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Ergenyl Side Effects submitted to FDA

Total Ergenyl reports: 20.
Ergenyl FDA safety alerts: No.
Reported deaths: 1    Reported hospitalizations: 15.
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FDA Reported Ergenyl Side Effects: respiratory failure, autism spectrum disorder, poor sucking reflex, hypotonia, hyporeflexia, dermatitis diaper, cyanosis, convulsion neonatal, blood ph decreased, apgar score low, lipase increased,
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Ergenyl Side Effects Report #5655798-1
Consumer or non-health professional from FRANCE reported ERGENYL problem on Feb 27, 2008. Female patient, 71 years of age, was diagnosed with epilepsy and was treated with ERGENYL. After drug was administered, patient experienced the following problems/side effects: pseudodementia. ERGENYL dosage: unknown. Patient recovered.



Ergenyl Side Effects Report #5670455-3
ERGENYL problem was reported by a Consumer or non-health professional from FRANCE on Mar 10, 2008. Male patient, 58 years of age, was diagnosed with bipolar i disorder and was treated with ERGENYL. After drug was administered, patient experienced the following problems/side effects: status epilepticus. ERGENYL dosage: unknown. Patient recovered.



Ergenyl Side Effects Report #5673264-4
Health Professional from FRANCE reported ERGENYL problem on Mar 12, 2008. Male patient was treated with ERGENYL. After drug was administered, patient experienced the following problems/side effects: blood creatine phosphokinase increased. ERGENYL dosage: INCREASING DOSES UP TO 1000 MG. During the same period patient was treated with QUETIAPINE FUMARATE. Patient recovered.



Ergenyl Side Effects Report #5680578-0
ERGENYL problem was reported by a Health Professional from FRANCE on Mar 20, 2008. Male patient, weighting 72.75 lb, was diagnosed with epilepsy, aggression and was treated with ERGENYL. After drug was administered, patient experienced the following problems/side effects: extraskeletal ossification, gait disturbance. ERGENYL dosage: unknown. During the same period patient was treated with ERGENYL CHRONO, MESUXIMIDE, TOPIRAMATE, RISPERIDONE, LEVETIRACETAM. Patient was hospitalized and became disabled. Patient recovered.




Ergenyl Side Effects Report #5611419-5
Physician from FRANCE reported ERGENYL problem on Jan 22, 2008. Female patient, weighting 65.70 lb, was diagnosed with petit mal epilepsy and was treated with ERGENYL. After drug was administered, patient experienced the following problems/side effects: anaemia, ascites, blood pressure increased, complement factor c3 decreased, dyspnoea, haematochezia, hypoalbuminaemia, interstitial lung disease. ERGENYL dosage: unknown. During the same period patient was treated with ERGENYL CHRONO GRANULE, ERGENYL CHRONO GRANULE, ERGENYL CHRONO GRANULE, ERGENYL CHRONO GRANULE, ERGENYL CHRONO GRANULE. Patient was hospitalized. Patient recovered.



Ergenyl Side Effects Report #5583549-8
ERGENYL problem was reported by a Consumer or non-health professional from FRANCE on Dec 28, 2007. Female patient, 25 years of age, was treated with ERGENYL. After drug was administered, patient experienced the following problems/side effects: leukopenia, neutropenia. ERGENYL dosage: unknown. During the same period patient was treated with QUETIAPINE FUMARATE, LAMOTRIGINE. Patient was hospitalized. Patient recovered.



Ergenyl Side Effects Report #5558193-9
Physician from FRANCE reported ERGENYL problem on Dec 05, 2007. Female patient, 31 years of age, was diagnosed with epilepsy and was treated with ERGENYL. After drug was administered, patient experienced the following problems/side effects: blood electrolytes decreased, confusional state, diarrhoea, urine barbiturates, vomiting. ERGENYL dosage: unknown. Patient was hospitalized. Patient recovered.



Ergenyl Side Effects Report #5576626-9
ERGENYL problem was reported by a Physician from FRANCE on Dec 20, 2007. Male patient, 18 years of age, was diagnosed with grand mal convulsion and was treated with ERGENYL. After drug was administered, patient experienced the following problems/side effects: akathisia, anxiety, dyspnoea, panic attack. ERGENYL dosage: unknown. During the same period patient was treated with ERGENYL CHRONO. Patient recovered.



Ergenyl Side Effects Report #5576791-3
Physician from FRANCE reported ERGENYL problem on Dec 19, 2007. Female patient, 31 years of age, was diagnosed with epilepsy and was treated with ERGENYL. After drug was administered, patient experienced the following problems/side effects: blood electrolytes decreased, confusional state, diarrhoea, urine barbiturates, vomiting. ERGENYL dosage: unknown. Patient was hospitalized. Patient recovered.




Ergenyl Side Effects Report #5520209-3
ERGENYL problem was reported by a Physician from FRANCE on Nov 08, 2007. Female patient was diagnosed with epilepsy and was treated with ERGENYL. After drug was administered, patient experienced the following problems/side effects: balance disorder, coordination abnormal, extrapyramidal disorder, fall, incontinence, parkinsonism, urinary tract infection. ERGENYL dosage: 600 MG IN THE MORNING, 900 MG IN THE EVENING. During the same period patient was treated with LAMOTRIGINE, LOSARTAN POTASSIUM, AMLODIPINE. Patient was hospitalized. Patient recovered.



Ergenyl Side Effects Report #5529736-6
Physician from FRANCE reported ERGENYL problem on Nov 19, 2007. Female patient, 52 years of age, was diagnosed with epilepsy and was treated with ERGENYL. After drug was administered, patient experienced the following problems/side effects: convulsion. ERGENYL dosage: unknown. During the same period patient was treated with ESTROGENS. Patient recovered.



Ergenyl Side Effects Report #5531038-9
ERGENYL problem was reported by a Consumer or non-health professional from FRANCE on Nov 22, 2007. Female patient, 24 years of age, was diagnosed with epilepsy and was treated with ERGENYL. After drug was administered, patient experienced the following problems/side effects: activities of daily living impaired, condition aggravated, dysphemia, fatigue, haemoglobin decreased, menorrhagia. ERGENYL dosage: unknown. During the same period patient was treated with FLUOXETINE HYDROCHLORIDE. Patient recovered.



Ergenyl Side Effects Report #5483104-4
Health Professional from FRANCE reported ERGENYL problem on Oct 03, 2007. Male patient, 40 years of age, was treated with ERGENYL. After drug was administered, patient experienced the following problems/side effects: epilepsy. ERGENYL dosage: unknown. Patient recovered.



Ergenyl Side Effects Report #5376478-6
ERGENYL problem was reported by a Physician from FRANCE on June 22, 2007. Male patient, 24 years of age, was diagnosed with personality disorder and was treated with ERGENYL. After drug was administered, patient experienced the following problems/side effects: blood amylase increased, lipase increased. ERGENYL dosage: unknown. During the same period patient was treated with RISPERIDONE, CHLORPROTHIXENE HYDROCHLORIDE, CHLORPROTHIXENE HYDROCHLORIDE. Patient was hospitalized. Patient recovered.




Ergenyl Side Effects Report #5376478-6
Physician from FRANCE reported ERGENYL problem on June 22, 2007. Male patient, 24 years of age, was diagnosed with personality disorder and was treated with ERGENYL. After drug was administered, patient experienced the following problems/side effects: blood amylase increased, lipase increased. ERGENYL dosage: unknown. During the same period patient was treated with RISPERIDONE, CHLORPROTHIXENE HYDROCHLORIDE, CHLORPROTHIXENE HYDROCHLORIDE. Patient was hospitalized. Patient recovered.



Ergenyl Side Effects Report #5759203-6
ERGENYL problem was reported by a Physician from FRANCE on May 29, 2008. Female patient, 69 years of age, was diagnosed with epilepsy and was treated with ERGENYL. After drug was administered, patient experienced the following problems/side effects: toxic encephalopathy. ERGENYL dosage: unknown. During the same period patient was treated with LAMOTRIGINE. Patient recovered.



Ergenyl Side Effects Report #5710210-9
Health Professional from FRANCE reported ERGENYL problem on Apr 09, 2008. Male patient was diagnosed with schizoaffective disorder and was treated with ERGENYL. After drug was administered, patient experienced the following problems/side effects: blood creatine phosphokinase increased. ERGENYL dosage: INCREASING DOSES UP TO 1000 MG. During the same period patient was treated with QUETIAPINE FUMARATE, BIPERIDEN HYDROCHLORIDE, QUETIAPINE FUMARATE. Patient recovered.



Ergenyl Side Effects Report #5367959-X
ERGENYL problem was reported by a Health Professional from FRANCE on June 15, 2007. Male patient, 60 years of age, was diagnosed with bipolar disorder and was treated with ERGENYL. After drug was administered, patient experienced the following problems/side effects: disorientation, dysarthria, fall, restlessness, vertigo. ERGENYL dosage: unknown. During the same period patient was treated with ARIPIPRAZOLE, PIPAMPERONE HYDROCHLORIDE, MIRTAZAPINE, ZOPICLONE, NORTRIPTYLINE. Patient was hospitalized. Patient recovered.



Ergenyl Side Effects Report #5340935-9
Physician from FRANCE reported ERGENYL problem on May 23, 2007. Male patient, weighting 7.14 lb, was treated with ERGENYL. After drug was administered, patient experienced the following problems/side effects: apgar score low, blood ph decreased, convulsion neonatal, cyanosis, dermatitis diaper, hyporeflexia, hypotonia, poor sucking reflex, respiratory failure. ERGENYL dosage: unknown. Patient was hospitalized. Patient recovered.




Ergenyl Side Effects Report #5267606-1
ERGENYL problem was reported by a Physician from FRANCE on Mar 08, 2007. Male patient, weighting 7.14 lb, was treated with ERGENYL. After drug was administered, patient experienced the following problems/side effects: apgar score low, blood ph decreased, convulsion neonatal, cyanosis, dermatitis diaper, hyporeflexia, hypotonia, poor sucking reflex, respiratory failure. ERGENYL dosage: unknown. Patient was hospitalized. Patient recovered.




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