OpenClaim

Datopotamab Side Effects

The most commonly reported side effects of datopotamab include disease progression, off label use, and stomatitis, based on 322 FDA adverse event reports from 2022 to 2025.

#1 Reported: Disease ProgressionAll side effects ↓Top Co-Medication: DurvalumabDrug interactions ↓58% of Reports Are AdultDemographics ↓

Datopotamab side effects

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

1
Disease Progression22.0%71
2
Off Label Use14.9%48
3
Stomatitis14.6%47
4
No Adverse Event10.6%34
5
Death7.5%24
6
Nausea5.3%17
7
Interstitial Lung Disease3.4%11
8
Infusion Related Reaction3.1%10
9
Dyspnoea3.1%10
10
Prescribed Underdose2.8%9
11
Mucosal Inflammation2.5%8
12
Pyrexia2.5%8
13
Dry Eye2.5%8
14
Pneumonitis2.5%8
15
Fatigue2.2%7

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

Report severity

59.9%Serious193 reports
21.7%Hospitalizations70 reports
26.4%Fatal85 reports

Seriousness is determined by the reporter, not by OpenClaim.

Datopotamab drug interactions

Other drugs that appear in adverse event reports alongside datopotamab. 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
Durvalumab3.4%11
2
Carboplatin2.8%9
3
Pembrolizumab2.5%8
4
Osimertinib-mesylate2.5%8
5
Paclitaxel1.9%6
6
Cyclophosphamide1.6%5
7
Trastuzumab1.2%4
8
Doxorubicin-hydrochloride0.9%3
9
Olaparib0.9%3
10
Epirubicin-hydrochloride0.6%2
11
Bevacizumab0.6%2
12
Selpercatinib0.6%2
13
Ketoprofen0.3%1
14
Omeprazole0.3%1
15
Netupitant0.3%1

Taken alongside

1
Dexamethasone4.3%14
2
Palonosetron-hydrochloride2.8%9
3
Acetaminophen2.5%8
4
Diphenhydramine1.6%5
5
Dexchlorpheniramine-maleate1.6%5
6
Aspirin1.2%4
7
Ondansetron1.2%4
8
Tamsulosin-hydrochloride1.2%4
9
Pantoprazole-sodium1.2%4
10
Netupitant1.2%4
11
Amlodipine0.9%3
12
Rosuvastatin0.9%3
13
Prochlorperazine0.9%3
14
Vonoprazan-fumarate0.9%3
15
Rivaroxaban0.9%3

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 datopotamab side effects

76.1% of datopotamab adverse event reports involve female patients and 17.7% involve male patients. The largest age group is adult at 58%. These figures reflect who reports side effects, not underlying risk.

Sex

Female76.1%
Male17.7%
Unknown6.2%

Age group

< 20.0%
2–110.0%
12–170.0%
18–6458.5%
65+41.5%

What is datopotamab used for

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

Breast CancerBreast Cancer MaleBreast Cancer MetastaticBreast Cancer RecurrentChemotherapyDisease ProgressionEgfr Gene MutationEndometrial CancerHer2 Low Breast CancerHer2 Negative Breast CancerHer2 Positive Breast CancerHepatitisHormone Receptor Positive Her2 Negative Breast CancerHormone Receptor Positive Breast CancerInfusion

Showing 15 of 31 indications

Datopotamab brand names and reporting trend

Datopotamab is sold under the brand name Datroway.

Brand names

Datroway111

Quarterly reports (2022–2025)

202220242025

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

Taking datopotamab with another medication?

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