ontak
Pharmaranks rates Ontak 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Ontak (Denileukin Diftitox) is a cd25-directed cytotoxin used to treat T-Cell Lymphoma.
Denileukin Diftitox · by Eisai Inc
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
- Denileukin Diftitox
- Drug class
- Cd25-Directed Cytotoxin
- Form
- Injectable
- Strength
- Denileukin Diftitox 150UG/ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- t-cell lymphoma
- Manufacturer
- Eisai Inc
- FDA application
- BLA103767
Drug class
May treat (source: NIH RxClass)
Dosage forms
Injectable
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.
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Frequently asked questions
- What does Ontak treat?
- Ontak (Denileukin Diftitox) may be used to treat t-cell lymphoma, 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 is Ontak rated?
- pharmaranks gives Ontak a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Ontak?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Ontak. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Ontak?
- Ontak is marketed by Eisai Inc. You can see Eisai Inc's full profile, rating, and other products on pharmaranks.
- Is Ontak a brand-name or generic drug?
- Ontak is a brand-name product with the active ingredient Denileukin Diftitox.
- Is Ontak available over the counter?
- No. Ontak 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 Ontak come in?
- Ontak is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Ontak?
- Ontak is classified as cd25-directed cytotoxin, per the FDA's Established Pharmacologic Class.
- Is Ontak FDA-registered?
- Ontak is on record with the U.S. FDA under application number BLA103767. You can verify this on its official FDA label.
- Has Ontak been recalled by the FDA?
- Ontak 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 Ontak safe?
- There's no single safe-or-not verdict. pharmaranks gives Ontak a recall-safety score of 70/100, 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 DENILEUKIN DIFTITOX
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 47 reports naming DENILEUKIN DIFTITOX — the active ingredient in Ontak, and the FDA flagged 96% 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:
- pyrexia7 reports
- blood albumin decreased6 reports
- capillary leak syndrome6 reports
- sepsis6 reports
- fatigue4 reports
- abscess3 reports
- cough3 reports
- dyspnoea3 reports
Read these as a signal, not a rate. A report does not mean DENILEUKIN DIFTITOX 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 25, 2026.
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ontak
70/100