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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
on Mar 11, 2014 Female from US , 49 years of age, weighting 108.0 lb, was treated with Topiramate. Directly after, patient experienced the unwanted or unexpected Topiramate side effects: cognitive disorder, depression, suicidal ideation. Topiramate dosage: 2 Pills Twice Daily.

Priapism, Off Label Use
Patient was taking Topiramate. Patient felt the following Topiramate side effects: priapism, off label use on Mar 12, 2014 from IT Additional patient health information: Male , 22 years of age, was diagnosed with and. Topiramate dosage: N/A.
Multiple prescriptions taken:
  • Olanzapine


Granuloma Annulare, Skin Hyperpigmentation, Weight Decreased
Adverse event was reported on Mar 10, 2014 by a Female taking Topiramate (Dosage: N/A) was diagnosed with and. Location: IT , 50 years of age, After Topiramate was administered, patient encountered several Topiramate side effects: granuloma annulare, skin hyperpigmentation, weight decreased.

Granuloma Annulare, Skin Hyperpigmentation, Weight Decreased
on Mar 10, 2014 Female from IT , 50 years of age, was diagnosed with and was treated with Topiramate. Directly after, patient experienced the unwanted or unexpected Topiramate side effects: granuloma annulare, skin hyperpigmentation, weight decreased. Topiramate dosage: N/A.


Lethargy, Fatigue, Euphoric Mood, Feeling Abnormal
on Mar 11, 2014 Female from US , 15 years of age, weighting 200.8 lb, was diagnosed with and was treated with Topiramate. Patient felt the following Topiramate side effects: lethargy, fatigue, euphoric mood, feeling abnormal. Topiramate dosage: N/A.

Feeling Abnormal, Glaucoma, Visual Acuity Reduced
Patient was taking Topiramate 25mg Glenmark Pharmaceuticals. After Topiramate was administered, patient encountered several Topiramate side effects: feeling abnormal, glaucoma, visual acuity reduced on Mar 05, 2014 from US Additional patient health information: Female , 34 years of age, was diagnosed with and. Topiramate 25mg Glenmark Pharmaceuticals dosage: 1 Bid Oral.
Multiple concurrent drugs taken:
  • Sumatriptan


Angle Closure Glaucoma
Adverse event was reported on Jan 07, 2014 by a Patient taking Topiramate (Dosage: N/A) was diagnosed with and. Location: IN , 28 years of age, Directly after, patient experienced the unwanted or unexpected Topiramate side effects: angle closure glaucoma.

Choroidal Detachment, Iridocyclitis
on Jan 07, 2014 Female from IN , 38 years of age, was treated with Topiramate. Patient felt the following Topiramate side effects: choroidal detachment, iridocyclitis. Topiramate dosage: N/A.

Visual Impairment, Hallucination, Chromatopsia, Vision Blurred, Tinnitus
on Feb 24, 2014 Female from US , 33 years of age, weighting 120.0 lb, was diagnosed with and was treated with Topiramate. After Topiramate was administered, patient encountered several Topiramate side effects: visual impairment, hallucination, chromatopsia, vision blurred, tinnitus. Topiramate dosage: 3 Pills Once Daily Taken By Mouth.

Mania, Suicidal Ideation, Homicidal Ideation
Patient was taking Topiramate. Directly after, patient experienced the unwanted or unexpected Topiramate side effects: mania, suicidal ideation, homicidal ideation on Feb 26, 2014 from DE Additional patient health information: Female , 57 years of age, was diagnosed with and. Topiramate dosage: 200 Mg/day.
Associated medications used:
  • Tiagabine (40 Mg/day)
Patient was hospitalized.

Sudden Visual Loss, Eye Pain, Vomiting, Corneal Oedema
Adverse event was reported on Feb 19, 2014 by a Female taking Topiramate (Dosage: 2mg 1 Pill Qam Oral) was diagnosed with and. Location: US , 59 years of age, weighting 195.0 lb, Patient felt the following Topiramate side effects: sudden visual loss, eye pain, vomiting, corneal oedema.
Multiple prescriptions taken:
  • Losartan
  • Advair
  • Zyrtec
  • Synthroid
  • Omeprazole


Granuloma Annulare, Skin Mass, Skin Lesion, Post Inflammatory Pigmentation Change, Weight Decreased
on Feb 20, 2014 Female from IT , 50 years of age, was diagnosed with and was treated with Topiramate. After Topiramate was administered, patient encountered several Topiramate side effects: granuloma annulare, skin mass, skin lesion, post inflammatory pigmentation change, weight decreased. Topiramate dosage: 50 Mg, Unk.

Completed Suicide, Exposure Via Ingestion, Toxicity To Various Agents
on Feb 12, 2014 Female from US , 51 years of age, was treated with Topiramate. Directly after, patient experienced the unwanted or unexpected Topiramate side effects: completed suicide, exposure via ingestion, toxicity to various agents. Topiramate dosage: N/A.
Associated medications used:
  • Gabapentin (gabapentin)
  • Diltiazem
  • Metoprolol (metoprolol)
  • Bupropion (bupropion)
  • Tramadol (tramadol)
  • Oxcarbazepine (oxcarbazepine)
  • Trazodone (trazodone)
  • Diphenhydramine (diphenhydramine)


Toxicity To Various Agents
Patient was taking Topiramate (topiramate). Patient felt the following Topiramate side effects: toxicity to various agents on Feb 12, 2014 from US Additional patient health information: Female , 51 years of age, . Topiramate (topiramate) dosage: N/A.
Multiple prescriptions taken:
  • Oxycodone (oxycodone)
  • Morphine
  • Amitriptyline (amitriptyline)
  • Tramadol (tramadol)
  • Diphenhydramine (diphenhydramine)


Paraesthesia, Abdominal Distension, Thirst, Gingival Bleeding, Tooth Socket Haemorrhage, Dry Eye, Vomiting, Throat Irritation, Lacrimation Increased
Adverse event was reported on Feb 19, 2014 by a Female taking Topiramate 100mg Zydus (Dosage: 2 Pills Twice Daily Taken By Mouth) . Location: US , 18 years of age, weighting 218.0 lb, After Topiramate was administered, patient encountered several Topiramate side effects: paraesthesia, abdominal distension, thirst, gingival bleeding, tooth socket haemorrhage, dry eye, vomiting, throat irritation, lacrimation increased. Patient was hospitalized.

Toxicity To Various Agents
on Feb 12, 2014 Female from US , 34 years of age, was treated with Topiramate (topiramate). Directly after, patient experienced the unwanted or unexpected Topiramate side effects: toxicity to various agents. Topiramate (topiramate) dosage: N/A.
Associated medications used:
  • Mirtazapine (mirtazapine)
  • Methadone (methadone)
  • Heroin (diamorphine) (diamorphine)
  • Promethazine (promethazine)
  • Diphenhydramine (diphenhydramine)


Exposure Via Ingestion, Toxicity To Various Agents, Cardiac Arrest, Respiratory Arrest
on Feb 14, 2014 Female from US , 34 years of age, was treated with Topiramate. Patient felt the following Topiramate side effects: exposure via ingestion, toxicity to various agents, cardiac arrest, respiratory arrest. Topiramate dosage: N/A.

Conjunctival Hyperaemia, Conjunctival Oedema, Myopia
Patient was taking Topiramate. After Topiramate was administered, patient encountered several Topiramate side effects: conjunctival hyperaemia, conjunctival oedema, myopia on Feb 19, 2014 from PT Additional patient health information: Female , 34 years of age, was diagnosed with and. Topiramate dosage: 75 Mg, Unk.

Myopia, Retinal Tear, Angle Closure Glaucoma
Adverse event was reported on Feb 18, 2014 by a Female taking Topiramate (Dosage: N/A) was diagnosed with and. Location: US , 29 years of age, weighting 156.0 lb, Directly after, patient experienced the unwanted or unexpected Topiramate side effects: myopia, retinal tear, angle closure glaucoma.

Cardio-respiratory Arrest, Completed Suicide, Exposure Via Ingestion
on Feb 12, 2014 Male from US , 30 years of age, was treated with Topiramate (topiramate). Patient felt the following Topiramate side effects: cardio-respiratory arrest, completed suicide, exposure via ingestion. Topiramate (topiramate) dosage: N/A.
Multiple prescriptions taken:
  • Lacosamide
  • Pregabalin (pregabalin)
  • Phenytoin (phenytoin)
  • Folic Acid (folic Acid)
  • Azithromycin (azithromycin)


Toxicity To Various Agents
on Feb 11, 2014 Male from US , 41 years of age, was treated with Topiramate (topiramate). After Topiramate was administered, patient encountered several Topiramate side effects: toxicity to various agents. Topiramate (topiramate) dosage: N/A.
Multiple concurrent drugs taken:
  • Heroin (diamorphine) (diamorphine)
  • Cocaine (cocaine)
  • Diltiazem (diltiazem) (diltiazem)
  • Quinine


Respiratory Arrest, Cardiac Arrest, Exposure Via Ingestion, Toxicity To Various Agents
Patient was taking Topiramate (topiramate). Directly after, patient experienced the unwanted or unexpected Topiramate side effects: respiratory arrest, cardiac arrest, exposure via ingestion, toxicity to various agents on Feb 11, 2014 from US Additional patient health information: Female , 40 years of age, . Topiramate (topiramate) dosage: N/A.

Toxicity To Various Agents, Exposure Via Ingestion
Adverse event was reported on Feb 11, 2014 by a Male taking Topiramate (topiramate) (Dosage: N/A) . Location: US , 44 years of age, Patient felt the following Topiramate side effects: toxicity to various agents, exposure via ingestion.
Multiple prescriptions taken:
  • Olanzapine (olanzapine)
  • Heroin (diamorphine) (diamorphine) (Parenteral)
  • Methadone (methadone)
  • Cocaine (cocaine)
  • Dextromethorphan (dextromethorphan)
  • Diltiazem
  • Codeine (codeine)


Paraesthesia, Product Substitution Issue
on Feb 12, 2014 Female from US , 46 years of age, weighting 159.0 lb, was diagnosed with and was treated with Topiramate. After Topiramate was administered, patient encountered several Topiramate side effects: paraesthesia, product substitution issue. Topiramate dosage: One Tablet Twice Daily Taken By Mouth.

Status Epilepticus, Off Label Use
on Feb 14, 2014 Male from DE , 79 years of age, was diagnosed with and was treated with Topiramate. Directly after, patient experienced the unwanted or unexpected Topiramate side effects: status epilepticus, off label use. Topiramate dosage: N/A.

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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


    Track Online

  • User Sign In
  • Register to track your side effects

  • 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

    Safety Alerts, Active Ingredients, Usage Information

    Alternative TOPIRAMATE Names:TOPIRAMAT

    Active Ingredient: TOPIRAMAT

    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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