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What the label lists and what reports show

Dinutuximab side effects

Dinutuximab's FDA label: “The most common adverse drug reactions (≥25%) are pain, pyrexia, thrombocytopenia, lymphopenia, infusion reactions, hypotension, hyponatremia, increased alanine aminotransferase, anemia, vomiting, diarrhea, hypokalemia, capillary leak syndrome, neutropenia …” FAERS holds 832 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 pyrexia (169 reports).

  • No generic listed
  • Boxed warning

Check it at the source: the dinutuximab FDA label on DailyMed (effective July 6, 2026, United Therapeutics Corporation); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The most common adverse drug reactions (≥25%) are pain, pyrexia, thrombocytopenia, lymphopenia, infusion reactions, hypotension, hyponatremia, increased alanine aminotransferase, anemia, vomiting, diarrhea, hypokalemia, capillary leak syndrome, neutropenia, urticaria, hypoalbuminemia, increased aspartate aminotransferase, and hypocalcemia.

Table 5: Selected Adverse Reactions Occurring in at Least 10% of Patients in the Unituxin/RA Group in Study 1

ReactionAll Grades (%)Grades 3 to 4 (%)All Grades (%)Grades 3 to 4 (%)
Pain Includes preferred terms abdominal pain, abdominal pain upper, arthralgia, back…8551166
Pyrexia7240276
Edema17000
Thrombocytopenia66394325
Lymphopenia62513620
Anemia51342216
Neutropenia39341613
Infusion reactions602591
Hypotension601630
Capillary leak syndrome One Grade 5 adverse reaction.402310
Hemorrhage Includes preferred terms gastrointestinal hemorrhage, hematochezia, rectal…17663
Hypertension14271
Hyponatremia5823124
Hypokalemia433742
Hypoalbuminemia33730
Hypocalcemia27700
Hypophosphatemia20830
Hyperglycemia18641
Hypertriglyceridemia161111
Decreased appetite151054
Hypomagnesemia12210
Increased alanine aminotransferase5623313
Increased aspartate aminotransferase281070
Increased serum creatinine15260
Increased weight10000

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 adverse reactions are discussed in greater detail in other sections of the labeling: Serious Infusion Reactions [see Boxed Warning and Warnings and Precautions (5.1) ] Neurotoxicity, including Pain, Peripheral Neuropathy, Neurological Disorders of the Eye, Prolonged Urinary Retention, Transverse Myelitis, and Reversible Posterior Leukoencephalopathy Syndrome [see Boxed Warning and Warnings and Precautions (5.2) ] Capillary Leak Syndrome [see Warnings and Precautions (5.3) ] Hypotension [see Warnings and Precautions (5.4) ] Infection [see Warnings and Precautions (5.5) ] Bone Marrow Suppression [see Warnings and Precautions (5.6) ] Electrolyte Abnormalities [see Warnings and Precautions (5.7) ] Atypical Hemolytic Uremic Syndrome [see Warnings and Precautions (5.8) ] Embryo-Fetal Toxicity [see Warnings and Precautions (5.9) ] The most common adverse drug reactions (≥25%) are pain, pyrexia, thrombocytopenia, lymphopenia, infusion reactions, hypotension, hyponatremia, increased alanine aminotransferase, anemia, vomiting, diarrhea, hypokalemia, capillary leak syndrome, neutropenia, urticaria, hypoalbuminemia, increased aspartate aminotransferase, and hypocalcemia. ( 5 , 6.1 ) The most common serious adverse reactions (≥5%) are infections, infusion reactions, hypokalemia, hypotension, pain, fever, and capillary leak syndrome.

Source: FDA drug label, United Therapeutics Corporation, effective July 6, 2026 (SPL set d66bdf0d-9d65-45de-ae5b-a58617c27492), via openFDA; the full label on DailyMed

What do FAERS reports show?

832 reports list dinutuximab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 168 are coded as a death and 283 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, 14 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

  • Pyrexia (named in the label)169
  • Off Label Use (a use or a product term, not a reaction)115
  • Pain87
  • Neuroblastoma Recurrent86
  • Abdominal Pain (named in the label)78
  • Aspartate Aminotransferase Increased (named in the label)63
  • Vomiting (named in the label)62
  • Alanine Aminotransferase Increased (named in the label)61
  • Hypotension (named in the label)58
  • Neuroblastoma (a use or a product term, not a reaction)58
  • Anaemia (named in the label)56
  • Hypoalbuminaemia (named in the label)54
  • Diarrhoea (named in the label)50
  • Pain In Extremity (named in the label)50
  • Hypoxia (named in the label)48
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)46
  • Platelet Count Decreased43
  • Nausea (named in the label)41
  • Thrombocytopenia (named in the label)37
  • Gamma-Glutamyltransferase Increased36
  • Cough35
  • Capillary Leak Syndrome (named in the label)33
  • Malaise33
  • Pancytopenia33
  • Constipation32

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

What next?

Dinutuximab: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions