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Zonegran (Zonisamide) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Zonegran (Zonisamide) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (101)
Death (6)
Life Threatening Events (4)
Disability (1)

Reports by Reaction Type

Rash (11)Convulsion (11)Agitation (8)Foetal Exposure During Pregnancy (6)Drug Interaction (6)Fatigue (6)Confusional State (5)Drug Ineffective (5)Chest Pain (5)Vomiting (5)Maternal Exposure During Pregnancy (5)Tremor (5)

Below are a few examples of reports where side effects / adverse reactions may be related to Zonegran (Zonisamide). For a complete list or a specific selection of reports, please use the links above.

Possible Zonegran side effects in female

Reported by a individual with unspecified qualification on 2012-08-21

Patient: female

Reactions: Product Substitution Issue, Anticonvulsant Drug Level Decreased

Drug(s) suspected as cause:
Zonegran



Possible Zonegran side effects in 35 year old female

Reported by a physician from Norway on 2012-08-21

Patient: 35 year old female, weighing 45.0 kg (99.0 pounds)

Reactions: Psychotic Disorder, Drug Interaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zonegran

Other drugs received by patient possibly interacting with the suspect drug:
Topiramate
    Indication: Epilepsy
    Start date: 2009-09-01
    End date: 2012-05-01

Other drugs received by patient: Phenobarbital TAB; Karbamazepin; Clonazepam; Levetriazetam; Lamotrigine; Valproate Sodium; Nitrozepam



Possible Zonegran side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: female

Reactions: Confusional State, Agitation, Nightmare, Drug Ineffective, Hyperglycaemia, Rash, Toxicity To Various Agents, Convulsion, Tremor, Weight Increased, Bipolar Disorder, Chest Pain

Drug(s) suspected as cause:
Trileptal

Tizanidine Hydrochloride
    Indication: Migraine

Depakote

Darvocet-N 50

Skelaxin

Prozac

Paxil

Lunesta

Beta Blocking Agents

Topamax

Zonegran

Valium
    Indication: Agitation

Reglan

Abilify

Elavil

Zyprexa

Tegretol

Requip

MAO Inhibitors

Remeron

Buspar

Adderall

Erythromycin

Ritalin

Effexor

Sumatriptan

Wellbutrin

Tofranil

Zoloft

Daytrana

Antidepressants

Steroids NOS

Desyrel

Neurontin

Sinequan

Seroquel

Pamelor

Other drugs received by patient: Aspirin; Vitamin B-Complex, Other Combinations; Ensure; Caltrate +D; ONE A DAY



Possible Zonegran side effects in 35 year old female

Reported by a physician on 2012-08-06

Patient: 35 year old female, weighing 45.0 kg (99.0 pounds)

Reactions: Psychotic Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zonegran

Other drugs received by patient possibly interacting with the suspect drug:
Topiramate
    Indication: Epilepsy
    Start date: 2009-09-01
    End date: 2012-05-01

Other drugs received by patient: Levetriazetam; Lamotrigine; Clonazepam; Nitrozepam; Valproate Sodium; Karbamazepin; Phenobarbital TAB



Possible Zonegran side effects in 27 year old female

Reported by a physician from Spain on 2012-08-03

Patient: 27 year old female

Reactions: Thinking Abnormal, Restlessness, Dizziness, Salivary Hypersecretion, Depressed Mood

Drug(s) suspected as cause:
Zonegran



Possible Zonegran side effects in 10 year old male

Reported by a physician from Germany on 2012-08-02

Patient: 10 year old male

Reactions: Drug Interaction, Thrombocytopenia

Drug(s) suspected as cause:
Zonegran

Other drugs received by patient possibly interacting with the suspect drug:
Valproate Sodium
    Dosage: 40 mg/kg
    Start date: 2004-01-01



Possible Zonegran side effects in 20 year old male

Reported by a physician from Spain on 2012-08-02

Patient: 20 year old male

Reactions: Pneumonia, Respiratory Failure, Aplastic Anaemia, Pancytopenia, Respiratory Tract Infection, Septic Shock

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Zonegran

Other drugs received by patient: Depakene; Keppra; Rivotril



Possible Zonegran side effects in 57 year old female

Reported by a physician from Spain on 2012-08-02

Patient: 57 year old female

Reactions: Brugada Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zonegran
    Dosage: 150 mg 1 in 2 days
    Administration route: Oral
    Start date: 2005-01-01

Lamotrigine
    Dosage: 250 mg, 1 in 2 days
    Administration route: Oral
    Indication: Epilepsy
    Start date: 1996-01-01

Zonegran
    Dosage: 100 mg 1 in 2 days
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2005-01-01
    End date: 2005-01-01



Possible Zonegran side effects in 10 year old male

Reported by a physician from Germany on 2012-07-27

Patient: 10 year old male

Reactions: Drug Interaction, Thrombocytopenia

Drug(s) suspected as cause:
Zonegran

Other drugs received by patient possibly interacting with the suspect drug:
Valproate Sodium
    Dosage: 40 mg/kg
    Start date: 2004-01-01



Possible Zonegran side effects in 12 year old male

Reported by a physician from Philippines on 2012-07-24

Patient: 12 year old male, weighing 14.0 kg (30.8 pounds)

Reactions: Psychomotor Hyperactivity, Drug Interaction, Crying

Drug(s) suspected as cause:
Zonegran

Other drugs received by patient possibly interacting with the suspect drug:
Carbamazepine
    Dosage: 200 mg
    Administration route: Oral
    Start date: 2012-02-01

Zonegran
    Administration route: Oral
    Start date: 2012-06-19
    End date: 2012-06-21

Valproic Acid
    Dosage: 125 mg
    Administration route: Oral
    Start date: 2012-02-01

Levetiracetam
    Dosage: 250 mg
    Administration route: Oral
    Start date: 2012-01-01

Clonazepam
    Dosage: 0.5 mg
    Administration route: Oral
    Start date: 2012-02-01



Possible Zonegran side effects in 28 year old male

Reported by a physician from Philippines on 2012-07-23

Patient: 28 year old male

Reactions: Rash

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zonegran

Other drugs received by patient: Clopidogrel; Gliclazide; Amlodipine



Possible Zonegran side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-11

Patient: female

Reactions: Confusional State, Agitation, Nightmare, Drug Ineffective, Hyperglycaemia, Toxicity To Various Agents, Rash, Convulsion, Tremor, Weight Increased, Bipolar Disorder, Chest Pain

Drug(s) suspected as cause:
Tegretol

Requip

Neurontin

Darvocet-N 50

Remeron

Reglan

Depakote

Imitrex

Zonegran

Erythromycin

Ritalin

Sinequan

Elavil

Adderall 5

Wellbutrin

Pamelor

Prozac

Buspar

Lunesta

Trileptal

Topamax

Beta Blocking Agents

Abilify

Valium
    Indication: Agitation

Steroids NOS

Seroquel

MAO Inhibitors

Tofranil

Zoloft

Paxil

Daytrana

Effexor

Skelaxin

Antidepressants

Tizanidine Hydrochloride

Desyrel

Zyprexa

Other drugs received by patient: Vitamin B-Complex, Other Combinations; Caltrate +D; Ensure; ONE A DAY; Aspirin



Possible Zonegran side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-08

Patient: female

Reactions: Agitation, Confusional State, Nightmare, Drug Ineffective, Hyperglycaemia, Rash, Toxicity To Various Agents, Tremor, Convulsion, Weight Increased, Bipolar Disorder, Chest Pain

Drug(s) suspected as cause:
Skelaxin

Elavil

Prozac

Reglan

Tegretol

Depakote

Steroids NOS

Zonegran

MAO Inhibitors

Pamelor

Paxil

Requip

Sinequan

Abilify

Remeron

Tofranil

Buspar

Topamax

Imitrex

Darvocet-N 50

Seroquel

Tizanidine Hydrochloride

Adderall 5

Neurontin

Beta Blocking Agents

Desyrel

Zoloft

Ritalin

Trileptal

Valium
    Indication: Agitation

Lunesta

Daytrana

Erythromycin

Effexor

Antidepressants

Wellbutrin

Zyprexa

Other drugs received by patient: Aspirin; Caltrate +D; ONE A DAY; Vitamin B-Complex, Other Combinations; Ensure



Possible Zonegran side effects in 55 year old female

Reported by a physician from Portugal on 2012-06-04

Patient: 55 year old female

Reactions: Leukopenia

Drug(s) suspected as cause:
Zonegran
    Administration route: Oral

Zonegran
    Administration route: Oral
    Start date: 2011-02-01

Zonegran
    Administration route: Oral
    Indication: Essential Tremor
    Start date: 2011-02-01

Other drugs received by patient: Botulinum Toxin; Escitalopram; Espironolactone; Mysoline; Ezetimibe; Triticum AC; Boniva; Kainever



Possible Zonegran side effects in 20 year old male

Reported by a physician from Spain on 2012-05-31

Patient: 20 year old male

Reactions: Pneumonia, Respiratory Failure, Aplastic Anaemia, Pancytopenia, Septic Shock, Respiratory Tract Infection

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Zonegran

Other drugs received by patient: Depakene; Keppra; Clonazepam



Possible Zonegran side effects in male

Reported by a physician from France on 2012-05-24

Patient: male

Reactions: Nephrolithiasis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zonegran

Other drugs received by patient: Lamictal; Keppra



Possible Zonegran side effects in 25 year old male

Reported by a physician from United Kingdom on 2012-05-15

Patient: 25 year old male

Reactions: Balance Disorder, Chest Pain, Musculoskeletal Discomfort, Tremor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zonegran
    Dosage: titrated up to 125 mg bid
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2012-01-01
    End date: 2012-03-01

Zonegran
    Dosage: titrated down
    Administration route: Oral
    Start date: 2012-03-01



Possible Zonegran side effects in 25 year old male

Reported by a physician from United Kingdom on 2012-05-10

Patient: 25 year old male

Reactions: Balance Disorder, Chest Pain, Musculoskeletal Discomfort, Tremor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zonegran
    Dosage: titrated up to 125 mg bid
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2012-01-01
    End date: 2012-03-01

Zonegran
    Dosage: titrated down
    Administration route: Oral
    Start date: 2012-03-01



Possible Zonegran side effects in male

Reported by a physician from United Kingdom on 2012-05-09

Patient: male

Reactions: Drug Interaction, Convulsion

Drug(s) suspected as cause:
Zonegran

Other drugs received by patient possibly interacting with the suspect drug:
Zonegran
    Dosage: down titration to 200 mg
    Administration route: Oral

Carbamazepine
    Dosage: 800 mg total daily dose
    Indication: Epilepsy
    Start date: 2008-01-01



Possible Zonegran side effects in female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-04-30

Patient: female, weighing 3.0 kg (6.5 pounds)

Reactions: Microcephaly, Anorectal Disorder, Hypoglycaemia, Foetal Exposure During Pregnancy, Kidney Malformation, Anal Atresia, Epilepsy, Congenital Tracheomalacia

Drug(s) suspected as cause:
Clobazam
    Dosage: unk ukn, unk
    Indication: Epilepsy

Zonegran
    Dosage: unk ukn, unk
    Indication: Epilepsy

Phenobarbital TAB
    Dosage: unk ukn, unk
    Indication: Epilepsy

Carbamazepine
    Dosage: unk ukn, unk
    Indication: Epilepsy



Possible Zonegran side effects in female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-04-25

Patient: female, weighing 3.0 kg (6.5 pounds)

Reactions: Microcephaly, Anorectal Disorder, Hypoglycaemia, Foetal Exposure During Pregnancy, Kidney Malformation, Anal Atresia, Epilepsy, Congenital Tracheomalacia

Drug(s) suspected as cause:
Carbamazepine
    Dosage: unk ukn, unk
    Indication: Epilepsy

Clobazam
    Dosage: unk ukn, unk
    Indication: Epilepsy

Zonegran
    Dosage: unk ukn, unk
    Indication: Epilepsy

Phenobarbital TAB
    Dosage: unk ukn, unk
    Indication: Epilepsy



Possible Zonegran side effects in 59 year old female

Reported by a consumer/non-health professional from United States on 2012-04-18

Patient: 59 year old female

Reactions: Thrombosis, Sepsis, Blood Disorder, Cystitis, Osteopenia, Parathyroid Disorder, Cardiac Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zonegran
    Administration route: Oral
    Start date: 2004-01-01

Zonegran

Other drugs received by patient: Tizanidine HCL



Possible Zonegran side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-12

Patient: female

Reactions: LOW Birth Weight Baby, Premature Baby

Drug(s) suspected as cause:
Dilaudid
    Indication: Back Pain

Zonegran
    Indication: Convulsion

Nexium

Topiramate
    Indication: Convulsion



Possible Zonegran side effects in 52 year old male

Reported by a consumer/non-health professional from United States on 2012-04-10

Patient: 52 year old male, weighing 107.5 kg (236.5 pounds)

Reactions: Grand MAL Convulsion

Drug(s) suspected as cause:
Zonegran
    Dosage: daily dose: 200 mg
    Indication: Epilepsy
    End date: 2011-07-26

Vimpat
    Administration route: Oral
    Indication: Epilepsy

Other drugs received by patient: Genric Keppra



Possible Zonegran side effects in 16 year old female

Reported by a physician from Germany on 2012-04-10

Patient: 16 year old female, weighing 49.0 kg (107.8 pounds)

Reactions: Accidental Exposure

Drug(s) suspected as cause:
Strattera
    Dosage: 40 mg, 3 tablet, total amount: 120 mg
    Administration route: Oral

Keppra
    Dosage: 250 mg, 6 tablet, total amount: 1500 mg
    Administration route: Oral

Zonegran
    Dosage: 100 mg, 10 tablet, total amount: 1000 mg
    Administration route: Oral



Possible Zonegran side effects in female

Reported by a physician from United Kingdom on 2012-04-05

Patient: female, weighing 3.0 kg (6.5 pounds)

Reactions: Microcephaly, Anorectal Disorder, Congenital Anomaly, Hypoglycaemia, Maternal Exposure During Pregnancy, Kidney Malformation, Anal Atresia, Epilepsy, Congenital Tracheomalacia

Drug(s) suspected as cause:
Zonegran
    Dosage: unknown

Carbamazepine
    Dosage: unknown

Clobazam
    Dosage: unknown

Phenobarbital TAB
    Dosage: unknown



Possible Zonegran side effects in 36 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-29

Patient: 36 year old female, weighing 80.0 kg (176.0 pounds)

Reactions: Agitation, Fatigue, Wrong Drug Administered, Pyrexia, Somnolence, Periostitis

Drug(s) suspected as cause:
Clozapine
    Dosage: 1 df, unk
    Administration route: Oral
    Start date: 2011-07-08

Clonazepam
    Dosage: 15 drp, unk
    Administration route: Oral
    Start date: 2011-07-08

Zonegran
    Dosage: 1 df, unk
    Start date: 2011-07-08

Oxazepam
    Dosage: 1 df, unk
    Start date: 2011-07-08

Lamictal
    Dosage: 1 df, unk
    Start date: 2011-07-08

Loxapine
    Dosage: 75 drp, unk
    Administration route: Oral
    Start date: 2011-07-08

Keppra
    Dosage: 1 df, unk
    Start date: 2011-07-08

Other drugs received by patient: Lithium Carbonate; Atarax; Nozinan / NET /; Dipiperon



Possible Zonegran side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-29

Patient: male, weighing 29.5 kg (64.9 pounds)

Reactions: Product Substitution Issue, Convulsion

Drug(s) suspected as cause:
Zonegran



Possible Zonegran side effects in 12 year old male

Reported by a pharmacist from United States on 2012-03-27

Patient: 12 year old male, weighing 52.0 kg (114.4 pounds)

Reactions: Grand MAL Convulsion, Viral Infection, Vomiting, Respiratory Failure, Nausea, General Physical Health Deterioration, Neutropenia, Pyrexia, Hypogammaglobulinaemia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Zonegran

Other drugs received by patient: Lamictal



Possible Zonegran side effects in 20 year old male

Reported by a physician from Spain on 2012-03-15

Patient: 20 year old male

Reactions: Respiratory Failure, Aplastic Anaemia, Respiratory Tract Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Zonegran

Other drugs received by patient: Clonazepam; Keppra; Depakene

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