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Lurasidone Side Effects

Medically reviewed by Drugs.com. Last updated on Dec 5, 2023.

Applies to lurasidone: oral tablet.

Warning

Oral route (Tablet)

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Lurasidone is not approved for the treatment of patients with dementia-related psychosis. An increased risk of suicidal thoughts and behavior was found in pediatric and young adult patients taking antidepressants. Monitor for clinical worsening and emergence of suicidal thoughts and behaviors.

Serious side effects of Lurasidone

Along with its needed effects, lurasidone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking lurasidone:

More common

Less common

Rare

Incidence not known

Other side effects of Lurasidone

Some side effects of lurasidone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common

Rare

For Healthcare Professionals

Applies to lurasidone: oral tablet.

General

The most commonly reported adverse events included somnolence, akathisia, extrapyramidal symptoms, and nausea.[Ref]

Metabolic

In uncontrolled, long-term schizophrenia trials, this drug was associated with a mean increase in glucose from baseline of 1.8 mg/dL at 24 weeks, 0.8 mg/dL at 36 weeks, and 2.3 mg/dL at 52 weeks. Similar results were observed in bipolar depression studies. The proportion of patients with a 7% or greater increase in body weight was 4.8% (compared with 3.3% for placebo). Pooled data from short-term trials showed a mean weight gain of 0.43 kg in treated patients (compared with -0.2 kg in placebo).[Ref]

Common (1% to 10%): Decreased appetite, increased appetite, increased weight

Uncommon (0.1% to 1%): Hyponatremia, increase in blood sugar levels/blood glucose increased[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 17.4%), dyspepsia (up to 11%)

Common (1% to 10%): Abdominal pain, diarrhea, dry mouth, salivary hypersecretion, stomach discomfort, upper abdominal pain, vomiting

Uncommon (0.1% to 1%): Dysphagia, flatulence, gastritis

Frequency not reported: Difficulty swallowing, tongue protrusion, tongue spasm, tongue swelling[Ref]

Nervous system

Very common (10% or more): Somnolence (up to 26%), akathisia (up to 22%), extrapyramidal disorder/symptoms (up to 22%), parkinsonism (up to 17%)

Common (1% to 10%): Dizziness, dyskinesia, dystonia/acute dystonia, tardive dyskinesia

Uncommon (0.1% to 1%): Cerebrovascular accident/adverse reactions, dysarthria, gait disturbance, lethargy, syncope, vertigo

Rare (less than 0.1%): Neuroleptic malignant syndrome, seizure

Frequency not reported: Abnormal glabellar reflex, bradykinesia, cogwheel rigidity, convulsion, drooling, hyperkinesia, hypersomnia, hypersomnolence, hypokinesia, motor impairment, oromandibular dystonia, sedation, stroke, tremor[Ref]

Akathisia and extrapyramidal symptoms were dose-related.[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 11%)

Common (1% to 10%): Abnormal dreams, agitation, anxiety, psychomotor hyperactivity, restlessness

Uncommon (0.1% to 1%): Activation of mania/hypomania, catatonia, nightmare, panic attack, sleep disorder

Rare (less than 0.1%): Suicidal behavior/ideation

Frequency not reported: Cognitive impairment, psychomotor retardation[Ref]

Hematologic

Uncommon (0.1% to 1%): Anemia

Rare (less than 0.1%): Eosinophilia

Frequency not reported: Agranulocytosis, leukopenia, neutropenia[Ref]

Cardiovascular

Common (1% to 10%): Hypertension, tachycardia

Uncommon (0.1% to 1%): Angina pectoris, atrioventricular (AV) block first degree, bradycardia, hot flush, hypotension, increased blood pressure, orthostatic hypotension

Frequency not reported: Deep vein thrombosis, venous thromboembolism[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, increased blood creatinine phosphokinase, musculoskeletal stiffness

Uncommon (0.1% to 1%): Joint stiffness, myalgia, neck pain

Rare (less than 0.1%): Rhabdomyolysis

Frequency not reported: Muscle rigidity, muscle spasms, neck muscle spasm, torticollis, trismus[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus

Uncommon (0.1% to 1%): Hyperhidrosis

Frequency not reported: , Stevens-Johnson syndrome, urticaria

Postmarketing reports: Bullous dermatitis, maculopapular rash, pustular rash, severe cutaneous reactions, skin eruption, skin exfoliation[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection

Uncommon (0.1% to 1%): Amenorrhea, dysmenorrhea, dysuria, erectile dysfunction

Rare (less than 0.1%): Breast enlargement, breast pain, galactorrhea[Ref]

Renal

Common (1% to 10%): Elevated serum creatinine/increased creatinine phosphokinase

Rare (less than 0.1%): Renal failure[Ref]

Endocrine

Uncommon (0.1% to 1%): Elevated prolactin levels/blood prolactin increased

Frequency not reported: Hyperprolactinemia[Ref]

Hepatic

Uncommon (0.1% to 1%): Alanine aminotransferase increased[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity

Rare (less than 0.1%): Angioedema

Frequency not reported: Allergic rhinitis[Ref]

Immunologic

Very common (10% or more): Viral infection (up to 11%)

Common (1% to 10%): Influenza[Ref]

Ocular

Common (1% to 10%): Blurred vision

Frequency not reported: Oculogyric crisis[Ref]

Other

Common (1% to 10%): Fatigue

Rare (less than 0.1%): Sudden death

Frequency not reported: Body temperature dysregulation, falls, neonatal drug withdrawal syndrome[Ref]

Respiratory

Common (1% to 10%): Nasopharyngitis, oropharyngeal pain, rhinitis

Frequency not reported: Difficulty breathing, nasal congestion, rhinorrhea, pulmonary embolism, throat tightness, upper respiratory tract infection

Postmarketing reports: Dyspnea, throat swelling[Ref]

Frequently asked questions

References

1. Cerner Multum, Inc. UK Summary of Product Characteristics.

2. Cerner Multum, Inc. Australian Product Information.

3. Product Information. Latuda (lurasidone). Sunovion Pharmaceuticals Inc. 2010.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.