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Latuda

Last reviewed on RxList: 10/12/2017
Latuda Side Effects Center

Last reviewed on RxList 10/12/2017

Latuda (lurasidone hydrochloride) is an atypical antipsychotic used to treat schizophrenia. Common side effects of Latuda include:

  • drowsiness,
  • dizziness,
  • nausea,
  • diarrhea,
  • stomach pain,
  • loss of appetite,
  • shaking,
  • muscle stiffness,
  • weight gain,
  • mask-like facial expression,
  • inability to keep still,
  • restlessness,
  • agitation,
  • blurred vision,
  • breast swelling or discharge,
  • missed menstrual periods,
  • decreased sex drive,
  • impotence, or
  • difficulty having an orgasm.

Tell your doctor right if you experience serious side effects of Latuda including:

  • drooling,
  • trouble swallowing,
  • fainting,
  • signs of infection (such as persistent cough, fever)
  • fast or uneven or pounding heartbeats;
  • agitation, hostility, confusion, thoughts about hurting yourself,
  • seizures (convulsions),
  • fever, chills, body aches, flu symptoms,
  • sores in your mouth and throat,
  • high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss),
  • very stiff (rigid) muscles, high fever, sweating, confusion, tremors, feeling like you might pass out, or
  • twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs.

The recommended starting dose of Latuda is 40 mg once daily, and it has been shown to be effective in a dose range of 40 mg/day to 160 mg/day. Latuda may interact with diltiazem, azole antifungals, HIV drugs, antibiotics, rifamycins, antidepressants, or other products that cause dizziness or drowsiness, including alcohol, antihistamines, drugs for sleep or anxiety, muscle relaxants, and narcotics. Tell your doctor all medications and supplements you use. During pregnancy, Latuda should be used only when prescribed. Do not stop taking this medication unless directed by your doctor. Babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice symptoms in your newborn during their first month, tell the doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Our Latuda (lurasidone hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Latuda Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking lurasidone and call your doctor at once if you have a serious side effect such as:

  • dizziness, fainting, fast or pounding heartbeats;
  • agitation, hostility, confusion, thoughts about hurting yourself;
  • seizure (convulsions);
  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;
  • high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss);
  • very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
  • trouble swallowing; or
  • twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs.

Less serious side effects may include:

  • drowsiness;
  • feeling restless;
  • nausea, diarrhea, stomach pain, loss of appetite;
  • blurred vision;
  • weight gain;
  • breast swelling or discharge;
  • missed menstrual periods; or
  • decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Latuda (Lurasidone HCL Tablets for Oral Administration)

Latuda Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in more detail in other sections of the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Adults

The information below is derived from an integrated clinical study database for LATUDA consisting of 3799 adult patients exposed to one or more doses of LATUDA for the treatment of schizophrenia, and bipolar depression in placebo-controlled studies. This experience corresponds with a total experience of 1250.9 patient-years. A total of 1106 LATUDA-treated patients had at least 24 weeks and 371 LATUDA-treated patients had at least 52 weeks of exposure.

Adverse events during exposure to study treatment were obtained by general inquiry and voluntarily reported adverse experiences, as well as results from physical examinations, vital signs, ECGs, weights and laboratory investigations. Adverse experiences were recorded by clinical investigators using their own terminology. In order to provide a meaningful estimate of the proportion of individuals experiencing adverse events, events were grouped in standardized categories using MedDRA terminology.

Schizophrenia

The following findings are based on the short-term, placebo-controlled premarketing adult studies for schizophrenia in which LATUDA was administered at daily doses ranging from 20 to 160 mg (n=1508).

Commonly Observed Adverse Reactions:

The most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo) in patients treated with LATUDA were somnolence, akathisia, extrapyramidal symptoms, and nausea.

Adverse Reactions Associated with Discontinuation of Treatment:

A total of 9.5% (143/1508) LATUDA-treated patients and 9.3% (66/708) of placebo-treated patients discontinued due to adverse reactions. There were no adverse reactions associated with discontinuation in subjects treated with LATUDA that were at least 2% and at least twice the placebo rate.

Adverse Reactions Occurring at an Incidence of 2% or More in LATUDA-Treated Patients:

Adverse reactions associated with the use of LATUDA (incidence of 2% or greater, rounded to the nearest percent and LATUDA incidence greater than placebo) that occurred during acute therapy (up to 6 weeks in patients with schizophrenia) are shown in Table 17.

Table 17: Adverse Reactions in 2% or More of LATUDA-Treated Patients and That Occurred at Greater Incidence than in the Placebo-Treated Patients in Adult Short-term Schizophrenia Studies

Percentage of Patients Reporting Reaction
LATUDA
Body System or Organ Class Placebo
(N=708)
(%)
20mg/day
(N=71)
(%)
40mg/day
(N=487)
(%)
80 mg/day
(N=538)
(%)
120 mg/day
(N=291)
(%)
160 mg/day
(N=121)
(%)
AllLATUDA
(N=1508)
(%)
Gastrointestinal Disorders
  Nausea 5 11 10 9 13 7 10
  Vomiting 6 7 6 9 9 7 8
  Dyspepsia 5 11 6 5 8 6 6
  Salivary Hypersecretion <1 1 1 2 4 2 2
Musculoskeletal and Connective Tissue Disorders
  Back Pain 2 0 4 3 4 0 3
Nervous System Disorders
  Somnolence* 7 15 16 15 26 8 17
  Akathisia 3 6 11 12 22 7 13
  Extrapyramidal Disorder** 6 6 11 12 22 13 14
  Dizziness 2 6 4 4 5 6 4
Psychiatric Disorders
  Insomnia 8 8 10 11 9 7 10
  Agitation 4 10 7 3 6 5 5
  Anxiety 4 3 6 4 7 3 5
  Restlessness 1 1 3 1 3 2 2
Note: Figures rounded to the nearest integer
* Somnolence includes adverse event terms: hypersomnia, hypersomnolence, sedation, and somnolence
** Extrapyramidal symptoms include adverse event terms: bradykinesia, cogwheel rigidity, drooling, dystonia, extrapyramidal disorder, hypokinesia, muscle rigidity, oculogyric crisis, oromandibular dystonia, parkinsonism, psychomotor retardation, tongue spasm, torticollis, tremor, and trismus

Dose-Related Adverse Reactions in the Schizophrenia Studies

Akathisia and extrapyramidal symptoms were dose-related. The frequency of akathisia increased with dose up to 120 mg/day (5.6% for LATUDA 20 mg, 10.7% for LATUDA 40 mg, 12.3% for LATUDA 80 mg, and 22.0% for LATUDA 120 mg). Akathisia was reported by 7.4% (9/121) of patients receiving 160 mg/day. Akathisia occurred in 3.0% of subjects receiving placebo. The frequency of extrapyramidal symptoms increased with dose up to 120 mg/day (5.6% for LATUDA 20 mg, 11.5% for LATUDA 40 mg, 11.9% for LATUDA 80 mg, and 22.0% for LATUDA 120 mg).

Bipolar Depression (Monotherapy)

The following findings are based on the adult short-term, placebo-controlled premarketing study for bipolar depression in which LATUDA was administered at daily doses ranging from 20 to 120 mg (n=331).

Commonly Observed Adverse Reactions:

The most common adverse reactions (incidence ≥5%, in either dose group, and at least twice the rate of placebo) in patients treated with LATUDA were akathisia, extrapyramidal symptoms, somnolence, nausea, vomiting, diarrhea, and anxiety.

Adverse Reactions Associated with Discontinuation of Treatment:

A total of 6.0% (20/331) LATUDA-treated patients and 5.4% (9/168) of placebo-treated patients discontinued due to adverse reactions. There were no adverse reactions associated with discontinuation in subjects treated with LATUDA that were at least 2% and at least twice the placebo rate.

Adverse Reactions Occurring at an Incidence of 2% or More in LATUDA-Treated Patients:

Adverse reactions associated with the use of LATUDA (incidence of 2% or greater, rounded to the nearest percent and LATUDA incidence greater than placebo) that occurred during acute therapy (up to 6 weeks in patients with bipolar depression) are shown in Table 18.

Table 18: Adverse Reactions in 2% or More of LATUDA-Treated Patients and That Occurred at Greater Incidence than in the Placebo-Treated Patients in the Adult Short-term Monotherapy Bipolar Depression Study

Body System or Organ Class
Dictionary-derived Term
Percentage of Patients Reporting Reaction
Placebo
(N=168)
(%)
LATUDA
20-60 mg/day
(N=164)
(%)
LATUDA
80-120 mg/day
(N=167)
(%)
All LATUDA
(N=331)
(%)
Gastrointestinal Disorders
  Nausea 8 10 17 14
  Vomiting 2 2 6 4
  Diarrhea 2 5 3 4
  Dry Mouth 4 6 4 5
Infections and Infestations
  Nasopharyngitis 1 4 4 4
  Influenza 1 <1 2 2
  Urinary Tract Infection <1 2 1 2
Musculoskeletal and Connective Tissue Disorders
  Back Pain <1 3 <1 2
Nervous System Disorders
  Extrapyramidal Symptoms* 2 5 9 7
  Akathisia 2 8 11 9
  Somnolence** 7 7 14 11
Psychiatric Disorders
  Anxiety 1 4 5 4
Note: Figures rounded to the nearest integer
*Extrapyramidal symptoms include adverse event terms: bradykinesia, cogwheel rigidity, drooling, dystonia, extrapyramidal disorder, glabellar reflex abnormal, hypokinesia, muscle rigidity, oculogyric crisis, oromandibular dystonia, parkinsonism, psychomotor retardation, tongue spasm, torticollis, tremor, and trismus
** Somnolence includes adverse event terms: hypersomnia, hypersomnolence, sedation, and somnolence

Dose-Related Adverse Reactions in the Monotherapy Study:

In the adult short-term, placebo-controlled study (involving lower and higher LATUDA dose ranges) [see Clinical Studies] the adverse reactions that occurred with a greater than 5% incidence in the patients treated with LATUDA in any dose group and greater than placebo in both groups were nausea (10.4%, 17.4%), somnolence (7.3%, 13.8%), akathisia (7.9%, 10.8%), and extrapyramidal symptoms (4.9%, 9.0%) for LATUDA 20 to 60 mg/day and LATUDA 80 to 120 mg/day, respectively.

Bipolar Depression

Adjunctive Therapy With Lithium Or Valproate

The following findings are based on two adult short-term, placebo-controlled premarketing studies for bipolar depression in which LATUDA was administered at daily doses ranging from 20 to 120 mg as adjunctive therapy with lithium or valproate (n=360).

Commonly Observed Adverse Reactions:

The most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) in subjects treated with LATUDA were akathisia and somnolence.

Adverse Reactions Associated with Discontinuation of Treatment:

A total of 5.8% (21/360) LATUDA-treated patients and 4.8% (16/334) of placebo-treated patients discontinued due to adverse reactions. There were no adverse reactions associated with discontinuation in subjects treated with LATUDA that were at least 2% and at least twice the placebo rate.

Adverse Reactions Occurring at an Incidence of 2% or More in LATUDA-Treated Patients:

Adverse reactions associated with the use of LATUDA (incidence of 2% or greater, rounded to the nearest percent and LATUDA incidence greater than placebo) that occurred during acute therapy (up to 6 weeks in patients with bipolar depression) are shown in Table 19.

Table 19: Adverse Reactions in 2% or More of LATUDA-Treated Patients and That Occurred at Greater Incidence than in the Placebo-Treated Patients in the Adult Short-term Adjunctive Therapy Bipolar Depression Studies

Body System or Organ Class
Dictionary-derived Term
Percentage of Patients Reporting Reaction
Placebo
(N=334)
(%)
LATUDA
20 to 120 mg/day
(N=360)
(%)
Gastrointestinal Disorders
  Nausea 10 14
  Vomiting 1 4
General Disorders
  Fatigue 1 3
Infections and Infestations
  Nasopharyngitis 2 4
Investigations
  Weight Increased <1 3
Metabolism and Nutrition Disorders
  Increased Appetite 1 3
Nervous System Disorders
  Extrapyramidal Symptoms* 9 14
  Somnolence** 5 11
  Akathisia 5 11
Psychiatric Disorders
  Restlessness <1 4
Note: Figures rounded to the nearest integer
*Extrapyramidal symptoms include adverse event terms: bradykinesia, cogwheel rigidity, drooling, dystonia, extrapyramidal disorder, glabellar reflex abnormal, hypokinesia, muscle rigidity, oculogyric crisis, oromandibular dystonia, parkinsonism, psychomotor retardation, tongue spasm, torticollis, tremor, and trismus
** Somnolence includes adverse event terms: hypersomnia, hypersomnolence, sedation, and somnolence

Adolescents

The following findings are based on the short-term, placebo-controlled adolescent study for schizophrenia in which LATUDA was administered at daily doses ranging from 40 (N=110) to 80 mg (N=104).

Commonly Observed Adverse Reactions:

The most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) in adolescent patients (13 to 17 years) treated with LATUDA were somnolence, nausea, akathisia, extrapyramidal symptoms (non-akathisia, 40mg only), vomiting, and rhinorrhea/rhinitis (80mg only).

Adverse Reactions Associated with Discontinuation of Treatment:

The incidence of discontinuation due to adverse reactions between LATUDA-and placebo-treated adolescent patients (13 to 17 years) was 4% and 8%, respectively.

Adverse Reactions Occurring at an Incidence of 2% or More in LATUDA-Treated Patients:

Adverse reactions associated with the use of LATUDA (incidence of 2% or greater, rounded to the nearest percent and LATUDA incidence greater than placebo) that occurred during acute therapy (up to 6-weeks in adolescent patients with schizophrenia) are shown in Table 20.

Table 20: Adverse Reactions in 2% or More of LATUDA-Treated Patients and That Occurred at Greater Incidence than in the Placebo-Treated Patients in the Adolescent Short-term Schizophrenia Study

Body System or Organ Class
Dictionary-derived Term
Percentage of Patients Reporting Reaction
Placebo
(N=112)
LATUDA
40 mg/day
(N=110)
LATUDA
80 mg/day
(N=104)
All LATUDA
(N=214)
Gastrointestinal Disorders
  Nausea 3 13 14 14
  Vomiting 2 8 6 8
  Diarrhea 1 3 5 4
  Dry Mouth 0 2 3 2
Infections and Infestations
  Viral Infection** 6 11 10 10
  Rhinitis*** 2 <1 8 4
  Oropharyngeal pain 0 <1 3 2
  Tachycardia 0 0 3 1
Nervous System Disorders
  Somnolence* 7 15 13 15
  Akathisia 2 9 9 9
  Dizziness 1 5 5 5
Note: Figures rounded to the nearest integer
* Somnolence includes adverse event terms: hypersomnia, sedation, and somnolence
** Viral Infection includes adverse event terms: nasopharyngitis, influenza, viral infection, upper respiratory tract infection *** Rhinitis incudes adverse event terms: rhinitis, allergic rhinitis, rhinorrhea, and nasal congestion

Extrapyramidal Symptoms
Schizophrenia

Adults

In the short-term, placebo-controlled schizophrenia studies, for LATUDA-treated patients, the incidence of reported events related to extrapyramidal symptoms (EPS), excluding akathisia and restlessness, was 13.5% versus 5.8% for placebo-treated patients. The incidence of akathisia for LATUDA-treated patients was 12.9% versus 3.0% for placebo-treated patients. Incidence of EPS by dose is provided in Table 21.

Table 21: Incidence of EPS Compared to Placebo in Adult Schizophrenia Studies

Adverse Event Term LATUDA
Placebo
(N=708)
(%)
20 mg/day
(N=71)
(%)
40 mg/day
(N=487)
(%)
80 mg/day
(N=538)
(%)
120 mg/day
(N=291
) (%)
160 mg/day
(N=121)
(%)
All EPS events 9 10 21 23 39 20
All EPS events, excluding Akathisia/ Restlessness 6 6 11 12 22 13
  Akathisia 3 6 11 12 22 7
  Dystonia* <1 0 4 5 7 2
  Parkinsonism** 5 6 9 8 17 11
  Restlessness 1 1 3 1 3 2
Note: Figures rounded to the nearest integer
* Dystonia includes adverse event terms: dystonia, oculogyric crisis, oromandibular dystonia, tongue spasm, torticollis, and trismus
** Parkinsonism includes adverse event terms: bradykinesia, cogwheel rigidity, drooling, extrapyramidal disorder, hypokinesia, muscle rigidity, parkinsonism, psychomotor retardation, and tremor

Adolescents

In the short-term, placebo-controlled, study of schizophrenia in adolescents, the incidence of EPS, excluding events related to akathisia, for LATUDA-treated patients was higher in the 40 mg (10%) and the 80 mg (7.7%) treatment groups vs. placebo (3.6%); and the incidence of akathisia-related events for LATUDA-treated patients was 8.9% vs. 1.8% for placebo-treated patients. Incidence of EPS by dose is provided in Table 22.

Table 22: Incidence of EPS Compared to Placebo in the Adolescent Schizophrenia Study

Adverse Event Term   LATUDA
Placebo
(N=112)
(%)
40 mg/day
(N=110)
(%)
80 mg/day
(N=104)
(%)
All EPS events 5 14 14
All EPS events, excluding Akathisia/Restlessness 4 7 7
  Akathisia 2 9 9
  Parkinsonism** <1 4 0
  Dyskinesia <1 <1 1
  Dystonia* 0 <1 1
Note: Figures rounded to the nearest integer
* Dystonia includes adverse event terms: dystonia, trismus, oculogyric crisis, oromandibular dystonia, tongue spasm, and torticollis
** Parkinsonism includes adverse event terms: bradykinesia, drooling, extrapyramidal disorder, glabellar reflex abnormal, hypokinesia, parkinsonism, and psychomotor retardation

Bipolar Depression

Monotherapy

In the adult short-term, placebo-controlled monotherapy bipolar depression study, for LATUDA-treated patients, the incidence of reported events related to EPS, excluding akathisia and restlessness was 6.9% versus 2.4% for placebo-treated patients. The incidence of akathisia for LATUDA-treated patients was 9.4% versus 2.4% for placebo-treated patients. Incidence of EPS by dose groups is provided in Table 23.

Table 23: Incidence of EPS Compared to Placebo in the Adult Monotherapy Bipolar Depression Study

Adverse Event Term Placebo
(N=168)
(%)
LATUDA
20 to 60 mg/day
(N=164)
(%)
80 to 120 mg/day
(N=167)
(%)
All EPS events 5 12 20
All EPS events, excluding Akathisia/Restlessness 2 5 9
  Akathisia 2 8 11
  Dystonia* 0 0 2
  Parkinsonism** 2 5 8
  Restlessness <1 0 3
Note: Figures rounded to the nearest integer
* Dystonia includes adverse event terms: dystonia, oculogyric crisis, oromandibular dystonia, tongue spasm, torticollis, and trismus
** Parkinsonism includes adverse event terms: bradykinesia, cogwheel rigidity, drooling, extrapyramidal disorder, glabellar reflex abnormal, hypokinesia, muscle rigidity, parkinsonism, psychomotor retardation, and tremor

Adjunctive Therapy with Lithium or Valproate

In the adult short-term, placebo-controlled adjunctive therapy bipolar depression studies, for LATUDA-treated patients, the incidence of EPS, excluding akathisia and restlessness, was 13.9% versus 8.7% for placebo. The incidence of akathisia for LATUDA-treated patients was 10.8% versus 4.8% for placebo-treated patients. Incidence of EPS is provided in Table 24.

Table 24: Incidence of EPS Compared to Placebo in the Adult Adjunctive Therapy Bipolar Depression Studies

Adverse Event Term Placebo
(N=334)
(%)
LATUDA
20 to 120 mg/day
(N=360)
(%)
All EPS events 13 24
All EPS events, excluding Akathisia/Restlessness 9 14
  Akathisia 5 11
  Dystonia* <1 1
  Parkinsonism** 8 13
  Restlessness <1 4
Note: Figures rounded to the nearest integer
* Dystonia includes adverse event terms: dystonia, oculogyric crisis, oromandibular dystonia, tongue spasm, torticollis, and trismus
' ** Parkinsonism includes adverse event terms: bradykinesia, cogwheel rigidity, drooling, extrapyramidal disorder, glabellar reflex abnormal, hypokinesia, muscle rigidity, parkinsonism, psychomotor retardation, and tremor

In the short-term, placebo-controlled schizophrenia and bipolar depression studies, data was objectively collected on the Simpson Angus Rating Scale (SAS) for extrapyramidal symptoms (EPS), the Barnes Akathisia Scale (BAS) for akathisia and the Abnormal Involuntary Movement Scale (AIMS) for dyskinesias.

Schizophrenia

Adults

The mean change from baseline for LATUDA-treated patients for the SAS, BAS and AIMS was comparable to placebo-treated patients, with the exception of the Barnes Akathisia Scale global score (LATUDA, 0.1; placebo, 0.0). The percentage of patients who shifted from normal to abnormal was greater in LATUDA-treated patients versus placebo for the BAS (LATUDA, 14.4%; placebo, 7.1%), the SAS (LATUDA, 5.0%; placebo, 2.3%) and the AIMS (LATUDA, 7.4%; placebo, 5.8%).

Adolescents

The mean change from baseline for LATUDA-treated patients with adolescent schizophrenia for the SAS, BAS and AIMS was comparable to placebo-treated patients. The percentage of patients who shifted from normal to abnormal was greater in LATUDA-treated patients versus placebo for the BAS (LATUDA, 7.0%; placebo, 1.8%), the SAS (LATUDA, 8.3%; placebo, 2.7%) and the AIMS (LATUDA, 2.8%; placebo, 0.9%).

Bipolar Depression

onotherapy

The mean change from baseline for LATUDA-treated adult patients for the SAS, BAS and AIMS was comparable to placebo-treated patients. The percentage of patients who shifted from normal to abnormal was greater in LATUDA-treated patients versus placebo for the BAS (LATUDA, 8.4%; placebo, 5.6%), the SAS (LATUDA, 3.7%; placebo, 1.9%) and the AIMS (LATUDA, 3.4%; placebo, 1.2%).

Adjunctive Therapy with Lithium or Valproate

The mean change from baseline for LATUDA-treated adult patients for the SAS, BAS and AIMS was comparable to placebo-treated patients. The percentage of patients who shifted from normal to abnormal was greater in LATUDA-treated patients versus placebo for the BAS (LATUDA, 8.7%; placebo, 2.1%), the SAS (LATUDA, 2.8%; placebo, 2.1%) and the AIMS (LATUDA, 2.8%; placebo, 0.6%).

Dystonia

Class Effect

Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first-generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.

Schizophrenia

Adults

In the short-term, placebo-controlled schizophrenia clinical studies, dystonia occurred in 4.2% of LATUDA-treated subjects (0.0% LATUDA 20 mg, 3.5% LATUDA 40 mg, 4.5% LATUDA 80 mg, 6.5% LATUDA 120 mg and 2.5% LATUDA 160 mg) compared to 0.8% of subjects receiving placebo. Seven subjects (0.5%, 7/1508) discontinued clinical trials due to dystonic events – four were receiving LATUDA 80 mg/day and three were receiving LATUDA 120 mg/day.

Adolescents

In the short-term, placebo-controlled, adolescent schizophrenia study, dystonia occurred in 1% of LATUDA-treated patients (1% LATUDA 40 mg and 1% LATUDA 80 mg) compared to 0% of patients receiving placebo. No patients discontinued the clinical study due to dystonic events.

Bipolar Depression

Monotherapy

In the adult short-term, flexible-dose, placebo-controlled monotherapy bipolar depression study, dystonia occurred in 0.9% of LATUDA-treated subjects (0.0% and 1.8% for LATUDA 20 to 60 mg/day and LATUDA 80 to 120 mg/day, respectively) compared to 0.0% of subjects receiving placebo. No subject discontinued the clinical study due to dystonic events.

Adjunctive Therapy with Lithium or Valproate

In the adult short-term, flexible-dose, placebo-controlled adjunctive therapy bipolar depression studies, dystonia occurred in 1.1% of LATUDA-treated subjects (20 to 120 mg) compared to 0.6% of subjects receiving placebo. No subject discontinued the clinical study due to dystonic events.

Other Adverse Reactions Observed During The Premarketing Evaluation Of LATUDA

Following is a list of adverse reactions reported by adult patients treated with LATUDA at multiple doses of ≥ 20 mg once daily within the premarketing database of 2905 patients with schizophrenia. The reactions listed are those that could be of clinical importance, as well as reactions that are plausibly drug-related on pharmacologic or other grounds. Reactions listed in Table 16 or those that appear elsewhere in the LATUDA label are not included. Although the reactions reported occurred during treatment with LATUDA, they were not necessarily caused by it.

Reactions are further categorized by organ class and listed in order of decreasing frequency according to the following definitions: those occurring in at least 1/100 patients (frequent) (only those not already listed in the tabulated results from placebo-controlled studies appear in this listing); those occurring in 1/100 to 1/1000 patients (infrequent); and those occurring in fewer than 1/1000 patients (rare).

Blood and Lymphatic System Disorders: Infrequent: anemia

Cardiac Disorders: Frequent: tachycardia; Infrequent: AV block 1st degree, angina pectoris, bradycardia

Ear and Labyrinth Disorders: Infrequent: vertigo

Eye Disorders: Frequent: blurred vision

Gastrointestinal Disorders: Frequent: abdominal pain, diarrhea; Infrequent: gastritis

General Disorders and Administrative Site Conditions: Rare: sudden death

Investigations: Frequent: CPK increased

Metabolism and Nutritional System Disorders: Frequent: decreased appetite

Musculoskeletal and Connective Tissue Disorders: Rare: rhabdomyolysis

Nervous System Disorders: Infrequent: cerebrovascular accident, dysarthria

Psychiatric Disorders: Infrequent: abnormal dreams, panic attack, sleep disorder

Renal and Urinary Disorders: Infrequent: dysuria; Rare: renal failure

Reproductive System and Breast Disorders: Infrequent: amenorrhea, dysmenorrhea; Rare: breast enlargement, breast pain, galactorrhea, erectile dysfunction

Skin and Subcutaneous Tissue Disorders: Frequent: rash, pruritus; Rare: angioedema

Vascular Disorders: Frequent: hypertension

Clinical Laboratory Changes

Schizophrenia

Adults

Serum Creatinine: In short-term, placebo-controlled trials, the mean change from Baseline in serum creatinine was +0.05 mg/dL for LATUDA-treated patients compared to +0.02 mg/dL for placebo-treated patients. A creatinine shift from normal to high occurred in 3.0% (43/1453) of LATUDA-treated patients and 1.6% (11/681) on placebo. The threshold for high creatinine value varied from > 0.79 to > 1.3 mg/dL based on the centralized laboratory definition for each study (Table 25).

Table 25: Serum Creatinine Shifts from Normal at Baseline to High at Study End-Point in Adult Schizophrenia Studies

Laboratory Parameter Placebo
(N=708)
LATUDA
20 mg/day
(N=71)
LATUDA
40 mg/day
(N=487)
LATUDA
80 mg/day
(N=538)
LATUDA
120 mg/day
(N=291)
LATUDA
160 mg/day
(N=121)
Serum Creatinine Elevated 2% 1% 2% 2% 5% 7%

Adolescents

Serum Creatinine: In the short-term, placebo-controlled, adolescent schizophrenia study, the mean change from Baseline in serum creatinine was −0.009 mg/dL for LATUDA-treated patients compared to +0.017 mg/dL for placebo-treated patients. A creatinine shift from normal to high (based on the centralized laboratory definition) occurred in 7.2% (14/194) of LATUDA-treated patients and 2.9% (3/103) on placebo (Table 26).

Table 26: Serum Creatinine Shifts from Normal at Baseline to High at Study End-Point in the Adolescent Schizophrenia Study

Laboratory Parameter Placebo
(N=103)
LATUDA
40 mg/day
(N=97)
LATUDA
80 mg/day
(N=97)
Serum Creatinine Elevated 2.9% 7.2% 7.2%

Bipolar Depression

Monotherapy

Serum Creatinine: In the adult short-term, flexible-dose, placebo-controlled monotherapy bipolar depression study, the mean change from Baseline in serum creatinine was +0.01 mg/dL for LATUDA-treated patients compared to -0.02 mg/dL for placebo-treated patients. A creatinine shift from normal to high occurred in 2.8% (9/322) of LATUDA-treated patients and 0.6% (1/162) on placebo (Table 27).

Table 27: Serum Creatinine Shifts from Normal at Baseline to High at Study End-Point in the Adult Monotherapy Bipolar Depression Study

Laboratory Parameter Placebo
(N=168)
LATUDA
20 to 60 mg/day
(N=164)
LATUDA
80 to 120 mg/day
(N=167)
Serum Creatinine Elevated <1% 2% 4%

Adjunctive Therapy with Lithium or Valproate

Serum Creatinine: In adult short-term, placebo-controlled premarketing adjunctive studies for bipolar depression, the mean change from Baseline in serum creatinine was +0.04 mg/dL for LATUDA-treated patients compared to -0.01 mg/dL for placebo-treated patients. A creatinine shift from normal to high occurred in 4.3% (15/360) of LATUDA-treated patients and 1.6% (5/334) on placebo (Table 28).

Table 28: Serum Creatinine Shifts from Normal at Baseline to High at Study End-Point in the Adult Adjunctive Therapy Bipolar Depression Studies

Laboratory Parameter Placebo
(N=334)
LATUDA
20 to 120 mg/day
(N=360)
Serum Creatinine Elevated 2% 4%

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Latuda. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hypersensitivity Reactions: Urticaria, throat swelling, tongue swelling, and dyspnea.

Hyponatremia

Read the entire FDA prescribing information for Latuda (Lurasidone HCL Tablets for Oral Administration)

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