Drug · FAERS side-effect profile with label screen
Selinexor side effects: what 8,601 FDA adverse event reports show
Drug class
Nuclear Export Inhibitor
FDA label (Established Pharmacologic Class)
Brand names
Xpovio
openFDA label
Who reports
8,601 reports · 55% serious · 1,459 with death outcome · 46% female
openFDA FAERS counts, all years, deduplication not applied
Used for
XPOVIO is a nuclear export inhibitor indicated: In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy ( 1.1 ). In combination with dexamethasone for the t.
FDA label, Indications and Usage
What it is
Selinexor is a nuclear export inhibitor. Selinexor is (2 Z )-3-{3-[3,5-bis(trifluoromethyl)phenyl]-1 H -1,2,4-triazol-1-yl}- N '-(pyrazin-2-yl)prop-2-enehydrazide. It is a white to off-white powder and has the molecular formula C 17 H 11 F 6 N 7 O and a molecular mass of 443.31 g/mol.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 10Labeled (related wording) 3Likely indication confounding 4Reporting / coding artifact 3Lab value / disease marker 4Not in label — unassessed 16
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. 713 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Aeromonas infection | 12 | 179.1 99.7–321.9ROR 179.4 · χ² 1,816 / p <1e-300 | 132.2 EB05 80.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Diffuse large b-cell lymphoma refractory | 51 | 141.4 106.7–187.4ROR 142.2 · χ² 6,582 / p <1e-300 | 127.3 EB05 100.6 · IC025 +5.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=24 | no trial data cached |
| Plasma cell myeloma refractory | 62 | 122.4 94.9–157.9ROR 123.3 · χ² 6,991 / p <1e-300 | 112.6 EB05 91.0 · IC025 +5.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=60 · ♀ 25% (drug 46%) · 92% clinician | no trial data cached |
| Plasma cell myeloma | 1,186 | 76.2 72.2–80.4ROR 88.2 · χ² 85,426 / p <1e-300 | 73.8 EB05 70.4 · IC025 +6.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 47.7 | no trial data cached |
| Pneumonia respiratory syncytial viral | 16 | 48.1 29.4–78.9ROR 48.2 · χ² 678 / p 7e-150 | 44.9 EB05 29.3 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious n=16 | no trial data cached |
| Plasma cell myeloma recurrent | 41 | 30.9 22.7–42.1ROR 31.1 · χ² 1,143 / p 7e-251 | 30.2 EB05 23.2 · IC025 +4.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=38 | no trial data cached |
| Glioblastoma | 20 | 29.5 19.0–45.8ROR 29.5 · χ² 516 / p 2e-114 | 28.4 EB05 19.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Plasmacytoma | 20 | 26.2 16.9–40.7ROR 26.3 · χ² 455 / p 3e-101 | 25.4 EB05 17.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Sarcoma | 11 | 23.9 13.2–43.2ROR 23.9 · χ² 217 / p 2e-49 | 22.6 EB05 13.1 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Pneumonia pneumococcal | 12 | 19.9 11.3–35.1ROR 19.9 · χ² 195 / p 1e-44 | 18.9 EB05 10.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Taste disorder | 154 | 18.9 16.1–22.1ROR 19.2 · χ² 2,569 / p <1e-300 | 18.7 EB05 16.3 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 14.1 · 89% consumer | no trial data cached |
| Full blood count decreased | 140 | 17.0 14.4–20.1ROR 17.3 · χ² 2,084 / p <1e-300 | 16.9 EB05 14.7 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious PRR 11.2 · 86% consumer | no trial data cached |
| Thrombocytopenia (low platelets) | 756 | 16.6 15.5–17.8ROR 18.1 · χ² 11,070 / p <1e-300 | 16.5 EB05 15.5 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.0 | no trial data cached |
| Platelet count decreased | 687 | 15.8 14.7–17.0ROR 17.1 · χ² 9,503 / p <1e-300 | 15.7 EB05 14.7 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.4 · 74% consumer | no trial data cached |
| Cytopenia | 75 | 15.4 12.3–19.3ROR 15.5 · χ² 988 / p 3e-217 | 15.2 EB05 12.5 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.1 | no trial data cached |
| Hypogeusia | 12 | 15.0 8.5–26.4ROR 15.0 · χ² 142 / p 4e-33 | 13.6 EB05 7.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Diffuse large b-cell lymphoma | 46 | 14.8 11.1–19.7ROR 14.8 · χ² 574 / p 5e-127 | 14.5 EB05 11.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 13.2 · ♀ 16% (drug 46%) | no trial data cached |
| Decreased appetite (loss of appetite) | 1,384 | 14.6 14.0–15.4ROR 17.3 · χ² 17,667 / p <1e-300 | 14.6 EB05 13.9 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.7 · 78% consumer | no trial data cached |
| Rhinovirus infection | 20 | 12.9 8.3–20.0ROR 12.9 · χ² 206 / p 4e-47 | 12.0 EB05 7.8 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious n=19 | no trial data cached |
| Therapy partial responder | 60 | 9.7 7.6–12.5ROR 9.8 · χ² 460 / p 2e-102 | 9.4 EB05 7.5 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 11.9 · 100% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 218 | 9.5 8.3–10.8ROR 9.7 · χ² 1,644 / p <1e-300 | 9.4 EB05 8.3 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 | no trial data cached |
| Hiccups | 31 | 9.3 6.5–13.2ROR 9.3 · χ² 220 / p 4e-50 | 8.6 EB05 6.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=13 · 87% consumer | no trial data cached |
| Ageusia (loss of taste) | 94 | 9.2 7.5–11.2ROR 9.3 · χ² 676 / p 2e-149 | 8.9 EB05 7.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 · 90% consumer | no trial data cached |
| Immune effector cell-associated neurotoxicity syndrome | 21 | 9.1 6.0–14.0ROR 9.2 · χ² 144 / p 2e-33 | 8.1 EB05 5.4 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=11 · 100% clinician | no trial data cached |
| Cytokine release syndrome | 71 | 9.1 7.2–11.5ROR 9.2 · χ² 503 / p 1e-111 | 8.8 EB05 7.1 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 · 99% clinician | no trial data cached |
| Renal function test abnormal | 17 | 9.0 5.6–14.6ROR 9.1 · χ² 113 / p 9e-27 | 7.8 EB05 5.0 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious n=11 | no trial data cached |
| Gastrointestinal toxicity | 16 | 8.3 5.1–13.6ROR 8.3 · χ² 95 / p 8e-23 | 7.1 EB05 4.5 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious n=14 | no trial data cached |
| Brain neoplasm malignant | 15 | 8.1 4.9–13.5ROR 8.2 · χ² 87 / p 6e-21 | 6.8 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=2 | no trial data cached |
| Nausea | 2,622 | 8.1 7.9–8.4ROR 11.2 · χ² 16,950 / p <1e-300 | 8.1 EB05 7.8 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.0 · 77% consumer | no trial data cached |
| Red blood cell count decreased | 95 | 8.1 6.6–9.9ROR 8.2 · χ² 584 / p 3e-129 | 7.9 EB05 6.6 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious PRR 4.1 · 89% consumer | no trial data cached |
| White blood cell count decreased | 325 | 7.3 6.6–8.1ROR 7.6 · χ² 1,770 / p <1e-300 | 7.2 EB05 6.6 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.3 · 73% consumer | no trial data cached |
| Blood sodium decreased | 56 | 7.3 5.6–9.4ROR 7.3 · χ² 296 / p 1e-66 | 6.9 EB05 5.5 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.5 · 80% consumer | no trial data cached |
| Respiratory syncytial virus infection | 25 | 7.1 4.8–10.4ROR 7.1 · χ² 124 / p 5e-29 | 6.3 EB05 4.5 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.2 | no trial data cached |
| Full blood count abnormal | 30 | 6.9 4.9–9.9ROR 7.0 · χ² 147 / p 5e-34 | 6.3 EB05 4.6 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 4.2 · 90% consumer | no trial data cached |
| Blood phosphorus decreased | 10 | 6.7 3.6–12.5ROR 6.7 · χ² 43 / p 3e-11 | 5.3 EB05 3.1 · IC025 +1.3 3/3 methods agree | Lab value / disease marker | serious n=4 | no trial data cached |
| Myelosuppression | 89 | 6.4 5.2–7.9ROR 6.4 · χ² 399 / p 5e-89 | 6.2 EB05 5.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 · 96% clinician | no trial data cached |
| Laboratory test abnormal | 77 | 6.4 5.1–8.0ROR 6.4 · χ² 343 / p 6e-77 | 6.2 EB05 5.1 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 6.6 · 83% consumer | no trial data cached |
| Fatigue (tiredness) | 1,985 | 6.2 6.0–6.5ROR 7.8 · χ² 9,041 / p <1e-300 | 6.2 EB05 6.0 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 · 77% consumer | no trial data cached |
| Photopsia | 16 | 6.2 3.8–10.1ROR 6.2 · χ² 64 / p 5e-16 | 5.3 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Brain fog | 36 | 6.0 4.3–8.3ROR 6.0 · χ² 146 / p 8e-34 | 5.6 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 · 92% consumer | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
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 |
|---|---|---|---|---|---|---|
| Nausea | 2,622 | 8.1 7.9–8.4ROR 11.2 · χ² 16,950 / p <1e-300 | 8.1 EB05 7.8 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.0 · 77% consumer | no trial data cached |
| Fatigue (tiredness) | 1,985 | 6.2 6.0–6.5ROR 7.8 · χ² 9,041 / p <1e-300 | 6.2 EB05 6.0 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 · 77% consumer | no trial data cached |
| Decreased appetite (loss of appetite) | 1,384 | 14.6 14.0–15.4ROR 17.3 · χ² 17,667 / p <1e-300 | 14.6 EB05 13.9 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.7 · 78% consumer | no trial data cached |
| Diarrhoea (diarrhea) | 1,325 | 5.0 4.8–5.3ROR 5.8 · χ² 4,397 / p <1e-300 | 5.0 EB05 4.8 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 · 79% consumer | no trial data cached |
| Plasma cell myeloma | 1,186 | 76.2 72.2–80.4ROR 88.2 · χ² 85,426 / p <1e-300 | 73.8 EB05 70.4 · IC025 +6.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 47.7 | no trial data cached |
| Vomiting | 951 | 5.0 4.7–5.3ROR 5.4 · χ² 3,056 / p <1e-300 | 4.9 EB05 4.7 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 · 75% consumer | no trial data cached |
| Asthenia (weakness) | 863 | 5.6 5.3–6.0ROR 6.1 · χ² 3,310 / p <1e-300 | 5.6 EB05 5.3 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 · 83% consumer | no trial data cached |
| Death | 852 | 2.4 2.3–2.6ROR 2.6 · χ² 732 / p 2e-161 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | Outcome field, not a reaction | serious PRR 2.5 | no trial data cached |
| Thrombocytopenia (low platelets) | 756 | 16.6 15.5–17.8ROR 18.1 · χ² 11,070 / p <1e-300 | 16.5 EB05 15.5 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.0 | no trial data cached |
| Platelet count decreased | 687 | 15.8 14.7–17.0ROR 17.1 · χ² 9,503 / p <1e-300 | 15.7 EB05 14.7 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.4 · 74% consumer | no trial data cached |
| Weight decreased (weight loss) | 648 | 5.7 5.3–6.1ROR 6.0 · χ² 2,515 / p <1e-300 | 5.6 EB05 5.3 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 · 77% consumer | no trial data cached |
| Off label use (used outside approved label) | 534 | 1.5 1.4–1.6ROR 1.5 · χ² 92 / p 4e-22 | 1.5 EB05 1.4 · IC025 +0.4 | Reporting / coding artifact | serious PRR 1.5 | no trial data cached |
| Pneumonia (lung infection) | 472 | 3.6 3.3–3.9ROR 3.7 · χ² 879 / p 1e-193 | 3.5 EB05 3.3 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 | no trial data cached |
| Dizziness | 470 | 2.3 2.1–2.5ROR 2.4 · χ² 353 / p 6e-79 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.6 · 83% consumer | no trial data cached |
| Anaemia (low red blood cells) | 466 | 6.0 5.5–6.5ROR 6.2 · χ² 1,932 / p <1e-300 | 5.9 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 | no trial data cached |
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.
- Glioblastoma — n=20, PRR 29.5
- Plasmacytoma — n=20, PRR 26.2
- Taste disorder — n=154, PRR 18.9
- Diffuse large b-cell lymphoma — n=46, PRR 14.8
- Hiccups — n=31, PRR 9.3
- Ageusia — n=94, PRR 9.2
- Immune effector cell-associated neurotoxicity syndrome — n=21, PRR 9.1
- Cytokine release syndrome — n=71, PRR 9.1
- Myelosuppression — n=89, PRR 6.4
- Brain fog — n=36, PRR 6.0
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 Selinexor?
In FDA FAERS, the most frequently co-reported reaction terms for Selinexor are nausea, fatigue, decreased appetite, diarrhoea, plasma cell myeloma, vomiting. 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 Selinexor have an FDA boxed warning?
No. The FDA label retrieved for Selinexor has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Selinexor 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 f6dd2682-75a6-4863-90a8-a3197f6f78a8, effective 20260512; matched on
openfda.generic_name.exact:"SELINEXOR") - 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, 753 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
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.