Paliperidone
Pronunciation: (pal-ee-PER-i-done).
- Generic name
- Paliperidone
- Brand names
- Trevicta, Palido ER, Palip XR, Xeplion, Invega Trinza, Invega Sustenna
- Drug class
- Atypical antipsychotic
Availability and supply rules vary by country
Trade names by country: United States · Canada
Australia: · Full directory
What Paliperidone is and how it works
Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.
Mechanism of action: how Paliperidone works
Paliperidone is an atypical antipsychotic that primarily acts as an antagonist at central dopamine D2 and serotonin 5-HT2A receptors. It also has antagonistic activity at alpha-1 and alpha-2 adrenergic receptors and H1 histaminergic receptors. This receptor profile helps reduce psychotic symptoms and stabilize mood. (1) (2)
What Paliperidone is used for
Schizophrenia (adults and adolescents 12-17 years)
Schizophrenia (adults and adolescents 12-17 years) (2)
Schizoaffective disorder (adults only)
Not an approved indication for adolescents — only schizophrenia is approved in the 12-17 age group. Can be used alone or added to mood stabilizers/antidepressants. (2)
Before taking Paliperidone
Do not take / not appropriate for
- Contraindicated in patients with hypersensitivity to paliperidone, risperidone, or any excipients. (Contraindication) (2)
Tell your clinician about
(2)How to take Paliperidone
- General Instructions: Take paliperidone exactly as prescribed by your doctor. Do not change your dose or stop taking it without medical advice.. Adult Dosing: For schizophrenia: Extended-release tablets are typically started at 6 mg once daily, with adjustments based on response. Long-acting injectables (Invega Sustenna) are given as an initial dose followed by monthly maintenance injections.. Pediatric Dosing: For adolescents (12-17 years) with schizophrenia only (not approved for schizoaffective disorder in this age group): starting dose 3 mg once daily; maximum dose is weight-based — under 51 kg, max 6 mg/day; 51 kg or more, max 12 mg/day. Safety and efficacy in children under 12 have not been established.. Administration: Tablets should be swallowed whole with water and not chewed, divided, or crushed. Injections are administered by a healthcare professional into the muscle.. When To Seek Review: Do not stop taking paliperidone suddenly unless directed by your doctor, as this may cause withdrawal symptoms or worsening of your condition.. Storage: Store tablets at room temperature away from moisture and heat. Keep injectables as directed by your pharmacist or healthcare provider.
- This page does not provide a dose calculator. Dosing must follow the prescriber, pharmacist, or product label.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (2)
Missed dose
If you miss a dose of the tablet, take it as soon as you remember unless it is almost time for your next dose. do not take an extra dose doses. For missed injections, contact your healthcare provider as soon as possible to reschedule.
Overdose
In case of overdose, seek emergency medical attention or call your local poison control center immediately. Symptoms may include severe drowsiness, rapid or irregular heartbeat, low blood pressure, and difficulty breathing. (2)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms to a healthcare professional.
Orthostatic hypotension (dizziness on standing)
Incidence: Syncope reported in about 0.8% of patients vs 0.3% on placebo
Increased blood sugar, cholesterol, and triglyceride levels
Incidence: Reported; periodic monitoring recommended
Drowsiness/sedation
Incidence: Reported in the clinician-authored database; frequency not established
Movement disorders (e.g., tremor, muscle stiffness)
Incidence: Reported; risk of tardive dyskinesia increases with duration and cumulative dose
Signs of neuroleptic malignant syndrome (high fever, severe muscle stiffness, confusion, irregular heartbeat)
(2)New or worsening involuntary movements (possible tardive dyskinesia)
(2)Serious warnings
FDA BOXED WARNING — serious
Symptoms: FDA BOXED WARNING: Elderly patients with dementia-related psychosis treated with antipsychotic drugs like paliperidone are at increased risk of death. In placebo-controlled trials, the risk of death in drug-treated patients was 1.6-1.7 times that of placebo-treated patients (about 4.5% vs 2.6% over a typical 10-week trial). Paliperidone is NOT approved for treating dementia-related psychosis.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
May cause neuroleptic malignant syndrome (NMS), a potentially fatal reaction with high fever, muscle rigidity, altered consciousness, and autonomic instability, requiring immediate medical attention and discontinuation — serious
Symptoms: May cause neuroleptic malignant syndrome (NMS), a potentially fatal reaction with high fever, muscle rigidity, altered consciousness, and autonomic instability, requiring immediate medical attention and discontinuation. Can increase blood sugar, cholesterol, and triglyceride levels — periodic monitoring is recommended. May cause movement disorders such as tardive dyskinesia, which can become irreversible with longer use and higher cumulative doses. Risk of orthostatic hypotension (sudden drop in blood pressure when standing; syncope reported in about 0.8% of patients vs 0.3% on placebo). Can modestly prolong the QT interval — avoid combining with other QT-prolonging medicines, and use added caution in patients with congenital long QT syndrome.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Contraindications recorded in the clinician database — serious
Symptoms: Contraindications recorded in the clinician database: Contraindicated in patients with hypersensitivity to paliperidone, risperidone, or any excipients. Use caution in patients with a history of cardiovascular disease, cerebrovascular disease, seizures, or conditions predisposing to hypotension. Monitor closely in patients with renal or hepatic impairment.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Recorded interactions | Paliperidone may interact with other medications that affect the central nervous system, such as other antipsychotics, antidepressants, and sedatives. It may also interact with drugs that affect heart rhythm (QT prolongation), certain antibiotics, antifungals, and medications that affect kidney function. Always inform your healthcare provider of all medications and supplements you are taking. | (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Third-trimester exposure carries a risk of extrapyramidal and/or withdrawal symptoms in the newborn (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, feeding difficulty); newborns exposed late in pregnancy should be monitored. Use only if clearly needed, after discussing risks and benefits with your healthcare provider. (2)
Breastfeeding
Paliperidone can pass into breast milk; discuss risks and benefits with your doctor if you are breastfeeding. (2)
Children
Approved for schizophrenia in adolescents 12-17 years only (NOT approved for schizoaffective disorder in this age group): starting dose 3 mg/day, max 6 mg/day if under 51 kg or max 12 mg/day if 51 kg or more. Safety and efficacy not established under age 12. (2)
Renal_impairment
Renal dose adjustment is required: mild impairment (CrCl 50 to under 80 mL/min): start 3 mg/day, max 6 mg/day. Moderate-to-severe impairment (CrCl 10 to under 50 mL/min): start 3 mg every other day, max 3 mg/day. Severe impairment (CrCl under 10 mL/min): use is not recommended. Monitor closely in hepatic impairment. (2)
Hepatic_impairment
Renal dose adjustment is required: mild impairment (CrCl 50 to under 80 mL/min): start 3 mg/day, max 6 mg/day. Moderate-to-severe impairment (CrCl 10 to under 50 mL/min): start 3 mg every other day, max 3 mg/day. Severe impairment (CrCl under 10 mL/min): use is not recommended. Monitor closely in hepatic impairment. (2)
Monitoring
(2)Storage
Store at 25 degC (77 degF); excursions permitted between 15-30 degC (59-86 degF). Keep injectable forms as directed by your pharmacist or healthcare provider.
Study the drug class: Atypical antipsychotics
Professional information
Clinician-facing context only. This section does not replace current product labeling.
General (US FDA label) — adults
Indication: Schizophrenia and schizoaffective disorder
Dose summary: Initial 6 mg/day; range 3-12 mg/day; max 12 mg/day.
Renal context: Mild impairment (CrCl 50-<80 mL/min): start 3 mg/day, max 6 mg/day. Moderate-severe (CrCl 10-<50 mL/min): start 3 mg every other day, max 3 mg/day. Severe (CrCl <10 mL/min): not recommended. (2)
General (US FDA label) — adolescents 12-17 (schizophrenia only)
Indication: Schizophrenia
Dose summary: Initial 3 mg/day; max 6 mg/day if under 51 kg, max 12 mg/day if 51 kg or more. Not approved for schizoaffective disorder in this age group.
Renal context: No pediatric-specific renal dosing established in the label reviewed. (2)
Frequently asked questions
What conditions does paliperidone treat?
Paliperidone is FDA-approved to treat schizophrenia in adults and adolescents (12-17 years), and schizoaffective disorder in adults only (not approved for schizoaffective disorder in adolescents). It helps manage symptoms such as hallucinations, delusions, and mood disturbances. It is not approved for dementia-related psychosis in older adults.
How long does it take for paliperidone to work?
Some people may notice improvement in symptoms within a few days, but it can take several weeks for the full effects to be seen. Consistent use as prescribed is important for best results.
Can I stop taking paliperidone suddenly?
No, do not stop taking paliperidone suddenly without consulting your doctor. Stopping abruptly can cause withdrawal symptoms or a return of psychotic symptoms.
Is paliperidone safe during pregnancy or breastfeeding?
Paliperidone should only be used during pregnancy if clearly needed. Exposure late in pregnancy can cause extrapyramidal or withdrawal symptoms in the newborn (agitation, tremor, feeding difficulty, respiratory distress), so exposed newborns should be monitored. It can also pass into breast milk — discuss risks and benefits with your doctor if you are pregnant or breastfeeding.
What should I do if I miss a dose?
Take the missed tablet dose as soon as you remember, unless it is almost time for your next dose. For missed injections, contact your healthcare provider to reschedule.
Are there foods or drinks I should avoid?
Avoid alcohol, as it can increase drowsiness and other side effects. There are no specific food restrictions, but maintain a healthy diet to help manage weight gain and metabolic effects.
What are the signs of a serious reaction to paliperidone?
Serious reactions include high fever, severe muscle stiffness, confusion, irregular heartbeat, seizures, or signs of an allergic reaction (rash, swelling, difficulty breathing). Seek immediate medical help if these occur.
What happens if I take too much Paliperidone?
Taking too much Paliperidone can lead to severe symptoms such as drowsiness, increased heart rate, low blood pressure, and severe extrapyramidal symptoms. In cases of suspected overdose, it is crucial to seek immediate emergency medical attention. Do not attempt to induce vomiting or self-treat, as this can worsen the situation.
Can I drink alcohol while taking Paliperidone?
It is generally advised to avoid alcohol consumption while taking Paliperidone. Alcohol can intensify the central nervous system depressant effects of antipsychotics, leading to increased drowsiness, dizziness, and impaired coordination. This combination can also heighten the risk of adverse reactions and reduce the effectiveness of your medication. Always consult your healthcare provider for personalized advice.
Is Paliperidone safe during pregnancy?
Paliperidone's pregnancy category requires careful consideration. It is essential to consult your doctor if you are pregnant, planning to become pregnant, or breastfeeding. Your healthcare provider will assess the potential risks and benefits to both you and your baby, and discuss alternative treatment options or monitoring strategies to ensure the safest possible outcome.
What is the mechanism of action of Paliperidone?
Paliperidone is an atypical antipsychotic that primarily acts as an antagonist at central dopamine D2 and serotonin 5-HT2A receptors. It also has antagonistic activity at alpha-1 and alpha-2 adrenergic receptors and H1 histaminergic receptors. This receptor profile helps reduce psychotic symptoms and stabilize mood. (1) (2)
What is the generic name of Paliperidone?
The generic name is Paliperidone. It is sold under brand names including Trevicta, Palido ER, Palip XR, Xeplion, Invega Trinza, Invega Sustenna.
What class of drug is Paliperidone?
Paliperidone is classed as: Atypical antipsychotic.
References
- Paliperidone clinician-authored medicine recordMedGuideGlobal · Global (internal database) · accessed 2026-08-06 · source 1
- INVEGA (paliperidone) Extended-Release Tablets prescribing informationU.S. Food and Drug Administration · United States · accessed 2026-08-06 · source 2
- PALIPERIDONE TABLET, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.] — US prescribing information (DailyMed SPL)U.S. National Library of Medicine (DailyMed) · US · accessed 2026-08-14 · source 3
- Paliperidone — patient drug information (MedlinePlus)U.S. National Library of Medicine (MedlinePlus) · US · accessed 2026-08-14 · source 4
- Paliperidone — FDA approval record (Drugs@FDA ANDA204707)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 5
- Paliperidone — RxNorm normalized drug concept (RXCUI 679314)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 6
Brand names by country
Single-ingredient Paliperidone names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Erzofri extended-release39 mg/.25mL, 117 mg/.75mL, 78 mg/.5mL, 156 mg/mL, 234 mg.5mL, 351 mg/2.25mL · shandong luye pharmaceutical co., ltd.
- INVEGA SUSTENNA234 mg.5mL, 78 mg/.5mL, 156 mg/mL, 39 mg/.25mL, 117 mg/.75mL · janssen pharmaceuticals, inc.
- INVEGA9 mg, 1.5 mg, 3 mg, 6 mg · janssen pharmaceuticals, inc.
- INVEGA TRINZA273 mg/.88mL, 546 mg.75mL, 410 mg.32mL, 819 mg/2.63mL · janssen pharmaceuticals, inc
- INVEGA HAFYERA1092 mg/3.5mL, 1560 mg/5mL · janssen pharmaceuticals, inc
Canada
- INVEGA SUSTENNA
- INVEGA TRINZA
- INVEGA