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Topiramate Side Effects

Common Topiramate Side Effects


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

Product Substitution Issue (210)
Convulsion (207)
Headache (120)
Angle Closure Glaucoma (96)
Confusional State (87)
Dizziness (79)
Somnolence (78)
Vision Blurred (74)
Migraine (73)
Paraesthesia (72)
Toxicity To Various Agents (71)
Metabolic Acidosis (70)
Myopia (67)
Weight Decreased (65)
Fatigue (65)
Nausea (62)
Condition Aggravated (61)
Depression (59)
Memory Impairment (58)
Completed Suicide (53)

➢ 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.

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.

Topiramate Side Effects Reported to FDA

The following Topiramate 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.


The appearance of Topiramate 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.
Cognitive Disorder, Depression, Suicidal Ideation
This is a report of a 49-year-old female patient (weight: NA) from US, suffering from the following symptoms/conditions: NA, who was treated with Topiramate (dosage: 2 Pills Twice Daily, start time: Feb 04, 2014), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Cognitive Disorder
  • Depression
  • Suicidal Ideation
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Topiramate treatment in female patients, resulting in cognitive disorder side effect.

Priapism, Off Label Use
This report suggests a potential Topiramate Priapism, Off Label Use side effect(s) that can have serious consequences. A 22-year-old male patient (weight: NA) from IT was diagnosed with the following symptoms/conditions: autism and used Topiramate (dosage: NA) starting NS. Soon after starting Topiramate the patient began experiencing various side effects, including:
  • Priapism
  • Off Label Use
Drugs used concurrently:
  • Olanzapine
Although Topiramate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as priapism, may still occur.

Granuloma Annulare, Skin Hyperpigmentation, Weight Decreased
This Granuloma Annulare, Skin Hyperpigmentation, Weight Decreased problem was reported by a physician from IT. A 50-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: headache,weight increased. On 201001 this consumer started treatment with Topiramate (dosage: NA). The following drugs were being taken at the same time: NA. When commencing Topiramate, the patient experienced the following unwanted symptoms/side effects:
  • Granuloma Annulare
  • Skin Hyperpigmentation
  • Weight Decreased
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as granuloma annulare, may become evident only after a product is in use by the general population.

Granuloma Annulare, Skin Hyperpigmentation, Weight Decreased
This is a report of a 50-year-old female patient (weight: NA) from IT. The patient developed the following symptoms/conditions: headache,weight increased and was treated with Topiramate (dosage: NA) starting 201001. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Granuloma Annulare
  • Skin Hyperpigmentation
  • Weight Decreased
This opens a possibility that Topiramate treatment could cause the above reactions, including granuloma annulare, and some female subjects may be more susceptible.


Lethargy, Fatigue, Euphoric Mood, Feeling Abnormal
A 15-year-old female patient (weight: NA) from US with the following symptoms/conditions: migraine started Topiramate treatment (dosage: NA) on Feb 12, 2014. Soon after starting Topiramate treatment, the subject experienced various side effects, including:
  • Lethargy
  • Fatigue
  • Euphoric Mood
  • Feeling Abnormal
Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Topiramate.

Feeling Abnormal, Glaucoma, Visual Acuity Reduced
A 34-year-old female patient from US (weight: NA) experienced symptoms, such as: migraine prophylaxis and was treated with Topiramate 25mg Glenmark Pharmaceuticals(dosage: 1 Bid Oral). The treatment was initiated on Feb 17, 2014. After that a consumer reported the following side effect(s):
  • Feeling Abnormal
  • Glaucoma
  • Visual Acuity Reduced
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Topiramate 25mg Glenmark Pharmaceuticals efficacy:
  • Sumatriptan


Angle Closure Glaucoma
In this report, Topiramate was administered for the following condition: headache.A 28-year-old consumer from IN (weight: NA) started Topiramate treatment (dosage: NA) on NS.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Angle Closure Glaucoma
A possible interaction with other drugs could have contributed to this reaction: NA.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Topiramate treatment could be related to the listed above side effect(s).

Choroidal Detachment, Iridocyclitis
This is a report of the following Topiramate side effect(s):
  • Choroidal Detachment
  • Iridocyclitis
A 38-year-old female patient from IN (weight: NA) presented with the following condition: NA and received a treatment with Topiramate (dosage: NA) starting: NS.The following concurrently used drugs could have generated interactions: NA.This report suggests that a Topiramate treatment could be associated with the listed above side effect(s).

Visual Impairment, Hallucination, Chromatopsia, Vision Blurred, Tinnitus
This Topiramate report was submitted by a 33-year-old female consumer from US (weight: NA). The patient was diagnosed with: migraine and Topiramate was administered (dosage: 3 Pills Once Daily Taken By Mouth) starting: Jan 01, 2014. The consumer developed a set of symptoms:
  • Visual Impairment
  • Hallucination
  • Chromatopsia
  • Vision Blurred
  • Tinnitus
Other drugs used simultaneously: NA.Those unexpected symptoms could be linked to a Topiramate treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Mania, Suicidal Ideation, Homicidal Ideation
This is a report of a possible correlation between Topiramate use and the following symptoms/side effect(s):
  • Mania
  • Suicidal Ideation
  • Homicidal Ideation
which could contribute to an assessment of Topiramate risk profile.A 57-year-old female consumer from DE (weight: NA) was suffering from epilepsy and was treated with Topiramate (dosage: 200 Mg/day) starting NS.Other concurrent medications:
  • Tiagabine (40 Mg/day)
The patient was hospitalized.

Sudden Visual Loss, Eye Pain, Vomiting, Corneal Oedema
A 59-year-old female patient from US (weight: NA) presented with the following symptoms: weight control and after a treatment with Topiramate (dosage: 2mg 1 Pill Qam Oral) experienced the following side effect(s):
  • Sudden Visual Loss
  • Eye Pain
  • Vomiting
  • Corneal Oedema
The treatment was started on Nov 11, 2013. Topiramate was used in combination with the following drugs:
  • Losartan
  • Advair
  • Zyrtec
  • Synthroid
  • Omeprazole
This report could alert potential Topiramate consumers.

Granuloma Annulare, Skin Mass, Skin Lesion, Post Inflammatory Pigmentation Change, Weight Decreased
In this report, a 50-year-old female patient from IT (weight: NA) was affected by a possible Topiramate side effect.The patient was diagnosed with headache. After a treatment with Topiramate (dosage: 50 Mg, Unk, start date: 201001), the patient experienced the following side effect(s):
  • Granuloma Annulare
  • Skin Mass
  • Skin Lesion
  • Post Inflammatory Pigmentation Change
  • Weight Decreased
The following simultaneously used drugs could have led to this reaction: NA.The findings here stress that side effects should be taken into consideration when evaluating a Topiramate treatment.

Completed Suicide, Exposure Via Ingestion, Toxicity To Various Agents
This is a report of a 51-year-old female patient from US (weight: NA), who used Topiramate (dosage: NA) for a treatment of NA. After starting a treatment on NS, the patient experienced the following side effect(s):
  • Completed Suicide
  • Exposure Via Ingestion
  • Toxicity To Various Agents
The following drugs could possibly have interacted with the Topiramate treatment
  • Gabapentin (gabapentin)
  • Diltiazem
  • Metoprolol (metoprolol)
  • Bupropion (bupropion)
  • Tramadol (tramadol)
  • Oxcarbazepine (oxcarbazepine)
  • Trazodone (trazodone)
  • Diphenhydramine (diphenhydramine)
Taken together, these observations suggest that a Topiramate treatment could be related to side effect(s), such as Completed Suicide, Exposure Via Ingestion, Toxicity To Various Agents.

Toxicity To Various Agents
This toxicity to various agents side effect was reported by a pharmacist from US. A 51-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA. The patient was prescribed Topiramate (topiramate) (dosage: NA), which was started on NS. Concurrently used drugs:
  • Oxycodone (oxycodone)
  • Morphine
  • Amitriptyline (amitriptyline)
  • Tramadol (tramadol)
  • Diphenhydramine (diphenhydramine)
When starting to take Topiramate (topiramate) the consumer reported the following symptoms:
  • Toxicity To Various Agents
These side effects may potentially be related to Topiramate (topiramate).

Paraesthesia, Abdominal Distension, Thirst, Gingival Bleeding, Tooth Socket Haemorrhage, Dry Eye, Vomiting, Throat Irritation, Lacrimation Increased
This is a Topiramate 100mg Zydus side effect report of a 18-year-old female patient (weight:NA) from US, suffering from the following symptoms/conditions: NA, who was treated with Topiramate 100mg Zydus (dosage:2 Pills Twice Daily Taken By Mouth, start time: NS), combined with: NA., and developed a serious reaction and a paraesthesia side effect. The patient presented with:
  • Paraesthesia
  • Abdominal Distension
  • Thirst
  • Gingival Bleeding
  • Tooth Socket Haemorrhage
  • Dry Eye
  • Vomiting
  • Throat Irritation
  • Lacrimation Increased
which developed after the beginning of treatment. The patient was hospitalized. This side effect report can indicate a possible existence of increased vulnerability to Topiramate 100mg Zydus treatment in female patients suffering from NA, resulting in paraesthesia.

Toxicity To Various Agents
This report suggests a potential Topiramate (topiramate) toxicity to various agents side effect(s) that can have serious consequences. A 34-year-old female patient from US (weight:NA) was diagnosed with the following health condition(s): NA and used Topiramate (topiramate) (dosage: NA) starting NS. Soon after starting Topiramate (topiramate) the patient began experiencing various side effects, including:
  • Toxicity To Various Agents
Drugs used concurrently:
  • Mirtazapine (mirtazapine)
  • Methadone (methadone)
  • Heroin (diamorphine) (diamorphine)
  • Promethazine (promethazine)
  • Diphenhydramine (diphenhydramine)
Although Topiramate (topiramate) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as toxicity to various agents, may still occur.

Exposure Via Ingestion, Toxicity To Various Agents, Cardiac Arrest, Respiratory Arrest
This exposure via ingestion problem was reported by a pharmacist from US. A 34-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): NA.On NS a consumer started treatment with Topiramate (dosage: NA). The following drugs/medications were being taken at the same time: NA. When commencing Topiramate, the patient experienced the following unwanted symptoms /side effects:
  • Exposure Via Ingestion
  • Toxicity To Various Agents
  • Cardiac Arrest
  • Respiratory Arrest
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as exposure via ingestion, may become evident only after a product is in use by the general population.

Conjunctival Hyperaemia, Conjunctival Oedema, Myopia
This is a Topiramate side effect report of a 34-year-old female patient (weight: NA) from PT. The patient developed the following symptoms/conditions: prophylaxis and was treated with Topiramate (dosage: 75 Mg, Unk) starting Aug 10, 2010. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
  • Conjunctival Hyperaemia
  • Conjunctival Oedema
  • Myopia
This opens a possibility that Topiramate could cause conjunctival hyperaemia and that some female patients may be more susceptible.

Myopia, Retinal Tear, Angle Closure Glaucoma
A 29-year-old female patient (weight: NA) from US with the following symptoms: migraine started Topiramate treatment (dosage: NA) on Jan 22, 2014. Soon after starting Topiramate treatment, the consumer experienced several side effects, including:
  • Myopia
  • Retinal Tear
  • Angle Closure Glaucoma
. Concurrently used drugs: NA. This finding indicates that some patients can be more vulnerable to developing Topiramate side effects, such as myopia.

Cardio-respiratory Arrest, Completed Suicide, Exposure Via Ingestion
This cardio-respiratory arrest side effect was reported by a pharmacist from US. A 30-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Topiramate (topiramate) (dosage: NA), which was started on NS. Concurrently used drugs:
  • Lacosamide
  • Pregabalin (pregabalin)
  • Phenytoin (phenytoin)
  • Folic Acid (folic Acid)
  • Azithromycin (azithromycin)
.When starting to take Topiramate (topiramate) the consumer reported symptoms, such as:
  • Cardio-respiratory Arrest
  • Completed Suicide
  • Exposure Via Ingestion
These side effects may potentially be related to Topiramate (topiramate).

Toxicity To Various Agents
This is a report of a 41-year-old male patient (weight: NA) from US, suffering from the following symptoms/conditions: NA, who was treated with Topiramate (topiramate) (dosage: NA, start time: NS), combined with:
  • Heroin (diamorphine) (diamorphine)
  • Cocaine (cocaine)
  • Diltiazem (diltiazem) (diltiazem)
  • Quinine
and developed a serious reaction and side effect(s). The consumer presented with:
  • Toxicity To Various Agents
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Topiramate (topiramate) treatment in male patients, resulting in toxicity to various agents side effect.

Respiratory Arrest, Cardiac Arrest, Exposure Via Ingestion, Toxicity To Various Agents
This report suggests a potential Topiramate (topiramate) Respiratory Arrest, Cardiac Arrest, Exposure Via Ingestion, Toxicity To Various Agents side effect(s) that can have serious consequences. A 40-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Topiramate (topiramate) (dosage: NA) starting NS. Soon after starting Topiramate (topiramate) the patient began experiencing various side effects, including:
  • Respiratory Arrest
  • Cardiac Arrest
  • Exposure Via Ingestion
  • Toxicity To Various Agents
Drugs used concurrently: NA. Although Topiramate (topiramate) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as respiratory arrest, may still occur.

Toxicity To Various Agents, Exposure Via Ingestion
This Toxicity To Various Agents, Exposure Via Ingestion problem was reported by a pharmacist from US. A 44-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Topiramate (topiramate) (dosage: NA). The following drugs were being taken at the same time:
  • Olanzapine (olanzapine)
  • Heroin (diamorphine) (diamorphine) (Parenteral)
  • Methadone (methadone)
  • Cocaine (cocaine)
  • Dextromethorphan (dextromethorphan)
  • Diltiazem
  • Codeine (codeine)
When commencing Topiramate (topiramate), the patient experienced the following unwanted symptoms/side effects:
  • Toxicity To Various Agents
  • Exposure Via Ingestion
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as toxicity to various agents, may become evident only after a product is in use by the general population.

Paraesthesia, Product Substitution Issue
This is a report of a 46-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: migraine and was treated with Topiramate (dosage: One Tablet Twice Daily Taken By Mouth) starting Apr 30, 2012. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Paraesthesia
  • Product Substitution Issue
This opens a possibility that Topiramate treatment could cause the above reactions, including paraesthesia, and some female subjects may be more susceptible.

Status Epilepticus, Off Label Use
A 79-year-old male patient (weight: NA) from DE with the following symptoms/conditions: status epilepticus started Topiramate treatment (dosage: NA) on NS. Soon after starting Topiramate treatment, the subject experienced various side effects, including:
  • Status Epilepticus
  • Off Label Use
Concurrently used drugs: NA. This finding indicates that some male patients could be more vulnerable to Topiramate.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your 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

    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.


    Discuss Topiramate Side Effects

    Did You Have a Topiramate Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Topiramate for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Topiramate Safety Alerts, Active Ingredients, Usage Information

    NDC0093-0155
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameTopiramate
    NameTopiramate
    Dosage FormTABLET
    RouteORAL
    On market since20090331
    LabelerTeva Pharmaceuticals USA Inc
    Active Ingredient(s)TOPIRAMATE
    Strength(s)25
    Unit(s)mg/1
    Pharma ClassAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]

    Topiramate Dosage, Warnings, Usage.

    Side Effects reported to FDA: 2115

    Topiramate safety alerts: 2011 2005 2003 2001

    Reported deaths: 191

    Reported hospitalizations: 589

    Topamax (topiramate): Recall - Musty Odor

    [Posted 04/15/2011]

    AUDIENCE: Risk Manager, Pharmacy, Patients

    ISSUE: Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is recalling two lots of Topamax (topiramate) 100mg Tablets. The recall stems from four consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole). While not considered to be toxic, TBA can generate an offensive odor and a small number of patients have reported temporary gastrointestinal symptoms. There have been no reported serious adverse events caused by the presence of TBA in Topamax.

    BACKGROUND: Topamax is indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures; as adjunctive therapy for adults and pediatric patients ages 2 − 16 years with partial onset seizures, or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome; and for adults for the prophylaxis of migraine headache.

    RECOMMENDATION: Patients taking Topamax 100mg Tablets who experience an uncharacteristic odor associated with their medication should return the tablets to their pharmacist, and contact their healthcare professional if they have questions.

    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

     

    [04/14/2011 - Press Release - Ortho-McNeil]

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