Two medicines, side by side
Everolimus vs tacrolimus
Everolimus and tacrolimus are both labeled for organ transplant rejection. Drugs@FDA records approvals of everolimus since 2009 and of tacrolimus since 1994. Pharmacies paid $26.32 per everolimus 10 mg tablet and $0.970 per gram (Tacrolimus 0.1% ointment) (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, everolimus is a mtor inhibitor immunosuppressant and tacrolimus a calcineurin inhibitor immunosuppressant.
Check it at the source: the everolimus FDA label on DailyMed (effective June 1, 2026); the tacrolimus FDA label on DailyMed (effective July 17, 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 tacrolimus record
Tacrolimus (Prograf) · label of July 17, 2026
MALIGNANCIES AND SERIOUS INFECTIONS Increased risk for developing serious infections and malignancies with Tacrolimus or other immunosuppressants that may lead to hospitalization or death. ( 5.1 , 5.2 ) WARNING: MALIGNANCIES AND SERIOUS INFECTIONS See full prescribing information for complete boxed warning. Increased risk for developing serious infections and malignancies with tacrolimus or other immunosuppressants that may lead to hospitalization or death.
Used for
From the label: indicationsTacrolimus capsules are a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney or heart transplants, in combination with other immunosuppressants. […]
On the market
- Earliest approval on file
- April 8, 1994
- Generic labelers
- 33 labelers
- Pharmacy cost
- $0.970 per gram
Supply and safety
- Shortage
- No current entry
- Recalls
- 9
Source: FDA drug labels via openFDA (Everolimus label of June 1, 2026, Tacrolimus label of July 17, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do everolimus and tacrolimus differ on the record?
In FDA's classes, everolimus is a mtor inhibitor immunosuppressant and tacrolimus a calcineurin inhibitor immunosuppressant.
Half-life, in each label's words: Everolimus, “Elimination The mean elimination half-life of everolimus is approximately 30 hours.”; Tacrolimus, “Fecal elimination accounted for 92.4±1.0% and the elimination half-life based on radioactivity was 48.1±15.9 hours …”
Only the tacrolimus label carries a boxed warning.
Generics: everolimus since 2018; tacrolimus since 2009 (Drugs@FDA).
| Everolimus | Tacrolimus | |
|---|---|---|
| Labeled for | Breast cancer, Seizures and epilepsy, Organ transplant rejection | Organ transplant rejection, Eczema (atopic dermatitis) |
| Pharmacologic class | Kinase Inhibitor, mTOR Inhibitor Immunosuppressant | Calcineurin 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). | n/a |
| Half-life (label) | Elimination The mean elimination half-life of everolimus is approximately 30 hours. | Fecal elimination accounted for 92.4±1.0% and the elimination half-life based on radioactivity was 48.1±15.9 hours whereas it was 43.5±11.6 hours based on tacrolimus concentrations. |
| Earliest approval on file (Drugs@FDA) | March 30, 2009 | April 8, 1994 |
| First generic approved | April 12, 2018 | August 10, 2009 |
| Generic labelers (NDC) | 14 labelers | 33 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $26.32 per tablet (Everolimus 10 mg tablet) | $0.970 per gram (Tacrolimus 0.1% ointment) |
| 12-month price change | -12% | +3% |
| Boxed warning | No | Yes |
| Shortage now | A presentation being discontinued | No current entry |
| Recalls recorded | 5 | 9 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 49,208 | 156,020 |
| 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, drug interactionsThere 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.
Everolimus label, warnings and precautionsReduced doses of tacrolimus should be used in combination with Zortress in order to minimize the potential risk of nephrotoxicity [ s ee Indications and Usage (1.2), Clinical Pharmacology (12.
Source: FDA drug labels via openFDA
What next?
- Alternatives to everolimus
- every medicine labeled for the same conditions