Ixazomib side effects: what 28,602 FDA adverse event reports show
Drug class
Proteasome inhibitor
Brand names
Ninlaro
Who reports
28,602 reports · 74% serious · 5,284 with death outcome · 48% female
Used for
NINLARO ® 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.
What it is
Ixazomib is a proteasome inhibitor. Ixazomib citrate, a prodrug, rapidly hydrolyzes under physiological conditions to its biologically active form, ixazomib.
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 996 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Light chain disease | 26 | 157.8 103.3–241.2ROR 158.0 · χ² 3,197 / p <1e-300 | 118.6 EB05 85.1 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 0% (drug 48%) · 100% clinician | not reported in cached trials |
| Monoclonal immunoglobulin increased | 40 | 120.9 86.5–168.9ROR 121.1 · χ² 3,972 / p <1e-300 | 98.9 EB05 75.8 · IC025 +5.0 3/3 methods agree | Lab value / disease marker | serious n=34 | not reported in cached trials |
| Light chain analysis increased | 115 | 92.5 76.2–112.3ROR 92.9 · χ² 9,146 / p <1e-300 | 81.0 EB05 69.4 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=92 | not reported in cached trials |
| Plasma cell myeloma refractory | 138 | 87.4 73.2–104.2ROR 87.8 · χ² 10,434 / p <1e-300 | 77.2 EB05 67.0 · IC025 +5.7 3/3 methods agree | Labeled (related wording) related wording | serious n=138 | not reported in cached trials |
| Paraproteinaemia | 33 | 86.4 60.2–123.9ROR 86.5 · χ² 2,411 / p <1e-300 | 74.1 EB05 55.2 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=33 | not reported in cached trials |
| Plasma cell myeloma | 3,665 | 75.8 73.4–78.3ROR 86.8 · χ² 245,264 / p <1e-300 | 68.7 EB05 66.8 · IC025 +6.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 56.0 | NCT03169361: 1/742 (0.1%) on Ixazomib (serious AE) |
| Plasma cell myeloma recurrent | 294 | 72.4 64.3–81.6ROR 73.1 · χ² 18,754 / p <1e-300 | 65.6 EB05 59.6 · IC025 +5.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=274 | not reported in cached trials |
| Monoclonal immunoglobulin present | 58 | 60.1 46.0–78.5ROR 60.2 · χ² 3,058 / p <1e-300 | 54.6 EB05 43.8 · IC025 +4.8 3/3 methods agree | Lab value / disease marker | serious n=46 | not reported in cached trials |
| Light chain analysis abnormal | 15 | 57.3 33.9–97.0ROR 57.4 · χ² 718 / p 2e-158 | 50.0 EB05 32.2 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=11 | not reported in cached trials |
| Plasma cell leukaemia | 33 | 42.7 30.1–60.7ROR 42.8 · χ² 1,230 / p 8e-270 | 39.5 EB05 29.5 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=33 | NCT01564537: 2/359 (0.6%) control (serious AE) |
| Respiratory tract infection bacterial | 25 | 38.5 25.8–57.6ROR 38.5 · χ² 832 / p 3e-183 | 35.7 EB05 25.4 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious n=25 · ♀ 0% (drug 48%) · 100% clinician | not reported in cached trials |
| Morganella infection | 12 | 31.2 17.5–55.6ROR 31.2 · χ² 308 / p 4e-69 | 28.7 EB05 17.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Plasmacytoma | 76 | 30.9 24.5–38.8ROR 31.0 · χ² 2,078 / p <1e-300 | 29.5 EB05 24.3 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=75 | NCT01564537: 4/361 (1.1%) on Ixazomib (serious AE) |
| Bronchial haemorrhage | 12 | 29.0 16.3–51.6ROR 29.0 · χ² 285 / p 2e-64 | 26.8 EB05 16.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Body dysmorphic disorder | 12 | 24.4 13.7–43.4ROR 24.4 · χ² 238 / p 4e-54 | 22.7 EB05 13.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Immunoglobulins increased | 15 | 24.4 14.6–40.8ROR 24.4 · χ² 303 / p 3e-68 | 23.0 EB05 14.6 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious n=14 | not reported in cached trials |
| Covid-19 immunisation | 26 | 23.2 15.7–34.3ROR 23.2 · χ² 514 / p 4e-114 | 22.2 EB05 15.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 76% (drug 48%) | not reported in cached trials |
| Neutrophil count abnormal | 85 | 22.7 18.3–28.2ROR 22.8 · χ² 1,690 / p <1e-300 | 22.0 EB05 18.3 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious n=82 | NCT03169361: 14/742 (1.9%) on Ixazomib (serious AE) |
| Product blister packaging issue | 29 | 21.2 14.7–30.7ROR 21.3 · χ² 524 / p 3e-116 | 20.4 EB05 14.9 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious n=9 | not reported in cached trials |
| Blood immunoglobulin g increased | 34 | 21.0 14.9–29.5ROR 21.0 · χ² 609 / p 8e-135 | 20.2 EB05 15.1 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious n=29 | not reported in cached trials |
| Full blood count increased | 32 | 20.1 14.2–28.6ROR 20.2 · χ² 548 / p 2e-121 | 19.4 EB05 14.3 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious n=8 | not reported in cached trials |
| Vertebral lesion | 13 | 19.2 11.0–33.2ROR 19.2 · χ² 201 / p 7e-46 | 17.9 EB05 10.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Blood immunoglobulin a increased | 13 | 18.2 10.5–31.5ROR 18.2 · χ² 190 / p 2e-43 | 16.9 EB05 9.8 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious n=11 | not reported in cached trials |
| Cardiac amyloidosis | 23 | 15.8 10.5–23.9ROR 15.8 · χ² 298 / p 4e-67 | 15.1 EB05 10.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=23 · 91% clinician | not reported in cached trials |
| Joint ankylosis | 12 | 15.6 8.8–27.7ROR 15.7 · χ² 147 / p 4e-34 | 14.1 EB05 7.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Cryptosporidiosis infection | 10 | 14.2 7.6–26.5ROR 14.2 · χ² 108 / p 2e-25 | 12.1 EB05 6.0 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Neoplasm skin | 28 | 13.4 9.2–19.5ROR 13.4 · χ² 304 / p 2e-68 | 12.7 EB05 8.9 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=28 · ♀ 78% (drug 48%) | not reported in cached trials |
| Respiratory tract infection viral | 41 | 13.2 9.7–17.9ROR 13.2 · χ² 441 / p 3e-98 | 12.7 EB05 9.6 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious n=38 | NCT01564537: 1/359 (0.3%) control (serious AE) |
| Pneumonia influenzal | 21 | 13.1 8.5–20.1ROR 13.1 · χ² 219 / p 9e-50 | 12.2 EB05 7.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=21 · 100% clinician | NCT03169361: 1/742 (0.1%) on Ixazomib (serious AE) |
| Cytopenia | 203 | 12.6 11.0–14.5ROR 12.7 · χ² 2,130 / p <1e-300 | 12.4 EB05 11.0 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.7 | NCT03169361: 1/742 (0.1%) on Ixazomib (serious AE) |
| Protein total increased | 44 | 12.3 9.2–16.6ROR 12.4 · χ² 440 / p 5e-98 | 11.8 EB05 9.0 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious n=25 | not reported in cached trials |
| Immunoglobulins decreased | 22 | 12.0 7.9–18.2ROR 12.0 · χ² 207 / p 3e-47 | 11.0 EB05 7.3 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious n=21 | not reported in cached trials |
| Amyloidosis | 27 | 11.6 7.9–17.0ROR 11.6 · χ² 248 / p 4e-56 | 10.8 EB05 7.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=27 | not reported in cached trials |
| Neuropathy peripheral (nerve damage in hands/feet) | 1,451 | 11.4 10.8–12.0ROR 12.0 · χ² 13,620 / p <1e-300 | 11.2 EB05 10.8 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.4 | NCT03169361: 7/742 (0.9%) on Ixazomib (serious AE) |
| Product physical issue | 299 | 11.1 10.0–12.5ROR 11.3 · χ² 2,713 / p <1e-300 | 10.9 EB05 9.9 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious n=87 | not reported in cached trials |
| Full blood count decreased | 297 | 10.9 9.8–12.3ROR 11.0 · χ² 2,636 / p <1e-300 | 10.7 EB05 9.7 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 8.9 | not reported in cached trials |
| Proteus infection | 10 | 10.3 5.5–19.2ROR 10.3 · χ² 74 / p 5e-18 | 8.1 EB05 4.3 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=10 | NCT01564537: 1/361 (0.3%) on Ixazomib (serious AE) |
| Keratopathy | 21 | 9.9 6.4–15.2ROR 9.9 · χ² 157 / p 3e-36 | 8.8 EB05 5.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=21 | not reported in cached trials |
| Escherichia bacteraemia | 30 | 9.6 6.7–13.8ROR 9.6 · χ² 220 / p 4e-50 | 8.8 EB05 6.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=30 | NCT01564537: 2/361 (0.6%) on Ixazomib; 1/359 (0.3%) control (serious AE) |
| Upper respiratory tract inflammation | 15 | 9.2 5.5–15.3ROR 9.2 · χ² 101 / p 6e-24 | 7.7 EB05 4.8 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=14 | NCT03169361: 2/742 (0.3%) on Ixazomib (serious AE) |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Ixazomib as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (11 of 40 signal terms matched).
- NCT03169361 — NINLARO Capsules Drug Use-Results Survey (All-Case Surveillance) "Relapsed/Refractory Multiple Myeloma" (N=774, phase n/a; 108 AE terms posted; arms: Ixazomib 4 mg)
- NCT01564537 — A Phase 3 Study Comparing Oral Ixazomib Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide a (N=722, PHASE3; 406 AE terms posted; arms: Ixazomib+ Lenalidomide + Dexamethasone; Placebo + Lenalidomide + Dexamethasone)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Plasma cell myeloma | 3,665 | 75.8 73.4–78.3ROR 86.8 · χ² 245,264 / p <1e-300 | 68.7 EB05 66.8 · IC025 +6.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 56.0 | NCT03169361: 1/742 (0.1%) on Ixazomib (serious AE) |
| Death | 3,315 | 2.8 2.7–2.9ROR 3.1 · χ² 4,068 / p <1e-300 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree | Outcome field, not a reaction | serious PRR 2.2 | NCT03169361: 1/742 (0.1%) on Ixazomib (serious AE) |
| Diarrhoea (diarrhea) | 3,156 | 3.6 3.5–3.7ROR 3.9 · χ² 6,109 / p <1e-300 | 3.6 EB05 3.5 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | NCT03169361: 44/742 (5.9%) on Ixazomib (serious AE) |
| Off label use (used outside approved label) | 2,966 | 2.5 2.4–2.6ROR 2.7 · χ² 2,800 / p <1e-300 | 2.5 EB05 2.4 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 | not reported in cached trials |
| Pneumonia (lung infection) | 1,934 | 4.4 4.2–4.6ROR 4.7 · χ² 5,137 / p <1e-300 | 4.4 EB05 4.2 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.5 | NCT03169361: 22/742 (3.0%) on Ixazomib (serious AE) |
| Fatigue (tiredness) | 1,918 | 1.8 1.7–1.9ROR 1.9 · χ² 722 / p 3e-159 | 1.8 EB05 1.7 · IC025 +0.8 | Not in label — unassessed | serious PRR 1.7 | NCT01564537: 2/361 (0.6%) on Ixazomib; 1/359 (0.3%) control (serious AE) |
| Nausea | 1,841 | 1.7 1.6–1.8ROR 1.8 · χ² 564 / p 5e-125 | 1.7 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.6 · ♀ 68% (drug 48%) | NCT03169361: 11/742 (1.5%) on Ixazomib (serious AE) |
| Neuropathy peripheral (nerve damage in hands/feet) | 1,451 | 11.4 10.8–12.0ROR 12.0 · χ² 13,620 / p <1e-300 | 11.2 EB05 10.8 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.4 | NCT03169361: 7/742 (0.9%) on Ixazomib (serious AE) |
| Vomiting | 1,108 | 1.7 1.6–1.8ROR 1.8 · χ² 351 / p 2e-78 | 1.7 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.3 · ♀ 73% (drug 48%) | NCT03169361: 17/742 (2.3%) on Ixazomib (serious AE) |
| Rash | 1,087 | 1.8 1.7–2.0ROR 1.9 · χ² 423 / p 2e-94 | 1.8 EB05 1.7 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.1 | NCT03169361: 3/742 (0.4%) on Ixazomib (serious AE) |
| Thrombocytopenia (low platelets) | 1,046 | 6.9 6.5–7.4ROR 7.2 · χ² 5,281 / p <1e-300 | 6.9 EB05 6.5 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 | NCT03169361: 73/742 (9.8%) on Ixazomib (serious AE) |
| Platelet count decreased | 1,003 | 7.0 6.5–7.4ROR 7.2 · χ² 5,089 / p <1e-300 | 6.9 EB05 6.5 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.3 | NCT03169361: 1/742 (0.1%) on Ixazomib (serious AE) |
| Constipation | 967 | 3.3 3.1–3.5ROR 3.4 · χ² 1,544 / p <1e-300 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 | NCT01564537: 1/361 (0.3%) on Ixazomib; 1/359 (0.3%) control (serious AE) |
| Asthenia (weakness) | 915 | 1.8 1.7–1.9ROR 1.8 · χ² 320 / p 6e-72 | 1.8 EB05 1.7 · IC025 +0.7 | Not in label — unassessed | serious PRR 1.5 | NCT01564537: 2/361 (0.6%) on Ixazomib (serious AE) |
| Product dose omission issue | 799 | 2.1 1.9–2.2ROR 2.1 · χ² 439 / p 7e-98 | 2.1 EB05 1.9 · IC025 +0.9 | Reporting / coding artifact | serious PRR 4.2 | not reported in cached trials |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Light chain disease — n=26, PRR 157.8
- Light chain analysis increased — n=115, PRR 92.5
- Paraproteinaemia — n=33, PRR 86.4
- Plasma cell leukaemia — n=33, PRR 42.7 (also seen in trial arm)
- Plasmacytoma — n=76, PRR 30.9 (also seen in trial arm)
- Covid-19 immunisation — n=26, PRR 23.2
- Cardiac amyloidosis — n=23, PRR 15.8
- Neoplasm skin — n=28, PRR 13.4
- Pneumonia influenzal — n=21, PRR 13.1 (also seen in trial arm)
- Amyloidosis — n=27, PRR 11.6
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Ixazomib?
In FDA FAERS, the most frequently co-reported reaction terms for Ixazomib are plasma cell myeloma, diarrhoea, pneumonia, fatigue, nausea, neuropathy peripheral. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Ixazomib have an FDA boxed warning?
No. The FDA label retrieved for Ixazomib has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ixazomib causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 038f2461-834b-4488-9ebd-863c83eef5a7, effective 20260811; matched on
openfda.generic_name.exact:"IXAZOMIB") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,036 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
IXAZOMIB, results-bearing studies sorted by enrollment)
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.