Prescription medicine
Ixazomib Brand names: Ninlaro
Ixazomib (Ninlaro) is a prescription medicine with an FDA approval on record since 2015. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the ixazomib FDA label on DailyMed (effective August 11, 2026, Takeda Pharmaceuticals America, Inc.); the NDA 208462 record on Drugs@FDA; every ixazomib label on DailyMed.
Highlights of the record
FDA label of August 11, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageNINLARO ® is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.
Forms and strengths
- 2.3 mg
- 3 mg
- 4 mg
Capsule.
On the market
- Earliest approval on file
- November 20, 2015 Ninlaro, Takeda Pharms Usa; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- November 20, 2029 Ninlaro capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 28,609 through July 30, 2026
What is ixazomib used for?
From the label: indications and usageNINLARO ® is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. NINLARO is a proteasome inhibitor indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. ( 1 ) Limitations of Use: NINLARO is not recommended for use in the maintenance setting or in newly diagnosed multiple myeloma in combination with lenalidomide and dexamethasone outside of controlled clinical trials. […]
Conditions named in the indications of ixazomib's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Proteasome Inhibitor.
Source: FDA drug label (NINLARO), Takeda Pharmaceuticals America, Inc., effective August 11, 2026 (SPL set 038f2461-834b-4488-9ebd-863c83eef5a7), via openFDA; the full label on DailyMed
Is there a generic for ixazomib (Ninlaro)?
No generic ixazomib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 7 patents for Ninlaro capsules: the compound patent runs to November 20, 2029. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2015 earliest approval on file
- 2029 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the ixazomib label say about other medicines?
The ixazomib label names 4 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Carbamazepine | drug interactions | Avoid concomitant administration of NINLARO with strong CYP3A inducers (such as rifampin, phenytoin, carbamazepine, and St. John's Wort) [see Clinical Pharmacology (12.3) ]. |
| Dexamethasone | warnings and precautions | Adjust dosing of dexamethasone per its prescribing information or NINLARO for Grade 3 or 4 symptoms [see Dosage and Administration (2.2) ]. |
| Phenytoin | drug interactions | Avoid concomitant administration of NINLARO with strong CYP3A inducers (such as rifampin, phenytoin, carbamazepine, and St. John's Wort) [see Clinical Pharmacology (12.3) ]. |
| Rifampin | drug interactions | Avoid concomitant administration of NINLARO with strong CYP3A inducers (such as rifampin, phenytoin, carbamazepine, and St. John's Wort) [see Clinical Pharmacology (12.3) ]. |
Source: FDA drug label (NINLARO), Takeda Pharmaceuticals America, Inc., effective August 11, 2026 (SPL set 038f2461-834b-4488-9ebd-863c83eef5a7), via openFDA; the full label on DailyMed
What do FAERS reports show for ixazomib?
The FDA Adverse Event Reporting System holds 28,609 reports that list ixazomib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5,284 are coded as a death and 8,748 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ixazomib?
37 other medicines are given the same way (oral) and in the same FDA class as ixazomib or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Lenalidomide | Leukemia, lymphoma and myeloma | 18 labelers | n/a | No current entry |
| Dasatinib | Leukemia, lymphoma and myeloma | 14 labelers | $26.46 per tablet 100 mg tablet | No current entry |
| Pomalidomide | Leukemia, lymphoma and myeloma | 11 labelers | n/a | No current entry |
| Imatinib | Leukemia, lymphoma and myeloma | 20 labelers | $0.624 per tablet 100 mg tablet | No current entry |
| Arsenic trioxide | Leukemia, lymphoma and myeloma | none listed | n/a | A presentation being discontinued |
| Nilotinib | Leukemia, lymphoma and myeloma | 6 labelers | n/a | No current entry |
| Hydroxyurea | Leukemia, lymphoma and myeloma | 10 labelers | $0.184 per capsule 500 mg capsule | No current entry |
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 4 labelers | $1.67 per capsule 50 mg capsule | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Other proteasome inhibitors
- the pharmacologic class, with prices and generics
- Ixazomib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other