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Short Term Memory Confusion (35)
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Topamax Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 3419 

Hepatic Failure (8402811-4)
on May 24, 2012 Male from UNITED STATES , 15 years of age, was treated with Topamax. Directly after, patient experienced the unwanted or unexpected Topamax side effects: hepatic failure. Topamax dosage: N/A.

Cleft Palate, Cleft Lip, Tachycardia Foetal (8398001-4)
Patient was taking Topamax. Patient felt the following Topamax side effects: cleft palate, cleft lip, tachycardia foetal on May 24, 2012 from UNITED STATES Additional patient health information: Female , weighting 6.00 lb, was diagnosed with
  • foetal exposure during pregnancy
and. Topamax dosage: N/A.
Multiple prescriptions taken:
  • Vitamin K Tab
  • Amoxil
  • Augmentin
  • Bicitra
  • Zithromax
  • Primacare
  • Phenergan
  • Zantac
Patient was hospitalized.

Laryngeal Cleft (8396592-0)
Adverse event was reported on May 24, 2012 by a Female taking Topamax (Dosage: N/A) was diagnosed with
  • foetal exposure during pregnancy
and. Location: UNITED STATES , weighting 6.00 lb, After Topamax was administered, patient encountered several Topamax side effects: laryngeal cleft.

Self Injurious Behaviour, Intentional Overdose (8396591-9)
on May 22, 2012 Female from ITALY , 18 years of age, was treated with Topamax. Directly after, patient experienced the unwanted or unexpected Topamax side effects: self injurious behaviour, intentional overdose. Topamax dosage: N/A.
Associated medications used:
  • Fluoxetine Hydrochloride



Feeling Abnormal, Oesophageal Ulcer (8395240-3)
on May 17, 2012 Patient from UNITED STATES , 26 years of age, was diagnosed with
  • headache
  • migraine
and was treated with Topamax. Patient felt the following Topamax side effects: feeling abnormal, oesophageal ulcer. Topamax dosage: Daily Dose 100 Mg.
Multiple prescriptions taken:
  • Aleve (caplet)
  • Tylenol (Unk Unk, Prn)


Maternal Exposure During Pregnancy (8394374-7)
Patient was taking Topamax. After Topamax was administered, patient encountered several Topamax side effects: maternal exposure during pregnancy on May 26, 2012 from PAKISTAN Additional patient health information: Female , 23 years of age, was diagnosed with
  • epilepsy
and. Topamax dosage: N/A.
Multiple concurrent drugs taken:
  • Carbamazepine


Myopia, Glaucoma (8394026-3)
Adverse event was reported on May 17, 2012 by a Female taking Topamax (Dosage: N/A) . Location: AUSTRALIA , weighting 127.9 lb, Directly after, patient experienced the unwanted or unexpected Topamax side effects: myopia, glaucoma.
Associated medications used:
  • Verapamil Hydrochloride


Self Injurious Behaviour (8390770-2)
on May 20, 2012 Female from ITALY , 36 years of age, was treated with Topamax. Patient felt the following Topamax side effects: self injurious behaviour. Topamax dosage: N/A.

Amblyopia, Astigmatism (8390509-0)
on May 19, 2012 Male from CHINA , weighting 44.09 lb, was diagnosed with
  • epilepsy
and was treated with Topamax. After Topamax was administered, patient encountered several Topamax side effects: amblyopia, astigmatism. Topamax dosage: N/A.

Overdose, Self Injurious Behaviour, Confusional State (8390506-5)
Patient was taking Topamax. Directly after, patient experienced the unwanted or unexpected Topamax side effects: overdose, self injurious behaviour, confusional state on May 18, 2012 from ITALY Additional patient health information: Female , 48 years of age, . Topamax dosage: N/A.

Polyarthritis, Femur Fracture, Neuropathy Peripheral, Osteoporosis, Abdominal Pain Upper, Type 2 Diabetes Mellitus, Fall, Spinal Deformity (8390503-X)
Adverse event was reported on May 14, 2012 by a Female taking Topamax (Dosage: N/A) was diagnosed with
  • epilepsy
and. Location: UNITED STATES , 61 years of age, weighting 270.0 lb, Patient felt the following Topamax side effects: polyarthritis, femur fracture, neuropathy peripheral, osteoporosis, abdominal pain upper, type 2 diabetes mellitus, fall, spinal deformity.
Multiple prescriptions taken:
  • Mysoline (500 Mg In The Morning And 250 Mg At Night)
  • Dilantin (300 Mg In The Morning And 200 Mg At Night)
  • Dilantin
  • Dilantin (250 Mg In The Morning And 300 Mg At Night)
Patient was hospitalized.

Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased (8390502-8)
on May 25, 2012 Female from CHINA , weighting 29.76 lb, was treated with Topamax. After Topamax was administered, patient encountered several Topamax side effects: alanine aminotransferase increased, aspartate aminotransferase increased. Topamax dosage: N/A. Patient was hospitalized.

Premature Baby (8385837-9)
on May 10, 2012 Female from SWITZERLAND , weighting 6.46 lb, was diagnosed with
  • foetal exposure during pregnancy
and was treated with Topamax. Directly after, patient experienced the unwanted or unexpected Topamax side effects: premature baby. Topamax dosage: N/A.
Associated medications used:
  • Escitalopram
  • Xenical


Injury, Pain, Cholecystitis Chronic, Appendicitis, Fear, Gallbladder Injury (8382490-5)
Patient was taking Topamax. Patient felt the following Topamax side effects: injury, pain, cholecystitis chronic, appendicitis, fear, gallbladder injury on May 16, 2012 from UNITED STATES Additional patient health information: Female , 24 years of age, weighting 195.0 lb, . Topamax dosage: N/A.
Multiple prescriptions taken:
  • Topiramate (Unk)
  • Effexor
  • Yaz (Unk)
  • Zomig
  • Fluoxetine (Unk)
  • Yaz
  • Prozac
Patient was hospitalized.

Self Injurious Behaviour, Agitation (8382420-6)
Adverse event was reported on May 11, 2012 by a Male taking Topamax (Dosage: N/A) . Location: ITALY , 34 years of age, After Topamax was administered, patient encountered several Topamax side effects: self injurious behaviour, agitation.
Multiple concurrent drugs taken:
  • Depakin
  • Xanax
  • Sodium Hypochlorite


Caesarean Section, Premature Baby, Twin Pregnancy, Premature Rupture Of Membranes (8382100-7)
on May 07, 2012 Female from UNITED STATES , weighting 5.00 lb, was diagnosed with
  • foetal exposure during pregnancy
and was treated with Topamax. Directly after, patient experienced the unwanted or unexpected Topamax side effects: caesarean section, premature baby, twin pregnancy, premature rupture of membranes. Topamax dosage: N/A.
Associated medications used:
  • Antibiotics
  • Macrobid
  • Steroids Nos


Maternal Exposure During Pregnancy, Premature Labour (8382099-3)
on May 07, 2012 Female from UNITED STATES , 37 years of age, was diagnosed with
  • epilepsy
  • urinary tract infection
and was treated with Topamax. Patient felt the following Topamax side effects: maternal exposure during pregnancy, premature labour. Topamax dosage: N/A.
Multiple prescriptions taken:
  • Macrobid
  • Steroids Nos
  • Antibiotics


Cognitive Disorder (8382098-1)
Patient was taking Topamax. After Topamax was administered, patient encountered several Topamax side effects: cognitive disorder on May 07, 2012 from UNITED STATES Additional patient health information: Female , 47 years of age, . Topamax dosage: N/A.
Multiple concurrent drugs taken:
  • Gabapentin
  • Propranolol
  • Fioricet


Coma, Self Injurious Behaviour, Hypertension, Conduct Disorder (8382097-X)
Adverse event was reported on May 08, 2012 by a Female taking Topamax (Dosage: N/A) . Location: ITALY , 49 years of age, Directly after, patient experienced the unwanted or unexpected Topamax side effects: coma, self injurious behaviour, hypertension, conduct disorder.

Epilepsy, Product Counterfeit (8381543-5)
on May 17, 2012 Male from RUSSIAN FEDERATION , child 5 years of age, was treated with Topamax. Patient felt the following Topamax side effects: epilepsy, product counterfeit. Topamax dosage: N/A.
Multiple prescriptions taken:
  • Depakene (300 Mg Daily)
  • Trileptal


Headache, Intracranial Pressure Increased (8381041-9)
on May 08, 2012 Male from UNITED STATES , weighting 107.2 lb, was treated with Topamax. After Topamax was administered, patient encountered several Topamax side effects: headache, intracranial pressure increased. Topamax dosage: Unk.
Multiple concurrent drugs taken:
  • Supprelin La
  • Prozac (Unk)
  • Norditropin (1.9 Mg)
  • Seroquel (Unk)


Eye Pain, Cholelithiasis, Speech Disorder, Weight Decreased, Ocular Hyperaemia, Acne (8379014-5)
Patient was taking Topamax. Directly after, patient experienced the unwanted or unexpected Topamax side effects: eye pain, cholelithiasis, speech disorder, weight decreased, ocular hyperaemia, acne on May 22, 2012 from UNITED STATES Additional patient health information: Male , 34 years of age, weighting 132.0 lb, was diagnosed with
  • migraine
and. Topamax dosage: 1 Once Day Po.

Visual Impairment, Body Dysmorphic Disorder, Abdominal Pain, Diarrhoea (8377655-2)
Adverse event was reported on May 15, 2012 by a Male taking Topamax (Dosage: N/A) . Location: CHINA , weighting 154.3 lb, Patient felt the following Topamax side effects: visual impairment, body dysmorphic disorder, abdominal pain, diarrhoea. Patient was hospitalized.

Slow Response To Stimuli, Asthenia, Disturbance In Attention, Fatigue (8377653-9)
on May 15, 2012 Female from CHINA , weighting 22.05 lb, was diagnosed with
  • epilepsy
and was treated with Topamax. After Topamax was administered, patient encountered several Topamax side effects: slow response to stimuli, asthenia, disturbance in attention, fatigue. Topamax dosage: N/A.

Post Herpetic Neuralgia, Condition Aggravated, Pain, Application Site Vesicles, Feeling Hot (8376020-1)
on May 04, 2012 Female from UNITED STATES , weighting 149.0 lb, was treated with Topamax. Directly after, patient experienced the unwanted or unexpected Topamax side effects: post herpetic neuralgia, condition aggravated, pain, application site vesicles, feeling hot. Topamax dosage: N/A. Patient was hospitalized.

Showing 1-25 of 3419 

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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.

Topamax Information

Alternative TOPAMAX Names:TOPIRAMAT

Active Ingredient: TOPIRAMAT

Topamax Dosage, Warnings, Usage.

Side Effects reported to FDA: 3419. View Topamax Adverse Reports

Topamax safety alerts: 2011 2005 2003 2001

Reported deaths: 108

Reported hospitalizations: 880

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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