Rosemide Adverse Reactions

The most frequently reported adverse drug reactions (ADRs) (incidence ≥ 10%) are: Parkinsonism, sedation/somnolence, headache, and insomnia.
The ADRs that appeared to be dose-related included parkinsonism and akathisia.
The following are all the ADRs that were reported in clinical trials and post-marketing experience with risperidone by frequency category estimated from Rosemide Orodispersible Tablet clinical trials. The following terms and frequencies are applied: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. (See table.)

Click on icon to see table/diagram/image

Undesirable effects noted with paliperidone formulations: Paliperidone is the active metabolite of risperidone, therefore, the adverse reaction profiles of these compounds (including both the oral and injectable formulations) are relevant to one another. In addition to the previously mentioned adverse reactions, the following adverse reaction has been noted with the use of paliperidone products and can be expected to occur with Rosemide Orodispersible Tablet.
Cardiac disorders: Postural orthostatic tachycardia syndrome.
Class effects: As with other antipsychotics, very rare cases of QT prolongation have been reported post-marketing 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.
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 (Rosemide) Orodispersible 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 (Rosemide) Orodispersible 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 Rosemide Orodispersible 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 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 population: In general, type of adverse reactions in children is expected to be similar to those observed in adults.
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.
The effect of long-term risperidone treatment on sexual maturation and height has not been adequately studied (see Use in Children under Precautions).