Unwanted reactions are given with a frequency distribution and organ systems.The frequency of unwanted reactions was classified as follows: very often (≥1/10), often (≥1 / 100, <1/10), infrequently (≥1 / 1000 and <1/100), rarely (≥1 / 10000 and < 1/1000), very rarely (<1/10000, including individual cases) and the frequency is unknown (the frequency can not be estimated from the available data).
The most frequent adverse reactions (whose frequency was more than 5% and exceeded that in the placebo group for at least one of the indications during controlled clinical trials of topiramate) are: anorexia, decreased appetite, delayed thinking, depression, speech disorders, insomnia, disorders coordination of movements, violation of concentration, dizziness, dysarthria, dysgeusia, hypoesthesia, retardation, memory impairment, nystagmus, paresthesia, drowsiness, tremor, diplopia, blurred vision, diarrhea, nausea, fatigue, irritability and weight loss.
Infections and invasions: very often: nasopharyngitis *.
Violations of the blood and lymphatic system: often: anemia; infrequently: leukopenia, lymphadenopathy, thrombocytopenia, eosinophilia; rarely: neutropenia *.
Immune system disorders: often: hypersensitivity; frequency unknown: allergic edema *, edema of the conjunctiva *.
Disorders from the metabolism and nutrition: often: anorexia, decreased appetite; infrequently: metabolic acidosis, hypokalemia, increased appetite, polydipsia; rarely: hyperchloroemic acidosis; hyperammonemia, hyperammonemic encephalopathy.
Mental disorders: very often: depression; often: delayed thinking, insomnia, speech disorders, anxiety, confusion, disorientation, aggressive reactions, mood disorders, agitation, emotional lability, depressed mood, anger, behavioral disorder; infrequently: suicidal thoughts, suicide attempts, hallucinations, psychotic disorders, auditory hallucinations, visual hallucinations, apathy, difficulty speaking, sleep disorders, affective lability, decreased libido, excited state, crying, dysphhemia, euphoric mood, paranoia, perseveration of thinking, panic attacks , tearfulness, violation of reading skills, falling asleep, flattening emotions, pathological thinking, loss of libido, lethargy, intrasomnic disorder, absent-mindedness,early waking up in the morning, panic reactions, high spirits; rarely: mania, panic disorder, feeling of hopelessness *, hypomania.
Disorders from the central nervous system: very often: paresthesia, drowsiness, dizziness; often: violation of concentration, memory impairment, amnesia, cognitive disorders, mental disorders, psychomotor disorders, convulsions, impaired coordination of movements, tremor, inhibition, hypesthesia, nystagmus, dysgeusia, imbalance, dysarthria, intentional tremor, sedation; infrequently: depressed consciousness, tonic-clonic seizures like "grand mal", visual impairment, complex partial seizures, speech disorders, psychomotor hyperactivity, fainting, sensory disorders, salivation, hypersomnia, aphasia, repetitive speech, hypokinesia, dyskinesia, postural dizziness , poor quality of sleep, burning sensation, loss of sensation, parosmia, cerebral syndrome, dysesthesia, hypogesia, stupor, clumsiness, aura, agevzia, dysphagia, dysphasia, peripheral neuropathy, dystonia,sensation of "goosebumps" in the body; rarely: apraxia, disturbed circadian rhythm of sleep, hyperesthesia, hyposmia, anosmia, essential tremor, akinesia, no reaction to stimuli.
Disturbances on the part of the organ of sight: often: blurred vision, diplopia, violation view; infrequent: visual acuity, scotoma, myopia *, strange sensations in the eyes *, dry eyes, photophobia, blepharospasm, increased lacrimation, photopsy, mydriasis, presbyopia; rarely: unilateral blindness, transient blindness, glaucoma, disruption of accommodation, impairment of visual spatial perception, ciliary scotoma, eyelid edema *, night blindness, amblyopia; frequency unknown: angle-closure glaucoma *, maculopathy *, impaired mobility of the eye *.
Hearing and balance disorders: often: vertigo, ringing in the ears, pain in the ear; infrequently: deafness, one-sided deafness, neurosensory deafness, discomfort in the ear, hearing impairment.
Disorders from the cardiovascular system: infrequently: bradycardia, sinus bradycardia, palpitation.
Disorders from the vascular system: infrequently: hypotension, Orthostatic hypotension, hot flushes, hot flashes; rarely: the phenomenon of Raynaud.
Disturbances from the respiratory system, chest and mediastinal organs: often: shortness of breath, nosebleed, nasal congestion, rhinorrhea, cough *; infrequently: dyspnoea with physical exertion, hypersecretion in the paranasal sinuses, dysphonia.
Disorders from the gastrointestinal tract: very often: nausea, diarrhea; often: vomiting, constipation, epigastric pain, dyspepsia, abdominal pain, dry mouth, stomach discomfort, hypersensitivity in the oral cavity, gastritis, abdominal discomfort; infrequently: pancreatitis, flatulence, gastroesophageal reflux, lower abdominal pain, decreased sensitivity in the oral cavity, bleeding gums, bloating, epigastric discomfort, abdominal sensitivity, hypersalivation, oral pain, bad breath, glossodynia .
Disorders from the hepatobiliary system: rarely: hepatitis, hepatic failure.
Disturbances from the skin and subcutaneous tissues: often: alopecia, rash, itching; infrequently: anhidrosis,impaired sensation in the face, urticaria, erythema, generalized itching, macular rash, skin pigmentation disorder, allergic dermatitis, face swelling; infrequently: Stevens-Johnson syndrome *, polymorphic erythema *, skin odor change, paraorbital edema *, localized urticaria; frequency unknown: toxic epidermal necrolysis *.
Disturbances from musculoskeletal system and connective tissue: often: arthralgia, muscle spasms, myalgia, muscle cramps, muscle weakness, musculoskeletal pain in the chest; infrequently: swelling of the joints *, stiffness of the muscles, pain in the side, fatigue in the muscles; rarely: discomfort in the extremities *.
Disorders from the kidneys and urinary tract: often: nephrolithiasis, pollakiuria, dysuria; infrequent: exacerbation of urolithiasis (kidney stones), urinary incontinence with tension, hematuria, urinary incontinence, frequent urge to urinate, renal colic, pain in the kidney; rarely: exacerbation of urolithiasis (stones in the urethra) renal tubular acidosis *.
Violations of the genitals and mammary gland: infrequently: erectile dysfunction, sexual dysfunction.
General disorders and disorders due to the method of application: very often: fatigue; often: fever, asthenia, irritability, gait disturbance, poor health, anxiety; infrequently: hyperthermia, thirst, flu-like syndrome *, sluggishness, coldness of the limbs, a feeling of intoxication, a feeling of anxiety; rarely: swelling of the face, calcification.
Change in laboratory indicators: very often: weight loss; often: weight gain *; infrequently: crystalluria, abnormal test result "tandem walk", leukopenia, increased activity of hepatic enzymes in the blood serum, rarely: decrease in the content of hydrocarbonates in the blood.
Violations of social functioning: infrequently: impaired ability to training.
* - an undesirable reaction was registered in the post-marketing period from spontaneous messages. The frequency is calculated on the basis of data from clinical studies.
Special Groups:
Children:
Below is a list of unwanted reactions that, in the course of controlled clinical trials, were registered in children 2 or more times more often,than in adults: decreased appetite, increased appetite, hyperchloremic acidosis, hypokalemia, behavioral disorders, aggressive reactions, apathy, disturbed sleep, suicidal thoughts, impaired concentration, inhibition, disturbance of circadian rhythm of sleep, poor sleep quality, increased lacrimation, sinus bradycardia, poor state of health, gait disturbance.
Below is a list of unwanted reactions that, in the course of controlled clinical trials, were recorded only in children: eosinophilia, psychomotor hyperactivity, vertigo, vomiting, hyperthermia, pyrexia, impaired ability to learn.