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Index of reports
> Cases with Fall (18)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Depakene (Valproic Acid) where reactions include fall. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Depakene side effects in 3 year old male
Reported by a consumer/non-health professional from China on 2012-08-24
Patient: 3 year old male
Reactions: Toothache, Pallor, Epilepsy, Fall
Drug(s) suspected as cause:
Depakene
Dosage: 7-8 ml
Administration route: Oral
Start date: 2012-05-01
End date: 2012-06-01
Depakene
Indication: Epilepsy
Start date: 2012-07-01
Depakene
Administration route: Oral
Start date: 2012-07-01
End date: 2012-07-01
Possible Depakene side effects in 6 year old female
Reported by a consumer/non-health professional from China on 2012-08-21
Patient: 6 year old female
Reactions: Product Counterfeit, Fall, Epilepsy, Convulsion, Tremor
Drug(s) suspected as cause:
Depakene
Administration route: Oral
Indication: Epilepsy
Start date: 2006-01-01
End date: 2012-06-01
Depakene
Dosage: 12 ml, oral solution, 3 times a day
Administration route: Oral
Start date: 2012-08-01
Depakene
Administration route: Oral
Start date: 2012-06-01
End date: 2012-07-31
Possible Depakene side effects in male
Reported by a consumer/non-health professional from Brazil on 2012-08-14
Patient: male
Reactions: Femur Fracture, Physical Assault, Fall
Drug(s) suspected as cause:
Depakene
Possible Depakene side effects in 6 year old female
Reported by a consumer/non-health professional from China on 2012-08-13
Patient: 6 year old female
Reactions: Product Counterfeit, Fall, Epilepsy, Tremor, Convulsion
Drug(s) suspected as cause:
Depakene
Administration route: Oral
Start date: 2012-06-01
Depakene
Administration route: Oral
Indication: Epilepsy
Start date: 2006-01-01
End date: 2012-06-01
Possible Depakene side effects in female
Reported by a consumer/non-health professional from Brazil on 2012-08-06
Patient: female, weighing 45.0 kg (99.0 pounds)
Reactions: Agitation, Head Injury, Headache, Fall, Convulsion, Syncope, Gingival Pain, Depressed Mood, Feeling Abnormal
Drug(s) suspected as cause:
Carbamazepine
Dosage: 200 mg, unk
Carbamazepine
Dosage: 200 mg, unk
Depakene
Dosage: 1 df, q12h
Indication: Convulsion
Tegretol
Dosage: 1 df, q8h
Administration route: Oral
Tegretol
Dosage: 1 df, q8h
Tegretol
Dosage: 1 df, q12h
Administration route: Oral
Indication: Convulsion
Tegretol
Dosage: 200 mg, unk
Administration route: Oral
Tegretol
Dosage: 1 df, q6h
Carbamazepine
Dosage: 200 mg, unk
Indication: Convulsion
Possible Depakene side effects in 31 year old male
Reported by a consumer/non-health professional from China on 2012-07-30
Patient: 31 year old male
Reactions: Epilepsy, Fall, Loss of Consciousness, Foaming AT Mouth
Drug(s) suspected as cause:
Depakene
Administration route: Oral
Start date: 2012-07-02
Depakene
Administration route: Oral
Indication: Epilepsy
Start date: 2010-01-01
End date: 2012-07-01
Possible Depakene side effects in male
Reported by a consumer/non-health professional from China on 2012-07-16
Patient: male
Reactions: Epilepsy, Fall, Foaming AT Mouth, Loss of Consciousness
Drug(s) suspected as cause:
Depakene
Administration route: Oral
Start date: 2012-07-02
Depakene
Administration route: Oral
Indication: Epilepsy
Start date: 2010-01-01
End date: 2012-07-01
Possible Depakene side effects in 77 year old female
Reported by a consumer/non-health professional from China on 2012-07-10
Patient: 77 year old female
Reactions: Gait Disturbance, Asthenia, Fall, Epilepsy, Loss of Consciousness
Drug(s) suspected as cause:
Depakene
Dosage: daily, extended release
Administration route: Oral
Indication: Epilepsy
Start date: 2012-01-01
End date: 2012-05-01
Depakene
Dosage: twice a day, extended release
Administration route: Oral
Start date: 2012-05-01
End date: 2012-07-01
Depakene
Dosage: twice a day, extended release
Administration route: Oral
Start date: 2012-07-02
Other drugs received by patient: Topiramate
Possible Depakene side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-05-04
Patient: female
Reactions: Hypothermia, Neurological Examination Abnormal, Bundle Branch Block Left, Cerebral Atrophy, Fall, Escherichia Test Positive, Ecchymosis, Atrioventricular Block, Bradycardia, Blood Pressure Decreased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Atenolol
Dosage: 50 mg, unk
End date: 2011-09-01
Lisinopril
Dosage: 1 df, qd
Administration route: Oral
Haldol
Dosage: 1 df (1df - 0.5df - 1df)
Lorazepam
Dosage: 1 df, bid
Administration route: Oral
Depakene
Dosage: 1 df, bid
Administration route: Oral
Esidrix
Dosage: 12.5 mg, per day
Administration route: Oral
Nexium
Dosage: 20 mg, qd
Administration route: Oral
Xanax
Dosage: 0.50 mg, qd
Administration route: Oral
Lepticur
Dosage: 1 df, bid
Administration route: Oral
Other drugs received by patient: Zolpidem Tartrate
Possible Depakene side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-03-30
Patient: female
Reactions: Hypothermia, Neurological Examination Abnormal, Cerebral Atrophy, Bundle Branch Block Left, Fall, Escherichia Test Positive, Ecchymosis, Atrioventricular Block, Bradycardia, Blood Pressure Decreased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lorazepam
Dosage: 2.5 mg, bid
Administration route: Oral
Esidrix
Dosage: 12.5 mg, per day
Administration route: Oral
Lepticur
Dosage: 10 mg, bid
Administration route: Oral
Lisinopril
Dosage: 1 df, qd
Administration route: Oral
Xanax
Dosage: 0.50 mg, qd
Administration route: Oral
Nexium
Dosage: 20 mg, qd
Administration route: Oral
Haldol
Depakene
Dosage: 500 mg, bid
Administration route: Oral
Other drugs received by patient: Zolpidem Tartrate; Atenolol
Possible Depakene side effects in 84 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-03-13
Patient: 84 year old female
Reactions: Confusional State, Orthostatic Hypotension, Drug Interaction, Dizziness, Fall, Somnolence
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Depakene
Other drugs received by patient possibly interacting with the suspect drug:
Depakene
Administration route: Oral
Start date: 2012-01-21
Lorazepam
Dosage: daily
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2012-01-21
Other drugs received by patient: Oxazepam
Possible Depakene side effects in 55 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-03-01
Patient: 55 year old male
Reactions: Pneumonia Aspiration, Rhabdomyolysis, Encephalopathy, Fall, Renal Failure Acute
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Depakene
Administration route: Oral
Start date: 2011-12-27
Depakene
Administration route: Oral
Start date: 2011-12-15
Depakene
Administration route: Oral
Start date: 2012-01-03
End date: 2012-01-03
Depakene
Administration route: Oral
Start date: 2011-12-30
Depakene
Administration route: Oral
Start date: 2011-12-11
Depakene
Dosage: gastro-resistant tablet
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-01-01
Other drugs received by patient: Atenolol; Ramipril; Digoxin
Possible Depakene side effects in 55 year old female
Reported by a consumer/non-health professional from China on 2012-02-21
Patient: 55 year old female
Reactions: Fall, Epilepsy, Loss of Consciousness
Drug(s) suspected as cause:
Depakene
Other drugs received by patient: ALL Other Therapeutic Products; Herbal Preparatioin
Possible Depakene side effects in male
Reported by a consumer/non-health professional from Brazil on 2012-02-07
Patient: male, weighing 60.0 kg (132.0 pounds)
Reactions: Vomiting, Tooth Fracture, Restlessness, Bipolar Disorder, Headache, Fall, Convulsion
Drug(s) suspected as cause:
Depakote
Depakene
Indication: Product Used FOR Unknown Indication
Start date: 2011-07-01
Depakote
Dosage: 1 about 8am; 1 about 3pm, 1 about 8pm
Administration route: Oral
Indication: Convulsion
Other drugs received by patient: Lamotrigine
Possible Depakene side effects in 21 year old male
Reported by a consumer/non-health professional from China on 2012-01-23
Patient: 21 year old male
Reactions: Urinary Incontinence, Fall, Epilepsy, Foaming AT Mouth, Loss of Consciousness, Convulsion
Drug(s) suspected as cause:
Depakene
Administration route: Oral
Indication: Epilepsy
Start date: 2010-06-01
End date: 2011-07-01
Depakene
Administration route: Oral
Start date: 2010-06-01
End date: 2011-07-01
Depakene
Administration route: Oral
Start date: 2011-07-01
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 41 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2011-11-23
Patient: 41 year old male
Reactions: Renal Disorder, Drug Effect Decreased, Suicidal Behaviour, Laceration, Fall, Platelet Aggregation Decreased, Wound Haemorrhage, Convulsion, Affective Disorder, Coagulation Factor Decreased, Anticonvulsant Drug Level Increased, VON Willebrand's Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Depakene
Dosage: 2500mg daily
Administration route: Oral
Indication: Epilepsy
Start date: 1974-01-01
End date: 2007-01-01
Depakene
Dosage: 2000mg daily, 4 in 1 day
Administration route: Oral
Other drugs received by patient: Valium; Lexomil; Neuleptil; Trihexyphenidyl Hydrochloride; Fluphenazine Decanoate; Neurontin; Tegretol; Tercian; Clonazepam
Possible Depakene side effects in 21 year old male
Reported by a consumer/non-health professional from China on 2011-11-18
Patient: 21 year old male
Reactions: Urinary Incontinence, Fall, Epilepsy, Loss of Consciousness, Convulsion, Foaming AT Mouth
Drug(s) suspected as cause:
Depakene
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