Topamax Adverse Reactions

Throughout this section, adverse reactions are presented. Adverse reactions are adverse events that were considered to be reasonably associated with the use of topiramate based on the comprehensive assessment of the available adverse event information. A causal relationship with topiramate cannot be reliably established in individual cases. Further, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Clinical Trial Data: The safety of TOPAMAX was evaluated from a clinical trial database consisting of 4111 patients (3182 on TOPAMAX and 929 on placebo) who participated in 20 double-blind trials and 2847 patients who participated in 34 open-label trials, respectively, for the treatment of primary generalized tonic-clonic seizures, partial onset seizures, seizures associated with Lennox-Gastaut syndrome, newly or recently diagnosed epilepsy or migraine. The information presented in this section was derived from pooled data.
The majority of all adverse reactions were mild to moderate in severity.
Double-Blind, Placebo-Controlled Data, Adjunctive Epilepsy Trials-Adult Patients: Adverse reactions reported in ≥ 1% of TOPAMAX-treated adult patients in double-blind, placebo-controlled adjunctive epilepsy trials are shown in Table 2. Adverse reactions that had an incidence > 5% in the recommended dose range (200 to 400 mg/day) in adults in double-blind, placebo-controlled adjunctive epilepsy studies in descending order of frequency included somnolence, dizziness, fatigue, irritability, weight decreased, bradyphrenia, paresthesias, diplopia, coordination abnormal, nausea, nystagmus, lethargy, anorexia, dysarthria, vision blurred, decreased appetite, memory impairment and diarrhoea. (See Table 2.)

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The recommended dose for adjunctive epilepsy therapy in adults is 200-400 mg/day.
Double-Blind, Placebo-Controlled Data, Adjunctive Epilepsy Trial-Pediatric Patients: Adverse reactions reported in >2% of TOPAMAX-treated pediatric patients (2 to 16 years of age) in double-blind, placebo-controlled adjunctive epilepsy trials are shown in Table 3. Adverse reactions that had an incidence > 5% in the recommended dose range (5 to 9 mg/kg/day) in descending order of frequency included decreased appetite, fatigue, somnolence, lethargy, irritability, disturbance in attention, weight decreased, aggression, rash, abnormal behavior, anorexia, balance disorder, and constipation. (See Table 3.)

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The recommended dose for adjunctive epilepsy therapy in children (2-16 years of age) is 5 to 9 mg/kg/day.
Double-Blind, Controlled Data, Monotherapy Epilepsy Trials-Adult Patients: Adverse reactions reported in ≥ 1% of TOPAMAX-treated adult patients in double-blind, controlled monotherapy epilepsy trials are shown in Table 4. Adverse reactions that had an incidence >5% at the recommended dose (400 mg/day) in descending order of frequency included paraesthesia, weight decreased, fatigue, anorexia, depression, memory impairment, anxiety, diarrhoea, asthenia, dysgeusia, and hypoesthesia. (See Table 4.)

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The recommended dose for monotherapy therapy in adults is 400 mg/day.
Double-Blind, Controlled Data, Monotherapy Epilepsy Trials-Pediatric Patients: Adverse reactions reported in ≥2% of TOPAMAX-treated pediatric patients (10 to 16 years of age) in double-blind, controlled monotherapy epilepsy trials are shown in Table 5. Adverse reactions that had an incidence > 5% at the recommended dose (400 mg/day) in descending order of frequency included weight decreased, paraesthesia, diarrhoea, disturbance in attention, pyrexia, and alopecia. (See Table 5.)

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The recommended dose for monotherapy therapy in children 10 years and older is 400 mg/day.
Double-Blind, Placebo-Controlled Data, Migraine Prophylaxis Trials-Adults Patients: Adverse reactions reported in ≥ 1% of TOPAMAX-treated adult patients in double-blind, placebo-controlled migraine prophylaxis trials are shown in Table 6. Adverse reactions that had an incidence > 5% at the recommended dose (100 mg/day) in descending order of frequency included paraesthesia, fatigue, nausea, diarrhea, weight decreased, dysgeusia, anorexia, decreased appetite, insomnia, hypoesthesia, disturbance in attention, anxiety, somnolence, and expressive language disorder. (See Table 6.)

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The recommended dose for migraine prophylaxis is 100 mg/day.
Other Clinical Trial Data-Adult Patients: Adverse reactions reported in double-blind controlled clinical trials in <1% of TOPAMAX-treated adult patients or at any rate in open-label clinical trials of TOPAMAX-treated adult patients are shown in Table 7.

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Other Clinical Trial Data-Pediatric Patients: Adverse reactions reported in double-blind controlled clinical trials in < 1% of TOPAMAX-treated pediatric patients or at any rate in open-label clinical trials of TOPAMAX-treated pediatric patients are shown in Table 8.

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Postmarketing Data: Adverse events first identified as adverse reactions during postmarketing experience with TOPAMAX are included in Table 9. In table, the frequencies are provided according to the following convention: Very common ≥ 1/10; Common ≥ 1/100 to < 1/10; Uncommon ≥ 1/1000 to < 1/100; Rare ≥ 1/10000 to < 1/1000; Very rare < 1/10000, including isolated reports.
In Table 9, Adverse reactions are presented by frequency category based on spontaneous reporting rates.

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