Invega Side Effects

Generic Name: paliperidone

Please note - some side effects for Invega may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Invega - for the Consumer

Invega

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 Invega:

Dizziness; drowsiness; dry mouth; headache; lightheadedness; restlessness; weight gain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thoughts; behavior changes; chest pain; confusion; decreased sexual ability; decreased urination; enlarged breasts; fainting; fast or irregular heartbeat; fever; increased saliva production or drooling; increased sweating; mental/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.

Invega Side Effects - for the Professional

Invega

Most common adverse reactions (incidence ≥ 5% and at least twice that for placebo): akathisia and extrapyramidal disorder. (6)

Side Effects by Body System

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%), and sinus arrhythmia (up to 2%) 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 14%), 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%), and hypertonia (up to 4%) 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 anxiety (up to 9%) have been reported. A confusional state has been reported infrequently.

Gastrointestinal

Gastrointestinal side effects including nausea (up to 6%), dyspepsia (up to 5%), salivary hypersecretion (up to 4%) upper abdominal pain (up to 3%), and dry mouth (up to 3%) have been reported. Abdominal pain has been reported frequently. Swollen tongue has been reported infrequently.

Respiratory

Respiratory side effects including 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%) have been reported.

Musculoskeletal

Musculoskeletal side effects including back pain (up to 2%) and pain in extremity (up to 2%) have been reported.

Ocular

Ocular side effects including blurred vision (up to 2%) have been reported.

Hematologic

Hematologic side effects including thrombocytopenia have been reported rarely.

Hypersensitivity

Hypersensitivity side effects including anaphylactic reaction have been reported rarely.

Endocrine

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

Other

Other side effects have included weight gain with use of the 9 mg and 12 mg daily dose.

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).

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