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Topiramate Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 1619 

Completed Suicide (8431827-7)
on Jun 12, 2012 Male from UNITED STATES , 64 years of age, was treated with Topiramate. Directly after, patient experienced the unwanted or unexpected Topiramate side effects: completed suicide. Topiramate dosage: N/A.
Associated medications used:
  • Diazepam
  • Verapamil Hcl


Fanconi Syndrome, Nephrocalcinosis, Hypophosphataemic Rickets (8430060-2)
Patient was taking Topiramate. Patient felt the following Topiramate side effects: fanconi syndrome, nephrocalcinosis, hypophosphataemic rickets on Jun 08, 2012 from CANADA Additional patient health information: Female , child 10 years of age, weighting 25.13 lb, was diagnosed with
  • convulsion
and. Topiramate dosage: 25 Mg A.m, 12.5 Mg P.m, 25 Mg Nocte.
Multiple prescriptions taken:
  • L-carnitine
  • Valproic Acid (125 Md A.m, 62.5 Mg P.m, 125 Mg Nocte)
  • Lansoprazole
  • Calcium Carbonate


Completed Suicide (8429663-0)
Adverse event was reported on Jun 12, 2012 by a Male taking Topiramate (Dosage: Unk) . Location: UNITED STATES , 64 years of age, After Topiramate was administered, patient encountered several Topiramate side effects: completed suicide.
Multiple concurrent drugs taken:
  • Diazepam (Unk)
  • Verapamil Hcl (Unk)


(8429621-6)
on Jun 10, 2012 Female from CANADA , 27 years of age, was treated with Topiramate. . Topiramate dosage: N/A.
Associated medications used:
  • Valproic Acid
  • Midazolam
  • Ketamine Hcl
  • Clobazam
  • Immune Globulin (human)
  • Levetiracetam
  • Magnesium
  • Oxcarbazepine



Refraction Disorder, Choroidal Effusion, Headache, Scleritis, Visual Acuity Reduced, Angle Closure Glaucoma, Vision Blurred, Toxicity To Various Agents, Intraocular Pressure Increased (8429501-6)
on May 25, 2012 Female from , 18 years of age, was diagnosed with
  • headache
and was treated with Topiramate. Patient felt the following Topiramate side effects: refraction disorder, choroidal effusion, headache, scleritis, visual acuity reduced, angle closure glaucoma, vision blurred, toxicity to various agents, intraocular pressure increased. Topiramate dosage: 1000 Mg (50 Mg, 2 In 1 D),.

Completed Suicide (8429383-2)
Patient was taking Topiramate. After Topiramate was administered, patient encountered several Topiramate side effects: completed suicide on Jun 12, 2012 from UNITED STATES Additional patient health information: Female , 38 years of age, . Topiramate dosage: N/A.
Multiple concurrent drugs taken:
  • Verapamil Hcl
  • Hydromorphone


Visual Impairment (8428337-X)
Adverse event was reported on May 29, 2012 by a Patient taking Topiramate (Dosage: N/A) was diagnosed with
  • epilepsy
and. Location: ITALY , 43 years of age, Directly after, patient experienced the unwanted or unexpected Topiramate side effects: visual impairment.

Psychomotor Hyperactivity, Aggression (8425277-7)
on May 28, 2012 Female from SPAIN , 28 years of age, was treated with Topiramate. Patient felt the following Topiramate side effects: psychomotor hyperactivity, aggression. Topiramate dosage: N/A.
Multiple prescriptions taken:
  • Quetiapine
  • Trazodone Hcl
Patient was hospitalized.

Menstruation Irregular, Fatigue, Mood Altered, Product Substitution Issue, Gastrointestinal Disorder, Abdominal Pain, Product Quality Issue, Gastric Ulcer (8421099-1)
on Jun 04, 2012 Female from UNITED STATES , 21 years of age, weighting 149.0 lb, was diagnosed with
  • migraine
and was treated with Topiramate. After Topiramate was administered, patient encountered several Topiramate side effects: menstruation irregular, fatigue, mood altered, product substitution issue, gastrointestinal disorder, abdominal pain, product quality issue, gastric ulcer. Topiramate dosage: N/A. Patient was hospitalized.

Eye Pain, Vision Blurred, Myopia, Glaucoma (8417966-5)
Patient was taking Topiramate. Directly after, patient experienced the unwanted or unexpected Topiramate side effects: eye pain, vision blurred, myopia, glaucoma on May 31, 2012 from UNITED STATES Additional patient health information: Female , 46 years of age, . Topiramate dosage: 1 Tablet Twice Daily Po.

Convulsion, Hypoaesthesia (8416556-8)
Adverse event was reported on Jun 04, 2012 by a Male taking Topiramate (Dosage: N/A) was diagnosed with
  • convulsion
and. Location: GERMANY , 70 years of age, Patient felt the following Topiramate side effects: convulsion, hypoaesthesia.
Multiple prescriptions taken:
  • Promacta


Amnesia, Paraesthesia, Abnormal Behaviour, Aggression, Visual Impairment, Weight Decreased, Dizziness (8416361-2)
on May 28, 2012 Female from FRANCE , 27 years of age, was diagnosed with
  • migraine prophylaxis
and was treated with Topiramate. After Topiramate was administered, patient encountered several Topiramate side effects: amnesia, paraesthesia, abnormal behaviour, aggression, visual impairment, weight decreased, dizziness. Topiramate dosage: N/A.

Suicide Attempt, Fatigue (8409988-5)
on May 21, 2012 Male from GERMANY , 50 years of age, was treated with Topiramate. Directly after, patient experienced the unwanted or unexpected Topiramate side effects: suicide attempt, fatigue. Topiramate dosage: N/A.
Associated medications used:
  • Citalopram Hydrobromide
  • Mirtazapine
  • Ubretid
  • Citalopram Hydrobromide
  • Lorazepam
  • Duloxetime Hydrochloride
  • Ubretid
  • Pregabalin
Patient was hospitalized.

Metamorphopsia (8409459-6)
Patient was taking Topiramate. Patient felt the following Topiramate side effects: metamorphopsia on May 22, 2012 from BRAZIL Additional patient health information: Female , 33 years of age, was diagnosed with
  • migraine
and. Topiramate dosage: 25 Mg/day.

Somnolence, Amnesia (8405849-6)
Adverse event was reported on Jun 01, 2012 by a Male taking Topiramate (Dosage: Unk) . Location: UNITED STATES , weighting 210.0 lb, After Topiramate was administered, patient encountered several Topiramate side effects: somnolence, amnesia.
Multiple concurrent drugs taken:
  • Simvastatin (Unk)
  • Flomax (Unk)
  • Lyrica
  • Lyrica (100 Mg, 3x/day)
  • Propranolol (Unk)
  • Primidone (Unk)
  • Cymbalta (Unk)


Status Epilepticus (8401500-X)
on May 15, 2012 Female from TURKEY , child 10 years of age, was diagnosed with
  • partial seizures
and was treated with Topiramate. Directly after, patient experienced the unwanted or unexpected Topiramate side effects: status epilepticus. Topiramate dosage: 200 Mg.
Associated medications used:
  • Levetiracetam (1750 Mg)
  • Carbamazepine (600 Mg)
  • Onfi (25 Mg)
Patient was hospitalized.

Photophobia, Headache, Visual Impairment (8401456-X)
on May 30, 2012 Female from UNITED STATES , 44 years of age, weighting 228.0 lb, was diagnosed with
  • convulsion
and was treated with Topiramate. Patient felt the following Topiramate side effects: photophobia, headache, visual impairment. Topiramate dosage: 75 Mg Day Po.

Maculopathy, Choroidal Effusion, Angle Closure Glaucoma, Toxicity To Various Agents (8398321-3)
Patient was taking Topiramate. After Topiramate was administered, patient encountered several Topiramate side effects: maculopathy, choroidal effusion, angle closure glaucoma, toxicity to various agents on May 15, 2012 from Additional patient health information: Female , 25 years of age, was diagnosed with
  • headache
and. Topiramate dosage: N/A.

Maculopathy, Angle Closure Glaucoma, Choroidal Effusion, Toxicity To Various Agents (8398220-7)
Adverse event was reported on May 15, 2012 by a Female taking Topiramate (Dosage: N/A) was diagnosed with
  • migraine
and. Location: , 20 years of age, Directly after, patient experienced the unwanted or unexpected Topiramate side effects: maculopathy, angle closure glaucoma, choroidal effusion, toxicity to various agents.

Depressed Mood, Lethargy, Aggression, Memory Impairment, Night Sweats (8395992-2)
on May 15, 2012 Male from UNITED KINGDOM , 63 years of age, was treated with Topiramate. Patient felt the following Topiramate side effects: depressed mood, lethargy, aggression, memory impairment, night sweats. Topiramate dosage: 100 Mg, Bid Dose Gradually Reduced Down To 25mg Twice A Day And Discontinued..
Multiple prescriptions taken:
  • Lidocaine (15 Ml, Q1h (initially 15ml/hr, Increased To 30ml/hr))
  • Lamotrgine (250 Mg, Bid - Gradually Decrease Lamotrigine)
  • Tamsulosin Hcl
  • Adalat Cc
  • Atorvastatin Calcium
  • Ranitidine


Renal Tubular Acidosis (8395990-9)
on May 15, 2012 Female from SWITZERLAND , 42 years of age, was diagnosed with
  • migraine
and was treated with Topiramate. After Topiramate was administered, patient encountered several Topiramate side effects: renal tubular acidosis. Topiramate dosage: Unk.

Face Injury, Joint Injury, Injection Site Erythema, Sjogren's Syndrome, Fall (8394301-2)
Patient was taking Topiramate. Directly after, patient experienced the unwanted or unexpected Topiramate side effects: face injury, joint injury, injection site erythema, sjogren's syndrome, fall on May 22, 2012 from UNITED STATES Additional patient health information: Female , weighting 145.5 lb, . Topiramate dosage: N/A.
Associated medications used:
  • Cymbalta
  • Rebif
  • Nuvigil
  • Oxycontin


Pulmonary Embolism (8391040-9)
Adverse event was reported on May 21, 2012 by a Female taking Topiramate (Dosage: 25 Mg, Bid) was diagnosed with
  • migraine
and. Location: UNITED STATES , 37 years of age, weighting 155.0 lb, Patient felt the following Topiramate side effects: pulmonary embolism.
Multiple prescriptions taken:
  • Dilaudid
  • Zolpidem (10 Mg, Take One Tablet At Bedtime As Needed)
  • Bupropion Hcl (300 Mg, Qd)
  • Lorazepam (0.5 Mg, Take One Tablet Twice Daily As Needed)
  • Yaz
  • Propranolol (10 Mg, Daily As Needed)
Patient was hospitalized.

Self Injurious Behaviour (8390508-9)
on May 19, 2012 Female from ITALY , 52 years of age, was treated with Topiramate. After Topiramate was administered, patient encountered several Topiramate side effects: self injurious behaviour. Topiramate dosage: N/A.

Cardiac Disorder, Dyspnoea (8390504-1)
on May 16, 2012 Male from FRANCE , weighting 200.6 lb, was diagnosed with
  • epilepsy
and was treated with Topiramate. Directly after, patient experienced the unwanted or unexpected Topiramate side effects: cardiac disorder, dyspnoea. Topiramate dosage: The Start Date Was More Than 15 Years.

Showing 1-25 of 1619 

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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.

Topiramate Information

Alternative TOPIRAMATE Names:TOPIRAMAT

Active Ingredient: TOPIRAMAT

Topiramate Dosage, Warnings, Usage.

Side Effects reported to FDA: 1619. View Topiramate Adverse Reports

Topiramate safety alerts: 2011 2005 2003 2001

Reported deaths: 126

Reported hospitalizations: 445

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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