Recommended Topic Related To:

Invega

"Feb. 22, 2011 -- The FDA has issued a safety announcement notifying health care professionals that it has updated the pregnancy section of drug labels for the entire class of antipsychotic medications.

Antipsychotic drugs are used to "...

Invega

Invega Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Invega (paliperidone) is used to treat schizophrenia. It is an antipsychotic medication. Common side effects include drowsiness, dizziness, lightheadedness, abdominal/stomach pain, weight gain, cough, or dry mouth.

The recommended dose of Invega Extended-Release Tablets for the treatment of schizophrenia in adults is 6 mg once daily, and the recommended dose for adolescents 12-17 years of age is 3 mg once daily. Invega may interact with arsenic trioxide, blood pressure medications, carbamazepine, droperidol, anti-anxiety medications, antibiotics, antidepressants, anti-malaria medications, anti-seizure medications, heart rhythm medicine, medicine to prevent or treat nausea and vomiting, medicines to treat Parkinson's Disease, medicines to treat psychiatric disorders, migraine headache medicine, muscle relaxers, narcotics, sleeping pills, or any cold or allergy medicine that can make you sleepy. Tell your doctor all medications you are taking. During pregnancy, Invega should be used only when prescribed. Babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn during their first month, tell the doctor. This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Our Invega (paliperidone) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Invega in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using paliperidone and call your doctor at once if you have a serious side effect such as:

  • very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling like you might pass out;
  • restless muscle movements in your eyes, tongue, jaw, or neck;
  • tremor (uncontrolled shaking);
  • trouble swallowing;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden and severe headache, or problems with vision, speech, or balance;
  • fever, chills, body aches, flu symptoms; or
  • white patches or sores inside your mouth or on your lips.

Less serious side effects may include:

  • breast swelling or discharge;
  • changes in menstrual periods;
  • mild restlessness, drowsiness, or tremor;
  • blurred vision;
  • dizziness or headache;
  • weight gain;
  • nausea, dry mouth, upset stomach; or
  • decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Invega (Paliperidone) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Invega Overview - Patient Information: Side Effects

SIDE EFFECTS: Drowsiness, dizziness, lightheadedness, drooling, stomach/abdominal pain, weight gain, or tiredness may occur. If any of these side effects persist or worsen, tell your doctor promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

An empty tablet shell may appear in your stool. This effect is harmless because your body has already absorbed the medication.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: difficulty swallowing, muscle spasms, shaking (tremor), mental/mood changes (such as restlessness), signs of infection (such as fever, persistent sore throat).

This drug may infrequently make your blood sugar level rise, which can cause or worsen diabetes. Tell your doctor immediately if you develop symptoms of high blood sugar, such as increased thirst and urination. If you already have diabetes, be sure to check your blood sugars regularly. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This drug may also cause significant weight gain and a rise in your blood cholesterol (or triglyceride) levels. These effects, along with diabetes, may increase your risk for developing heart disease. Discuss the risks and benefits of treatment with your doctor. (See also Notes section.)

Paliperidone may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor immediately if you develop any unusual/uncontrolled movements (especially of the face, lips, mouth, tongue, arms, or legs).

This medication may increase a certain natural substance (prolactin) made by your body. For females, this increase in prolactin may result in unwanted breast milk, missed/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor immediately.

Get medical help right away if you have any very serious side effects, including: severe dizziness, fainting, seizures.

This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, change in the amount of urine.

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Invega (Paliperidone)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Invega FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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.

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 *

Body System or Organ Class Dictionary-Derived Term Placebo
(N=355)
Percentage of Patients INVEGA®
3 mg once daily
(N=127)
6 mg once daily
(N=235)
9 mg once daily
(N=246)
12 mg once daily
(N=242)
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
* 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]. 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.

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 *

Body System or Organ Class Dictionary-Derived Term Placebo
(N=51)
Percentage of Patients INVEGA®
1.5 mg once daily
(N=54)
3 mg once daily
(N=16)
6 mg once daily
(N=45)
12 mg once daily
(N=35)
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 mediastinaldisorders
  Epistaxis 0 0 0 2 0
* 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.

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 *

Body System or Organ Class Dictionary-Derived Term Placebo
(N=202)
Percentage of Patients
INVEGA® 3-6 mg once-daily fixed-dose range
(N=108)
INVEGA® 9-12 mg once-daily fixed-dose range
(N=98)
INVEGA® 3-12 mg once-daily flexible dose
(N=214)
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
* 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.

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].

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

EPS Group Placebo
(N=355)
Percentage of Patients INVEGA®
3 mg once daily
(N=127)
6 mg once daily
(N=235)
9 mg once daily
(N=246)
12 mg once daily
(N=242)
Parkinsonisma 9 11 3 15 14
Akathisiab 6 6 4 7 9
Use of anticholinergic medicationsc 10 10 9 22 22
aFor 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)
bFor Akathisia, percent of patients with Barnes Akathisia Rating Scale global score ≥ 2
cPercent of patients who received anticholinergic medications to treat emergent EPS

Table 8: Treatment-Emergent Extrapyramidal Symptoms (EPS)-Related Adverse Events by MedDRA Preferred Term - Schizophrenia Studies in Adults

EPS Group Placebo
(N=355)
3 mg once daily
(N=127)
6 mg once daily
(N=235)
9 mg once daily
(N=246)
12 mg once daily
(N=242)
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
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

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

EPS Group Placebo
(N=202)
Percentage of Patients
INVEGA®
3-6 mg once-daily fixed-dose range
(N=108)
9-12 mg once-daily fixed-dose range
(N=98)
3-12 mg once-daily flexible dose
(N=214)
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
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

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

EPS Group Placebo
(N=51)
Percentage of Patients INVEGA®
1.5 mg once daily (N=54) 3 mg once daily
(N=16)
6 mg once daily
(N=45)
12 mg once daily
(N=35)
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
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

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].

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]. 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, ileus, 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.

Read the entire FDA prescribing information for Invega (Paliperidone) »

A A A

Invega - User Reviews

Invega User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Invega sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Emotional Wellness

Get tips on therapy and treatment.