Latuda
Latuda Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Latuda (lurasidone hydrochloride) is used to treat schizophrenia. It is an atypical antipsychotic. Common side effects include drowsiness, dizziness, nausea, shaking, muscle stiffness, weight gain, mask-like facial expression, inability to keep still, and agitation.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Latuda in Detail - Patient Information: Side Effects
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) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Latuda Overview - Patient Information: Side Effects
This medication may cause a serious drop in blood pressure, especially when starting this medication. To reduce your risk of side effects from low blood pressure (such as dizziness), get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if any of these serious side effects occur: drooling/trouble swallowing, fainting, fast/irregular heartbeat, signs of infection (such as persistent cough, fever).
Infrequently, this medication may cause face/muscle twitching and uncontrollable movements (tardive dyskinesia). In some cases, this condition may be permanent. Tell your doctor immediately if you develop any uncontrollable movements such as lip smacking, mouth puckering, tongue thrusting, chewing, or unusual arm/leg movements.
This drug may rarely make your blood sugar level rise, which can cause or worsen diabetes. Weight gain from this drug may increase the risk of this side effect. Tell your doctor immediately if you develop symptoms of high blood sugar such as increased thirst and urination. If you already have diabetes, be sure to check your blood sugar level regularly.
In rare cases, lurasidone may increase your level of a certain substance made by the body (prolactin). For females, this increase in prolactin may result in unwanted breast milk, missed/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor immediately.
Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.
This drug may rarely cause a serious (sometimes fatal) nervous system problem (neuroleptic malignant syndrome-NMS). Get medical help right away if you notice any of the following side effects: unexplained fever, stiff muscles, increased sweating, fast/irregular heartbeat, sudden mental/mood changes (such as confusion, loss of consciousness).
Get medical help right away if this serious side effects occur: seizure.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Latuda (Lurasidone HCL Tablets for Oral Administration)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Latuda FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
The following adverse reactions are discussed in more detail in other sections of the labeling:
- Use in Elderly Patients with Dementia-Related Psychosis [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
- Cerebrovascular Adverse Reactions, Including Stroke [see WARNINGS AND PRECAUTIONS]
- Neuroleptic Malignant Syndrome [see WARNINGS AND PRECAUTIONS]
- Tardive Dyskinesia [see WARNINGS AND PRECAUTIONS]
- Hyperglycemia and Diabetes Mellitus [see WARNINGS AND PRECAUTIONS]
- Hyperprolactinemia [see WARNINGS AND PRECAUTIONS]
- Leukopenia, Neutropenia, and Agranulocytosis [see WARNINGS AND PRECAUTIONS]
- Orthostatic Hypotension and Syncope [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
- Potential for Cognitive and Motor Impairment [see WARNINGS AND PRECAUTIONS]
- Body Temperature Regulation [see WARNINGS AND PRECAUTIONS]
- Suicide [see WARNINGS AND PRECAUTIONS]
- Dysphagia [see WARNINGS AND PRECAUTIONS]
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.
The information below is derived from a clinical study database for LATUDA consisting of 2905 patients with schizophrenia exposed to one or more doses with a total experience of 985.3 patient-years. Of these patients, 1508 participated in short-term, placebo-controlled schizophrenia studies with doses of 20 mg, 40 mg, 80 mg, 120 mg or 160 mg once daily. A total of 769 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.
The following findings are based on the short-term, placebo-controlled premarketing 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, nausea and parkinsonism.
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 6.
Table 6: Adverse Reactions in 2% or More of LATUDA-Treated
Patients and That Occurred at Greater Incidence than in the Placebo-Treated
Patients in Short-term Schizophrenia Studies
| Body System or Organ Class Dictionary-derived Term | Percentage of Reporting Reaction | |
| Patients Placebo (N=708) |
All LATUDA (N=1508) |
|
| Gastrointestinal Disorders | ||
| Nausea | 5 | 10 |
| Vomiting | 6 | 8 |
| Dyspepsia | 5 | 6 |
| Salivary Hypersecretion | < 1 | 2 |
| Musculoskeletal and Connective Tissue Disorders | ||
| Back Pain | 2 | 3 |
| Nervous System Disorders | ||
| Somnolence* | 7 | 17 |
| Akathisia | 3 | 13 |
| Parkinsonism** | 5 | 10 |
| Dizziness | 2 | 4 |
| Dystonia*** | < 1 | 4 |
| Psychiatric Disorders | ||
| Insomnia | 8 | 10 |
| Agitation | 4 | 5 |
| Anxiety | 4 | 5 |
| Restlessness | 1 | 2 |
| Note: Figures rounded to the
nearest integer * Somnolence includes adverse event terms: hypersomnia, hypersomnolence, sedation, and somnolence ** Parkinsonism includes adverse event terms: bradykinesia, cogwheel rigidity, drooling, extrapyramidal disorder, hypokinesia, muscle rigidity, parkinsonism, psychomotor retardation, and tremor *** Dystonia includes adverse event terms: dystonia, oculogyric crisis, oromandibular dystonia, tongue spasm, torticollis, and trismus |
||
Dose-Related Adverse Reactions
In pooled data from the short-term, placebo-controlled, fixed-dose studies, there were no dose-related adverse reactions (greater than 5% incidence) in patients treated with LATUDA across the 20 mg/day to 160 mg/day dose range. However, the frequency of akathisia increased with dose up to 120 mg/day (5.6% LATUDA 20 mg, 10.7% LATUDA 40 mg, 12.3% LATUDA 80 mg, 22.0% 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.
Extrapyramidal Symptoms
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 7.
Table 7: Incidence of EPS Compared to Placebo
| Adverse Event Term | LATUDA | |||||
| Placebo (N=709) (%) |
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 |
||||||
In the short-term, placebo-controlled schizophrenia studies, data was objectively collected on the Simpson Angus Rating Scale for extrapyramidal symptoms (EPS), the Barnes Akathisia Scale (for akathisia) and the Abnormal Involuntary Movement Scale (for dyskinesias). The mean change from baseline for LATUDA-treated patients 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%) and the SAS (LATUDA, 5.0%; placebo, 2.3%).
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.
In the short-term, placebo-controlled clinical trials, 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.
Other Adverse Reactions Observed During the Premarketing Evaluation of LATUDA
Following is a list of adverse reactions reported by patients treated with LATUDA at multiple doses of ≥ 20 mg once daily during any phase of a study within the database of 2905 patients. 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 6 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
Read the entire FDA prescribing information for Latuda (Lurasidone HCL Tablets for Oral Administration) »
Additional Latuda Information
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