Safety of application of topiramate for all indications for use was studied in 4111 patients (3182 took topiramate 929 placebo) who participated in 20 double-blind clinical trials, 2847 patients participated in 34 open-label studies. Undesirable effects are presented with a frequency distribution and organ systems. The most common adverse reactions (with a frequency of> 5%) compared with placebo, observed in at least 1 double-blind study were: anorexia, decreased appetite, mental retardation, depression, slurred speech, insomnia, impaired coordination, dizziness, dysarthria, taste disorders, hypoesthesia, lethargy, memory loss, nystagmus,paresthesia, drowsiness, tremor, diplopia, visual impairment, diarrhea, nausea, fatigue, irritability, weight loss. The incidence of side effects was classified as follows: very frequent (≥1 / 10); frequent (≥1 / 100, <1/10); infrequent (≥1 / 1000 and <1/100); rare (≥1 / 10000 and <1/1000) and very rare (<1/10000).
Infections: very often - nasopharyngitis.
From the side of the blood and lymphatic system: often - anemia; infrequently - leukopenia, lymphadenopathy, leukopenia, thrombocytopenia, eosinophilia; very rarely - neutropenia.
From the immune system: often - hypersensitivity; frequency unknown - angioedema, edema of the conjunctiva.
From the side of metabolism and nutrition: often - anorexia, a decrease in appetite; infrequently - metabolic acidosis, hypokalemia, increased appetite, polydipsia; rarely - hyperchloremic acidosis.
From the central nervous system: very often - drowsiness, dizziness, paresthesia; often - violation of concentration of attention, convulsions, inhibition, impaired coordination of movements, nystagmus, lethargy, memory impairment, tremor, amnesia, dysarthria, intentional tremor, gait disturbance,Hypesesia, perversion of taste sensations, disturbance of thinking; Cognitive disorders, apathy, mental decline, psychomotor disorders, sedation; infrequently, depression of the visual field, loss of taste sensitivity, hypokinesia, loss of smell, aphasia, apraxia, aura, burning sensation in the limbs or face, cerebellar syndrome, complex partial seizures, convulsions, postural dizziness, dysesthesia, sensitivity disorder, dysgraphia , dyskinesia, dysphasia, dystonia, sensory disturbances, sensation of goosebumps, tonic-clonic seizures by type grand mal, hyperesthesia, hypogeousia, hypokinesia, psychomotor agitation, hyposmia, peripheral neuropathy, parosmia, pre-stupor states, repetitive speech, impaired touch, stupor, clumsiness, fainting, lack of response to stimuli, poor quality of sleep; rarely - apraxia, disturbance of circadian rhythm of sleep, hyperesthesia, hyposmia, essential tremor, anosmia, lack of response to stimuli.
From the side of the psyche: very often - depression; often - delayed thinking, pronounced speech disorders, anxiety,confusion, insomnia, aggressive reactions, agitation, mood changes, agitation, disorientation, emotional lability, anger, erectile dysfunction, behavior change; infrequent anorgasmia, sexual dysfunction, tearfulness, impaired sexual arousal, dyspharmia, early waking up in the morning, euphoric mood, auditory and visual hallucinations, psychotic disorders, decreased libido and lack of libido, lethargy, intrasomnia, absent-mindedness, upbeat mood, apathy, violation speeches, panic attacks, paranoid states, perseveration of thinking, violation of reading skills, sleep disorders, suicidal ideation or attempts, falling asleep, emotional cold ness, tearfulness; rarely - a sense of despair, mania, panic disorder, hypomania.
From the gastrointestinal tract and the hepatobiliary system: very often - nausea, diarrhea; often - vomiting, pain in the epigastric region, dyspepsia, dry mouth, abdominal pain, paresthesia of the oral mucosa, gastritis, abdominal discomfort; infrequently - pain in the lower abdomen, constipation,impaired sensation in the oral cavity, gastritis, gastroesophageal reflux, gum bleeding, heaviness in the stomach, bad breath, epigastric discomfort, flatulence, glossodynia, oral pain, pancreatitis, hypersecretion of the salivary glands, thirst; rarely - hepatitis, hepatic insufficiency.
From the musculoskeletal system and connective tissue: often: myalgia, including the chest, muscle spasms, muscle cramps, muscle weakness, chest pain, arthralgia; infrequently: pain in the side, swelling of the joints, stiffness of the muscles, fatigue of the muscles; rarely: discomfort in the extremities.
From the genitals and the breast: infrequent - an erection disorder, a violation of sexual function.
From the CAS side: infrequently bradycardia, including sinus, palpitation, flushing, orthostatic hypotension, hypotension, rarely - Raynaud's syndrome.
Common violations: very often fatigue; often - asthenia, anxiety, gait disturbance, poor health, anxiety, irritability, fever; infrequently - hyperthermia, thirst, flu-like syndrome, sluggishness, asthenia, cold extremities, allergic reactions, hyperchloremic acidosis, hypokalemia, anxiety, increased appetite, metabolic acidosis, polydipsia, fatigue, weakness; rarely - edema of the face, calcification.
Ophthalmic disorders: often - diplopia, blurred vision, dry eyes; infrequent - photophobia, blepharospasm, discomfort in the eyes, increased lacrimation, mydriasis, photopsy, presbyopia, scotoma, dry eyes, decreased visual acuity; rarely - transient blindness, unilateral blindness, glaucoma, accommodation disorder, amblyopia, binocular vision impairment, ciliary scotoma, eyelid edema, night blindness; very rarely - closed-angle glaucoma, violations of eyeballs, maculopathy, conjunctival edema.
From the organ of hearing: often - pain in the ears, ringing in the ears, vertigo; infrequently - deafness, incl. neurosensory and one-sided, hearing loss, discomfort in the ears, hearing loss.
From the respiratory system: often - shortness of breath, shortness of breath, rhinorrhea, nasal congestion, epistaxis; infrequently - dysphonia, shortness of breath with physical exertion, hypersecretion in the paranasal sinuses.
From the skin: often - rash, alopecia, itching; infrequently - anhidrosis, vitiligo, oligohydrosis, allergic dermatitis, reddening of the skin, skin pigmentation disorder, itching, macular rash, rashes, face swelling, hives, acne; rarely - polymorphic erythema, paraorbital edema, unpleasant skin odor, Stevens-Johnson syndrome, toxic epidermal necrolysis, focal urticaria.
From the side of the kidneys and urinary tract: often - nephrolithiasis, dysuria, pollakiuria; infrequently: urolithiasis, hematuria, urinary incontinence, frequent urge to urination, renal colic, renal tubular acidosis of pain in the kidney, infection of the genitourinary system.
Change in laboratory indicators: very often - a decrease in body weight; often - weight gain; infrequently - kristalluriya, abnormal result of the "tandem gait" test, leukopenia, hypokalemia (serum potassium level lower than 3.5 mmol / l), lowering of leukocyte count, increased activity of "liver" transaminases and alkaline phosphatase; very rarely - a decrease in the content of bicarbonate in the blood (an average of 4 mmol / l).
Social Disorders - impaired ability to learn.
In controlled clinical trials, the most common adverse reactions in children (with a frequency of occurrence 2 times more common in children than in adults): decreased appetite, increased appetite, hyperchloremic acidosis, hypokalemia, behavioral disorders, aggression, apathy, insomnia (including disturbance of falling asleep), suicidal thoughts, attention deficit disorder, lethargy, disturbance of circadian rhythms, poor sleep, increased tearfulness, sinus bradycardia, sensitive disorders, gait disorders.
Adverse reactions observed only in children: eosinophilia, psychomotor hyperactivity, dizziness, vomiting, hyperthermia, learning difficulties.