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
- Midostaurin
- Form
- Capsule
- Strength
- Midostaurin 25MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Teva
- FDA application
- ANDA216076
- Availability
- Discontinued (per FDA)
May treat (source: NIH RxClass)
Dosage forms
Capsule
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
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Frequently asked questions
- What does Midostaurin treat?
- Midostaurin (Midostaurin) may be used to treat acute myeloid leukemia, hematologic neoplasms, systemic mastocytosis, 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 Midostaurin rated?
- pharmaranks gives Midostaurin a composite score of 2.7 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 Midostaurin?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Midostaurin. To pay less, Midostaurin 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 Midostaurin?
- Midostaurin is marketed by Teva. You can see Teva's full profile, rating, and other products on pharmaranks.
- Is Midostaurin a brand-name or generic drug?
- Midostaurin is a generic medication; its active ingredient is Midostaurin. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Midostaurin available over the counter?
- No. Midostaurin 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 Midostaurin come in?
- Midostaurin is currently marketed as capsule, per the FDA's National Drug Code Directory.
- Is Midostaurin FDA-registered?
- Midostaurin is on record with the U.S. FDA under application number ANDA216076. You can verify this on its official FDA label.
- Has Midostaurin been recalled by the FDA?
- Midostaurin 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 Midostaurin safe?
- There's no single safe-or-not verdict. pharmaranks gives Midostaurin a recall-safety score of 54/100, 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 Midostaurin
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1,279 reports naming Midostaurin, and the FDA flagged 97% 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 neutropenia177 reports
- diarrhoea128 reports
- thrombocytopenia119 reports
- pyrexia113 reports
- neutropenia106 reports
- nausea98 reports
- acute myeloid leukaemia recurrent86 reports
- pancytopenia86 reports
Read these as a signal, not a rate. A report does not mean Midostaurin 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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midostaurin
54/100