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Topamax

Last reviewed on RxList: 1/9/2019
Topamax Side Effects Center

Last reviewed on RxList 01/09/2019

Topamax (topiramate) is an anticonvulsant prescribed for preventing epileptic seizures and migraine headaches. Topamax is available as a generic drug. Common side effects of Topamax include:

  • tiredness,
  • drowsiness,
  • dizziness,
  • nervousness,
  • numbness or tingly feeling in the hands or feet,
  • coordination problems,
  • diarrhea,
  • weight loss,
  • speech/language problems,
  • changes in vision,
  • sensory distortion,
  • loss of appetite,
  • bad taste in your mouth,
  • confusion,
  • slowed thinking,
  • trouble concentrating or paying attention,
  • memory problems,
  • and cold symptoms such as stuffy nose, sneezing, or sore throat.

Tell your doctor if you have unlikely but serious side effects of Topamax including:

  • signs of kidney stones (such as severe back/side/abdominal/groin pain, fever, chills, painful/frequent urination, bloody/pink urine);
  • unusual or sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself;
  • rapid breathing, fast/slow/irregular heartbeat, bone pain, broken bones, loss of consciousness, or unusual bleeding or bruising.

Topamax usual adult dose is 200mg twice a day. Drug interactions include acetazolamide (Diamox), methazolamide (Neptazane), dichlorphenamide (Daranide), carbamazepine (Tegretol) and phenytoin (Dilantin) and oral contraceptives. There are no adequate studies of Topamax in pregnant women and it is not known if Topamax is secreted in human breast milk. Use during pregnancy is not recommended unless the potential benefit outweighs the potential unknown risk to the fetus. Topamax passes into breast milk and may harm a nursing baby. Consult your doctor before breastfeeding.

Our Topamax Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. articles.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Topamax Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening mood symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • vision problems, blurred vision, eye pain or redness, sudden vision loss (can be permanent if not treated quickly);
  • confusion, problems with thinking or memory, trouble concentrating, problems with speech;
  • dehydration symptoms--decreased sweating, high fever, hot and dry skin;
  • signs of a kidney stone--severe pain in your side or lower back, painful or difficult urination;
  • signs of too much acid in your blood--irregular heartbeats, feeling tired, loss of appetite, trouble thinking, feeling short of breath; or
  • signs of too much ammonia in your blood--vomiting, unexplained weakness, feeling like you might pass out.

Common side effects may include:

  • dizziness, drowsiness, tired feeling, slow reactions;
  • problems with speech or memory;
  • abnormal vision;
  • numbness or tingling in your arms and legs, decreased sensation (especially in the skin);
  • changes in your sense of taste;
  • feeling nervous;
  • nausea, diarrhea, stomach pain, loss of appetite;
  • fever, weight loss; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Topamax (Topiramate)

QUESTION

If you have had a seizure, it means you have epilepsy. See Answer
Topamax Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed in more detail in other sections of the labeling:

  • Acute Myopia and Secondary Angle Closure Glaucoma [see WARNINGS AND PRECAUTIONS]
  • Visual Field Defects [see WARNINGS AND PRECAUTIONS]
  • Oligohidrosis and Hyperthermia [see WARNINGS AND PRECAUTIONS]
  • Metabolic Acidosis [see WARNINGS AND PRECAUTIONS]
  • Suicidal Behavior and Ideation [see WARNINGS AND PRECAUTIONS]
  • Cognitive/Neuropsychiatric Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Hyperammonemia and Encephalopathy (Without and With Concomitant Valproic Acid [VPA] Use) [see WARNINGS AND PRECAUTIONS]
  • Kidney Stones [see WARNINGS AND PRECAUTIONS]
  • Hypothermia with Concomitant Valproic Acid (VPA) Use [see WARNINGS AND PRECAUTIONS]

The data described in the following sections were obtained using TOPAMAX® Tablets.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the incidence of adverse reactions observed in the clinical trials of a drug cannot be directly compared to the incidence of adverse reactions in the clinical trials of another drug, and may not reflect the incidence of adverse reactions observed in practice.

Monotherapy Epilepsy

Adults 16 Years of Age and Older

The most common adverse reactions in the controlled clinical trial that occurred in adults in the 400 mg/day TOPAMAX® group and at an incidence higher (≥ 10 %) than in the 50 mg/day group were: paresthesia, weight loss and anorexia (see Table 5).

Approximately 21% of the 159 adult patients in the 400 mg/day group who received TOPAMAX® as monotherapy in the controlled clinical trial discontinued therapy due to adverse reactions. The most common (≥ 2% more frequent than low-dose 50 mg/day TOPAMAX®) adverse reactions causing discontinuation were difficulty with memory, fatigue, asthenia, insomnia, somnolence, and paresthesia.

Pediatric Patients 6 to 15 Years of Age

The most common adverse reactions in the controlled clinical trial that occurred in pediatric patients in the 400 mg/day TOPAMAX® group and at an incidence higher (≥10%) than in the 50 mg/day group were fever and weight loss (see Table 5).

Approximately 14% of the 77 pediatric patients in the 400 mg/day group who received TOPAMAX® as monotherapy in the controlled clinical trial discontinued therapy due to adverse reactions. The most common (≥2% more frequent than low-dose 50 mg/day TOPAMAX®) adverse reactions resulting in discontinuation were difficulty with concentration/attention, fever, flushing, and confusion.

Table 5 presents the incidence of adverse reactions occurring in at least 3% of adult and pediatric patients treated with 400 mg/day TOPAMAX® and occurring with greater incidence than 50 mg/day TOPAMAX®.

Table 5: Adverse Reactions in the High Dose Group As Compared to the Low Dose Group, in Monotherapy Epilepsy Trials in Adult and Pediatric Patients

Body System
  Adverse Reaction
Age Group
Pediatric
(6 to 15 Years)
Adult
(Age ≥16 Years)
TOPAMAX® Daily Dosage Group (mg/day)
50 400 50 400
(N=74) % (N=77) % (N=160) % (N=159) %
Body as a Whole - General Disorders
  Asthenia 0 3 4 6
  Fever 1 12    
  Leg pain     2 3
Central & Peripheral Nervous System Disorders
  Paresthesia 3 12 21 40
  Dizziness     13 14
  Ataxia     3 4
  Hypoesthesia     4 5
  Hypertonia     0 3
  Involuntary muscle contractions 0 3    
  Vertigo 0 3    
Gastro-Intestinal System Disorders
  Constipation     1 4
  Diarrhea 8 9    
  Gastritis     0 3
  Dry mouth     1 3
Liver and Biliary System Disorders
  Increase in Gamma-GT     1 3
Metabolic and Nutritional Disorders
  Weight loss 7 17 6 17
Platelet, Bleeding & Clotting Disorders
  Epistaxis 0 4    
Psychiatric Disorders
  Anorexia     4 14
  Anxiety     4 6
  Cognitive problems 1 6 1 4
  Confusion 0 3    
  Depression 0 3 7 9
  Difficulty with concentration or attention 7 10 7 8
  Difficulty with memory 1 3 6 11
  Insomnia     8 9
  Decrease in libido     0 3
  Mood problems 1 8 2 5
  Personality disorder (behavior problems) 0 3    
  Psychomotor slowing     3 5
  Somnolence     10 15
Red Blood Cell Disorders
  Anemia 1 3    
Reproductive Disorders, Female
  Intermenstrual bleeding 0 3    
  Vaginal hemorrhage     0 3
Resistance Mechanism Disorders
  Infection 3 8 2 3
  Viral infection 3 6 6 8
Respiratory System Disorders
  Bronchitis 1 5 3 4
  Upper respiratory tract infection 16 18    
  Rhinitis 5 6 2 4
  Sinusitis 1 4    
Skin and Appendages Disorders
  Alopecia 1 4 3 4
  Pruritus     1 4
  Rash 3 4 1 4
  Acne     2 3
Special Senses Other, Disorders
  Taste perversion     3 5
Urinary System Disorders
  Cystitis     1 3
  Micturition frequency 0 3    
  Renal calculus     0 3
  Urinary incontinence 1 3    
Vascular (Extracardiac) Disorders
  Flushing 0 5    

Adjunctive Therapy Epilepsy

Adults 16 Years of Age and Older

In pooled controlled clinical trials in adults with partial onset seizures, primary generalized tonicclonic seizures, or Lennox-Gastaut syndrome, 183 patients received adjunctive therapy with TOPAMAX® at dosages of 200 to 400 mg/day (recommended dosage range) and 291 patients received placebo. Patients in these trials were receiving 1 to 2 concomitant antiepileptic drugs in addition to TOPAMAX® or placebo.

The most common adverse reactions in the controlled clinical trial that occurred in adult patients in the 200-400 mg/day TOPAMAX® group with an incidence higher (≥ 10 %) than in the placebo group were: dizziness, speech disorders/related speech problems, somnolence, nervousness, psychomotor slowing, and vision abnormal (Table 6).

Table 6 presents the incidence of adverse reactions occurring in at least 3% of adult patients treated with 200 to 400 mg/day TOPAMAX® and was greater than placebo incidence. The incidence of some adverse reactions (e.g., fatigue, dizziness, paresthesia, language problems, psychomotor slowing, depression, difficulty with concentration/attention, mood problems) was dose-related and much greater at higher than recommended TOPAMAX® dosing (i.e., 600 mg – 1000 mg daily) compared to the incidence of these adverse reactions at the recommended dosing (200 mg to 400 mg daily) range.

Table 6: Most Common Adverse Reactions in Pooled Placebo-Controlled, Add-On Epilepsy Trials in Adultsa

Body System
Adverse Reaction
Placebo TOPAMAX®
Dosage (mg/day)
200-400
(N=291) (N=183)
Body as a Whole-General Disorders
Fatigue 13 15
Asthenia 1 6
Back pain 4 5
Chest pain 3 4
Influenza-like symptoms 2 3
Central & Peripheral Nervous System Disorders
Dizziness 15 25
Ataxia 7 16
Speech disorders/Related speech problems 2 13
Paresthesia 4 11
Nystagmus 7 10
Tremor 6 9
Language problems 1 6
Coordination abnormal 2 4
Gait abnormal 1 3
Gastro-Intestinal System Disorders
Nausea 8 10
Dyspepsia 6 7
Abdominal pain 4 6
Constipation 2 4
Metabolic and Nutritional Disorders
Weight loss 3 9
Psychiatric Disorders
Somnolence 12 29
Nervousness 6 16
Psychomotor slowing 2 13
Difficulty with memory 3 12
Anorexia 4 10
Confusion 5 11
Difficulty with concentration/attention 2 6
Mood problems 2 4
Agitation 2 3
Aggressive reaction 2 3
Emotional lability 1 3
Cognitive problems 1 3
Breast pain 2 4
Respiratory System Disorders
Pharyngitis 2 6
Rhinitis 6 7
Sinusitis 4 5
Vision Disorders
Vision abnormal 2 13
Diplopia 5 10
a Patients in these add-on/adjunctive trials were receiving 1 to 2 concomitant antiepileptic drugs in addition to TOPAMAX® or placebo.

In controlled clinical trials in adults, 11% of patients receiving TOPAMAX® 200 to 400 mg/day as adjunctive therapy discontinued due to adverse reactions. This rate appeared to increase at dosages above 400 mg/day. Adverse reactions associated with discontinuing TOPAMAX® included somnolence, dizziness, anxiety, difficulty with concentration or attention, fatigue, and paresthesia and increased at dosages above 400 mg/day.

Pediatric Patients 2 to 15 Years of Age

In pooled, controlled clinical trials in pediatric patients (2 to 15 years of age) with partial onset seizures, primary generalized tonic-clonic seizures, or Lennox-Gastaut syndrome, 98 patients received adjunctive therapy with TOPAMAX® at dosages of 5 to 9 mg/kg/day (recommended dose range) and 101 patients received placebo.

The most common adverse reactions in the controlled clinical trial that occurred in pediatric patients in the 5 mg to 9 mg/kg/day TOPAMAX® group with an incidence higher (≥ 10 %) than in the placebo group were: fatigue and somnolence (Table 7).

Table 7 presents the incidence of adverse reactions that occurred in at least 3% of pediatric patients 2 to 15 years of age receiving 5 mg to 9 mg/kg/day (recommended dose range) of TOPAMAX® and was greater than placebo incidence.

Table 7: Adverse Reactions in Pooled Placebo-Controlled, Add-On Epilepsy Trials in Pediatric Patients 2 to 15 Years of Agea,b

Body System/
Adverse Reaction
Placebo
(N=101)
%
TOPAMAX®
(N=98)
%
Body as a Whole - General Disorders
Fatigue 5 16
Injury 13 14
Central & Peripheral Nervous System Disorders
Gait abnormal 5 8
Ataxia 2 6
Hyperkinesia 4 5
Dizziness 2 4
Speech disorders/Related speech problems 2 4
Gastro-Intestinal System Disorders
Nausea 5 6
Saliva increased 4 6
Constipation 4 5
Gastroenteritis 2 3
Metabolic and Nutritional Disorders
Weight loss 1 9
Platelet, Bleeding, & Clotting Disorders
Purpura 4 8
Epistaxis 1 4
Psychiatric Disorders
Somnolence 16 26
Anorexia 15 24
Nervousness 7 14
Personality disorder (behavior problems) 9 11
Difficulty with concentration/attention 2 10
Aggressive reaction 4 9
Insomnia 7 8
Difficulty with memory 0 5
Confusion 3 4
Psychomotor slowing 2 3
Resistance Mechanism Disorders
Infection viral 3 7
Respiratory System Disorders
Pneumonia 1 5
Skin and Appendages Disorders
Skin disorder 2 3
Urinary System Disorders
Urinary incontinence 2 4
a Patients in these add-on/adjunctive trials were receiving 1 to 2 concomitant antiepileptic drugs in addition to TOPAMAX® or placebo.
b Values represent the percentage of patients reporting a given adverse reaction. Patients may have reported more than one adverse reaction during the study and can be included in more than one adverse reaction category.

None of the pediatric patients who received TOPAMAX® adjunctive therapy at 5 to 9 mg/kg/day in controlled clinical trials discontinued due to adverse reactions.

Migraine

Adults

In the four multicenter, randomized, double-blind, placebo-controlled, parallel group migraine prophylaxis clinical trials (which included 35 pediatric patients 12 to 15 years of age), most adverse reactions occurred more frequently during the titration period than during the maintenance period.

The most common adverse reactions with TOPAMAX® 100 mg in migraine prophylaxis clinical trials of predominantly adults that were seen at an incidence higher (≥ 5 %) than in the placebo group were: paresthesia, anorexia, weight loss, taste perversion, diarrhea, difficulty with memory, hypoesthesia, and nausea (see Table 8).

Table 8 includes those adverse reactions that occurred in the placebo-controlled trials where the incidence in any TOPAMAX® treatment group was at least 3% and was greater than that for placebo patients. The incidence of some adverse reactions (e.g., fatigue, dizziness, somnolence, difficulty with memory, difficulty with concentration/attention) was dose-related and greater at higher than recommended TOPAMAX® dosing (200 mg daily) compared to the incidence of these adverse reactions at the recommended dosing (100 mg daily).

Table 8: Adverse Reactions in Pooled, Placebo-Controlled, Migraine Trials in Adultsa,b

Body System/
Adverse Reaction
Placebo
(N=445)
%
TOPAMAX® Dosage (mg/day)
50
(N=235)
%
100
(N=386)
%
Body as a Whole-General Disorders
Fatigue 11 14 15
Injury 7 9 6
Central & Peripheral Nervous System Disorders
Paresthesia 6 35 51
Dizziness 10 8 9
Hypoesthesia 2 6 7
Language problems 2 7 6
Gastro-Intestinal System Disorders
Nausea 8 9 13
Diarrhea 4 9 11
Abdominal pain 5 6 6
Dyspepsia 3 4 5
Dry mouth 2 2 3
Gastroenteritis 1 3 3
Metabolic and Nutritional Disorders
Weight loss 1 6 9
Musculoskeletal System Disorders
Arthralgia 2 7 3
Psychiatric Disorders
Anorexia 6 9 15
Somnolence 5 8 7
Difficulty with memory 2 7 7
Insomnia 5 6 7
Difficulty with concentration/attention 2 3 6
Mood problems 2 3 6
Anxiety 3 4 5
Depression 4 3 4
Nervousness 2 4 4
Confusion 2 2 3
Psychomotor slowing 1 3 2
Reproductive Disorders, Female
Menstrual disorder 2 3 2
Reproductive Disorders, Male
Ejaculation premature 0 3 0
Resistance Mechanism Disorders
Viral infection 3 4 4
Respiratory System Disorders
Upper respiratory tract infection 12 13 14
Sinusitis 4 10 6
Pharyngitis 4 5 6
Coughing 2 2 4
Bronchitis 2 3 3
Dyspnea 2 1 3
Skin and Appendages Disorders
Pruritis 2 4 2
Special Sense Other, Disorders
Taste perversion 1 15 8
Urinary System Disorders
Urinary tract infection 2 4 2
Vision Disorders
Blurred visionc 2 4 2
a Includes 35 adolescent patients age 12 to 15 years.
b Values represent the percentage of patients reporting a given adverse reaction. Patients may have reported more than one adverse reaction during the study and can be included in more than one adverse reaction category.
c Blurred vision was the most common term considered as vision abnormal. Blurred vision was an included term that accounted for >50% of reactions coded as vision abnormal, a preferred term.

Of the 1,135 patients exposed to TOPAMAX® in the adult placebo-controlled studies, 25% of TOPAMAX®-treated patients discontinued due to adverse reactions, compared to 10% of the 445 placebo-treated patients. The adverse reactions associated with discontinuing therapy in the TOPAMAX®-treated patients included paresthesia (7%), fatigue (4%), nausea (4%), difficulty with concentration/attention (3%), insomnia (3%), anorexia (2%), and dizziness (2%).

Patients treated with TOPAMAX® experienced mean percent reductions in body weight that were dose-dependent. This change was not seen in the placebo group. Mean changes of 0%, -2%, -3%, and -4% were seen for the placebo group, TOPAMAX® 50, 100, and 200 mg groups, respectively.

Pediatric Patients 12 to 17 Years of Age

In five, randomized, double-blind, placebo-controlled, parallel group migraine prophylaxis clinical trials, most adverse reactions occurred more frequently during the titration period than during the maintenance period. Among adverse reactions with onset during titration, approximately half persisted into the maintenance period.

In four, fixed-dose, double-blind migraine prophylaxis clinical trials in TOPAMAX®-treated pediatric patients 12 to 17 years of age, the most common adverse reactions with TOPAMAX® 100 mg that were seen at an incidence higher (≥5%) than in the placebo group were: paresthesia, upper respiratory tract infection, anorexia, and abdominal pain (see Table 9). Table 9 shows adverse reactions from the pediatric trial (Study 12 [see Clinical Studies]) in which 103 pediatric patients were treated with placebo or 50 mg or 100 mg of TOPAMAX®, and three predominantly adult trials in which 49 pediatric patients (12 to 17 years of age) were treated with placebo or 50 mg, 100 mg or 200 mg of TOPAMAX®. Table 9 also shows adverse reactions in pediatric patients in the controlled migraine trials when the incidence in a TOPAMAX® dose group was at least 5 % or higher and greater than the incidence of placebo. Many adverse reactions shown in Table 9 indicate a dose-dependent relationship. The incidence of some adverse reactions (e.g., allergy, fatigue, headache, anorexia, insomnia, somnolence, and viral infection) was dose-related and greater at higher than recommended TOPAMAX® dosing (200 mg daily) compared to the incidence of these adverse reactions at the recommended dosing (100 mg daily).

Table 9: Adverse Reactions in Pooled Double-Blind Migraine Prophylaxis Studies in Pediatric Patients 12 to 17 Years of Agea,b,c

Body System/
Adverse Reaction
Placebo (N=45)
%
TOPAMAX®Dosage
50 mg/day (N=46)
%
100 mg/day (N=48)
%
Body as a Whole – General Disorders
  Fatigue 7 7 8
  Fever 2 4 6
Central & Peripheral Nervous System Disorders
  Paresthesia 7 20 19
  Dizziness 4 4 6
Gastrointestinal System Disorders
  Abdominal pain 9 7 15
  Nausea 4 4 8
Metabolic and Nutritional Disorders
  Weight loss 2 7 4
Psychiatric Disorders
  Anorexia 4 9 10
  Insomnia 2 9 2
  Somnolence 2 2 6
Resistance Mechanism Disorders
  Infection viral 4 4 8
Respiratory System Disorders
  Upper respiratory tract infection 11 26 23
  Rhinitis 2 7 6
  Sinusitis 2 9 4
  Coughing 0 7 2
Special Senses Other, Disorders
  Taste perversion 2 2 6
Vision Disorders
  Conjunctivitis 4 7 4
a 35 adolescent patients aged 12 to <16 years were also included in adverse reaction assessment for adults (Tables 10 and 11)
b Incidence is based on the number of subjects experiencing at least 1 adverse event, not the number of events.
c Included studies MIG-3006, MIGR-001, MIGR-002 and MIGR-003

In the double-blind placebo-controlled studies, adverse reactions led to discontinuation of treatment in 8% of placebo patients compared with 6% of TOPAMAX®-treated patients. Adverse reactions associated with discontinuing therapy that occurred in more than one TOPAMAX®-treated patient were fatigue (1%), headache (1%), and somnolence (1%).

Increased Risk For Bleeding

TOPAMAX® is associated with an increased risk for bleeding. In a pooled analysis of placebo-controlled studies of approved and unapproved indications, bleeding was more frequently reported as an adverse reaction for TOPAMAX® than for placebo (4.5% versus 3.0% in adult patients, and 4.4% versus 2.3% in pediatric patients). In this analysis, the incidence of serious bleeding events for TOPAMAX® and placebo was 0.3% versus 0.2% for adult patients, and 0.4% versus 0% for pediatric patients.

Adverse bleeding reactions reported with TOPAMAX® ranged from mild epistaxis, ecchymosis, and increased menstrual bleeding to life-threatening hemorrhages. In patients with serious bleeding events, conditions that increased the risk for bleeding were often present, or patients were often taking drugs that cause thrombocytopenia (other antiepileptic drugs) or affect platelet function or coagulation (e.g., aspirin, nonsteroidal anti-inflammatory drugs, selective serotonin reuptake inhibitors, or warfarin or other anticoagulants).

Other Adverse Reactions Observed During Clinical Trials

Other adverse reactions seen during clinical trials were: abnormal coordination, eosinophilia, gingival bleeding, hematuria, hypotension, myalgia, myopia, postural hypotension, scotoma, suicide attempt, syncope, and visual field defect.

Laboratory Test Abnormalities

Adult Patients

In addition to changes in serum bicarbonate (i.e., metabolic acidosis), sodium chloride and ammonia, TOPAMAX® was associated with changes in several clinical laboratory analytes in randomized, double-blind, placebo-controlled studies [see WARNINGS AND PRECAUTIONS]. Controlled trials of adjunctive TOPAMAX® treatment of adults for partial onset seizures showed an increased incidence of markedly decreased serum phosphorus (6% TOPAMAX® versus 2% placebo), markedly increased serum alkaline phosphatase (3% TOPAMAX® versus 1% placebo), and decreased serum potassium (0.4 % TOPAMAX® versus 0.1 % placebo).

Pediatric Patients

In pediatric patients (1-24 months) receiving adjunctive TOPAMAX® for partial onset seizures, there was an increased incidence for an increased result (relative to normal analyte reference range) associated with TOPAMAX® (vs placebo) for the following clinical laboratory analytes: creatinine, BUN, alkaline phosphatase, and total protein, The incidence was also increased for a decreased result for bicarbonate (i.e., metabolic acidosis), and potassium with TOPAMAX® (vs placebo) [see Use In Specific Populations]. TOPAMAX® is not indicated for partial onset seizures in pediatric patients less than 2 years of age.

In pediatric patients (ranging from 6-17 years old) receiving TOPAMAX® for migraine prophylaxis, there was an increased incidence for an increased result (relative to normal analyte reference range) associated with TOPAMAX® (vs placebo) for the following clinical laboratory analytes: creatinine, BUN, uric acid, chloride, ammonia, alkaline phosphatase, total protein, platelets, and eosinophils, The incidence was also increased for a decreased result for phosphorus, bicarbonate, total white blood count, and neutrophils [see Use In Specific Populations]. TOPAMAX® is not indicated for prophylaxis of migraine headache in pediatric patients less than 12 years of age.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of TOPAMAX®. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Body as a Whole-General Disorders: oligohydrosis and hyperthermia [see WARNINGS AND PRECAUTIONS], hyperammonemia, hyperammonemic encephalopathy [see WARNINGS AND PRECAUTIONS], hypothermia with concomitant valproic acid [see WARNINGS AND PRECAUTIONS]

Gastrointestinal System Disorders: hepatic failure (including fatalities), hepatitis, pancreatitis

Skin and Appendage Disorders: bullous skin reactions (including erythema multiforme, Stevens- Johnson syndrome, toxic epidermal necrolysis), pemphigus

Urinary System Disorders: kidney stones [see WARNINGS AND PRECAUTIONS]

Vision Disorders: acute myopia, secondary angle closure glaucoma [see WARNINGS AND PRECAUTIONS], maculopathy

Hematological Disorders: decrease of the International Normalized Ratio (INR) or prothrombin time when given concomitantly with vitamin K antagonist anticoagulant medications such as warfarin.

Read the entire FDA prescribing information for Topamax (Topiramate)

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