What is Topamax (topiramate)?
Topamax (topiramate) is an anticonvulsant (antiepileptic drug) used alone or with other medications to prevent and control seizures (epilepsy). Topamax is also used to prevent migraine headaches and decrease how often they occur. Topamax will not treat a migraine headache once it occurs.
Common side effects of Topamax include:
- tiredness,
- drowsiness,
- dizziness,
- loss of coordination,
- tingling of the hands/feet,
- loss of appetite,
- bad taste in the mouth,
- diarrhea,
- weight loss,
- confusion,
- slowed thinking,
- trouble concentrating or paying attention,
- nervousness,
- memory problems, and
- speech or language problems.
Serious side effects of Topamax include:
- signs of kidney stones (such as severe back/side/abdominal/groin pain, fever, chills, painful or frequent urination, bloody/pink urine).
Anticonvulsants such as Topamax may rarely cause:
- depression,
- suicidal thoughts/attempts, or
- other mental/mood problems.
Drug interactions of Topamax include hormonal birth control products (such as pills, patch, ring); Topamax can decrease their effectiveness.
Combining Topamax with other products that cause drowsiness can increase the sedative effects, including:
During pregnancy, Topamax should be used only when clearly needed. It may harm a fetus. If you are taking Topamax to treat seizures, note that untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, so do not stop taking Topamax unless directed by your doctor.
Topamax passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.
What are the important side effects of Topamax (topiramate)?
The most common side effects of topiramate are:
- tiredness,
- dizziness,
- coordination problems,
- nervousness,
- nausea,
- weight loss,
- confusion,
- speech problems,
- changes in vision or
- double vision,
- tingling or prickling sensation in hands and feet,
- difficulty with memory, and
- sensory distortion.
Other important side effects include:
- increased ammonia levels,
- metabolic acidosis,
- kidney stones,
- decreased sweating, and
- increased body temperature.
Topamax (topiramate) side effects list for healthcare professionals
The following serious adverse reactions are discussed in more detail in other sections of the labeling:
- Acute Myopia and Secondary Angle Closure Glaucoma
- Visual Field Defects
- Oligohidrosis and Hyperthermia
- Metabolic Acidosis
- Suicidal Behavior and Ideation
- Cognitive/Neuropsychiatric Adverse Reactions
- Hyperammonemia and Encephalopathy (Without and With Concomitant Valproic Acid [VPA] Use)
- Kidney Stones
- Hypothermia with Concomitant Valproic Acid (VPA) Use
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) 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.
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). 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. 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, hyperammonemia, hyperammonemic encephalopathy, hypothermia with concomitant valproic acid
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
Vision Disorders: acute myopia, secondary angle closure glaucoma, 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.
What drugs interact with Topamax (topiramate)?
Antiepileptic Drugs
Concomitant administration of phenytoin or carbamazepine with Topamax resulted in a clinically significant decrease in plasma concentrations of topiramate when compared to Topamax given alone. A dosage adjustment may be needed.
Concomitant administration of valproic acid and Topamax has been associated with hypothermia and hyperammonemia with and without encephalopathy. Examine blood ammonia levels in patients in whom the onset of hypothermia has been reported.
CNS Depressants
Concomitant administration of Topamax and alcohol or other CNS depressant drugs has not been evaluated in clinical studies. Because of the potential of topiramate to cause CNS depression, as well as other cognitive and/or neuropsychiatric adverse reactions, Topamax should be used with extreme caution if used in combination with alcohol and other CNS depressants.
Oral Contraceptives
The possibility of decreased contraceptive efficacy and increased breakthrough bleeding may occur in patients taking combination oral contraceptive products with Topamax. Patients taking estrogen-containing contraceptives should be asked to report any change in their bleeding patterns. Contraceptive efficacy can be decreased even in the absence of breakthrough bleeding.
Lithium
An increase in systemic exposure of lithium following Topamax doses of up to 600 mg/day can occur. Lithium levels should be monitored when co-administered with high-dose Topamax.
Other Carbonic Anhydrase Inhibitors
Concomitant use of topiramate, a carbonic anhydrase inhibitor, with any other carbonic anhydrase inhibitor (e.g., zonisamide or acetazolamide) may increase the severity of metabolic acidosis and may also increase the risk of kidney stone formation. Therefore, patients given Topamax concomitantly with another carbonic anhydrase inhibitor should be monitored particularly closely for the appearance or worsening of metabolic acidosis.
Hydrochlorothiazide (HCTZ)
Topiramate Cmax and AUC increased when HCTZ was added to Topamax. The clinical significance of this change is unknown. The addition of HCTZ to Topamax may require a decrease in the Topamax dose.
Pioglitazone
A decrease in the exposure of pioglitazone and its active metabolites were noted with the concurrent use of pioglitazone and Topamax in a clinical trial. The clinical relevance of these observations is unknown; however, when Topamax is added to pioglitazone therapy or pioglitazone is added to Topamax therapy, careful attention should be given to the routine monitoring of patients for adequate control of their diabetic disease state.
Amitriptyline
Some patients may experience a large increase in amitriptyline concentration in the presence of Topamax and any adjustments in amitriptyline dose should be made according to the patient's clinical response and not on the basis of plasma levels.
Summary
Topamax (topiramate) is an anticonvulsant (antiepileptic drug) used alone or with other medications to prevent and control seizures (epilepsy). Topamax is also used to prevent migraine headaches and decrease how often they occur. Topamax will not treat a migraine headache once it occurs. Common side effects of Topamax include tiredness, drowsiness, dizziness, loss of coordination, tingling of the hands/feet, loss of appetite, bad taste in the mouth, diarrhea, weight loss, confusion, slowed thinking, trouble concentrating or paying attention, nervousness, memory problems, and speech or language problems. During pregnancy, Topamax should be used only when clearly needed. It may harm a fetus. Topamax passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.
Multimedia: Slideshows, Images & Quizzes
-
Migraine Headaches: Test Your Medical IQ
Is it a headache or a migraine? Learn what a migraine is, causes, symptoms, treatments, and at-home remedies.
-
Epilepsy & Seizures Quiz: What Causes Seizures?
Do you know the difference between seizures and epilepsy? What are the types of seizures? Take the Epilepsy & Seizures Quiz to...
-
12 Surprising Headache Triggers Tips
Painful headaches can ruin your productivity and quality of life. But what triggers headaches and migraines? Learn some...
-
Migraine or Tension Headache? Symptoms, Triggers, Treatments
What does a migraine headache feel like compared to a tension headache? Learn to spot migraine symptoms early, how to identify...
-
Migraine Headaches: 14 Non-Drug Treatments for Migraines
Learn about 14 non-drug treatments for migraines. Acupuncture, biofeedback and massage therapy are among this list of non-drug...
-
Pictures of Famous People Coping With Migraines
See how celebrities cope with the pain caused by migraines. Learn their methods used to prevent and relieve migraine pain.
-
Migraine and Headaches: Top Migraine Hacks
A migraine can be more than just a whopping headache. Try these self-care tips for relief before and after it hits.
Related Disease Conditions
-
Abdominal Migraines in Children and Adults
-
Migraine Headache
Migraine headache is a type of headache associated with a sensitivity to light, smells, or sounds, eye pain, severe pounding on one side of the head, and sometimes nausea and vomiting. The exact cause of migraine headaches is not known. Triggers for migraine headaches include certain foods, stress, hormonal changes, strong stimuli (loud noises), and oversleeping. Treatment guidelines for migraines include medicine, pain management, diet changes, avoiding foods that trigger migraines, staying hydrated, getting adequate sleep, and exercising regularly. Prevention of migraine triggers include getting regular exercise, drinking water daily, reducing stress, and avoiding trigger foods.
-
Seizure (Epilepsy)
Epilepsy is a brain disorder in which the person has seizures. There are two kinds of seizures, focal and generalized. There are many causes of epilepsy. Treatment of epilepsy (seizures) depends upon the cause and type of seizures experienced.
-
Seizures Symptoms and Types
Seizures are divided into two categories: generalized and partial. Generalized seizures are produced by electrical impulses from throughout the brain, while partial seizures are produced by electrical impulses in a small part of the brain. Seizure symptoms include unconsciousness, convulsions, and muscle rigidity.
-
Febrile Seizures
Febrile seizures, or convulsions caused by fever, can be frightening in small children or infants. However, in general, febrile seizures are harmless. Febrile seizure is not epilepsy. It is estimated that one in every 25 children will have at least one febrile seizure. It is important to know what to do to help your child if he/she has a febrile seizure. Some of the features of a febrile seizure include: losing consciousness, shaking, moving limbs on both sides of the body, lasts 1-2 minutes. Less commonly, a febrile seizure may only affect one side of the body.
-
Abdominal Migraines in Children and Adults
Abdominal migraine in adults and children is a variant of migraine headaches. Abdominal migraine in children generally occurs in children who have a family history of migraines. Causes of abdominal migraine is not known. Symptoms of abdominal migraine include acute, severe, midline abdominal pain, nausea, vomiting, paleness, and inability to eat. Abdominal migraine is diagnosed through patient history, family history, and ruling out other medical causes. Treatment of abdominal migraine include tricyclic antidepressants and triptans.
-
Seizure vs. Seizure Disorders (Differences and Similarities)
The differences between a seizure, epilepsy, and seizure disorders are confusing to many people. What makes it more confusing, is that they are not the same thing. A seizure begins suddenly, and is a symptom of another disease. When a seizure occurs there is uncontrolled activity in the brain that usually only lasts for a short period. While a seizure disorder is a medical condition, in which the person has episodes of uncontrolled activity in the brain producing symptoms that include one or more seizures. Epilepsy is considered a seizure disorder.There are two types of major seizures, generalized and partial seizure type and the symptoms depend upon the part of the brain affected, and may include: Loss of consciousness Thought disturbances Convulsions Eye rolling Stiff limbs Twitching on only one side or a portion of the body like an arm or leg. Involuntary urination or bowel movement Repetitive shaking or jerking of the body Staring into space, sometimes with eye blinking No loss of consciousness, but the person becomes confused for a few minutes A third type of seizure is called unclassified seizure.Seizure disorders are classified under two types of major seizures (generalized and partial), and a third type called unclassified seizures. There are about 40 types of named seizure disorders. The symptoms and signs are different depending on the part of the brain affected by the seizure. Examples of seizure disorders are: Febrile seizures Benign Rolandic epilepsy Catamenial epilepsy Absence seizures Frontal lobe epilepsy Epilepsy Sometimes there is a known cause for a seizure like alcohol, cocaine or other illegal drug abuse, drug reactions, a severe chemical imbalance in the blood, or medical problems like low blood pressure. Treatment, management, and prevention of seizures include medication and avoiding any known causes or common triggers. REFERENCES: CDC. "Types of Seizures." Updated: Apr 10, 2017.Harvard Health Publications; Harvard Medical School. "Generalized Seizures (Grand Mal Seizures)."
-
Migraine vs. Headache: Differences and Similarities
Headaches are the most common reason why a person goes to the doctor or other healthcare professional for treatment. There are different types of headaches, for example, migraine, tension, and cluster headaches. The most common type of headache is tension headache. Migraine is much less common. There are few similarities between migraine and other headaches, for example, the severity of the pain can be the same, mild, moderate, or severe; and they can occur on one side or both sides of the head. However, there are many differences between migraine and other types of headaches. Migraine headaches also have different names, for example, migraine with aura and menstrual migraine. Symptoms of migraine that usually aren't experienced by a person with another type of headache include nausea, vomiting, worsens with mild exercise, debilitating pain, eye pain, throbbing head pain. Migraine trigger include light, mild exercise, strong smells, certain foods like red wine, aged cheese, smoked meats, artificial sweeteners, chocolate, alcohol, and dairy products, menstrual period, stress, oversleeping, and changes in barometric pressure. Untreated migraine attacks usually last from 4 to 72 hours, but may last for weeks. Most headaches resolve within 24-48 hours. Doctors don't know exactly what causes migraine headaches; however, other headaches like tension headaches have more specific triggers and causes. Additional tests usually are required to diagnose migraine from other types of headaches, diseases, or other medical problems. Most headaches can be treated and cured with home remedies like essential oils, massage, and over-the-counter pain medication like acetaminophen (Tylenol) and NSAIDs (nonsteroidal anti-inflammatory drugs) like naproxen (Aleve, Anaprox, Naprosyn) or ibuprofen (Advil, Midol, Motrin). Most headaches resolve with OTC and home remedy treatment, while your doctor may need to prescribe medication to treat your migraines. If you have the "worst headache of your life," seek medical care immediately.
-
Migraines and Seizures (Symptoms, Auras, Medication)
Migraines are a type of headache and seizures are the main symptom of epilepsy. Migraine headaches and seizures are two different neurological problems that have similar signs, symptoms, and auras, for example, sensitivity to light (photophobia) and sound, irritability, nausea, and vomiting. Symptoms unique to migraine and migraine auras are water retention, problems sleeping, appetite changes, and talkativeness. Symptoms unique to seizure and seizures auras are depression, a feeling of heaviness, a feeling that a seizure is approaching, and depression. Many of the symptoms of migraine and seizures are the same, however, seizures do not cause migraines; however, people who have seizures are twice as likely to have migraines and vice-versa. People who have migraines are twice as likely to have seizures, and people with seizures are twice as likely to have migraines; however, one condition does not cause the other.
-
Migraine and Stroke (Symptoms, Types, Causes, Treatment)
Migraine headache is a type of headache in which the exact cause is not known; however, they may be inherited, and certain foods and environmental factors can trigger and may contribute them. A stroke (brain attack) happens when a blood vessel in the brain leaks, bursts, or becomes blocked, which can be caused by many other health problems. Both migraines and strokes can can cause severe head pain (migraine pain usually is only on one side of the head). Migraine aura symptoms may mimic or feel like a stroke or mini-stroke (transient ischemic attack, TIA) because they have similar symptoms and signs like severe headache, numbness in the legs, feet, arms, hands, or face, nausea, vomiting, and dizziness. Other migraine aura symptoms include vision problems like flashing lights or blind spots in one eye. The main difference between migraine headache and stroke symptoms and signs is that a migraine headaches usually come on gradually while a stroke symptoms come on suddenly and unexpectedly. A migraine may cause photophobia (sensitivity to light and sound). Migraine triggers include hormonal changes, alcohol, insomnia, caffeine, stress, anxiety, bright lights, loud noises, strong odors, aspartame, MSG, and changes in the weather. Symptoms of a stroke that do not occur with migraines include confusion, speech, vision, and balance problems. You can have a migraine headache and a stroke at the same time, but migraines do not cause strokes. However, in certain individuals with migraines with auras there may be related to a higher risk of stroke. Stroke is a medical emergency. If you have stroke symptoms, call 9-1-1 and get medical attention immediately.
Treatment & Diagnosis
- Epilepsy and Seizures FAQs
- Migraine Headaches FAQs
- Seizures: When the Computer Goes Haywire
- Senator Ted Kennedy: Seizure, Brain Cancer, and Death
- Vestibular Migraine and Janet Jackson
- Brain Cancer Symptoms: Headaches and Seizures
- Seizure Symptoms: How to Assist the Victim
- Does Lupus Cause Seizures?
- What Is a Jacksonian Seizure?
- How Do You Get Rid of a Migraine?
- Can Botox Cure Migraines?
- Migraine Symptoms
- Migraine Headache Treatment
- Migraines: Eat to Minimize Your Migraines
Medications & Supplements

Report Problems to the Food and Drug Administration
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.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.