Sargramostim Side Effects

Some side effects of sargramostim may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to sargramostim: injectable powder for injection, injectable solution

Some people receiving a sargramostim injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, short of breath, or have a fast heartbeat, chest tightness, or trouble breathing during the injection.

Get emergency medical help if you have any of these signs of an allergic reaction while taking sargramostim: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• high fever, chills, sore throat, stuffy nose, flu symptoms;

• white patches or sores inside your mouth or on your lips;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• swelling, rapid weight gain;

• chest pain, fast or uneven heart rate;

• weakness or fainting;

• black, bloody, or tarry stools;

• coughing up blood or vomit that looks like coffee grounds;

• painful or difficult urination;

• dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• breathing problems; or

• problems with vision, speech, balance, or memory.

Less serious side effects of sargramostim may include:

• nausea, stomach pain, vomiting, diarrhea, loss of appetite;

• tired feeling;

• hair loss;

• weight loss;

• headache;

• mild skin rash or itching;

• bone pain;

• joint or muscle pain; or

• redness, swelling, or irritation where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to sargramostim: injectable powder for injection, injectable solution

Musculoskeletal

Bone pain associated with sargramostim generally has been localized to the sternum, hips, and lower back. The incidence of bone pain increased with higher dosages and usually occurred just prior an increase in white blood cell (WBC) count. Analgesics are helpful, however, the pain may resolve with continued therapy. Bone pain resolves within a few hours of discontinuation of therapy.

Musculoskeletal side effects including bone pain (21%) have been reported.

Other

Many patients receiving sargramostim have serious underlying conditions and are on concurrent medications associated with high toxicity. It is sometimes difficult to discern true drug toxicity from disease activity. Many adverse effects of sargramostim are dose-related and alleviated by a dosage reduction.

Other side effects have included a "flu-like" syndrome that has included symptoms of headache, low-grade fever, myalgias, arthralgias, and malaise. Fever has occurred in up to 22% of patients and should be evaluated to determine whether it is related to sargramostim or an infection requiring antibiotic therapy.

Gastrointestinal

Gastrointestinal side effects of nausea, vomiting, and diarrhea frequently have been reported and were often part of a "flu-like" syndrome associated with sargramostim therapy.

Hematologic

Hematologic side effects have included reversible eosinophilia, thrombocytopenia, and anemia. An increased incidence of clot formation has been reported in patients treated with GM-CSF. Splenomegaly has also been reported and rupture has resulted in at least one death.

In one study of patients undergoing peripheral stem cell collection for bone marrow transplantation, 54% experienced catheter thrombosis when treated with GM-CSF compared to 3% of patients who were not treated.

Dermatologic

Dermatologic side effects have occurred frequently and included local bruising and erythema at the injection site and a generalized, pruritic, maculopapular rash. Rarely, immune-mediated dermatologic reactions have been reported. Exacerbation of psoriasis may occur.

Metabolic

Metabolic side effects have included edema, ascites, hypoalbuminemia, fluid retention resulting in pericardial/pleural effusions, and capillary-leak syndrome. The risk of occurrence is greater at higher dosages.

Immunologic

Immunologic side effects have included exacerbation of autoimmune diseases such as psoriasis, rheumatoid arthritis, thyroiditis, and vasculitis. Patients with autoimmune disease may be at risk for sargramostim-associated adverse effects.

Respiratory

Respiratory side effects of sargramostim have included pleural effusions and pleuritis. A "first-dose" reaction with symptoms of dyspnea, hypoxia, and hypotension has also been reported. It has not occurred with subsequent doses. The reaction appears to occur more frequently with an E. coli-derived GM-CSF, at higher dosages given by short term infusion, and in the presence of preexisting lung disease.

Endocrine

Endocrine side effects have been reported occasionally including exacerbation of hypothyroidism. An autoimmune response has been suggested due to the presence of thyroid peroxidase antibodies.

Cardiovascular

Cardiovascular side effects have been limited to occasional reports of reversible, transient supraventricular arrhythmias.

Renal

Renal side effects including increased plasma creatinine concentrations have occurred in patients with existing renal dysfunction.

Hepatic

Hepatic side effects including elevated plasma bilirubin and liver enzyme concentrations have been reported in patients with existing liver dysfunction.

Hypersensitivity

Hypersensitivity side effects including anaphylaxis have occurred.

Oncologic

Oncologic side effects, primarily myeloid malignancies, may result due to the action of sargramostim as a growth factor for tumors with myeloid characteristics.

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