Sargramostim Side Effects
Medically reviewed by Drugs.com. Last updated on Sep 20, 2024.
Applies to sargramostim: injection powder for solution.
Precautions
It is very important that your doctor check you and your child's progress at regular visits to make sure that this medicine is working properly. Blood tests are needed to check for unwanted effects.
Tell your doctor about all the other medicines you are using, especially if you are being treated for cancer. This medicine should not be given at the same time as chemotherapy (cancer medicines) or radiation treatment or within 24 hours before or after you receive your cancer treatment.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have a rash, itching, swelling of the face, tongue, or throat, trouble breathing, or chest pain after you receive the medicine.
This medicine may cause infusion-related reactions, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting after receiving this medicine.
This medicine may cause a condition called capillary leak syndrome. It can cause fluid to leak from the blood vessels into your body's tissues. Call your doctor right away if you have swelling or puffiness, urinating less often, trouble breathing, feeling of fullness, dizziness, or feeling faint.
This medicine may cause heart rhythm problems. Tell your doctor right away if you or your child gets dizzy or lightheaded, have fast or irregular heart beats, or feels like fainting.
This medicine may increase your risk of having cancer and the number of white blood cells in the blood. Talk to your doctor if you have concerns.
This medicine contains benzyl alcohol, which can be harmful to infants and unborn babies.
Serious side effects of sargramostim
Along with its needed effects, sargramostim may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking sargramostim:
More common side effects
- black, tarry stools
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blood in the eye
- bloody nose
- blurred vision
- body aches or pain
- bone pain
- chest pain or tightness
- cloudy urine
- cough
- decrease in urine output or decrease in urine-concentrating ability
- difficult or labored breathing
- drowsiness
- dry mouth
- dryness or soreness of the throat
- eye pain
- fast, pounding, or irregular heartbeat or pulse
- 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
- nausea
- rapid weight gain
- redness in whites of eyes
- stomach pain
- stuffy or runny nose
- sweating
- tender, swollen glands in the neck
- tingling of the hands or feet
- trouble with swallowing
- trembling
- twitching
- unusual tiredness or weakness
- unusual weight gain or loss
- voice changes
- vomiting
- vomiting of blood or material that looks like coffee grounds
- yellow eyes or skin
Incidence not known
- chills
- confusion
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- general feeling of illness
- headache
- pain in the chest, groin, or legs, especially the calves
- severe, sudden headache
- slurred speech
- sudden loss of coordination
- sudden, severe weakness or numbness in the arm or leg
Other side effects of sargramostim
Some side effects of sargramostim may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common side effects
- diarrhea
- difficulty in moving
- fear or nervousness
- itching skin
- lack or loss of strength
- muscle pain or stiffness
- pain in the joints
- trouble sleeping
Incidence not known
- bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- feeling of warmth
- redness of the face, neck, arms, and occasionally, upper chest
For healthcare professionals
Applies to sargramostim: injectable powder for injection, injectable solution.
General adverse events
The most common adverse reactions (incidence greater than 30%) were:
--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.
--In patients with AML: Fever, liver toxicity, skin reactions, infections, metabolic laboratory abnormalities, nausea, diarrhea, genitourinary abnormalities, pulmonary toxicity, vomiting, neurotoxicity, stomatitis, alopecia and weight loss.[Ref]
Other
- Very common (10% or more): Fever (up to 95%), mucous membrane disorder (75%), infection (65%), asthenia (up to 66%), malaise (57%), edema (up to 34%), chills (up to 25%), pain (17%), chest pain (15%), peripheral edema (up to 15%), sepsis (11%)[Ref]
Gastrointestinal
- Very common (10% or more): Nausea (up to 90%), diarrhea (up to 89%), vomiting (up to 85%), stomatitis (up to 62%), abdominal pain (38%), gastrointestinal disorder (37%), gastrointestinal hemorrhage (up to 27%), dyspepsia (17%), hematemesis (13%), dysphagia (11%)[Ref]
Dermatologic
- Very common (10% or more): Alopecia (up to 73%), rash (up to 70%), pruritus (23%)[Ref]
Immunologic
- Very common (10% or more): Neutralizing antibodies (83%), allergy (12%)
- Frequency not reported: Allergic reaction, anaphylactoid reaction[Ref]
Metabolic
- Very common (10% or more): Anorexia (up to 54%), high glucose (49%), weight loss (37%), hypomagnesemia (15%)
- Frequency not reported: Weight gain[Ref]
Nervous system
- Very common (10% or more): Headache (up to 36%), central nervous system disorder (11%), paresthesia (11%)
- Frequency not reported: Dizziness
- Postmarketing reports: Fainting[Ref]
Cardiovascular
- Very common (10% or more): Hypertension (34%), hemorrhage (up to 29%), pericardial effusion (25%), hypotension (13%), tachycardia (11%)
- Postmarketing reports: Supraventricular arrhythmia, thromboembolic events, capillary leak syndrome[Ref]
Hepatic
- Very common (10% or more): Liver toxicity (77%), bilirubinemia (30%), liver damage (13%), ALT increased (13%)[Ref]
Respiratory
- Very common (10% or more): Dyspnea (28%), pharyngitis (23%), lung disorder (20%), epistaxis (17%), rhinitis (11%)[Ref]
Hematologic
- Very common (10% or more): Albumin low (36%), blood dyscrasia (25%), thrombocytopenia (19%), leukopenia (17%)
- Frequency not reported: Anemia, low serum proteins, prothrombin time prolonged, progressive increase in circulating monocytes and promonocytes and blasts in the marrow
- Postmarketing reports: Leukocytosis (including eosinophilia)[Ref]
Renal
- Very common (10% or more): BUN elevation (17%), increased creatinine (15%)
- Frequency not reported: Renal failure[Ref]
Musculoskeletal
- Very common (10% or more): Bone pain (21%), arthralgia (up to 21%), myalgia (18%)
- Postmarketing reports: Joint pain[Ref]
Genitourinary
- Very common (10% or more): Genitourinary abnormalities (50%), urinary tract disorder (14%)[Ref]
Psychiatric
- Very common (10% or more): Insomnia (11%), anxiety (11%)[Ref]
Ocular
- Very common (10% or more): Eye hemorrhage (11%)[Ref]
Local
- Postmarketing reports: Injection site reactions[Ref]
Hypersensitivity
- Frequency not reported: Infusion-related and allergic reactions/hypersensitivity including anaphylaxis, skin rash, urticaria, generalized erythema, hypotension, tachycardia, syncope and flushing.
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References
1. (2001) "Product Information. Leukine (sargramostim)." Immunex Corporation
More about sargramostim
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Further information
Sargramostim side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.