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Everolimus

Everolimus is an mTOR inhibitor used as a cancer and tuberous sclerosis complex treatment (in Afinitor, Yulithira, Torpenz and generic everolimus products) and as an anti-rejection medicine after kidney or liver transplant (in Zortress and generic everolimus transplant tablets).

Brand names Afinitor DisperzAfinitorZortressTorpenzYulithira
Drug classes Kinase Inhibitor
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 22 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

Everolimus at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Everolimus is a specialist drug that blocks mTOR, a cell growth protein, which slows certain cancers and tuberous sclerosis complex (TSC) growths and calms the immune attack on a transplanted kidney or liver (marketed since about 2009, available generically). Side effects are common but usually manageable, led by mouth sores, tiredness and rash. The transplant versions, such as Zortress, carry a boxed warning for serious infections, lymphoma and skin cancer, clots and damage in a new kidney, and higher death rates in heart transplant. With any product, report new cough or breathlessness (possible lung inflammation), expect regular blood work, and use contraception, since it can harm an unborn baby.

Clinical pearls

  • Take it the same way every day, always with food or always without, so your blood levels stay steady.
  • Clarithromycin, itraconazole, rifampin and St. John’s Wort can push everolimus levels too high or too low.
  • If you also take an ACE inhibitor for blood pressure, such as lisinopril, watch closely for face, lip or tongue swelling.
  • Never combine regular tablets with Afinitor Disperz tablets for oral suspension to make up a single dose.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

This boxed warning applies to the transplant products (such as Zortress). Everolimus suppresses your immune system, which raises the risk of serious infections and cancers such as lymphoma and skin cancer. It should be prescribed only by doctors experienced in transplant care.

  • Kidney transplant: blood clots in the kidney’s arteries or veins can cause loss of the new kidney, mostly in the first 30 days.
  • Kidney damage can occur if everolimus is used with standard doses of cyclosporine. Reduced cyclosporine doses and blood level monitoring are needed.
  • Heart transplant: higher death rates, often tied to serious infections, were seen in the first three months. Use in heart transplant is not recommended.

Report signs of infection, new skin changes, or any change in the transplanted organ right away.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet
Earliest FDA record2009
Companies listing it with the FDA15
FDA label last updatedJun 1, 2026
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Everolimus, written from its FDA label.

What Everolimus is used for

▾

Everolimus has different approved uses depending on the product.

  • Afinitor, Yulithira and generic everolimus tablets: advanced hormone receptor-positive, HER2-negative breast cancer in postmenopausal women, with exemestane after letrozole or anastrozole has failed.
  • Afinitor, Yulithira and generic everolimus tablets: progressive neuroendocrine tumors of pancreatic origin, and non-functional tumors of gastrointestinal or lung origin. They are not for functional carcinoid tumors.
  • Afinitor, Yulithira and generic everolimus tablets: advanced renal cell carcinoma after sunitinib or sorafenib has failed.
  • Afinitor, Yulithira, Torpenz and generic everolimus tablets: TSC-associated renal angiomyolipoma not needing immediate surgery.
  • Afinitor, Yulithira, Torpenz and generic everolimus: TSC-associated SEGA (a brain tumor) that cannot be fully removed, in patients 1 year and older.
  • Afinitor Disperz and everolimus tablets for oral suspension: added treatment for TSC-associated partial-onset seizures in patients 2 years and older.
  • Zortress and generic transplant everolimus tablets: preventing organ rejection in adults with a kidney or liver transplant.

How Everolimus works

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Everolimus attaches to a protein inside cells called FKBP-12. This complex blocks mTOR, a key switch for cell growth and division. In cancer and TSC, where this pathway is overactive, blocking it slows growth, new blood vessel formation and sugar uptake by cells.

In transplant use, the same action calms T and B immune cells, so they are less likely to attack the new organ.

Everolimus dosage

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Everolimus is taken by mouth. Cancer and TSC products are generally taken once daily. Transplant products are generally taken twice daily with cyclosporine or tacrolimus.

  • Take it the same way each time, either always with food or always without.
  • Tablets and tablets for oral suspension are different forms and should not be combined to make up a dose.
  • Your doctor may check blood levels and adjust the dose.

Follow your prescriber and the label for your exact dose and what to do if you miss one.

Dosing details from the FDA-approved label

From the Everolimus prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Hormone Receptor-Positive, HER2-Negative Breast Cancer
    • 10 mg orally once daily until disease progression or unacceptable toxicity
    • Mild hepatic impairment (Child-Pugh class A): 7.5 mg orally once daily; decrease to 5 mg orally once daily if 7.5 mg once daily is not tolerated. Moderate hepatic impairment (Child-Pugh class B): 5 mg orally once daily
  • Neuroendocrine Tumors (NET) (Yulithira label)
    • 10 mg orally once daily until disease progression or unacceptable toxicity
  • Renal Cell Carcinoma (RCC) (Yulithira label)
    • 10 mg orally once daily until disease progression or unacceptable toxicity
  • Tuberous Sclerosis Complex (TSC)-Associated Renal Angiomyolipoma
    • 10 mg orally once daily until disease progression or unacceptable toxicity
    • Mild hepatic impairment (Child-Pugh class A): 7.5 mg orally once daily; decrease to 5 mg orally once daily if 7.5 mg once daily is not tolerated. Moderate hepatic impairment (Child-Pugh class B): 5 mg orally once daily
  • Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA)
    • Starting dosage 4.5 mg/m2 orally once daily until disease progression or unacceptable toxicity
    • Titrate the dose to attain trough concentrations of 5 ng/mL to 15 ng/mL
    • Maximum: The maximum dose increment at any titration must not exceed 5 mg
    • Monitor whole blood trough concentrations 1 to 2 weeks after initiation or dose modification
Read the label’s full dosing text

2. DOSAGE AND ADMINISTRATION Do not combine everolimus tablets and everolimus tablets for oral suspension to achieve the total daily dose. ( 2.1 ) Modify the dose for patients with hepatic impairment or for patients taking drugs that inhibit or induce P-glycoprotein (P-gp) and CYP3A4. ( 2.1 ) Breast Cancer: 10 mg orally once daily. ( 2.2 ) NET: 10 mg orally once daily. ( 2.3 ) RCC: 10 mg orally once daily. ( 2.4 ) TSC-Associated Renal Angiomyolipoma: 10 mg orally once daily. ( 2.5 ) TSC-Associated SEGA: 4.5 mg/m 2 orally once daily; adjust dose to attain trough concentrations of 5-15 ng/mL. ( 2.6 , 2.8 ) TSC-Associated Partial-Onset Seizures: 5 mg/ m 2 orally once daily; adjust dose to attain trough concentrations of 5-­15 ng/mL. ( 2.7 , 2.8 ) 2.1 Important Dosage Information Everolimus tablets and everolimus tablets for oral suspension are two different dosage forms. Select the recommended dosage form based on the indication [see Indications and Usage (1) ] . Do not combine everolimus tablets and everolimus tablets for oral suspension to achieve the total dose. Modify the dosage for patients with hepatic impairment or for patients taking drugs that inhibit or induce P-glycoprotein (P-gp) and CYP3A4 [see Dosage and Administration (2.10 , 2.11 , 2.12) ]. 2.2 Recommended Dosage for Hormone Receptor-Positive, HER2-Negative Breast Cancer The recommended dosage of everolimus tablets is 10 mg orally once daily until disease progression or unacceptable toxicity. 2.3 Recommended Dosage for Neuroendocrine Tumors (NET) The recommended dosage of everolimus tablets is 10 mg orally once daily until disease progression or unacceptable toxicity. 2.4 Recommended Dosage for Renal Cell Carcinoma (RCC) The recommended dosage of everolimus tablets is 10 mg orally once daily until disease progression or unacceptable toxicity. 2.5 Recommended Dosage for Tuberous Sclerosis Complex (TSC)-Associated Renal Angiomyolipoma The recommended dosage of everolimus tablets is 10 mg orally once daily until disease progression or unacceptable toxicity. 2.6 Recommended Dosage for Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA) The recommended starting dosage of everolimus tablets/everolimus tablets for oral suspension is 4.5 mg/m 2 orally once daily until disease progression or unacceptable toxicity [see Dosage and Administration (2.8) ].

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Everolimus side effects

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Common side effects include:

Common side effects

  • Mouth sores (stomatitis)
  • Infections
  • Rash
  • Tiredness or weakness
  • Diarrhea
  • Swelling (edema)
  • Nausea and decreased appetite
  • Cough and headache
  • Nausea, abdominal pain and decreased appetite

When to get medical help

  • Call your doctor if you have a new cough, shortness of breath or breathing trouble. This could be lung inflammation (non-infectious pneumonitis or interstitial lung disease).
  • Get help for fever, chills or other signs of infection. Infections can be serious or even fatal.
  • Seek urgent care for swelling of the face, lips, tongue or throat (angioedema) or other severe allergic reactions.
  • Tell your doctor about a wound that is slow to heal, or about swelling or fluid buildup.
  • Report new skin changes or lumps. Lymphoma and skin cancer are risks with immunosuppressants.
  • Transplant patients: report sudden pain, swelling or reduced urine from the transplanted organ, which could signal a blood clot.
  • Report foamy urine or signs of high blood sugar, since protein in the urine and new diabetes after a transplant can occur.

Call your doctor promptly for breathing problems, signs of infection, facial or throat swelling, or poor wound healing.

Everolimus warnings and precautions

▾
  • Immune suppression raises the risk of serious infections, lymphoma and skin cancer.
  • Lung inflammation (pneumonitis) can occur and may be fatal in rare cases.
  • Angioedema, delayed wound healing and fluid buildup can occur.
  • High cholesterol, high triglycerides, protein in the urine and new diabetes after transplant can occur.
  • Transplant use carries risks of kidney graft clots, liver artery clots, kidney damage with cyclosporine, and higher death rates in heart transplant. Zortress should not start earlier than 30 days after a liver transplant.
  • Avoid live vaccines.
  • It can harm an unborn baby and may affect fertility.

Everolimus interactions

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Many drugs change everolimus levels, mainly through CYP3A4 and P-gp.

  • Strong CYP3A4 inhibitors (ketoconazole, itraconazole, voriconazole, clarithromycin, ritonavir) raise levels and are not recommended.
  • Strong inducers (rifampin, rifabutin) lower levels and are not recommended.
  • St. John’s Wort and certain seizure medicines (carbamazepine, phenobarbital, phenytoin) may lower levels.
  • Erythromycin, verapamil, fluconazole and diltiazem may raise levels.
  • Cyclosporine raises everolimus levels.
  • Cannabidiol may raise levels.
  • ACE inhibitors raise angioedema risk.
  • Grapefruit and grapefruit juice should be avoided with transplant use alongside cyclosporine or tacrolimus.

Interactions listed in the FDA-approved label

From the Everolimus prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, boceprevir, telaprevir): Ketoconazole significantly increased everolimus Cmax, AUC, and half-life in healthy volunteers. Should not be coadministered with everolimus.
  • Strong CYP3A4/P-gp inducers (e.g., rifampin, rifabutin): Rifampin pretreatment increased everolimus clearance and decreased everolimus Cmax and AUC. Concurrent treatment is not recommended.
  • Cyclosporine (CYP3A4/P-gp inhibitor): Significantly increased steady-state Cmax and AUC of everolimus. Dose adjustment of everolimus might be needed if the cyclosporine dose is altered.
  • Erythromycin (moderate CYP3A4 inhibitor): Significantly increased single dose everolimus Cmax, AUC, and half-life. Monitor everolimus blood concentrations and make a dose adjustment as necessary.
  • Verapamil: Significantly increased single dose everolimus Cmax and AUC; half-life was not changed. Monitor everolimus blood concentrations and make a dose adjustment as necessary.
  • Atorvastatin and pravastatin: Did not influence the pharmacokinetics of atorvastatin, pravastatin and everolimus to a clinically relevant extent. Monitor patients for rhabdomyolysis and other adverse reactions; results cannot be extrapolated to other HMG-CoA reductase inhibitors.
  • Midazolam and other CYP3A4/5 substrates: Everolimus is a weak inhibitor of CYP3A4/5. Dose adjustment of midazolam or other CYP3A4/5 substrates is not necessary.
  • Moderate inhibitors of CYP3A4 and P-gp (e.g., fluconazole, macrolide antibiotics, nicardipine, diltiazem, nelfinavir, indinavir, amprenavir): May increase everolimus blood concentrations.
  • Octreotide (depot): Coadministration with everolimus increased octreotide Cmin by approximately 50%.
  • Tacrolimus: Little to no pharmacokinetic interaction of tacrolimus on everolimus. Dose adjustment of everolimus is not necessary.
Read the label’s full interactions text

7 DRUG INTERACTIONS Strong-moderate CYP3A4 inhibitors (e.g., cyclosporine, ketoconazole, erythromycin, verapamil) and CYP3A4 inducers (e.g., rifampin) may affect everolimus concentrations ( 7.1 ). Consider everolimus tablets dose adjustment ( 5.14 ) Therapeutic drug monitoring and dose reduction for everolimus tablets should be considered when everolimus tablets are coadministered with cannabidiol (5.22, 7.13) 7.1 Interactions With Strong Inhibitors or Inducers of CYP3A4 and P-glycoprotein Everolimus is mainly metabolized by CYP3A4 in the liver and to some extent in the intestinal wall and is a substrate for the multidrug efflux pump, P-glycoprotein (P-gp). Therefore, absorption and subsequent elimination of systemically absorbed everolimus may be influenced by medicinal products that affect CYP3A4 and/or P-gp. 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. Inhibitors of P-gp (e.g., digoxin, cyclosporine) may decrease the efflux of everolimus from intestinal cells and increase everolimus blood concentrations. In vitro , everolimus was a competitive inhibitor of CYP3A4 and of CYP2D6, potentially increasing the concentrations of medicinal products eliminated by these enzymes. Thus, caution should be exercised when coadministering everolimus with CYP3A4 and CYP2D6 substrates with a narrow therapeutic index [ s ee Dosage and Administration ( 2. 3 ) ] . All in vivo interaction studies were conducted without concomitant cyclosporine. Pharmacokinetic interactions between everolimus and concomitantly administered drugs are discussed below. Drug interaction studies have not been conducted with drugs other than those described below.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿156 supplements and herbs with documented Everolimus interactions, ranked by severity Check Everolimus against a supplement or herb →

Before taking Everolimus

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  • Do not use it if you are allergic to everolimus or sirolimus.
  • Liver problems may require a lower dose.
  • Pregnancy: it can cause fetal harm. Use effective contraception during treatment and for 8 weeks after the last dose (women) or 4 weeks (men with female partners).
  • Do not breastfeed during treatment and for 2 weeks after the last dose.
  • It may affect fertility.
  • Children: use is established only for certain TSC conditions, and younger children had more infections.
  • Older adults had more serious side effects and treatment stops in the breast cancer trial.

Everolimus overdose

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Experience with overdose is very limited. Single doses up to 25 mg in transplant patients and up to 70 mg in other studies were tolerated acutely. General supportive care is advised, and dialysis is not expected to remove much everolimus.

What Everolimus does in the body

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In TSC-related brain tumors (SEGA), the shrinking of tumor volume was linked to everolimus blood levels. In TSC-related seizures, the reduction in seizure frequency also followed blood levels. A single dose up to 50 mg did not prolong the QT interval, a heart rhythm measure, in healthy people.

How your body processes Everolimus

▾

Everolimus peaks in the blood about 1 to 2 hours after a dose. Food lowers how much is absorbed, so take it the same way each time. It is mostly broken down by the liver enzyme CYP3A4, and its half-life is about 30 hours. Most is cleared in the stool, with little in urine. Liver impairment raises levels.

How to store Everolimus

▾

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Store in the original container, protect from light and moisture.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

156

Supplements & herbs that interact with Everolimus

156 supplements and herbal products have documented interactions with Everolimus in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 5
  • Moderate · 112
  • Minor · 39
ACTIVATED CHARCOAL Major ASARABACCA Major GRAPEFRUIT Major SIBERIAN COCKLEBUR Major ST. JOHN'S WORT Major ACACIA RIGIDULA Moderate ADRAFINIL Moderate AFRICAN WILD POTATO Moderate +148 more
Every supplement checked against Everolimus — ranked by severity The full interaction hub: 5 major · 112 moderate · 39 minor · every one linked to its full report. Check Everolimus against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Everolimus: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Everolimus — the kind of thing our pharmacy team would talk through with you at the counter.

What is everolimus used for?

▾
It depends on the product. Afinitor, Yulithira and generic everolimus tablets treat certain cancers and tuberous sclerosis complex conditions. Zortress and generic transplant tablets help prevent organ rejection after a kidney or liver transplant. Your pharmacist can confirm which one you have.

How should I take it?

▾
Take it by mouth, the same way every time, either always with food or always without. The cancer and TSC products are usually once a day. The transplant products are usually twice a day, along with cyclosporine or tacrolimus. Do not combine tablets with tablets for oral suspension to make up a dose.

What side effects should I expect?

▾
Mouth sores are very common, along with infections, rash, tiredness, diarrhea, swelling and low appetite. Mention mouth sores early, since they can be managed. Call your doctor right away for breathing trouble, fever or other signs of infection, or facial swelling.

Can I take other medicines or supplements with it?

▾
Check with me first. Many drugs change everolimus levels, including ketoconazole, clarithromycin, rifampin, St. John’s Wort and certain seizure medicines. Cannabidiol can raise levels, and ACE inhibitors can raise angioedema risk. If you are a transplant patient taking cyclosporine or tacrolimus, avoid grapefruit and grapefruit juice.

Is it safe during pregnancy or while breastfeeding?

▾
Everolimus can harm an unborn baby, so effective contraception is needed during treatment and for 8 weeks after the last dose for women. Men with female partners who can become pregnant should use it for 4 weeks after. Do not breastfeed during treatment or for 2 weeks after the last dose.

Do I need any vaccines or special checks?

▾
Avoid live vaccines while you are on it. Your doctor will likely monitor blood work, cholesterol, blood sugar, kidney function and sometimes everolimus blood levels. Limit sun exposure and use sunscreen to protect your skin.

Is Everolimus available over the counter?

▾
No. Everolimus is a prescription medicine: every Everolimus product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Everolimus first available?

▾
The earliest FDA record we hold for Everolimus is from 2009: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Everolimus was first used.

Who makes Everolimus?

▾
15 companies currently list Everolimus products in the FDA's NDC Directory, including Biocon Pharma Inc., Breckenridge Pharmaceutical, Inc., Novartis Pharmaceuticals Corporation. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Everolimus on HelloPharmacist

📊Everolimus supplement interactions156 checked — ranked by severity 🌿Drug & Supplement CheckerEverolimus vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Everolimus NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Everolimus Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Everolimus forms and strengths (how it comes)

Everolimus is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Everolimus inactive ingredients by manufacturer.

Tablet

By mouth
Brands Afinitor Torpenz Yulithira Zortress
How this form is used
What it may be used for
  • Afinitor, Yulithira and generic everolimus tablets are used for hormone receptor-positive, HER2-negative breast cancer with exemestane, certain neuroendocrine tumors, advanced kidney cancer, TSC kidney angiomyolipoma and TSC-related SEGA.
  • Torpenz tablets are used for hormone receptor-positive, HER2-negative breast cancer with exemestane, TSC kidney angiomyolipoma and TSC-related SEGA.
  • Zortress is used to prevent rejection in adults with a kidney or liver transplant.
Important instructions
  • Torpenz tablets and tablets for oral suspension are different forms and should not be combined to reach a total dose.
  • Yulithira tablets and everolimus tablets for oral suspension should not be combined to reach a total dose.
  • Zortress should be taken consistently with or without food, at the same time as cyclosporine or tacrolimus.
  • Zortress doses may be adjusted based on blood levels.
Available strengths 10 strengths
0.25 mg 0.5 mg 0.75 mg 1 mg 2 mg 2.5 mg
Show 4 more strengths Show fewer strengths
3 mg 5 mg 7.5 mg 10 mg
203 FDA-listed product records ⓘ

Everolimus on the U.S. market: products, makers and brands

How Everolimus appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

15 companies list 88 Everolimus product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2009. Brand names on the directory include Afinitor Disperz, Afinitor, Zortress and 2 more; the rest are generics.

1
Dose forms ⓘ
15
Labelers (makers, repackagers, distributors)
6
Brand names
88
FDA-listed product records ⓘ
2009
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (17) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Biocon Pharma Inc.13%
Breckenridge Pharmaceutical, Inc.13%
Novartis Pharmaceuticals Corporation13%
Hikma Pharmaceuticals USA Inc.9%
Natco Pharma Limited9%
Ascend Laboratories, LLC5%
Other makers40%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Everolimus is used (Medicaid data)

A general measure of how commonly Everolimus is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Everolimus is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

11,955
Medicaid prescriptions filled (Q1–Q4 2025)
$72.1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Everolimus prescribed? Of the 1,601 medications we measure, Everolimus ranks #899 by Medicaid prescriptions — more than 44% of them.

Where Everolimus ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #899 of 1,601
#894 Phytonadione 12,205 Rx #895 Amlodipine / Hydrochlo... 12,179 Rx #896 Olmesartan Medoxomil /... 12,179 Rx #897 Dextrose / Potassium C... 12,170 Rx #898 Nitroglycerin Transder... 12,007 Rx #899 Everolimus 11,955 Rx #900 Famciclovir 11,935 Rx #901 Cyclophosphamide Injec... 11,741 Rx #902 Dasatinib 11,700 Rx #903 Nateglinide 11,692 Rx #904 Doravirine 11,622 Rx

Utilization by Everolimus product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 1 mg oral tablet is the most-dispensed Everolimus product — about 24% of these Medicaid prescriptions.

everolimus 1 MG Oral Tablet Most dispensed

2,873 Medicaid prescriptions (Q1–Q4 2025) 24% of Everolimus prescriptions shown $4.6M gross reimbursement (before rebates) ≈ $1,603 per prescription (gross)

Summed across the 4 of 18 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2056895

everolimus 0.5 MG Oral Tablet

2,238 Medicaid prescriptions (Q1–Q4 2025) 19% of Everolimus prescriptions shown $1.6M gross reimbursement (before rebates) ≈ $706 per prescription (gross)

Summed across the 6 of 18 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 977434

everolimus 10 MG Oral Tablet

1,457 Medicaid prescriptions (Q1–Q4 2025) 12% of Everolimus prescriptions shown $11.2M gross reimbursement (before rebates) ≈ $7,707 per prescription (gross)

Summed across the 7 of 30 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 845507

everolimus 5 MG Oral Tablet

1,318 Medicaid prescriptions (Q1–Q4 2025) 11% of Everolimus prescriptions shown $10.7M gross reimbursement (before rebates) ≈ $8,138 per prescription (gross)

Summed across the 8 of 29 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 845515

everolimus 0.75 MG Oral Tablet

944 Medicaid prescriptions (Q1–Q4 2025) 8% of Everolimus prescriptions shown $809,866 gross reimbursement (before rebates) ≈ $858 per prescription (gross)

Summed across the 5 of 18 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 977438

everolimus 0.25 MG Oral Tablet

740 Medicaid prescriptions (Q1–Q4 2025) 6% of Everolimus prescriptions shown $188,271 gross reimbursement (before rebates) ≈ $254 per prescription (gross)

Summed across the 5 of 19 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 977427

everolimus 2 MG Tablet for Oral Suspension

665 Medicaid prescriptions (Q1–Q4 2025) 6% of Everolimus prescriptions shown $12.9M gross reimbursement (before rebates) ≈ $19,395 per prescription (gross)

Summed across the 4 of 12 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1308428

everolimus 5 MG Tablet for Oral Suspension

582 Medicaid prescriptions (Q1–Q4 2025) 5% of Everolimus prescriptions shown $12.5M gross reimbursement (before rebates) ≈ $21,516 per prescription (gross)

Summed across the 2 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1308432

everolimus 7.5 MG Oral Tablet

550 Medicaid prescriptions (Q1–Q4 2025) 5% of Everolimus prescriptions shown $5.8M gross reimbursement (before rebates) ≈ $10,480 per prescription (gross)

Summed across the 4 of 30 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1119400

everolimus 2.5 MG Oral Tablet

295 Medicaid prescriptions (Q1–Q4 2025) 2% of Everolimus prescriptions shown $6M gross reimbursement (before rebates) ≈ $20,199 per prescription (gross)

Summed across the 5 of 30 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 998189

everolimus 3 MG Tablet for Oral Suspension

293 Medicaid prescriptions (Q1–Q4 2025) 2% of Everolimus prescriptions shown $5.8M gross reimbursement (before rebates) ≈ $19,845 per prescription (gross)

Summed across the 2 of 12 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1308430

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Everolimus, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 52 of 227 listed Everolimus NDCs with Medicaid activity.

Compare Everolimus products

A representative set of FDA-listed product records for Everolimus — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 88 of 88 products — FDA National Drug Code Directory. See every product, package size and price: browse all 88 Everolimus NDCs →

Everolimus side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Everolimus — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Everolimus are death, malignant neoplasm progression, diarrhoea; about 77% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

50,589
Reports mentioning it
77%
Reported as serious
12
Distinct effects shown
Most reported effects
Death
6,350
Malignant Neoplasm Progression
4,683
Diarrhoea
4,073
Fatigue
3,811
Stomatitis
3,189
Nausea
2,854
Dyspnoea
2,637
Pyrexia
2,142
Vomiting
2,139
Decreased Appetite
2,125
Age groups
Adult · 2,538Elderly · 1,252Child · 138Adolescent · 58Neonate · 50Infant · 19

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Everolimus in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Everolimus FDA approval history

How Everolimus went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Everolimus was first approved by the FDA in 2009 (Brand: AFINITOR · Novartis); the first generic version was approved in 2018. It remains available in U.S. pharmacies today.

2009
Brand approved
Brand: AFINITOR · Novartis
2018
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Everolimus recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Everolimus recalls since July 2021.

✅No Everolimus recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Everolimus RxCUI 141704 2 dose forms · 11 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 845506 In current FDA listings
    Clinical drug / strength (SCD) 0.25 MG RxCUI 977427 0.5 MG RxCUI 977434 0.75 MG RxCUI 977438 1 MG RxCUI 2056895 2.5 MG RxCUI 998189 5 MG RxCUI 845515 7.5 MG RxCUI 1119400 10 MG RxCUI 845507
  2. Dose form (SCDF) Tablet for Oral Suspension RxCUI 1869513 In current FDA listings
    Clinical drug / strength (SCD) 2 MG RxCUI 1308428 3 MG RxCUI 1308430 5 MG RxCUI 1308432

Look up RxCUI 141704 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Everolimus supply and shortage status

Whether Everolimus is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.

Everolimus is not in shortage right now; the FDA has 10 past shortage records for it.

✅No current shortage of Everolimus on record

Read the full Everolimus shortage page — affected NDCs, other makers, and what to do →

To be discontinued Everolimus, Tablet, 5 mg (NDC 0093-7767-24)
Teva Pharmaceuticals USA, Inc. · Since 03/02/2026 · Updated 03/02/2026
To be discontinued Everolimus, Tablet, 10 mg (NDC 0093-7769-24)
Teva Pharmaceuticals USA, Inc. · Since 03/02/2026 · Updated 03/02/2026
To be discontinued Everolimus, Tablet, 7.5 mg (NDC 0093-7768-24)
Teva Pharmaceuticals USA, Inc. · Since 03/02/2026 · Updated 03/02/2026
To be discontinued Everolimus, Tablet, 2.5 mg (NDC 0093-7766-24)
Teva Pharmaceuticals USA, Inc. · Since 03/02/2026 · Updated 03/02/2026
To be discontinued Everolimus, Tablet, 7.5 mg (NDC 49884-127-91)
Endo Pharmaceuticals, Inc. · Since 01/06/2026 · Updated 01/06/2026
To be discontinued Everolimus, Tablet, 2.5 mg (NDC 49884-119-91)
Endo Pharmaceuticals, Inc. · Since 01/06/2026 · Updated 01/06/2026
To be discontinued Everolimus, Tablet, 10 mg (NDC 49884-128-91)
Endo Pharmaceuticals, Inc. · Since 01/06/2026 · Updated 01/06/2026
To be discontinued Everolimus, Tablet, 5 mg (NDC 49884-125-91)
Endo Pharmaceuticals, Inc. · Since 01/06/2026 · Updated 01/06/2026
To be discontinued Everolimus, Tablet, 5 mg (NDC 0378-0007-85)
Mylan Pharmaceuticals Inc., a Viatris Company · Since 11/03/2025 · Updated 11/03/2025
To be discontinued Everolimus, Tablet, 3 mg (NDC 0378-0006-85)
Mylan Pharmaceuticals Inc., a Viatris Company · Since 11/03/2025 · Updated 11/03/2025

Source: openFDA, from the FDA Drug Shortages database.

💵 What Everolimus costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet · Oral 10 mg $26.32 per tablet NDC details & price history
Tablet · Oral 5 mg $14.77 per tablet NDC details & price history
Tablet · Oral 0.25 mg $1.79 per tablet NDC details & price history
Tablet · Oral 1 mg $5.25 per tablet NDC details & price history
Tablet · Oral 0.75 mg $4.18 per tablet NDC details & price history
Tablet · Oral 0.5 mg $3.52 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Everolimus brand names

Everolimus is sold under 5 brand names in the FDA directory — Afinitor Disperz, Afinitor, Zortress, Torpenz and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Afinitor Disperz Afinitor Zortress Torpenz Yulithira

Who makes Everolimus: manufacturers and labelers

15 companies list Everolimus products with the FDA. By number of product records, the largest are Biocon Pharma Inc., Breckenridge Pharmaceutical, Inc., Novartis Pharmaceuticals Corporation. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Biocon Pharma Inc. 11 Breckenridge Pharmaceutical, Inc. 11 Novartis Pharmaceuticals Corporation 11 Hikma Pharmaceuticals USA Inc. 8 Natco Pharma Limited 8 Ascend Laboratories, LLC 4 Aurobindo Pharma Limited 4 CivicaScript, LLC 4 NorthStar RxLLC 4 Novugen Pharma (USA) LLC. 4 Par Health USA, LLC 4 Teva Pharmaceuticals USA, Inc. 4 Upsher-Smith Laboratories, LLC 4 i3 Pharmaceuticals, LLC 4 Amneal Pharmaceuticals NY LLC 3

Everolimus drug class (RxNorm)

Everolimus belongs to the Kinase Inhibitor class.

Pharmacologic class Kinase Inhibitor, mTOR Inhibitor Immunosuppressant
Drug family (ATC) Mammalian target of rapamycin (mTOR) kinase inhibitors, Mammalian target of rapamycin (mTOR) kinase inhibitors
How it works Protein Kinase Inhibitors, mTOR Inhibitors, Cytochrome P450 2D6 Inhibitors, Cytochrome P450 3A4 Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Everolimus page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jun 1, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Everolimus.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Everolimus after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
22
Finished products in the current FDA directory
88
Companies listing them (makers, repackagers, distributors)
15
FDA labeler codes behind them ⓘ
15
Linked representative label ⓘ
Novartis Pharmaceuticals Corporation
Linked label effective
Jun 1, 2026
Composite sections available
26
Linked SPL Set ID
2150f73a-179b-4afc-b8ce-67c85cc72f04
Linked SPL Document ID
b808a4e0-23a8-40c8-834d-b31cd642febe
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Novartis Pharmaceuticals Corporation is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →