Sargramostim Side Effects

It is possible that some side effects of sargramostim may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to sargramostim: intravenous powder for solution, intravenous solution

As well as its needed effects, sargramostim may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking sargramostim, check with your doctor immediately:

More common
  • Abdominal pain
  • black, tarry stools
  • bloating or swelling of face, arms, hands, lower legs, or feet
  • blood in eye
  • bloody nose
  • bloody stools
  • blurred vision
  • body aches or pain
  • bone pain
  • chest pain
  • cloudy urine
  • congestion
  • cough
  • decrease in urine output or decrease in urine-concentrating ability
  • difficult or labored breathing
  • drowsiness
  • dry mouth
  • dryness or soreness of throat
  • eye pain
  • fast, pounding, or irregular heartbeat or pulse
  • fatigue
  • fever
  • flushed, dry skin
  • fruit-like breath odor
  • hoarseness
  • increased hunger
  • increased thirst
  • increased urination
  • irregular heartbeat
  • large amount of cholesterol in the blood
  • loss of appetite
  • mood or mental changes
  • muscle spasms [tetany] or twitching seizures
  • nausea or vomiting
  • rapid weight gain
  • redness in whites of eyes
  • runny nose
  • shortness of breath
  • sweating
  • tender, swollen glands in neck
  • tightness in chest
  • tingling of hands or feet
  • trouble in swallowing
  • troubled breathing
  • trembling
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • voice changes
  • vomiting of blood or material that looks like coffee grounds
  • wheezing
  • yellow eyes or skin

If any of the following symptoms of overdose occur while taking sargramostim, get emergency help immediately:

Symptoms of overdose
  • General feeling of discomfort or illness
  • headache
  • rash

Some sargramostim side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Chills
  • diarrhea
  • difficulty in moving
  • fear or nervousness
  • itching skin
  • lack or loss of strength
  • muscle pain or stiffness
  • pain in joints
  • sleeplessness
  • trouble sleeping
  • unable to sleep

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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