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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