
sirolimus
Pharmaranks rates Sirolimus 3.3/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Sirolimus is a kinase inhibitor used to treat Lymphangioleiomyomatosis, Perivascular Epithelioid Cell Neoplasms.
Kinase Inhibitor · by Apotex
Generic of Fyarro
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Sirolimus
- Drug class
- Kinase Inhibitor
- Form
- Solution
- Strength
- Sirolimus 1MG/ML
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Apotex
- What the pharmacy pays
- ~$48.61 for 30 — not your price
- FDA application
- ANDA211406
Drug class
- Kinase Inhibitor
- mTOR Inhibitor Immunosuppressant
How this class works, per Tyrosine Kinase Inhibitors - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Sirolimus ranks — best-rated kinase inhibitor for:
Dosage forms
Solution
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Sirolimus treat?
- Sirolimus (Sirolimus) may be used to treat lymphangioleiomyomatosis, perivascular epithelioid cell neoplasms, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Sirolimus work?
- Sirolimus is 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.
- How is Sirolimus rated?
- pharmaranks gives Sirolimus a composite score of 3.3 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Sirolimus cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $48.61 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Sirolimus?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Sirolimus. To pay less, Sirolimus is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Sirolimus?
- Sirolimus is marketed by Apotex. You can see Apotex's full profile, rating, and other products on pharmaranks.
- Is Sirolimus a brand-name or generic drug?
- Sirolimus is a generic medication; its active ingredient is Sirolimus. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Sirolimus available over the counter?
- No. Sirolimus is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Sirolimus come in?
- Sirolimus is currently marketed as solution, per the FDA's National Drug Code Directory.
- What class of drug is Sirolimus?
- Sirolimus is classified as kinase inhibitor, mtor inhibitor immunosuppressant, per the FDA's Established Pharmacologic Class.
- Is Sirolimus FDA-registered?
- Sirolimus is on record with the U.S. FDA under application number ANDA211406. You can verify this on its official FDA label.
- Has Sirolimus been recalled by the FDA?
- Sirolimus has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Sirolimus safe?
- There's no single safe-or-not verdict. pharmaranks gives Sirolimus a recall-safety score of 66/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
Information is sourced from public FDA regulatory data. Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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.
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sirolimus
66/100