What the label lists and what reports show

Sargramostim side effects

Sargramostim's FDA label: “The most common adverse reactions (incidence >30%) were ( 6.1 ): In recipients of autologous BMT: fever, nausea, diarrhea, vomiting, mucous membrane disorder, alopecia, asthenia, malaise, anorexia, rash, gastrointestinal disorder and edema.” FAERS holds 1,703 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pyrexia (157 reports).

No generic listed

Check it at the source: the sargramostim FDA label on DailyMed (effective December 6, 2024, Partner Therapeutics, Inc.); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of LEUKINE?
LEUKINE may cause serious side effects, including: Serious allergic reactions. LEUKINE can cause serious allergic reactions that can be severe. Get medical help right away if you get any of the following signs or symptoms of a serious allergic reaction with LEUKINE, including: skin rash over your entire body, hives, trouble breathing, wheezing, swelling around your mouth or eyes, a fast heartbeat, sweating, and dizziness or feeling faint. Infusion related reactions. When LEUKINE is given as an infusion, it can cause reactions during or soon after an infusion. Tell your healthcare provider or nurse right away if you develop trouble breathing, skin flushing, a fast pulse, dizziness or you feel faint during or soon after your infusion. Too much body fluid (fluid retention) and Capillary Leak Syndrome. […]

Source: FDA drug label, BLA103362 (Berlex Labs), as published by Partner Therapeutics, Inc., effective December 6, 2024 (SPL set bb9a3820-f31a-4dd9-bef4-97094c01a398), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions
The most common adverse reactions (incidence >30%) were ( 6.1 ): In recipients of autologous BMT: fever, nausea, diarrhea, vomiting, mucous membrane disorder, alopecia, asthenia, malaise, anorexia, rash, gastrointestinal disorder and edema.

Table 1: Adverse Reactions after Autologous Marrow or PBPC Transplantation in at Least 10% of Patients Receiving Intravenous LEUKINE or at Least 5% Higher than the Placebo Arm

Adverse Reactions by Body System	LEUKINE (n=79) %	Placebo (n=77) %	Adverse Reactions by Body System	LEUKINE (n=79) %	Placebo (n=77) %
Fever	95	96	Edema	34	35
Mucous membrane disorder	75	78	Peripheral edema	11	7
Malaise	57	51	Dyspnea	28	31
Sepsis	11	14	Lung disorder	20	23
Nausea	90	96	Blood dyscrasia	25	27
Vomiting	85	90	Hemorrhage	23	30
GI disorder	37	47	Urinary tract disorder	14	13
Stomatitis	24	29	CNS disorder	11	16

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

From the label: adverse reactions, continued
The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Infusion Related Reactions [see Warnings and Precautions ( 5.2 )] Risk of Severe Myelosuppression when LEUKINE Administered within 24 Hours of Chemotherapy or Radiotherapy [see Warnings and Precautions ( 5.3 )] Effusions and Capillary Leak Syndrome [see Warnings and Precautions ( 5.4 )] Supraventricular Arrhythmias [see Warnings and Precautions ( 5.5 )] Leukocytosis [see Warnings and Precautions ( 5.6 )] Potential Effect on Malignant Cells [see Warnings and Precautions ( 5.7 )] Immunogenicity [see Warnings and Precautions ( 5.8 )] Risk of Serious Adverse Reactions in Infants Due to Benzyl Alcohol Preservative [see Warnings and Precautions ( 5.9 )] The most common adverse reactions (incidence >30%) were ( 6.1 ): In recipients of autologous BMT: fever, nausea, diarrhea, vomiting, mucous membrane disorder, alopecia, asthenia, malaise, anorexia, rash, gastrointestinal disorder and edema. In recipients of allogeneic BMT: diarrhea, fever, nausea, rash, vomiting, stomatitis, anorexia, high glucose, alopecia, abdominal pain, low albumin, headache and hypertension. …

What do FAERS reports show?

1,703 reports list sargramostim among the medicines taken, each a report of something that happened, not proof the medicine caused it; 250 are coded as a death and 568 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 23 reactions below, 15 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

Pyrexia157
Off Label Use (a use or a product term, not a reaction)143
Nausea (named in the label)123
Pain113
Hypotension (named in the label)112
Dyspnoea (named in the label)111
Fatigue94
Diarrhoea (named in the label)87
Death (an outcome recorded in the report)84
Vomiting (named in the label)84
Dizziness (named in the label)63
Chills (named in the label)57
Dehydration55
Syncope (named in the label)55
Headache (named in the label)50
Rash (named in the label)50
Abdominal Pain (named in the label)48
Decreased Appetite (named in the label)47
Febrile Neutropenia45
Neutropenia44
Thrombocytopenia (named in the label)43
Anaemia (named in the label)42
Cough42
Back Pain41
Chest Pain (named in the label)41

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Sargramostim: the full record: label, generics, price, shortages, recalls
Report a side effect to the FDA: MedWatch
Side effects hub: the most reported medicines and reactions