The most frequently observed adverse reactions (incidence ≥ 5%) were insomnia, anxiety, headache, upper respiratory tract infections, and parkinsonism.
Dose-dependent adverse reactions are parkinsonism and akathisia.
Side effects of risperidone, noted in clinical studies of Rispolept® in oral dosage forms and in the injectable form of prolonged action Rispolept® Quiquette, as well as during post-registration observation, are given with frequency and organ distribution.
The frequency of side effects was classified as follows: very often (≥ 1/10 cases), often (≥1 / 100 and <1/10 cases) infrequently (≥ 1/1000 and <1/100 cases), rarely (≥ 1 / 10000 and <1/1000 cases), very rarely (<1/10000 cases) and with unknown frequency (it is impossible to estimate the frequency from the available data).
In each frequency group, side effects are presented in order of decreasing importance.
Infections:
often - pneumonia, influenza, bronchitis, upper respiratory tract infections, urinary tract infections, sinusitis, ear infections;
infrequently - viral infections, tonsillitis, inflammation of subcutaneous fat, otitis media, eye infections, localized infections, acarobacteria, respiratory infections, cystitis, onychomycosis;
rarely - lower respiratory infections, infections, chronic otitis media, subcutaneous abscess.
Hematologic disorders and disorders of the lymphatic system:
infrequently - neutropenia, a decrease in the number of leukocytes, anemia, thrombocytopenia, a decrease in hematocrit, a decrease in the number of eosinophils, a decrease in the level of hemoglobin;
rarely - granulocytopenia, agranulocytosis.
From the immune system:
infrequently - hypersensitivity;
rarely - drug hypersensitivity, anaphylactic reaction.
From the endocrine system:
often - an increase in the level of prolactin1;
rarely - a violation of the production of antidiuretic hormone, glucosuria.
Metabolic and nutritional disorders:
often - weight gain, increased appetite, decreased appetite;
infrequently - weight loss, diabetes mellitus3, anorexia, polydipsia, hyperglycemia, increased cholesterol concentration;
rarely - hypoglycemia, water intoxication, increased insulin, increased concentration of triglycerides;
very rarely diabetic ketoacidosis.
Mental disorders:
very often insomnia;
often - anxiety, agitation, sleep disorders, anxiety, depression;
infrequently - confusion, mania, decreased libido, lethargy, nervousness, nightmares;
rarely - anorgasmia, flattening of affect.
From the nervous system:
very often - parkinsonism2, headache, drowsiness, sedation;
often - akathisia2, dizziness2, tremor2, dystonia2, lethargy, dyskinesia2;
infrequent - lack of response to stimuli, loss of consciousness, decreased level of consciousness, fainting, impaired consciousness, stroke, transient ischemic attack, dysarthria, attention disturbance, hypersomnia, postural dizziness, imbalance, tardive dyskinesia, speech impairment, coordination disorder, hypoesthesia, disorders taste sensations, perversion of taste, convulsions, cerebral ischemia, impaired movement, psychomotor agitation, paresthesia;
rarely - malignant neuroleptic syndrome, diabetic coma, cerebrovascular disorders, tremor of the head.
Disturbances on the part of the organ of sight:
often - blurred vision, conjunctivitis;
infrequent - redness of the eyes, visual impairment, discharge from the eyes, edema around the eyes, dry eyes, increased lacrimation, photophobia;
rarely - reduced visual acuity, eye movement disorder, involuntary eyeball rotation, crust formation at the edge of the eyelid, glaucoma, intraoperative sagging syndrome, occlusion of retinal artery.
From the ear and the labyrinth:
infrequently - vertigo, pain in the ear, tinnitus.
From the side of the cardiovascular system:
often - tachycardia, arterial hypertension;
infrequently - atrioventricular blockade, bundle bundle blockage, atrial fibrillation, palpitations, impaired conduction of the heart, lengthening of the interval QT on the electrocardiogram, bradycardia, ECG deviations, hypotension, orthostatic hypotension, hot flashes;
rarely - sinus arrhythmia, sinus bradycardia, pulmonary embolism, deep vein thrombosis.
Respiratory, thoracic disorders and disorders of the mediastinum:
often - shortness of breath, nosebleed, cough, nasal congestion, pain in the larynx and pharynx;
infrequently - wheezing, aspiration pneumonia, stagnation in the lungs, impaired breathing, wet wheezing, impaired airway, dysphonia;
rarely - sleep apnea syndrome, hyperventilation.
From the gastrointestinal tract:
often - vomiting, diarrhea, backache, nausea, abdominal pain, indigestion, dry mouth, abdominal discomfort, hypersalivation, toothache;
infrequently - dysphagia, gastritis, fecal incontinence, fecaloma, gastroenteritis, flatulence;
rarely - intestinal obstruction, pancreatitis, edema of the lips, edema of the tongue, cheilitis;
very rarely - ileus.
From the skin and subcutaneous tissues:
often - a rash, erythema;
infrequently - hives, skin lesions, skin disorders, itching, acne, acne, skin discoloration, alopecia, seborrheic dermatitis, dry skin, hyperkeratosis, eczema;
rarely - a drug rash, dandruff;
very rarely - Quincke's edema.
From the musculoskeletal system and connective tissue:
often - muscle spasms, musculoskeletal pain, arthralgia, back pain, pain in the extremities, pain in the buttocks;
Infrequent - increased levels of creatine kinase, muscle weakness, myalgia, neck pain, joint swelling, impaired posture, stiffness in the joints, muscle pain in the chest;
rarely rhabdomyolysis.
Since the old days of the kidneys and urine output ways:
often - enuresis, urinary incontinence;
infrequent - the delay of urination, dysuria, pollakiuria.
Pregnancy, postpartum and neonatal periods:
rarely - the syndrome of "cancellation" in newborns.
From the side of the reproductive system and mammary glands:
infrequently - amenorrhea, sexual dysfunction, erectile dysfunction, ejaculation disorder, galactorrhea, gynaecomastia, menstrual disorder, vaginal discharge, pain in the breast area, discomfort in the breast area;
rarely - priapism, delay in menstruation, engorgement of the mammary glands, enlargement of mammary glands, discharge from the mammary glands.
Common disturbances and phenomena, caused by "administering the drug:
often - edema, pyrexia, fatigue, peripheral edema, generalized edema, asthenia, pain in the chest, pain;
infrequently - facial edema, gait disturbance, malaise, sluggishness, flu-like state, malaise, thirst, discomfort in the chest, chills, fever, discomfort;
rarely - hypothermia, lowering of body temperature, withdrawal syndrome, cooling of limbs, induration.
Hepatobiliary disorders:
infrequently - an increase in the level of transaminases, an increase in the level of gamma-glutamyltransferase, an increase in hepatic enzymes;
rarely - jaundice.
Injuries, poisonings, complications during procedures:
often: falling;
infrequently: pain during procedures.
1 - giperprolaktinemiya in some cases can lead to gynecomastia, menstrual disorders, amenorrhea and galactorrhea.
2 - extrapyramidal disorders can manifest as parkinsonism (hypersalivation, musculoskeletal stiffness, parkinsonism, salivation, stiffness of the "cogwheel", bradykinesia, hypokinesia, masculine face, muscle tension, akinesia, stiff neck, muscle rigidity, parkinsonian gait, disorders glabellar reflex, Parkinsonian tremor of rest), akathisia (akathisia, anxiety, hyperkinesia and restless leg syndrome), tremor, dyskinesia (dyskinesia, muscle twitching, choreoathetosis, athetosis and myoclonus), dystonia.
Term "dystonia" includes dystonia, muscle spasms, hypertension, torticollis, involuntary muscle contractions, muscle contracture, blepharospasm, eyeball movements, paralysis of the tongue, facial spasm, laryngospasm, myotonia, opisthotonus, oropharyngeal spasm, pleurototonus, spasm of the tongue and trismus. Tremor includes tremor and Parkinson's tremor tremor. It should also be noted that there is a wider range of symptoms that do not always have extrapyramidal origin. Insomnia includes sleep disorder, intrasomnic disorder. Convulsions include a large seizure. Disorder of the menstrual cycle includes irregular menstruation, oligomenorrhoea. Edema includes generalized edema, peripheral edema, mild edema.
3 - in placebo-controlled studies, diabetes mellitus was observed in 0.18% patients who took risperidone compared with 0.11% of patients in the placebo group. The overall incidence of diabetes by the results of all clinical trials was 0.43% of all patients taking risperidone.
Undesirable effects with paliperidone
Paliperidone is an active metabolite of risperidone, therefore the profiles of adverse reactions of risperidone and paliperidone are interrelated. In addition to the above, with the use of paliperidone, the following adverse reaction was noted, which may occur with the use of risperidone:
From the side of the cardiovascular system: syndrome of postural orthostatic tachycardia.
Class Effects
As with other antipsychotics, very rare cases of augmentation of the tooth QT were observed in the post-marketing period of observation. Other class-effects from the cardiovascular system, observed with the use of antipsychotics, which increase the prong QT, include ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia, sudden death, cardiac arrest, and bidirectional ventricular tachycardia.
Venous thromboembolism
Cases of venous thromboembolism, including pulmonary embolism and cases of deep vein thrombosis, were observed with the use of antipsychotics (the frequency is unknown).
Weight gain
In placebo-controlled studies in patients with schizophrenia, an increase in body weight of at least 7% at 6-8 weeks was observed in 18% of patients taking Rispolept® and in 9% of patients taking placebo. In placebo-controlled clinical trials in patients with manic episodes, the number of cases of weight gain of 7% or more after 3 weeks of treatment was comparable in the group taking Rispolept® (2.5%) and in the placebo group ( 2.4%), while in the active control group there was slightly more (3.5%).
In children with behavioral disorders during long-term clinical trials, the body weight increased by an average of 7.3 kg after 12 months of therapy. The expected increase in body weight in children 5-12 years old with normal development is 3-5 kg per year. From the age of 12-16, the increase in body weight should be 3-5 kg per year for girls and about 5 kg per year for boys.
Additional information about specific populations of patients
Side effects that have been observed more frequently in elderly patients with dementia and in children than in adult patients are described below.
Elderly 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 with a frequency that is at least 2 times higher than in other patient populations: urinary tract infections, peripheral edema, lethargy, and cough.
Children
The following side effects were observed in children (5 to 17 years) with a frequency ≥ 5% and at a frequency at least twice that in other patient populations in clinical trials: drowsiness / sedation, fatigue, headache, appetite, vomiting, upper respiratory tract infection, nasal congestion, abdominal pain, dizziness, cough, pyrexia, tremor, diarrhea, enuresis.