Melphalan: adverse event reports filed with FDA

17,190

reports as suspect product

0.1% of all reports · about 764 a year

956

reports, 12 months to June 2026

1,291 in the 12 months before

98.5%

marked serious by the reporter

93.5% across the class

23.2%

record death among outcomes, as reported

3,984 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Melphalan reports recording the termmedian drug in alkylating drug

1. Off label useused for a purpose or in a way not on the label11.5%1,970
2. Febrile neutropeniafever with low white blood cells5.8%998
3. Mucosal inflammation5.5%946
4. Neutropenialow neutrophils, a type of white blood cell5.2%891
5. Drug ineffectivethe medicine did not work as expected5.1%879
6. Pyrexiafever4.8%823
7. Plasma cell myeloma4.7%805
8. Pneumonialung infection4.7%802
9. Thrombocytopenialow platelets4.6%792
10. Diarrhoealoose or frequent stools4.2%722
11. Product use in unapproved indicationused for a purpose not on the label4.1%709
12. Disease progressionthe disease advanced3.9%676
13. Sepsisa severe body-wide response to infection3.7%634
14. Myelodysplastic syndrome3.5%599
15. Infectionan infection, type not specified2.9%492
16. Neuropathy peripheralnerve damage in hands or feet2.7%464
17. Pancytopenialow counts of all blood cells2.7%461
18. Anaemialow red blood cells2.6%455
19. Venoocclusive liver disease2.6%439
20. Acute myeloid leukaemia2.4%419
21. Acute kidney injurysudden loss of kidney function2.4%404
22. Deaththe patient died; cause not stated by this term2.3%396
23. Nauseafeeling sick2.3%395
24. Cytomegalovirus infection2.1%360
25. Toxicity to various agentspoisoning or toxic effect of one or more substances2%348
26. Vomitingbeing sick1.9%333
27. Thrombotic microangiopathy1.9%330
28. Renal failurekidney failure1.9%322
29. Septic shockshock arising from infection1.8%311
30. Multiple organ dysfunction syndromeseveral organs failing1.8%304

Top 30 of 1,862 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 23 drugs in the alkylating drug class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 253,205 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 24.6% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 17,190 reports.

Drugs most often listed in the same reports

Other products listed in reports where Melphalan is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the alkylating drug class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Melphalan as a suspect or interacting product; reports listing it only as a concomitant medication (6,163) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.