Prescription medicine
Sirolimus Brand names: Fyarro, Hyftor; first approved as Rapamune
Sirolimus (Rapamune) is a prescription medicine with an FDA approval on record since 1999. FDA's NDC Directory lists it from 17 generic labelers, and pharmacies paid $0.723 per sirolimus 1 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the sirolimus FDA label on DailyMed (effective January 28, 2026, Glenmark Pharmaceuticals Inc., USA); the NDA 21083 record on Drugs@FDA; every sirolimus label on DailyMed.
Highlights of the record
FDA label of January 28, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 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. Only physicians experienced in immunosuppressive therapy and management of renal transplant patients should use sirolimus for prophylaxis of organ rejection in patients receiving renal transplants. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient [ see Warnings and Precautions ( 5.1 ) ].
The safety and efficacy of sirolimus as immunosuppressive therapy have not been established in liver or lung transplant patients, and therefore, such use is not recommended [ see Warnings and Precautions ( 5.2 , 5.3 ) ].
Liver Transplantation – Excess Mortality, Graft Loss, and Hepatic Artery Thrombosis (HAT) The use of sirolimus in combination with tacrolimus was associated with excess mortality and graft loss in a study in de novo liver transplant patients. Many of these patients had evidence of infection at or near the time of death. […]
Used for
From the label: indications and usageSirolimus 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.
Forms and strengths
- 0.5 mg
- 1 mg
- 2 mg
- 1 mg/ml
- 2 mg/g
- 5 mg/ml
Film-coated tablet; solution; tablet; sugar-coated tablet; injection (powder) (lyophilized) for suspension.
On the market
- Earliest approval on file
- September 15, 1999 Rapamune, Pf Prism Cv; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 11 first January 8, 2014; 10 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 20 of which 17 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- October 28, 2040 Fyarro injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.723 per tablet Sirolimus 1 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 5 since 2013 0 Class I among all firms' recalls; latest May 1, 2024; 1 more by firms not listed as its makers
- FAERS reports
- 13,365 through July 30, 2026
What is sirolimus used for?
From the label: indications and usageSirolimus 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. CsA withdrawal is recommended 2 to 4 months after transplantation ( 1.1 ). ○ Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation ( 1.1 ). […]
Conditions named in the indications of sirolimus's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Kinase Inhibitor and mTOR Inhibitor Immunosuppressant.
Source: FDA drug label (sirolimus), Glenmark Pharmaceuticals Inc., USA, effective January 28, 2026 (SPL set 57fb4d90-3ccb-4a69-af1e-53be83f7a504), via openFDA; the full label on DailyMed
What does the patient leaflet for sirolimus 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 sirolimus tablets?Sirolimus tablets can cause serious side effects, including: 1. Increased risk of getting infections. Serious infections can happen including infections caused by viruses, bacteria, and fungi (yeast). Your doctor may put you on medicine to help prevent some of these infections. Call your doctor right away if you have symptoms of infection including fever or chills while taking sirolimus tablets. Sirolimus has not been shown to be safe and effective in people who have had liver or lung transplants. Serious complications and death may happen in people who take sirolimus after a liver or lung transplant. You should not take sirolimus tablets if you have had a liver or lung transplant without talking with your doctor. See the section "What are the possible side effects of sirolimus tablets?" for information about other side effects of sirolimus tablets.
From the patient leaflet: What should I avoid while taking sirolimus tablets?Avoid receiving live vaccines while taking sirolimus tablets. Some vaccines may not work as well while you are taking sirolimus tablets. • Limit your time in sunlight and UV light. Cover your skin with clothing and use a broad spectrum sunscreen with a high protection factor because of the increased risk for skin cancer with sirolimus tablets.
From the patient leaflet: How should I store sirolimus tablets?Sirolimus tablets: • Store sirolimus tablets at room temperature between 68°F to 77°F (20°C to 25°C). • Bottles: Keep the bottle of sirolimus tablets tightly closed. Do not use sirolimus tablets after the expiration date. The expiration date refers to the last day of that month. Safely throw away medicine that is out of date or no longer needed. Keep sirolimus tablets and all medicines out of the reach of children. General Information about the safe and effective use of sirolimus tablets. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use sirolimus tablets for a condition for which it was not prescribed. Do not give sirolimus tablets to other people even if they have the same symptoms that you have. It may harm them. This Medication Guide summarizes the most important information about sirolimus tablets. […]
Source: FDA drug label (sirolimus), Glenmark Pharmaceuticals Inc., USA, effective January 28, 2026 (SPL set 57fb4d90-3ccb-4a69-af1e-53be83f7a504), via openFDA; the full label on DailyMed
Is there a generic for sirolimus (Rapamune)?
The FDA approved the first generic sirolimus on January 8, 2014. 11 generic applications are approved; 10 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 sirolimus from 17 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Rapamune tablets; a patent listed only for Fyarro injection runs to October 28, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1999 earliest approval on file
- 2014 first generic approved
- 2040 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 sirolimus (Rapamune)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.723 per Sirolimus 1 mg tablet, down 50% from $1.43 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. 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.
- Sirolimus 1 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Sirolimus 0.5 mg tablet | Generic | $0.841 per tablet | $25.24 | -53% |
| Sirolimus 1 mg tablet | Generic | $0.723 per tablet | $21.69 | -50% |
| Sirolimus 1 mg/mL solution | Generic | $4.39 per mL | n/a | -8% |
| Sirolimus 2 mg tablet | Generic | $2.53 per tablet | $75.86 | -53% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has sirolimus been recalled?
The FDA's Enforcement Report lists 6 recalls naming sirolimus since 2013: 0 Class I (the most serious), 1 Class II, 5 Class III; 1 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of sirolimus and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 1, 2024 | Class III | Dr. Reddy's Laboratories, Inc. | Failed Impurities/Degradation Specifications |
| October 13, 2022 | Class III | Aadi Bioscience | Failed Stability Specifications |
| May 3, 2022 | Class III | Apotex Corp. | Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint. |
| May 12, 2021 | Class III | American Health Packaging | Failed Impurities/Degradation Specifications |
| June 3, 2016 | Class III | Dr. Reddy's Laboratories, Inc. | Failed impurities/degradation: out of specification result for impurity secorapamycin. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: SIROLIMUS, Tablet, 1 mg may be potentially mislabeled as one of the following drugs: PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the sirolimus label say about other medicines?
The sirolimus label names 28 other medicines in its interaction, contraindication or warning sections. The labels of 42 other medicines name sirolimus. 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 |
|---|---|---|
| Amphotericin b | warnings and precautions | Caution should be exercised when using agents (e.g., aminoglycosides and amphotericin B) that are known to have a deleterious effect on renal function. |
| Azathioprine | warnings and precautions | Increased serum cholesterol and triglycerides requiring treatment occurred more frequently in patients treated with sirolimus compared with azathioprine or placebo controls in Studies 1 and 2 [ see Adverse Reactions ( 6.1 ) ]. |
| Bromocriptine | drug interactions | Drugs that could increase sirolimus blood concentrations: Bromocriptine, cimetidine, cisapride, clotrimazole, danazol, diltiazem, fluconazole, letermovir, protease inhibitors (e.g., HIV and hepatitis C that include drugs such as ritonavir, indinavir, boceprevir, and telaprevir), metoclopramide, nicardipine … |
| Cannabidiol | drug interactions | Se Therapeutic drug monitoring and dose reduction for sirolimus should be considered when sirolimus is co-administered with cannabidiol ( 5.21 , 7.5 ). |
| Carbamazepine | drug interactions | Drugs and other agents that could decrease sirolimus concentrations: Carbamazepine, phenobarbital, phenytoin, rifapentine, St. John’s Wort ( Hypericum perforatum ) |
| Cimetidine | drug interactions | Drugs that could increase sirolimus blood concentrations: Bromocriptine, cimetidine, cisapride, clotrimazole, danazol, diltiazem, fluconazole, letermovir, protease inhibitors (e.g., HIV and hepatitis C that include drugs such as ritonavir, indinavir, boceprevir, and telaprevir), metoclopramide, nicardipine … |
| Clarithromycin | drug interactions | Inducers and Strong Inhibitors of CYP3A4 and P-gp Avoid concomitant use of sirolimus with strong inducers (e.g., rifampin, rifabutin) and strong inhibitors (e.g., ketoconazole, voriconazole, itraconazole, erythromycin, telithromycin, clarithromycin) of CYP3A4 and P-gp. |
| Clotrimazole | drug interactions | Drugs that could increase sirolimus blood concentrations: Bromocriptine, cimetidine, cisapride, clotrimazole, danazol, diltiazem, fluconazole, letermovir, protease inhibitors (e.g., HIV and hepatitis C that include drugs such as ritonavir, indinavir, boceprevir, and telaprevir), metoclopramide, nicardipine … |
| Cyclosporine | boxed warning | In this and another study in de novo liver transplant patients, the use of sirolimus in combination with cyclosporine or tacrolimus was associated with an increase in HAT; most cases of HAT occurred within 30 days post-transplantation and most led to graft loss or death [ see Warnings and Precautions ( 5.2 ) ]. |
| Danazol | drug interactions | Drugs that could increase sirolimus blood concentrations: Bromocriptine, cimetidine, cisapride, clotrimazole, danazol, diltiazem, fluconazole, letermovir, protease inhibitors (e.g., HIV and hepatitis C that include drugs such as ritonavir, indinavir, boceprevir, and telaprevir), metoclopramide, nicardipine … |
| Diltiazem | drug interactions | Drugs that could increase sirolimus blood concentrations: Bromocriptine, cimetidine, cisapride, clotrimazole, danazol, diltiazem, fluconazole, letermovir, protease inhibitors (e.g., HIV and hepatitis C that include drugs such as ritonavir, indinavir, boceprevir, and telaprevir), metoclopramide, nicardipine … |
| Erythromycin | drug interactions | Inducers and Strong Inhibitors of CYP3A4 and P-gp Avoid concomitant use of sirolimus with strong inducers (e.g., rifampin, rifabutin) and strong inhibitors (e.g., ketoconazole, voriconazole, itraconazole, erythromycin, telithromycin, clarithromycin) of CYP3A4 and P-gp. |
| Fluconazole | drug interactions | Drugs that could increase sirolimus blood concentrations: Bromocriptine, cimetidine, cisapride, clotrimazole, danazol, diltiazem, fluconazole, letermovir, protease inhibitors (e.g., HIV and hepatitis C that include drugs such as ritonavir, indinavir, boceprevir, and telaprevir), metoclopramide, nicardipine … |
| Itraconazole | drug interactions | Inducers and Strong Inhibitors of CYP3A4 and P-gp Avoid concomitant use of sirolimus with strong inducers (e.g., rifampin, rifabutin) and strong inhibitors (e.g., ketoconazole, voriconazole, itraconazole, erythromycin, telithromycin, clarithromycin) of CYP3A4 and P-gp. |
Every other medicine the sirolimus label names
| Medicine named | Section | What the label says |
|---|---|---|
| Ketoconazole | drug interactions | … inducers (e.g., rifampin, rifabutin) and strong inhibitors (e.g., ketoconazole, voriconazole, itraconazole, erythromycin, telithromycin, clarithromycin) of CYP3A4 and P-gp. |
| Letermovir | drug interactions | Drugs that could increase sirolimus blood concentrations: Bromocriptine, cimetidine, cisapride, clotrimazole, danazol, diltiazem, fluconazole, letermovir, protease inhibitors (e.g., HIV and hepatitis … |
| Metoclopramide | drug interactions | … include drugs such as ritonavir, indinavir, boceprevir, and telaprevir), metoclopramide, nicardipine, troleandomycin, verapamil |
| Mycophenolate mofetil | warnings and precautions | In a multicenter clinical study, de novo renal transplant patients treated with sirolimus, mycophenolate mofetil (MMF), steroids, and an IL-2 receptor antagonist had significantly higher acute … |
| Nicardipine | drug interactions | … ritonavir, indinavir, boceprevir, and telaprevir), metoclopramide, nicardipine, troleandomycin, verapamil |
| Phenobarbital | drug interactions | Drugs and other agents that could decrease sirolimus concentrations: Carbamazepine, phenobarbital, phenytoin, rifapentine, St. John’s Wort ( Hypericum perforatum ) |
| Phenytoin | drug interactions | Drugs and other agents that could decrease sirolimus concentrations: Carbamazepine, phenobarbital, phenytoin, rifapentine, St. John’s Wort ( Hypericum perforatum ) |
| Rifabutin | drug interactions | Inducers and Strong Inhibitors of CYP3A4 and P-gp Avoid concomitant use of sirolimus with strong inducers (e.g., rifampin, rifabutin) and strong inhibitors (e.g., ketoconazole, voriconazole … |
| Rifampin | drug interactions | Inducers and Strong Inhibitors of CYP3A4 and P-gp Avoid concomitant use of sirolimus with strong inducers (e.g., rifampin, rifabutin) and strong inhibitors (e.g., ketoconazole, voriconazole … |
| Rifapentine | drug interactions | Drugs and other agents that could decrease sirolimus concentrations: Carbamazepine, phenobarbital, phenytoin, rifapentine, St. John’s Wort ( Hypericum perforatum ) |
| Ritonavir | drug interactions | … protease inhibitors (e.g., HIV and hepatitis C that include drugs such as ritonavir, indinavir, boceprevir, and telaprevir), metoclopramide, nicardipine, troleandomycin, verapamil |
| Tacrolimus | boxed warning | In this and another study in de novo liver transplant patients, the use of sirolimus in combination with cyclosporine or tacrolimus was associated with an increase in HAT; … |
| Verapamil | drug interactions | … boceprevir, and telaprevir), metoclopramide, nicardipine, troleandomycin, verapamil |
| Voriconazole | drug interactions | … (e.g., rifampin, rifabutin) and strong inhibitors (e.g., ketoconazole, voriconazole, itraconazole, erythromycin, telithromycin, clarithromycin) of CYP3A4 and P-gp. |
Other labels that name sirolimus
- Atazanavir
- Benazepril
- Captopril
- Cobicistat
- Darunavir
- Deferasirox
- Efavirenz
- Elexacaftor and ivacaftor and tezacaftor
- Enalapril
- Enzalutamide
- Etravirine
- Everolimus
- Fosamprenavir
- Isavuconazonium
- Ivacaftor and lumacaftor
- Ivacaftor and tezacaftor
- Lisinopril
- Maribavir
- Micafungin
- Mifepristone
- Nelfinavir
- Nevirapine
- Palbociclib
- Posaconazole
- Ranolazine
- Spironolactone
- Temsirolimus
- Trandolapril
Source: FDA drug label (sirolimus), Glenmark Pharmaceuticals Inc., USA, effective January 28, 2026 (SPL set 57fb4d90-3ccb-4a69-af1e-53be83f7a504), via openFDA; the full label on DailyMed
What do FAERS reports show for sirolimus?
The FDA Adverse Event Reporting System holds 13,365 reports that list sirolimus among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,150 are coded as a death and 4,559 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 sirolimus?
6 other medicines are given the same way (oral) and in the same FDA class as sirolimus or labeled mainly for the same use (organ transplant rejection), the same class first. Organ transplant rejection lists all 13 medicines labeled for it, by any route. 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 |
|---|---|---|---|---|
| Everolimus | Organ transplant rejection | 14 labelers | $26.32 per tablet 10 mg tablet | A presentation being discontinued |
| Tacrolimus | Organ transplant rejection | 30 labelers | $0.123 per capsule 0.5 mg capsule (immediate release) | No current entry |
| Mycophenolate mofetil | Organ transplant rejection | 30 labelers | $0.138 per capsule 250 mg capsule | No current entry |
| Mycophenolic acid | Organ transplant rejection | 16 labelers | $0.0996 per tablet 180 mg tablet | No current entry |
| Azathioprine | Organ transplant rejection | 16 labelers | $0.124 per tablet 50 mg tablet | No current entry |
| Cyclosporine | Organ transplant rejection | 8 labelers | $0.314 per unit 25 mg | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does sirolimus compare with medicines for the same use?
2 side-by-side pages set sirolimus beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to sirolimus
- 6 medicines for the same use
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Sirolimus side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other