APPROVED USE
WELTRUZATM (olanzapine) for extended-release injectable suspension is a prescription medicine used in adults for the treatment of schizophrenia.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about WELTRUZA?
WELTRUZA can cause serious side effects, including an increased risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). WELTRUZA is not for the treatment of people with dementia-related psychosis.
WELTRUZA may cause serious side effects, including:
- Post-injection delirium/sedation syndrome (PDSS) is a serious problem that can happen when too much olanzapine enters the bloodstream too quickly. PDSS has happened in people who received another extended-release olanzapine medicine by injection into their muscles (intramuscularly). WELTRUZA is injected under the skin (subcutaneously). It is not known whether PDSS can happen with WELTRUZA. PDSS with an extended-release intramuscular injection has led to hospitalization, has happened within the first 3 hours of injection, but also happened after 3 hours of injection, and has the risk each time an injection is received. Tell your healthcare provider right away or go to the nearest emergency room if you get signs or symptoms of PDSS, including more sleepiness than usual, dizziness, confusion or disorientation, trouble walking or talking, stiff muscles or shakiness, weakness, feeling grouchy or angry, feeling anxious or nervous, increased blood pressure, seizures (convulsions), or passing out.
- Strokes in elderly people (cerebral problems) that can lead to death.
- Neuroleptic Malignant Syndrome (NMS). NMS is a serious condition that can lead to death. Seek medical attention right away if you have any of these symptoms: high fever, stiff muscles, confusion, changes in pulse, heart rate, or blood pressure, increased sweating.
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS is an allergic reaction that can cause death that may affect your skin or other parts of your body including your liver, kidney, lungs, or heart. Contact your healthcare provider right away if you experience any signs or symptoms of DRESS, including fever, skin rash or blistering or peeling skin, swelling of face, glands, or other body parts, cough or trouble breathing, chest pain, yellowing of the skin or eyes, dark urine or changes in urination.
- Problems with your metabolism that may include high blood sugar (hyperglycemia), diabetes mellitus, changes in the fat levels in your blood (dyslipidemia), and weight gain. Extremely high blood sugar can lead to coma or death. If you have diabetes or are at risk of diabetes (e.g., obesity, family history of diabetes), your healthcare provider should check your blood sugar before you start and during treatment with WELTRUZA. Call your healthcare provider if you have symptoms of high blood sugar, including feeling very thirsty, hungry, sick to your stomach, weak or tired, or confused; needing to urinate more than usual; or your breath smells fruity.
- Uncontrolled facial or body movements (tardive dyskinesia) that may not go away, even if you stop receiving WELTRUZA. Tell your healthcare provider if you get any body movements that you cannot control.
- Decreased blood pressure (orthostatic hypotension). You may feel dizzy or lightheaded, get a fast or slow heartbeat, or faint, when you rise too quickly from a sitting or lying position. Drinking alcohol and using other medicines that make you dizzy can increase your risk for orthostatic hypotension. Avoid drinking alcohol during treatment with WELTRUZA.
- Falls. WELTRUZA may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries.
- Low white blood cell counts. Your healthcare provider may do white blood cell count tests during your first few months of treatment with WELTRUZA.
- Difficulty swallowing that can cause food or liquid to get into your lungs.
- Seizures (convulsions).
- Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities. Do not drive, operate machinery, or do other dangerous activities until you know how WELTRUZA affects you.
- Problems controlling your body temperature so that you feel too warm. Avoid getting overheated or dehydrated.
- Certain side effects from the way WELTRUZA works in your body such as constipation, dry mouth, fast heartbeat, urinary retention, or prostate and bowel problems. Your risk is increased if you take other medicines that also cause these side effects.
- Increased prolactin levels in your blood (hyperprolactinemia). WELTRUZA can cause a rise in the blood levels of a hormone called prolactin that may cause side effects including missed menstrual periods, a reversible reduction in fertility in females who are able to become pregnant, leakage of milk from the breasts, development of breasts in men, or problems with erection.
The most common side effects of olanzapine in patients with schizophrenia include weight gain, sleepiness, headache, and constipation. Injection site reactions, including hardness, pain, redness, itching, and swelling, were reported with WELTRUZA.
These are not all the possible side effects with WELTRUZA. Tell your healthcare provider if you have any side effect that does not go away. For more information, ask your healthcare provider or pharmacist.
Before receiving WELTRUZA, tell your healthcare provider about all of your medical conditions, including if you:
- have or had diabetes or high blood sugar
- have or had high levels of total cholesterol, LDL cholesterol, or triglycerides, or low HDL levels in your blood
- have or had low or high blood pressure
- have or had heart problems or stroke
- are dehydrated
- have or had a low white blood cell count
- have or had seizures (convulsions)
- have or had problems with urination or prostate problems
- have Alzheimer’s disease
- have or had constipation or bowel obstruction
- have or had breast cancer
- are pregnant or plan to become pregnant. WELTRUZA may harm your unborn baby. Receiving WELTRUZA during your third trimester of pregnancy may cause your baby to have abnormal muscle movements or withdrawal symptoms such as agitation, stiffness or floppiness, tremors, sleepiness, and breathing or feeding problems after birth. Talk to your healthcare provider about the risks to your baby if you receive WELTRUZA during pregnancy.
- are breastfeeding or plan to breastfeed. WELTRUZA passes into breast milk. If you breastfeed during treatment with WELTRUZA, tell your healthcare provider if your baby is very sleepy, irritable, is feeding poorly, or gets tremors or abnormal muscle movements. Talk to your healthcare provider about the best way to feed your baby during treatment with WELTRUZA.
Tell your healthcare provider about all the medicines you take or plan to take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take: blood pressure medicines, levodopa or dopamine, or other olanzapine medicines. Your healthcare provider can tell you if it is safe to receive WELTRUZA with your other medicines.
Do not start or stop any medicines during treatment with WELTRUZA without talking to your healthcare provider first.
You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch , or call 1-800-FDA-1088.
For more information about WELTRUZA, see the full Prescribing Information, including Medication Guide and Boxed WARNING, or talk to your healthcare provider.
© 2026 Teva Neuroscience, Inc.
OLZ-40044 October 2026
