301110-7
Physician from ITALY reported MIRAPEXIN problem on Apr 12, 2007. Female patient, weighting 154.3 lb, was diagnosed with parkinson's disease, hiatus hernia, migraine and was treated with MIRAPEXIN. After drug was administered, patient experienced the following problems/side effects: road traffic accident, sudden onset of sleep. MIRAPEXIN dosage: unknown. During the same period patient was treated with LEVODOPA, OMEPRAZOLE, FROVATRIPTAN. Patient recovered.


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coordination abnormal, hallucination, speech disorder, vascular encephalopathy, blood glucose increased, , was diagnosed with parkinson's disease, vascular encephalopathy, diabetes mellitus, depression, constipation and