Rizem 2 ODT 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. (See table.)

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Venous thromboembolism: Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis, have been reported with antipsychotic drugs (frequency unknown).
Weight gain: The proportions of Risperidone Orally Disintegrating Tablet 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 Orally Disintegrating Tablet (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 Orally Disintegrating Tablet (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 behavior 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 pediatric patients than in adult populations are described as follows:
Elderly patients with dementia: Transient ischemic 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 edema, lethargy and cough.
Pediatric patients: The following ADRs were reported with a frequency 5% in pediatric 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, diarrhea, and enuresis.