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Unituxin Side Effects

Generic name: dinutuximab

Medically reviewed by Last updated on Jan 10, 2024.

Note: This document contains side effect information about dinutuximab. Some dosage forms listed on this page may not apply to the brand name Unituxin.

Applies to dinutuximab: intravenous solution.


Intravenous route (Solution)

Serious and possibly life-threatening infusion reactions have been reported in 26% of patients receiving treatment with dinutuximab. Administer prehydration and premedication prior to each infusion and monitor patients for signs and symptoms of infusion reactions during treatment and for at least 4 hours after the infusion is completed. If severe infusion reactions occur during treatment, immediately stop the infusion. Permanently discontinue use if anaphylaxis occurs. Dinutuximab causes serious neurologic adverse reactions including severe neuropathic pain in most patients, as well as peripheral neuropathy (eg, peripheral sensory neuropathy, severe motor neuropathy). Not all cases of neuropathy were resolved during clinical trials. Administer IV opioids prior to, during, and for 2 hours after completion of treatment. Discontinue use if severe unresponsive pain, severe sensory neuropathy, or moderate to severe peripheral motor neuropathy occur.

Serious side effects of Unituxin

Along with its needed effects, dinutuximab (the active ingredient contained in Unituxin) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking dinutuximab:

More common

Less common

Incidence not known

Other side effects of Unituxin

Some side effects of dinutuximab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

For Healthcare Professionals

Applies to dinutuximab: intravenous solution.


Very common (10% or more): Hypotension (60%), capillary leak syndrome (40%), hemorrhage (17%) (including gastrointestinal hemorrhage, hematochezia, rectal hemorrhage, hematemesis, upper GI hemorrhage, hematuria, hemorrhage urinary tract, renal hemorrhage, epistaxis, respiratory tract hemorrhage, disseminated intravascular coagulation, catheter site hemorrhage, hematoma), hypertension (14%), tachycardia (19%) (e.g., tachycardia, sinus tachycardia)[Ref]


Very common (10% or more): Urticaria (37%)[Ref]


Very common (10% or more): Pain (85%) (e.g., gingival pain, proctalgia, oropharyngeal pain, abdominal pain, abdominal pain upper), vomiting (46%), diarrhea (43%), nausea (10%)[Ref]


Very common (10% or more): Pain (85%) (e.g., bladder pain), proteinuria (16%)[Ref]


Very common (10% or more): Thrombocytopenia (66%), lymphopenia (62%), anemia (51%), neutropenia (39%)[Ref]


Very common (10% or more): Increased alanine aminotransferase (56%), increased aspartate aminotransferase (28%)[Ref]


Very common (10% or more): Infusion reactions (66%)[Ref]


Very common (10% or more): Patients developing anti-drug antibodies to dinutuximab (the active ingredient contained in Unituxin) (18%), sepsis (18%), device related infection (16%)[Ref]


Very common (10% or more): Infusion related pain (85%)[Ref]


Very common (10% or more): Hyponatremia (58%), hypokalemia (43%), hypoalbuminemia (33%), hypocalcemia (27%), hypophosphatemia (20%), hyperglycemia (16%), hypertriglyceridemia (16%), decreased appetite (up to 15%), hypomagnesemia (12%), increased weight (10%)[Ref]


Very common (10% or more): Pain (85%) (e.g., arthralgia, back pain, bone pain, chest pain, facial pain, musculoskeletal chest pain, myalgia, nick pain, pain in extremity)[Ref]

Nervous system

Very common (10% or more): Peripheral neuropathy (13%)[Ref]


Frequency not reported: Blurred vision, photophobia, mydriasis, fixed or unequal pupils, optic nerve disorder, eyelid ptosis, papilledema, loss of vision[Ref]


Very common (10% or more): Pain (85%) (e.g., abdominal pain, abdominal pain upper, arthralgia, back pain, bladder pain, bone pain, chest pain, facial pain, gingival pain, musculoskeletal chest pain, myalgia, neck pain, neuralgia, oropharyngeal pain, pain in extremity, proctalgia), pyrexia (72%), edema (17%)[Ref]


Very common (10% or more): Increased serum creatinine (15%)[Ref]


Very common (10% or more): Hypoxia (24%)[Ref]


The most common adverse drug reactions (25% or more) 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.


1. (2015) "Product Information. Unituxin (dinutuximab)." United Therapeutics Corporation

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.