Common Gabitril Side Effects


The most commonly reported Gabitril side effects (click to view or check a box to report):

Convulsion (94)
Loss Of Consciousness (32)
Confusional State (30)
Grand Mal Convulsion (29)
Fall (26)
Dizziness (17)
Headache (17)
Tremor (16)
Status Epilepticus (15)
Abnormal Behaviour (14)
Aphasia (14)
Agitation (13)
Amnesia (12)
Overdose (12)
Aggression (11)
Somnolence (10)
Dyskinesia (10)
Speech Disorder (10)
Disorientation (10)
Coordination Abnormal (9)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Gabitril Side Effects Reported to FDA



Gabitril Side Effect Report#9778774
Dyskinesia
This is a report of a 19-year-old female patient (weight: NA) from IT, suffering from the following health symptoms/conditions: NA, who was treated with Gabitril (dosage: 4 Dosage Forms Daily;, start time:
Jul 17, 2012), combined with: NA. and developed a serious reaction and side effect(s): Dyskinesia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Gabitril treatment in female patients, resulting in Dyskinesia side effect. The patient was hospitalized.
Gabitril Side Effect Report#9744402
Migraine, Pain In Extremity, Abdominal Pain Upper
This report suggests a potential Gabitril Migraine side effect(s) that can have serious consequences. A 49-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: convulsion and used Gabitril (dosage: 8 Mg Am/10 Mg Hs) starting
Dec 01, 2013. After starting Gabitril the patient began experiencing various side effects, including: Migraine, Pain In Extremity, Abdominal Pain UpperAdditional drugs used concurrently: NA. Although Gabitril demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Migraine, may still occur.
Gabitril Side Effect Report#9633484
Convulsion, Off Label Use
This Convulsion problem was reported by a consumer or non-health professional from US. A 49-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: anxiety,fibromyalgia,migraine,insomnia. On
Aug 28, 2013 this consumer started treatment with Gabitril (dosage: 4 Milligram Daily;). The following drugs were being taken at the same time: NA. When using Gabitril, the patient experienced the following unwanted symptoms/side effects: Convulsion, Off Label UseThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Convulsion, may become evident only after a product is in use by the general population.
Gabitril Side Effect Report#9414437
Convulsion
This Convulsion side effect was reported by a pharmacist from US. A 67-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Gabitril (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Gabitril the consumer reported adverse symptoms, such as: ConvulsionThese side effects may potentially be related to Gabitril.
Gabitril Side Effect Report#9414433
Toxicity To Various Agents, Grand Mal Convulsion, Seizure Like Phenomena, Cerebral Atrophy
This is a report of a female patient (weight: NA) from US, suffering from the following health symptoms/conditions: epilepsy,hypothyroidism, who was treated with Gabitril (dosage: NA, start time: 1982), combined with:
  • Synthroid (112 Microgram Daily;)
  • Topamax (100 Milligram Daily;)
  • Singulair (10 Milligram Daily;)
  • Singulair
and developed a serious reaction and side effect(s): Toxicity To Various Agents, Grand Mal Convulsion, Seizure Like Phenomena, Cerebral Atrophy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Gabitril treatment in female patients, resulting in Toxicity To Various Agents side effect.
Gabitril Side Effect Report#9414383
Off Label Use
This report suggests a potential Gabitril Off Label Use side effect(s) that can have serious consequences. A 67-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: spinal pain,back pain and used Gabitril (dosage: 8 Milligram Daily;) starting
Oct 02, 2012. After starting Gabitril the patient began experiencing various side effects, including: Off Label UseAdditional drugs used concurrently:
  • Cymbalta (60 Milligram Daily;)
  • Asa (81 Milligram Daily;)
  • Amlodipine (10 Milligram Daily;)
  • Nabumetone (10000 Milligram Daily;)
  • Simvastatin (10 Milligram Daily;)
  • Furosemide (20 Milligram Daily;)
  • Benicar (40 Milligram Daily;)
  • Potassium (10 Milliequivalents Daily;)
Although Gabitril demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Off Label Use, may still occur.
Gabitril Side Effect Report#9220295
Unevaluable Event
This Unevaluable Event problem was reported by a physician from US. A 29-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: grand mal convulsion. On
Jun 25, 1998 this consumer started treatment with Gabitril (tiagabine) (dosage: NA). The following drugs were being taken at the same time: NA. When using Gabitril (tiagabine), the patient experienced the following unwanted symptoms/side effects: Unevaluable EventAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Unevaluable Event, may become evident only after a product is in use by the general population.
Gabitril Side Effect Report#9220266
Convulsion
This Convulsion side effect was reported by a health professional from US. A 17-year-old female patient (weight:NA) experienced the following symptoms/conditions: petit mal epilepsy.The patient was prescribed Gabitril (drug dosage: NA), which was initiated on
Jan 09, 1998. Concurrently used drugs: NA..After starting to take Gabitril the consumer reported adverse symptoms, such as: ConvulsionThese side effects may potentially be related to Gabitril.
Gabitril Side Effect Report#9220250
Status Epilepticus
This is a report of a 45-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: convulsion, who was treated with Gabitril ( Tiagabine) (dosage: 24 Mg ( 24 Mg, 1 In 1 D), Oral, start time: 199712), combined with:
  • Tegretol
and developed a serious reaction and side effect(s): Status Epilepticus after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Gabitril ( Tiagabine) treatment in female patients, resulting in Status Epilepticus side effect.
Gabitril Side Effect Report#9220243
Convulsion
This report suggests a potential Gabitril (tiagabine) Convulsion side effect(s) that can have serious consequences. A 17-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: convulsion and used Gabitril (tiagabine) (dosage: NA) starting NS. After starting Gabitril (tiagabine) the patient began experiencing various side effects, including: ConvulsionAdditional drugs used concurrently:
  • Lamictal
Although Gabitril (tiagabine) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Convulsion, may still occur.
Gabitril Side Effect Report#9220225
Convulsion, Abdominal Pain Upper
This Convulsion problem was reported by a physician from US. A 18-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: complex partial seizures. On 200608 this consumer started treatment with Gabitril ( Tiagabine) (dosage: 8 Mg ( 4 Mg, 2 In 1 D), Oral). The following drugs were being taken at the same time:
  • Zonegran
  • Tegretol Xr
When using Gabitril ( Tiagabine), the patient experienced the following unwanted symptoms/side effects: Convulsion, Abdominal Pain UpperAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Convulsion, may become evident only after a product is in use by the general population.
Gabitril Side Effect Report#9220063
Convulsion
This Convulsion side effect was reported by a physician from US. A 54-year-old female patient (weight:NA) experienced the following symptoms/conditions: partial seizures.The patient was prescribed Gabitril (tiagabine) (drug dosage: NA), which was initiated on 1998. Concurrently used drugs:
  • Phenobarbital
.After starting to take Gabitril (tiagabine) the consumer reported adverse symptoms, such as: ConvulsionThese side effects may potentially be related to Gabitril (tiagabine).
Gabitril Side Effect Report#9220048
Grand Mal Convulsion, Pyrexia, Hiccups, Vomiting, Chills
This is a report of a 56-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Gabitril (tiagabine) (dosage: NA, start time:
Mar 23, 1998), combined with:
  • Depakote
and developed a serious reaction and side effect(s): Grand Mal Convulsion, Pyrexia, Hiccups, Vomiting, Chills after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Gabitril (tiagabine) treatment in male patients, resulting in Grand Mal Convulsion side effect.
Gabitril Side Effect Report#9220037
Convulsion, Anosmia
This report suggests a potential Gabitril (tiagabine) Convulsion side effect(s) that can have serious consequences. A 62-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: convulsion and used Gabitril (tiagabine) (dosage: NA) starting
Jan 09, 1999. After starting Gabitril (tiagabine) the patient began experiencing various side effects, including: Convulsion, AnosmiaAdditional drugs used concurrently:
  • Tegretol
  • Klonopin
Although Gabitril (tiagabine) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Convulsion, may still occur.
Gabitril Side Effect Report#9220007
Convulsion, Confusional State
This Convulsion problem was reported by a consumer or non-health professional from US. A 41-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: convulsion. On
May 04, 1998 this consumer started treatment with Gabitril (tiagabine) (dosage: 1 In 1 D). The following drugs were being taken at the same time:
  • Insulin
  • Depakote
When using Gabitril (tiagabine), the patient experienced the following unwanted symptoms/side effects: Convulsion, Confusional StateAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Convulsion, may become evident only after a product is in use by the general population.
Gabitril Side Effect Report#9219998
Convulsion
This Convulsion side effect was reported by a physician from US. A 34-year-old female patient (weight:NA) experienced the following symptoms/conditions: partial seizures.The patient was prescribed Gabitril (drug dosage: 20 Mg (8 Mg, Each Am) Oral), which was initiated on
Jul 29, 1998. Concurrently used drugs:
  • Tegretol
  • Mebaral
.After starting to take Gabitril the consumer reported adverse symptoms, such as: ConvulsionThese side effects may potentially be related to Gabitril.
Gabitril Side Effect Report#9219991
Status Epilepticus, Myoclonus, Tremor
This is a report of a 10-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: convulsion, who was treated with Gabitril (dosage: 12 Mg (4 Mg, 3 In 1 D) Oral, start time:
Mar 29, 1999), combined with: NA. and developed a serious reaction and side effect(s): Status Epilepticus, Myoclonus, Tremor after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Gabitril treatment in male patients, resulting in Status Epilepticus side effect.
Gabitril Side Effect Report#8344893-4
Constipation, Respiratory Depression
This report suggests a potential Gabitril Constipation side effect(s) that can have serious consequences. A female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: myoclonic epilepsy and used Gabitril (dosage: 4 Milligram;) starting NS. After starting Gabitril the patient began experiencing various side effects, including: Constipation, Respiratory DepressionAdditional drugs used concurrently: NA.The patient was hospitalized. Although Gabitril demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Constipation, may still occur.
Gabitril Side Effect Report#8323092-6
Coordination Abnormal, Dyskinesia, Intentional Overdose, Somnolence
This Coordination Abnormal problem was reported by a health professional from Lithuania. A 61-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: completed suicide. On NS this consumer started treatment with Gabitril (dosage: NA). The following drugs were being taken at the same time:
  • Depakene
When using Gabitril, the patient experienced the following unwanted symptoms/side effects: Coordination Abnormal, Dyskinesia, Intentional Overdose, SomnolenceThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Coordination Abnormal, may become evident only after a product is in use by the general population.
Gabitril Side Effect Report#7994257-8
Multi-organ Failure, Status Epilepticus, Pneumonia Aspiration
This Multi-organ Failure side effect was reported by a physician from Germany. A 52-year-old male patient (weight:NA) experienced the following symptoms/conditions: epilepsy.The patient was prescribed Gabitril (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Tegretol-xr (Frequency :2.5 Times Every One Day Over Several Years)
  • Keppra (Over Several Years)
.After starting to take Gabitril the consumer reported adverse symptoms, such as: Multi-organ Failure, Status Epilepticus, Pneumonia AspirationThese side effects may potentially be related to Gabitril.
Gabitril Side Effect Report#7958264-3
Loss Of Consciousness, Laceration, Confusional State, Speech Disorder
This is a report of a female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Gabitril (dosage: NA, start time:
Nov 16, 2004), combined with:
  • Methadone Hcl
and developed a serious reaction and side effect(s): Loss Of Consciousness, Laceration, Confusional State, Speech Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Gabitril treatment in female patients, resulting in Loss Of Consciousness side effect.
Gabitril Side Effect Report#7955370-4
Autism, Convulsion, Dysphemia, Euphoric Mood, Weight Decreased
This report suggests a potential Gabitril Autism side effect(s) that can have serious consequences. A female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Gabitril (dosage: NA) starting
Jan 01, 1999. After starting Gabitril the patient began experiencing various side effects, including: Autism, Convulsion, Dysphemia, Euphoric Mood, Weight DecreasedAdditional drugs used concurrently: NA. Although Gabitril demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Autism, may still occur.
Gabitril Side Effect Report#7955359-5
Confusional State, Convulsion, Blood Creatine Phosphokinase Increased, Dizziness
This Confusional State problem was reported by a physician from United States. A 38-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: complex partial seizures,neuralgia. On
May 01, 1998 this consumer started treatment with Gabitril (dosage: NA). The following drugs were being taken at the same time:
  • Neurontin
  • Tegretol
When using Gabitril, the patient experienced the following unwanted symptoms/side effects: Confusional State, Convulsion, Blood Creatine Phosphokinase Increased, DizzinessAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Confusional State, may become evident only after a product is in use by the general population.
Gabitril Side Effect Report#7769987-3
Nasopharyngitis, Diabetes Mellitus, Blood Cholesterol Increased, Furuncle, Glycosuria, Hypercholesterolaemia
This Nasopharyngitis side effect was reported by a consumer or non-health professional from United States. A female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Gabitril (drug dosage: One To Two Mg), which was initiated on
Jul 07, 2003. Concurrently used drugs:
  • Zantac
  • Risperdal
  • Cymbalta
  • Seroquel (25 Mg Two Tablets Po Qam And 300 Mg One Tablet Po Qhs)
  • Clonazepam
  • Seroquel
  • Seroquel
  • Wellbutrin Sr
.After starting to take Gabitril the consumer reported adverse symptoms, such as: Nasopharyngitis, Diabetes Mellitus, Blood Cholesterol Increased, Furuncle, Glycosuria, HypercholesterolaemiaThese side effects may potentially be related to Gabitril.
Gabitril Side Effect Report#7647658-1
Psychotic Disorder, Lipoma, Vision Blurred, Amnesia, Loss Of Consciousness, Stress
This is a report of a 27-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: schizophrenia, paranoid type,depression, who was treated with Gabitril (dosage: NA, start time: NS), combined with:
  • Abilify
and developed a serious reaction and side effect(s): Psychotic Disorder, Lipoma, Vision Blurred, Amnesia, Loss Of Consciousness, Stress after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Gabitril treatment in male patients, resulting in Psychotic Disorder side effect. The patient was hospitalized.


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The appearance of Gabitril on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Gabitril Side Effects for Women?

Women Side Effects Reports
Convulsion 66
Confusional State 22
Loss Of Consciousness 19
Fall 17
Grand Mal Convulsion 16
Aphasia 12
Headache 12
Abnormal Behaviour 10
Amnesia 10
Dizziness 10

What are common Gabitril Side Effects for Men?

Men Side Effects Reports
Convulsion 27
Loss Of Consciousness 13
Grand Mal Convulsion 12
Fall 9
Status Epilepticus 9
Agitation 7
Confusional State 7
Dizziness 7
Overdose 6
Tremor 6

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    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.

    Gabitril reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    How Effective is Gabitril for You?

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    Gabitril Safety Alerts, Active Ingredients, Usage Information

    NDC 16590-832
    Type HUMAN PRESCRIPTION DRUG
    Proprietary Name GABITRIL
    Name TIAGABINE HYDROCHLORIDE
    Dosage Form TABLET
    Route ORAL
    On market since 19971103
    Labeler STAT RX USA LLC
    Active Ingredient(s) TIAGABINE HYDROCHLORIDE
    Strength(s) 12
    Unit(s) mg/1
    Pharma Class Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]

    Gabitril Dosage, Warnings, Usage.

    Side Effects reported to FDA: 224

    Gabitril safety alerts: 2005 2001

    Reported deaths: 9

    Reported hospitalizations: 115

    Gabitril (tiagabine)

    Audience: Neuropsychiatric and other healthcare professionals

    FDA and Cephalon, Inc. notified healthcare professionals and the public that a Bolded Warning has been added to the labeling for Gabitril (tiagabine) to warn prescribers of the risk of seizures in patients without epilepsy being treated with Gabitril. FDA has received reports of the occurrence of seizures in more than 30 patients prescribed Gabitril for conditions other than epilepsy. Most of these uses were in patients with psychiatric illnesses. Such off label prescribing is a common practice among physicians. Because of the risk of seizures, however, in addition to adding the Bolded Warning to product labeling, the sponsor has agreed to undertake an educational campaign, targeted to healthcare professionals and patients, in which such off-label use will be discouraged.

    [February 14, 2005 - Letter - Cephalon, Inc.]
    [February 18, 2005 - Public Health Advisory - FDA]
    [February 18, 2005 - Drug Information Page - FDA]
    [February 2005 - Label - Cephalon, Inc.]

    Latest Gabitril clinical trials