Paliperidone Side Effects

It is possible that some side effects of paliperidone may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to paliperidone: oral tablet extended release

As well as its needed effects, paliperidone may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking paliperidone, check with your doctor immediately:

More common
  • Difficulty with speaking
  • drooling
  • fast, pounding, or irregular heartbeat or pulse
  • increase in body movements
  • loss of balance control
  • muscle trembling, jerking, or stiffness
  • restlessness
  • shuffling walk
  • stiffness of the limbs
  • twisting movements of the body
  • uncontrolled movements, especially of the face, neck, and back
Less common
  • 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
  • loss of balance control
  • mask-like face
  • muscle tension or tightness
  • pain in the arms or legs
  • slow heartbeat
  • slowed movements
  • slurred speech
  • sticking out 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

Some paliperidone side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Absent, missed, or irregular menstrual periods
  • difficulty having a bowel movement (stool)
  • 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
  • Acid or sour stomach
  • back pain
  • belching
  • blurred vision
  • changes in appetite
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • fever
  • heartburn
  • indigestion
  • lack or loss of strength
  • muscle aches
  • sore throat
  • stomach discomfort, upset, or pain
  • stuffy or runny nose
  • swelling of the breasts or breast soreness in both females and males
  • swollen tongue
  • unexpected or excess milk flow from breasts
  • upper abdominal or stomach pain

For Healthcare Professionals

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


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


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


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


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 side effects including increases in serum prolactin have been reported.


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


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


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


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


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

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