OpenClaim

Dinutuximab Side Effects

The most commonly reported side effects of dinutuximab include pyrexia, off label use, and pain, based on 961 FDA adverse event reports from 2015 to 2025.

#1 Reported: PyrexiaAll side effects ↓Top Co-Medication: Irinotecan-hydrochlorideDrug interactions ↓76% of Reports Are ChildDemographics ↓

Dinutuximab side effects

Percentages show how often each reaction appears relative to total reports for dinutuximab.

1
Pyrexia20.4%196
2
Off Label Use20.2%194
3
Pain11.0%106
4
Neuroblastoma Recurrent8.3%80
5
Abdominal Pain7.3%70
6
Diarrhoea6.6%63
7
Hypotension6.2%60
8
Vomiting6.2%60
9
Anaemia6.2%60
10
Aspartate Aminotransferase Increased6.0%58
11
Alanine Aminotransferase Increased5.7%55
12
Product Use In Unapproved Indication5.5%53
13
Hypoalbuminaemia5.4%52
14
Neuroblastoma5.3%51
15
Hypoxia4.9%47

These are voluntary reports and do not establish that dinutuximab caused these reactions.

Report severity

89.4%Serious859 reports
32.2%Hospitalizations309 reports
19.6%Fatal188 reports

Seriousness is determined by the reporter, not by OpenClaim.

Dinutuximab drug interactions

Other drugs that appear in adverse event reports alongside dinutuximab. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Irinotecan-hydrochloride23.8%229
2
Temozolomide22.9%220
3
Cyclophosphamide18.6%179
4
Etoposide16.8%161
5
Topotecan-hydrochloride16.1%155
6
Isotretinoin13.9%134
7
Cisplatin12.1%116
8
Vincristine-sulfate11.3%109
9
Doxorubicin-hydrochloride10.4%100
10
Melphalan9.6%92
11
Sargramostim8.8%85
12
Carboplatin8.1%78
13
Filgrastim7.2%69
14
Busulfan6.8%65
15
Aldesleukin5.7%55

Taken alongside

1
Acetaminophen16.3%157
2
Hydroxyzine10.2%98
3
Apomorphine-hydrochloride9.5%91
4
Irinotecan-hydrochloride8.7%84
5
Gabapentin6.2%60
6
Ondansetron5.9%57
7
Vincristine-sulfate5.7%55
8
Temozolomide5.3%51
9
Cyclophosphamide5.1%49
10
Etoposide5.1%49
11
Cisplatin5.1%49
12
Carboplatin4.8%46
13
Filgrastim4.4%42
14
Topotecan-hydrochloride3.9%37
15
Isotretinoin3.9%37

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports dinutuximab side effects

34.0% of dinutuximab adverse event reports involve female patients and 50.8% involve male patients. The largest age group is child at 76%. These figures reflect who reports side effects, not underlying risk.

Sex

Female34.0%
Male50.8%
Unknown15.2%

Age group

< 26.1%
2–1175.6%
12–177.8%
18–647.5%
65+2.9%

What is dinutuximab used for

Conditions and purposes for which patients were taking dinutuximab when the adverse event was reported.

Adrenal Gland CancerAcute Myeloid LeukaemiaBiotherapyBone Cancer MetastaticBone Marrow Conditioning RegimenBone Marrow DisorderBrain Cancer MetastaticChemotherapyCoughCentral Nervous System MelanomaChemotherapyDisease ProgressionDiffuse Large B-cell LymphomaEwing^s SarcomaEwing^s Sarcoma Metastatic

Showing 15 of 55 indications

Dinutuximab brand names and reporting trend

Dinutuximab is sold under the brand name Unituxin.

Brand names

Unituxin813

Quarterly reports (2015–2025)

2016202020242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking dinutuximab with another medication?

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