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Invega Side Effects

Generic Name: paliperidone

Please note - some side effects for Invega may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Invega - for the Consumer

Invega Sustenna

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Invega Sustenna:

Dizziness; drowsiness; dry mouth; headache; indigestion; lightheadedness; pain, swelling, or redness at the injection site; restlessness; sore throat; weakness; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur when using Invega Sustenna:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal thoughts; behavior changes; chest pain; confusion; decreased sexual ability; decreased urination; enlarged breasts; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; increased saliva production or drooling; increased sweating; loss of consciousness; mental or mood changes; missed menstrual period; muscle cramps, pain, weakness, or stiffness; nipple discharge; one-sided weakness; prolonged, painful erection; seizures; severe or prolonged dizziness or headache; shortness of breath; slurred speech; suicidal thoughts or attempts; swelling of the hands, ankles, and feet; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; unusual weakness); tremor; trouble concentrating, speaking, or swallowing; trouble urinating or inability to control urination; trouble sitting still; trouble walking or standing; uncontrolled muscle movements (eg, arm or leg movements, twitching of the face or tongue, jerking or twisting); unusual eye movements; vision problems.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Invega Extended-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Invega Extended-Release Tablets:

Constipation; dizziness; drowsiness; dry mouth; headache; indigestion; light-headedness; restlessness; sore throat; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur when using Invega Extended-Release Tablets:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal thoughts; behavior changes; chest pain; confusion; decreased sexual ability; decreased urination; enlarged breasts; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; increased saliva production or drooling; increased sweating; mental or mood changes; missed menstrual period; muscle pain, weakness, or stiffness; nipple discharge; prolonged, painful erection; seizures; severe or prolonged dizziness or headache; shortness of breath; suicidal thoughts or attempts; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; unusual weakness); tremor; trouble concentrating, speaking, or swallowing; trouble sitting still; trouble walking or standing; uncontrolled muscle movements (eg, arm or leg movements, twitching of the face or tongue, jerking or twisting); unusual eye movements.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Invega Side Effects - for the Professional

Invega

Overall Adverse Reaction Profile

The following adverse reactions are discussed in more detail in other sections of the labeling:

The most common adverse reactions in clinical trials in adult subjects with schizophrenia (reported in 5% or more of subjects treated with Invega® and at least twice the placebo rate in any of the dose groups) were extrapyramidal symptoms, tachycardia, and akathisia. The most common adverse reactions in clinical trials in adult patients with schizoaffective disorder (reported in 5% or more of subjects treated with Invega® and at least twice the placebo rate) were extrapyramidal symptoms, somnolence, dyspepsia, constipation, weight increased, and nasopharyngitis.

The most common adverse reactions that were associated with discontinuation from clinical trials in adult subjects with schizophrenia (causing discontinuation in 2% of Invega®-treated subjects) were nervous system disorders. The most common adverse reactions that were associated with discontinuation from clinical trials in adult subjects with schizoaffective disorder were gastrointestinal disorders, which resulted in discontinuation in 1% of Invega®-treated subjects. [See Adverse Reactions (6.4)].

The safety of Invega® was evaluated in 1205 adult subjects with schizophrenia who participated in three placebo-controlled, 6-week, double-blind trials, of whom 850 subjects received Invega® at fixed doses ranging from 3 mg to 12 mg once daily. The information presented in this section was derived from pooled data from these three trials. Additional safety information from the placebo-controlled phase of the long-term maintenance study, in which subjects received Invega® at daily doses within the range of 3 mg to 15 mg (n=104), is also included.

The safety of Invega® was evaluated in 150 adolescent subjects 12–17 years of age with schizophrenia who received Invega® in the dose range of 1.5 mg to 12 mg/day in a 6-week, double-blind, placebo-controlled trial.

The safety of Invega® was also evaluated in 622 adult subjects with schizoaffective disorder who participated in two placebo-controlled, 6-week, double-blind trials. In one of these trials, 206 subjects were assigned to one of two dose levels of Invega®: 6 mg with the option to reduce to 3 mg (n = 108) or 12 mg with the option to reduce to 9 mg (n = 98) once daily. In the other study, 214 subjects received flexible doses of Invega® (3–12 mg once daily). Both studies included subjects who received Invega® either as monotherapy or as an adjunct to mood stabilizers and/or antidepressants. Adverse events during exposure to study treatment were obtained by general inquiry and recorded by clinical investigators using their own terminology. Consequently, to provide a meaningful estimate of the proportion of individuals experiencing adverse events, events were grouped in standardized categories using MedDRA terminology.

Throughout this section, adverse reactions are reported. Adverse reactions are adverse events that were considered to be reasonably associated with the use of Invega® (adverse drug reactions) based on the comprehensive assessment of the available adverse event information. A causal association for Invega® often cannot be reliably established in individual cases. Further, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials – Schizophrenia in Adults and Adolescents

Adult Patients with Schizophrenia

Table 4 enumerates the pooled incidences of adverse reactions reported in the three placebo-controlled, 6-week, fixed-dose studies in adults, listing those that occurred in 2% or more of subjects treated with Invega® in any of the dose groups, and for which the incidence in Invega®-treated subjects in any of the dose groups was greater than the incidence in subjects treated with placebo.

Table 4. Adverse Reactions Reported by ≥ 2% of Invega®-Treated Adult Subjects with Schizophrenia in Three Short-Term, Fixed-Dose, Placebo-Controlled Clinical Trials *
Percentage of Patients
Invega®
Placebo 3 mg once daily 6 mg once daily 9 mg once daily 12 mg once daily
Body System or Organ Class (N=355) (N=127) (N=235) (N=246) (N=242)
  Dictionary-Derived Term
*
Table includes adverse reactions that were reported in 2% or more of subjects in any of the Invega® dose groups and which occurred at greater incidence than in the placebo group. Data are pooled from three studies; one study included once-daily Invega® doses of 3 mg and 9 mg, the second study included 6 mg, 9 mg, and 12 mg, and the third study included 6 mg and 12 mg [see Clinical Studies (14)]. Extrapyramidal symptoms includes the terms dyskinesia, dystonia, extrapyramidal disorder, hypertonia, muscle rigidity, oculogyration, parkinsonism, and tremor. Somnolence includes the terms sedation and somnolence. Tachycardia includes the terms tachycardia, sinus tachycardia, and heart rate increased. Adverse reactions for which the Invega® incidence was equal to or less than placebo are not listed in the table, but included the following: vomiting.
Total percentage of subjects with adverse reactions 37 48 47 53 59

Cardiac disorders
  Atrioventricular block first degree 1 2 0 2 1
  Bundle branch block 2 3 1 3 <1
  Sinus arrhythmia 0 2 1 1 <1
  Tachycardia 7 14 12 12 14

Gastrointestinal disorders
  Abdominal pain upper 1 1 3 2 2
  Dry mouth 1 2 3 1 3
  Salivary hypersecretion <1 0 <1 1 4

General disorders
  Asthenia 1 2 <1 2 2
  Fatigue 1 2 1 2 2

Nervous system disorders
  Akathisia 4 4 3 8 10
  Dizziness 4 6 5 4 5
  Extrapyramidal symptoms 8 10 7 20 18
  Headache 12 11 12 14 14
  Somnolence 7 6 9 10 11

Vascular disorders
  Orthostatic hypotension 1 2 1 2 4

Adolescent Patients with Schizophrenia

Table 5 lists the adverse reactions reported in a fixed-dose, placebo-controlled study in adolescent subjects 12–17 years of age with schizophrenia, listing those that occurred in 2% or more of subjects treated with Invega® in any of the dose groups, and for which the incidence in Invega®-treated subjects in any of the dose groups was greater than the incidence in subjects treated with placebo.

Table 5. Adverse Reactions Reported by ≥ 2% of Invega®-Treated Adolescent Subjects with Schizophrenia in a Fixed-Dose, Placebo-Controlled Clinical Trial *
Percentage of Patients
Invega®
Placebo 1.5 mg once daily 3 mg once daily 6 mg once daily 12 mg once daily
Body System or Organ Class (N=51) (N=54) (N=16) (N=45) (N=35)
  Dictionary-Derived Term
*
Table includes adverse reactions that were reported in 2% or more of subjects in any of the Invega® dose groups and which occurred at greater incidence than in the placebo group. Extrapyramidal symptoms includes the terms oculogyric crisis, muscle rigidity, musculoskeletal stiffness, nuchal rigidity, torticollis, trismus, bradykinesia, cogwheel rigidity, dyskinesia, dystonia, extrapyramidal disorder, hypertonia, hypokinesia, muscle contractions involuntary, parkinsonian gait, parkinsonism, tremor, and restlessness. Somnolence includes the terms somnolence, sedation, and hypersomnia. Insomnia includes the terms insomnia and initial insomnia. Tachycardia includes the terms tachycardia, sinus tachycardia, and heart rate increased. Hypertension includes the terms hypertension and blood pressure increased. Gynecomastia includes the terms gynecomastia and breast swelling.
Total percentage of subjects with adverse reactions 43 37 50 58 74

Cardiac disorders
  Tachycardia 0 0 6 9 6

Eye disorders
  Vision blurred 0 0 0 0 3

Gastrointestinal disorders
  Dry mouth 2 0 0 0 3
  Salivary hypersecretion 0 2 6 2 0
  Swollen tongue 0 0 0 0 3
  Vomiting 10 0 6 11 3

General disorders
  Asthenia 0 0 0 2 3
  Fatigue 0 4 0 2 3

Infections and infestations
  Nasopharyngitis 2 4 0 4 0

Investigations
  Weight increased 0 7 6 2 3

Nervous system disorders
  Akathisia 0 4 6 11 17
  Dizziness 0 2 6 2 3
  Extrapyramidal symptoms 0 4 19 18 23
  Headache 4 9 6 4 14
  Lethargy 0 0 0 0 3
  Somnolence 4 9 13 20 26
  Tongue paralysis 0 0 0 0 3

Psychiatric disorders
  Anxiety 4 0 0 2 9

Reproductive system and breast disorders
  Amenorrhea 0 0 6 0 0
  Galactorrhea 0 0 0 4 0
  Gynecomastia 0 0 0 0 3

Respiratory, thoracic and mediastinal disorders
  Epistaxis 0 0 0 2 0

Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials – Schizoaffective Disorder in Adults

Table 6 enumerates the pooled incidences of adverse reactions reported in the two placebo-controlled 6-week studies in adult subjects, listing those that occurred in 2% or more of subjects treated with Invega® and for which the incidence in Invega®-treated subjects was greater than the incidence in subjects treated with placebo.

Table 6. Adverse Drug Reactions Reported by ≥ 2% of Invega®-Treated Adult Subjects with Schizoaffective Disorder in Two Double-Blind, Placebo-Controlled Clinical Trials *
Percentage of Patients
Invega® Invega® Invega®
Placebo 3–6 mg once-daily fixed-dose range 9–12 mg once-daily fixed-dose range 3–12 mg once-daily flexible dose
Body System or Organ Class (N=202) (N=108) (N=98) (N=214)
  Dictionary-Derived Term
*
Table includes adverse reactions that were reported in 2% or more of subjects in any of the Invega® dose groups and which occurred at greater incidence than in the placebo group. Data are pooled from two studies. One study included once-daily Invega® doses of 6 mg (with the option to reduce to 3 mg) and 12 mg (with the option to reduce to 9 mg). The second study included flexible once-daily doses of 3 to 12 mg. Among the 420 subjects treated with Invega®, 230 (55%) received Invega® as monotherapy and 190 (45%) received Invega® as an adjunct to mood stabilizers and/or antidepressants. Extrapyramidal symptoms includes the terms bradykinesia, drooling, dyskinesia, dystonia, hypertonia, muscle rigidity, muscle twitching, oculogyration, parkinsonian gait, parkinsonism, restlessness, and tremor. Somnolence includes the terms sedation and somnolence. Tachycardia includes the terms tachycardia, sinus tachycardia, and heart rate increased.
Total percentage of subjects with adverse reactions 32 48 50 43

Cardiac disorders
  Tachycardia 2 3 1 2

Gastrointestinal disorders
  Abdominal discomfort/Abdominal pain upper 1 1 0 3
  Constipation 2 4 5 4
  Dyspepsia 2 5 6 6
  Nausea 6 8 8 5
  Stomach discomfort 1 0 1 2

General disorders
  Asthenia 1 3 4 <1

Infections and Infestations
  Nasopharyngitis 1 2 5 3
  Rhinitis 0 1 3 1
  Upper respiratory tract infection 1 2 2 2

Investigations
  Weight increased 1 5 4 4

Metabolism and nutrition disorders
  Decreased appetite <1 1 0 2
  Increased appetite <1 3 2 2

Musculoskeletal and connective tissue disorders
  Back pain 1 1 1 3
  Myalgia <1 2 4 1

Nervous system disorders
  Akathisia 4 4 6 6
  Dysarthria 0 1 4 2
  Extrapyramidal symptoms 8 20 17 12
  Somnolence 5 12 12 8

Psychiatric disorders
  Sleep disorder <1 2 3 0

Respiratory, thoracic and mediastinal disorders
  Cough 1 1 3 1
  Pharyngolaryngeal pain <1 0 2 1

Monotherapy versus Adjunctive Therapy

The designs of the two placebo-controlled, 6-week, double-blind trials in adult subjects with schizoaffective disorder included the option for subjects to receive antidepressants (except monoamine oxidase inhibitors) and/or mood stabilizers (lithium, valproate, or lamotrigine). In the subject population evaluated for safety, 230 (55%) subjects received Invega® as monotherapy and 190 (45%) subjects received Invega® as an adjunct to mood stabilizers and/or antidepressants. When comparing these 2 subpopulations, only nausea occurred at a greater frequency (≥ 3% difference) in subjects receiving Invega® as monotherapy.

Discontinuations Due to Adverse Reactions

Schizophrenia Trials

The percentages of subjects who discontinued due to adverse reactions in the three schizophrenia placebo-controlled, 6-week, fixed-dose studies in adults were 3% and 1% in Invega®- and placebo-treated subjects, respectively. The most common reasons for discontinuation were nervous system disorders (2% and 0% in Invega®- and placebo-treated subjects, respectively).

Among the adverse reactions in the 6-week, fixed-dose, placebo-controlled study in adolescents with schizophrenia, only dystonia led to discontinuation (<1% of Invega®-treated subjects).

Schizoaffective Disorder Trials

The percentages of subjects who discontinued due to adverse reactions in the two schizoaffective disorder placebo-controlled 6-week studies in adults were 1% and <1% in Invega®- and placebo-treated subjects, respectively. The most common reasons for discontinuation were gastrointestinal disorders (1% and 0% in Invega®- and placebo-treated subjects, respectively).

Dose-Related Adverse Reactions

Schizophrenia Trials

Based on the pooled data from the three placebo-controlled, 6-week, fixed-dose studies in adult subjects with schizophrenia, among the adverse reactions that occurred with a greater than 2% incidence in the subjects treated with Invega®, the incidences of the following adverse reactions increased with dose: somnolence, orthostatic hypotension, akathisia, dystonia, extrapyramidal disorder, hypertonia, parkinsonism, and salivary hypersecretion. For most of these, the increased incidence was seen primarily at the 12 mg dose, and, in some cases, the 9 mg dose.

In the 6-week, fixed-dose, placebo-controlled study in adolescents with schizophrenia, among the adverse reactions that occurred with >2% incidence in the subjects treated with Invega®, the incidences of the following adverse reactions increased with dose: tachycardia, akathisia, extrapyramidal symptoms, somnolence, and headache.

Schizoaffective Disorder Trials

In a placebo-controlled, 6-week, high- and low-dose study in adult subjects with schizoaffective disorder, akathisia, dystonia, dysarthria, myalgia, nasopharyngitis, rhinitis, cough, and pharyngolaryngeal pain occurred more frequently (i.e., a difference of at least 2%) in subjects who received higher doses of Invega® compared with subjects who received lower doses.

Demographic Differences

An examination of population subgroups in the three placebo-controlled, 6-week, fixed-dose studies in adult subjects with schizophrenia and in the two placebo-controlled, 6-week studies in adult subjects with schizoaffective disorder did not reveal any evidence of clinically relevant differences in safety on the basis of gender or race alone; there was also no difference on the basis of age [see Use in Specific Populations (8.5)].

Extrapyramidal Symptoms (EPS)

Pooled data from the three placebo-controlled, 6-week, fixed-dose studies in adult subjects with schizophrenia provided information regarding treatment-emergent EPS. Several methods were used to measure EPS: (1) the Simpson-Angus global score (mean change from baseline) which broadly evaluates Parkinsonism, (2) the Barnes Akathisia Rating Scale global clinical rating score (mean change from baseline) which evaluates akathisia, (3) use of anticholinergic medications to treat emergent EPS (Table 7), and (4) incidence of spontaneous reports of EPS (Table 8). For the Simpson-Angus Scale, spontaneous EPS reports and use of anticholinergic medications, there was a dose-related increase observed for the 9 mg and 12 mg doses. There was no difference observed between placebo and Invega® 3 mg and 6 mg doses for any of these EPS measures.

Table 7. Treatment-Emergent Extrapyramidal Symptoms (EPS) Assessed by Incidence of Ratings Scales and Use of Anticholinergic Medication – Schizophrenia Studies in Adults
Percentage of Patients
Invega®
    Placebo 3 mg once daily 6 mg once daily 9 mg once daily 12 mg once daily
EPS Group (N=355) (N=127) (N=235) (N=246) (N=242)
*
For Parkinsonism, percent of patients with Simpson-Angus global score > 0.3 (Global score defined as total sum of items score divided by the number of items)
†
For Akathisia, percent of patients with Barnes Akathisia Rating Scale global score ≥ 2
‡
Percent of patients who received anticholinergic medications to treat emergent EPS
Parkinsonism* 9 11 3 15 14
Akathisia† 6 6 4 7 9
Use of anticholinergic medications‡ 10 10 9 22 22
Table 8. Treatment-Emergent Extrapyramidal Symptoms (EPS)-Related Adverse Events by MedDRA Preferred Term – Schizophrenia Studies in Adults
Percentage of Patients
Invega®
Placebo 3 mg once daily 6 mg once daily 9 mg once daily 12 mg once daily
EPS Group (N=355) (N=127) (N=235) (N=246) (N=242)
Dyskinesia group includes: Dyskinesia, extrapyramidal disorder, muscle twitching, tardive dyskinesia
Dystonia group includes: Dystonia, muscle spasms, oculogyration, trismus
Hyperkinesia group includes: Akathisia, hyperkinesia
Parkinsonism group includes: Bradykinesia, cogwheel rigidity, drooling,
hypertonia, hypokinesia, muscle rigidity, musculoskeletal stiffness, parkinsonism
Tremor group includes: Tremor
Overall percentage of patients with EPS-related AE 11 13 10 25 26
  Dyskinesia 3 5 3 8 9
  Dystonia 1 1 1 5 5
  Hyperkinesia 4 4 3 8 10
  Parkinsonism 2 3 3 7 6
  Tremor 3 3 3 4 3

Compared to data from the studies in adults subjects with schizophrenia, pooled data from the two placebo-controlled 6-week studies in adult subjects with schizoaffective disorder showed similar types and frequencies of EPS as measured by rating scales, anticholinergic medication use, and spontaneous reports of EPS-related adverse events. For subjects with schizoaffective disorder, there was no dose-related increase in EPS observed for parkinsonism with the Simpson-Angus scale or akathisia with the Barnes Akathisia Rating Scale. There was a dose-related increase observed with spontaneous EPS reports of hyperkinesia and dystonia and in the use of anticholinergic medications.

Table 9 shows the EPS data from the pooled schizoaffective disorder trials.

Table 9. Treatment-Emergent Extrapyramidal Symptoms (EPS)-Related Adverse Events by MedDRA Preferred Term – Schizoaffective Disorder Studies in Adults
Percentage of Patients
Invega®
Placebo 3–6 mg once-daily fixed-dose range 9–12 mg once-daily fixed-dose range 3–12 mg once-daily flexible dose
EPS Group (N=202) (N=108) (N=98) (N=214)
Dyskinesia group includes: Dyskinesia, muscle twitching
Dystonia group includes: Dystonia, muscle spasms, oculogyration
Hyperkinesia group includes: Akathisia, hyperkinesia, restlessness
Parkinsonism group includes: Bradykinesia, drooling, hypertonia, muscle rigidity, muscle tightness, musculoskeletal stiffness, parkinsonian gait, parkinsonism
Tremor group includes: Tremor
Overall percentage of patients with EPS-related AE 11 23 22 17
  Dyskinesia 1 3 1 1
  Dystonia 1 2 3 2
  Hyperkinesia 5 5 8 7
  Parkinsonism 3 14 7 7
  Tremor 3 12 11 5

The incidences of EPS-related adverse events in the adolescent schizophrenia studies showed a similar dose-related pattern to those in the adult studies. There were notably higher incidences of dystonia, hyperkinesia, tremor, and parkinsonism in the adolescent population as compared to the adult studies (Table 10).

Table 10. Treatment-Emergent Extrapyramidal Symptoms (EPS)-Related Adverse Events by MedDRA Preferred Term – Schizophrenia Studies in Adolescent Subjects
Percentage of Patients
Invega®
Placebo 1.5 mg once daily 3 mg once daily 6 mg once daily 12 mg once daily
EPS Group (N=51) (N=54) (N=16) (N=45) (N=35)
Hyperkinesia group includes: Akathisia
Dystonia group includes: Dystonia, muscle contracture, oculogyric crisis, tongue paralysis, torticollis
Tremor group includes: Tremor
Parkinsonism group includes: Cogwheel rigidity, extrapyramidal disorder, muscle rigidity
Dyskinesia group includes: Dyskinesia, muscle contractions involuntary
Overall percentage of patients with EPS-related AE 0 6 25 22 40
Hyperkinesia 0 4 6 11 17
Dystonia 0 2 0 11 14
Tremor 0 2 6 7 11
Parkinsonism 0 0 6 2 14
Dyskinesia 0 2 6 2 6

Dystonia

Class Effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.

Laboratory Test Abnormalities

In the pooled data from the three placebo-controlled, 6-week, fixed-dose studies in adult subjects with schizophrenia and from the two placebo-controlled, 6-week studies in adult subjects with schizoaffective disorder, between-group comparisons revealed no medically important differences between Invega® and placebo in the proportions of subjects experiencing potentially clinically significant changes in routine serum chemistry, hematology, or urinalysis parameters. Similarly, there were no differences between Invega® and placebo in the incidence of discontinuations due to changes in hematology, urinalysis, or serum chemistry, including mean changes from baseline in fasting glucose, insulin, c-peptide, triglyceride, HDL, LDL, and total cholesterol measurements. However, Invega® was associated with increases in serum prolactin [see Warnings and Precautions (5.7)].

Other Adverse Reactions Observed During Premarketing Evaluation of Invega®

The following additional adverse reactions occurred in < 2% of Invega®-treated subjects in the above schizophrenia and schizoaffective disorder clinical trial datasets. The following also includes additional adverse reactions reported at any frequency by Invega®-treated subjects who participated in other clinical studies.

Cardiac disorders: bradycardia, palpitations

Eye disorders: eye movement disorder

Gastrointestinal disorders: flatulence

General disorders: edema

Immune system disorders: anaphylactic reaction

Infections and infestations: urinary tract infection

Investigations: alanine aminotransferase increased, aspartate aminotransferase increased

Musculoskeletal and connective tissue disorders: arthralgia, pain in extremity

Nervous system disorders: opisthotonus

Psychiatric disorders: agitation, insomnia, nightmare

Reproductive system and breast disorders: breast discomfort, menstruation irregular, retrograde ejaculation

Respiratory, thoracic and mediastinal disorders: nasal congestion

Skin and subcutaneous tissue disorders: pruritus, rash

Vascular disorders: hypertension

The safety of Invega® was also evaluated in a long-term trial designed to assess the maintenance of effect with Invega® in adults with schizophrenia [see Clinical Studies (14)]. In general, adverse reaction types, frequencies, and severities during the initial 14-week open-label phase of this study were comparable to those observed in the 6-week, placebo-controlled, fixed-dose studies. Adverse reactions reported during the long-term double-blind phase of this study were similar in type and severity to those observed in the initial 14-week open-label phase.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Invega®; because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency: angioedema, priapism, swollen tongue, tardive dyskinesia, urinary incontinence, urinary retention.

Adverse Reactions Reported With Risperidone

Paliperidone is the major active metabolite of risperidone. Adverse reactions reported with risperidone can be found in the ADVERSE REACTIONS section of the risperidone package insert.

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Side Effects by Body System - for Healthcare Professionals

Cardiovascular

Cardiovascular side effects including tachycardia (up to 14%), prolonged QTc interval (up to 5%), orthostatic hypotension (up to 4%), bundle branch block (up to 3%), first degree atrioventricular block (up to 2%), increased blood pressure (up to 2%), abnormal electrocardiogram T wave (up to 2%), sinus arrhythmia (up to 2%), and postural orthostatic tachycardia syndrome have been reported. Palpitations have been reported frequently. Bradycardia has been reported infrequently. Ischemia and venous thrombosis have been reported rarely. A case of atrial fibrillation has also been reported.

Nervous system

Nervous system side effects including headache (up to 15%), somnolence (up to 11%), akathisia (up to 10%), hyperkinesia (up to 9.9%), dyskinesia (up to 8.7%), Parkinsonism (up to 7.3%), extrapyramidal disorder (up to 7%), dizziness (up to 6%), dystonia (up to 5.3%), tremor (up to 4.5%), hypertonia (up to 4%), convulsion, dysarthria, lethargy, neuroleptic malignant syndrome, oromandibular dystonia, psychomotor hyperactivity, syncope, and vertigo have been reported. Abnormal coordination has been reported rarely. An apparent new onset grand mal seizure has also been reported.

The dyskinesia group included dyskinesia, extrapyramidal disorder, muscle twitching, and tardive dyskinesia. The dystonia group included dystonia, muscle spasms, oculogyration, and trismus. The hyperkinesia group included akathisia, and hyperkinesia. The Parkinsonism group included bradykinesia, cogwheel rigidity, drooling, hypertonia, hypokinesia, muscle rigidity, musculoskeletal stiffness, and Parkinsonism.

Psychiatric

Psychiatric side effects including insomnia (up to 15%), agitation (up to 10%), anxiety (up to 9%), nightmares (up to 2%), suicidal ideation (up to 2%) and restlessness have been reported. A confusional state has been reported infrequently.

Gastrointestinal

Gastrointestinal side effects including nausea (up to 6%), dyspepsia (up to 5%), vomiting (up to 5%), constipation (up to 5%), salivary hypersecretion (up to 4%) upper abdominal pain (up to 3%), diarrhea (up to 3%), toothache (up to 3%), dry mouth (up to 3%), and stomach discomfort have been reported. Abdominal pain has been reported frequently. Swollen tongue has been reported infrequently.

Respiratory

Respiratory side effects including nasopharyngitis (up to 4%), upper respiratory tract infection (up to 4%), and cough (up to 3%) have been reported. Dyspnea has been reported frequently. Pulmonary embolus has been reported rarely.

General

General side effects including asthenia (up to 2%), fatigue (up to 2 %), and pyrexia (up to 2%) have been reported. Edema has been reported infrequently.

Metabolic

Metabolic side effects including increased blood insulin levels (up to 2%) and increased blood glucose levels have been reported.

Musculoskeletal

Musculoskeletal side effects including back pain (up to 3%), pain in extremity (up to 3%), musculoskeletal stiffness (up to 2%), and myalgia (up to 2%) have been reported.

Ocular

Ocular side effects including blurred vision (up to 2%), oculogyric crisis, and eye rolling have been reported.

Hematologic

Hematologic side effects including thrombocytopenia and increased blood cholesterol have been reported rarely.

Hypersensitivity

Hypersensitivity side effects including anaphylactic reaction have been reported rarely.

Isolated reports of immediate hypersensitivity reactions including flushing, erythema, and dyspnea have occurred during infusion of fosaprepitant. These hypersensitivity reactions have generally responded to discontinuation of the infusion and administration of appropriate therapy. It is not recommended to reinitiate the infusion in patients who experience hypersensitivity reactions.

Endocrine

Endocrine side effects including increases in serum prolactin have been reported.

Other

Other side effects have included weight gain as well as increased appetite and decreased appetite.

Oncologic

Oncologic side effects have included statistically significant increases in pituitary gland adenomas, endocrine pancreas adenomas, and mammary gland adenocarcinomas which have been reported in animal studies with risperidone (which is converted to paliperidone).

Genitourinary

Genitourinary side effects have included amenorrhea, galactorrhea, gynecomastia, irregular menstruation, sexual dysfunction, priapism, and erectile dysfunction.

Dermatologic

Dermatologic side effects including skin laceration (up to 2%) and rash have been reported.

Local

Local side effects with the use of the extended-release injectable suspension have included injection site reactions (up to 10%).

Hepatic

Hepatic side effects including increased alanine aminotransferase (up to 2%) has been reported.

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