Risperidone-Chanelle Adverse Reactions

The most frequently reported adverse drug reactions (ADRs) (incidence ≥10%) are: Parkinsonism, headache, and insomnia.
The following are all the ADRs that were reported in clinical trials and postmarketing. The following terms and frequencies are applied: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), and not known (cannot be estimated from the available clinical trial data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Adverse Drug Reactions by System Organ Class and Frequency: Investigations: Common: Blood prolactin increased^a, Weight increased.
Uncommon: Electrocardiogram QT prolonged, Electrocardiogram abnormal, Blood glucose increased, Transaminases increased, White blood cell count decreased, Body temperature increased, Eosinophil count increased, Haemoglobin decreased, Blood creatine phosphokinase increased.
Rare: Body temperature decreased.
Cardiac disorders: Common: Tachycardia.
Uncommon: Atrioventricular block, Bundle branch block, Atrial fibrillation, Sinus, Bradycardia, Palpitations.
Blood and lymphatic system disorders: Uncommon: Anaemia, Thrombocytopenia.
Rare: Granulocytopenia.
Not known: Agranulocytosis.
Nervous system disorders: Very common: Parkinsonism^b, Headache.
Common: Akathisia^b, Dizziness, Tremor^b, Dystonia^b, Somnolence, Sedation, Lethargy, Dyskinesia^b.
Uncommon: Unresponsive to stimuli, Loss of consciousness, Syncope, Depressed level of consciousness, Cerebrovascular accident, Transient ischaemic attack, Dysarthria, Disturbance in attention, Hypersomnia, Dizziness postural, Balance disorder, Tardive dyskinesia, Speech disorder, Coordination abnormal, Hypoaesthesia.
Rare: Neuroleptic malignant syndrome, Diabetic coma, Cerebrovascular disorder, Cerebral ischaemia, Movement disorder.
Eye disorders: Common: Vision blurred.
Uncommon: Conjunctivitis, Ocular hyperaemia, Eye discharge, Eye swelling, Dry eye, Lacrimation increased, Photophobia.
Rare: Visual acuity reduced, Eye rolling, Glaucoma.
Ear and labyrinth disorders: Uncommon: Ear pain, Tinnitus.
Respiratory, thoracic and mediastinal disorders: Common: Dyspnoea, Epistaxis, Cough, Nasal congestion, Pharyngolaryngeal pain.
Uncommon: Wheezing, Pneumonia aspiration, Pulmonary congestion, Respiratory disorder, Rales, Respiratory tract congestion, Dysphonia.
Rare: Sleep apnea syndrome, Hyperventilation.
Gastrointestinal disorders: Common: Vomiting, Diarrhoea, Constipation, Nausea, Abdominal pain, Dyspepsia, Dry mouth, Stomach discomfort.
Uncommon: Dysphagia, Gastritis, Faecal incontinence, Faecaloma.
Rare: Intestinal obstruction, Pancreatitis, Lip swelling, Cheilitis.
Renal and urinary disorders: Common: Enuresis.
Uncommon: Dysuria, Urinary incontinence, Pollakiuria.
Skin and subcutaneous tissue disorders: Common: Rash, Erythema.
Uncommon: Angioedema, Skin lesion, Skin disorder, Pruritus, Acne, Skin discolouration, Alopecia, Seborrhoeic dermatitis, Dry skin, Hyperkeratosis
Rare: Dandruff.
Musculoskeletal and connective tissue disorders: Common: Arthralgia, Back pain, Pain in extremity.
Uncommon: Muscular weakness, Myalgia, Neck pain, Joint swelling, Posture abnormal, Joint stiffness, Musculoskeletal chest pain.
Rare: Rhabdomyolysis.
Endocrine disorders: Rare: Inappropriate antidiuretic hormone secretion.
Metabolism and nutrition disorders: Common: Increased appetite, Decreased appetite.
Uncommon: Anorexia, Polydipsia.
Very rare: Diabetic ketoacidosis.
Not known: Water intoxication.
Infections and infestations: Common: Pneumonia, Influenza, Bronchitis, Upper respiratory tract infection, Urinary tract infection.
Uncommon: Sinusitis, Viral infection, Ear infection, Tonsillitis, Cellulitis, Otitis media, Eye infection, Localised infection, Acarodermatitis, Respiratory tract infection, Cystitis, Onychomycosis.
Rare: Otitis media chronic.
Vascular disorders: Uncommon: Hypotension, Orthostatic hypotension, Flushing.
Not known: Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs.
General disorders and administration site conditions: Common: Pyrexia, Fatigue, Peripheral oedema, Asthenia, Chest pain.
Uncommon: Face oedema, Gait disturbance, Feeling abnormal, Sluggishness, Influenza like illness, Thirst, Chest discomfort, Chills.
Rare: Generalised oedema, Hypothermia, Drug withdrawal syndrome, Peripheral coldness.
Immune system disorders: Uncommon: Hypersensitivity.
Rare: Drug hypersensitivity.
Not known: Anaphylactic reaction.
Hepatobiliary disorders: Rare: Jaundice.
Reproductive system and breast disorders: Uncommon: Amenorrhoea, Sexual dysfunction, Erectile dysfunction, Ejaculation disorder, Galactorrhoea, Gynaecomastia, Menstrual disorder, Vaginal discharge.
Not known: Priapism.
Psychiatric disorders: Very common: Insomnia.
Common: Anxiety, Agitation, Sleep disorder.
Uncommon: Confusional state, Mania, Libido decreased, Listless, Nervousness.
Rare: Anorgasmia, Blunted affect.
Pregnancy, puerperium and perinatal conditions: Not known: Drug withdrawal syndrome neonatal (see Use in Pregnancy & Lactation).
^a Hyperprolactinemia can in some cases lead to gynaecomastia, menstrual disturbances, amenorrhoea, galactorrhea.
^b Extrapyramidal disorder may occur: Parkinsonism (salivary hypersecretion, musculoskeletal stiffness, parkinsonism, drooling, cogwheel rigidity, bradykinesia, hypokinesia, masked facies, muscle tightness, akinesia, nuchal rigidity, muscle rigidity, parkinsonian gait, and glabellar reflex abnormal), akathisia (akathisia, restlessness, hyperkinesia, and restless leg syndrome), tremor, dyskinesia (dyskinesia, muscle twitching, choreoathetosis, athetosis, and myoclonus), dystonia. Dystonia includes dystonia, muscle spasms, hypertonia, torticollis, muscle contractions involuntary, muscle contracture, blepharospasm, oculogyration, tongue paralysis, facial spasm, laryngospasm, myotonia, opisthotonus, oropharyngeal spasm, pleurothotonus, tongue spasm, and trismus. Tremor includes tremor and parkinsonian rest tremor. It should be noted that a broader spectrum of symptoms are included, that do not necessarily have an extrapyramidal origin.
Class effects: As with other antipsychotics, very rare cases of QT prolongation have been reported postmarketing with risperidone. Other class-related cardiac effects reported with antipsychotics which prolong QT interval include ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia, sudden death, cardiac arrest and Torsades de Pointes.
Weight gain: The proportions of risperidone and placebo-treated adult patients with schizophrenia meeting a weight gain criterion of ≥7% of body weight were compared in a pool of 6- to 8-week, placebo-controlled trials, revealing a statistically significantly greater incidence of weight gain for risperidone (18%) compared to placebo (9%). In a pool of placebo-controlled 3-week studies in adult patients with acute mania, the incidence of weight increase of ≥7% at endpoint was comparable in the risperidone (2.5%) and placebo (2.4%) groups, and was slightly higher in the active-control group (3.5%).
In a population of children and adolescents with conduct and other disruptive behaviour disorders, in long term studies, weight increased by a mean of 7.3 kg after 12 months of treatment. The expected weight gain for normal children between 5-12 years of age is 3 to 5 kg per year. From 12-16 years of age, this magnitude of gaining 3 to 5 kg per year is maintained for girls, while boys gain approximately 5 kg per year.
Additional information on special populations: Adverse drug reactions that were reported with higher incidence in elderly patients with dementia or paediatric patients than in adult populations are described as follows: Elderly patients with dementia: Transient ischaemic attack and cerebrovascular accident were ADRs reported in clinical trials with a frequency of 1.4% and 1.5%, respectively, in elderly patients with dementia. In addition, the following ADRs were reported with a frequency ≥5% in elderly patients with dementia and with at least twice the frequency seen in other adult populations: urinary tract infection, peripheral oedema, lethargy, and cough.
Paediatric patients: The following ADRs were reported with a frequency ≥5% in paediatric patients (5 to 17 years) and with at least twice the frequency seen in clinical trials in adults: somnolence/sedation, fatigue, headache, increased appetite, vomiting, upper respiratory tract infection, nasal congestion, abdominal pain, dizziness, cough, pyrexia, tremor, diarrhoea, and enuresis.