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Sirolimus

Sirolimus is an mTOR inhibitor (a type of immune-calming medicine) used to prevent organ rejection after kidney transplant, to treat lymphangioleiomyomatosis (LAM), and, in specific products, to treat a rare tumor (PEComa) and facial skin growths linked to tuberous sclerosis.

Brand names RapamuneFyarroHyftorFelycin
Drug classes Mtor Inhibitor Immunosuppressant
Rx Forms 5
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 24 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 →

✓No current FDA shortage listed · checked Oct 5, 2026 🚨Recall on record
Sirolimus 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

Sirolimus (Rapamune), on the market since about 2000 and available generically, is a specialist immune-suppressing drug that blocks a cell-growth switch called mTOR, calming the T-cells that attack a new kidney and reducing antibody production; it also treats the rare lung disease LAM, and related products treat the tumor PEComa (Fyarro) and facial growths of tuberous sclerosis (Hyftor). Most people notice swelling in the legs or hands, and blood tests commonly show higher cholesterol and triglycerides. The boxed warning is that a weakened immune system raises the risk of serious infections and of cancers such as lymphoma and skin cancer, so report fever, chills or any new skin growth promptly.

Clinical pearls

  • Doses follow sirolimus blood levels, so take it the same way daily, always with food or always without.
  • If you also take cyclosporine, take sirolimus 4 hours after it, since cyclosporine raises sirolimus levels.
  • Skip grapefruit juice entirely, and flag sirolimus before starting azole antifungals, clarithromycin, rifampin or St. John’s Wort, which shift its levels.
  • Tell your surgeon before any operation, since sirolimus slows wound healing and wounds can reopen.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Sirolimus weakens the immune system, which raises the risk of serious infections and of cancers such as lymphoma and skin cancer. It should be prescribed only by doctors experienced in managing transplant patients and immune-suppressing medicines.

It is not recommended for liver or lung transplant patients. In liver transplant studies, it was linked to more deaths, loss of the transplanted liver, and blood clots in the liver’s main artery, mostly within the first 30 days. In lung transplant patients, the airway connection failed to heal in some people, and most of these cases were fatal. Report any signs of infection, fever or unusual symptoms right away.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet, Oral solution, Injection +2
Earliest FDA record1999
Companies listing it with the FDA20
FDA label last updatedMar 26, 2026
FDA’s strongest warning (boxed)Yes, read the warning

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

What Sirolimus is used for

▾

Sirolimus is used in several different products, each with its own approved use.

  • Sirolimus tablets and oral solution: preventing organ rejection in kidney transplant patients aged 13 and older.
  • Sirolimus tablets and oral solution: treating lymphangioleiomyomatosis (LAM).
  • Fyarro (IV): advanced malignant PEComa in adults.
  • Hyftor (topical gel): facial angiofibroma linked to tuberous sclerosis in people 6 years and older.

How Sirolimus works

▾

Sirolimus attaches to a protein inside cells called FKBP-12. This complex blocks mTOR, a key switch that controls cell growth and multiplication. Blocking it keeps T-cells from multiplying in response to immune signals, which helps protect a transplanted kidney. It also lowers antibody production.

In LAM, loss of the TSC gene leaves the mTOR pathway overactive, so cells grow too much. Sirolimus slows this growth.

Sirolimus dosage

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Oral sirolimus is taken by mouth once daily, either always with food or always without. Tablets must be swallowed whole. The solution is an option for people who cannot take tablets.

  • Kidney transplant patients start soon after transplant, taking it 4 hours after cyclosporine.
  • Your doctor adjusts the dose using blood level tests.
  • People with liver problems need a lower maintenance dose.
  • Fyarro is an IV infusion given in a clinic on a set cycle.
  • Hyftor is applied to the face twice daily.

Follow your prescriber and label directions.

Dosing details from the FDA-approved label

From the Sirolimus 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.

  • Fyarro (IV): recommended dosage
    • 100 mg/m2 administered as an intravenous infusion over 30 minutes on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity
    • Dose reductions: 75 mg/m2, then 56 mg/m2, then 45 mg/m2; reduce to 56 mg/m2 with a moderate or weak CYP3A4 inhibitor
  • Fyarro: mild hepatic impairment (total bilirubin ≤ULN, AST >ULN or total bilirubin >1 to 1.5×ULN, any AST)
    • 75 mg/m2
    • Closely monitor for increased toxicity
  • Fyarro: moderate hepatic impairment (total bilirubin >1.5 to 3.0×ULN, any AST)
    • 56 mg/m2
    • Avoid use in severe hepatic impairment
  • Hyftor (topical): facial angiofibroma, pediatric patients 6 to 11 years of age
    • Apply to the skin of the face affected with angiofibroma twice daily in the morning and at bedtime
    • Maximum: 600 mg (2 cm) daily
    • Reevaluate if no improvement within 12 weeks; do not use with occlusive dressings
  • Hyftor (topical): facial angiofibroma, adults and pediatric patients 12 years of age and older
    • Apply to the skin of the face affected with angiofibroma twice daily in the morning and at bedtime
    • Maximum: 800 mg (2.5 cm) daily
    • Reevaluate if no improvement within 12 weeks; do not use with occlusive dressings
  • Sirolimus tablets: renal transplant, low-to-moderate immunologic risk, sirolimus and CsA combination therapy
    • One loading dose of 6 mg on day 1, followed by daily maintenance doses of 2 mg
    • Give once daily by mouth, consistently with or without food; initial dose 4 hours after CsA; reduce maintenance dose in hepatic impairment
  • Sirolimus tablets: renal transplant, low-to-moderate immunologic risk, sirolimus following CsA withdrawal
    • 2 months to 4 months post-transplantation, withdraw CsA over 4 weeks to 8 weeks
    • Adjust maintenance dose to achieve trough concentrations within the target range
  • Sirolimus tablets: renal transplant, high immunologic risk, sirolimus and CsA combination therapy (first 12 months post-transplantation)
    • One loading dose of up to 15 mg on day 1, followed by daily maintenance doses of 5 mg
    • Reduce maintenance dose in hepatic impairment
  • Sirolimus tablets: lymphangioleiomyomatosis
    • Recommended initial dose is 2 mg/day, once daily by mouth, adjusted to achieve trough concentrations between 5 to 15 ng/mL
    • Consistently with or without food; reduce maintenance dose in hepatic impairment
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Sirolimus oral solution is to be administered orally once daily, consistently with or without food [ see Dosage and Administration (2.5) and Clinical Pharmacology (12.3) ]. Renal Transplant Patients: Administer once daily by mouth, consistently with or without food (2) . Administer the initial dose as soon as possible after transplantation and 4 hours after CsA (2.1 , 7.1) . Adjust the sirolimus oral solution maintenance dose to achieve sirolimus trough concentrations within the target-range (2.5) . Hepatic impairment: Reduce maintenance dose in patients with hepatic impairment (2.7 , 8.6 , 12.3 ). In renal transplant patients at low-to moderate-immunologic risk : Sirolimus Oral Solution and CsA Combination Therapy: One loading dose of 6 mg on day 1, followed by daily maintenance doses of 2 mg (2.2) . Sirolimus Oral Solution Following CsA Withdrawal: 2 to 4 months post-transplantation, withdraw CsA over 4 to 8 weeks (2.2) . In renal transplant patients at high-immunologic risk: Sirolimus Oral Solution and CsA Combination Therapy (for the first 12 months post-transplantation): One loading dose of up to 15 mg on day 1, followed by daily maintenance doses of 5 mg (2.3) . Lymphangioleiomyomatosis Patients: Administer once daily by mouth, consistently with or without food ( 2 ). Recommended initial sirolimus oral solution dose is 2 mg/day ( 2.4 ). Adjust the sirolimus oral solution dose to achieve sirolimus trough concentrations between 5 to 15 ng/mL ( 2.4 ). Hepatic impairment: Reduce maintenance dose in patients with hepatic impairment ( 2.7 , 8.6 , 12.3 ). Therapeutic drug monitoring is recommended for all patients ( 2.5 , 5.17 ). 2.1 General Dosing Guidance for Renal Transplant Patients The initial dose of sirolimus oral solution should be administered as soon as possible after transplantation. It is recommended that sirolimus oral solution be taken 4 hours after administration of cyclosporine oral solution (MODIFIED) and/or cyclosporine capsules (MODIFIED) [ see Drug Interactions (7.2) ]. Frequent sirolimus oral solution dose adjustments based on non-steady-state sirolimus concentrations can lead to overdosing or underdosing because sirolimus has a long half-life.

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

Sirolimus side effects

▾

Common side effects of oral sirolimus in transplant patients include:

Common side effects

  • Swelling in the legs or hands (peripheral edema)
  • High cholesterol and triglycerides
  • High blood pressure
  • Constipation, diarrhea, nausea or belly pain
  • Headache
  • Fever
  • Urinary tract infection
  • Anemia and low platelets
  • Joint pain and acne

When to get medical help

  • Signs of infection such as fever, chills, cough or burning with urination, because sirolimus weakens the immune system
  • Swelling of the face, lips, tongue or throat, or other signs of a severe allergic reaction
  • New cough or shortness of breath, which can signal lung inflammation
  • Confusion, weakness on one side, or trouble with balance or thinking, which can signal a rare brain infection (PML)
  • Slow wound healing, wound opening, or fluid buildup around the lungs, heart or belly
  • Foamy urine or worsening kidney function
  • Any new or changing skin growth or lump
  • Muscle pain or weakness, especially if you also take a cholesterol medicine

In LAM, mouth sores are also common. Call your doctor for signs of infection, trouble breathing, facial swelling, or poor wound healing.

Sirolimus warnings and precautions

▾
  • Weakened immune system: higher risk of serious infection and cancers, including skin cancer and lymphoma.
  • Not for liver or lung transplants: linked to deaths, graft loss, liver artery clots and airway healing failure.
  • Allergic reactions and angioedema: deep swelling of the face or throat.
  • Slow wound healing and fluid buildup.
  • High cholesterol and triglycerides: may need treatment.
  • Kidney effects: reduced kidney function and protein in the urine.
  • Lung inflammation (interstitial lung disease).
  • Viral infections: BK virus kidney infection and a rare brain infection (PML).
  • Pregnancy harm and reduced fertility.
  • Avoid live vaccines.

Sirolimus interactions

▾

Sirolimus is processed by the CYP3A4 enzyme and P-gp pump, so many medicines change its levels.

  • Cyclosporine: raises sirolimus levels, so take sirolimus 4 hours later.
  • Strong blockers (ketoconazole, voriconazole, itraconazole, erythromycin, telithromycin, clarithromycin): avoid, they raise levels.
  • Strong inducers (rifampin, rifabutin): avoid, they lower levels.
  • Grapefruit juice: never take or dilute with it.
  • Diltiazem, verapamil, fluconazole, cimetidine, HIV and hepatitis C protease inhibitors: may raise levels.
  • Carbamazepine, phenobarbital, phenytoin, rifapentine, St. John’s Wort: may lower levels.
  • Cannabidiol: can raise levels.
  • ACE inhibitors: may increase angioedema risk.
  • Cholesterol medicines (statins, fibrates): muscle problems have been reported with combined use.

Interactions listed in the FDA-approved label

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

  • Cyclosporine: Cyclosporine, a substrate and inhibitor of CYP3A4 and P-gp, increases sirolimus concentrations when co-administered. Take sirolimus 4 hours after cyclosporine oral solution (MODIFIED) and/or capsules (MODIFIED); if cyclosporine is withdrawn, higher sirolimus doses are needed to maintain recommended trough concentrations.
  • Strong CYP3A4/P-gp inducers (e.g., rifampin, rifabutin): Inducers of CYP3A4 and P-gp may decrease sirolimus concentrations. Avoid concomitant use; consider alternative agents with lesser interaction potential.
  • Strong CYP3A4/P-gp inhibitors (e.g., ketoconazole, voriconazole, itraconazole, erythromycin, telithromycin, clarithromycin): Inhibitors of CYP3A4 and P-gp may increase sirolimus concentrations. Avoid concomitant use; consider alternative agents with lesser interaction potential.
  • Grapefruit juice: Grapefruit juice inhibits the CYP3A4-mediated metabolism of sirolimus. Must not be taken with or used for dilution of sirolimus.
  • Cannabidiol: Blood levels of sirolimus may increase with concomitant use. Closely monitor sirolimus blood levels and for adverse reactions suggestive of sirolimus toxicity; consider dose reduction as needed.
  • Weak and moderate CYP3A4/P-gp inhibitors (bromocriptine, cimetidine, cisapride, clotrimazole, danazol, diltiazem, fluconazole, letermovir, protease inhibitors, metoclopramide, nicardipine, troleandomycin, verapamil): These could increase sirolimus blood concentrations. Exercise caution; the dosage of sirolimus and/or the co-administered drug may need to be adjusted.
  • Carbamazepine, phenobarbital, phenytoin, rifapentine, St. John's Wort (Hypericum perforatum): These could decrease sirolimus concentrations. Exercise caution; the dosage of sirolimus and/or the co-administered drug may need to be adjusted.
  • Verapamil: Verapamil concentrations could increase when given with sirolimus. Exercise caution; dosage may need to be adjusted.
  • Fyarro: moderate or weak CYP3A4 inhibitors: Concomitant use with a moderate or weak CYP3A4 inhibitor. Reduce the dosage of Fyarro to 56 mg/m2.
  • Fyarro: strong CYP3A4 and/or P-gp inhibitors and inducers, grapefruit and grapefruit juice: Interaction with strong CYP3A4 and/or P-gp inhibitors and inducers and with grapefruit and grapefruit juice. Avoid concomitant use.
Read the label’s full interactions text

7 DRUG INTERACTIONS Sirolimus is known to be a substrate for both cytochrome P-450 3A4 (CYP3A4) and p-glycoprotein (P-gp). Inducers of CYP3A4 and P-gp may decrease sirolimus concentrations whereas inhibitors of CYP3A4 and P-gp may increase sirolimus concentrations. Avoid concomitant use with strong CYP3A4/P-gp inducers or strong CYP3A4/P-gp inhibitors that decrease or increase sirolimus concentrations (7.4 , 12.3) . Therapeutic drug monitoring and dose reduction for sirolimus oral solution should be considered when sirolimus oral solution is co-administered with cannabidiol ( 5.21 , 7.5 ). See full prescribing information for complete list of clinically significant drug interactions (12.3) . 7.1 Use with Cyclosporine Cyclosporine, a substrate and inhibitor of CYP3A4 and P-gp, was demonstrated to increase sirolimus concentrations when co-administered with sirolimus. In order to diminish the effect of this interaction with cyclosporine, it is recommended that sirolimus be taken 4 hours after administration of cyclosporine oral solution (MODIFIED) and/or cyclosporine capsules (MODIFIED). If cyclosporine is withdrawn from combination therapy with sirolimus, higher doses of sirolimus are needed to maintain the recommended sirolimus trough concentration ranges [ see Dosage and Administration (2.2) and Clinical Pharmacology (12.3) ]. 7.2 Strong 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. Alternative agents with lesser interaction potential with sirolimus should be considered [ see Warnings and Precautions (5.20) and Clinical Pharmacology (12.3) ].

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.

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

Before taking Sirolimus

▾
  • Do not use if you are allergic to sirolimus.
  • Not recommended after liver or lung transplant.
  • Tell your doctor about liver problems, kidney problems, high cholesterol, or past skin cancer.
  • Pregnancy: can harm a baby. Use highly effective birth control during treatment and for 12 weeks after.
  • Breastfeeding: possible serious effects in infants, so talk with your doctor.
  • Fertility may be affected in men and women.
  • Oral sirolimus for kidney transplant is not established under age 13.
  • Hyftor is for ages 6 and older, and vaccines should be up to date first.

Sirolimus overdose

▾

Overdose reports are limited. Effects are generally the same as the side effects listed for sirolimus. Treatment is supportive care, and sirolimus is not expected to be removed by dialysis to any significant extent.

What Sirolimus does in the body

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In low- to moderate-risk kidney transplant patients, oral sirolimus significantly lowered rejection rates at 6 months compared with azathioprine or placebo. A higher maintenance dose showed no extra benefit over the lower one. Blood levels are monitored to keep them in a target range.

How your body processes Sirolimus

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Only a small portion of oral sirolimus is absorbed, and tablets are absorbed somewhat more than the solution. A high-fat meal raises exposure, which is why taking it consistently with or without food matters. It is processed mainly by CYP3A4 in the gut and liver and leaves mostly through stool. Its half-life is about 62 hours in transplant patients, and steady levels take about 6 days to build unless a loading dose is used.

How to store Sirolimus

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stored protected from light and refrigerated at 2°C to 8°C (36°F to 46°F). store the bottles at room temperatures up to 25°C (77°F) for a short period of time (e. refrigerated at 2°C to 8°C (36°F to 46°F).

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

188

Supplements & herbs that interact with Sirolimus

188 supplements and herbal products have documented interactions with Sirolimus 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 · 3
  • Moderate · 149
  • Minor · 36
ACTIVATED CHARCOAL Major GRAPEFRUIT Major ST. JOHN'S WORT Major ACACIA RIGIDULA Moderate ACTIVE HEXOSE CORRELATED COMPOUND (AHCC) Moderate ADRAFINIL Moderate AFRICAN WILD POTATO Moderate ALFALFA Moderate +180 more
Every supplement checked against Sirolimus — ranked by severity The full interaction hub: 3 major · 149 moderate · 36 minor · every one linked to its full report. Check Sirolimus 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.

Sirolimus: pharmacist answers to common questions

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

What is sirolimus for?

▾
Oral sirolimus helps prevent your body from rejecting a transplanted kidney if you are 13 or older. It is also used for LAM, a rare lung disease. Other sirolimus products treat a tumor called PEComa (Fyarro, by IV) and facial skin growths from tuberous sclerosis (Hyftor gel).

How should I take it?

▾
Take oral sirolimus once a day, the same way each time, either always with food or always without. Swallow tablets whole and do not crush, chew or split them. Never take it with grapefruit juice. If you take cyclosporine, take sirolimus 4 hours afterward.

What side effects are normal, and when should I call?

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Swelling, high blood pressure, high cholesterol, stomach upset, headache and acne are common. Call your doctor right away for fever or other signs of infection, new cough or trouble breathing, facial or throat swelling, a wound that won't heal, or any new skin growth.

Can I take other medicines or supplements with it?

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Many things change sirolimus levels, so check with me or your doctor first. Avoid strong antifungals, certain antibiotics like clarithromycin, rifampin, and St. John’s Wort. Grapefruit juice is off limits. Tell us about every medicine you take.

Do I need to worry about the sun or vaccines?

▾
Yes. Sirolimus raises skin cancer risk, so wear protective clothing and a broad spectrum, high protection sunscreen. Avoid live vaccines, and know that other vaccines may work less well.

Is it safe in pregnancy?

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It can harm an unborn baby. If you can become pregnant, use highly effective birth control before, during and for 12 weeks after treatment. Tell your doctor right away if you become pregnant or plan to breastfeed.

Is Sirolimus available over the counter?

▾
No. Sirolimus is a prescription medicine: every Sirolimus 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 Sirolimus first available?

▾
The earliest FDA record we hold for Sirolimus is from 1999: 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 Sirolimus was first used.

Who makes Sirolimus?

▾
20 companies currently list Sirolimus products in the FDA's NDC Directory, including Mylan Pharmaceuticals Inc., Northstar Rx Llc, Remedyrepack Inc.. 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 Sirolimus on HelloPharmacist

📊Sirolimus supplement interactions188 checked — ranked by severity 🌿Drug & Supplement CheckerSirolimus vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Sirolimus NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Sirolimus 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.

Sirolimus forms and strengths (how it comes)

Sirolimus is available in 5 forms. 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.

Tablet

By mouth
Brands Rapamune
How this form is used
What it may be used for
  • Sirolimus tablets are used to prevent organ rejection in kidney transplant patients aged 13 and older.
  • Sirolimus tablets are used to treat lymphangioleiomyomatosis (LAM).
Important instructions
  • Sirolimus tablets are taken by mouth once daily, consistently with or without food.
  • Sirolimus tablets should not be crushed, chewed or split.
  • People who cannot take sirolimus tablets should be prescribed the oral solution.
Available strengths 3 strengths
0.5 mg 1 mg 2 mg
66 FDA-listed product records ⓘ

Oral solution

By mouth
Brands Rapamune
How this form is used
What it may be used for
  • Sirolimus oral solution is used to prevent organ rejection in kidney transplant patients aged 13 and older.
  • Sirolimus oral solution is used to treat lymphangioleiomyomatosis (LAM).
Important instructions
  • Sirolimus oral solution is taken by mouth once daily, consistently with or without food.
  • Sirolimus oral solution must not be taken with or diluted with grapefruit juice.
Available strengths 1 strength
1 mg/mL
20 FDA-listed product records ⓘ

Injection

Into a vein
Brands Fyarro
How this form is used
What it may be used for
  • Fyarro is used for adults with locally advanced unresectable or metastatic malignant PEComa.
Important instructions
  • Fyarro is given as an IV infusion over about 30 minutes.
  • Fyarro is given on Days 1 and 8 of each 21-day cycle until the disease progresses or side effects become unacceptable.
Available strengths 1 strength
5 mg/mL
4 FDA-listed product records ⓘ

Topical cream, ointment or gel

On the skin
Brands Hyftor
How this form is used
What it may be used for
  • Hyftor is used for facial angiofibroma linked to tuberous sclerosis in adults and children 6 years and older.
Important instructions
  • Hyftor is applied to the affected facial skin twice daily, morning and bedtime.
  • Hyftor is for skin use only, not for the mouth, eyes or vagina.
  • Hyftor should not be used with occlusive dressings.
  • Hyftor users should finish age-appropriate vaccinations before starting.
Available strengths 1 strength
2 mg/g
3 FDA-listed product records ⓘ

Oral suspension

By mouth
Available strengths 1 strength
150 g/kg
1 FDA-listed product record ⓘ

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

How Sirolimus 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.

20 companies list 39 Sirolimus product records with the FDA, mostly as tablet, oral solution, injection; the earliest marketing or approval year on record is 1999. Brand names on the directory include Rapamune, Fyarro, Hyftor and 1 more; the rest are generics.

5
Dose forms ⓘ
20
Labelers (makers, repackagers, distributors)
3
Brand names
39
FDA-listed product records ⓘ
1999
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (24) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Mylan Pharmaceuticals Inc.10%
Northstar Rx Llc10%
Remedyrepack Inc.10%
Ascend Laboratories, LLC8%
Glenmark Pharmaceuticals Inc., USA8%
Zydus Lifesciences Limited8%
Other makers46%

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

How widely Sirolimus is used (Medicaid data)

A general measure of how commonly Sirolimus 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 Sirolimus 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.

44,322
Medicaid prescriptions filled (Q1–Q4 2025)
$19.4M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Sirolimus prescribed? Of the 1,601 medications we measure, Sirolimus ranks #656 by Medicaid prescriptions — more than 59% of them.

Where Sirolimus ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #656 of 1,601
#651 Sotalol 45,834 Rx #652 Pilocarpine 45,043 Rx #653 Glecaprevir and Pibren... 44,772 Rx #654 Plecanatide 44,504 Rx #655 Oxaliplatin Injection 44,448 Rx #656 Sirolimus 44,322 Rx #657 Tocilizumab Injection 43,670 Rx #658 Tenapanor 43,479 Rx #659 Etodolac 43,348 Rx #660 Ofatumumab Injection (... 43,282 Rx #661 Ofatumumab Injection (... 43,282 Rx

Utilization by Sirolimus 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 Sirolimus product — about 43% of these Medicaid prescriptions.

sirolimus 1 MG Oral Tablet Most dispensed

19,139 Medicaid prescriptions (Q1–Q4 2025) 43% of Sirolimus prescriptions shown $3.6M gross reimbursement (before rebates) ≈ $188 per prescription (gross)

Summed across the 6 of 26 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 349208

sirolimus 0.5 MG Oral Tablet

12,086 Medicaid prescriptions (Q1–Q4 2025) 27% of Sirolimus prescriptions shown $2.1M gross reimbursement (before rebates) ≈ $172 per prescription (gross)

Summed across the 5 of 35 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 905158

sirolimus 1 MG/ML Oral Solution

7,961 Medicaid prescriptions (Q1–Q4 2025) 18% of Sirolimus prescriptions shown $4M gross reimbursement (before rebates) ≈ $500 per prescription (gross)

Summed across the 6 of 15 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 314230

sirolimus 2 MG Oral Tablet

2,795 Medicaid prescriptions (Q1–Q4 2025) 6% of Sirolimus prescriptions shown $1.4M gross reimbursement (before rebates) ≈ $492 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 360110

sirolimus 0.002 MG/MG Topical Gel

2,154 Medicaid prescriptions (Q1–Q4 2025) 5% of Sirolimus prescriptions shown $6.7M gross reimbursement (before rebates) ≈ $3,132 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2596864

sirolimus 100 MG Injection

187 Medicaid prescriptions (Q1–Q4 2025) <1% of Sirolimus prescriptions shown $1.6M gross reimbursement (before rebates) ≈ $8,638 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2586863

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 Sirolimus, 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 23 of 96 listed Sirolimus NDCs with Medicaid activity.

Compare Sirolimus products

A representative set of FDA-listed product records for Sirolimus — 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 39 of 39 products — FDA National Drug Code Directory. See every product, package size and price: browse all 39 Sirolimus NDCs →

Sirolimus 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 Sirolimus — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Sirolimus are pyrexia, diarrhoea, pneumonia; about 86% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

13,367
Reports mentioning it
86%
Reported as serious
12
Distinct effects shown
Most reported effects
Pyrexia
524
Diarrhoea
514
Pneumonia
487
Drug Interaction
448
Acute Kidney Injury
434
Thrombotic Microangiopathy
376
Transplant Rejection
372
Cytomegalovirus Infection
348
Toxicity To Various Agents
314
Condition Aggravated
313
Age groups
Adult · 1,255Child · 317Elderly · 308Adolescent · 188Infant · 167Neonate · 67

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 Sirolimus 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.

Sirolimus FDA approval history

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

Sirolimus was first approved by the FDA in 1999 (Brand: RAPAMUNE · Pf Prism Cv); the first generic version was approved in 2014. It remains available in U.S. pharmacies today.

1999
Brand approved
Brand: RAPAMUNE · Pf Prism Cv
2014
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Sirolimus 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 3 Sirolimus recalls since July 2021. One of them is still ongoing and is listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class III May 1, 2024 · Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradation Specifications
  • Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-653-01 Lots: Lot H2200493; Exp 6/30/2025 FDA record D-0504-2024 →
Class III Oct 13, 2022 · Terminated · Aadi Bioscience
Failed Stability Specifications
  • Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100 mg per vial, NDC 80803-153-50, manufactured for Aadi Bioscience, Inc, CA. Lots: Lot# 6025701, Expiration Date: 31MAR2023, 100mg/vial, 50 ml single use vial, NDC 80803-153-50. FDA record D-0059-2023 →
Class III May 3, 2022 · Terminated · Apotex Corp.
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
  • Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-6197-2 Lots: Lot: RZ1598, exp. date 02/2023 FDA record D-0881-2022 →

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) Sirolimus RxCUI 35302 5 dose forms · 9 strengths
  1. Dose form (SCDF) Delayed Release Oral Tablet RxCUI 2717266 No current FDA listing
    Clinical drug / strength (SCD) 0.4 MG RxCUI 2717279 1.2 MG RxCUI 2717275 2.4 MG RxCUI 2717267
  2. Dose form (SCDF) Injection RxCUI 2586862 In current FDA listings
    Clinical drug / strength (SCD) 100 MG RxCUI 2586863
  3. Dose form (SCDF) Oral Solution RxCUI 375278 In current FDA listings
    Clinical drug / strength (SCD) 1 MG/ML RxCUI 314230
  4. Dose form (SCDF) Oral Tablet RxCUI 378277 In current FDA listings
    Clinical drug / strength (SCD) 0.5 MG RxCUI 905158 1 MG RxCUI 349208 2 MG RxCUI 360110
  5. Dose form (SCDF) Topical Gel RxCUI 2596863 In current FDA listings
    Clinical drug / strength (SCD) 0.002 MG/MG RxCUI 2596864

Look up RxCUI 35302 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.

💵 What Sirolimus 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, Film Coated · Oral 0.5 mg $0.841 per tablet NDC details & price history
Tablet, Film Coated · Oral 1 mg $0.723 per tablet NDC details & price history
Tablet, Film Coated · Oral 2 mg $2.53 per tablet NDC details & price history
Tablet · Oral 1 mg $0.723 per tablet NDC details & price history
Tablet · Oral 2 mg $2.53 per tablet NDC details & price history
Tablet · Oral 0.5 mg $0.841 per tablet NDC details & price history
Solution · Oral 1 mg/mL $4.39 per mL NDC details & price history
Tablet, Sugar Coated · Oral 2 mg $2.53 per tablet NDC details & price history
Tablet, Sugar Coated · Oral 1 mg $0.723 per tablet NDC details & price history
Tablet, Sugar Coated · Oral 0.5 mg $0.841 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.

Sirolimus brand names

Sirolimus is sold under 4 brand names in the FDA directory — Rapamune, Fyarro, Hyftor, Felycin. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Rapamune Fyarro Hyftor Felycin

Who makes Sirolimus: manufacturers and labelers

20 companies list Sirolimus products with the FDA. By number of product records, the largest are Mylan Pharmaceuticals Inc., Northstar Rx Llc, Remedyrepack Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Mylan Pharmaceuticals Inc. 4 Northstar Rx Llc 4 Remedyrepack Inc. 4 Ascend Laboratories, LLC 3 Glenmark Pharmaceuticals Inc., USA 3 Zydus Lifesciences Limited 3 Zydus Pharmaceuticals USA Inc. 3 American Health Packaging 2 Dr. Reddy's Laboratories Limited 2 Aadi Bioscience, Inc. 1 Amneal Pharmaceuticals NY LLC 1 Apotex Corp 1 AvPAK 1 Bryant Ranch Prepack 1 Camber Pharmaceuticals, Inc. 1 Major Pharmaceuticals 1 Nobelpharma America, LLC 1 Novadoz Pharmaceuticals LLC 1 Rising Pharma Holdings, Inc. 1 VistaPharm, LLC 1

Sirolimus drug class (RxNorm)

Sirolimus 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, Other ophthalmologicals
How it works Protein Kinase Inhibitors, mTOR 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 Sirolimus 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 Mar 26, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Sirolimus.
📈
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 Sirolimus after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
24
Finished products in the current FDA directory
39
Companies listing them (makers, repackagers, distributors)
20
FDA labeler codes behind them ⓘ
22
Linked representative label ⓘ
Greenstone LLC
Linked label effective
Mar 26, 2026
Composite sections available
26
Linked SPL Set ID
5908cd1a-fc5a-462f-99ed-1d8983e253c9
Linked SPL Document ID
8f2761f9-9bc3-47c3-8093-6375a39d1034
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. Greenstone LLC 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 →