Melphalan hydrochloride adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Melphalan hydrochloride
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Also reported as: Melphalan Hydrochloride For Injection

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Reports on file

From June 2009 to June 2026, FDA received 1,774 adverse event reports that name Melphalan hydrochloride. In these reports the drug is a suspect or interacting product.

In the same period, 724 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 43 reports in the 12 months to June 2026 and 46 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Melphalan hydrochloride is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 1 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

In April to June 2026, FDA received 13 reports that name Melphalan hydrochloride.
In January to March 2026, FDA received 13.
In April to June 2025, FDA received 7.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 205 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 1,739 of the 1,774 reports (98%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 205 terms.

Reaction terms in the reports that name Melphalan hydrochloride, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,774 reports
Mucosal inflammation	106	6%
Pyrexiafever	90	5.1%
Neutropenialow neutrophils, a type of white blood cell	79	4.5%
Febrile neutropeniafever with low white blood cells	78	4.4%
Sepsisa severe body-wide response to infection	72	4.1%
Toxicity to various agentspoisoning or toxic effect of one or more substances	69	3.9%
Deaththe patient died; cause not stated by this term	62	3.5%
Pancytopenialow counts of all blood cells	58	3.3%
Pneumonialung infection	57	3.2%
Thrombocytopenialow platelets	52	2.9%
Multi-organ failure	51	2.9%
Diarrhoealoose or frequent stools	49	2.8%
Off label useused for a purpose or in a way not on the label	49	2.8%
Myelodysplastic syndrome	48	2.7%
Fatiguetiredness	45	2.5%
Drug ineffectivethe medicine did not work as expected	44	2.5%
Anaemialow red blood cells	43	2.4%
Graft versus host disease	42	2.4%
Renal failurekidney failure	42	2.4%
Nauseafeeling sick	40	2.3%
Product use in unapproved indicationused for a purpose not on the label	39	2.2%
Acute myeloid leukaemia	38	2.1%
Acute graft versus host disease	36	2%
Vitreous haemorrhage	36	2%
Drug toxicity	35	2%
Haematotoxicity	34	1.9%
Infectionan infection, type not specified	34	1.9%
Astheniaweakness or lack of energy	33	1.9%
General physical health deteriorationgeneral decline in health	32	1.8%
Dyspnoeashortness of breath	31	1.7%
Hypotensionlow blood pressure	31	1.7%
Respiratory failurethe lungs could not supply enough oxygen	31	1.7%
Chronic graft versus host disease	29	1.6%
Eyelid oedemaa swollen eyelid	29	1.6%
Retinal pigment epitheliopathy	29	1.6%
Thrombotic microangiopathy	29	1.6%
Vomitingbeing sick	29	1.6%
Eyelid ptosis	28	1.6%
Septic shockshock arising from infection	28	1.6%
Venoocclusive disease	28	1.6%
Multiple myeloma	26	1.5%
Platelet count decreasedlow platelet count	26	1.5%
Dehydration	25	1.4%
Disease progressionthe disease advanced	25	1.4%
Extraocular muscle disorder	25	1.4%
Hepatotoxicityliver injury	24	1.4%
Renal failure acute	24	1.4%
Gastrointestinal toxicity	23	1.3%
Neuropathy peripheralnerve damage in hands or feet	23	1.3%
Acute respiratory distress syndrome	22	1.2%

Download all 205 terms of Melphalan hydrochloride (CSV)

The counts add to more than 1,774 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Melphalan with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Melphalan	Generic name	17,190
Melphalan hydrochloride (this page)	Generic name	1,774

Sum of the separately reported names: 18,964. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Melphalan hydrochloride, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2009	70	64	12	2	29	0	0	33	6
2010	365	360	132	25	135	12	0	156	5
2011	559	553	196	24	136	14	0	304	6
2012	397	389	109	22	99	22	0	232	8
2013	6	6	0	0	5	0	0	2	0
2014	2	1	0	0	1	0	0	1	1
2015	4	4	4	0	0	0	0	0	0
2016	5	5	0	0	0	0	0	5	0
2017	23	23	1	0	7	0	1	17	0
2018	33	32	3	0	8	0	1	25	1
2019	39	35	3	2	12	0	0	26	4
2020	23	23	7	1	6	1	0	19	0
2021	45	45	5	1	15	0	0	35	0
2022	47	47	3	6	12	0	0	41	0
2023	46	45	7	11	19	0	0	37	1
2024	41	41	1	2	14	0	0	40	0
2025	40	33	5	4	14	1	0	27	7
2026	29	25	2	7	14	0	0	18	4

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Melphalan hydrochloride, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Melphalan hydrochloride, by the year in which FDA received them
Year	Reports
2009	62
2010	363
2011	524
2012	443
2013	5
2014	2
2015	4
2016	5
2017	28
2018	38
2019	43
2020	20
2021	43
2022	50
2023	38
2024	45
2025	35
2026	26

Reports that name Melphalan hydrochloride, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Melphalan hydrochloride
Age	Reports	Share
Under 2	80	4.5%
2 to 11	133	7.5%
12 to 17	31	1.7%
18 to 44	89	5%
45 to 64	263	14.8%
65 to 74	174	9.8%
75 and over	96	5.4%
Age not given	908	51.2%

Sex of the patient in the reports that name Melphalan hydrochloride
Sex	Reports	Share
Female	540	30.4%
Male	631	35.6%
Unknown or not given	603	34%

Type of reporter in the reports that name Melphalan hydrochloride
Reporter	Reports	Share
Physician	757	42.7%
Pharmacist	29	1.6%
Other health professional	721	40.6%
Lawyer	0	0%
Consumer or non-health professional	99	5.6%
Not given	168	9.5%

Age and sex are as the report gives them. The reporter is the primary source in the report. 48.5% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Melphalan hydrochloride record
Indication as recorded (MedDRA)	Reports	Share
Multiple myeloma	509	28.7%
Retinoblastoma	116	6.5%
Bone marrow conditioning regimen	107	6%
Stem cell transplant	73	4.1%
Plasma cell myeloma	62	3.5%
Malignant melanoma	56	3.2%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,774 reports.

Pages near this one

Melphalan same ingredient
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These links are for navigation. No count selected them.

Official pages

DailyMed labels for Melphalan hydrochlorideThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Melphalan hydrochloride: adverse event reports that FDA received. https://reportedreactions.com/drug/melphalan-hydrochloride/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 1 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Melphalan hydrochloride as a suspect or interacting product. The 724 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Melphalan hydrochloride was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Melphalan hydrochloride?

No. It is a count of what people reported to FDA: 1,774 reports from June 2009 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Physician (42.7%), other health professional (40.6%) and consumer or non-health professional (5.6%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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