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Paliperidone Side Effects

The most commonly reported side effects of paliperidone include injury, gynaecomastia, and off label use, based on 51,831 FDA adverse event reports from 2004 to 2025. 6.3% of reports found the drug to be ineffective.

#1 Reported: InjuryAll side effects ↓Top Co-Medication: RisperidoneDrug interactions ↓85% of Reports Are AdultDemographics ↓

Paliperidone side effects

Percentages show how often each reaction appears relative to total reports for paliperidone.

1
Injury8.4%4,357
2
Gynaecomastia8.1%4,204
3
Off Label Use8.0%4,169
4
Drug Ineffective6.3%3,260
5
Weight Increased4.7%2,455
6
Hospitalisation4.0%2,051
7
Abnormal Weight Gain3.5%1,821
8
Hyperprolactinaemia2.8%1,448
9
Schizophrenia2.8%1,439
10
Drug Dose Omission2.7%1,418
11
Product Dose Omission Issue2.7%1,411
12
Galactorrhoea2.7%1,405
13
Treatment Noncompliance2.7%1,383
14
Condition Aggravated2.3%1,201
15
Product Use In Unapproved Indication2.3%1,182

These are voluntary reports and do not establish that paliperidone caused these reactions.

Report severity

45.0%Serious23,314 reports
20.3%Hospitalizations10,528 reports
3.7%Fatal1,901 reports

Seriousness is determined by the reporter, not by OpenClaim.

Paliperidone drug interactions

Other drugs that appear in adverse event reports alongside paliperidone. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Risperidone22.2%11,493
2
Olanzapine4.4%2,285
3
Aripiprazole4.3%2,212
4
Clozapine4.0%2,054
5
Quetiapine-fumarate3.7%1,936
6
Haloperidol1.8%923
7
Lurasidone-hydrochloride1.4%708
8
Ziprasidone1.1%596
9
Asenapine1.1%548
10
Lorazepam0.9%484
11
Sertraline-hydrochloride0.7%363
12
Divalproex-sodium0.7%358
13
Lithium0.6%329
14
Valproic-acid0.5%262
15
Diazepam0.5%253

Taken alongside

1
Risperidone2.3%1,202
2
Lorazepam2.2%1,123
3
Quetiapine-fumarate2.2%1,120
4
Benztropine-mesylate2.1%1,105
5
Olanzapine1.9%986
6
Divalproex-sodium1.9%981
7
Clonazepam1.9%967
8
Lithium1.5%789
9
Trazodone-hydrochloride1.5%772
10
Aripiprazole1.4%727
11
Metformin1.3%662
12
Lamotrigine1.1%573
13
Levothyroxine-sodium1.1%557
14
Sertraline-hydrochloride1.0%542
15
Haloperidol1.0%539

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports paliperidone side effects

28.3% of paliperidone adverse event reports involve female patients and 49.9% involve male patients. The largest age group is adult at 85%. These figures reflect who reports side effects, not underlying risk.

Sex

Female28.3%
Male49.9%
Unknown21.8%

Age group

< 20.1%
2–113.4%
12–175.0%
18–6485.3%
65+6.2%

What is paliperidone used for

Conditions and purposes for which patients were taking paliperidone when the adverse event was reported.

Abdominal DiscomfortAbdominal PainAbdominal Pain UpperAbnormal BehaviourAccidental Drug Intake By ChildAccidental ExposureAccidental Exposure To ProductAccidental Exposure To Product By ChildAcute PsychosisAdjustment DisorderAdverse Drug ReactionAdverse EventAffect LabilityAffective DisorderAggression

Showing 15 of 452 indications

Paliperidone brand names and reporting trend

Paliperidone is sold under brand names including Invega Sustenna, Paliperidone.

Brand names

Invega Sustenna7,521
Paliperidone6,611

Quarterly reports (2004–2025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking paliperidone with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.

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