Plerixafor side effects: what 1,464 FDA adverse event reports show

Plerixafor · 39 reaction terms · 899 drug–reaction co-reports · data 2026-09-14

Drug class

Hematopoietic Stem Cell Mobilizer

FDA label (Established Pharmacologic Class)

Who reports

1,464 reports · 79% serious · 243 with death outcome · 48% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Plerixafor injection is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM).

FDA label, Indications and Usage

What it is

Plerixafor injection is a sterile, preservative-free, clear, colorless to pale-yellow solution free from extraneous matter, isotonic solution for subcutaneous injection.

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 24 strongest signals

Labeled adverse reaction 4Labeled (related wording) 1Likely indication confounding 1Reporting / coding artifact 2Not 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.
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. 15 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Mucosal inflammation	83	45.8 37.1–56.4ROR 48.4 · χ² 3,582 / p <1e-300	45.2 EB05 37.6 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 35.4 · ♀ 21% (drug 48%)	no trial data cached
Febrile neutropenia	143	31.0 26.5–36.2ROR 34.2 · χ² 4,125 / p <1e-300	30.8 EB05 26.8 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 22.6	no trial data cached
Thrombotic microangiopathy	15	22.2 13.4–36.8ROR 22.4 · χ² 283 / p 1e-63	21.5 EB05 13.7 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 16.2	no trial data cached
Plasma cell myeloma	60	22.0 17.2–28.2ROR 22.9 · χ² 1,183 / p 2e-259	21.8 EB05 17.6 · IC025 +3.8 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 16.7 · 97% clinician	no trial data cached
Cytopenia	18	21.6 13.6–34.2ROR 21.9 · χ² 333 / p 1e-74	21.1 EB05 14.0 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 16.3	no trial data cached
Acute respiratory distress syndrome	25	20.3 13.7–29.9ROR 20.6 · χ² 439 / p 1e-97	19.9 EB05 14.1 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 14.8 · ♀ 83% (drug 48%)	no trial data cached
Acute myeloid leukaemia	21	19.3 12.6–29.6ROR 19.6 · χ² 347 / p 1e-77	18.9 EB05 12.9 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 14.2	no trial data cached
Cytomegalovirus infection	20	17.2 11.2–26.6ROR 17.5 · χ² 290 / p 3e-65	16.8 EB05 11.2 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 12.7	no trial data cached
Clostridium difficile colitis	12	16.2 9.2–28.5ROR 16.3 · χ² 156 / p 4e-36	15.1 EB05 8.3 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 12.0	no trial data cached
Ascites	31	15.1 10.7–21.4ROR 15.4 · χ² 395 / p 4e-88	14.8 EB05 10.7 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 11.2 · 97% clinician	no trial data cached
Therapy partial responder	14	13.3 7.9–22.4ROR 13.4 · χ² 147 / p 3e-34	12.1 EB05 6.9 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 11.8	no trial data cached
Therapy non-responder	41	13.2 9.7–17.8ROR 13.5 · χ² 450 / p 3e-100	12.9 EB05 9.7 · IC025 +3.0 3/3 methods agree	Reporting / coding artifact	serious PRR 3.4 · 100% clinician	no trial data cached
Myelodysplastic syndrome	13	12.9 7.5–22.1ROR 13.0 · χ² 131 / p 1e-30	11.5 EB05 6.4 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 9.5	no trial data cached
Pericardial effusion	19	11.8 7.6–18.5ROR 12.0 · χ² 178 / p 7e-41	10.9 EB05 6.9 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 8.7	no trial data cached
Leukocytosis	14	11.1 6.6–18.7ROR 11.2 · χ² 119 / p 6e-28	9.6 EB05 5.6 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.3	no trial data cached
Thrombocytopenia (low platelets)	82	10.5 8.5–13.0ROR 11.1 · χ² 702 / p 6e-155	10.3 EB05 8.5 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.9 · 96% clinician	no trial data cached
Hypomagnesaemia	10	10.3 5.6–19.2ROR 10.4 · χ² 75 / p 2e-18	8.2 EB05 4.4 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 7.8	no trial data cached
Colitis	22	8.4 5.5–12.7ROR 8.5 · χ² 136 / p 1e-31	7.4 EB05 5.1 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 6.6 · 91% clinician	no trial data cached
Fungal infection	19	8.2 5.2–12.8ROR 8.3 · χ² 113 / p 1e-26	7.1 EB05 4.7 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 10.9	no trial data cached
Pancytopenia (all blood cells low)	30	7.7 5.4–11.0ROR 7.9 · χ² 169 / p 6e-39	7.1 EB05 5.1 · IC025 +2.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.7 · ♀ 17% (drug 48%)	no trial data cached
Bone marrow failure	10	7.0 3.8–13.0ROR 7.0 · χ² 46 / p 7e-12	5.5 EB05 3.2 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 5.1	no trial data cached
Bone pain	28	6.8 4.7–9.9ROR 7.0 · χ² 134 / p 2e-31	6.2 EB05 4.5 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 8.2 · 100% clinician	no trial data cached
Neutropenia (low neutrophils (infection-fighting cells))	55	5.8 4.5–7.5ROR 6.0 · χ² 216 / p 4e-49	5.6 EB05 4.4 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 4.3 · 96% clinician	no trial data cached
Anaphylactic shock	10	5.6 3.0–10.4ROR 5.6 · χ² 33 / p 4e-9	4.5 EB05 2.7 · IC025 +1.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.1	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
Febrile neutropenia	143	31.0 26.5–36.2ROR 34.2 · χ² 4,125 / p <1e-300	30.8 EB05 26.8 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 22.6	no trial data cached
Mucosal inflammation	83	45.8 37.1–56.4ROR 48.4 · χ² 3,582 / p <1e-300	45.2 EB05 37.6 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 35.4 · ♀ 21% (drug 48%)	no trial data cached
Thrombocytopenia (low platelets)	82	10.5 8.5–13.0ROR 11.1 · χ² 702 / p 6e-155	10.3 EB05 8.5 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.9 · 96% clinician	no trial data cached
Plasma cell myeloma	60	22.0 17.2–28.2ROR 22.9 · χ² 1,183 / p 2e-259	21.8 EB05 17.6 · IC025 +3.8 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 16.7 · 97% clinician	no trial data cached
Neutropenia (low neutrophils (infection-fighting cells))	55	5.8 4.5–7.5ROR 6.0 · χ² 216 / p 4e-49	5.6 EB05 4.4 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 4.3 · 96% clinician	no trial data cached
Therapy non-responder	41	13.2 9.7–17.8ROR 13.5 · χ² 450 / p 3e-100	12.9 EB05 9.7 · IC025 +3.0 3/3 methods agree	Reporting / coding artifact	serious PRR 3.4 · 100% clinician	no trial data cached
Ascites	31	15.1 10.7–21.4ROR 15.4 · χ² 395 / p 4e-88	14.8 EB05 10.7 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 11.2 · 97% clinician	no trial data cached
Pancytopenia (all blood cells low)	30	7.7 5.4–11.0ROR 7.9 · χ² 169 / p 6e-39	7.1 EB05 5.1 · IC025 +2.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.7 · ♀ 17% (drug 48%)	no trial data cached
Bone pain	28	6.8 4.7–9.9ROR 7.0 · χ² 134 / p 2e-31	6.2 EB05 4.5 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 8.2 · 100% clinician	no trial data cached
Acute respiratory distress syndrome	25	20.3 13.7–29.9ROR 20.6 · χ² 439 / p 1e-97	19.9 EB05 14.1 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 14.8 · ♀ 83% (drug 48%)	no trial data cached
Colitis	22	8.4 5.5–12.7ROR 8.5 · χ² 136 / p 1e-31	7.4 EB05 5.1 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 6.6 · 91% clinician	no trial data cached
Acute myeloid leukaemia	21	19.3 12.6–29.6ROR 19.6 · χ² 347 / p 1e-77	18.9 EB05 12.9 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 14.2	no trial data cached
Cytomegalovirus infection	20	17.2 11.2–26.6ROR 17.5 · χ² 290 / p 3e-65	16.8 EB05 11.2 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 12.7	no trial data cached
Fungal infection	19	8.2 5.2–12.8ROR 8.3 · χ² 113 / p 1e-26	7.1 EB05 4.7 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 10.9	no trial data cached
Pericardial effusion	19	11.8 7.6–18.5ROR 12.0 · χ² 178 / p 7e-41	10.9 EB05 6.9 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 8.7	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.

Mucosal inflammation — n=83, PRR 45.8
Febrile neutropenia — n=143, PRR 31.0
Acute respiratory distress syndrome — n=25, PRR 20.3
Acute myeloid leukaemia — n=21, PRR 19.3
Cytomegalovirus infection — n=20, PRR 17.2
Ascites — n=31, PRR 15.1
Colitis — n=22, PRR 8.4
Bone pain — n=28, PRR 6.8
Neutropenia — n=55, PRR 5.8

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 Plerixafor?

In FDA FAERS, the most frequently co-reported reaction terms for Plerixafor are febrile neutropenia, mucosal inflammation, thrombocytopenia, plasma cell myeloma, neutropenia, ascites. 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 Plerixafor have an FDA boxed warning?

No. The FDA label retrieved for Plerixafor has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Plerixafor 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 58c9fa02-3701-d411-f946-790a62ddc064, effective 20240227; matched on openfda.generic_name.exact:"PLERIXAFOR")
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, field patient.drug.openfda.generic_name.exact, 39 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.