Paliperidone Side Effects

Brand Names: Invega, Invega Sustenna

Please note - some side effects for Paliperidone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Paliperidone - for the Consumer

Paliperidone

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Paliperidone:

Dizziness; drowsiness; dry mouth; headache; indigestion; lightheadedness; pain, swelling, or redness at the injection site; restlessness; sore throat; weakness; weight gain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal thoughts; behavior changes; chest pain; confusion; decreased sexual ability; decreased urination; enlarged breasts; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; increased saliva production or drooling; increased sweating; loss of consciousness; mental or mood changes; missed menstrual period; muscle cramps, pain, weakness, or stiffness; nipple discharge; one-sided weakness; prolonged, painful erection; seizures; severe or prolonged dizziness or headache; shortness of breath; slurred speech; suicidal thoughts or attempts; swelling of the hands, ankles, and feet; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; unusual weakness); tremor; trouble concentrating, speaking, or swallowing; trouble urinating or inability to control urination; trouble sitting still; trouble walking or standing; uncontrolled muscle movements (eg, arm or leg movements, twitching of the face or tongue, jerking or twisting); unusual eye movements; vision problems.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Paliperidone Extended-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Paliperidone Extended-Release Tablets:

Constipation; dizziness; drowsiness; dry mouth; headache; indigestion; light-headedness; restlessness; sore throat; weight gain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal thoughts; behavior changes; chest pain; confusion; decreased sexual ability; decreased urination; enlarged breasts; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; increased saliva production or drooling; increased sweating; mental or mood changes; missed menstrual period; muscle pain, weakness, or stiffness; nipple discharge; prolonged, painful erection; seizures; severe or prolonged dizziness or headache; shortness of breath; suicidal thoughts or attempts; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; unusual weakness); tremor; trouble concentrating, speaking, or swallowing; trouble sitting still; trouble walking or standing; uncontrolled muscle movements (eg, arm or leg movements, twitching of the face or tongue, jerking or twisting); unusual eye movements.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

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).

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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