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Olanzapine is an antipsychotic medication that affects chemicals in the brain.
Olanzapine is used to treat the symptoms of psychotic conditions such as schizophrenia and bipolar disorder (manic depression) in adults and children who are at least 13 years old. Olanzapine is sometimes used together with other antipsychotic medications or antidepressants.
Olanzapine may also be used for purposes not listed in this medication guide.
Olanzapine is not approved for use in psychotic conditions related to dementia. Olanzapine may increase the risk of death in older adults with dementia-related conditions.
Olanzapine is not approved for use in psychotic conditions related to dementia. Olanzapine may increase the risk of death in older adults with dementia-related conditions.
You should not take olanzapine if you are allergic to it.
Long-term use of olanzapine can cause a serious movement disorder that may not be reversible. Symptoms include uncontrollable muscle movements of your lips, tongue, eyes, face, arms, or legs. The longer you take olanzapine, the more likely you are to develop this movement disorder. The risk of this side effect is higher in women and older adults.
To make sure olanzapine is safe for you, tell your doctor if you have ever had:
liver disease;
heart disease, high or low blood pressure;
low white blood cell (WBC) counts;
high cholesterol or triglycerides;
heart failure, heart attack, or stroke;
breast cancer;
seizures or epilepsy;
diabetes;
an enlarged prostate or difficulty urinating;
bowel problems; or
narrow-angle glaucoma.
Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking olanzapine, do not stop taking it without your doctor's advice.
Olanzapine can pass into breast milk and may harm a nursing baby. You should not breast-feed while using olanzapine.
The olanzapine orally disintegrating tablet (Zyprexa Zydis) may contain phenylalanine. Talk to your doctor before using this form of olanzapine if you have phenylketonuria (PKU).
Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take olanzapine in larger or smaller amounts or for longer than recommended.
Olanzapine can be taken with or without food.
Olanzapine is usually taken once a day. Olanzapine may be only part of a complete program of treatment that also includes counseling and other psychological support programs. Follow your doctor's instructions.
To take olanzapine orally disintegrating tablet (Zyprexa Zydis):
Keep the tablet in its original container until you are ready to take it.
Using dry hands, place the tablet in your mouth. It will begin to dissolve right away.
Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.
Swallow several times as the tablet dissolves. If desired, you may drink liquid to help swallow the dissolved tablet.
Call your doctor if your symptoms do not improve, or if they get worse while using olanzapine.
Do not stop using olanzapine suddenly, even if you feel fine. Stopping suddenly may cause serious side effects.
Olanzapine can cause high blood sugar (hyperglycemia). If you are diabetic, check your blood sugar levels on a regular basis while you are taking olanzapine.
You may gain weight or have high cholesterol and triglycerides (types of fat) while taking this medicine, especially if you are a teenager. Your blood may need to be tested often. Visit your doctor regularly.
If you are taking a combination of drugs, use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.
Store at room temperature away from moisture, heat, and light.
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include drowsiness, agitation, aggression, slurred speech, confusion, increased heart rate, jerky or uncontrolled muscle movements, trouble breathing, or fainting.
Olanzapine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or severe drowsiness can cause falls, fractures, or other injuries.
Avoid drinking alcohol. Dangerous side effects could occur.
Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking olanzapine.
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Seek medical treatment if you have symptoms of a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, unusual bruising, or jaundice (yellowing of your skin or eyes).
Call your doctor at once if you have:
uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
trouble speaking or swallowing;
swelling in your hands or feet;
confusion, unusual thoughts or behavior, hallucinations, or thoughts about hurting yourself;
sudden weakness or ill feeling, fever, chills, sore throat, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough;
signs of dehydration--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;
liver problems--upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss; or
severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.
Common side effects may include:
weight gain (more likely in teenagers), increased appetite;
headache, dizziness, drowsiness, feeling tired or restless;
problems with speech or memory;
tremors or shaking, numbness or tingly feeling;
changes in personality;
dry mouth, or increased salivation;
stomach pain, constipation; or
pain in your arms or legs.
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.
Taking olanzapine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.
Other drugs may interact with olanzapine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Further informationRemember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Olanzapine (www.drugs.com/mtm/olanzapine.html).
Commonly reported side effects of olanzapine include: asthenia, dizziness, drowsiness, extrapyramidal reaction, hyperkinetic muscle activity, akinesia, cogwheel rigidity, drug-induced parkinson's disease, dyspepsia, mask-like face, and xerostomia. Other side effects include: abnormal gait, back pain, constipation, fever, orthostatic hypotension, weight gain, myoclonus, and personality disorder. See below for a comprehensive list of adverse effects.
For the ConsumerApplies to olanzapine: oral tablet, oral tablet disintegrating
Other dosage forms:
Oral route (Tablet; Tablet, Disintegrating)
Risk of death is increased in elderly patients with dementia-related psychosis treated with antipsychotic drugs. Although the causes of death in clinical trials were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that antipsychotic drugs may increase mortality. It is unclear from these studies to what extent the mortality findings may be attributed to the antipsychotic drug as opposed to patient characteristics. Olanzapine is not approved for the treatment of patients with dementia-related psychosis.
Along with its needed effects, olanzapine 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:
More common
Less common
Some side effects of olanzapine 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
Less common
For Healthcare Professionals
Applies to olanzapine: intramuscular powder for injection, intramuscular powder for injection extended release, oral tablet, oral tablet disintegrating
Nervous systemPost-Injection delirium/sedation syndrome, a collection of signs and symptoms consistent with olanzapine overdose has been reported following injections of the extended-release IM suspension. Events occurred in less than 0.1% of injections and in approximately 2% of patients receiving injections for up to 46 months. Onset of events ranged from soon after injection to greater than 3 hours later. The majority of patients were hospitalized and some required supportive care, including intubation. Two deaths have been reported occurring 3 to 4 days after receiving the appropriate dose of the extended-release IM suspension. In these patients, very high olanzapine blood levels were reported after death. A study undertaken to determine the cause of the elevated drug levels in these 2 deaths provides inconclusive results. As reported in a 3-23-2015 drug safety communication issued by the US Food and Drug Administration, a study in animals found much of the drug level increases could have occurred after death, but the possibility that the deaths were caused by a rapid, but delayed entry of the drug in to the bloodstream could not be ruled out.
Akathisia most commonly occurred with oral doses of 15 mg/day; akathisia events included akathisia and hyperkinesia.
Dyskinetic events included buccoglossal syndrome, choreoathetosis, dyskinesia, and tardive dyskinesia.
Dystonic events included dystonia, generalized spasm, neck rigidity, oculogyric crisis, opisthotonos, and torticollis.
Parkinsonism/parkinsonism events most commonly occurred with oral doses of 15 mg/day and included akinesia, cogwheel rigidity, extrapyramidal syndrome, hypertonia, hypokinesia, masked facies, and tremor.
Sedation most commonly occurred in adolescent patients given oral doses at least 2.5 mg/day over 3 weeks; sedation included hypersomnia, lethargy, sedation, and somnolence.
Somnolence and tremor most commonly occurred with oral doses given with lithium or valproate.
Oral formulations:
Very common (10% or more): Somnolence (up to 52%), sedation (up to 48%), akathisia/akathisia events (up to 27%), tremor (up to 23%), parkinsonism/parkinsonism events (up to 20%), dizziness (up to 18%), headache (up to 17%), any extrapyramidal event (up to 10%)
Common (1% to 10%): Abnormal gait, amnesia, articulation impairment, dyskinesia/dyskinetic events, dystonia/dystonic events, hypertonia, incoordination, mild/transient anticholinergic effects, paresthesia, speech disorder
Uncommon (0.1% to 1%): Ataxia, cerebrovascular accident, dysarthria, restless legs syndrome, seizures, stupor, tardive dyskinesia
Rare (0.01% to 0.1%): Coma, hangover effect, neuroleptic malignant syndrome
Frequency not reported: Akinesia, choreoathetosis, cogwheel rigidity, dyskinesia, dystonia, extrapyramidal disorder, generalized spasm, hypersomnia, hypokinesia, masked facies, movement disorder, myoclonus, opisthotonos, tardive dyskinesia, twitching
Postmarketing reports: Diabetic coma
Immediate-release IM injection:
Very common (10% or more): Sedation (up to 44.1%)
Common (1% to 10%): Abnormal gait, akathisia/akathisia events, any extrapyramidal events, dizziness, parkinsonism/parkinsonism events, somnolence, speech disorder, tremor
Uncommon (0.1% to 1%): Amnesia, restless legs syndrome, syncope
Frequency not reported: Akinesia, choreoathetosis, cogwheel rigidity, dyskinesia, dyskinetic events, dystonia, dystonic events, extrapyramidal disorder, generalized spasm, hyperkinesia, hypersomnia, hypertonia, hypokinesia, masked facies, movement disorder, myoclonus, opisthotonos, twitching
Postmarketing reports: Diabetic coma, neuroleptic malignant syndrome, seizures
Extended-release IM injection:
Very common (10% or more): Headache/tension headache (up to 18%), sedation/somnolence (up to 13%)
Common (1% to 10%): Akathisia, dizziness, dysarthria, dyskinesia, hypersomnia, mild/transient anticholinergic effects, parkinsonism, tremor
Uncommon (0.1% to 1%): Amnesia, dystonia, seizures, restless legs syndrome, tardive dyskinesia
Rare (0.01% to 0.1%): Neuroleptic malignant syndrome
Frequency not reported: Abnormal gait, ataxia, cerebrovascular adverse reactions, coma, convulsions, dystonia, extrapyramidal symptoms, speech disorder, tardive extrapyramidal syndromes
Postmarketing reports: Diabetic coma
CardiovascularOral formulations:
Common (1% to 10%): Chest pain, edema, hypertension, peripheral edema, postural/orthostatic hypotension, tachycardia
Uncommon (0.1% to 1%): Bradycardia, deep vein thrombosis, QT prolongation, vasodilation
Rare (0.01% to 0.1%): Ventricular tachycardia/fibrillation
Postmarketing reports: Cardiac arrest, torsade de pointes, venous thromboembolic events, venous thromboembolism, ventricular arrhythmia
Immediate-release IM injection:
Common (1% to 10%): Bradycardia, hypotension, peripheral edema, postural/orthostatic hypotension, tachycardia
Uncommon (0.1% to 1%): Photosensitivity reaction
Postmarketing reports: Deep vein thrombosis, cardiac arrest, QT prolongation, torsade de pointes, venous thromboembolic events, venous thromboembolism, ventricular arrhythmia
Extended-release IM injection:
Common (1% to 10%): Bradycardia with/without hypotension/syncope, edema, electrocardiogram QT-corrected interval prolonged, hypertension, hypotension, orthostatic hypotension, peripheral edema, tachycardia
Uncommon (0.1% to 1%): Deep vein thrombosis, thromboembolism
Rare (0.01% to 0.1%): Ventricular tachycardia/fibrillation
Postmarketing reports: Cardiac arrest, deep vein thrombosis, torsades de pointes, venous thromboembolic events/venous thromboembolism
Collective data gathered from 17 placebo-controlled clinical studies (n=5106) involving the use of atypical antipsychotic agents, including olanzapine, for the treatment of behavioral disorders in the elderly patient with dementia showed a risk of death 1.6 to 1.7 times greater in the drug treated patient than in the placebo treated patient. The average length of duration for the trials was 10 weeks with the cause of death in the majority of cases, though not all, reported as either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Olanzapine is not approved by the FDA for use in the treatment of behavioral disorders in elderly patients with dementia.
MetabolicOral formulations:
Very common (10% or more): Weight gain/increased weight greater than/equal to 7% of baseline body weight (up to 89.4%), fasting borderline to high triglycerides (up to 59.5%), fasting borderline to high total cholesterol (up to 38.9%), increased appetite (up to 29%), fasting normal to high triglycerides (up to 26.9%), fasting borderline to high glucose (up to 14.3%) thirst (up to 10%)
Common (1% to 10%): Fasting normal to high glucose, fasting normal to high total cholesterol, high uric acid, hyperglycemia, increased alkaline phosphatase, increased triglyceride levels, weight gain greater than/equal to 15% of baseline body weight
Uncommon (0.1% to 1%): Development/exacerbation of diabetes with/without ketoacidosis or coma (sometimes fatal)
Postmarketing reports: Diabetic ketoacidosis, hypertriglyceridemia, random cholesterol levels of 240 mg/dL or higher, random triglyceride levels of 1000 mg/dL or higher
Immediate-release IM injection:
Very common (10% or more): Weight gain/increased weight greater than/equal to 7% of baseline body weight (up to 89.4%), fasting borderline to high triglycerides/hypertriglyceridemia (up to 70.7%), fasting borderline to high total cholesterol/hypercholesterolemia (up to 55.2%), fasting borderline to high glucose/hyperglycemia (up to 26%)
Common (1% to 10%): Increased appetite, weight gain greater than/equal to 15% of baseline body weight
Postmarketing reports: Diabetic ketoacidosis, pre-existing diabetes exacerbation, random cholesterol levels of 240 mg/dL or higher, random triglyceride levels of 1000 mg/dL or higher
Extended-release IM injection:
Very common (10% or more): Weight gain/increased weight greater than/equal to 7% of baseline body weight (up to 64.4%)
Common (1% to 10%): Fasting borderline to high cholesterol/glucose/triglycerides, fasting normal to high cholesterol/triglycerides/glucose, high uric acid, increased alkaline phosphatase, increased appetite, weight gain greater than/equal to 15% of baseline body weight
Uncommon (0.1% to 1%): Development/exacerbation of diabetes with/without ketoacidosis or coma (sometimes fatal)
Frequency not reported: Changes in cholesterol/LDL/triglycerides/sodium
Postmarketing reports: Diabetic ketoacidosis, hyperglycemia, random cholesterol levels of 6.21 mmol/L or higher, random triglyceride levels of 11.29 mmol/L or higher
Olanzapine appears to have a greater association than some other atypical antipsychotics for increasing glucose levels. Mean increases of up to 15 mg/dL have been reported. The differences in mean changes in serum glucose were higher in patients with evidence of glucose dysregulation at baseline. In an analysis of patients who completed 9 to 12 months of therapy, the rate on increase in mean blood glucose slowed after approximately 6 months.
Clinically significant alterations in lipids have been observed including serum triglyceride elevations greater than 500 mg/dL. In long-term studies of at least 48-weeks in adults, increased from baseline in mean fasting cholesterol, LDL, triglycerides were 5.6 mg/dL, 2.5 mg/dL, and 18.7 mg/dL, respectively. Mean increases in fasting lipid values (total cholesterol, LDL and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline.
In 13 placebo-controlled monotherapy trials, olanzapine-treated patients gained an average of 2.6 kg compared to an average 0.3 kg weight loss in placebo patients; 22.5% gained at least 7% of their baseline weight, 4.2% at least 15% of their baseline (compared to 3% and 0.3% in placebo). Clinically significant weight gain was observed across all baseline BMIs. With longer term exposure (at least 24 weeks), weight gain of 7%, 15%, or 25% or more were reported in 89.4%, 55.3%, and 29.1%, respectively. Weight gain and increased appetite were reported in 40.6%, 7.1%, and 2.5% of adolescents receiving this drug in short term treatment (approximately 22 days), respectively.
GastrointestinalOral formulations:
Very common (10% or more): Dry mouth (up to 32%), constipation (up to 11%), dyspepsia (up to 11%)
Common (1% to 10%): Abdominal pain, diarrhea, dyspepsia, increased salivation, nausea, vomiting
Uncommon (0.1% to 1%): Abdominal distention, tongue edema
Rare (0.01% to 0.1%): Ileus, intestinal obstruction, pancreatitis
Frequency not reported: Buccoglossal syndrome, lower/upper abdominal pain
Immediate-release IM injection:
Common (1% to 10%): Constipation, dry mouth
Uncommon (0.1% to 1%): Abdominal distention, nausea
Frequency not reported: Buccoglossal syndrome
Postmarketing reports: Pancreatitis, vomiting
Extended-release IM injection:
Common (1% to 10%): Abdominal pain/upper abdominal pain, constipation, diarrhea, dry mouth, flatulence, nausea, toothache, tooth infection/abscess, vomiting
Uncommon (0.1% to 1%): Abdominal distention
Rare (0.01% to 0.1%): Pancreatitis
Abdominal pain included abdominal pain, lower abdominal pain, and upper abdominal pain.
Nausea and dry mouth have been reported to be dose related. Dry mouth was more commonly reported when given orally with lithium or valproate.
HepaticOral formulations:
Very common (10% or more): AST elevated (up to 27.6%), decreased total bilirubin (up to 22.1%), ALT 3-times upper limit of normal (3 x ULN) (up to 12.1%)
Common (1% to 10%): Asymptomatic liver enzyme elevations (ALT, AST), high gamma glutamyltransferase (GGT)
Uncommon (0.1% to 1%): Bilirubinemia/increased total bilirubin
Rare (0.01% to 0.1%): Fatty liver deposit
Frequency not reported: Hepatitis, hepatocellular/cholestatic hepatitis, mixed liver injury
Postmarketing reports: Jaundice
Immediate-release IM injection:
Very common (10% or more): AST elevated (up to 27.6%), decreased total bilirubin (up to 22.1%), ALT 3 x ULN (up to 12.1%)
Postmarketing reports: Cholestatic/mixed liver injury, jaundice, total bilirubin increased
Extended-release IM injection:
Common (1% to 10%): ALT 3 x ULN, High GGT levels, asymptomatic liver enzyme elevations (ALT, AST), increased hepatic enzymes (AST, ALT, GGT), low total bilirubin
Uncommon (0.1% to 1%): ALT elevation greater than 200 international units/L, increased total bilirubin
Rare (0.01% to 0.1%): Hepatocellular/cholestatic hepatitis, mixed liver injury
Frequency not reported: Changes in direct bilirubin/GGT
Postmarketing reports: Jaundice
Transient, asymptomatic elevations of hepatic transaminases were commonly seen, especially early in treatment.
RespiratoryOral formulations:
Common (1% to 10%): Dyspnea, increased cough, nasopharyngitis, pharyngitis, respiratory tract infection, rhinitis, sinusitis
Uncommon (0.1% to 1%): Epistaxis, pulmonary embolism
Rare (0.01% to 0.1%): Lung edema
Frequency not reported: Lower respiratory tract infection, pneumonia, upper respiratory tract infection, viral respiratory tract infection, viral upper respiratory tract infection
Immediate-release IM injection:
Common (1% to 10%): Pneumonia
Uncommon (0.1% to 1%): Epistaxis
Postmarketing reports: Pulmonary embolism
Extended-release IM injection:
Common (1% to 10%): Cough, nasal/sinus congestion, nasopharyngitis, pharyngolaryngeal pain, sneezing, upper respiratory tract infection
Uncommon (0.1% to 1%): Epistaxis, pulmonary embolism
Rare (0.01% to 0.1%):
Frequency not reported: Pneumonia
EndocrineOral formulations:
Very common (10% or more): Prolactin level elevation (up to 47.4%)
Uncommon (0.1% to 1%): Gynecomastia/male breast enlargement
Immediate-release IM injection:
Very common (10% or more): Increased prolactin (up to 47.4%)
Uncommon (0.1% to 1%): Gynecomastia/male breast enlargement
Extended-release IM injection:
Very common (10% or more): Plasma prolactin level elevation (up to 30%)
Uncommon (0.1% to 1%): Gynecomastia/male breast enlargement
In clinical studies, changes in prolactin levels were found to be statistically significantly different based on dose, higher doses were associated with higher levels of prolactin. In a study of up to 12 weeks, plasma prolactin concentrations exceeded the upper limit of normal (ULN) in approximately 30% of patients who had normal baseline prolactin values. The majority of these elevations were mild, and remained below 2 x ULN.
Approximately 47% of treated adolescent patients had significantly higher prolactin levels compared to adults.
HematologicOral formulations:
Common (1% to 10%): Eosinophilia, leukopenia, neutropenia
Uncommon (0.1% to 1%): Thrombocytopenia, thromboembolism
Immediate-release IM injection:
Common (1% to 10%): Eosinophilia, leukopenia, neutropenia
Postmarketing reports: Thrombocytopenia
Extended-release IM injection:
Common (1% to 10%): Eosinophilia, leukopenia, neutropenia
Rare (0.01% to 0.1%): Thrombocytopenia
Frequency not reported: Changes in monocytes/eosinophils, high leukocyte count, treatment-emergent low platelet count
OcularOral formulations:
Common (1% to 10%): Amblyopia, abnormal vision
Uncommon (0.1% to 1%): Accommodation abnormality, dry eyes, oculogyration
Rare (0.01% to 0.1%): Mydriasis
Frequency not reported: Oculogyric crisis
Immediate-release IM injection:
Frequency not reported: Oculogyric crisis
Extended-release IM injection:
Uncommon (0.1% to 1%): Oculogyration
OtherOral formulations:
Very common (10% or more): Asthenia (up to 20%), fatigue (up to 14%), accidental injury (up to 12%)
Common (1% to 10%): Fever/pyrexia, extremity pain (other than joint), lethargy, residual events, nonspecific events
Uncommon (0.1% to 1%): Chills
Rare (0.01% to 0.1%): Chills and fever, hypothermia, sudden death/sudden unexplained death
Frequency not reported: Falls, increased body temperature, neonatal drug withdrawal syndrome
Immediate-release IM injection:
Common (1% to 10%): Asthenia, fatigue, pyrexia, residual events
Frequency not reported: Falls, lethargy
Postmarketing reports: Sudden unexplained death
Extended-release IM injection:
Common (1% to 10%): Asthenia, ear pain, fatigue, fever/pyrexia, overdose, pain, procedural pain
Rare (0.01% to 0.1%): Hypothermia
Frequency not reported: Death, falls, increased body temperature, lethargy, neonatal drug withdrawal syndrome, sudden death/sudden unexplained death, weakness
Asthenia most frequently occurred in oral doses of 15 mg/day.
Residual events included movement disorder, myoclonus, and twitching.
HypersensitivityOral formulations:
Uncommon (0.1% to 1%): Hypersensitivity
Postmarketing reports: Allergic reaction, anaphylactoid reaction, angioedema
Immediate-release IM injection:
Postmarketing reports: Allergic reaction, anaphylactoid reaction, angioedema
Extended-release IM injection:
Uncommon (0.1% to 1%): Hypersensitivity
Postmarketing reports: Allergic reaction, anaphylactoid reaction, angioedema
GenitourinaryOral formulations:
Common (1% to 10%): Dysmenorrhea, erectile dysfunction, glucosuria, urinary incontinence, urinary tract infection, vaginitis
Uncommon (0.1% to 1%): Amenorrhea, breast enlargement/pain, decreased menstruation, galactorrhea, impaired urination, impotence, increased menstruation, menorrhagia, metrorrhagia, polyuria, urinary frequency, urinary hesitation, urinary retention, urinary urgency
Rare (0.01% to 0.1%): Priapism
Immediate-release IM injection:
Common (1% to 10%): Erectile dysfunction, urinary incontinence
Uncommon (0.1% to 1%): Amenorrhea, breast enlargement, galactorrhea
Postmarketing reports: Priapism, urinary hesitation, urinary retention
Extended-release IM injection:
Common (1% to 10%): Erectile dysfunction, vaginal discharge
Uncommon (0.1% to 1%): Amenorrhea, breast enlargement, galactorrhea, urinary hesitation, urinary incontinence, urinary retention
Rare (0.01% to 0.1%): Priapism
MusculoskeletalOral formulations:
Common (1% to 10%): Arthralgia, back pain, high creatine/creatinine phosphokinase, joint pain, musculoskeletal stiffness
Rare (0.01% to 0.1%): Osteoporosis, rhabdomyolysis
Frequency not reported: Neck rigidity, torticollis
Immediate-release IM injection:
Common (1% to 10%): Arthralgia
Uncommon (0.1% to 1%): Increased creatinine phosphokinase
Rare (0.01% to 0.1%): Elevated creatine kinase levels
Frequency not reported: Neck rigidity, torticollis
Postmarketing reports: Rhabdomyolysis
Extended-release IM injection:
Common (1% to 10%): Arthralgia, back pain, high creatine phosphokinase, muscle spasms, musculoskeletal spasms
Rare (0.01% to 0.1%): Rhabdomyolysis
DermatologicOral formulations:
Common (1% to 10%): Acne, dry skin, ecchymosis, rash, sweating/diaphoresis
Uncommon (0.1% to 1%): Alopecia, face edema, photosensitivity reaction
Frequency not reported: Drug reaction with eosinophilia and systemic symptoms (DRESS), erythema, pruritus, urticaria
Immediate-release IM injection:
Postmarketing reports: Alopecia, drug reaction with eosinophilia and systemic symptoms (DRESS), pruritus, rash, sweating/diaphoresis, urticaria
Extended-release IM injection:
Common (1% to 10%): Acne, rash
Uncommon (0.1% to 1%): Alopecia, photosensitivity reaction
Frequency not reported: Diaphoresis/sweating, erythema
Postmarketing reports: Drug reaction with eosinophilia and systemic symptoms (DRESS), pruritus, urticaria
PsychiatricOral formulations:
Very common (10% or more): Depression (up to 18%), insomnia (up to 12%)
Common (1% to 10%): Apathy, confusion, decreased libido, euphoria, personality disorder, restlessness
Uncommon (0.1% to 1%): Suicide attempt
Rare (0.01% to 0.1%): Discontinuation symptoms
Frequency not reported: Anxiety, visual hallucinations/hallucinations
Postmarketing reports: Discontinuation reaction
Immediate-release IM injection:
Common (1% to 10%): Decreased libido
Frequency not reported: Hallucinations
Postmarketing reports: Anxiety, discontinuation reaction, insomnia
Extended-release IM injection:
Common (1% to 10%): Abnormal dreams, abnormal thinking, auditory hallucinations, decreased libido, restlessness, sleep disorder
Rare (0.01% to 0.1%): Discontinuation reaction/symptoms
Frequency not reported: Aggression, agitation, anxiety, confusion, delirium, hallucinations, insomnia, other cognitive impairment, visual hallucinations
For the collection of adverse reactions, the term personality disorder was used to collect data on nonaggressive objectionable behavior.
Depression most commonly occurred with oral doses given with lithium or valproate.
LocalImmediate-release IM injection:
Common (1% to 10%): Injection site pain
Extended-release IM injection:
Common (1% to 10%): Anesthesia, bruising, buttock pain, hemorrhage, induration, injection site induration/mass/pain, irritation
Rare (0.01% to 0.1%): Injection site abscess requiring/not requiring surgical intervention
Frequency not reported: Edema-type reaction, erythema-type reaction, nodule-type reaction, non-specific injection-site reaction
ImmunologicExtended-release IM injection:
Common (1% to 10%): Viral infection
RenalOral formulations:
Common (1% to 10%): Glycosuria
Immediate-release IM injection:
Common (1% to 10%): Glycosuria
Extended-release IM injection:
Common (1% to 10%): Glycosuria
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Olanzapine (www.drugs.com/mtm/olanzapine.html).
October 13, 2020
August 31, 2020
July 13, 2020
November 24, 2020
December 2, 2020
November 15, 2020