The frequency of a side effect is determined as follows: very frequent (≥1/10 cases), frequent (≥1/100 and <1/10 cases), infrequent (≥1/1000 and <1/100 cases), rare (≥1/10000 and <1/1000 cases) and very rare (<1/10000 cases).
Infections: very often urinary tract infections; often - nasopharyngitis, infections of the upper respiratory tract, sinusitis, pneumonia, phlegmon; infrequently - ear infections, viral infections, pharyngitis, tonsillitis, eye infections, localized infections, cystitis, onychomycosis, acrodermatitis, bronchopneumonia, respiratory infections, tracheobronchitis.
Hematologic disorders and disorders of the lymphatic system: infrequently - anemia, thrombocytopenia, neutropenia; rarely - granulocytopenia; very rarely - agranulocytosis.
From the immune system: infrequently - hypersensitivity; very rarely - anaphylactic shock.
From the endocrine system: often - hyperprolactinemia; infrequently - diabetic coma; rarely - a violation of the production of antidiuretic hormone.
Metabolic and nutritional disorders: often - decreased appetite, increased appetite, anorexia, polydipsia, increased cholesterol and triglycerides in the blood; infrequently - polydipsia, anorexia; very rarely - diabetic ketoacidosis, diabetes mellitus, hypoglycemia, water intoxication; frequency is not known - weight gain.
Mental disorders: very often insomnia; often - anxiety, nervousness, sleep disturbances, confusion; infrequent - excitation, flattening of affect, weakening of libido, anorgasmia, mania.
From the nervous system: very often - parkinsonism (including extrapyramidal disorders, cogwheel syndrome, akinesia, bradykinesia, hypokinesia, muscle rigidity), headache; often - akathisia (incl.anxiety) drowsiness, dizziness, sedation, tremors, dystonia (including muscle spasms, involuntary muscle contractions, muscle contractions, involuntary eyeball movements, tongue paralysis), lethargy, postural dizziness, dyskinesia (including muscle twitching, chorea and choreoathetosis), fainting, depressed state; infrequent - lack of response to irritants, impaired coordination, loss of consciousness, speech impairment, hypoesthesia; rarely - dysfunction, tardive dyskinesia, ischemia, brain, cerebrovascular disorders, malignant neuroleptic syndrome.
Ophthalmic disorders: often - violation of visual acuity; infrequently - conjunctivitis, conjunctival hyperemia, visual impairment, eyelid edema, periorbital edema, crust formation on the edges of the eyelids, dry eyes, increased lacrimation, photophobia, increased intraocular pressure, eye pain; rarely - glaucoma, involuntary rotation of eyeballs.
From the ear and the labyrinth: infrequently - pain in the ears, tinnitus; rarely - chronic otitis media.
From the side of the cardiovascular system: often - tachycardia, orthostatic hypotension,lowering blood pressure, transient ischemic attack, myocardial infarction, stroke; infrequent - bradycardia / sinus bradycardia, sinus tachycardia, lengthening of the interval QT on an electrocardiogram, palpitation, atrioventricular blockade, blockage of the right and left legs of the bundle of His, "tides" of blood to the skin of the face; very rarely - atrial fibrillation, ventricular tachycardia, ventricular arrhythmia, ventricular fibrillation and flutter, cardiac arrest, sudden death; frequency unknown - embolism and thrombosis of veins, deep vein thrombosis, pulmonary embolism.
When using risperidone with other antipsychotic drugs infrequently - lengthening the interval QT on the ECG.
Respiratory, thoracic disorders and disorders of the mediastinum: often - stuffy nose, shortness of breath, epistaxis, sinus congestion, cough, rhinorrhea, bronchitis; infrequent - wheezing, aspiration pneumonia, dysphonia, productive coughing, blockage of the respiratory tract, wet wheezing, respiratory failure, swelling of the nose, laryngism (stridor); very rarely - sleep apnea syndrome, hyperventilation.
From the gastrointestinal tract: often - nausea, constipation, indigestion, vomiting, diarrhea, hypersecretion of the salivary glands, dryness of the oral mucosa, dyspepsia, abdominal pain, infrequently - dysphagia, fecaloma, encopresis, gastritis; rarely - edema of the lips, cheilitis, hypo secretion of the salivary glands; very rarely - intestinal obstruction, pancreatitis.
Hepatobiliary disorders: very rarely - jaundice.
From the skin and subcutaneous tissues: often - a rash, erythema; infrequent - dry skin, seborrheic dermatitis, hyperkeratosis, skin pigmentation disorder, erythematous rashes, papular rashes, generalized rash, maculopapular rash, alopecia areata; very rarely - Quincke's edema, dandruff.
From the osteomuscular system and connective tissue: often - back pain, arthralgia, pain in the extremities, torticollis; infrequent - abnormalities of gait, swelling of the joints, myalgia, muscle pain in the chest, joint stiffness, muscle weakness; rarely rhabdomyolysis.
From the side of the kidneys and urinary tract: often - urinary incontinence; infrequently - pain when urinating, urinary retention, dysuria, frequent urination.
On the part of the reproductive system and mammary glands: infrequent - menstruation disorder, amenorrhea, galactorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculation, lack of ejaculation, retrograde ejaculation, sexual dysfunction; very rarely - priapism.
Common violations: often - fatigue, asthenia, fever, pain in the chest, peripheral edema; infrequent - thirst, flu-like condition, swelling, poor health, swelling of the face, chills, cold extremities; rarely - hypothermia, general edema, withdrawal syndrome.
Violations of laboratory and instrumental indicators: often - an increase in the activity of creatine phosphokinase, an increase in heart rate, an increase in body temperature; infrequently, an increase in alanine aminotransferase activity, an ECG disorder, an increase in the number of eosinophils in the blood, an increase in the activity of aspartate aminotransferase, an increase / decrease in the number of leukocytes in the blood, an increase in blood glucose concentration, a decrease in hemoglobin concentration, a decrease in hematocrit, a decrease in blood pressure, an increase in transaminase activity; very rarely - interval lengthening QT on the ECG.
Class - Effects
Interval lengthening QT on the ECG
When risperidone is used, the lengthening of the interval QT on ECG was observed in the post-marketing period of observation in very rare cases. Due to the lengthening of the interval QT on the ECG against the background of the use of antipsychotic agents, the following side effects from the cardiovascular system were recorded: ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia, sudden death, cardiac arrest and polymorphic ventricular pirouette tachycardia.
Venous thromboembolism
Cases of venous thromboembolism, including pulmonary embolism and cases of deep vein thrombosis, have been observed with the use of antipsychotics (the frequency is unknown).
Weight gain
In 6-8 weeks of placebo-controlled trials in patients with schizophrenia, a clinically significant increase in body weight of 7% or more was observed in the risperidone group (18%), higher than in the placebo group (9%). In placebo-controlled clinical trials in adults with acute mania, the number of cases of weight gain of 7% or more after 3 weeks of treatment was comparable in the group receiving risperidone (2.5%) and in the placebo group (2.4%), while in the active control group there was slightly more (3.5%).
Additional information about specific patient groups
Side effects that have been observed with greater frequency in elderly patients with dementia than in adult patients are described below:
Older patients with dementia
Transient ischemic attack and stroke were observed in clinical trials with a frequency of 1.4% and 1.5%, respectively, in elderly patients with dementia. In addition, the following side effects were observed in elderly patients with dementia with a frequency of ≥5% and at a frequency at least twice that in the other patient groups: urinary tract infections, peripheral edema, lethargy, and cough.