What the label lists and what reports show
Melphalan side effects
Melphalan's FDA label: “The most common side effect is bone marrow suppression leading to leukopenia, thrombocytopenia, and anemia.” FAERS holds 24,926 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is febrile neutropenia (1,316 reports).
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the melphalan FDA label on DailyMed (effective July 7, 2026, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of Evomela?Evomela may cause serious side effects, including: • Low blood cell counts are common with Evomela and can be serious. Your healthcare provider will do blood tests as needed to check your blood counts during your treatment with Evomela. ᴼ Low platelet counts: Tell your healthcare provider right away if you have unusual bleeding or bruising under your skin. ᴼ Low red blood cell counts: Tell your healthcare provider if you are feeling weak, tired, or you get tired easily, you look pale, or you feel short of breath. ᴼ Low white blood cell counts: A low white blood cell count can cause you to get infections, which may be serious. Tell your healthcare provider right away if you have symptoms of infection, such as fever, chills, cough, pain or burning during urination. • Redness and sores of the lining of the mouth, lips, throat, stomach, and genitals (mucositis). […]
Source: FDA drug label (EVOMELA), Acrotech Biopharma Inc, effective June 9, 2023 (SPL set 69f55869-dc11-408e-8fc7-47634269a52c), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common side effect is bone marrow suppression leading to leukopenia, thrombocytopenia, and anemia.
Table 2 All Adverse Reactions Observed at a Frequency of >10% in Patients Treated with HEPZATO
This table is printed in the Hepzato Kit label published by Delcath Systems, Inc. of June 9, 2026; the label quoted above does not print one.
| Reaction | All Grades (%) | Grades 3 or 4 (%) |
|---|---|---|
| Nausea | 57 | 0 |
| Abdominal Pain 1 | 39 | 1 |
| Vomiting 1 | 35 | 0 |
| Diarrhea 1 | 17 | 1 |
| Fatigue 1 | 65 | 0 |
| Pyrexia 1 | 16 | 0 |
| Musculoskeletal Pain 1 | 46 | 1 |
| Groin Pain | 11 | 0 |
| Dyspnea 1 | 23 | 2 |
| Cough 1 | 15 | 0 |
| Headache 1 | 19 | 0 |
| Lethargy | 12 | 0 |
| Dizziness 1 | 11 | 0 |
| Contusion | 17 | 0 |
| Decreased appetite | 16 | 0 |
| Hemorrhage 1 | 15 | 1 |
| Hypotension 1 | 13 | 3 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continued(SEE OVERDOSAGE ) The following information on adverse reactions is based on data from both oral and IV administration of melphalan as a single agent, using several different dose schedules for treatment of a wide variety of malignancies. Hematologic The most common side effect is bone marrow suppression leading to leukopenia, thrombocytopenia, and anemia. White blood cell count and platelet count nadirs usually occur 2 to 3 weeks after treatment, with recovery in 4 to 5 weeks after treatment. Irreversible bone marrow failure has been reported. Gastrointestinal Gastrointestinal disturbances such as nausea and vomiting, diarrhea, and oral ulceration occur infrequently. Hepatic disorders ranging from abnormal liver function tests to clinical manifestations such as hepatitis and jaundice have been reported. Hepatic veno-occlusive disease has been reported. Hypersensitivity Acute hypersensitivity reactions including anaphylaxis were reported in 2.4% of 425 patients receiving Melphalan Hydrochloride for Injection for myeloma (see WARNINGS ). These reactions were characterized by urticaria, pruritus, edema, skin rashes, and in some patients, tachycardia, bronchospasm, dyspnea, and hypotension. These patients appeared to respond to antihistamine and corticosteroid therapy. …
Source: FDA drug label, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., effective July 7, 2026 (SPL set 2c18beeb-7bd4-4591-94cb-9d7156c1b8e0), via openFDA; the full label on DailyMed
What do FAERS reports show?
24,926 reports list melphalan among the medicines taken, each a report of something that happened, not proof the medicine caused it; 5,941 are coded as a death and 7,187 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Melphalan: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions