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Axatilimab Side Effects

The most commonly reported side effects of axatilimab include off label use, anxiety, and abdominal pain, based on 131 FDA adverse event reports from 2022 to 2025. 5.3% of reports found the drug to be ineffective.

Axatilimab side effects

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

1
Off Label Use23.7%31
2
Anxiety7.6%10
3
Abdominal Pain7.6%10
4
Cough7.6%10
5
Dyspnoea6.9%9
6
Nausea6.9%9
7
Death6.9%9
8
Pneumonia6.9%9
9
Diarrhoea6.1%8
10
Immunodeficiency6.1%8
11
Drug Ineffective5.3%7
12
Chronic Graft Versus Host Disease4.6%6
13
Immunosuppression4.6%6
14
Pneumonia Fungal4.6%6
15
Hypoxia4.6%6

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

Report severity

54.2%Serious71 reports
26.7%Hospitalizations35 reports
13.0%Fatal17 reports

Seriousness is determined by the reporter, not by OpenClaim.

Axatilimab drug interactions

Other drugs that appear in adverse event reports alongside axatilimab. 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
Ruxolitinib35.9%47
2
Belumosudil-mesylate14.5%19
3
Voriconazole3.1%4
4
Posaconazole3.1%4
5
Mycophenolate3.1%4
6
Ibrutinib3.1%4
7
Bleomycin-sulfate2.3%3
8
Dacarbazine2.3%3
9
Doxorubicin-hydrochloride2.3%3
10
Vinblastine-sulfate2.3%3
11
Methylprednisolone1.5%2
12
Cyclosporine1.5%2
13
Fingolimod1.5%2
14
Prednisone1.5%2
15
Infliximab0.8%1

Taken alongside

1
Prednisone20.6%27
2
Acyclovir19.8%26
3
Belumosudil-mesylate18.3%24
4
Trimethoprim13.7%18
5
Tacrolimus13.0%17
6
Sulfamethoxazole13.0%17
7
Pantoprazole-sodium12.2%16
8
Ergocalciferol11.5%15
9
Budesonide10.7%14
10
Albuterol9.9%13
11
Tamsulosin-hydrochloride8.4%11
12
Gabapentin8.4%11
13
Lidocaine8.4%11
14
Montelukast-sodium8.4%11
15
Acetaminophen8.4%11

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 axatilimab side effects

9.2% of axatilimab adverse event reports involve female patients and 10.7% involve male patients. The largest age group is adult at 61%. These figures reflect who reports side effects, not underlying risk.

Sex

Female9.2%
Male10.7%
Unknown80.2%

Age group

< 20.0%
2–1112.9%
12–171.6%
18–6461.3%
65+24.2%

What is axatilimab used for

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

Acute Graft Versus Host DiseaseChronic Graft Versus Host DiseaseChronic Graft Versus Host Disease In EyeChronic Graft Versus Host Disease In LiverChronic Graft Versus Host Disease In LungChronic Graft Versus Host Disease In SkinChronic Graft Versus Host Disease OralEncephalitisGraft Versus Host DiseaseGraft Versus Host Disease In EyeGraft Versus Host Disease In Gastrointestinal TractGraft Versus Host Disease In LiverGraft Versus Host Disease In LungGraft Versus Host Disease In SkinGraft Versus Host Disease Oral

Showing 15 of 18 indications

Axatilimab brand names and reporting trend

Axatilimab is sold under the brand name Niktimvo.

Brand names

Niktimvo82

Quarterly reports (20222025)

202220242025

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

Taking axatilimab with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.