What the label lists and what reports show
Ixazomib side effects
Ixazomib's FDA label: “The most common adverse reactions (≥20%) are thrombocytopenia, neutropenia, diarrhea, constipation, peripheral neuropathy, nausea, peripheral edema, rash, vomiting, and bronchitis.” FAERS holds 28,609 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is plasma cell myeloma (3,665 reports).
- No generic listed
Check it at the source: the ixazomib FDA label on DailyMed (effective August 11, 2026, Takeda Pharmaceuticals America, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of NINLARO?NINLARO may cause serious side effects, including: Low platelet counts (thrombocytopenia). Low platelet counts are common with NINLARO, and can sometimes be serious. You may need platelet transfusions if your counts are too low. Tell your healthcare provider if you have any signs of low platelet counts, including bleeding and easy bruising. Stomach and intestinal (gastrointestinal) problems. Diarrhea, constipation, nausea, and vomiting are common with NINLARO, and can sometimes be severe. Call your healthcare provider if you get any of these symptoms and they do not go away during treatment with NINLARO. Your healthcare provider may prescribe medicine to help treat your symptoms. Nerve problems. Nerve problems are common with NINLARO and may also be severe. […]
Source: FDA drug label, Takeda Pharmaceuticals America, Inc., effective August 11, 2026 (SPL set 038f2461-834b-4488-9ebd-863c83eef5a7), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥20%) are thrombocytopenia, neutropenia, diarrhea, constipation, peripheral neuropathy, nausea, peripheral edema, rash, vomiting, and bronchitis.
Table 4: Non-Hematologic Adverse Reactions Occurring in ≥5% of Patients with a ≥5% Difference Between the NINLARO Regimen and the Placebo Regimen (All Grades, Grade 3 and Grade 4)
| Reaction | All Grades | Grade 3 | Grade 4 | All Grades | Grade 3 | Grade 4 |
|---|---|---|---|---|---|---|
| Diarrhea | 52 | 10 | 0 | 43 | 3 | 0 |
| Constipation | 35 | <1 | 0 | 28 | <1 | 0 |
| Nausea | 32 | 2 | 0 | 23 | 0 | 0 |
| Vomiting | 26 | 1 | 0 | 13 | <1 | 0 |
| Peripheral neuropathies Represents a pooling of preferred terms | 32 | 2 | 0 | 24 | 2 | 0 |
| Back pain At the time of the final analysis, these adverse reactions no longer met the… | 27 | <1 | 0 | 24 | 3 | 0 |
| Upper respiratory tract infection | 27 | 1 | 0 | 23 | 1 | 0 |
| Bronchitis | 22 | 2 | 0 | 17 | 2 | <1 |
| Rash | 27 | 3 | 0 | 16 | 2 | 0 |
| Edema peripheral | 27 | 2 | 0 | 21 | 1 | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are described in detail in other sections of the prescribing information: Thrombocytopenia [see Warnings and Precautions (5.1) ] Gastrointestinal Toxicities [see Warnings and Precautions (5.2) ] Peripheral Neuropathy [see Warnings and Precautions (5.3) ] Peripheral Edema [see Warnings and Precautions (5.4) ] Cutaneous Reactions [see Warnings and Precautions (5.5) ] Thrombotic Microangiopathy [see Warnings and Precautions (5.6) ] Hepatotoxicity [see Warnings and Precautions (5.7) ] The most common adverse reactions (≥20%) are thrombocytopenia, neutropenia, diarrhea, constipation, peripheral neuropathy, nausea, peripheral edema, rash, vomiting, and bronchitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-844-617-6468 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety population from the randomized, double-blind, placebo-controlled clinical study included 720 patients with relapsed and/or refractory multiple myeloma, who received NINLARO in combination with lenalidomide and dexamethasone (NINLARO regimen; …
Source: FDA drug label, 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?
28,609 reports list ixazomib among the medicines taken, 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. Of the 21 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Ixazomib: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions