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Sargramostim Side Effects

The most commonly reported side effects of sargramostim include off label use, pyrexia, and pain, based on 1,696 FDA adverse event reports from 2004 to 2025.

Sargramostim side effects

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

1
Off Label Use8.1%138
2
Pyrexia6.1%103
3
Pain5.3%90
4
Dyspnoea4.8%82
5
Nausea4.4%75
6
Death4.2%72
7
Hypotension3.6%61
8
Fatigue3.5%59
9
Vomiting3.3%56
10
Pyrexia3.2%54
11
Hypotension3.1%52
12
Syncope2.8%48
13
Diarrhoea2.8%47
14
Dizziness2.7%46
15
Nausea2.7%45

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

Report severity

73.1%Serious1,240 reports
33.1%Hospitalizations561 reports
14.3%Fatal242 reports

Seriousness is determined by the reporter, not by OpenClaim.

Sargramostim drug interactions

Other drugs that appear in adverse event reports alongside sargramostim. 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
Dinutuximab5.7%97
2
Ipilimumab5.4%92
3
Gemcitabine5.0%85
4
Capecitabine4.8%81
5
Cyclophosphamide4.6%78
6
Isotretinoin3.8%64
7
Doxorubicin-hydrochloride3.5%60
8
Rituximab3.5%60
9
Vincristine-sulfate3.0%51
10
Lenalidomide2.8%47
11
Aldesleukin2.5%42
12
Naxitamab-gqgk2.5%42
13
Etoposide2.1%36
14
Prednisone2.1%36
15
Thalidomide2.0%34

Taken alongside

1
Acetaminophen14.0%237
2
Ondansetron7.5%127
3
Diphenhydramine6.7%114
4
Dexamethasone6.2%105
5
Oxycodone5.2%88
6
Aspirin5.0%85
7
Omeprazole4.8%82
8
Gabapentin4.5%77
9
Lorazepam4.2%72
10
Ergocalciferol4.2%72
11
Filgrastim4.0%68
12
Acyclovir4.0%67
13
Cyclophosphamide3.8%65
14
Sulfamethoxazole3.8%64
15
Prednisone3.8%64

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 sargramostim side effects

36.6% of sargramostim adverse event reports involve female patients and 48.9% involve male patients. The largest age group is adult at 46%. These figures reflect who reports side effects, not underlying risk.

Sex

Female36.6%
Male48.9%
Unknown14.5%

Age group

< 22.4%
2–1117.1%
12–173.9%
18–6446.0%
65+30.6%

What is sargramostim used for

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

Acute Myeloid LeukaemiaAdjuvant TherapyAdrenal Gland CancerAdverse Drug ReactionAgranulocytosisAlveolar ProteinosisAnaemiaAnal CancerAnaplastic Large Cell Lymphoma T- And Null-cell TypesAplastic AnaemiaAutoimmune DisorderAbscess DrainageAcute Myeloid LeukaemiaAdrenal Gland CancerAgranulocytosis

Showing 15 of 208 indications

Sargramostim brand names and reporting trend

Sargramostim is sold under the brand name Leukine.

Brand names

Leukine639

Quarterly reports (20042025)

20052010201520202025

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

Taking sargramostim with another medication?

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