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Index of reports
> Cases with Drug Ineffective (27)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Depakene (Valproic Acid) where reactions include drug ineffective. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Depakene side effects in male
Reported by a consumer/non-health professional from Brazil on 2012-08-27
Patient: male, weighing 84.0 kg (184.8 pounds)
Reactions: Vomiting, Dyspnoea, Hepatic Pain, Spinal Pain, Drug Ineffective, Nausea, Headache, Somnolence, Convulsion, Palpitations, Renal Pain, Hypertension, Decreased Appetite
Drug(s) suspected as cause:
Depakene
Other drugs received by patient: Zyprexa; Diazepam; Lithium Carbonate
Possible Depakene side effects in
Reported by a consumer/non-health professional from Argentina on 2012-08-24
Patient:
Reactions: Drug Ineffective, Convulsion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Depakene
Possible Depakene side effects in 52 year old male
Reported by a consumer/non-health professional from Netherlands on 2012-08-09
Patient: 52 year old male
Reactions: Drug Ineffective, Disturbance in Attention, Memory Impairment, Somnolence, Epilepsy, Tremor, Dysphemia
Drug(s) suspected as cause:
Depakene
Administration route: Oral
Indication: Epilepsy
Start date: 2011-07-01
Depakene
Administration route: Oral
Clobazam
Administration route: Oral
Indication: Epilepsy
End date: 2011-07-01
Other drugs received by patient: Tamsulosin Hydrochloride; Azarga
Possible Depakene side effects in 52 year old male
Reported by a consumer/non-health professional from Netherlands on 2012-08-06
Patient: 52 year old male
Reactions: Drug Ineffective, Disturbance in Attention, Somnolence, Epilepsy, Amnesia, Tremor, Dysphemia
Drug(s) suspected as cause:
Depakene
Dosage: 300 mg milligram(s) 1 in 1 d, oral, 800 mg milligram(s), 2 in 1 d, oral
Administration route: Oral
Indication: Epilepsy
Start date: 2011-07-01
Onfi
Dosage: 10 mg milligram(s), oral
Administration route: Oral
Indication: Epilepsy
End date: 2011-07-01
Other drugs received by patient: Azarga (Azarga); Tamsulosin HCL
Possible Depakene side effects in 3 year old female
Reported by a health professional (non-physician/pharmacist) from Russian Federation on 2012-08-01
Patient: 3 year old female
Reactions: Product Counterfeit, Drug Ineffective, Condition Aggravated, Muscle Twitching, Epilepsy
Drug(s) suspected as cause:
Depakene
Administration route: Oral
Start date: 2012-06-01
End date: 2012-07-09
Depakene
Administration route: Oral
Indication: Epilepsy
Start date: 2012-04-01
End date: 2012-06-01
Depakene
Start date: 2012-07-09
Other drugs received by patient: Valproate Sodium; Valproate Sodium
Possible Depakene side effects in 3 year old male
Reported by a consumer/non-health professional from China on 2012-07-31
Patient: 3 year old male
Reactions: Drug Level Below Therapeutic, Drug Ineffective, Epilepsy, Muscle Twitching, Somnolence
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Depakene
Possible Depakene side effects in 16 year old male
Reported by a consumer/non-health professional from China on 2012-07-20
Patient: 16 year old male
Reactions: Drug Ineffective, Diarrhoea, Epilepsy, Gastritis, Abdominal Pain Upper
Drug(s) suspected as cause:
Depakene
Dosage: 1.5 gastro-resistant tablet daily
Administration route: Oral
Start date: 2012-05-22
End date: 2012-06-06
Depakene
Dosage: 1 gastro-resistant tablet daily
Administration route: Oral
Indication: Epilepsy
Start date: 2012-05-15
End date: 2012-05-21
Other drugs received by patient: Vitamin D
Possible Depakene side effects in 31 year old female
Reported by a consumer/non-health professional from China on 2012-07-13
Patient: 31 year old female
Reactions: Vomiting, Drug Ineffective, Abnormal Behaviour, Epilepsy, Loss of Consciousness, Convulsion, Flushing, Vision Blurred, Staring
Drug(s) suspected as cause:
Depakene
Administration route: Oral
Start date: 2012-06-01
Depakene
Administration route: Oral
Indication: Epilepsy
Start date: 2012-05-21
End date: 2012-06-01
Other drugs received by patient: Carbamazepine
Possible Depakene side effects in 3 year old male
Reported by a consumer/non-health professional from China on 2012-06-13
Patient: 3 year old male
Reactions: Drug Level Below Therapeutic, Drug Ineffective, Muscle Twitching, Somnolence, Epilepsy
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Depakene
Possible Depakene side effects in 17 year old male
Reported by a consumer/non-health professional from Russian Federation on 2012-05-23
Patient: 17 year old male
Reactions: Drug Ineffective, Drug Level Decreased, Convulsion
Drug(s) suspected as cause:
Depakene
Dosage: extended release coated tablets, daily
Administration route: Oral
Indication: Epilepsy
Start date: 2012-01-01
Depakene
Start date: 2012-04-23
Depakene
Start date: 2004-01-01
Depakene
Start date: 2011-01-01
Depakene
Dosage: extended release coated tablets, daily
Administration route: Oral
Start date: 2012-04-01
End date: 2012-04-23
Other drugs received by patient: Topamax
Possible Depakene side effects in 5 year old male
Reported by a consumer/non-health professional from Russian Federation on 2012-05-23
Patient: 5 year old male
Reactions: Product Counterfeit, Drug Ineffective, Epilepsy
Drug(s) suspected as cause:
Depakene
Other drugs received by patient: Topamax; Trileptal
Possible Depakene side effects in 49 year old female
Reported by a health professional (non-physician/pharmacist) from Switzerland on 2012-05-15
Patient: 49 year old female
Reactions: Renal Failure, Vomiting, Drug Ineffective, Pancytopenia, Hypercalcaemia, Somnolence, Thrombocytopenia
Drug(s) suspected as cause:
Depakene
Dosage: 500 mg, unk
Administration route: Oral
Indication: Schizophrenia
Start date: 2011-09-28
End date: 2011-10-19
Haldol
Dosage: 12.5 mg, unk
Administration route: Oral
Start date: 2011-10-29
End date: 2011-10-29
Haldol
Dosage: 10 mg, unk
Administration route: Oral
Start date: 2011-10-30
End date: 2011-10-30
Haldol
Dosage: 5 mg, unk
Administration route: Oral
Start date: 2011-11-01
End date: 2011-11-01
Clozapine
Dosage: 75 mg, unk
Administration route: Oral
End date: 2011-11-02
Haldol
Dosage: 15 mg, unk
Administration route: Oral
Start date: 2011-10-20
End date: 2011-10-28
Haldol
Dosage: 2.5 mg, unk
Administration route: Oral
Start date: 2011-11-02
End date: 2011-11-02
Zyprexa
Dosage: 20 mg, unk
Administration route: Oral
Start date: 2011-10-07
End date: 2011-11-01
Zyprexa
Dosage: 20 mg, unk
Administration route: Oral
Start date: 2011-11-04
End date: 2011-11-10
Clozapine
Administration route: Oral
Indication: Schizophrenia
Start date: 2011-10-27
Haldol
Dosage: 7.5 mg, unk
Administration route: Oral
Start date: 2011-10-31
End date: 2011-10-31
Haldol
Dosage: 7.5 mg, unk
Administration route: Oral
Indication: Schizophrenia
Start date: 2011-10-08
End date: 2011-10-19
Depakene
Dosage: 1000 mg, unk
Administration route: Oral
Start date: 2011-10-20
End date: 2011-11-10
Zyprexa
Dosage: 15 mg, unk
Administration route: Oral
Indication: Schizophrenia
Start date: 2011-09-28
End date: 2011-10-06
Zyprexa
Dosage: 10 mg, unk
Administration route: Oral
Start date: 2011-11-02
End date: 2011-11-03
Other drugs received by patient: Diazepam; Cinacalcet Hydrochloride
Possible Depakene side effects in 52 year old male
Reported by a consumer/non-health professional from Netherlands on 2012-05-04
Patient: 52 year old male
Reactions: Drug Ineffective, Disturbance in Attention, Amnesia, Epilepsy, Tremor
Drug(s) suspected as cause:
Depakene
Administration route: Oral
Depakene
Administration route: Oral
Indication: Epilepsy
Other drugs received by patient: Frisium; Tamsulosin Hydrochloride; Azarga
Possible Depakene side effects in 17 year old male
Reported by a consumer/non-health professional from Russian Federation on 2012-05-04
Patient: 17 year old male
Reactions: Drug Ineffective, Drug Level Decreased, Convulsion
Drug(s) suspected as cause:
Depakene
Dosage: extended release coated tablets, daily
Administration route: Oral
Indication: Epilepsy
Start date: 2012-01-01
Depakene
Dosage: extended release coated tablets, daily
Administration route: Oral
Start date: 2012-01-01
Other drugs received by patient: Topamax
Possible Depakene side effects in male
Reported by a consumer/non-health professional from Brazil on 2012-04-03
Patient: male, weighing 20.0 kg (44.0 pounds)
Reactions: Product Packaging Issue, Drug Ineffective, Central Nervous System Lesion, Insomnia, Ammonia Increased, Convulsion
Drug(s) suspected as cause:
Depakene
Administration route: Oral
Indication: Epilepsy
Start date: 2008-01-01
Depakene
Administration route: Oral
Other drugs received by patient: Bromazepam; Unspecified Drug; Ketotifen Fumarate; Topiramate
Possible Depakene side effects in male
Reported by a consumer/non-health professional from Brazil on 2012-03-29
Patient: male, weighing 20.0 kg (44.0 pounds)
Reactions: Product Packaging Issue, Drug Ineffective, Central Nervous System Lesion, Insomnia, Ammonia Increased, Convulsion
Drug(s) suspected as cause:
Depakene
Administration route: Oral
Depakene
Administration route: Oral
Indication: Epilepsy
Start date: 2008-01-01
Other drugs received by patient: Unspecified Drug; Bromazepam; Topiramate; Ketotifen Fumarate
Possible Depakene side effects in male
Reported by a consumer/non-health professional from Brazil on 2012-03-20
Patient: male, weighing 20.0 kg (44.0 pounds)
Reactions: Product Packaging Issue, Drug Ineffective, Insomnia, Central Nervous System Lesion, Ammonia Increased, Convulsion
Drug(s) suspected as cause:
Depakene
Administration route: Oral
Indication: Epilepsy
Start date: 2008-01-01
Depakene
Administration route: Oral
Other drugs received by patient: Bromazepam; Unspecified Drug; Ketotifen Fumarate; Topiramate
Possible Depakene side effects in 8 year old female
Reported by a consumer/non-health professional from Russian Federation on 2012-02-29
Patient: 8 year old female
Reactions: Hyperpyrexia, Drug Ineffective, Petit MAL Epilepsy, Respiratory Tract Infection, Leukopenia
Drug(s) suspected as cause:
Depakene
Administration route: Oral
Start date: 2012-01-20
Depakene
Dosage: extended release, daily
Administration route: Oral
Indication: Epilepsy
Start date: 2012-01-16
End date: 2012-01-18
Other drugs received by patient: Suxilep
Possible Depakene side effects in 5 year old male
Reported by a consumer/non-health professional from Russian Federation on 2012-02-28
Patient: 5 year old male
Reactions: Product Counterfeit, Drug Ineffective, Epilepsy
Drug(s) suspected as cause:
Depakene
Other drugs received by patient: Topamax; Trileptal
Possible Depakene side effects in 8 year old female
Reported by a consumer/non-health professional from Russian Federation on 2012-02-03
Patient: 8 year old female
Reactions: Hyperpyrexia, Drug Ineffective, Petit MAL Epilepsy, Respiratory Tract Infection
Drug(s) suspected as cause:
Depakene
Administration route: Oral
Start date: 2012-01-20
Depakene
Dosage: extended release, daily
Administration route: Oral
Indication: Epilepsy
Start date: 2012-01-16
End date: 2012-01-18
Possible Depakene side effects in 5 year old male
Reported by a consumer/non-health professional from Russian Federation on 2012-01-20
Patient: 5 year old male
Reactions: Product Counterfeit, Drug Ineffective, Epilepsy
Drug(s) suspected as cause:
Depakene
Other drugs received by patient: Topamax; Trileptal
Possible Depakene side effects in 5 year old male
Reported by a consumer/non-health professional from Russian Federation on 2012-01-18
Patient: 5 year old male
Reactions: Product Counterfeit, Drug Ineffective, Epilepsy
Drug(s) suspected as cause:
Depakene
Other drugs received by patient: Topamax; Trileptal
Possible Depakene side effects in female
Reported by a consumer/non-health professional from Brazil on 2012-01-11
Patient: female, weighing 16.0 kg (35.2 pounds)
Reactions: Agitation, Head Injury, Drug Ineffective, Fear, Fall, Constipation, Palpitations, Cyanosis, Psychiatric Symptom, Blood Cholesterol Increased, Anger, Nervousness, Muscle Spasms, Aggression, Convulsion, Insomnia, Hypothyroidism, Influenza
Drug(s) suspected as cause:
Depakene
Indication: Convulsion
Depakene
Dosage: 16 ml per day
Administration route: Oral
Indication: Cerebral Palsy
Other drugs received by patient: Clusivol; Phenobarbital TAB; Tegretol
Possible Depakene side effects in 15 month old female
Reported by a health professional (non-physician/pharmacist) from Portugal on 2011-11-29
Patient: 15 month old female
Reactions: Drug Level Below Therapeutic, Product Quality Issue, Drug Ineffective, Convulsion
Drug(s) suspected as cause:
Depakene
Other drugs received by patient: Topiramate
Possible Depakene side effects in 62 year old female
Reported by a pharmacist from France on 2011-11-17
Patient: 62 year old female
Reactions: Drug Ineffective, Convulsion
Drug(s) suspected as cause:
Depakene
Possible Depakene side effects in female
Reported by a consumer/non-health professional from Brazil on 2011-11-14
Patient: female, weighing 15.0 kg (33.0 pounds)
Reactions: Drug Ineffective, Cyanosis, Palpitations, Blood Cholesterol Increased, Hypothyroidism, Muscle Spasms, Convulsion
Drug(s) suspected as cause:
Depakene
Indication: Convulsion
Depakene
Dosage: 16 ml per day
Administration route: Oral
Indication: Cerebral Palsy
Other drugs received by patient: Tegretol; Phenobarbital TAB
Possible Depakene side effects in 62 year old female
Reported by a pharmacist from France on 2011-10-31
Patient: 62 year old female
Reactions: Drug Ineffective, Convulsion
Drug(s) suspected as cause:
Depakene
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