Epamate TEVA Adverse Reactions

The safety of topiramate was evaluated from a clinical trial database consisting of 4,111 patients (3,182 on topiramate and 929 on placebo) who participated in 20 double-blind trials and 2,847 patients who participated in 34 open-label trials, respectively, for topiramate as adjunctive treatment of primary generalized tonic-clonic seizures, partial onset seizures, seizures associated with Lennox-Gastaut syndrome, monotherapy for newly or recently diagnosed epilepsy or migraine prophylaxis. The majority of ADRs were mild to moderate in severity. ADRs identified in clinical trials, and during post-marketing experience (as indicated by "*") are listed by their incidence in clinical trials in Table 1. Assigned frequencies are as follows: Very common: ≥1/10; Common: ≥1/100 to <1/10; Uncommon: ≥1/1,000 to <1/100; Rare: ≥1/10,000 to <1/1,000; Not known: cannot be estimated from the available data.
The most common ADRs (those with an incidence of >5% and greater than that observed in placebo in at least 1 indication in double-blind controlled studies with topiramate) include: anorexia, decreased appetite, bradyphrenia, depression, expressive language disorder, insomnia, coordination abnormal, disturbance in attention, dizziness, dysarthria, dysgeusia, hypoesthesia, lethargy, memory impairment, nystagmus, paresthesia, somnolence, tremor, diplopia, vision blurred, diarrhoea, nausea, fatigue, irritability, and weight decreased.
Paediatric population: ADRs reported more frequently (≥2-fold) in children than in adults in double-blind controlled studies include: decreased appetite; increased appetite; hyperchloraemic acidosis; hypokalaemia; abnormal behaviour; aggression; apathy; initial insomnia; suicidal ideation; disturbance in attention; lethargy; circadian rhythm sleep disorder; poor quality sleep; lacrimation increased; sinus bradycardia; feeling abnormal; gait disturbance.
ADRs that were reported in children but not in adults in double-blind controlled studies include: eosinophilia; psychomotor hyperactivity; vertigo; vomiting; hyperthermia; pyrexia; learning disability. (See Tables 1a and 1b.)

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Congenital malformations and fetal growth restrictions (see Precautions and Use in Pregnancy & Lactation).