Leukine Side Effects

Generic name: sargramostim

Medically reviewed by Drugs.com. Last updated on Sep 20, 2024.

Note: This document provides detailed information about Leukine.

Applies to sargramostim: injection powder for solution Side Effects associated with sargramostim. Some dosage forms listed on this page may not apply specifically to the brand name Leukine.

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 Leukine

Along with its needed effects, sargramostim (the active ingredient contained in Leukine) 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:

Other side effects of Leukine

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:

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.

See also:

Further information

Leukine 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.

Medical Disclaimer