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Gabitril (Tiagabine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Gabitril (Tiagabine) 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 (19)
Death (2)
Disability (1)

Reports by Reaction Type

Status Epilepticus (4)Convulsion (4)Drug Ineffective (3)Confusional State (2)Intentional Overdose (2)Dyskinesia (2)Fall (2)Somnolence (2)Loss of Consciousness (2)Coordination Abnormal (2)Blood Creatine Phosphokinase Increased (1)Dysmorphism (1)

Possible Gabitril side effects in 61 year old female

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: 61 year old female, weighing 77.1 kg (169.6 pounds)

Reactions: Nerve Injury, Diabetes Mellitus, Drug Ineffective, Chills, Constipation, Fall, Blood Creatinine Increased, Vomiting, Renal Disorder, Nausea, Mental Impairment, Renal Impairment, Panic Attack, Kidney Small, Blood Potassium Decreased, Arthralgia, Swelling, Dehydration, Memory Impairment, Gait Disturbance, Feeling Abnormal

Drug(s) suspected as cause:
Bextra
    Dosage: unk
    Administration route: Oral
    Indication: Arthritis
    End date: 2005-01-01

Celebrex
    Dosage: 1 df, 1x/day
    Administration route: Oral
    Indication: Arthritis
    Start date: 1999-01-01
    End date: 2002-01-01

Cymbalta
    Administration route: Oral
    Indication: Neuralgia

Gabitril
    Dosage: 10 mg, 1x/day
    Administration route: Oral
    Indication: Neuralgia

Maxzide
    Dosage: unk
    Administration route: Oral
    Indication: Hypertension

Morphine Sulfate
    Dosage: unk

Neurontin
    Dosage: 100 mg, daily
    Administration route: Oral
    Indication: Nerve Injury

Neurontin
    Dosage: 100 mg, 2x/day

Neurontin
    Dosage: 600 mg, 3x/day
    Indication: Pain

Neurontin
    Dosage: 300 mg, 2x/day

Potassium Chloride
    Dosage: unk
    Indication: Blood Potassium Decreased
    Start date: 2012-01-01

Topamax
    Dosage: unk
    Administration route: Oral
    Indication: Neuralgia

Toprol-XL
    Dosage: unk
    Administration route: Oral
    Indication: Hypertension

Zyrtec
    Dosage: 10 mg, daily
    Indication: House Dust Allergy

Other drugs received by patient: Toprol-XL; Lyrica; Lipitor; Aspirin; Norvasc



Possible Gabitril side effects in 19 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-16

Patient: 19 year old female, weighing 59.0 kg (129.7 pounds)

Reactions: Hallucination, Auditory

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gabitril



Possible Gabitril side effects in 61 year old female

Reported by a health professional (non-physician/pharmacist) from Lithuania on 2012-05-17

Patient: 61 year old female

Reactions: Intentional Overdose, Dyskinesia, Coordination Abnormal, Somnolence

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakene
    Administration route: Oral
    Indication: Completed Suicide

Gabitril
    Administration route: Oral
    Indication: Completed Suicide



Possible Gabitril side effects in male

Reported by a pharmacist from United States on 2012-05-08

Patient: male

Reactions: Rash

Drug(s) suspected as cause:
Gabitril



Possible Gabitril side effects in 61 year old female

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

Patient: 61 year old female

Reactions: Intentional Overdose, Dyskinesia, Coordination Abnormal, Somnolence

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakene
    Administration route: Oral
    Indication: Completed Suicide

Gabitril
    Administration route: Oral
    Indication: Completed Suicide



Possible Gabitril side effects in 52 year old male

Reported by a physician from Germany on 2011-12-20

Patient: 52 year old male, weighing 63.0 kg (138.6 pounds)

Reactions: Multi-Organ Failure, Pneumonia Aspiration, Drug Ineffective, Status Epilepticus

Adverse event resulted in: death

Drug(s) suspected as cause:
Gabitril
    Administration route: Oral
    Indication: Epilepsy

Keppra
    Dosage: over several years
    Administration route: Oral
    Indication: Epilepsy

Tegretol-XR
    Dosage: frequency :2.5 times every one day over several years
    Administration route: Oral
    Indication: Epilepsy

Other drugs received by patient: NO Concomitant Medication



Possible Gabitril side effects in

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-12-05

Patient:

Reactions: Convulsion

Drug(s) suspected as cause:
Gabitril



Possible Gabitril side effects in female

Reported by a physician from United States on 2011-12-05

Patient: female, weighing 61.0 kg (134.2 pounds)

Reactions: Confusional State, Speech Disorder, Laceration, Loss of Consciousness

Drug(s) suspected as cause:
Gabitril
    Administration route: Oral
    Start date: 2004-12-02
    End date: 2005-01-04

Gabitril
    Administration route: Oral
    Indication: Pain
    Start date: 2004-11-03
    End date: 2004-11-15

Gabitril
    Administration route: Oral
    Start date: 2004-11-22
    End date: 2004-12-01

Gabitril
    Administration route: Oral
    Start date: 2005-01-05
    End date: 2005-01-13

Gabitril
    Administration route: Oral
    Start date: 2004-11-16
    End date: 2004-11-21

Methadone HCL
    Administration route: Oral

Other drugs received by patient: Amitriptyline HCL; Neurontin; Vicodin



Possible Gabitril side effects in male

Reported by a consumer/non-health professional from United States on 2011-12-02

Patient: male

Reactions: Status Epilepticus

Drug(s) suspected as cause:
Gabitril

Other drugs received by patient: NOT Reported



Possible Gabitril side effects in female

Reported by a physician from United States on 2011-12-02

Patient: female

Reactions: Status Epilepticus

Drug(s) suspected as cause:
Gabitril

Other drugs received by patient: NOT Reported



Possible Gabitril side effects in male

Reported by a physician from United States on 2011-12-02

Patient: male

Reactions: Status Epilepticus

Drug(s) suspected as cause:
Gabitril

Other drugs received by patient: NOT Reported



Possible Gabitril side effects in 38 year old male

Reported by a physician from United States on 2011-12-02

Patient: 38 year old male

Reactions: Confusional State, Blood Creatine Phosphokinase Increased, Drug Ineffective, Dizziness, Convulsion

Drug(s) suspected as cause:
Gabitril

Other drugs received by patient: Neurontin; Tegretol



Possible Gabitril side effects in

Reported by a physician from United States on 2011-12-02

Patient:

Reactions: Convulsion

Drug(s) suspected as cause:
Gabitril



Possible Gabitril side effects in female

Reported by a consumer/non-health professional from United States on 2011-12-02

Patient: female, weighing 68.0 kg (149.6 pounds)

Reactions: Weight Decreased, Autism, Euphoric Mood, Dysphemia, Convulsion

Drug(s) suspected as cause:
Gabitril
    Administration route: Oral
    Start date: 1999-01-01

Gabitril
    Administration route: Oral
    Indication: Convulsion
    Start date: 1998-02-25

Gabitril
    Administration route: Oral
    Start date: 1998-06-01

Gabitril
    Administration route: Oral
    Start date: 1998-01-01
    End date: 1999-01-01

Gabitril
    Administration route: Oral

Gabitril
    Administration route: Oral
    Start date: 1999-01-01

Gabitril
    Administration route: Oral
    Start date: 1999-01-01



Possible Gabitril side effects in

Reported by a physician from United States on 2011-12-01

Patient:

Reactions: Petit MAL Epilepsy

Drug(s) suspected as cause:
Gabitril



Possible Gabitril side effects in 50 year old male

Reported by a physician from United States on 2011-11-30

Patient: 50 year old male

Reactions: Myocardial Infarction

Drug(s) suspected as cause:
Gabitril

Other drugs received by patient: Tegretol



Possible Gabitril side effects in male

Reported by a consumer/non-health professional from United States on 2011-11-21

Patient: male

Reactions: Lower Limb Fracture, Fall

Adverse event resulted in: disablity

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

Gabitril
    Administration route: Oral
    Indication: Initial Insomnia



Possible Gabitril side effects in 27 year old male

Reported by a consumer/non-health professional from United States on 2011-11-15

Patient: 27 year old male, weighing 64.0 kg (140.8 pounds)

Reactions: Psychomotor Hyperactivity, Head Injury, Increased Appetite, Pollakiuria, Logorrhoea, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Abilify
    Dosage: continued in 2006; stopped and restarted on 07oct2011(10-15mg) also taken 30mg
    Administration route: Oral
    Indication: Major Depression

Abilify
    Dosage: continued in 2006; stopped and restarted on 07oct2011(10-15mg) also taken 30mg
    Administration route: Oral
    Indication: Depression

Gabitril
    Indication: Convulsion
    Start date: 2006-01-01

Gabitril
    Indication: Mood Swings
    Start date: 2006-01-01

Lexapro
    Dosage: duration:7years ago
    Indication: Depression

Lexapro
    Dosage: duration:7years ago
    Indication: Major Depression

Other drugs received by patient: Ibuprofen



Possible Gabitril side effects in female

Reported by a physician from Denmark on 2011-10-27

Patient: female

Reactions: Dysmorphism, Congenital Hand Malformation, Maternal Exposure During Pregnancy, Congenital Foot Malformation, Heart Disease Congenital, Cerebellar Hypoplasia

Adverse event resulted in: death

Drug(s) suspected as cause:
Depakene
    Indication: Maternal Exposure During Pregnancy

Gabitril

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