Sirolimus: uses, dosing, side effects & brands
Sirolimus is a kinase inhibitor sold in the U.S. under 4 brand and generic names, for lymphangioleiomyomatosis and perivascular epithelioid cell neoplasms. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Kinase Inhibitor
- Treats (across its forms)
- Lymphangioleiomyomatosis and Perivascular Epithelioid Cell Neoplasms
- Available as
- Solution · Injectable · Topical
- Sold as
- 4 products — Sirolimus, Fyarro and Hyftor, and others
- Prescription?
- Prescription only
- Generic available?
- Yes
- What the pharmacy pays
- about $49 for a 30-count supply — not your price
How Hyftor is dosed
From the FDA label for Hyftor (application NDA213478). Other sirolimus products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to HYFTOR initiation [see Warning and Precautions (5.6) ] . Apply HYFTOR to the skin of the face affected with angiofibroma twice daily in the morning and at bedtime. The maximum recommended daily dosage is: 600 mg (2 cm) for pediatric patients 6 to 11 years of age 800 mg (2.5 cm) for adults and pediatric patients 12 years of age and older If symptoms do not improve within 12 weeks of treatment, reevaluate the need for continuing HYFTOR. Do not use HYFTOR with occlusive dressings. For topical use only. Not for oral, ophthalmic, or intravaginal use. Complete all age-appropriate vaccinations as recommended by current immunization guidelines prior to HYFTOR initiation. ( 2 ) Apply to the skin of the face affected with angiofibroma twice daily. ( 2 ) The maximum daily dosage is: 600 mg (2 cm) for patients 6 to 11 years of age. ( 2 ) 800 mg (2.5 cm) for patients 12 years of age and older. ( 2 ) Do not use with occlusive dressings. ( 2 ) For topical use only. Not for oral, ophthalmic, or intravaginal use. ( 2 )
Everything below is the FDA label for Hyftor (topical). Sirolimus is also sold as solution and injectable, and those are different medicines to take — follow the label for the one you were prescribed.
Hyftor side effects
Most common adverse reactions (≥1%) are dry skin, application site irritation, pruritus, acne, acneiform dermatitis, ocular hyperemia, skin hemorrhage, and skin irritation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Nobelpharma America, LLC at 1 (877) 375-0825 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In a randomized, double-blind, vehicle-controlled trial, subjects aged 6 years and older with facial angiofibroma associated with tuberous sclerosis applied HYFTOR twice daily for 12 weeks. A total of 30 subjects were treated with HYFTOR and 32 with the vehicle. The majority of the subjects were female (54.8%). A total of 40.3% were less than 18 years of age. The most common adverse reactions reported by ≥1% of subjects treated with HYFTOR and more frequently than in subjects treated with vehicle are presented in Table 1. Adverse reactions occurred with similar frequency in pediatric subjects 6 years of age and older. Table 1: Adverse Reactions in ≥1% of Subjects Aged 6 Years and Older with Facial Angiofibroma Associated with Tuberous Sclerosis Through Week 12 Preferred…
Who shouldn’t take Hyftor
HYFTOR is contraindicated in patients with a history of hypersensitivity to sirolimus or any other component of HYFTOR. Reactions to sirolimus have included anaphylactic/anaphylactoid reactions, angioedema, exfoliative dermatitis, and hypersensitivity vasculitis [see Warning and Precautions (5.1) ] . History of hypersensitivity to sirolimus or any other component of HYFTOR. ( 4 )
Hyftor drug interactions
CYP3A4 Inhibitors: During concomitant use of HYFTOR with CYP3A4 inhibitors, monitor for adverse reactions of HYFTOR. ( 7.1 ) Substrates and Inhibitors of CYP3A : During concomitant use of HYFTOR with drugs that are both substrates and inhibitors of CYP3A, monitor for adverse reactions of the CYP3A substrate and inhibitor. ( 7.2 ) 7.1 Effects of Other Drugs on HYFTOR Table 2 presents clinically significant drug interactions involving drugs that affect HYFTOR. Table 2: Effects of CYP3A4 Inhibitors on HYFTOR Clinical Impact Concomitant use of HYFTOR with inhibitors of CYP3A4 has the potential to increase the systemic exposure of sirolimus and increase the risk of HYFTOR adverse reactions. Intervention Monitor for adverse reactions of HYFTOR. 7.2 Effects of HYFTOR on Other Drugs Systemic exposure of drugs that are both substrates and inhibitors of CYP3A could be increased with coadministration with HYFTOR. Monitor for adverse reactions of such co-administered drugs.
Every sirolimus product we track (4)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 66/100 | Prescription | Solution | Generic | $49 | View → | |
| 2 | Not yet rated | Prescription | Injectable | Generic | $49 | View → | |
| 3 | Not yet rated | Prescription | Topical | Generic | $49 | View → | |
| 4 | Not yet rated | Prescription | Solution | Generic | $49 | View → |
What sirolimus pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| 1 | 0.5 mg | yellow | round | — |
| Y;7 | 0.5 mg | gray | round | — |
| Y;77 | 1 mg | white | round | — |
| Y;71 | 2 mg | yellow | round | — |
| RAPAMUNE;05;MG | 0.5 mg | brown | triangle | — |
| RAPAMUNE;1;MG | 1 mg | white | triangle | — |
| RAPAMUNE;2;MG | 2 mg | yellow | triangle | — |
Sirolimus recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Can you crush or split sirolimus?
At least one sirolimusproduct 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 sirolimus label says about crushing, splitting and chewingHow long sirolimus keeps
No sirolimus 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.
Sirolimus and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for sirolimus: levels in milk, effects in breastfed infants, and the drugs it would consider insteadBecause almost no information is available on the use of oral sirolimus during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.
National Institute of Child Health and Human Development, record revised August 15, 2025. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about sirolimus
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 14,105 reports naming sirolimus, and the FDA flagged 85% 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:
- pyrexia558 reports
- diarrhoea557 reports
- pneumonia517 reports
- acute kidney injury435 reports
- thrombotic microangiopathy386 reports
- transplant rejection381 reports
- cytomegalovirus infection358 reports
- nausea335 reports
Read these as a signal, not a rate. A report does not mean sirolimus 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.
Source: openFDA drug/event (FAERS), retrieved September 26, 2026.
Related calculators
Frequently asked questions
What is Hyftor?
HYFTOR ® (sirolimus topical gel) 0.2% is an mTOR inhibitor immunosuppressant for topical use. Each gram contains 2 mg of sirolimus, which is solubilized in a gel consisting of alcohol 51%, Carbomer 940, purified water, and trolamine.
What kind of drug is sirolimus?
The FDA classifies sirolimus 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.
Can you take sirolimus 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 sirolimus 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 sirolimus sold under?
We track 4 sirolimus-containing products in the U.S.: Sirolimus, Fyarro, Hyftor and Rapamune. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does sirolimus come in?
Across the brands we track, sirolimus is currently marketed as solution, injectable and topical, 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 sirolimus?
Yes. Our catalog lists 1 generic sirolimus 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 sirolimus been recalled?
The FDA's Enforcement database lists 1 recall record whose product description mentions sirolimus. The most recent: Sirolimus Tablets 1mg 100-count bottle (May 1, 2024). 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). Sirolimus: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/sirolimus
- MLA
- “Sirolimus: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/sirolimus.
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 sirolimus on DailyMed (NIH) ↗.