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Alopecia (1)
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Valpakine Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Product Quality Issue, Dyspnoea, Epilepsy (7435104-2)
on Apr 19, 2011 Male from BRAZIL , child 4 years of age, was diagnosed with
  • cerebral disorder
and was treated with Valpakine Oral Soulution. Directly after, patient experienced the unwanted or unexpected Valpakine side effects: product quality issue, dyspnoea, epilepsy. Valpakine Oral Soulution dosage: 30 Drops In The Am, 30 Drops In The Pm.
Associated medications used:
  • Clonazepam


Pyrexia, Pneumonia, Somnolence, Confusional State, Fatigue, Alopecia, Tremor, Convulsion (7235076-X)
Patient was taking Valpakine. Patient felt the following Valpakine side effects: pyrexia, pneumonia, somnolence, confusional state, fatigue, alopecia, tremor, convulsion on Jan 14, 2011 from BRAZIL Additional patient health information: Female , 41 years of age, was diagnosed with
  • convulsion
and. Valpakine dosage: Twice A Day.
Multiple prescriptions taken:
  • Primidone
  • Lamotrigine
Patient was hospitalized.

Alopecia, Confusional State, Convulsion, Fatigue, Pneumonia, Pyrexia, Somnolence, Tremor (7158747-2)
Adverse event was reported on Dec 07, 2010 by a Female taking Valpakine (Dosage: Twice A Day) was diagnosed with
  • convulsion
and. Location: BRAZIL , 41 years of age, After Valpakine was administered, patient encountered several Valpakine side effects: alopecia, confusional state, convulsion, fatigue, pneumonia, pyrexia, somnolence, tremor.
Multiple concurrent drugs taken:
  • Primidone
  • Lamotrigine
Patient was hospitalized.

Alopecia, Confusional State, Convulsion, Fatigue, Pneumonia, Pyrexia, Somnolence, Tremor (7158709-5)
on Dec 07, 2010 Female from BRAZIL , 41 years of age, was diagnosed with
  • convulsion
and was treated with Valpakine. Directly after, patient experienced the unwanted or unexpected Valpakine side effects: alopecia, confusional state, convulsion, fatigue, pneumonia, pyrexia, somnolence, tremor. Valpakine dosage: Twice A Day.
Associated medications used:
  • Primidone
  • Lamotrigine
Patient was hospitalized.


Alopecia, Confusional State, Convulsion, Fatigue, Overweight, Somnolence (7080825-7)
on Oct 26, 2010 Female from BRAZIL , 41 years of age, was diagnosed with
  • convulsion
and was treated with Valpakine. Patient felt the following Valpakine side effects: alopecia, confusional state, convulsion, fatigue, overweight, somnolence. Valpakine dosage: N/A.
Multiple prescriptions taken:
  • Primidone


Balance Disorder, Initial Insomnia, Syncope, Tremor (7012991-3)
Patient was taking Valpakine. After Valpakine was administered, patient encountered several Valpakine side effects: balance disorder, initial insomnia, syncope, tremor on Sep 15, 2010 from BRAZIL Additional patient health information: Male , 13 years of age, . Valpakine dosage: N/A.

Convulsion, Product Quality Issue (6973128-X)
Adverse event was reported on Sep 02, 2010 by a Female taking Valpakine (Dosage: Gastroresistant Tab) was diagnosed with
  • convulsion
and. Location: FRANCE , 34 years of age, Directly after, patient experienced the unwanted or unexpected Valpakine side effects: convulsion, product quality issue. Patient was hospitalized.

Convulsion, Fall (6815607-1)
on Jun 23, 2010 Female from BRAZIL , child 10 years of age, was diagnosed with
  • epilepsy
and was treated with Valpakine. Patient felt the following Valpakine side effects: convulsion, fall. Valpakine dosage: 5.5 Unit Daily.

Anaemia, Hypoalbuminaemia, Hyponatraemia, Macrocytosis, Thrombocytopenia, Vitamin B12 Deficiency (6813580-3)
on Jun 23, 2010 Male from FRANCE , child 4 years of age, was diagnosed with
  • infantile spasms
and was treated with Valpakine. After Valpakine was administered, patient encountered several Valpakine side effects: anaemia, hypoalbuminaemia, hyponatraemia, macrocytosis, thrombocytopenia, vitamin b12 deficiency. Valpakine dosage: N/A.
Multiple concurrent drugs taken:
  • Clobazam
Patient was hospitalized.

Alopecia, Convulsion, Dry Skin, Dysgeusia, Erythema, Weight Increased (6754734-4)
Patient was taking Valpakine. Directly after, patient experienced the unwanted or unexpected Valpakine side effects: alopecia, convulsion, dry skin, dysgeusia, erythema, weight increased on May 26, 2010 from BRAZIL Additional patient health information: Female , weighting 185.2 lb, was diagnosed with
  • convulsion
and. Valpakine dosage: Gastro-resistant Tablet.
Associated medications used:
  • Clonazepam
  • Sertraline Hcl


Convulsion, Product Quality Issue (6754724-1)
Adverse event was reported on May 26, 2010 by a Female taking Valpakine (Dosage: N/A) was diagnosed with
  • convulsion
and. Location: FRANCE , 17 years of age, Patient felt the following Valpakine side effects: convulsion, product quality issue.
Multiple prescriptions taken:
  • Hidantal
  • Rivotril


Convulsion, Product Quality Issue, Speech Disorder (6752572-X)
on May 26, 2010 Male from FRANCE , 52 years of age, was diagnosed with
  • convulsion
and was treated with Valpakine. After Valpakine was administered, patient encountered several Valpakine side effects: convulsion, product quality issue, speech disorder. Valpakine dosage: N/A.

Convulsion, Headache, Product Quality Issue, Product Taste Abnormal, Skin Discolouration, Vomiting (6744255-7)
on May 21, 2010 Female from FRANCE , child 7 years of age, was diagnosed with
  • convulsion
and was treated with Valpakine. Directly after, patient experienced the unwanted or unexpected Valpakine side effects: convulsion, headache, product quality issue, product taste abnormal, skin discolouration, vomiting. Valpakine dosage: N/A.

Convulsion, Inappropriate Affect, Insomnia, Product Odour Abnormal, Product Quality Issue (6742860-5)
Patient was taking Valpakine. Patient felt the following Valpakine side effects: convulsion, inappropriate affect, insomnia, product odour abnormal, product quality issue on May 21, 2010 from FRANCE Additional patient health information: Male , 19 years of age, was diagnosed with
  • convulsion
and. Valpakine dosage: N/A.

Anaemia Macrocytic, Hypoalbuminaemia, Hyponatraemia, Thrombocytopenia, Vitamin B12 Deficiency (6674821-9)
Adverse event was reported on Apr 01, 2010 by a Male taking Valpakine (Dosage: N/A) was diagnosed with
  • infantile spasms
and. Location: FRANCE , child 4 years of age, After Valpakine was administered, patient encountered several Valpakine side effects: anaemia macrocytic, hypoalbuminaemia, hyponatraemia, thrombocytopenia, vitamin b12 deficiency.
Multiple concurrent drugs taken:
  • Clobazam
Patient was hospitalized.

Anaemia Macrocytic, Hypoalbuminaemia, Hyponatraemia, Thrombocytopenia, Vitamin B12 Deficiency (6663744-7)
on Mar 23, 2010 Male from FRANCE , child 4 years of age, was diagnosed with
  • epilepsy
and was treated with Valpakine. Directly after, patient experienced the unwanted or unexpected Valpakine side effects: anaemia macrocytic, hypoalbuminaemia, hyponatraemia, thrombocytopenia, vitamin b12 deficiency. Valpakine dosage: N/A.
Associated medications used:
  • Clobazam
Patient was hospitalized.

Convulsion, Product Quality Issue, Speech Disorder (6637776-9)
on Mar 09, 2010 Male from FRANCE , 52 years of age, was diagnosed with
  • convulsion
and was treated with Valpakine. Patient felt the following Valpakine side effects: convulsion, product quality issue, speech disorder. Valpakine dosage: N/A.

Convulsion, Product Quality Issue (6637775-7)
Patient was taking Valpakine. After Valpakine was administered, patient encountered several Valpakine side effects: convulsion, product quality issue on Mar 09, 2010 from FRANCE Additional patient health information: Female , 17 years of age, was diagnosed with
  • convulsion
and. Valpakine dosage: N/A.
Multiple concurrent drugs taken:
  • Hidantal
  • Clonazepam


Skin Lesion, Stevens-johnson Syndrome, Visual Acuity Reduced (6612835-5)
Adverse event was reported on Feb 25, 2010 by a Male taking Valpakine (Dosage: N/A) was diagnosed with
  • convulsion
and. Location: FRANCE , 13 years of age, Directly after, patient experienced the unwanted or unexpected Valpakine side effects: skin lesion, stevens-johnson syndrome, visual acuity reduced.
Associated medications used:
  • Acetylsalicylic Acid
  • Tegretol
Patient was hospitalized and became disabled.

Convulsion, Inappropriate Affect, Insomnia, Product Odour Abnormal, Product Quality Issue (6580527-7)
on Feb 02, 2010 Male from FRANCE , 19 years of age, was diagnosed with
  • convulsion
and was treated with Valpakine. Patient felt the following Valpakine side effects: convulsion, inappropriate affect, insomnia, product odour abnormal, product quality issue. Valpakine dosage: N/A.

Convulsion, Headache, Product Quality Issue, Product Taste Abnormal, Skin Discolouration, Vomiting (6579509-0)
on Feb 03, 2010 Female from FRANCE , child 7 years of age, was diagnosed with
  • convulsion
and was treated with Valpakine. After Valpakine was administered, patient encountered several Valpakine side effects: convulsion, headache, product quality issue, product taste abnormal, skin discolouration, vomiting. Valpakine dosage: N/A.

Accidental Overdose, Agitation, Irritability (6552416-5)
Patient was taking Valpakine. Directly after, patient experienced the unwanted or unexpected Valpakine side effects: accidental overdose, agitation, irritability on Jan 19, 2010 from FRANCE Additional patient health information: Male , child 2 years of age, . Valpakine dosage: N/A. Patient was hospitalized.

Decreased Appetite, Weight Decreased (6543741-2)
Adverse event was reported on Jan 12, 2010 by a Male taking Valpakine (Dosage: N/A) was diagnosed with
  • epilepsy
and. Location: FRANCE , 21 years of age, weighting 110.2 lb, Patient felt the following Valpakine side effects: decreased appetite, weight decreased.
Multiple prescriptions taken:
  • Gardenal
  • Carbamazepine


Convulsion, Petit Mal Epilepsy (6543549-8)
on Jan 11, 2010 Male from FRANCE , child 6 years of age, was diagnosed with
  • convulsion
and was treated with Valpakine. After Valpakine was administered, patient encountered several Valpakine side effects: convulsion, petit mal epilepsy. Valpakine dosage: N/A.
Multiple concurrent drugs taken:
  • Urbanil
  • Lamotrigine
Patient was hospitalized.

Dermatitis Bullous, Hypersensitivity (5000575-8)
on May 04, 2006 Female from FRANCE , 65 years of age, was diagnosed with
  • convulsion prophylaxis
and was treated with Valpakine. Directly after, patient experienced the unwanted or unexpected Valpakine side effects: dermatitis bullous, hypersensitivity. Valpakine dosage: N/A.
Associated medications used:
  • Phenytoin
  • Phenobarbital Tab
Patient was hospitalized.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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