Lurasidone Side Effects
Medically reviewed by Drugs.com. Last updated on Apr 15, 2025.
Applies to lurasidone: oral tablet.
Important warnings
This medicine can cause some serious health issues
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.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Lurasidone should not be used with certain medicines such as carbamazepine (Tegretol®), clarithromycin (Biaxin®), ketoconazole (Nizoral®), phenytoin (Dilantin®), rifampin (Rifadin®, Rimactane®), ritonavir (Norvir®), St. John's wort, or voriconazole (Vfend®). Using these medicines together may cause serious unwanted effects. Make sure your doctor knows all of the medicines you are taking.
Lurasidone may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies. If you or your caregiver notice any of these side effects, tell your doctor right away.
This medicine may increase risk of transient ischemic attack or stroke in elderly patients. Tell your doctor right away if you have confusion, double vision, headache, inability to move the arms, legs, or facial muscles, slow speech, or trouble speaking, thinking, or walking while using this medicine.
Check with your doctor right away if you have any of the following symptoms while using this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).
This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs while you are using this medicine.
This medicine may increase the amount of sugar in your blood. Check with your doctor right away if you have increased thirst or increased urination. If you have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor.
This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are using this medicine. Talk to your doctor about ways to prevent weight gain.
Lurasidone can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection, or if you have a fever or chills, a cough or hoarseness, lower back or side pain, or painful or difficult urination.
Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.
This medicine may cause some people to become drowsy or dizzy, or to have trouble with thinking or controlling body movements, which may lead to falls, fractures or other injuries. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Avoid activities involving high temperature or humidity. This medicine may reduce your body's ability to adjust to the heat.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicines including other narcotics, medicine for seizures (eg, barbiturates), muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.
Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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 side effects
- 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 side effects
- 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 side effects
- 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 side effects
- 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 side effects
- 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 side effects
- 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 adverse events
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]
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References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. Cerner Multum, Inc. "Australian Product Information."
3. (2010) "Product Information. Latuda (lurasidone)." Sunovion Pharmaceuticals Inc
Frequently asked questions
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Further information
Lurasidone side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.