Lybalvi Side Effects

Generic name: olanzapine / samidorphan

Medically reviewed by Drugs.com. Last updated on Nov 5, 2024.

Note: This document provides detailed information about Lybalvi Side Effects associated with olanzapine / samidorphan. Some dosage forms listed on this page may not apply specifically to the brand name Lybalvi.

Applies to olanzapine / samidorphan: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may increase your risk for opioid overdose. Do not use this medicine if you are also using opioid medicines. Wait at least 7 days after you stopped taking short-acting opioids and at least 14 days after you stopped taking long-acting opioids before you start this medicine. Do not start taking opioid medicines for at least 5 days after treatment with this medicine.

Tell your doctor if you are pregnant or planning to become pregnant. This medicine may cause unwanted effects to newborn babies if used during the later part of pregnancy.

Check with your doctor right away if you have difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, seizures, 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 a condition called drug reaction with eosinophilia and systemic symptoms (DRESS). Call your doctor right away if you have a black, tarry stools, chest pain, chills, cough, fever, painful or difficult urination, sore throat, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness after 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 cholesterol and fats in the blood. If this condition occurs, your doctor may give you or your child some medicines that can lower the amount of cholesterol and fats in the blood.

This medicine may increase your weight. Your doctor may need to check your or your child's weight on a regular basis while you are using this medicine.

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.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

This medicine may add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for allergies or colds, sedatives, tranquilizers, or sleeping medicines, prescription pain medicines or narcotics, medicines for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any CNS depressants while you are taking this medicine.

Olanzapine and samidorphan may cause drowsiness, trouble with thinking, trouble with controlling body movements, or trouble with your vision, which may lead to falls, fractures or other injuries. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.

This medicine 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 immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, painful or difficult urination, sore throat, sores, ulcer, or white spots in the mouth, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness.

This medicine may make it more difficult for your body to cool down. It might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might vomit or have an upset stomach. Do not get too hot while you are exercising. Avoid places that are very hot. Call your doctor if you are too hot and can not cool down.

Check with your doctor right away if you have unexpected or excess milk flow from breasts, absent, missed, or irregular menstrual periods, stopping of menstrual bleeding, swelling of the breasts or breast soreness in both females and males, loss in sexual ability, desire, drive, or performance, decreased interest in sexual intercourse, or inability to have or keep an erection. These may be symptoms of high prolactin levels in the body (eg, galactorrhea, amenorrhea, gynecomastia, and impotence).

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 Lybalvi

Along with its needed effects, olanzapine / samidorphan 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 olanzapine / samidorphan:

Other side effects of Lybalvi

Some side effects of olanzapine / samidorphan 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:

For healthcare professionals

Applies to olanzapine / samidorphan: oral tablet.

General adverse events

The most commonly reported side effects included weight gain, somnolence, dyslipidemia, and dry mouth.^[Ref]

Metabolic

• Very common (10% or more): Weight gain (up to 25%), dyslipidemia (up to 14%), increased appetite (up to 11%)
• Common (1% to 10%): Decreased weight, increased glycosylated hemoglobin
• Frequency not reported: Metabolic changes
• Postmarketing reports: Diabetic ketoacidosis, hyperlipidemia, rhabdomyolysis^[Ref]

Hyperlipidemia included random cholesterol levels of at least 240 mg/dL and/or triglyceride levels of at least 1000 mg/dL.^[Ref]

Nervous system

• Very common (10% or more): Somnolence (up to 21%)
• Common (1% to 10%): Akathisia, amnesia, bradykinesia, dizziness, dyskinesia, dystonia, extrapyramidal adverse events, extrapyramidal disorder, extrapyramidal symptoms, headache, lethargy, paresthesia, parkinsonism, sedation, speech disorder, tremor
• Frequency not reported: Anticholinergic/antimuscarinic effects, cerebrovascular adverse reactions (in older patients with dementia-related psychosis), cognitive impairment, motor impairment, neuroleptic malignant syndrome, seizures, stroke, syncope, tardive dyskinesia
• Postmarketing reports: Diabetic coma, restless legs syndrome^[Ref]

Gastrointestinal

• Very common (10% or more): Dry mouth (up to 13%)
• Common (1% to 10%): Constipation, dyspepsia, increased salivation, nausea
• Frequency not reported: Dysphagia
• Postmarketing reports: Pancreatitis, salivary hypersecretion, vomiting^[Ref]

Musculoskeletal

• Common (1% to 10%): Back pain, increased blood creatine phosphokinase, muscle spasm, neck muscle spasm^[Ref]

Other

• Common (1% to 10%): Asthenia, fatigue, increased waist circumference
• Frequency not reported: Body temperature regulation, falls, increased mortality (in older patients with dementia-related psychosis), opioid withdrawal precipitation, risks with combination treatment with lithium/valproate, vulnerability to life-threatening opioid overdose
• Postmarketing reports: Discontinuation reaction^[Ref]

Hematologic

• Common (1% to 10%): Decreased neutrophil count, neutropenia
• Frequency not reported: Agranulocytosis, leukopenia^[Ref]

Psychiatric

• Common (1% to 10%): Restlessness, schizophrenia
• Postmarketing reports: Stuttering^[Ref]

Cardiovascular

• Common (1% to 10%): Increased blood pressure
• Frequency not reported: Orthostatic hypotension
• Postmarketing reports: Deep venous thrombosis, venous thromboembolic events^[Ref]

Endocrine

• Common (1% to 10%): Blood insulin increased
• Postmarketing reports: Hyperprolactinemia^[Ref]

Hypersensitivity

• Postmarketing reports: Allergic reaction, anaphylactoid reaction, angioedema^[Ref]

Respiratory

• Postmarketing reports: Pulmonary embolism^[Ref]

Genitourinary

• Postmarketing reports: Priapism^[Ref]

Dermatologic

• Postmarketing reports: Diaphoresis, drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome^[Ref]

Hepatic

• Common (1% to 10%): Abnormal liver function tests, increased ALT, increased AST
• Postmarketing reports: Cholestatic liver injury, hepatitis, jaundice, mixed liver injury^[Ref]

See also:

Frequently asked questions

• Does Lybalvi cause weight gain?
• Will Lybalvi trigger a false positive for opioids?

Further information

Lybalvi 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.

Medical Disclaimer