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Review Ropinirole Safety Reports submitted to FDA

Total Ropinirole reports: 29.
Ropinirole FDA safety alerts: No.
Reported deaths: 1    Reported hospitalizations: 20.
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FDA Reported Ropinirole Side Effects: dizziness, confusional state, palpitations, vertigo, transient ischaemic attack, muscular weakness, hypotension, hypoaesthesia, drop attacks, coordination abnormal, dyspnoea.
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Ropinirole Side Effects Report #5655256-4
Physician from GERMANY reported ROPINIROLE problem on Mar 05, 2008. Female patient, 71 years of age, weighting 154.3 lb, was diagnosed with restless legs syndrome and was treated with ROPINIROLE. After drug was administered, patient experienced the following problems/side effects: brain stem ischaemia, diplopia, hyperlipidaemia, hypoaesthesia facial. ROPINIROLE dosage: unknown. Patient was hospitalized. Patient recovered.

Ropinirole Side Effects Report #5611018-5
ROPINIROLE problem was reported by a Physician from GERMANY on Jan 28, 2008. Female patient, 71 years of age, weighting 154.3 lb, was diagnosed with restless legs syndrome and was treated with ROPINIROLE. After drug was administered, patient experienced the following problems/side effects: brain stem ischaemia, diplopia, hyperlipidaemia, hypoaesthesia facial. ROPINIROLE dosage: unknown. Patient was hospitalized. Patient recovered.

Ropinirole Side Effects Report #5630592-6
Physician from BELGIUM reported ROPINIROLE problem on Feb 14, 2008. Male patient, 80 years of age, was diagnosed with parkinson's disease and was treated with ROPINIROLE. After drug was administered, patient experienced the following problems/side effects: psychotic disorder. ROPINIROLE dosage: unknown. Patient was hospitalized. Patient recovered.

Ropinirole Side Effects Report #5635641-7
ROPINIROLE problem was reported by a Consumer or non-health professional from SPAIN on Feb 06, 2008. Female patient, 83 years of age, was diagnosed with parkinson's disease and was treated with ROPINIROLE. After drug was administered, patient experienced the following problems/side effects: bundle branch block right, cardiac murmur, cardiomegaly, confusional state, depressed level of consciousness, orthostatic hypotension, syncope. ROPINIROLE dosage: 2 MG / PER DAY / ORAL. During the same period patient was treated with OXYBUTYNIN CHLORIDE, ASPIRIN, OMEPRAZOLE, TELMISARTAN. Patient recovered.

Ropinirole Side Effects Report #5588777-3
Physician from GERMANY reported ROPINIROLE problem on Jan 02, 2008. Female patient, 71 years of age, weighting 154.3 lb, was diagnosed with restless legs syndrome and was treated with ROPINIROLE. After drug was administered, patient experienced the following problems/side effects: brain stem ischaemia, diplopia, hyperlipidaemia, hypoaesthesia facial. ROPINIROLE dosage: unknown. Patient was hospitalized. Patient recovered.

Ropinirole Side Effects Report #5605299-1
ROPINIROLE problem was reported by a Physician from UNITED STATES on Jan 14, 2008. Male patient, 44 years of age, was treated with ROPINIROLE. ROPINIROLE dosage: unknown. During the same period patient was treated with LAMOTRIGINE, DONEPEZIL, AMANTADINE, METAXALONE, CLONAZEPAM, MEMANTINE. Patient died.

Ropinirole Side Effects Report #5506552-2
Consumer or non-health professional from UNITED KINGDOM reported ROPINIROLE problem on Oct 31, 2007. Male patient, 66 years of age, was diagnosed with parkinson's disease, blood cholesterol increased, depression and was treated with ROPINIROLE. After drug was administered, patient experienced the following problems/side effects: intentional self-injury. ROPINIROLE dosage: 9MG PER DAY. During the same period patient was treated with ATENOLOL, NIFEDIPINE, SIMVASTATIN, ASPIRIN, MIRTAZAPINE, RAMIPRIL. Patient recovered.

Ropinirole Side Effects Report #5512597-9
ROPINIROLE problem was reported by a Pharmacist from UNITED STATES on Nov 08, 2007. Female patient, 82 years of age, was diagnosed with parkinson's disease and was treated with ROPINIROLE. After drug was administered, patient experienced the following problems/side effects: metabolic encephalopathy, toxic encephalopathy, tremor. ROPINIROLE dosage: 0.25MG TID PO. During the same period patient was treated with ASCORBIC ACID, TRAZODONE, COUMADIN, CLARITIN, PROTONIX, LOPRESSOR. Patient was hospitalized. Patient recovered.

Ropinirole Side Effects Report #5441964-7
Physician from POLAND reported ROPINIROLE problem on Aug 30, 2007. Male patient, 72 years of age, weighting 198.4 lb, was diagnosed with parkinson's disease, hypertension and was treated with ROPINIROLE. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, cardiomegaly, confusional state, dyspnoea, left ventricular failure, palpitations, pneumonia. ROPINIROLE dosage: unknown. During the same period patient was treated with CONCOR, GOPTEN, AMLOZEK, DIAPREL MR. Patient was hospitalized and became disabled. Patient recovered.

Ropinirole Side Effects Report #5441970-2
ROPINIROLE problem was reported by a Physician from FRANCE on Aug 29, 2007. Female patient, 72 years of age, was diagnosed with parkinson's disease and was treated with ROPINIROLE. After drug was administered, patient experienced the following problems/side effects: lung infection. ROPINIROLE dosage: unknown. Patient was hospitalized. Patient recovered.

Ropinirole Side Effects Report #5447503-9
Physician from SOUTH AFRICA reported ROPINIROLE problem on Sept 06, 2007. Male patient, 66 years of age, weighting 130.1 lb, was diagnosed with parkinson's disease and was treated with ROPINIROLE. After drug was administered, patient experienced the following problems/side effects: chest x-ray abnormal, cough, pulmonary granuloma, tuberculosis. ROPINIROLE dosage: unknown. Patient recovered.

Ropinirole Side Effects Report #5450164-6
ROPINIROLE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Sept 05, 2007. Female patient, 65 years of age, weighting 218.3 lb, was diagnosed with restless legs syndrome, pain, inflammation, hypothyroidism and was treated with ROPINIROLE. After drug was administered, patient experienced the following problems/side effects: mobility decreased. ROPINIROLE dosage: unknown. During the same period patient was treated with EZETIMIBE, IBUPROFEN, ISPAGHULA HUSK, LEVOTHYROXINE, ROSUVASTATIN. Patient recovered.

Ropinirole Side Effects Report #5453859-3
Physician from SOUTH AFRICA reported ROPINIROLE problem on Sept 13, 2007. Male patient, 66 years of age, weighting 130.1 lb, was diagnosed with parkinson's disease and was treated with ROPINIROLE. After drug was administered, patient experienced the following problems/side effects: chest x-ray abnormal, cough, pulmonary granuloma, tuberculosis. ROPINIROLE dosage: unknown. During the same period patient was treated with CARBIDOPA AND LEVODOPA. Patient recovered.

Ropinirole Side Effects Report #5409737-9
ROPINIROLE problem was reported by a Physician from FRANCE on Aug 01, 2007. Female patient, 72 years of age, was diagnosed with parkinson's disease and was treated with ROPINIROLE. After drug was administered, patient experienced the following problems/side effects: lung infection. ROPINIROLE dosage: unknown. Patient was hospitalized. Patient recovered.

Ropinirole Side Effects Report #5426205-9
Physician from SOUTH AFRICA reported ROPINIROLE problem on Aug 17, 2007. Male patient, 66 years of age, weighting 130.1 lb, was diagnosed with parkinson's disease and was treated with ROPINIROLE. After drug was administered, patient experienced the following problems/side effects: pulmonary granuloma. ROPINIROLE dosage: unknown. Patient recovered.

Ropinirole Side Effects Report #5378766-6
ROPINIROLE problem was reported by a Physician from POLAND on June 28, 2007. Male patient, 72 years of age, weighting 198.4 lb, was diagnosed with parkinson's disease, hypertension and was treated with ROPINIROLE. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, cardiomegaly, confusional state, dyspnoea, left ventricular failure, palpitations, pneumonia. ROPINIROLE dosage: unknown. During the same period patient was treated with CONCOR, GOPTEN, AMLOZEK, DIAPREL MR. Patient was hospitalized and became disabled. Patient recovered.

Ropinirole Side Effects Report #5380789-8
Physician from POLAND reported ROPINIROLE problem on June 28, 2007. Male patient, 72 years of age, weighting 198.4 lb, was diagnosed with parkinson's disease, hypertension and was treated with ROPINIROLE. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, cardiomegaly, confusional state, dyspnoea, left ventricular failure, palpitations, pneumonia. ROPINIROLE dosage: unknown. During the same period patient was treated with CONCOR, GOPTEN, AMLOZEK, DIAPREL MR. Patient was hospitalized and became disabled. Patient recovered.

Ropinirole Side Effects Report #5382990-6
ROPINIROLE problem was reported by a Physician from POLAND on July 03, 2007. Male patient, 72 years of age, weighting 198.4 lb, was diagnosed with parkinson's disease, hypertension and was treated with ROPINIROLE. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, cardiomegaly, confusional state, dyspnoea, left ventricular failure, palpitations, pneumonia. ROPINIROLE dosage: unknown. During the same period patient was treated with CONCOR, GOPTEN, AMLOZEK, DIAPREL MR. Patient was hospitalized and became disabled. Patient recovered.

Ropinirole Side Effects Report #5390096-5
Physician from FRANCE reported ROPINIROLE problem on July 16, 2007. Male patient, 72 years of age, weighting 176.4 lb, was diagnosed with parkinson's disease, arrhythmia and was treated with ROPINIROLE. After drug was administered, patient experienced the following problems/side effects: hypertension. ROPINIROLE dosage: unknown. During the same period patient was treated with MODOPAR, PREVISCAN, FLECAINIDE ACETATE, DETENSIEL. Patient recovered.

Ropinirole Side Effects Report #5392395-X
ROPINIROLE problem was reported by a Physician from ITALY on July 11, 2007. Female patient, 75 years of age, weighting 138.9 lb, was diagnosed with parkinson's disease, hypertension and was treated with ROPINIROLE. After drug was administered, patient experienced the following problems/side effects: coordination abnormal, dizziness, drop attacks, hypoaesthesia, hypotension, muscular weakness, transient ischaemic attack, vertigo. ROPINIROLE dosage: unknown. During the same period patient was treated with PLENDIL, VASERETIC, GLUCONORM. Patient was hospitalized. Patient recovered.

Ropinirole Side Effects Report #5400406-8
Physician from FRANCE reported ROPINIROLE problem on July 20, 2007. Female patient, 72 years of age, was diagnosed with parkinson's disease and was treated with ROPINIROLE. After drug was administered, patient experienced the following problems/side effects: lung infection. ROPINIROLE dosage: unknown. Patient was hospitalized. Patient recovered.

Ropinirole Side Effects Report #5401366-6
ROPINIROLE problem was reported by a Physician from ITALY on July 24, 2007. Female patient, 75 years of age, weighting 138.9 lb, was diagnosed with parkinson's disease, hypertension, diabetes mellitus and was treated with ROPINIROLE. After drug was administered, patient experienced the following problems/side effects: coordination abnormal, dizziness, drop attacks, hypoaesthesia, hypotension, muscular weakness, transient ischaemic attack, vertigo. ROPINIROLE dosage: unknown. During the same period patient was treated with PLENDIL, VASERETIC, GLUCONORM. Patient was hospitalized. Patient recovered.

Ropinirole Side Effects Report #5378766-6
Physician from POLAND reported ROPINIROLE problem on June 28, 2007. Male patient, 72 years of age, weighting 198.4 lb, was diagnosed with parkinson's disease, hypertension and was treated with ROPINIROLE. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, cardiomegaly, confusional state, dyspnoea, left ventricular failure, palpitations, pneumonia. ROPINIROLE dosage: unknown. During the same period patient was treated with CONCOR, GOPTEN, AMLOZEK, DIAPREL MR. Patient was hospitalized and became disabled. Patient recovered.

Ropinirole Side Effects Report #5380789-8
ROPINIROLE problem was reported by a Physician from POLAND on June 28, 2007. Male patient, 72 years of age, weighting 198.4 lb, was diagnosed with parkinson's disease, hypertension and was treated with ROPINIROLE. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, cardiomegaly, confusional state, dyspnoea, left ventricular failure, palpitations, pneumonia. ROPINIROLE dosage: unknown. During the same period patient was treated with CONCOR, GOPTEN, AMLOZEK, DIAPREL MR. Patient was hospitalized and became disabled. Patient recovered.

Ropinirole Side Effects Report #5382990-6
Physician from POLAND reported ROPINIROLE problem on July 03, 2007. Male patient, 72 years of age, weighting 198.4 lb, was diagnosed with parkinson's disease, hypertension and was treated with ROPINIROLE. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, cardiomegaly, confusional state, dyspnoea, left ventricular failure, palpitations, pneumonia. ROPINIROLE dosage: unknown. During the same period patient was treated with CONCOR, GOPTEN, AMLOZEK, DIAPREL MR. Patient was hospitalized and became disabled. Patient recovered.

Ropinirole Side Effects Report #5390096-5
ROPINIROLE problem was reported by a Physician from FRANCE on July 16, 2007. Male patient, 72 years of age, weighting 176.4 lb, was diagnosed with parkinson's disease, arrhythmia and was treated with ROPINIROLE. After drug was administered, patient experienced the following problems/side effects: hypertension. ROPINIROLE dosage: unknown. During the same period patient was treated with MODOPAR, PREVISCAN, FLECAINIDE ACETATE, DETENSIEL. Patient recovered.

Ropinirole Side Effects Report #5392395-X
Physician from ITALY reported ROPINIROLE problem on July 11, 2007. Female patient, 75 years of age, weighting 138.9 lb, was diagnosed with parkinson's disease, hypertension and was treated with ROPINIROLE. After drug was administered, patient experienced the following problems/side effects: coordination abnormal, dizziness, drop attacks, hypoaesthesia, hypotension, muscular weakness, transient ischaemic attack, vertigo. ROPINIROLE dosage: unknown. During the same period patient was treated with PLENDIL, VASERETIC, GLUCONORM. Patient was hospitalized. Patient recovered.

Ropinirole Side Effects Report #5400406-8
ROPINIROLE problem was reported by a Physician from FRANCE on July 20, 2007. Female patient, 72 years of age, was diagnosed with parkinson's disease and was treated with ROPINIROLE. After drug was administered, patient experienced the following problems/side effects: lung infection. ROPINIROLE dosage: unknown. Patient was hospitalized. Patient recovered.

Ropinirole Side Effects Report #5401366-6
Physician from ITALY reported ROPINIROLE problem on July 24, 2007. Female patient, 75 years of age, weighting 138.9 lb, was diagnosed with parkinson's disease, hypertension, diabetes mellitus and was treated with ROPINIROLE. After drug was administered, patient experienced the following problems/side effects: coordination abnormal, dizziness, drop attacks, hypoaesthesia, hypotension, muscular weakness, transient ischaemic attack, vertigo. ROPINIROLE dosage: unknown. During the same period patient was treated with PLENDIL, VASERETIC, GLUCONORM. Patient was hospitalized. Patient recovered.