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Review Amantadine Safety Reports submitted to FDA

Total Amantadine reports: 19.
Amantadine FDA safety alerts: No.
Reported deaths: 8    Reported hospitalizations: 6.
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FDA Reported Amantadine Side Effects: myoclonus, gait disturbance, communication disorder, pyrexia, inappropriate antidiuretic hormone secretion, diabetes insipidus, restlessness, psychotic disorder, cognitive disorder, agitation, convulsion.
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Amantadine Side Effects Report #5654426-9
Physician from UNITED STATES reported AMANTADINE problem on Feb 27, 2008. Female patient, 30 years of age, was diagnosed with pain and was treated with AMANTADINE. After drug was administered, patient experienced the following problems/side effects: blood potassium decreased, deep vein thrombosis, disseminated intravascular coagulation, ecchymosis, electrocardiogram qt prolonged, fall, haemodynamic instability, intentional overdose. AMANTADINE dosage: 100 MG, OER ORAL. During the same period patient was treated with ZIPRASIDONE, IBUPROFEN. Patient was hospitalized. Patient died on 01/01/2007.

Amantadine Side Effects Report #5683538-9
AMANTADINE problem was reported by a Physician from TAIWAN, PROVINCE OF CHINA on Mar 17, 2008. Male patient, 78 years of age, was diagnosed with parkinson's disease and was treated with AMANTADINE. After drug was administered, patient experienced the following problems/side effects: asthenia, blood creatine increased, blood sodium increased, blood urea increased, delirium, pyrexia, serotonin syndrome. AMANTADINE dosage: 100 MG; QD. During the same period patient was treated with CARBIDOPA, LEVODOPA, ROPINIROLE, BENSERAZIDE. Patient was hospitalized. Patient recovered.

Amantadine Side Effects Report #5621935-8
Physician from TAIWAN, PROVINCE OF CHINA reported AMANTADINE problem on Jan 25, 2008. Male patient, 78 years of age, was diagnosed with parkinson's disease and was treated with AMANTADINE. After drug was administered, patient experienced the following problems/side effects: asthenia, blood creatine phosphokinase increased, confusional state, delirium, diarrhoea, disorientation, electroencephalogram abnormal, hallucination, visual, hypertension. AMANTADINE dosage: 100 MG, QD. During the same period patient was treated with LEVODOPA W, CARBIDOPA, ROPINIROLE, CLONAZEPAM. Patient was hospitalized. Patient recovered.

Amantadine Side Effects Report #5579675-X
AMANTADINE problem was reported by a Consumer or non-health professional from on Dec 19, 2007. Male patient, 79 years of age, weighting 145.5 lb, was diagnosed with gait disturbance, parkinsonism and was treated with AMANTADINE. After drug was administered, patient experienced the following problems/side effects: disease progression, somnolence. AMANTADINE dosage: unknown. During the same period patient was treated with PRAMIPEXOLE DIHYDROCHLORIDE. Patient recovered.

Amantadine Side Effects Report #5594145-0
Physician from UNITED STATES reported AMANTADINE problem on Jan 04, 2008. Female patient, 30 years of age, was treated with AMANTADINE. After drug was administered, patient experienced the following problems/side effects: completed suicide, deep vein thrombosis, disseminated intravascular coagulation, ecchymosis, escherichia bacteraemia, fall, hypokalaemia, lethargy. AMANTADINE dosage: 100MG, BID,ORAL; INTENTIONAL OVERDOSE. During the same period patient was treated with ZIPRASIDONE, IBUPROFEN. Patient was hospitalized. Patient died.

Amantadine Side Effects Report #5607499-3
AMANTADINE problem was reported by a Consumer or non-health professional from GERMANY on Jan 21, 2008. Female patient, 69 years of age, was treated with AMANTADINE. After drug was administered, patient experienced the following problems/side effects: scleroderma. AMANTADINE dosage: unknown. Patient recovered.

Amantadine Side Effects Report #5565630-2
Consumer or non-health professional from reported AMANTADINE problem on Dec 07, 2007. Male patient, 79 years of age, weighting 145.5 lb, was diagnosed with gait disturbance, parkinsonism and was treated with AMANTADINE. After drug was administered, patient experienced the following problems/side effects: disease progression, somnolence. AMANTADINE dosage: unknown. During the same period patient was treated with PRAMIPEXOLE DIHYDROCHLORIDE. Patient recovered.

Amantadine Side Effects Report #5566757-1
AMANTADINE problem was reported by a Pharmacist from UNITED STATES on Dec 18, 2007. Male patient, 18 years of age, weighting 130.0 lb, was treated with AMANTADINE. After drug was administered, patient experienced the following problems/side effects: nausea, vomiting. AMANTADINE dosage: 200MG PO. During the same period patient was treated with ZYPREXA, METOPROLOL, CLONAZEPAM, SEROQUEL. Patient recovered.

Amantadine Side Effects Report #5580071-X
Consumer or non-health professional from UNITED STATES reported AMANTADINE problem on Dec 27, 2007. Female patient, child 8 years of age, weighting 47.00 lb, was diagnosed with influenza and was treated with AMANTADINE. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, formication, hallucinations, mixed, insomnia. AMANTADINE dosage: unknown. During the same period patient was treated with PROMETHAZINE W. Patient recovered.

Amantadine Side Effects Report #5528634-1
AMANTADINE problem was reported by a Health Professional from UNITED STATES on Jan 09, 2007. Female patient, 77 years of age, was diagnosed with parkinson's disease and was treated with AMANTADINE. After drug was administered, patient experienced the following problems/side effects: hallucinations, mixed. AMANTADINE dosage: unknown. During the same period patient was treated with SINEMET, NAPROXEN. Patient was hospitalized. Patient recovered.

Amantadine Side Effects Report #5528635-3
Physician from UNITED STATES reported AMANTADINE problem on Mar 16, 2007. Male patient, 55 years of age, weighting 247.0 lb, was diagnosed with weight control and was treated with AMANTADINE. After drug was administered, patient experienced the following problems/side effects: hallucination, auditory. AMANTADINE dosage: 100-300 MG QHS, PER ORAL. During the same period patient was treated with ZYPREXA, ZOLOFT. Patient was hospitalized. Patient recovered.

Amantadine Side Effects Report #5475132-X
AMANTADINE problem was reported by a Consumer or non-health professional from on Sept 28, 2007. Male patient, 57 years of age, was diagnosed with depressive symptom, schizophrenia, paranoid type and was treated with AMANTADINE. After drug was administered, patient experienced the following problems/side effects: agitation, anxiety, psychotic disorder. AMANTADINE dosage: unknown. During the same period patient was treated with SERTRALINE, ARIPIPRAZOLE, LORAZEPAM, NIFEDIPINE. Patient recovered.

Amantadine Side Effects Report #5414935-4
Consumer or non-health professional from UNITED STATES reported AMANTADINE problem on Aug 13, 2007. Female patient, 49 years of age, weighting 200.0 lb, was diagnosed with chronic fatigue syndrome and was treated with AMANTADINE. After drug was administered, patient experienced the following problems/side effects: dizziness, fatigue, gait disturbance, nausea. AMANTADINE dosage: 100 MG 2 X MOUTH. Patient recovered.

Amantadine Side Effects Report #5377693-8
AMANTADINE problem was reported by a Consumer or non-health professional from on July 02, 2007. Female patient, child 10 years of age, was diagnosed with rabies and was treated with AMANTADINE. After drug was administered, patient experienced the following problems/side effects: brain herniation, diabetes insipidus, inappropriate antidiuretic hormone secretion, intracranial pressure increased, intracranial venous sinus thrombosis, pancreatitis. AMANTADINE dosage: unknown. During the same period patient was treated with MIDAZOLAM, ASCORBIC ACID, PHENOBARBITAL, KETAMINE, RIBAVIRIN, COENZYME Q, TETRAHYDROBIOPTERIN. Patient died on 11/02/2006.

Amantadine Side Effects Report #5377695-1
Consumer or non-health professional from reported AMANTADINE problem on July 03, 2007. Male patient, child 11 years of age, was diagnosed with rabies and was treated with AMANTADINE. After drug was administered, patient experienced the following problems/side effects: atrioventricular block, autonomic nervous system imbalance, brain oedema, cerebrovascular spasm, convulsion, diabetes insipidus, inappropriate antidiuretic hormone secretion, pancreatic enzymes increased. AMANTADINE dosage: unknown. During the same period patient was treated with MIDAZOLAM, KETAMINE, RIBAVIRIN, TETRAHYDROBIOPTERIN, COENZYME Q. Patient died on 12/13/2006.

Amantadine Side Effects Report #5398737-3
AMANTADINE problem was reported by a Physician from UNITED STATES on July 05, 2007. Male patient, 51 years of age, was diagnosed with secondary progressive multiple sclerosis and was treated with AMANTADINE. After drug was administered, patient experienced the following problems/side effects: myocardial infarction. AMANTADINE dosage: 100 MG, BID, PO. During the same period patient was treated with NOVANTRONE, BACLOFEN. Patient died on 06/18/2007.

Amantadine Side Effects Report #5377693-8
Consumer or non-health professional from reported AMANTADINE problem on July 02, 2007. Female patient, child 10 years of age, was diagnosed with rabies and was treated with AMANTADINE. After drug was administered, patient experienced the following problems/side effects: brain herniation, diabetes insipidus, inappropriate antidiuretic hormone secretion, intracranial pressure increased, intracranial venous sinus thrombosis, pancreatitis. AMANTADINE dosage: unknown. During the same period patient was treated with MIDAZOLAM, ASCORBIC ACID, PHENOBARBITAL, KETAMINE, RIBAVIRIN, COENZYME Q, TETRAHYDROBIOPTERIN. Patient died on 11/02/2006.

Amantadine Side Effects Report #5377695-1
AMANTADINE problem was reported by a Consumer or non-health professional from on July 03, 2007. Male patient, child 11 years of age, was diagnosed with rabies and was treated with AMANTADINE. After drug was administered, patient experienced the following problems/side effects: atrioventricular block, autonomic nervous system imbalance, brain oedema, cerebrovascular spasm, convulsion, diabetes insipidus, inappropriate antidiuretic hormone secretion, pancreatic enzymes increased. AMANTADINE dosage: unknown. During the same period patient was treated with MIDAZOLAM, KETAMINE, RIBAVIRIN, TETRAHYDROBIOPTERIN, COENZYME Q. Patient died on 12/13/2006.

Amantadine Side Effects Report #5398737-3
Physician from UNITED STATES reported AMANTADINE problem on July 05, 2007. Male patient, 51 years of age, was diagnosed with secondary progressive multiple sclerosis and was treated with AMANTADINE. After drug was administered, patient experienced the following problems/side effects: myocardial infarction. AMANTADINE dosage: 100 MG, BID, PO. During the same period patient was treated with NOVANTRONE, BACLOFEN. Patient died on 06/18/2007.


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