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What the label lists and what reports show

Plerixafor side effects

Plerixafor's FDA label: “Most common adverse reactions (≥10%): diarrhea, nausea, fatigue, injection site reactions, headache, arthralgia, dizziness, and vomiting.” FAERS holds 1,464 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 febrile neutropenia (143 reports).

  • Generic listed
  • A presentation discontinued

Check it at the source: the plerixafor FDA label on DailyMed (effective November 19, 2025, Fresenius Kabi Usa, LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Most common adverse reactions (≥10%): diarrhea, nausea, fatigue, injection site reactions, headache, arthralgia, dizziness, and vomiting.

Table 2: Adverse Reactions in ≥5% of Non-Hodgkin's Lymphoma and Multiple Myeloma Patients Receiving Plerixafor and More Frequent than Placebo during HSC Mobilization and Apheresis

ReactionAll Grades Grades based on criteria from the World Health Organization (WHO)Grade 3Grade 4All GradesGrade 3Grade 4
Diarrhea37<101700
Nausea34102200
Vomiting10<10600
Flatulence700300
Injection site reactions34001000
Fatigue27002500
Arthralgia13001200
Headache22<102110
Dizziness1100600
Insomnia700500

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, continued

The following clinically significant adverse reactions are discussed elsewhere in the labeling: Anaphylactic shock and hypersensitivity reactions [see Warnings and Precautions (5.1) ] Potential for tumor cell mobilization in leukemia patients [see Warnings and Precautions (5.2) ] Increased circulating leukocytes and decreased platelet counts [see Warnings and Precautions (5.3) ] Potential for tumor cell mobilization [see Warnings and Precautions (5.4) ] Splenic enlargement [see Warnings and Precautions (5.5) ] Most common adverse reactions (≥10%): diarrhea, nausea, fatigue, injection site reactions, headache, arthralgia, dizziness, and vomiting. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 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. …

Source: FDA drug label, NDA022311 (Genzyme), as published by Fresenius Kabi Usa, LLC, effective November 19, 2025 (SPL set 5d670cb4-163e-498c-b5fa-c193ea9d55c0), via openFDA; the full label on DailyMed

What do FAERS reports show?

1,464 reports list plerixafor among the medicines taken, each a report of something that happened, not proof the medicine caused it; 243 are coded as a death and 471 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 22 reactions below, 7 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

  • Febrile Neutropenia143
  • Off Label Use (a use or a product term, not a reaction)124
  • Diarrhoea (named in the label)99
  • Pyrexia86
  • Mucosal Inflammation83
  • Thrombocytopenia (named in the label)82
  • Nausea (named in the label)81
  • Death (an outcome recorded in the report)60
  • Plasma Cell Myeloma60
  • Pneumonia58
  • Vomiting (named in the label)57
  • Neutropenia55
  • Dyspnoea (named in the label)54
  • Drug Ineffective (a use or a product term, not a reaction)50
  • Infection45
  • Acute Kidney Injury44
  • Anaemia42
  • Therapy Non-Responder41
  • Fatigue (named in the label)40
  • Hypotension (named in the label)36
  • Sepsis36
  • Venoocclusive Liver Disease33
  • Ascites31
  • Pleural Effusion31
  • Pancytopenia30

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Plerixafor: the full record
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Side effects hub
the most reported medicines and reactions