Reported Reactions

Adverse event reports that FDA received

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Disease recurrence adverse event reports that record this term

Kind of term
MedDRA preferred term
Plain meaning
the disease came back

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 January 2004 to June 2026, FDA received 47,022 adverse event reports that record the MedDRA preferred term Disease recurrence. In plain words, the term means: the disease came back. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 2,141 reports in the 12 months to June 2026 and 4,109 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 341 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, 2,141 (0.2%) record this term. Reports for patients aged 45 to 64 were 29.8% of the reports that record this term and 20% 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.

Plain meaning

The disease came back. The words are from the fixed dictionary of this site. They add nothing to a report.

Data version

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

Drugs in these reports

The table has the 124 drug pages with 100 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 Disease recurrence name as a suspect product, in order of name
DrugClassReports with this term
5-fluorouracil114
AbilifyAtypical antipsychotic112
Acetaminophen122
ActemraInterleukin-6 receptor antagonist172
AcyclovirHerpes simplex virus nucleoside analog DNA polymerase inhibitor110
AdalimumabTumor necrosis factor blocker223
Albuterolbeta2-Adrenergic agonist163
Albuterol sulfatebeta2-Adrenergic agonist185
Alvesco129
AravaAntirheumatic agent164
AripiprazoleAtypical antipsychotic174
AspirinNonsteroidal anti-inflammatory drug291
AzathioprinePurine antimetabolite606
AzithromycinMacrolide antimicrobial124
Bendamustine119
BevacizumabVascular endothelial growth factor inhibitor200
BleomycinCytoprotective agent101
BortezomibProteasome inhibitor174
Breo ElliptaCorticosteroid123
BudesonideCorticosteroid130
CapecitabineNucleoside metabolic inhibitor231
CarbamazepineMood stabilizer123
CarboplatinPlatinum-based drug826
CelebrexNonsteroidal anti-inflammatory drug167
CelecoxibNonsteroidal anti-inflammatory drug104
Ciclosporin122
CiprofloxacinFluoroquinolone antibacterial119
CisplatinPlatinum-based drug581
ClarithromycinMacrolide antimicrobial108
ClozapineAtypical antipsychotic106
CosentyxInterleukin-17A antagonist333
CyclophosphamideAlkylating drug1,466
CyclosporineCalcineurin inhibitor immunosuppressant571
CytarabineNucleoside metabolic inhibitor463
DexamethasoneCorticosteroid844
Dificid152
DocetaxelMicrotubule inhibitor321
DoxorubicinAnthracycline topoisomerase inhibitor773
Doxorubicin hydrochlorideAnthracycline topoisomerase inhibitor212
DoxycyclineTetracycline-class drug126
DupixentInterleukin-4 receptor alpha antagonist110
Eltrombopag olamineThrombopoietin receptor agonist112
EnbrelTumor necrosis factor blocker566
Endoxan 1000 Mg - Powder for Solution for Injection100
Endoxan Baxter150
Epirubicin377
EtanerceptTumor necrosis factor blocker103
EtoposideTopoisomerase inhibitor800
FilgrastimLeukocyte growth factor145
FluconazoleAzole antifungal132
FludarabineNucleoside metabolic inhibitor151
FluorouracilNucleoside metabolic inhibitor278
FurosemideLoop diuretic100
GemcitabineNucleoside metabolic inhibitor398
GilenyaSphingosine 1-phosphate receptor modulator239
HerceptinHER2/neu receptor antagonist226
Humira283
HydrocortisoneCorticosteroid127
HydroxychloroquineAntimalarial208
Hydroxychloroquine sulfateAntimalarial143
IbranceKinase inhibitor106
IbuprofenNonsteroidal anti-inflammatory drug106
IfosfamideAlkylating drug307
ImatinibKinase inhibitor135
InflectraTumor necrosis factor blocker177
InfliximabTumor necrosis factor blocker299
Irinotecan232
KesimptaCD20-directed cytolytic antibody114
KeveyisCarbonic anhydrase inhibitor172
LamivudineHepatitis B virus nucleoside analog reverse transcriptase inhibitor110
LamotrigineAnti-epileptic agent160
LeflunomideAntirheumatic agent133
LenalidomideThalidomide analog196
LetrozoleAromatase inhibitor108
Levetiracetam210
LevofloxacinFluoroquinolone antibacterial110
LucentisVascular endothelial growth factor inhibitor130
Lyrica291
Mabthera119
MelphalanAlkylating drug202
MethotrexateFolate analog metabolic inhibitor1,342
Methotrexate sodiumFolate analog metabolic inhibitor227
MethylprednisoloneCorticosteroid569
Mycophenolate mofetilAntimetabolite immunosuppressant1,025
Mycophenolic acidAntimetabolite immunosuppressant141
NexiumProton pump inhibitor146
NucalaInterleukin-5 antagonist206
OlanzapineAtypical antipsychotic232
OmeprazoleProton pump inhibitor144
OtezlaPhosphodiesterase 4 inhibitor120
OxaliplatinPlatinum-based drug339
PaclitaxelMicrotubule inhibitor506
PantoprazoleProton pump inhibitor152
Paxlovid20,100
PlaquenilAntimalarial114
PrednisoloneCorticosteroid1,077
PrednisoneCorticosteroid2,253
PrografCalcineurin inhibitor immunosuppressant111
QuetiapineAtypical antipsychotic127
RebifInterferon beta148
RemicadeTumor necrosis factor blocker195
RevlimidThalidomide analog102
RibavirinNucleoside analog antiviral154
RisperidoneAtypical antipsychotic189
RituxanCD20-directed cytolytic antibody178
RituximabCD20-directed cytolytic antibody1,555
RuxolitinibJanus kinase inhibitor112
Siliq130
SimvastatinHMG-CoA reductase inhibitor105
SolirisComplement inhibitor120
SulfasalazineAminosalicylate152
SymbicortCorticosteroid131
TacrolimusCalcineurin inhibitor immunosuppressant923
Tamoxifen104
TemozolomideAlkylating drug303
Tiotropium bromideAnticholinergic131
Topiramate106
TrastuzumabHER2/neu receptor antagonist134
Valproic acidAnti-epileptic agent140
VancomycinGlycopeptide antibacterial101
Vincristine908
Vincristine sulfateVinca alkaloid120
XeljanzJanus kinase inhibitor647
XifaxanRifamycin antibacterial123

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 38 pharmacologic classes with 250 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 Disease recurrence name, in order of name
ClassReports with this term
Alkylating drug2,622
Anthracycline topoisomerase inhibitor1,016
Anti-epileptic agent666
Anticholinergic293
Antimalarial504
Antimetabolite immunosuppressant1,270
Antirheumatic agent297
Aromatase inhibitor254
Atypical antipsychotic1,330
Azole antifungal359
Benzodiazepine404
beta-Adrenergic blocker369
beta2-Adrenergic agonist514
Calcineurin inhibitor immunosuppressant1,678
CD20-directed cytolytic antibody2,062
Corticosteroid5,981
Fluoroquinolone antibacterial299
Folate analog metabolic inhibitor1,641
HER2/neu receptor antagonist457
HMG-CoA reductase inhibitor334
Interleukin-17A antagonist398
Interleukin-5 antagonist274
Janus kinase inhibitor908
Kinase inhibitor1,101
Microtubule inhibitor837
Mood stabilizer251
Nonsteroidal anti-inflammatory drug929
Nucleoside metabolic inhibitor1,821
Platinum-based drug1,746
Proteasome inhibitor284
Proton pump inhibitor857
Purine antimetabolite720
Serotonin reuptake inhibitor456
Sphingosine 1-phosphate receptor modulator330
Thalidomide analog355
Topoisomerase inhibitor884
Tumor necrosis factor blocker1,801
Vascular endothelial growth factor inhibitor478

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

Reports by month

Reports that record Disease recurrence, by month, five years to June 2026
02,5005,00020222023202420252026

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 Disease recurrence
AgeReportsShareShare as a bar
Under 23110.7%
2 to 118751.9%
12 to 177061.5%
18 to 448,76518.6%
45 to 6413,99229.8%
65 to 748,63718.4%
75 and over3,5617.6%
Age not given10,17521.6%
Sex of the patient in the reports that record Disease recurrence
SexReportsShareShare as a bar
Female25,23653.7%
Male16,81135.8%
Unknown or not given4,97510.6%

Age and sex are as the report gives them. 63.9% of these reports give the United States as the country.

Terms near this one

Official pages

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Reported Reactions. Disease recurrence: adverse event reports that record this term. https://reportedreactions.com/reaction/disease-recurrence/ 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 Disease recurrence mean in an adverse event report?

In plain words: the disease came back. 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 .