Reported Reactions

Adverse event reports that FDA received

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Haemophagocytic lymphohistiocytosis adverse event reports that record this term

Kind of term
MedDRA preferred term

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 . The data have the reports that FDA received through .

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 .

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 .

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 May 2008 to June 2026, FDA received 7,130 adverse event reports that record the MedDRA preferred term Haemophagocytic lymphohistiocytosis. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 1,119 reports in the 12 months to June 2026 and 1,127 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

By reports in the 12 months to June 2026, this term was number 565 of 1,436 reaction terms with a page. Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 1,119 (0.1%) record this term. Reports for female patients were 42.1% of the reports that record this term and 52.7% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate.

MedDRA

The Medical Dictionary for Regulatory Activities. The person who codes a report selects the preferred term that agrees best with the description of the reporter. FDA does not publish the description.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 134 drug pages with 25 or more reports that record this term. The rows are in order of name. A drug page with fewer reports for this term is not in the table. The counts are the counts that the site keeps for each reaction term, and a count can be lower than the count of FDA.

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 .

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 . The site read the page on .

Drugs that the reports with the term Haemophagocytic lymphohistiocytosis name as a suspect product, in order of name
DrugClassReports with this term
AbataceptSelective T cell costimulation modulator34
Acetaminophen29
ActemraInterleukin-6 receptor antagonist105
AcyclovirHerpes simplex virus nucleoside analog DNA polymerase inhibitor37
AdalimumabTumor necrosis factor blocker219
AlemtuzumabCD52-directed cytolytic antibody79
AllopurinolXanthine oxidase inhibitor66
Amphotericin bLipid-based polyene antifungal38
AnakinraInterleukin-1 receptor antagonist352
Asparaginase27
AtezolizumabProgrammed death Receptor-1 blocking antibody50
AvastinVascular endothelial growth factor inhibitor47
Axicabtagene ciloleucelCD19-directed chimeric antigen receptor39
AzacitidineNucleoside metabolic inhibitor45
AzathioprinePurine antimetabolite193
BactrimDihydrofolate reductase inhibitor antibacterial50
BaricitinibJanus kinase inhibitor48
BasiliximabInterleukin-2 receptor blocking antibody71
BelataceptSelective T cell costimulation blocker35
BevacizumabVascular endothelial growth factor inhibitor38
BortezomibProteasome inhibitor35
BusulfanAlkylating drug79
Busulfex37
Canakinumab98
CarbamazepineMood stabilizer33
CarboplatinPlatinum-based drug229
Carvykti86
Caspofungin29
CefotaximeCephalosporin antibacterial25
CeftriaxoneCephalosporin antibacterial32
CellCeptAntimetabolite immunosuppressant44
Ciclosporin55
Ciltacabtagene autoleucel28
CisplatinPlatinum-based drug70
ClobazamBenzodiazepine34
Cotrimoxazole29
CyclophosphamideAlkylating drug571
CyclosporineCalcineurin inhibitor immunosuppressant420
CytarabineNucleoside metabolic inhibitor171
DabrafenibKinase inhibitor33
Daunorubicin45
DexamethasoneCorticosteroid531
DoxorubicinAnthracycline topoisomerase inhibitor165
Doxorubicin hydrochlorideAnthracycline topoisomerase inhibitor71
Emapalumab46
EtanerceptTumor necrosis factor blocker74
EtoposideTopoisomerase inhibitor451
EverolimusKinase inhibitor42
FilgrastimLeukocyte growth factor60
FluconazoleAzole antifungal51
FludarabineNucleoside metabolic inhibitor235
Fludarabine phosphateNucleoside metabolic inhibitor69
GanciclovirCytomegalovirus nucleoside analog DNA polymerase inhibitor69
GemcitabineNucleoside metabolic inhibitor29
Human immunoglobulin gHuman immunoglobulin G83
Humira32
HydrocortisoneCorticosteroid27
HydroxychloroquineAntimalarial100
IbuprofenNonsteroidal anti-inflammatory drug49
Idarubicin25
IfosfamideAlkylating drug31
Ilaris131
ImbruvicaKinase inhibitor29
Immune globulin (human)Human immunoglobulin G29
InfliximabTumor necrosis factor blocker193
IpilimumabCTLA-4-directed blocking antibody75
IsoniazidAntimycobacterial38
JakafiJanus kinase inhibitor47
KeytrudaProgrammed death Receptor-1 blocking antibody230
KineretInterleukin-1 receptor antagonist140
KymriahCD19-directed chimeric antigen receptor91
LamictalAnti-epileptic agent52
LamivudineHepatitis B virus nucleoside analog reverse transcriptase inhibitor30
LamotrigineAnti-epileptic agent316
Lapine t-lymphocyte immune globulin26
LeflunomideAntirheumatic agent48
LenalidomideThalidomide analog54
LenvimaKinase inhibitor25
Levetiracetam82
LevofloxacinFluoroquinolone antibacterial35
LinezolidOxazolidinone antibacterial28
MekinistKinase inhibitor39
MelphalanAlkylating drug115
MercaptopurineNucleoside metabolic inhibitor57
MeropenemPenem antibacterial56
MethotrexateFolate analog metabolic inhibitor554
Methotrexate sodiumFolate analog metabolic inhibitor68
MethylprednisoloneCorticosteroid486
Methylprednisolone sodium succinateCorticosteroid34
MetronidazoleNitroimidazole antimicrobial52
MidazolamBenzodiazepine34
MoxifloxacinFluoroquinolone antibacterial35
Mycophenolate mofetilAntimetabolite immunosuppressant536
Mycophenolic acidAntimetabolite immunosuppressant168
NivolumabProgrammed death Receptor-1 blocking antibody116
OpdivoProgrammed death Receptor-1 blocking antibody142
OxaliplatinPlatinum-based drug31
PaclitaxelMicrotubule inhibitor121
PembrolizumabProgrammed death Receptor-1 blocking antibody172
PemetrexedFolate analog metabolic inhibitor81
PhenytoinAnti-epileptic agent67
Piperacillin and tazobactamPenicillin-class antibacterial43
Piperacillin sodium,tazobactam sodium52
PrednisoloneCorticosteroid442
PrednisoneCorticosteroid743
PrografCalcineurin inhibitor immunosuppressant25
QuetiapineAtypical antipsychotic27
RemicadeTumor necrosis factor blocker37
RifampinRifamycin antibacterial43
RituximabCD20-directed cytolytic antibody424
RuxolitinibJanus kinase inhibitor123
Sulfamethoxazole, trimethoprimDihydrofolate reductase inhibitor antibacterial93
SulfasalazineAminosalicylate38
TacrolimusCalcineurin inhibitor immunosuppressant651
TafinlarKinase inhibitor39
Tecartus30
TecentriqProgrammed death Receptor-1 blocking antibody74
Thalidomide33
ThiotepaAlkylating drug53
Thymocyte Immune Globulin46
ThymoglobulinImmunoglobulin G48
TisagenlecleucelCD19-directed chimeric antigen receptor28
TocilizumabInterleukin-6 receptor antagonist278
TofacitinibJanus kinase inhibitor65
TrametinibKinase inhibitor41
TrastuzumabHER2/neu receptor antagonist25
Treosulfan30
ValganciclovirCytomegalovirus nucleoside analog DNA polymerase inhibitor50
VancomycinGlycopeptide antibacterial92
VenetoclaxBCL-2 inhibitor63
Vincristine148
Vincristine sulfateVinca alkaloid52
YervoyCTLA-4-directed blocking antibody94
YescartaCD19-directed chimeric antigen receptor100

The page of each drug has the count of each reaction term in its reaction lookup.

Drug classes in these reports

The table has the 48 pharmacologic classes with 50 or more reports that record this term. The rows are in order of name.

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 .

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 . The site read the page on .

Pharmacologic classes of the drugs that the reports with the term Haemophagocytic lymphohistiocytosis name, in order of name
ClassReports with this term
Alkylating drug896
Anthracycline topoisomerase inhibitor250
Anti-epileptic agent485
Antimalarial132
Antimetabolite immunosuppressant748
Antimycobacterial63
Antirheumatic agent54
Atypical antipsychotic51
Azole antifungal104
BCL-2 inhibitor83
Benzodiazepine74
Calcineurin inhibitor immunosuppressant1,130
CD19-directed chimeric antigen receptor258
CD20-directed cytolytic antibody452
CD52-directed cytolytic antibody95
Cephalosporin antibacterial89
Corticosteroid2,325
CTLA-4-directed blocking antibody181
Cytomegalovirus nucleoside analog DNA polymerase inhibitor121
Dihydrofolate reductase inhibitor antibacterial158
Fluoroquinolone antibacterial83
Folate analog metabolic inhibitor722
Glycopeptide antibacterial98
Herpes simplex virus nucleoside analog DNA polymerase inhibitor51
Human immunoglobulin G117
Immunoglobulin G67
Interleukin-1 receptor antagonist492
Interleukin-2 receptor blocking antibody71
Interleukin-6 receptor antagonist385
Janus kinase inhibitor356
Kinase inhibitor372
Leukocyte growth factor64
Microtubule inhibitor147
Nitroimidazole antimicrobial52
Nonsteroidal anti-inflammatory drug78
Nucleoside metabolic inhibitor644
Penem antibacterial56
Penicillin-class antibacterial76
Platinum-based drug330
Programmed death Receptor-1 blocking antibody784
Proteasome inhibitor83
Purine antimetabolite214
Thalidomide analog74
Topoisomerase inhibitor472
Tumor necrosis factor blocker535
Vascular endothelial growth factor inhibitor85
Vinca alkaloid60
Xanthine oxidase inhibitor69

A class with many reports in all has many reports for almost every term.

Reports by month

Reports that record Haemophagocytic lymphohistiocytosis, by month, five years to June 2026
010020020222023202420252026

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

Patients in these reports

Age of the patient in the reports that record Haemophagocytic lymphohistiocytosis
AgeReportsShareShare as a bar
Under 21592.2%
2 to 116328.9%
12 to 173565%
18 to 441,55821.9%
45 to 641,64323%
65 to 741,01614.2%
75 and over4055.7%
Age not given1,36119.1%
Sex of the patient in the reports that record Haemophagocytic lymphohistiocytosis
SexReportsShareShare as a bar
Female3,00142.1%
Male3,16944.4%
Unknown or not given96013.5%

Age and sex are as the report gives them. 29.5% of these reports give the United States as the country.

Terms near this one

Official pages

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

Cite this page

Reported Reactions. Haemophagocytic lymphohistiocytosis: adverse event reports that record this term. https://reportedreactions.com/reaction/haemophagocytic-lymphohistiocytosis/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of . Reports received through .

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 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 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

The count has the reports with each spelling of one MedDRA preferred term. 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

What does Haemophagocytic lymphohistiocytosis mean in an adverse event report?

It is a MedDRA preferred term. FDA codes the description of a reporter with the MedDRA dictionary. The openFDA files do not have the description itself, and this site does not show it.

Does a drug in the table mean that the drug was responsible for this reaction?

No. FDA says:

No individual drug is connected to any individual reaction.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

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 .

What does this page tell a person who has this symptom?

This page gives counts of reports. It cannot assess a person. A pharmacist or a clinician can assess a person.

If this is a medical emergency, please call 911.

Source: FDA, MedWatch Online Voluntary Reporting Form. The site read the page on .