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Valcote Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Convulsion, Stevens-johnson Syndrome (6810873-0)
on Jun 22, 2010 Male from VENEZUELA , 69 years of age, was diagnosed with
  • depression
  • convulsion
and was treated with Valcote R. Directly after, patient experienced the unwanted or unexpected Valcote side effects: convulsion, stevens-johnson syndrome. Valcote R dosage: 1500 Mg Daily.
Associated medications used:
  • Lamictal (75 Mg Daily)
Patient was hospitalized.

Ataxia, Confusional State, Disorientation, Dysarthria, Encephalopathy, Psychotic Disorder (6439870-4)
Patient was taking Valcote Tablets. Patient felt the following Valcote side effects: ataxia, confusional state, disorientation, dysarthria, encephalopathy, psychotic disorder on Nov 13, 2009 from CHILE Additional patient health information: Female , 42 years of age, weighting 116.8 lb, was diagnosed with
  • bipolar disorder
  • mania
  • bipolar i disorder
and. Valcote Tablets dosage: N/A. Patient was hospitalized.

Ataxia, Confusional State, Disorientation, Dysarthria, Encephalopathy, Psychotic Disorder (6437758-6)
Adverse event was reported on Nov 02, 2009 by a Female taking Valcote Tablets (Dosage: N/A) was diagnosed with
  • bipolar disorder
  • mania
and. Location: CHILE , 42 years of age, weighting 116.8 lb, After Valcote was administered, patient encountered several Valcote side effects: ataxia, confusional state, disorientation, dysarthria, encephalopathy, psychotic disorder. Patient was hospitalized.

Myopia (6337879-2)
on Aug 27, 2009 Female from ARGENTINA , 18 years of age, weighting 149.9 lb, was diagnosed with
  • impulsive behaviour
and was treated with Valcote. Directly after, patient experienced the unwanted or unexpected Valcote side effects: myopia. Valcote dosage: N/A.


Intestinal Cyst (6309017-3)
on Aug 06, 2009 Patient from ARGENTINA , 47 years of age, was treated with Valcote Tablets. Patient felt the following Valcote side effects: intestinal cyst. Valcote Tablets dosage: N/A.

Corneal Deposits, Myopia (6210926-4)
Patient was taking Valcote. After Valcote was administered, patient encountered several Valcote side effects: corneal deposits, myopia on May 22, 2009 from ARGENTINA Additional patient health information: Female , 18 years of age, weighting 149.9 lb, was diagnosed with
  • impulsive behaviour
and. Valcote dosage: N/A.

Presyncope (6184639-1)
Adverse event was reported on May 04, 2009 by a Female taking Valcote Er (Dosage: N/A) was diagnosed with
  • bipolar disorder
and. Location: FRANCE , weighting 110.2 lb, Directly after, patient experienced the unwanted or unexpected Valcote side effects: presyncope.
Associated medications used:
  • Olanzapine
Patient was hospitalized.

Convulsion (6141177-X)
on Mar 26, 2009 Patient from ARGENTINA , 25 years of age, was treated with Valcote Tablets. Patient felt the following Valcote side effects: convulsion. Valcote Tablets dosage: N/A.

Overdose, Suicide Attempt (6137489-6)
on Mar 20, 2009 Male from ARGENTINA , 39 years of age, weighting 165.3 lb, was treated with Valcote Tablets. After Valcote was administered, patient encountered several Valcote side effects: overdose, suicide attempt. Valcote Tablets dosage: N/A.
Multiple concurrent drugs taken:
  • Clonazepam
  • Lithium Carbonate
  • Lamotrigine
Patient was hospitalized.

Fatigue, Immunosuppression, Organ Failure, Pyrexia, Salivary Hypersecretion, Testis Cancer, Weight Decreased (6029501-X)
Patient was taking Valcote Tablets. Directly after, patient experienced the unwanted or unexpected Valcote side effects: fatigue, immunosuppression, organ failure, pyrexia, salivary hypersecretion, testis cancer, weight decreased on Dec 29, 2008 from ARGENTINA Additional patient health information: Male , weighting 187.4 lb, was diagnosed with
  • borderline personality disorder
and. Valcote Tablets dosage: N/A.
Associated medications used:
  • Clozapine
  • Clonazepam
  • Risperidone


Salivary Hypersecretion, Testis Cancer (5983822-5)
Adverse event was reported on Dec 03, 2008 by a Male taking Valcote Tablets (Dosage: N/A) was diagnosed with
  • borderline personality disorder
and. Location: ARGENTINA , weighting 187.4 lb, Patient felt the following Valcote side effects: salivary hypersecretion, testis cancer.
Multiple prescriptions taken:
  • Clozapine
  • Clonazepam
  • Risperidone


Salivary Hypersecretion, Testis Cancer (5976065-2)
on Nov 26, 2008 Male from ARGENTINA , weighting 187.4 lb, was diagnosed with
  • borderline personality disorder
and was treated with Valcote Tablets. After Valcote was administered, patient encountered several Valcote side effects: salivary hypersecretion, testis cancer. Valcote Tablets dosage: N/A.
Multiple concurrent drugs taken:
  • Clozapine
  • Risperidone


Presyncope (5944935-7)
on Oct 29, 2008 Female from FRANCE , weighting 110.2 lb, was diagnosed with
  • bipolar disorder
and was treated with Valcote Er. Directly after, patient experienced the unwanted or unexpected Valcote side effects: presyncope. Valcote Er dosage: N/A.
Associated medications used:
  • Olanzapine
Patient was hospitalized.

Syncope (5929341-3)
Patient was taking Valcote Er. Patient felt the following Valcote side effects: syncope on Oct 14, 2008 from ARGENTINA Additional patient health information: Female , weighting 110.2 lb, was diagnosed with
  • bipolar disorder
and. Valcote Er dosage: N/A.
Multiple prescriptions taken:
  • Olanzapine
Patient was hospitalized.

Depressed Level Of Consciousness, Dysarthria, Motor Dysfunction, Psychomotor Hyperactivity (5918992-8)
Adverse event was reported on Oct 09, 2008 by a Female taking Valcote Er (Dosage: N/A) was diagnosed with
  • bipolar disorder
  • depression
and. Location: CHILE , 25 years of age, After Valcote was administered, patient encountered several Valcote side effects: depressed level of consciousness, dysarthria, motor dysfunction, psychomotor hyperactivity. Patient was hospitalized.

Convulsion (5898185-3)
on Sep 19, 2008 Female from ARGENTINA , weighting 125.7 lb, was diagnosed with
  • cytogenetic abnormality
  • insomnia
and was treated with Valcote. Directly after, patient experienced the unwanted or unexpected Valcote side effects: convulsion. Valcote dosage: 250 Mg (8 Am) 500mg (2 Pm).
Associated medications used:
  • Melatonin


Aphasia, Hyperammonaemia, Loss Of Consciousness, Sensory Disturbance, Vomiting (5835685-6)
on Aug 01, 2008 Female from ARGENTINA , 50 years of age, weighting 110.2 lb, was diagnosed with
  • mania
  • bipolar disorder
and was treated with Valcote. Patient felt the following Valcote side effects: aphasia, hyperammonaemia, loss of consciousness, sensory disturbance, vomiting. Valcote dosage: N/A.
Multiple prescriptions taken:
  • Clonazepam
  • Fluoxetine (6/25 Mg)
  • Flumazenil
Patient was hospitalized.

Ventricular Extrasystoles (5396590-5)
Patient was taking Valcote. After Valcote was administered, patient encountered several Valcote side effects: ventricular extrasystoles on Jul 17, 2007 from ARGENTINA Additional patient health information: Female , 68 years of age, was diagnosed with
  • bipolar disorder
and. Valcote dosage: N/A.

Ventricular Extrasystoles (5275013-0)
Adverse event was reported on Mar 14, 2007 by a Female taking Valcote (Dosage: N/A) was diagnosed with
  • bipolar disorder
and. Location: ARGENTINA , 68 years of age, Directly after, patient experienced the unwanted or unexpected Valcote side effects: ventricular extrasystoles.
Associated medications used:
  • Risperidone


Amnesia, Hemianopia, Visual Acuity Reduced (4933725-X)
on Feb 24, 2006 Male from VENEZUELA , 35 years of age, was diagnosed with
  • major depression
  • hypertension
and was treated with Valcote Er. Patient felt the following Valcote side effects: amnesia, hemianopia, visual acuity reduced. Valcote Er dosage: N/A.
Multiple prescriptions taken:
  • Propranolol
  • Nimodipine
  • Lexapro


Aphasia, Hyperammonaemia, Loss Of Consciousness, Sensory Disturbance, Vomiting (4749335-3)
on Aug 01, 2005 Female from ARGENTINA , 50 years of age, weighting 110.2 lb, was diagnosed with
  • mania
  • bipolar disorder
and was treated with Valcote. After Valcote was administered, patient encountered several Valcote side effects: aphasia, hyperammonaemia, loss of consciousness, sensory disturbance, vomiting. Valcote dosage: N/A.
Multiple concurrent drugs taken:
  • Clonazepam
  • Fluoxetine (6/25 Mg)
  • Flumazenil
Patient was hospitalized.

Hyperammonaemia, Loss Of Consciousness, Sensory Disturbance (4742446-8)
Patient was taking Valcote. Directly after, patient experienced the unwanted or unexpected Valcote side effects: hyperammonaemia, loss of consciousness, sensory disturbance on Aug 01, 2005 from ARGENTINA Additional patient health information: Female , 50 years of age, was diagnosed with
  • mania
  • bipolar disorder
and. Valcote dosage: N/A.
Associated medications used:
  • Clonazepam
  • Fluoxetine
Patient was hospitalized.

Completed Suicide (4641653-2)
Adverse event was reported on Apr 13, 2005 by a Male taking Valcote Tablets (Dosage: N/A) was diagnosed with
  • bipolar disorder
and. Location: , 28 years of age, weighting 198.4 lb, Patient felt the following Valcote side effects: completed suicide.

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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.

Valcote Information

More About Valcote

Side Effects reported to FDA: 23. View Valcote Adverse Reports

Valcote safety alerts: No

Reported deaths: 1

Reported hospitalizations: 4

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