Skip to content
ppharmaranks
Menu
Emd Serono logo

novantrone

Pharmaranks rates Novantrone 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Novantrone (Mitoxantrone Hydrochloride) is a medication used to treat Breast Neoplasms, Lymphoma, Multiple Sclerosis, Pain.

Mitoxantrone Hydrochloride · by Emd Serono

70/100Limited · 1 source

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 →

Rated against independent regulatory sources·Last updated October 10, 2026·How we rate
Verified againstopenFDANIH DailyMedRxClass

Key facts

Form
Injectable
Strength
Mitoxantrone Hydrochloride EQ 20MG BASE/10ML (EQ 2MG BASE/ML) **Federal Register Determination That Product was not Discontinued or Withdrawn for Safety or Effectiveness reasons** · Mitoxantrone Hydrochloride EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) **Federal Register Determination That Product was not Discontinued or Withdrawn for Safety or Effectiveness reasons** · Mitoxantrone Hydrochloride EQ 30MG BASE/15ML (EQ 2MG BASE/ML) **Federal Register Determination That Product was not Discontinued or Withdrawn for Safety or Effectiveness reasons**
Type
Prescription (Rx)
Brand or generic
Brand-name
Manufacturer
Emd Serono
FDA application
NDA019297
Availability
Discontinued (per FDA)

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.

Compare alternatives

A same-class option may cost less. See alternatives →

Frequently asked questions

What does Novantrone treat?
Novantrone (Mitoxantrone Hydrochloride) may be used to treat breast neoplasms, lymphoma, multiple sclerosis, pain, prostatic neoplasms, sarcoma, 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 Novantrone rated?
pharmaranks gives Novantrone 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 Novantrone?
pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Novantrone. 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 Novantrone?
Novantrone is marketed by Emd Serono. You can see Emd Serono's full profile, rating, and other products on pharmaranks.
Is Novantrone a brand-name or generic drug?
Novantrone is a brand-name product with the active ingredient Mitoxantrone Hydrochloride.
Is Novantrone available over the counter?
No. Novantrone 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 Novantrone come in?
Novantrone is currently marketed as injectable, per the FDA's National Drug Code Directory.
Is Novantrone FDA-registered?
Novantrone is on record with the U.S. FDA under application number NDA019297. You can verify this on its official FDA label.
Has Novantrone been recalled by the FDA?
Novantrone 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 Novantrone safe?
There's no single safe-or-not verdict. pharmaranks gives Novantrone 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 MITOXANTRONE HYDROCHLORIDE

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 987 reports naming MITOXANTRONE HYDROCHLORIDE — the active ingredient in Novantrone, and the FDA flagged 98% 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:

  • febrile neutropenia178 reports
  • pyrexia88 reports
  • neutropenia82 reports
  • myelosuppression68 reports
  • sepsis62 reports
  • hypotension57 reports
  • septic shock47 reports
  • platelet count decreased46 reports

Read these as a signal, not a rate. A report does not mean MITOXANTRONE HYDROCHLORIDE 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.

Reviews

No reviews yet. Be the first to write one.

Write a review

Reviews are user opinions, not medical advice. Consult a licensed professional.

People also viewed

Compare Novantrone head-to-head

Identify a pill by its imprint →Check a drug interaction →Drug recalls →

Browse medications A–Z

Research products from A to Z, compare independent ratings, and find alternatives.

novantrone

70/100