Invega Side Effects

Generic name: paliperidone

Note: This document contains side effect information about paliperidone. Some of the dosage forms listed on this page may not apply to the brand name Invega.

Some side effects of Invega may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to paliperidone: oral tablet extended release

Get emergency medical help if you have any of these signs of an allergic reaction while taking paliperidone (the active ingredient contained in Invega) 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 of paliperidone 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.

For Healthcare Professionals

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

Cardiovascular

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

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

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

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

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

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

Musculoskeletal

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

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

Hematologic

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

Hypersensitivity

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

Endocrine side effects including increases in serum prolactin have been reported.

Other

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

Oncologic

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 (the active ingredient contained in Invega) .

Genitourinary

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

Dermatologic

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

Local

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

Hepatic

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

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