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Melphalan Side Effects

The most commonly reported side effects of melphalan include off label use, plasma cell myeloma, and febrile neutropenia, based on 29,522 FDA adverse event reports from 2004 to 2025. 4.7% of reports found the drug to be ineffective.

#1 Reported: Off Label UseAll side effects ↓Top Co-Medication: BortezomibDrug interactions ↓46% of Reports Are AdultDemographics ↓

Melphalan side effects

Percentages show how often each reaction appears relative to total reports for melphalan.

1
Off Label Use8.6%2,537
2
Drug Ineffective4.7%1,395
3
Plasma Cell Myeloma4.5%1,342
4
Febrile Neutropenia4.2%1,251
5
Neutropenia3.8%1,129
6
Thrombocytopenia3.5%1,043
7
Mucosal Inflammation3.5%1,029
8
Diarrhoea3.4%1,012
9
Pneumonia3.4%1,004
10
Product Use In Unapproved Indication3.3%987
11
Pyrexia3.3%977
12
Sepsis2.7%792
13
Disease Progression2.5%729
14
Neuropathy Peripheral2.4%706
15
Anaemia2.3%690

These are voluntary reports and do not establish that melphalan caused these reactions.

Report severity

97.1%Serious28,674 reports
31.0%Hospitalizations9,151 reports
24.0%Fatal7,082 reports

Seriousness is determined by the reporter, not by OpenClaim.

Melphalan drug interactions

Other drugs that appear in adverse event reports alongside melphalan. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Bortezomib21.9%6,457
2
Dexamethasone21.3%6,295
3
Etoposide20.1%5,925
4
Cyclophosphamide18.8%5,560
5
Lenalidomide16.4%4,838
6
Prednisone14.8%4,356
7
Fludarabine-phosphate14.5%4,274
8
Cytarabine12.7%3,744
9
Doxorubicin-hydrochloride11.1%3,263
10
Vincristine-sulfate9.6%2,846
11
Carmustine9.3%2,734
12
Thalidomide9.2%2,720
13
Rituximab8.1%2,389
14
Busulfan7.6%2,239
15
Cisplatin7.1%2,109

Taken alongside

1
Dexamethasone9.6%2,842
2
Acyclovir8.7%2,564
3
Prednisone7.5%2,214
4
Fludarabine-phosphate6.6%1,960
5
Cyclophosphamide6.1%1,792
6
Fluconazole4.7%1,387
7
Etoposide4.6%1,363
8
Bortezomib4.4%1,302
9
Aspirin4.1%1,221
10
Methotrexate3.9%1,141
11
Tacrolimus3.7%1,092
12
Sulfamethoxazole3.7%1,083
13
Acetaminophen3.5%1,045
14
Furosemide3.3%980
15
Cytarabine3.0%900

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports melphalan side effects

33.9% of melphalan adverse event reports involve female patients and 43.6% involve male patients. The largest age group is adult at 46%. These figures reflect who reports side effects, not underlying risk.

Sex

Female33.9%
Male43.6%
Unknown22.5%

Age group

< 24.2%
2–1112.0%
12–174.4%
18–6445.7%
65+33.7%

What is melphalan used for

Conditions and purposes for which patients were taking melphalan when the adverse event was reported.

Acquired HaemophiliaAcral Lentiginous MelanomaAcute Biphenotypic LeukaemiaAcute Graft Versus Host DiseaseAcute LeukaemiaAcute Lymphocytic LeukaemiaAcute Lymphocytic Leukaemia RecurrentAcute Megakaryocytic LeukaemiaAcute Monocytic LeukaemiaAcute Myeloid LeukaemiaAcute Myeloid Leukaemia RecurrentAcute Myeloid Leukaemia RefractoryAcute Myelomonocytic LeukaemiaAcute Promyelocytic LeukaemiaAdrenoleukodystrophy

Showing 15 of 727 indications

Melphalan brand names and reporting trend

Melphalan is sold under the brand name Alkeran.

Brand names

Alkeran29,352

Quarterly reports (2004–2025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking melphalan with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.

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