Two medicines, side by side
Everolimus vs sirolimus
Everolimus and sirolimus are both labeled for organ transplant rejection. Drugs@FDA records approvals of everolimus since 2009 and of sirolimus since 1999. Pharmacies paid $26.32 per everolimus 10 mg tablet and $0.723 per sirolimus 1 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. How each works, in its label's words: Everolimus, “Everolimus is an inhibitor of mammalian target of rapamycin (mTOR), a serine-threonine kinase, downstream of the PI3K/AKT pathway.”; Sirolimus, “Sirolimus inhibits T-lymphocyte activation and proliferation that occurs in response to antigenic and cytokine (Interleukin [IL]-2, IL-4, and IL-15) stimulation by a mechanism that is distinct from …”
Check it at the source: the everolimus FDA label on DailyMed (effective June 1, 2026); the sirolimus FDA label on DailyMed (effective January 28, 2026).
Highlights of the everolimus record
Everolimus (Afinitor) · label of June 1, 2026
Used for
From the label: indicationsAFINITOR 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. […]
On the market
- Earliest approval on file
- March 30, 2009
- Generic labelers
- 14 labelers
- Pharmacy cost
- $26.32 per tablet
Supply and safety
- Shortage
- A presentation being discontinued
- Recalls
- 5
Highlights of the sirolimus record
Sirolimus (Rapamune) · label of January 28, 2026
IMMUNOSUPPRESSION, USE IS NOT RECOMMENDED IN LIVER OR LUNG TRANSPLANT PATIENTS
Increased susceptibility to infection and the possible development of lymphoma and other malignancies may result from immunosuppression Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression.
Used for
From the label: indicationsSirolimus tablets are an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: ○ Patients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. […]
On the market
- Earliest approval on file
- September 15, 1999
- Generic labelers
- 17 labelers
- Pharmacy cost
- $0.723 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 5
Source: FDA drug labels via openFDA (Everolimus label of June 1, 2026, Sirolimus label of January 28, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do everolimus and sirolimus differ on the record?
How each works, in its label's words: Everolimus, “Everolimus is an inhibitor of mammalian target of rapamycin (mTOR), a serine-threonine kinase, downstream of the PI3K/AKT pathway.”; Sirolimus, “Sirolimus inhibits T-lymphocyte activation and proliferation that occurs in response to antigenic and cytokine (Interleukin [IL]-2, IL-4, and IL-15) stimulation by a mechanism that is distinct from …”
Only the sirolimus label carries a boxed warning.
Both are in FDA's class mtor inhibitor immunosuppressants.
Half-life, in each label's words: Everolimus, “Elimination The mean elimination half-life of everolimus is approximately 30 hours.”; Sirolimus, “The mean ± SD terminal elimination half-life (t ½ ) of sirolimus after multiple dosing in stable renal transplant …”
Generics: everolimus since 2018; sirolimus since 2014 (Drugs@FDA).
| Everolimus | Sirolimus | |
|---|---|---|
| Labeled for | Breast cancer, Seizures and epilepsy, Organ transplant rejection | Organ transplant rejection |
| Pharmacologic class | Kinase Inhibitor, mTOR Inhibitor Immunosuppressant | Kinase Inhibitor, mTOR Inhibitor Immunosuppressant |
| How it works (label) | Everolimus is an inhibitor of mammalian target of rapamycin (mTOR), a serine-threonine kinase, downstream of the PI3K/AKT pathway. The mTOR pathway is dysregulated in several human cancers and in tuberous sclerosis complex (TSC). | Sirolimus inhibits T-lymphocyte activation and proliferation that occurs in response to antigenic and cytokine (Interleukin [IL]-2, IL-4, and IL-15) stimulation by a mechanism that is distinct from that of other immunosuppressants. |
| Half-life (label) | Elimination The mean elimination half-life of everolimus is approximately 30 hours. | The mean ± SD terminal elimination half-life (t ½ ) of sirolimus after multiple dosing in stable renal transplant patients was estimated to be about 62 ± 16 hours. |
| Earliest approval on file (Drugs@FDA) | March 30, 2009 | September 15, 1999 |
| First generic approved | April 12, 2018 | January 8, 2014 |
| Generic labelers (NDC) | 14 labelers | 17 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $26.32 per tablet (Everolimus 10 mg tablet) | $0.723 per tablet (Sirolimus 1 mg tablet) |
| 12-month price change | -12% | -50% |
| Boxed warning | No | Yes |
| Shortage now | A presentation being discontinued | No current entry |
| Recalls recorded | 5 | 5 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 49,208 | 13,365 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
Do their labels mention each other?
Everolimus label, contraindicationsCONTRAINDICATIONS Hypersensitivity to everolimus, sirolimus, or to components of the drug product
Source: FDA drug labels via openFDA
What next?
- Alternatives to everolimus
- every medicine labeled for the same conditions