Summary

Commonly reported side effects of lurasidone include: psychomotor impairment, akathisia, basal ganglia disease, bradykinesia, cogwheel rigidity, drowsiness, hypokinesia, muscle rigidity, nausea, parkinson's disease, sedated state, tremor, altered serum glucose, and drooling. Other side effects include: oculogyric crisis, trismus, agitation, anxiety, dystonia, torticollis, increased serum prolactin, and weight gain. Continue reading for a comprehensive list of adverse effects.

Applies to lurasidone: oral tablet.

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

• Absence of or decrease in body movement
• difficulty with swallowing
• drooling
• inability to sit still
• incremental or ratchet-like movement of the muscle
• loss of balance control
• mask-like face
• muscle discomfort
• muscle trembling, jerking, or stiffness
• need to keep moving
• restlessness
• rigid or stiff muscles
• shakiness in the legs, arms, hands, or feet
• shuffling walk
• slow movements
• slow reflexes
• slurred speech
• stiffness of the arms and legs
• tic-like (jerky) movements of the head, face, mouth, and neck
• trembling or shaking of the hands or feet
• twisting movements of the body
• uncontrolled movements, especially of the face, neck, and back

Less common

• Arm, back, or jaw pain
• blurred vision
• burning while urinating
• changes in patterns and rhythms of speech
• chest pain or discomfort
• chills
• cold sweats
• confusion
• difficult or painful urination
• difficulty opening the mouth
• difficulty with breathing
• dizziness
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
• fast, pounding, or irregular heartbeat or pulse
• fixed position of the eye
• headache
• high fever
• inability to move the eyes
• inability to speak
• increased blinking or spasms of the eyelid
• increased sweating
• lockjaw
• loss of bladder control
• muscle spasm, especially of the neck and back
• nervousness
• pale skin
• pounding in the ears
• seizures
• severe muscle stiffness
• severe or sudden headache
• slow or fast heartbeat
• slurred speech
• sticking out of the tongue
• sweating
• temporary blindness
• tiredness
• trouble with breathing, speaking, or swallowing
• troubled breathing with exertion
• uncontrolled twisting movements of the neck, trunk, arms, or legs
• unusual bleeding or bruising
• unusual facial expressions
• unusual tiredness or weakness
• unusually pale skin
• weakness in the arm or leg on one side of the body, sudden and severe

Rare

• Black, tarry stools
• bloody urine
• breast pain or swelling
• cough
• dark-colored urine
• decreased frequency or amount of urine
• fever
• increased thirst
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• lower back or side pain
• muscle cramp, pain, or stiffness
• nausea
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swelling of the face, fingers, or lower legs
• swollen glands
• vomiting
• weight gain

Incidence not known

• Decreased urine output
• hives or welts, itching, skin rash
• loss of consciousness
• redness of the skin
• swelling of the throat or tongue
• tightness in the chest

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

• Anxiety
• belching
• drowsiness
• dry mouth
• heartburn
• hyperventilation
• indigestion
• irritability
• relaxed and calm feeling
• sleepiness or unusual drowsiness
• stomach discomfort, upset, or pain
• trouble sleeping
• unusually deep sleep
• unusually long duration of sleep

Less common

• Abnormal dreams
• back pain
• blurred vision
• burning feeling in the chest or stomach
• decreased appetite
• diarrhea
• feeling of constant movement of self or surroundings
• indigestion
• sensation of spinning
• sweating
• tenderness in the stomach area
• watering of mouth and drooling

Rare

• Decreased interest in sexual intercourse
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance
• unexpected or excess milk flow from the breasts

For Healthcare Professionals

Applies to lurasidone: oral tablet.

General

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

Metabolic

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]

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]

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]