Melphalan Side Effects

Some side effects of melphalan 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 melphalan: intravenous powder for injection, oral tablet

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

Call your doctor at once if you have any of these serious side effects:

• easy bruising or bleeding, unusual weakness;

• fever, chills, body aches, flu symptoms;

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• missed menstrual periods;

• unusual lumps or masses;

• red skin rash, rapid pulse, pain, weight loss;

• breathing problems or a cough that won't go away; or

• pale or yellowed skin, dark colored urine, confusion and weakness.

Less serious side effects of melphalan may include:

• mild nausea, vomiting, diarrhea;

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

• temporary hair loss; or

• mild skin itching and rash.

In some cases, second cancers have been reported to occur during and after treatment with melphalan. Talk to your doctor about your individual risk and benefit in using this medication.

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 melphalan: intravenous powder for injection, oral tablet

Hematologic

Hematologic side effects including bone marrow suppression and anemia have been reported. Bone marrow suppression is the most common and the most significant toxicity associated with melphalan in most patients. Hemolytic anemia has also been reported.

Bone marrow suppression is usually reversible if melphalan is withdrawn early enough.

Oncologic

Oncologic side effects including secondary malignancies such as acute nonlymphocytic leukemia, myeloproliferative syndrome, and carcinoma have been reported. Melphalan has been reported to cause chromatid or chromosome damage in humans.

The risk of leukemogenesis increases with chronicity of treatment and with cumulative dose.

Genitourinary

The suppression of ovarian function in premenopausal women has been reported to result in amenorrhea in a significant number of patients.

Genitourinary side effects including the suppression of ovarian function in premenopausal women and both reversible and irreversible testicular suppression have been reported.

Respiratory

Fatal outcomes associated with pulmonary fibrosis have been reported.

Respiratory side effects including pulmonary fibrosis and interstitial pneumonitis have been reported.

Dermatologic

Dermatologic side effects including , maculopapular rashes, skin rashes, alopecia, and skin hypersensitivity have been reported.

Cardiovascular

Cardiovascular side effects including cardiac arrest and vasculitis have been reported.

Gastrointestinal

Gastrointestinal side effects including nausea and vomiting, diarrhea, and oral ulceration have been reported infrequently.

Hepatic

Hepatic side effects including toxicity have been reported rarely.

Hypersensitivity

Hypersensitivity reactions have been reported after multiple courses of treatment and have recurred in patients who previously experienced a hypersensitivity reaction.

Hypersensitivity side effects including anaphylaxis have been reported rarely.

Endocrine

Endocrine side effects including two cases of syndrome of inappropriate antidiuretic hormone secretion have been reported following high-dose intravenous melphalan.

Other

Other side effects including a sensation of warmth and/or tingling have been reported.

Renal

Renal side effects including temporary significant elevation of the blood urea have been seen in the early stages of therapy in patients with renal damage.

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