Prescription medicine
Everolimus Brand names: Afinitor, Zortress, Torpenz, Yulithira
Everolimus (Afinitor) is a prescription medicine with an FDA approval on record since 2009. FDA's NDC Directory lists it from 14 generic labelers, and pharmacies paid $26.32 per everolimus 10 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
Check it at the source: the everolimus FDA label on DailyMed (effective June 1, 2026, Novartis Pharmaceuticals Corporation); the NDA 22334 record on Drugs@FDA; every everolimus label on DailyMed.
Highlights of the record
FDA label of June 1, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageAFINITOR is a kinase inhibitor indicated for the treatment of: Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole.
Forms and strengths
- 0.25 mg
- 0.5 mg
- 0.75 mg
- 1 mg
- 2 mg
- 2.5 mg
- 3 mg
- 5 mg
- 7.5 mg
- 10 mg
Tablet; tablet for suspension.
On the market
- Earliest approval on file
- March 30, 2009 Afinitor, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 20 first April 12, 2018; 17 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 15 of which 14 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- July 1, 2028 Afinitor tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $26.32 per tablet Everolimus 10 mg tablet
- Shortage (FDA)
- None current 11 past records
- Recalls by its makers (FDA)
- 5 since 2025 0 Class I among all firms' recalls; latest October 10, 2025
- FAERS reports
- 49,208 through July 30, 2026
What is everolimus used for?
From the label: indications and usageAFINITOR is a kinase inhibitor indicated for the treatment of: Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. ( 1.1 ) Adults with progressive neuroendocrine tumors of pancreatic origin (PNET) and adults with progressive, well-differentiated, non-functional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced or metastatic. Limitations of Use: AFINITOR is not indicated for the treatment of patients with functional carcinoid tumors. […]
Conditions named in the indications of everolimus's FDA labels, with every medicine labeled for each:
From other everolimus labelsBreast cancer: Hormone Receptor-Positive, HER2-Negative Breast Cancer AFINITOR ® is indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of …
Seizures and epilepsy: Complex (TSC)-Associated Partial-Onset Seizures AFINITOR DISPERZ is indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures.
Organ transplant rejection: Everolimus is a mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients:
FDA pharmacologic class: Kinase Inhibitor and mTOR Inhibitor Immunosuppressant.
Source: FDA drug label (Afinitor), Novartis Pharmaceuticals Corporation, effective June 1, 2026 (SPL set 2150f73a-179b-4afc-b8ce-67c85cc72f04), via openFDA; the full label on DailyMed
What does the patient leaflet for everolimus 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 AFINITOR and AFINITOR DISPERZ?AFINITOR and AFINITOR DISPERZ can cause serious side effects, including: 1. You may develop lung or breathing problems. In some people lung or breathing problems may be severe and can lead to death. Tell your healthcare provider right away if you have any of these symptoms: New or worsening cough Shortness of breath Chest pain Difficulty breathing or wheezing 2. You may be more likely to develop an infection, such as pneumonia, or a bacterial, fungal or viral infection. Viral infections may include active hepatitis B in people who have had hepatitis B in the past (reactivation). In some people (including adults and children) these infections may be severe and can lead to death. You may need to be treated as soon as possible. Tell your healthcare provider right away if you have a temperature of 100.5˚F or above, chills, or do not feel well. Symptoms of hepatitis B or infection may include the following: Fever Chills Skin rash Joint pain and swelling Tiredness Loss of appetite Nausea Pale stools or dark urine Yellowing of the skin Pain in the upper right side of the stomach 3. Severe allergic reactions. Call your healthcare provider or get medical help right away if you get signs and symptoms of a severe allergic reaction, including: rash, itching, hives, flushing, trouble breathing or swallowing, chest pain or dizziness. 4. Possible increased risk for a type of allergic reaction called angioedema, in people who take an Angiotensin-Converting Enzyme (ACE) inhibitor medicine during treatment with AFINITOR or AFINITOR DISPERZ. Talk with your healthcare provider before taking AFINITOR or AFINITOR DISPERZ if you are not sure if you take an ACE inhibitor medicine. […]
From the patient leaflet: What should I avoid while taking AFINITOR or AFINITOR DISPERZ?You should not drink grapefruit juice or eat grapefruit during your treatment with AFINITOR or AFINITOR DISPERZ. It may make the amount of AFINITOR or AFINITOR DISPERZ in your blood increase to a harmful level.
From the patient leaflet: How should I store AFINITOR or AFINITOR DISPERZ?Store AFINITOR or AFINITOR DISPERZ at room temperature, between 68°F to 77°F (20°C to 25°C). Keep AFINITOR or AFINITOR DISPERZ in the pack it comes in. Open the blister pack just before taking AFINITOR or AFINITOR DISPERZ. Keep AFINITOR or AFINITOR DISPERZ dry and away from light. Do not use AFINITOR or AFINITOR DISPERZ that is out of date or no longer needed. Keep AFINITOR or AFINITOR DISPERZ and all medicines out of the reach of children.
Source: FDA drug label (Afinitor), Novartis Pharmaceuticals Corporation, effective June 1, 2026 (SPL set 2150f73a-179b-4afc-b8ce-67c85cc72f04), via openFDA; the full label on DailyMed
Is there a generic for everolimus (Afinitor)?
The FDA approved the first generic everolimus on April 12, 2018. 20 generic applications are approved; 17 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists everolimus from 14 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.
The Orange Book lists 2 patents for Afinitor tablets, the last expiring on July 1, 2028. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2009 earliest approval on file
- 2018 first generic approved
- 2028 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for everolimus (Afinitor)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $26.32 per Everolimus 10 mg tablet, down 12% from $29.96 on October 8, 2025. 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.
- Everolimus 5 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Everolimus 0.25 mg tablet | Generic | $1.79 per tablet | $53.56 | -18% |
| Everolimus 0.5 mg tablet | Generic | $3.52 per tablet | $105.74 | -24% |
| Everolimus 0.75 mg tablet | Generic | $4.18 per tablet | $125.48 | -38% |
| Everolimus 1 mg tablet | Generic | $5.25 per tablet | $157.59 | -63% |
| Everolimus 10 mg tablet | Generic | $26.32 per tablet | $789.73 | -12% |
| Everolimus 5 mg tablet | Generic | $14.77 per tablet | $443.12 | -16% |
| Torpenz 10 mg tablet | Generic | $26.32 per tablet | $789.73 | -12% |
| Torpenz 5 mg tablet | Generic | $14.77 per tablet | $443.12 | -16% |
| Yulithira 10 mg tablet | Generic | $26.32 per tablet | $789.73 | n/a |
| Yulithira 5 mg tablet | Generic | $14.77 per tablet | $443.12 | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is everolimus in shortage?
No everolimus presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 11 records are all marked to be discontinued, the latest updated March 2, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Everolimus, Tablet, 10 mg (NDC 0093-7769-24) | Teva Pharmaceuticals USA, Inc. | To Be Discontinued | March 2, 2026 |
| Everolimus, Tablet, 10 mg (NDC 49884-128-91) | Endo Pharmaceuticals, Inc. | To Be Discontinued | January 6, 2026 |
| Everolimus, Tablet, 2 mg (NDC 0378-0005-85) | Mylan Pharmaceuticals Inc., a Viatris Company | To Be Discontinued | November 3, 2025 |
| Everolimus, Tablet, 2.5 mg (NDC 0093-7766-24) | Teva Pharmaceuticals USA, Inc. | To Be Discontinued | March 2, 2026 |
| Everolimus, Tablet, 2.5 mg (NDC 49884-119-91) | Endo Pharmaceuticals, Inc. | To Be Discontinued | January 6, 2026 |
| Everolimus, Tablet, 3 mg (NDC 0378-0006-85) | Mylan Pharmaceuticals Inc., a Viatris Company | To Be Discontinued | November 3, 2025 |
| Everolimus, Tablet, 5 mg (NDC 0093-7767-24) | Teva Pharmaceuticals USA, Inc. | To Be Discontinued | March 2, 2026 |
| Everolimus, Tablet, 5 mg (NDC 0378-0007-85) | Mylan Pharmaceuticals Inc., a Viatris Company | To Be Discontinued | November 3, 2025 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has everolimus been recalled?
The FDA's Enforcement Report lists 5 recalls naming everolimus since 2025: 0 Class I (the most serious), 0 Class II, 5 Class III; 5 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| October 10, 2025 | Class III | Endo USA, Inc. | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. |
| September 5, 2025 | Class III | Endo USA, Inc. | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the everolimus label say about other medicines?
The everolimus label names 30 other medicines in its interaction, contraindication or warning sections. The labels of 30 other medicines name everolimus. 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 |
|---|---|---|
| Atorvastatin | drug interactions | Atorvastatin (CYP3A4 Substrate) and Pravastatin (P-gp Substrate) Single-dose administration of Zortress with either atorvastatin or pravastatin to healthy subjects did not influence the pharmacokinetics of atorvastatin, pravastatin and everolimus, as well as total HMG-CoA reductase bioreactivity in plasma to a … |
| Cannabidiol | drug interactions | Reduce the dosage as recommended. ( 2.11 , 7.1 ) Cannabidiol oral solution: Reduce the dosage as recommended. ( 2.11 , 7.1 ) Strong CYP3A inducer and P-gp inducer: |
| Carbamazepine | drug interactions | Inducers of CYP3A4 may increase the metabolism of everolimus and decrease everolimus blood concentrations (e.g., St. John’s Wort [ Hypericum perforatum ]; anticonvulsants: carbamazepine, phenobarbital, phenytoin; efavirenz, nevirapine). |
| Clarithromycin | drug interactions | Concurrent treatment with strong inhibitors (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, boceprevir, telaprevir) and inducers (e.g., rifampin, rifabutin) of CYP3A4 is not recommended. |
| Cyclosporine | boxed warning | Nephrotoxicity Increased nephrotoxicity can occur with use of standard doses of cyclosporine in combination with Zortress. |
| Dexamethasone | warnings and precautions | When starting AFINITOR/AFINITOR DISPERZ, initiating dexamethasone alcohol-free oral solution as a swish and spit mouthwash reduces the incidence and severity of stomatitis [see Adverse Reactions (6.1)]. |
| Digoxin | drug interactions | Inhibitors of P-gp (e.g., digoxin, cyclosporine) may decrease the efflux of everolimus from intestinal cells and increase everolimus blood concentrations. |
| Diltiazem | drug interactions | Moderate inhibitors of CYP3A4 and P-gp may increase everolimus blood concentrations (e.g., fluconazole; macrolide antibiotics; nicardipine, diltiazem; nelfinavir, indinavir, amprenavir). |
| Efavirenz | drug interactions | Inducers of CYP3A4 may increase the metabolism of everolimus and decrease everolimus blood concentrations (e.g., St. John’s Wort [ Hypericum perforatum ]; anticonvulsants: carbamazepine, phenobarbital, phenytoin; efavirenz, nevirapine). |
| Erythromycin | drug interactions | DRUG INTERACTIONS Strong-moderate CYP3A4 inhibitors (e.g., cyclosporine, ketoconazole, erythromycin, verapamil) and CYP3A4 inducers (e.g., rifampin) may affect everolimus concentrations ( 7.1 ). |
| Fluconazole | drug interactions | Moderate inhibitors of CYP3A4 and P-gp may increase everolimus blood concentrations (e.g., fluconazole; macrolide antibiotics; nicardipine, diltiazem; nelfinavir, indinavir, amprenavir). |
| Itraconazole | drug interactions | Concurrent treatment with strong inhibitors (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, boceprevir, telaprevir) and inducers (e.g., rifampin, rifabutin) of CYP3A4 is not recommended. |
| Ketoconazole | drug interactions | DRUG INTERACTIONS Strong-moderate CYP3A4 inhibitors (e.g., cyclosporine, ketoconazole, erythromycin, verapamil) and CYP3A4 inducers (e.g., rifampin) may affect everolimus concentrations ( 7.1 ). |
| Lovastatin | drug interactions | Due to an interaction with cyclosporine, clinical studies of Zortress with cyclosporine conducted in kidney transplant patients strongly discouraged patients with receiving HMG-CoA reductase inhibitors such as simvastatin and lovastatin [ s ee Warnings and Precautions ( 5.1 1 )]. |
Every other medicine the everolimus label names
| Medicine named | Section | What the label says |
|---|---|---|
| Midazolam | drug interactions | Midazolam (CYP3A4/5 Substrate) Single-dose administration of midazolam to healthy volunteers following administration of multiple-dose Zortress indicated that everolimus is a weak inhibitor of … |
| Nelfinavir | drug interactions | Moderate inhibitors of CYP3A4 and P-gp may increase everolimus blood concentrations (e.g., fluconazole; macrolide antibiotics; nicardipine, diltiazem; nelfinavir, indinavir, amprenavir). |
| Nevirapine | drug interactions | … anticonvulsants: carbamazepine, phenobarbital, phenytoin; efavirenz, nevirapine). |
| Nicardipine | drug interactions | Moderate inhibitors of CYP3A4 and P-gp may increase everolimus blood concentrations (e.g., fluconazole; macrolide antibiotics; nicardipine, diltiazem; nelfinavir, indinavir, amprenavir). |
| Octreotide | drug interactions | Coadministration of everolimus and depot octreotide increased octreotide C min by approximately 50%. |
| Phenobarbital | drug interactions | … John’s Wort [ Hypericum perforatum ]; anticonvulsants: carbamazepine, phenobarbital, phenytoin; efavirenz, nevirapine). |
| Phenytoin | drug interactions | … Hypericum perforatum ]; anticonvulsants: carbamazepine, phenobarbital, phenytoin; efavirenz, nevirapine). |
| Pravastatin | drug interactions | Atorvastatin (CYP3A4 Substrate) and Pravastatin (P-gp Substrate) Single-dose administration of Zortress with either atorvastatin or pravastatin to healthy subjects did not influence the … |
| Rifabutin | drug interactions | … telithromycin, ritonavir, boceprevir, telaprevir) and inducers (e.g., rifampin, rifabutin) of CYP3A4 is not recommended. |
| Rifampin | drug interactions | DRUG INTERACTIONS Strong-moderate CYP3A4 inhibitors (e.g., cyclosporine, ketoconazole, erythromycin, verapamil) and CYP3A4 inducers (e.g., rifampin) may affect everolimus concentrations ( 7.1 ). |
| Ritonavir | drug interactions | Concurrent treatment with strong inhibitors (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, boceprevir, telaprevir) and inducers (e.g., rifampin, rifabutin) … |
| Simvastatin | drug interactions | … discouraged patients with receiving HMG-CoA reductase inhibitors such as simvastatin and lovastatin [ s ee Warnings and Precautions ( 5.1 1 )]. |
| Sirolimus | contraindications | CONTRAINDICATIONS Hypersensitivity to everolimus, sirolimus, or to components of the drug product |
| Tacrolimus | drug interactions | There is little to no pharmacokinetic interaction of tacrolimus on everolimus, and consequently, dose adjustment of Zortress is not necessary when Zortress is coadministered with tacrolimus. |
| Verapamil | drug interactions | DRUG INTERACTIONS Strong-moderate CYP3A4 inhibitors (e.g., cyclosporine, ketoconazole, erythromycin, verapamil) and CYP3A4 inducers (e.g., rifampin) may affect everolimus concentrations ( 7.1 ). |
| Voriconazole | drug interactions | Concurrent treatment with strong inhibitors (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, boceprevir, telaprevir) and inducers (e.g., rifampin, rifabutin) … |
Other labels that name everolimus
Source: FDA drug label (Afinitor), Novartis Pharmaceuticals Corporation, effective June 1, 2026 (SPL set 2150f73a-179b-4afc-b8ce-67c85cc72f04), via openFDA; the full label on DailyMed
What do FAERS reports show for everolimus?
The FDA Adverse Event Reporting System holds 49,208 reports that list everolimus among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 10,667 are coded as a death and 14,763 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 everolimus?
18 other medicines are given the same way (oral) and in the same FDA class as everolimus or labeled mainly for the same use (breast cancer), the same class first. Breast cancer lists all 44 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 |
|---|---|---|---|---|
| Sirolimus | Organ transplant rejection | 18 labelers | $0.723 per tablet 1 mg tablet | No current entry |
| Palbociclib | Breast cancer | none listed | n/a | A presentation being discontinued |
| Abemaciclib | Breast cancer | none listed | n/a | No current entry |
| Lapatinib ditosylate | Breast cancer | 3 labelers | n/a | No current entry |
| Ribociclib | Breast cancer | none listed | $289.72 per unit 600 mg daily dose | No current entry |
| Tucatinib | Breast cancer | none listed | n/a | No current entry |
| Neratinib | Breast cancer | none listed | n/a | No current entry |
| Anastrozole | Breast cancer | 24 labelers | $0.142 per tablet 1 mg tablet | No current entry |
Every medicine labeled for the same conditions as everolimus
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does everolimus compare with medicines for the same use?
2 side-by-side pages set everolimus beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to everolimus
- 18 medicines for the same use
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Everolimus side effects
- the label's list beside FAERS reports
- Everolimus shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other