Everolimus: uses, dosing, side effects & brands

Everolimus is a kinase inhibitor sold in the U.S. under 3 brand and generic names. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Drug class: Kinase Inhibitor
Available as: Tablet
Sold as: 3 products — Afinitor, Everolimus and Zortress
Prescription?: Prescription only
Generic available?: Yes
Half-life: about 30 hours (mean terminal elimination half-life)
What the pharmacy pays: about $229 for a 30-count supply — not your price
Boxed warning: Boxed warning

How everolimus is dosed

From the FDA label for Afinitor (application NDA022334). Other everolimus products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

Do not combine AFINITOR and AFINITOR DISPERZ to achieve the total daily dose. ( 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 AFINITOR and AFINITOR DISPERZ are two different dosage forms. Select the recommended dosage form based on the indication [see Indications and Usage (1)] . Do not combine AFINITOR and AFINITOR DISPERZ to achieve the total dose. 2.2 Recommended Dosage for Hormone Receptor-Positive, HER2-Negative Breast Cancer The recommended dosage of AFINITOR is 10 mg orally once daily until disease progression or unacceptable toxicity. 2.3 Recommended Dosage for Neuroendocrine Tumors (NET) The recommended dosage of AFINITOR 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 AFINITOR is 10 mg orally once daily until disease progression or unacceptable toxicity. 2.5 Recommended Dosage for Tuberous Sclerosis Complex…

Everolimus side effects

The following serious adverse reactions are described elsewhere in the labeling: Non-Infectious Pneumonitis [see Warnings and Precautions (5.1)] Infections [see Warnings and Precautions (5.2)] Severe Hypersensitivity Reactions [see Warnings and Precautions (5.3)] Angioedema with Concomitant Use of ACE inhibitors [see Warnings and Precautions (5.4)] Stomatitis [see Warnings and Precautions (5.5)] Renal Failure [see Warnings and Precautions (5.6)] Impaired Wound Healing [see Warnings and Precautions (5.7)] Metabolic Disorders [see Warnings and Precautions (5.9)] Myelosuppression [see Warnings and Precautions (5.10)] Radiation Sensitization and Radiation Recall [see Warnings and Precautions (5.12)] Breast cancer, NET, RCC : Most common adverse reactions (incidence ≥ 30%) include stomatitis, infections, rash, fatigue, diarrhea, edema, abdominal pain, nausea, fever, asthenia, cough, headache, and decreased appetite. ( 6.1 ) TSC-Associated Renal Angiomyolipoma : Most common adverse reaction (incidence ≥ 30%) is stomatitis. ( 6.1 ) TSC-Associated SEGA : Most common adverse reactions (incidence ≥ 30%) are stomatitis and respiratory tract infection. ( 6.1 ) TSC-Associated Partial-Onset Seizures : Most common adverse reaction (incidence ≥ 30%) is stomatitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at…

Who shouldn’t take everolimus

AFINITOR/AFINITOR DISPERZ is contraindicated in patients with clinically significant hypersensitivity to everolimus or to other rapamycin derivatives [see Warnings and Precautions (5.3)] . Clinically significant hypersensitivity to everolimus or to other rapamycin derivatives. ( 4 )

Everolimus drug interactions

Strong CYP3A inhibitor and P-gp inhibitor : Avoid coadministration. ( 2.11 , 7.1 ) Moderate CYP3A inhibitor and P-gp inhibitor : 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 : Increase the dosage as recommended. ( 2.11 , 7.1 ) 7.1 Effect of Other Drugs on AFINITOR/AFINITOR DISPERZ Strong or Moderate CYP3A Inhibitor and P-gp Inhibitor Avoid the coadministration of a strong CYP3A inhibitor and P-gp inhibitor [see Dosage and Administration (2.11), Clinical Pharmacology (12.3)] . Reduce the dosage for AFINITOR/AFINITOR DISPERZ with a moderate CYP3A inhibitor and Pg-p inhibitor as recommended [see Dosage and Administration (2.11), Clinical Pharmacology (12.3)] . Cannabidiol Oral Solution Reduce the dosage of AFINITOR/AFINITOR DISPERZ when coadministered with cannabidiol oral solution [see Dosage and Administration (2.11)] . Coadministration with cannabidiol oral solution increases everolimus exposure [see Clinical Pharmacology (12.3)] , which may increase the risk of everolimus adverse reactions. The effects of other cannabidiol products on everolimus exposure are unknown. Strong CYP3A Inducer and P-gp Inducer Increase the dosage for AFINITOR/AFINITOR DISPERZ with a strong CYP3A inducer and Pg-p inducer as recommended [see Dosage and Administration (2.11), Clinical Pharmacology (12.3)] . 7.2 Effects of Combination Use of Angiotensin Converting Enzyme (ACE) Inhibitors Patients taking concomitant ACE inhibitors with AFINITOR/AFINITOR DISPERZ may be at increased risk for angioedema. Avoid the concomitant use of ACE inhibitors with AFINITOR/AFINITOR DISPERZ [see Warnings and Precautions (5.4)] .

Every everolimus product we track (3)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Everolimus products
#	Drug	Rating	Type	Form	Generic?	Pharmacy pays
1	Afinitor	70/100	Prescription	Tablet	Generic	$229	View →
2	Everolimus Boxed warning	70/100	Prescription	Tablet	Generic	$229	View →
3	Zortress Boxed warning	70/100	Prescription	Tablet	Generic	$229	View →

What everolimus pills look like

Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.

Everolimus pill imprints
Imprint	Strength	Colour	Shape	Maker
EVR;2;5	2.5 mg	white	oval	—
EVR;5	5 mg	white	oval	—
EVR;7;5	7.5 mg	white	oval	—
EVR;NAT	10 mg	white	oval	—
5;NVR	5 mg	white	oval	—
UHE;NVR	10 mg	white	oval	—
LCL;NVR	2.5 mg	white	oval	—
7P5;NVR	7.5 mg	white	oval	—
D2;NVR	2 mg	white	round	—
D3;NVR	3 mg	white	round	—
D5;NVR	5 mg	white	round	—
B;5	5 mg	white	capsule	—

Everolimus recalls

From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.

Can you crush or split everolimus?

At least one everolimusproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.

What each everolimus label says about crushing, splitting and chewing

How long everolimus keeps

No everolimus label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.

Does everolimus expire? The in-use limits and storage rules from its labels

Everolimus and breastfeeding

From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.

In two women, everolimus was either undetectable or detectable in very small amounts in the colostrum. However, no information is available on the use of everolimus during breastfeeding. An alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Full LactMed record for everolimus: levels in milk, effects in breastfed infants, and the drugs it would consider instead

National Institute of Child Health and Human Development, record revised June 15, 2026. LactMed states its information is not a substitute for professional judgement.

What people report to the FDA about everolimus

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 17,187 reports naming everolimus, and the FDA flagged 89% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

malignant neoplasm progression1,553 reports
diarrhoea1,234 reports
fatigue873 reports
nausea797 reports
dyspnoea680 reports
pyrexia644 reports
vomiting638 reports
pneumonia617 reports

Read these as a signal, not a rate. A report does not mean everolimus caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.

Source: openFDA drug/event (FAERS), retrieved August 25, 2026.

How long everolimus stays in your system

The elimination half-life of everolimus is about 30 hours (mean terminal elimination half-life). Not a prodrug; everolimus is the main circulating component in blood. Its six detected metabolites showed roughly 100-times less activity than everolimus itself, so there is no active metabolite that outlasts the parent. The label reports no clinically meaningful change with age or sex, and renal impairment (creatinine clearance 25-178 mL/min) did not significantly affect clearance. Hepatic impairment increases exposure substantially, though: AUC rose about 1.8-, 3.2-, and 3.6-fold in mild, moderate, and severe (Child-Pugh A/B/C) impairment, so the label calls for dose reduction in hepatic impairment.

Everolimus tablets - DailyMed label, Clinical Pharmacology (12.3) ↗

Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.

Related calculators

How long it stays in your system →

Frequently asked questions

What is everolimus?

AFINITOR (everolimus) and AFINITOR DISPERZ (everolimus tablets for oral suspension) are kinase inhibitors.

What kind of drug is everolimus?

The FDA classifies everolimus as a kinase inhibitor. Kinase inhibitors block protein kinases, the enzymes that relay 'grow and divide' signals inside cells. By shutting down the overactive kinase signals that a tumor depends on, they help slow or stop cancer cells from multiplying. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.

How long does everolimus stay in your system?

The elimination half-life of everolimus is about 30 hours (mean terminal elimination half-life) — that is how long the body takes to clear half of a dose. Not a prodrug; everolimus is the main circulating component in blood. Its six detected metabolites showed roughly 100-times less activity than everolimus itself, so there is no active metabolite that outlasts the parent. The label reports no clinically meaningful change with age or sex, and renal impairment (creatinine clearance 25-178 mL/min) did not significantly affect clearance. Hepatic impairment increases exposure substantially, though: AUC rose about 1.8-, 3.2-, and 3.6-fold in mild, moderate, and severe (Child-Pugh A/B/C) impairment, so the label calls for dose reduction in hepatic impairment. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.

Can you take everolimus with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run everolimus against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What brand names is everolimus sold under?

We track 3 everolimus-containing products in the U.S.: Afinitor, Everolimus and Zortress. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.

What forms does everolimus come in?

Across the brands we track, everolimus is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic everolimus?

Yes. Our catalog lists 1 generic everolimus product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.

Has everolimus been recalled?

The FDA's Enforcement database lists at least 5 recall records whose product description mentions everolimus. The most recent: Everolimus tablets 7.5mg (Oct 10, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.

Cite this page

APA: pharmaranks. (2026, July 24). Everolimus: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/everolimus
MLA: “Everolimus: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/everolimus.

We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Read the full FDA label for everolimus on DailyMed (NIH) ↗ — including its boxed warning in full.