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Lurasidone Side Effects

In Summary

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

For the Consumer

Applies to lurasidone: oral tablet

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
  • 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
  • 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 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

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
  • Acid or sour stomach
  • anxiety
  • belching
  • drowsiness
  • dry mouth
  • heartburn
  • hyperventilation
  • indigestion
  • irritability
  • relaxed and calm
  • sleepiness or unusual drowsiness
  • stomach discomfort, upset, or pain
  • trouble sleeping
  • 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 or skin rash
  • 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[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]

Gastrointestinal

Very common (10% or more): Nausea (up to 17%), 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: Tongue spasm, tongue swelling[Ref]

Nervous system

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

Very common (10% or more): Somnolence (up to 26%), akathisia (up to 22%), extrapyramidal disorder (up to 22%), parkinsonism (up to 17%)
Common (1% to 10%): Dizziness, dyskinesia, dystonia/acute dystonia
Uncommon (0.1% to 1%): Cerebrovascular accident, dysarthria, gait disturbance, syncope, tardive dyskinesia, vertigo
Rare (less than 0.1%): Neuroleptic malignant syndrome, seizure
Frequency not reported: Abnormal glabellar reflex, bradykinesia, cogwheel rigidity, drooling, hypersomnia, hypersomnolence, hypokinesia, neck muscle spasm, oromandibular dystonia, sedation, tremor[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 11%)
Common (1% to 10%): Agitation, anxiety, restlessness
Uncommon (0.1% to 1%): Abnormal dreams, activation of mania/hypomania, catatonia, nightmare, panic attack, sleep disorder
Rare (less than 0.1%): Suicidal behavior/ideation
Frequency not reported: Psychomotor retardation[Ref]

Hematologic

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

Cardiovascular

Common (1% to 10%): Hypertension, tachycardia
Uncommon (0.1% to 1%): AV block 1st degree, angina pectoris, 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, 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[Ref]

Hepatic

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

Hypersensitivity

Rare (less than 0.1%): Angioedema
Frequency not reported: Allergic rhinitis, hypersensitivity[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
Uncommon (0.1% to 1%): Lethargy
Rare (less than 0.1%): Sudden death
Frequency not reported: Neonatal drug withdrawal syndrome[Ref]

Respiratory

Common (1% to 10%): Nasopharyngitis, oropharyngeal pain, rhinitis
Postmarketing reports: Difficulty breathing, dyspnea, nasal congestion, pulmonary embolism, rhinorrhea, throat swelling, throat tightness, tongue protrusion, upper respiratory tract infection[Ref]

References

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

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

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

Some side effects of lurasidone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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