Lurasidone Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 23, 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

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]