Prescription medicine
Olanzapine Brand names: Zyprexa
Olanzapine (Zyprexa) is a prescription medicine with an FDA approval on record since 1996. FDA's NDC Directory lists it from 43 generic labelers, and pharmacies paid $0.147 per olanzapine 20 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the olanzapine FDA label on DailyMed (effective March 5, 2026, Macleods Pharmaceuticals Limited); the NDA 20592 record on Drugs@FDA; every olanzapine label on DailyMed.
Highlights of the record
FDA label of March 5, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS.
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. […]
Used for
From the label: indications and usageOlanzapine is an atypical antipsychotic indicated: As oral formulation for the: · Treatment of schizophrenia.
Forms and strengths
- 2.5 mg
- 5 mg
- 7.5 mg
- 10 mg
- 15 mg
- 20 mg
- 10 mg/2ml
Film-coated tablet; orally disintegrating tablet; tablet; injection (powder) for solution; injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- September 30, 1996 Zyprexa, Cheplapharm; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 46 first October 24, 2011; 33 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 44 of which 43 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.147 per tablet Olanzapine 20 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 14 since 2013 0 Class I among all firms' recalls; latest August 27, 2026; 4 more by firms not listed as its makers
- FAERS reports
- 107,881 through July 30, 2026
What is olanzapine used for?
From the label: indications and usageOlanzapine is an atypical antipsychotic indicated: As oral formulation for the: · Treatment of schizophrenia. ( 1.1 ) · Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1 ) · Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1 ). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1 ) · Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. […]
Conditions named in the indications of olanzapine's FDA labels, with every medicine labeled for each:
From other olanzapine labelsDepression: Treatment of treatment resistant depression.
FDA pharmacologic class: Atypical Antipsychotic.
Source: FDA drug label (Olanzapine), Macleods Pharmaceuticals Limited, effective March 5, 2026 (SPL set 8e095987-bdea-42f2-9550-c7155cf07d30), via openFDA; the full label on DailyMed
What does the patient leaflet for olanzapine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about olanzapine tablets?Olanzapine tablets may cause serious side effects, including: 1. Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis). 2. High blood sugar (hyperglycemia). 3. High fat levels in your blood (increased cholesterol and triglycerides), especially in teenagers age 13 to 17 or when used in combination with fluoxetine in children age 10 to 17. 4. Weight gain, especially in teenagers age 13 to 17 or when used in combination with fluoxetine in children age 10 to 17. These serious side effects are described below. 1. Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis). Olanzapine tablets are not approved for treating psychosis in elderly people with dementia. 2. High blood sugar (hyperglycemia). High blood sugar can happen if you have diabetes already or if you have never had diabetes. High blood sugar could lead to: • a build up of acid in your blood due to ketones (ketoacidosis) • coma • death Your doctor should do tests to check your blood sugar before you start taking olanzapine tablets and during treatment. In people who do not have diabetes, sometimes high blood sugar goes away when olanzapine tablets are stopped. People with diabetes and some people who did not have diabetes before taking olanzapine tablets need to take medicine for high blood sugar even after they stop taking olanzapine tablets. If you have diabetes, follow your doctor’s instructions about how often to check your blood sugar while taking olanzapine tablets. […]
From the patient leaflet: What should I avoid while taking olanzapine tablets?Olanzapine tablets can cause sleepiness and may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how olanzapine tablets affects you. • Avoid drinking alcohol while taking olanzapine tablets. Drinking alcohol while you take olanzapine tablets may make you sleepier than if you take olanzapine tablets alone.
From the patient leaflet: How should I store olanzapine tablets?Store olanzapine tablets at room temperature, between 68°F to 77°F (20°C to 25°C). • Keep olanzapine tablets away from light. • Keep olanzapine tablets dry and away from moisture. Keep olanzapine tablets and all medicines out of the reach of children.
Source: FDA drug label (Olanzapine), Macleods Pharmaceuticals Limited, effective March 5, 2026 (SPL set 8e095987-bdea-42f2-9550-c7155cf07d30), via openFDA; the full label on DailyMed
Is there a generic for olanzapine (Zyprexa)?
The FDA approved the first generic olanzapine on October 24, 2011. 46 generic applications are approved; 33 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists olanzapine from 43 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1996 earliest approval on file
- 2011 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for olanzapine (Zyprexa)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.147 per Olanzapine 20 mg tablet, down 5% from $0.155 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Olanzapine 20 mg tablet (generic)
- Zyprexa 5 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Olanzapine 10 mg tablet | Generic | $0.109 per tablet | $3.27 | +3% |
| Olanzapine 10 mg vial | Generic | $20.92 per vial many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -12% |
| Olanzapine 15 mg tablet | Generic | $0.135 per tablet | $4.04 | +2% |
| Olanzapine 2.5 mg tablet | Generic | $0.0811 per tablet | $2.43 | +4% |
| Olanzapine 20 mg tablet | Generic | $0.147 per tablet | $4.40 | -5% |
| Olanzapine 5 mg tablet | Generic | $0.0871 per tablet | $2.61 | -3% |
| Olanzapine 7.5 mg tablet | Generic | $0.0944 per tablet | $2.83 | +3% |
| Olanzapine ODT 10 mg tablet | Generic | $0.366 per tablet | $10.99 | -11% |
| Olanzapine ODT 15 mg tablet | Generic | $0.639 per tablet | $19.16 | -4% |
| Olanzapine ODT 20 mg tablet | Generic | $0.722 per tablet | $21.67 | -4% |
| Olanzapine ODT 5 mg tablet | Generic | $0.304 per tablet | $9.11 | -3% |
| Zyprexa 20 mg tablet | Brand | $49.88 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $1,496.45 | -0.1% |
| Zyprexa 5 mg tablet | Brand | $16.62 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $498.47 | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has olanzapine been recalled?
The FDA's Enforcement Report lists 18 recalls naming olanzapine since 2013: 0 Class I (the most serious), 6 Class II, 12 Class III; 2 still ongoing. 4 of them are by firms that FDA's NDC Directory does not list as a maker of olanzapine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 27, 2026 | Class III | Macleods Pharmaceuticals Limited | Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification. |
| November 25, 2024 | Class II | Macleods Pharmaceuticals Ltd | Failed Impurities/Degradation Specifications |
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office not a listed maker | cGMP deviations: Temperature abuse |
| February 16, 2022 | Class II | Macleods Pharma Usa Inc | cGmp Deviations |
| May 26, 2020 | Class III | Aurobindo Pharma USA Inc. | Failed Impurities/ Degradation Specifications |
| March 22, 2017 | Class III | Sun Pharmaceutical Industries, Inc. | Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities). |
| October 13, 2016 | Class III | Dr. Reddy's Laboratories, Inc. not a listed maker | Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month … |
| April 7, 2015 | Class III | Apotex Inc. | Subpotent drug |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the olanzapine label say about other medicines?
The olanzapine label names 14 other medicines in its interaction, contraindication or warning sections. The labels of 31 other medicines name olanzapine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Carbamazepine | drug interactions | Carbamazepine: Increased clearance of olanzapine. |
| Cimetidine | drug interactions | Cimetidine and Antacids – Single doses of cimetidine (800 mg) or aluminum- and magnesium-containing antacids did not affect the oral bioavailability of olanzapine. |
| Desipramine | drug interactions | Imipramine – Single doses of olanzapine did not affect the pharmacokinetics of imipramine or its active metabolite desipramine. |
| Diazepam | drug interactions | Drugs to Affect Olanzapine Diazepam – The co-administration of diazepam with olanzapine potentiated the orthostatic hypotension observed with olanzapine [see Drug Interactions ( 7.2 )]. |
| Fluoxetine | boxed warning | Olanzapine is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.5 ), and Patient Counseling Information ( 17 )] When using olanzapine and fluoxetine in combination, also refer to the Boxed Warning section of the package … |
| Fluvoxamine | drug interactions | Inhibitors of CYP1A2 Fluvoxamine: Fluvoxamine, a CYP1A2 inhibitor, decreases the clearance of olanzapine. |
| Imipramine | drug interactions | Imipramine – Single doses of olanzapine did not affect the pharmacokinetics of imipramine or its active metabolite desipramine. |
| Levodopa | drug interactions | Levodopa and Dopamine Agonists: May antagonize levodopa/dopamine agonists. |
| Lithium | contraindications | For specific information about the contraindications of lithium or valproate, refer to the Contraindications section of the package inserts for these other products. |
| Lorazepam | drug interactions | Enhanced antihypertensive effect. ( 7.2 ) Levodopa and Dopamine Agonists: May antagonize levodopa/dopamine agonists. ( 7.2 ) Lorazepam (IM): |
| Omeprazole | drug interactions | Inducers of CYP1A2 or Glucuronyl Transferase – Omeprazole and rifampin may cause an increase in olanzapine clearance. |
| Rifampin | drug interactions | Inducers of CYP1A2 or Glucuronyl Transferase – Omeprazole and rifampin may cause an increase in olanzapine clearance. |
| Theophylline | drug interactions | Theophylline – Multiple doses of olanzapine did not affect the pharmacokinetics of theophylline or its metabolites. |
| Warfarin | drug interactions | Warfarin – Warfarin (20 mg single dose) did not affect olanzapine pharmacokinetics [see Drug Interactions ( 7.2 )]. |
Other labels that name olanzapine
- Aripiprazole lauroxil
- Asenapine
- Brexpiprazole
- Bromocriptine
- Cariprazine
- Ciprofloxacin
- Eszopiclone
- Glimepiride
- Glipizide
- Iloperidone
- Insulin aspart
- Insulin degludec
- Insulin detemir
- Insulin glargine
- Insulin human
- Insulin lispro
- Lurasidone
- Milsaperidone
- Paliperidone
- Quetiapine
- Repaglinide
- Selegiline
- Tetrabenazine
- Ziprasidone
Source: FDA drug label (Olanzapine), Macleods Pharmaceuticals Limited, effective March 5, 2026 (SPL set 8e095987-bdea-42f2-9550-c7155cf07d30), via openFDA; the full label on DailyMed
What do FAERS reports show for olanzapine?
The FDA Adverse Event Reporting System holds 107,881 reports that list olanzapine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 13,264 are coded as a death and 47,549 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as olanzapine?
20 other medicines are given the same way (oral) and in the same FDA class as olanzapine or labeled mainly for the same use (schizophrenia), the same class first. Schizophrenia lists all 24 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Quetiapine | Depression, Bipolar disorder, Schizophrenia | 50 labelers | $0.127 per tablet 300 mg tablet | No current entry |
| Aripiprazole | Depression, Bipolar disorder, Schizophrenia | 47 labelers | $0.110 per tablet 5 mg tablet | No current entry |
| Risperidone | Bipolar disorder, Schizophrenia | 35 labelers | $0.0368 per tablet 0.25 mg tablet | No current entry |
| Lurasidone | Depression, Bipolar disorder, Schizophrenia | 29 labelers | $0.142 per tablet 20 mg tablet | No current entry |
| Ziprasidone | Bipolar disorder, Schizophrenia | 16 labelers | $0.269 per capsule 20 mg capsule | No current entry |
| Paliperidone | Schizophrenia | 18 labelers | $0.972 per tablet 3 mg tablet | No current entry |
| Clozapine | Schizophrenia | 11 labelers | $0.610 per tablet 100 mg tablet | No current entry |
| Iloperidone | Bipolar disorder, Schizophrenia | 1 labeler | $60.01 per tablet 12 mg tablet | No current entry |
Every medicine labeled for the same conditions as olanzapine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does olanzapine compare with medicines for the same use?
20 side-by-side pages set olanzapine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to olanzapine
- 20 medicines for the same use
- Other atypical antipsychotics
- the pharmacologic class, with prices and generics
- Olanzapine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other