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Epilim Side Effects submitted to FDA

Total Epilim reports: 44.
Epilim FDA safety alerts: No.
Reported deaths: 6    Reported hospitalizations: 20.
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FDA Reported Epilim Side Effects: convulsion, speech disorder developmental, blood mercury abnormal, somnolence, diarrhoea, fall, delirium, liver function test abnormal, lethargy, jaundice, headache,
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Epilim Side Effects Report #5654338-0
Pharmacist from FRANCE reported EPILIM problem on Feb 27, 2008. Female patient, 79 years of age, was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased, cholestasis, gamma-glutamyltransferase increased. EPILIM dosage: unknown. During the same period patient was treated with SIMVASTATIN. Patient recovered.



Epilim Side Effects Report #5655770-1
EPILIM problem was reported by a Health Professional from FRANCE on Feb 28, 2008. Male patient, 70 years of age, was diagnosed with epilepsy, hypertension, cerebrovascular accident and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: amnesia, confusional state, depressed level of consciousness, encephalopathy, hyperammonaemia, metabolic encephalopathy, movement disorder, muscle rigidity, paranoia. EPILIM dosage: unknown. During the same period patient was treated with EPILIM CHRONOSHERE, DOXAZOSIN MESYLATE, DIPYRIDAMOLE, SIMVASTATIN. Patient was hospitalized and became disabled. Patient recovered.



Epilim Side Effects Report #5655884-6
Pharmacist from FRANCE reported EPILIM problem on Feb 27, 2008. Male patient, 38 years of age, was diagnosed with epilepsy and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: petit mal epilepsy. EPILIM dosage: unknown. During the same period patient was treated with PHENYTOIN, LAMOTRIGINE, SOMNOL. Patient recovered.



Epilim Side Effects Report #5683037-4
EPILIM problem was reported by a Consumer or non-health professional from FRANCE on Mar 17, 2008. Female patient, 56 years of age, was diagnosed with epilepsy, type 2 diabetes mellitus, hypercholesterolaemia, arthritis, weight decreased and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, epilepsy, glossodynia. EPILIM dosage: unknown. During the same period patient was treated with INSULIN ASPART, METFORMIN, SIMVASTATIN, DICLOFENAC, RIMONABANT. Patient was hospitalized. Patient recovered.




Epilim Side Effects Report #5583328-1
Physician from FRANCE reported EPILIM problem on Dec 28, 2007. Male patient, child 5 years of age, was diagnosed with epilepsy and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: disturbance in attention, hypokinesia. EPILIM dosage: unknown. Patient recovered.



Epilim Side Effects Report #5602972-6
EPILIM problem was reported by a Pharmacist from FRANCE on Jan 17, 2008. Male patient, 38 years of age, was diagnosed with epilepsy and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: petit mal epilepsy. EPILIM dosage: unknown. During the same period patient was treated with PHENYTOIN, LAMOTRIGINE, SOMNOL. Patient recovered.



Epilim Side Effects Report #5610240-1
Physician from FRANCE reported EPILIM problem on Jan 24, 2008. Male patient, child 7 years of age, was diagnosed with myoclonus and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: myoclonus, psychomotor hyperactivity. EPILIM dosage: unknown. During the same period patient was treated with EPILIM SYRUP. Patient recovered.



Epilim Side Effects Report #5551621-4
EPILIM problem was reported by a Physician from FRANCE on Dec 06, 2007. Male patient, child 5 years of age, was diagnosed with epilepsy and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: disturbance in attention, hypokinesia. EPILIM dosage: unknown. Patient recovered.



Epilim Side Effects Report #5513194-1
Health Professional from FRANCE reported EPILIM problem on Nov 02, 2007. Male patient, child 7 years of age, was diagnosed with headache, vomiting, abdominal pain upper and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: burning sensation, erythema, mouth ulceration. EPILIM dosage: unknown. During the same period patient was treated with EPILIM CHRONO, NAPROXEN, RANITIDINE. Patient was hospitalized. Patient recovered.




Epilim Side Effects Report #5474176-1
EPILIM problem was reported by a Health Professional from FRANCE on Sept 27, 2007. Female patient, 40 years of age, was diagnosed with epilepsy and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: ecchymosis, thrombocytopenia. EPILIM dosage: unknown. During the same period patient was treated with PHENYTOIN. Patient died.



Epilim Side Effects Report #5478602-3
Health Professional from FRANCE reported EPILIM problem on Sept 26, 2007. Male patient, 52 years of age, was diagnosed with epilepsy and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: anorexia, cognitive disorder, coordination abnormal, encephalopathy, hyperammonaemia, irritability, malaise, metabolic encephalopathy. EPILIM dosage: unknown. During the same period patient was treated with TOPIRAMATE. Patient recovered.



Epilim Side Effects Report #5490010-8
EPILIM problem was reported by a Health Professional from FRANCE on Oct 09, 2007. Female patient, 33 years of age, was diagnosed with affective disorder, schizophrenia and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: idiopathic thrombocytopenic purpura, somnolence, tachycardia, thrombocytopenia. EPILIM dosage: unknown. During the same period patient was treated with CLOZAPINE, AMISULPRIDE, PAROXETINE, SENNOSIDE A, HYOSCINE. Patient was hospitalized. Patient recovered.



Epilim Side Effects Report #5502368-1
Health Professional from FRANCE reported EPILIM problem on Oct 25, 2007. Female patient, 40 years of age, was diagnosed with epilepsy and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: dehydration, diarrhoea, ecchymosis, gastroenteritis, hypotension, oral intake reduced, thrombocytopenia. EPILIM dosage: unknown. During the same period patient was treated with PHENYTOIN. Patient was hospitalized. Patient died on 12/16/2006.



Epilim Side Effects Report #5445614-5
EPILIM problem was reported by a Physician from FRANCE on Aug 31, 2007. Male patient, child 7 years of age, was diagnosed with epilepsy, psychotic disorder and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, convulsion, disinhibition. EPILIM dosage: unknown. During the same period patient was treated with RISPERIDONE, CITALOPRAM HYDROBROMIDE, LAMOTRIGINE. Patient recovered.




Epilim Side Effects Report #5456452-1
Physician from FRANCE reported EPILIM problem on Sept 13, 2007. Female patient, 59 years of age, was diagnosed with bipolar disorder and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: delirium. EPILIM dosage: unknown. During the same period patient was treated with CITALOPRAM. Patient recovered.



Epilim Side Effects Report #5464500-8
EPILIM problem was reported by a Health Professional from FRANCE on Sept 13, 2007. Female patient, 33 years of age, weighting 163.1 lb, was diagnosed with epilepsy and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: abortion missed. EPILIM dosage: unknown. During the same period patient was treated with GABAPENTIN. Patient recovered.



Epilim Side Effects Report #5472118-6
Pharmacist from FRANCE reported EPILIM problem on Sept 20, 2007. Female patient, 36 years of age, was diagnosed with affective disorder, epilepsy and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: arrhythmia. EPILIM dosage: unknown. During the same period patient was treated with CLOZAPINE. Patient died.



Epilim Side Effects Report #5405220-5
EPILIM problem was reported by a Health Professional from FRANCE on July 24, 2007. Male patient, child 10 years of age, was diagnosed with epilepsy and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: blood mercury abnormal, convulsion. EPILIM dosage: unknown. Patient was hospitalized. Patient recovered.



Epilim Side Effects Report #5410159-5
Consumer or non-health professional from AUSTRALIA reported EPILIM problem on Aug 02, 2007. Female patient, 34 years of age, was diagnosed with depression and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: convulsion. EPILIM dosage: unknown. During the same period patient was treated with PROTHIADEN. Patient recovered.




Epilim Side Effects Report #5425022-3
EPILIM problem was reported by a Consumer or non-health professional from FRANCE on Aug 14, 2007. Female patient, 47 years of age, was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: intentional overdose, loss of consciousness, suicide attempt. EPILIM dosage: unknown. During the same period patient was treated with CARBAMAZEPINE. Patient was hospitalized. Patient recovered.



Epilim Side Effects Report #5376491-9
Physician from FRANCE reported EPILIM problem on June 25, 2007. Male patient, child 3 years of age, was diagnosed with epilepsy and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: diarrhoea, jaundice, lethargy, liver function test abnormal, somnolence, speech disorder developmental. EPILIM dosage: unknown. During the same period patient was treated with PHENYTOIN. Patient recovered.



Epilim Side Effects Report #5388880-7
EPILIM problem was reported by a Consumer or non-health professional from AUSTRALIA on July 06, 2007. Female patient, 34 years of age, was diagnosed with depression and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: convulsion. EPILIM dosage: unknown. During the same period patient was treated with PROTHIADEN. Patient recovered.



Epilim Side Effects Report #5389368-X
Consumer or non-health professional from AUSTRALIA reported EPILIM problem on July 05, 2007. Male patient was diagnosed with depression and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: amnesia, somnambulism, thermal burn. EPILIM dosage: unknown. During the same period patient was treated with STILNOX CR, ANTIDEPRESSANTS. Patient recovered.



Epilim Side Effects Report #5376491-9
EPILIM problem was reported by a Physician from FRANCE on June 25, 2007. Male patient, child 3 years of age, was diagnosed with epilepsy and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: diarrhoea, jaundice, lethargy, liver function test abnormal, somnolence, speech disorder developmental. EPILIM dosage: unknown. During the same period patient was treated with PHENYTOIN. Patient recovered.



Epilim Side Effects Report #5388880-7
Consumer or non-health professional from AUSTRALIA reported EPILIM problem on July 06, 2007. Female patient, 34 years of age, was diagnosed with depression and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: convulsion. EPILIM dosage: unknown. During the same period patient was treated with PROTHIADEN. Patient recovered.



Epilim Side Effects Report #5389368-X
EPILIM problem was reported by a Consumer or non-health professional from AUSTRALIA on July 05, 2007. Male patient was diagnosed with depression and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: amnesia, somnambulism, thermal burn. EPILIM dosage: unknown. During the same period patient was treated with STILNOX CR, ANTIDEPRESSANTS. Patient recovered.



Epilim Side Effects Report #5761703-X
Health Professional from FRANCE reported EPILIM problem on May 28, 2008. Male patient, weighting 6.71 lb, was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, astigmatism, balance disorder, congenital floppy infant, congenital hair disorder, congenital nose malformation, coordination abnormal, croup infectious, developmental coordination disorder. EPILIM dosage: unknown. Patient recovered.



Epilim Side Effects Report #5766868-1
EPILIM problem was reported by a Physician from FRANCE on June 12, 2008. Male patient, weighting 7.14 lb, was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, anomaly of orbit, congenital, aortogram abnormal, arthritis reactive, congenital aortic anomaly, congenital hair disorder, congenital nose malformation, cough. EPILIM dosage: unknown. During the same period patient was treated with LAMOTRIGINE. Patient recovered.



Epilim Side Effects Report #5776833-6
Physician from FRANCE reported EPILIM problem on June 18, 2008. Female patient, weighting 8.29 lb, was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: anomaly of orbit, congenital, cardiac murmur, congenital foot malformation, congenital nose malformation, developmental delay, dysmorphism, enamel anomaly, expressive language disorder. EPILIM dosage: unknown. Patient recovered.



Epilim Side Effects Report #5779642-7
EPILIM problem was reported by a Consumer or non-health professional from FRANCE on June 11, 2008. Female patient, 71 years of age, was diagnosed with mood altered and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: convulsion. EPILIM dosage: unknown. Patient recovered.



Epilim Side Effects Report #5342761-3
Health Professional from FRANCE reported EPILIM problem on May 24, 2007. Female patient, 34 years of age, was diagnosed with epilepsy and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: stomach discomfort. EPILIM dosage: unknown. Patient recovered.



Epilim Side Effects Report #5351909-6
EPILIM problem was reported by a Health Professional from FRANCE on May 29, 2007. Female patient, 18 years of age, was diagnosed with epilepsy and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: convulsion. EPILIM dosage: unknown. During the same period patient was treated with ORLISTAT. Patient recovered.



Epilim Side Effects Report #5374730-1
Pharmacist from FRANCE reported EPILIM problem on June 22, 2007. Female patient, 30 years of age, was diagnosed with affective disorder, epilepsy and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: epilepsy. EPILIM dosage: unknown. Patient died.



Epilim Side Effects Report #5315898-2
EPILIM problem was reported by a Pharmacist from FRANCE on Apr 24, 2007. Male patient, 26 years of age, was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: convulsion. EPILIM dosage: unknown. Patient recovered.



Epilim Side Effects Report #5320772-1
Health Professional from FRANCE reported EPILIM problem on Apr 30, 2007. Male patient, 15 years of age, was diagnosed with mood swings, hypomania, depression and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: deep vein thrombosis, protein total decreased. EPILIM dosage: unknown. During the same period patient was treated with QUETIAPINE FUMARATE, FLUOXETINE. Patient was hospitalized. Patient recovered.



Epilim Side Effects Report #5340872-X
EPILIM problem was reported by a Physician from FRANCE on May 25, 2007. Male patient was diagnosed with epilepsy, diabetes mellitus, glaucoma and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: fatigue, somnolence. EPILIM dosage: unknown. During the same period patient was treated with GLICLAZIDE, ATORVASTATIN, ANTIEPILEPTICS, LANTANOPROST, ACETYLSALICYLIC ACID SRT. Patient was hospitalized. Patient recovered.



Epilim Side Effects Report #5295146-2
Physician from FRANCE reported EPILIM problem on Apr 06, 2007. Male patient, child 3 years of age, was diagnosed with convulsion and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: abasia, cerebral atrophy, tremor. EPILIM dosage: unknown. Patient recovered.



Epilim Side Effects Report #5254373-0
EPILIM problem was reported by a Health Professional from FRANCE on Feb 22, 2007. Male patient, 68 years of age, was diagnosed with epilepsy, sinusitis and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: convulsion. EPILIM dosage: unknown. During the same period patient was treated with DOXYCYCLINE. Patient was hospitalized. Patient recovered.



Epilim Side Effects Report #5254398-5
Health Professional from FRANCE reported EPILIM problem on Feb 20, 2007. Male patient, weighting 63.05 lb, was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: convulsion, somnolence. EPILIM dosage: unknown. Patient recovered.



Epilim Side Effects Report #5261290-9
EPILIM problem was reported by a Consumer or non-health professional from FRANCE on Mar 02, 2007. Male patient, child 10 years of age, was diagnosed with epilepsy and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: blood mercury abnormal, convulsion. EPILIM dosage: unknown. Patient was hospitalized. Patient recovered.



Epilim Side Effects Report #5263479-1
Consumer or non-health professional from AUSTRALIA reported EPILIM problem on Feb 28, 2007. Male patient, 55 years of age, was diagnosed with epilepsy and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: grand mal convulsion, spinal compression fracture. EPILIM dosage: unknown. During the same period patient was treated with TOPAMAX, TEGRETOL. Patient was hospitalized. Patient recovered.



Epilim Side Effects Report #5267772-8
EPILIM problem was reported by a Consumer or non-health professional from FRANCE on Mar 09, 2007. Male patient, child 10 years of age, was diagnosed with epilepsy and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: blood mercury abnormal, convulsion. EPILIM dosage: unknown. Patient was hospitalized. Patient recovered.



Epilim Side Effects Report #5271544-8
Pharmacist from FRANCE reported EPILIM problem on Mar 13, 2007. Female patient, child 5 years of age, was diagnosed with epilepsy and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: convulsion. EPILIM dosage: unknown. During the same period patient was treated with VALPROATE. Patient recovered.



Epilim Side Effects Report #5277868-2
EPILIM problem was reported by a Health Professional from FRANCE on Mar 23, 2007. Male patient, child 10 years of age, was diagnosed with epilepsy and was treated with EPILIM. After drug was administered, patient experienced the following problems/side effects: blood mercury abnormal, convulsion. EPILIM dosage: unknown. Patient was hospitalized. Patient recovered.




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