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Invega Trinza Side Effects

Generic name: paliperidone

Medically reviewed by Drugs.com. Last updated on Mar 31, 2025.

Note: This document provides detailed information about Invega Trinza Side Effects associated with paliperidone. Some dosage forms listed on this page may not apply specifically to the brand name Invega Trinza.

Applies to paliperidone: oral tablet extended release.

Other dosage forms:

Important warnings This medicine can cause some serious health issues

Oral route (tablet, extended release)

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

Paliperidone is not approved for the treatment of patients with dementia-related psychosis.

Precautions

It is very important that your doctor check you or your child's progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects.

This medicine may raise your risk of having a stroke. This is more likely in people who already have heart or blood vessel disease. Check with your doctor right away if you are having confusion, difficulty in speaking, slow speech, inability to speak or move the arms, legs, or facial muscles, double vision, or headache.

Check with your doctor right away if you or your child have difficulty with breathing, fast heartbeat, high fever, high or low blood pressure, increased sweating, loss of bladder control, seizures, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you or your child have lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

This medicine may increase the amount of sugar in your blood. Check with your doctor right away if you or your child have blurred vision, dry mouth, flushed, dry skin, increased hunger, increased thirst or urination, nausea, sweating, trouble breathing, unexplained weight loss, unusual tiredness or weakness, or vomiting. If you have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor.

Dizziness, lightheadedness, or fainting may occur, especially when you suddenly get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

This medicine can cause changes in heart rhythm, including QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Call your doctor right away if you or your child have any symptoms of heart rhythm problems, such as dizziness, feeling faint, or a fast, pounding, or irregular heartbeat.

Paliperidone can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may cause drowsiness, trouble with thinking, or trouble with controlling body movements, which may lead to falls, fractures, or other injuries. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with risperidone may worsen the side effects of this medicine, including dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

This medicine may make it more difficult for your body to cool itself down.Use care not to become overheated during exercise or hot weather since overheating may result in heat stroke. Also, use extra care not to become too cold while you are using paliperidone (the active ingredient contained in Invega Trinza) If you become too cold, you may feel drowsy, confused, or clumsy.

This medicine may increase your or your child's weight. Your doctor may need to check your or your child's weight on a regular basis while you are using this medicine.

This medicine may increase prolactin blood levels if used for a long time. Check with your doctor if you have breast swelling or soreness, unusual breast milk production, absent, missed, or irregular menstrual periods, stopping of menstrual bleeding, loss in sexual ability, desire, drive, or performance, decreased interest in sexual intercourse, or an inability to have or keep an erection.

If you plan to have children, talk with your doctor before using this medicine. Some women using this medicine have become infertile (unable to have children).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Invega Trinza

Along with its needed effects, paliperidone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking paliperidone:

More common side effects

  • difficulty with speaking
  • drooling
  • fast, pounding, or irregular heartbeat or pulse
  • increase in body movements
  • loss of balance control
  • muscle trembling, jerking, or stiffness
  • shuffling walk
  • stiffness of the limbs
  • twisting movements of the body
  • uncontrolled movements, especially of the face, neck, and back

Less common side effects

  • chest pain
  • cold sweats
  • confusion
  • cough
  • difficulty with swallowing
  • dizziness
  • excessive muscle tone
  • fainting
  • inability to move the eyes
  • increased blinking or spasms of the eyelid
  • increased blood pressure
  • mask-like face
  • muscle tension or tightness
  • pain in the arms or legs
  • slow heartbeat
  • slowed movements
  • slurred speech
  • sticking out of the tongue when not meaning to
  • tic-like (jerky) movements of the head, face, mouth, and neck
  • trembling and shaking of the fingers and hands
  • tremors
  • trouble with breathing, speaking, or swallowing
  • uncontrolled twisting movements of the neck, trunk, arms, or legs
  • unusual facial expressions
  • unusual tiredness or weakness

Incidence not known

  • black, tarry stools
  • blood in the urine
  • bloody nose
  • decrease in the frequency of urination
  • decrease in urine volume
  • decreased awareness or responsiveness
  • difficulty in passing urine (dribbling)
  • heavier menstrual periods
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  • lip smacking or puckering
  • loss of bladder control
  • mimicry of speech or movements
  • peculiar postures or movements, mannerisms, or grimacing
  • painful or prolonged erection of the penis
  • painful urination
  • pinpoint red spots on the skin
  • puffing of cheeks
  • rapid or worm-like movements of the tongue
  • severe constipation
  • severe sleepiness
  • severe vomiting
  • skin rash
  • stomach pain
  • uncontrolled chewing movements
  • uncontrolled movements of the arms and legs

Other side effects of Invega Trinza

Some side effects of paliperidone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common side effects

  • absent, missed, or irregular menstrual periods
  • difficulty having a bowel movement
  • fear or nervousness
  • headache
  • inability to sit still
  • nausea
  • need to keep moving
  • sleepiness or unusual drowsiness
  • stopping of menstrual bleeding
  • vomiting
  • weight gain

Less common side effects

  • back pain
  • belching
  • blurred vision
  • changes in appetite
  • dry mouth
  • fever
  • heartburn
  • indigestion
  • lack or loss of strength
  • muscle aches
  • sore throat
  • stomach discomfort or upset
  • stuffy or runny nose
  • swelling or soreness of the breasts in both females and males
  • swollen tongue
  • unexpected or excess milk flow from breasts
  • upper stomach pain

Incidence not known

  • sleepwalking

For healthcare professionals

Applies to paliperidone: intramuscular suspension extended release, oral tablet extended release.

General adverse events

EXTENDED RELEASE TABLETS: The most commonly reported side effects included sedation, extrapyramidal disorder, akathisia, and hyperkinesia.

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION: The most commonly reported side effects included akathisia, parkinsonism, insomnia, and headache.

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION: The most commonly reported side effects included increased weight, insomnia, and use of anticholinergic medications (for extrapyramidal symptoms).[Ref]

Nervous system

EXTENDED RELEASE TABLETS:

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Extrapyramidal symptoms included oculogyric crisis, muscle rigidity, musculoskeletal stiffness, nuchal rigidity, torticollis, trismus, bradykinesia, cogwheel rigidity, dyskinesia, dystonia, extrapyramidal disorder, hypertonia, hypokinesia, involuntary muscle contractions, parkinsonism gait, parkinsonism, tremor, and restlessness. Somnolence includes the terms somnolence, sedation, and hypersomnia.

Based on pooled data from 6-week fixed dose studies, the following nervous system adverse events appear to be dose-related: akathisia, dystonia, extrapyramidal disorder, hypertonia, and parkinsonism. The increased incidence occurred primarily at the 12 mg dose, although in some cases, also the 9 mg dose.[Ref]

Metabolic

EXTENDED RELEASE TABLETS:

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Rare (0.01% to 0.1%)K Diabetic ketoacidosis, hypoglycemia, polydipsia, thirst

Psychiatric

EXTENDED RELEASE TABLETS:

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Cardiovascular

EXTENDED RELEASE TABLETS:

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

In a QT study evaluating the effect of immediate-release oral paliperidone 8 mg (n=50), a mean placebo-subtracted increase from baseline on day 8 at 1.5 hours postdose was 12.3 milliseconds (ms). The mean steady-state peak plasma concentration achieved with immediate-release paliperidone was determined to be more than twice the exposure expected with the recommended 12 mg dose. None of the subjects had a QTc interval exceeding 60 ms. According to the phase 3 safety database which included double-blind and open-label extension studies (n=2054), 2 patients experienced QTc interval prolongation greater than 500 ms.

In placebo controlled trials with oral paliperidone, orthostatic hypotension increased with increasing doses, primarily at the 12 mg per day dose.[Ref]

Other

EXTENDED RELEASE TABLETS:

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Gastrointestinal

EXTENDED RELEASE TABLETS:

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Local

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%):

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Redness and swelling were observed in 2% or less of patients receiving the 3-month IM extended-release suspension. Residual injection pain peaked 1 or 6 hours after injection and trended downward 3 days after the injection. Deltoid injections were numerically more painful than gluteal injections.[Ref]

Musculoskeletal

EXTENDED RELEASE TABLETS:

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Respiratory

EXTENDED RELEASE TABLETS:

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Genitourinary

EXTENDED RELEASE TABLETS:

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Galactorrhea, amenorrhea, and impotence have been reported in patients receiving prolactin-elevating compounds.[Ref]

Dermatologic

EXTENDED RELEASE TABLETS:

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Hepatic

EXTENDED RELEASE TABLETS:

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Immunologic

EXTENDED RELEASE TABLETS:

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Ocular

EXTENDED RELEASE TABLETS:

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Endocrine

EXTENDED RELEASE TABLETS:

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Paliperidone (the active ingredient contained in Invega Trinza) has a prolactin-elevating effect similar to that seen with risperidone. Risperidone is associated with higher levels of prolactin elevation than other antipsychotic drugs.

Hyperprolactinemia may suppress hypothalamic gonadotropin-releasing hormone (GnRH), resulting in reduced pituitary gonadotropin secretion and in turn inhibit reproductive function by impairing gonadal steroidogenesis. Gynecomastia has been reported in patients receiving prolactin-elevating compounds.[Ref]

Hematologic

EXTENDED RELEASE TABLETS:

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Hypersensitivity

EXTENDED RELEASE TABLETS:

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

There have been postmarketing reports of anaphylactic reaction in patients receiving long-acting injection who had previously tolerated oral risperidone or oral paliperidone (the active ingredient contained in Invega Trinza) [Ref]

Renal

EXTENDED RELEASE TABLETS:

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

See also:

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics."

2. (2007) "Product Information. Invega (paliperidone)." Janssen Pharmaceuticals

3. Cerner Multum, Inc. "Australian Product Information."

4. (2014) "Product Information. Invega Sustenna (paliperidone)." Janssen Pharmaceuticals

5. (2015) "Product Information. Invega Trinza (paliperidone)." Janssen Pharmaceuticals

Frequently asked questions

Further information

Invega Trinza side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.