Index of reports
> Cases with Drug Ineffective (10)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Depakote ER (Divalproex) where reactions include drug ineffective. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Depakote ER side effects in 11 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22
Patient: 11 year old female, weighing 66.2 kg (145.7 pounds)
Reactions: Product Substitution Issue, Drug Ineffective, Crying
Drug(s) suspected as cause:
Depakote ER
Dosage: 500 mg, 2xday, imd
Indication: Autism
Depakote ER
Dosage: 500 mg, 2xday, imd
Indication: Attention Deficit / Hyperactivity Disorder
Possible Depakote ER side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-06
Patient: male
Reactions: Product Counterfeit, Product Packaging Issue, Drug Ineffective, Counterfeit Drug Administered, Product LOT Number Issue, Drug Level Decreased
Drug(s) suspected as cause:
Depakote ER
Other drugs received by patient: Lamictal; Dilantin; Dilantin; Lamictal
Possible Depakote ER side effects in 71 year old female
Reported by a consumer/non-health professional from Brazil on 2012-07-30
Patient: 71 year old female, weighing 86.0 kg (189.2 pounds)
Reactions: Agitation, Weight Decreased, Gingivitis, Drug Ineffective, Hypovitaminosis, Increased Appetite, Mouth Ulceration, Oral Discomfort, Weight Increased, Off Label Use, Mood Altered, Cataract, Anxiety, Cholelithiasis, Bipolar Disorder, Hypothyroidism
Drug(s) suspected as cause:
Depakote ER
Other drugs received by patient: Protos; Levothyroxine Sodium; Sinvaston; Venlafaxine Hydrocholride; Lyrica; Venlafaxine Hydrocholride; Protos; Calcium Carbonate; Levothyroxine Sodium; Depuran; Venlafaxine Hydrocholride; Venlafaxine Hydrocholride
Possible Depakote ER side effects in female
Reported by a consumer/non-health professional from Brazil on 2012-05-31
Patient: female
Reactions: Weight Increased, Drug Ineffective, Unevaluable Event, Convulsion
Drug(s) suspected as cause:
Depakote
Dosage: 1 tablet daily
Indication: Convulsion
Depakote ER
Indication: Convulsion
Depakote
Dosage: 2 tablets daily
Depakote ER
Indication: Epilepsy
End date: 2012-04-20
Depakote
Dosage: 2 tablets daily
Other drugs received by patient: Topiramate
Possible Depakote ER side effects in male
Reported by a consumer/non-health professional from Brazil on 2012-05-24
Patient: male, weighing 80.0 kg (176.0 pounds)
Reactions: Drug Ineffective, Moaning, Ill-Defined Disorder, Facial Pain, Tremor, Cardiorenal Syndrome, Convulsion
Drug(s) suspected as cause:
Depakote ER
Dosage: after dinner
Administration route: Oral
Start date: 2011-12-01
Depakote ER
Dosage: as needed (in crisis)
Administration route: Oral
Indication: Muscle Spasms
Start date: 2006-01-01
Depakote ER
Dosage: 3 tablets after dinner
Administration route: Oral
Start date: 2012-03-27
Depakote ER
Dosage: 2.5 tablets after dinner
Administration route: Oral
Start date: 2012-03-04
Possible Depakote ER side effects in
Reported by a consumer/non-health professional from United States on 2012-03-08
Patient: , weighing 79.5 kg (174.8 pounds)
Reactions: Fatigue, Drug Ineffective, Dizziness, Vision Blurred, Headache, Withdrawal Syndrome, Hypertension
Drug(s) suspected as cause:
Lisinopril
Indication: Hypertension
Depakote ER
Start date: 1997-01-01
End date: 2002-01-01
Depakote
Indication: Bipolar Disorder
Start date: 2002-01-01
End date: 2011-08-01
Depakote ER
Indication: Bipolar Disorder
Start date: 1997-01-01
End date: 1997-01-01
Other drugs received by patient: Wellbutrin; Lithium Carbonate
Possible Depakote ER side effects in female
Reported by a physician from United States on 2012-03-02
Patient: female, weighing 74.0 kg (162.8 pounds)
Reactions: Drug Ineffective, Dyskinesia, Speech Disorder, Dizziness, Coordination Abnormal, Back Pain, Ataxia, Cognitive Disorder, Amnesia, Ill-Defined Disorder, Tremor, Convulsion, Grand MAL Convulsion, Insomnia, Gait Disturbance, Asthenia, Head Titubation, Mobility Decreased
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Keppra
Indication: Convulsion Prophylaxis
Start date: 2010-11-01
End date: 2011-02-01
Divalproex Sodium
Indication: Convulsion
Depakote ER
Indication: Convulsion
Start date: 2007-01-01
End date: 2010-11-01
Primidone
Administration route: Oral
Indication: Tremor
Primidone
Depakote ER
Start date: 2011-02-01
Other drugs received by patient: Adult Aspirin LOW Strength; Calcium; Triazolam
Possible Depakote ER side effects in female
Reported by a physician from United States on 2012-02-22
Patient: female, weighing 74.0 kg (162.8 pounds)
Reactions: Drug Ineffective, Dyskinesia, Speech Disorder, Dizziness, Coordination Abnormal, Back Pain, Ataxia, Cognitive Disorder, Amnesia, Ill-Defined Disorder, Convulsion, Tremor, Grand MAL Convulsion, Insomnia, Gait Disturbance, Asthenia, Mobility Decreased, Head Titubation
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Primidone
Administration route: Oral
Indication: Tremor
Divalproex Sodium
Indication: Convulsion
Primidone
Keppra
Indication: Convulsion Prophylaxis
Start date: 2010-11-01
End date: 2011-02-01
Depakote ER
Indication: Convulsion
Start date: 2007-01-01
End date: 2010-11-01
Depakote ER
Start date: 2011-02-01
Other drugs received by patient: Triazolam; Adult Aspirin LOW Strength; Calcium
Possible Depakote ER side effects in female
Reported by a consumer/non-health professional from United States on 2012-01-17
Patient: female, weighing 75.0 kg (165.0 pounds)
Reactions: Weight Decreased, Vomiting, Cataract, Drug Ineffective, Wrist Fracture, Pain in Extremity, Visual Acuity Reduced, Ankle Fracture, Fall, Tremor, Neuropathy Peripheral, Dizziness, Thyroid Neoplasm, Eye Disorder, Blood Pressure Decreased
Drug(s) suspected as cause:
Lisinopril
Dosage: unk
Indication: Hypertension
Tricor
Dosage: unk
Indication: Blood Cholesterol Increased
Start date: 2009-01-01
End date: 2011-01-01
Norvasc
Dosage: unk
Indication: Hypertension
Depakote ER
Dosage: unk
Indication: Bipolar Disorder
Start date: 1996-01-01
Trilipix
Dosage: unk
Indication: Blood Cholesterol Increased
Start date: 2011-01-01
End date: 2011-10-01
Other drugs received by patient: Calcium Plus B; Ezetimibe; Lipitac; Omeprazole; Estrogens Conjugated
Possible Depakote ER side effects in female
Reported by a consumer/non-health professional from United States on 2012-01-10
Patient: female, weighing 74.9 kg (164.8 pounds)
Reactions: Weight Decreased, Vomiting, Cataract, Drug Ineffective, Pain in Extremity, Wrist Fracture, Visual Acuity Reduced, Fall, Ankle Fracture, Tremor, Neuropathy Peripheral, Dizziness, Thyroid Neoplasm, Blood Pressure Decreased, Eye Disorder
Drug(s) suspected as cause:
Trilipix
Indication: Blood Cholesterol Increased
Start date: 2011-01-01
End date: 2011-10-01
Tricor
Indication: Blood Cholesterol Increased
Start date: 2009-01-01
End date: 2011-01-01
Depakote ER
Indication: Bipolar Disorder
Start date: 1996-01-01
Norvasc
Indication: Hypertension
Lisinopril
Indication: Hypertension
Other drugs received by patient: Prilosec; Premarin; Lovaza; Zetia; Calcium Plus B
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