Invega Sustenna Side Effects

Generic Name: paliperidone

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

Not all side effects for Invega Sustenna may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to paliperidone: oral tablet extended release

In addition to its needed effects, some unwanted effects may be caused by paliperidone (the active ingredient contained in Invega Sustenna). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking paliperidone:

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 of the side effects that can occur with paliperidone may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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

Very common (10% or more): Tachycardia (up to 14%)
Common (1% to 10%): Atrioventricular block first degree, bundle branch block, sinus arrhythmia, bradycardia, hypertension, conduction disorder, ECG QT prolongation, orthostatic hypotension
Uncommon (0.1% to 1%): Atrial fibrillation, postural orthostatic tachycardia syndrome, abnormal ECG, palpitations, hypotension
Rare (less than 0.1%): Flushing
Frequency not reported: QTc interval prolongation, edema
Postmarketing reports: Ischemia, venous thrombosis

In a QT study evaluating the effect of immediate-release oral paliperidone 8 mg (n=50), a mean placebo-subtracted increase from baseline on day 8 at 1.5 hours postdose was 12.3 milliseconds (ms). The mean steady-state peak plasma concentration achieved with immediate-release paliperidone was determined to be more than twice the exposure expected with the recommended 12 mg dose. None of the subjects had a QTc interval exceeding 60 ms. According to the phase 3 safety database which included double-blind and open-label extension studies (n=2054), 2 patients experienced QTc interval prolongation greater than 500 ms.

In placebo controlled trials with oral paliperidone, orthostatic hypotension increased with increasing doses, primarily at the 12 mg per day dose.

Nervous system

Very common (10% or more): Extrapyramidal symptoms (up to 40%), akathisia (up to 17%), headache (up to 15%), somnolence (up to 26%)
Common (1% to 10%): Dizziness, dystonia, dyskinesia, tremor, dysarthria, tongue paralysis
Uncommon (0.1% to 1%): Convulsion, syncope, psychomotor hyperactivity, dysgeusia, hypoesthesia, paresthesia, vertigo
Rare (less than 0.1%): Neuroleptic malignant syndrome, tardive dyskinesia, cerebral ischemia, balance disorder, abnormal coordination
Frequency not reported: Bradykinesia, cerebrovascular accident, convulsion, drooling, hypertonia, lethargy, oromandibular dystonia, parkinsonism, psychomotor hyperactivity, syncope, opisthotonus
Postmarketing reports: Cerebrovascular accident, loss of consciousness, head titubation

Extrapyramidal symptoms included oculogyric crisis, muscle rigidity, musculoskeletal stiffness, nuchal rigidity, torticollis, trismus, bradykinesia, cogwheel rigidity, dyskinesia, dystonia, extrapyramidal disorder, hypertonia, hypokinesia, involuntary muscle contractions, parkinsonism gait, parkinsonism, tremor, and restlessness. Somnolence includes the terms somnolence, sedation, and hypersomnia.

Based on pooled data from 6-week fixed dose studies, the following nervous system adverse events appear to be dose-related: akathisia, dystonia, extrapyramidal disorder, hypertonia, and parkinsonism. The increased incidence occurred primarily at the 12 mg dose, although in some cases, also the 9 mg dose.

Psychiatric

Very common (10% or more): Insomnia (up to 15%)
Common (1% to 10%): Agitation, anxiety, sleep disorder, nightmare, mania, depression, suicidal ideation
Uncommon (0.1% to 1%): Confusional state, decreased libido, anorgasmia, nervousness
Frequency not reported: Restlessness
Postmarketing reports: Blunted affect

Gastrointestinal

Very common (10% or more): Vomiting (11%)
Common (1% to 10%): Abdominal discomfort/upper abdominal pain, diarrhea, constipation, dyspepsia, stomach discomfort, dry mouth, nausea, toothache, salivary hypersecretion, swollen tongue
Uncommon (0.1% to 1%): Gastroenteritis, dysphagia, flatulence
Rare (less than 0.1%): Intestinal obstruction, fecal incontinence, cheletis
Postmarketing reports: Pancreatitis, ileus, fecaloma

Respiratory

Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection, cough, pharyngolaryngeal pain, epistaxis, rhinitis, bronchitis, sinusitis, nasal congestion
Uncommon (0.1% to 1%): Dyspnea, wheezing, pneumonia, tonsillitis
Rare (less than 0.1%): Sleep apnea, hyperventilation, aspiration pneumonia, dysphonia
Frequency not reported: Pulmonary congestion

General

The most commonly reported adverse reactions included extrapyramidal symptoms, tachycardia, akathisia, somnolence, tremor, dystonia, cogwheel rigidity, anxiety, weight increased, dyspepsia, constipation, nasopharyngitis, and injection site reactions with the injectable product.

Metabolic

Common (1% to 10%): Weight increased, weight decreased, decreased appetite, increased appetite
Uncommon (0.1% to 1%): Diabetes mellitus, hyperglycemia, anorexia, increased triglycerides
Rare (less than 0.1%): Water intoxication, hypoglycemia, polydipsia, increased cholesterol
Frequency not reported: Hyperinsulinemia
Postmarketing reports: Diabetic ketoacidosis

Musculoskeletal

Common (1% to 10%): Back pain, musculoskeletal stiffness, musculoskeletal pain, arthralgia, myalgia, extremity pain
Uncommon (0.1% to 1%): Elevated blood creatine phosphokinase, muscle spasms, joint stiffness, joint swelling, muscular weakness, neck pain
Frequency not reported: Muscle rigidity, muscle tightness, muscle twitching

Ocular

Common (1% to 10%): Blurred vision
Uncommon (0.1% to 1%): Conjunctivitis, dry eye
Rare (less than 0.1%): Glaucoma, photophobia, increased lacrimation, ocular hyperemia, eye infection
Frequency not reported: Oculogyric crisis
Postmarketing reports: Eye movement disorder, eye rolling

Hematologic

Uncommon (0.1% to 1%): Anemia, decreased hematocrit
Rare (less than 0.1%): Neutropenia, decreased WBC, thrombocytopenia, increased eosinophil count
Postmarketing reports: Thrombotic thrombocytopenic purpura, agranulocytosis

Hypersensitivity

There have been postmarketing reports of anaphylactic reaction in patients receiving long-acting injection who had previously tolerated oral risperidone or oral paliperidone (the active ingredient contained in Invega Sustenna)

Rare (less than 0.1%): Hypersensitivity
Postmarketing reports: Anaphylactic reaction

Endocrine

Paliperidone (the active ingredient contained in Invega Sustenna) has a prolactin-elevating effect similar to that seen with risperidone. Risperidone is associated with higher levels of prolactin elevation than other antipsychotic drugs. Hyperprolactinemia may suppress hypothalamic gonadotropin-releasing hormone (GnRH) resulting in reduced pituitary gonadotropin secretion and in turn inhibit reproductive function by impairing gonadal steroidogenesis. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds.

Common (1% to 10%): Galactorrhea, gynecomastia
Rare (less than 0.1%): Hyperprolactinemia, breast engorgement, breast discharge
Frequency not reported: Breast discharge, elevated serum prolactin, breast discomfort
Postmarketing reports: Inappropriate antidiuretic hormone secretion

Other

Common (1% to 10%): Asthenia, fatigue, pyrexia,
Uncommon (0.1% to 1%): Chills, increased body temperature, malaise, ear infection, tinnitus, lethargy
Rare (less than 0.1%): Ear pain, fall
Postmarketing reports: Hypothermia, drug withdrawal syndrome

Genitourinary

Paliperidone (the active ingredient contained in Invega Sustenna) has a prolactin-elevating effect similar to that seen with risperidone. Risperidone is associated with higher levels of prolactin elevation than other antipsychotic drugs. Hyperprolactinemia may suppress hypothalamic gonadotropin-releasing hormone (GnRH) resulting in reduced pituitary gonadotropin secretion and in turn inhibit reproductive function by impairing gonadal steroidogenesis. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds.

Common (1% to 10%): Urinary tract infection, amenorrhea
Uncommon (0.1% to 1%): Urinary incontinence, urinary retention, pollakiuria, dysuria, erectile dysfunction, ejaculation disorder, menstrual disorder, sexual dysfunction, cystitis
Rare (less than 0.1%): Vaginal discharge
Frequency not reported: Delayed menstruation, irregular menstruation, retrograde ejaculation
Postmarketing reports: Priapism

Dermatologic

Common (1% to 10%): Pruritus, rash
Uncommon (0.1% to 1%): Urticaria, alopecia, acne
Rare (less than 0.1%): Hyperkeratosis, eczema, dry skin, erythema, skin discoloration, seborrhoic dermatitis, dandruff, acarodermatitis
Postmarketing reports: Angioedema

Local

Uncommon (0.1% to 1%): Injection site reactions

Hepatic

Common (1% to 10%): Transaminase elevations
Uncommon (0.1% to 1%): Gamma glutamyltransferase increased, increased hepatic enzyme
Rare (less than 0.1%): Jaundice

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