What About All the Side Effects, Reactions and Interactions? The results from both the 9-week, fixed-dose, double-blind, placebo-controlled trial and the double-blind phase of the maintenance trial exhibited comparable findings.In the 13-week study involving 234 mg initiation dosing in subjects with schizophrenia, occurrences of induration, redness, or swelling, as assessed by blinded study personnel, were infrequent, generally mild, decreased over time, and similar in incidence between the Invega SustennaAdditional Adverse Reactions Reported in Clinical Trials with Oral PaliperidoneThe following is a list of additional adverse reactions that have been reported in clinical trials with oral paliperidone:The following adverse reactions have been identified during postapproval use of paliperidone; because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: angioedema, ileus, somnambulism, swollen tongue, thrombotic thrombocytopenic purpura, urinary incontinence, and urinary retention.Cases of anaphylactic reaction after injection with Invega SustennaPaliperidone is the major active metabolite of risperidone. Invega Sustenna is the brand name of Paliperidone palmitate and is manufactured by Janssen, a company located in the United States.Dopamine and serotonin are chemicals called neurotransmitters. In such patients, consider discontinuation of Invega SustennaMonitor patients with clinically significant neutropenia for fever or other symptoms or signs of infection and treat promptly if such symptoms or signs occur. It is not the same as an adverse drug event, which is a defined by the world health organization (WHO) as any adverse medical occurrence that may present during treatment with a medication, but does not necessarily have a cause-and-effect relationship with the medication.The main difference between the two is that a drug reaction may occur despite the normal and safe administration of that drug, whereas an adverse drug event may occur with the inappropriate use of the medication. and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Amenorrhea (5.8%) and galactorrhea (2.9%) in females and libido decrease (2.8%) and erectile dysfunction (2.5%) in males were observed with a rate greater than 2%.Somnolence, sedation, and dizziness were reported as adverse reactions in subjects treated with Invega SustennaIn the four fixed-dose double-blind placebo-controlled studies in subjects with schizophrenia, <1% (1/1293) of subjects treated with Invega SustennaEsophageal dysmotility and aspiration have been associated with antipsychotic drug use. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.Pooled data from the four placebo-controlled (one 9-week and three 13-week), fixed-dose studies in subjects with schizophrenia are presented in Table 5.In a long-term open-label pharmacokinetic and safety study in subjects with schizophrenia in which the highest dose available (234 mg) was evaluated, Invega SustennaDuring the initial 25-week open-label period of a long-term study in subjects with schizoaffective disorder, Invega SustennaUndesirable alterations in lipids have been observed in patients treated with atypical antipsychotics.Pooled data from the four placebo-controlled (one 9-week and three 13-week), fixed-dose studies in subjects with schizophrenia are presented in Table 6.In a long-term open-label pharmacokinetic and safety study in subjects with schizophrenia in which the highest dose available (234 mg) was evaluated, the mean changes from baseline in lipid values are presented in Table 7.The mean changes from baseline in lipid values during the initial 25-week open-label period and at the endpoint of the subsequent 15-month double-blind period in a long-term study in subjects with schizoaffective disorder are presented in Table 8.Weight gain has been observed with atypical antipsychotic use. Although no cases of priapism have been reported in clinical trials with Invega SustennaDisruption of the body's ability to reduce core body temperature has been attributed to antipsychotic agents. Invega SustennaIn placebo-controlled trials with risperidone, aripiprazole, and olanzapine in elderly subjects with dementia, there was a higher incidence of cerebrovascular adverse reactions (cerebrovascular accidents and transient ischemic attacks) including fatalities compared to placebo-treated subjects. It is part of a class of medication called a Serotonin-Dopamine Antagonist (SDA) Antipsychotic. They regulate innumerable functions and processes in the body, for example sleep and metabolism.

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