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Lurasidone Side Effects

In Summary

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

For the Consumer

Applies to lurasidone: oral tablet

In addition to its needed effects, some unwanted effects may be caused by lurasidone. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when 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
  • convulsions
  • 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
  • shortness of breath
  • 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
  • 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 cramps or spasms
  • muscle 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
  • troubled breathing
  • vomiting
  • weight gain

Minor Side Effects

Some of the side effects that can occur with lurasidone 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:
  • Acid or sour stomach
  • anxiety
  • belching
  • drowsiness
  • dry mouth
  • heartburn
  • hyperventilation
  • indigestion
  • irritability
  • relaxed and calm
  • sleepiness or unusual drowsiness
  • sleeplessness
  • stomach discomfort, upset, or pain
  • trouble sleeping
  • unable to sleep
  • unusually deep sleep
  • unusually long duration of sleep
Less common:
  • Abnormal dreams
  • anxiety
  • back pain
  • blurred vision
  • burning feeling in the chest or stomach
  • decreased appetite
  • diarrhea
  • feeling of constant movement of self or surroundings
  • indigestion
  • itching
  • sensation of spinning
  • skin rash
  • sweating
  • tenderness in the stomach area
  • watering of mouth and drooling
  • 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


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


Common (1% to 10%): Increase weight, increased appetite, decreased appetite
Frequency not reported: Increase in blood sugar levels[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 lurasidone-treated 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 lurasidone-treated patients (compared with -0.2 kg in placebo).[Ref]


Very common (10% or more): Nausea (up to 17%)
Common (1% to 10%): Vomiting, dyspepsia, salivary hypersecretion, dry mouth, diarrhea
Uncommon (0.1% to 1%): Abdominal pain, diarrhea
Rare (less than 0.1%): Gastritis
Frequency not reported: Dysphagia[Ref]

Nervous system

Very common (10% or more): Somnolence (up to 26%), akathisia (up to 22%), extrapyramidal disorder (up to 22%)
Common (1% to 10%): Dizziness, dystonia
Uncommon (0.1% to 1%): Cerebrovascular accident, dysarthria, seizures
Frequency not reported: Neuroleptic malignant syndrome, gait disturbance[Ref]

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


Very common (10% or more): Insomnia (11%)
Common (1% to 10%): Agitation, anxiety, restlessness
Uncommon (0.1% to 1%): Abnormal dreams, panic attack, sleep disorder, suicidal ideation, activation of mania/hypomania, catatonia
Frequency not reported: Panic attack, sleep disorder[Ref]


Uncommon (0.1% to 1%): Anemia
Rare (less than 0.1%): Eosinophilia
Frequency not reported: Leukopenia, neutropenia[Ref]


Common (1% to 10%): Tachycardia, hypertension
Uncommon (0.1% to 1%): AV block 1st degree, angina pectoris, bradycardia, orthostatic hypotension, hypotension
Rare (less than 0.1%): Syncope
Frequency not reported: Bradycardia[Ref]

In short-term trials, orthostatic hypotension and syncope were reported in 0.3% and 0.1% (n=1508) of patients in schizophrenia studies. There were no reports in the bipolar depression monotherapy trials.

ECG measurements taken at various points during clinical trials found no QT prolongations exceeding 500 milliseconds (ms) including a subset of patients defined as having an increased cardiac risk. In a dedicated QT study in clinically stable patients with schizophrenia or schizoaffective disorder (n=87), the maximum mean increase in QTc was 0.36 ms and 1.69 ms for a 120 mg and 600 mg dose, respectively. No patient experienced a QTc increase of greater than 60 ms from baseline and no patient experienced a QTc greater than 500 ms.[Ref]


Common (1% to 10%): Back pain, increased creatinine phosphokinase
Uncommon (0.1% to 1%): Joint stiffness, myalgia, neck pain
Rare (less than 0.1%): Rhabdomyolysis[Ref]


Common (1% to 10%): Rash, pruritus
Uncommon (0.1% to 1%): Hyperhidrosis
Rare (less than 0.1%): Angioedema[Ref]


Common (1% to 10%): Urinary tract infection
Uncommon (0.1% to 1%): Dysuria, amenorrhea, dysmenorrhea
Rare (less than 0.1%): Erectile dysfunction[Ref]


Common (1% to 10%): Elevated serum creatinine
Rare (less than 0.1%): Renal failure[Ref]


In schizophrenia studies, the proportion of patients with prolactin elevations 5 times the upper limit of normal (5 x ULN) or greater was 2.8% compared with 1% in placebo. The proportion of female patients and male patients with elevations of 5 x ULN or greater was 5.7% and 1.6%, respectively.[Ref]

Common (1% to 10%): Elevated prolactin levels
Rare (less than 0.1%): Breast enlargement, breast pain, galactorrhea[Ref]


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


Postmarketing reports: Hypersensitivity[Ref]


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


Common (1% to 10%): Blurred vision[Ref]


Common (1% to 10%): Fatigue
Uncommon (0.1% to 1%): Vertigo
Rare (less than 0.1%): Sudden death
Frequency not reported: Drug withdrawal syndrome neonatal[Ref]


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


1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Latuda (lurasidone)." Sunovion Pharmaceuticals Inc, Marlborough, MA.

3. Cerner Multum, Inc. "Australian Product Information." O 0

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

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