Reported Reactions

Adverse event reports that FDA received

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Nausea adverse event reports that record this term

Kind of term
MedDRA preferred term
Plain meaning
feeling sick

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 776,030 adverse event reports that record the MedDRA preferred term Nausea. In plain words, the term means: feeling sick. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 48,716 reports in the 12 months to June 2026 and 43,313 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 4 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, 48,716 (3.7%) record this term. Reports for female patients were 66.4% 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.

Plain meaning

Feeling sick. 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 91 drug pages with 2,500 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 Nausea name as a suspect product, in order of name
DrugClassReports with this term
Acetaminophen5,825
ActemraInterleukin-6 receptor antagonist6,723
AdalimumabTumor necrosis factor blocker3,622
Anticoagulant Sodium CitrateAnti-coagulant3,018
AravaAntirheumatic agent5,058
AspirinNonsteroidal anti-inflammatory drug2,529
AvastinVascular endothelial growth factor inhibitor2,669
BevacizumabVascular endothelial growth factor inhibitor3,305
ButransPartial opioid agonist2,869
ByettaGLP-1 receptor agonist11,735
CabometyxKinase inhibitor4,425
CapecitabineNucleoside metabolic inhibitor4,526
CarboplatinPlatinum-based drug6,017
CelebrexNonsteroidal anti-inflammatory drug3,141
Cetirizine hydrochlorideHistamine-1 receptor antagonist2,581
ChantixPartial cholinergic nicotinic agonist13,396
CimziaTumor necrosis factor blocker5,116
CisplatinPlatinum-based drug4,727
CosentyxInterleukin-17A antagonist5,621
CyclophosphamideAlkylating drug5,047
Cymbalta7,758
DexamethasoneCorticosteroid3,974
DiclofenacNonsteroidal anti-inflammatory drug2,579
Diclofenac sodiumNonsteroidal anti-inflammatory drug3,495
DocetaxelMicrotubule inhibitor3,437
DupixentInterleukin-4 receptor alpha antagonist4,764
EnbrelTumor necrosis factor blocker17,260
Erelzi2,744
EsbrietPyridone4,756
FluorouracilNucleoside metabolic inhibitor4,130
Folic acid2,902
ForteoParathyroid hormone analog8,110
FosamaxBisphosphonate3,526
GabapentinAnti-epileptic agent3,573
GilenyaSphingosine 1-phosphate receptor modulator3,364
Humira23,924
HydroxychloroquineAntimalarial4,359
Hydroxychloroquine sulfateAntimalarial3,804
IbranceKinase inhibitor7,729
IbuprofenNonsteroidal anti-inflammatory drug3,895
Incivek2,510
InfliximabTumor necrosis factor blocker4,927
KisqaliKinase inhibitor3,379
LeflunomideAntirheumatic agent5,239
LetrozoleAromatase inhibitor2,541
Lyrica4,989
MetforminBiguanide3,603
MethotrexateFolate analog metabolic inhibitor15,314
Methotrexate sodiumFolate analog metabolic inhibitor4,875
MirenaProgestin2,863
Morphine sulfateOpioid agonist3,006
MounjaroGLP-1 receptor agonist8,910
NaproxenNonsteroidal anti-inflammatory drug2,971
OfevKinase inhibitor4,036
OpsumitEndothelin receptor antagonist3,233
OrenciaSelective T cell costimulation modulator6,951
OrenitramProstacycline vasodilator3,220
OtezlaPhosphodiesterase 4 inhibitor21,055
OxaliplatinPlatinum-based drug4,855
OxyContinOpioid agonist2,568
OzempicGLP-1 receptor agonist8,820
PaclitaxelMicrotubule inhibitor4,107
Paxlovid2,555
PegasysInterferon alpha5,367
Plan B One-StepProgestin4,257
PlaquenilAntimalarial3,017
PrednisoneCorticosteroid8,951
RemicadeTumor necrosis factor blocker7,774
RemodulinProstacycline vasodilator4,568
RevlimidThalidomide analog9,048
RibavirinNucleoside analog antiviral5,597
RituxanCD20-directed cytolytic antibody3,004
RituximabCD20-directed cytolytic antibody8,760
SimponiTumor necrosis factor blocker4,562
StelaraInterleukin-12 antagonist3,240
SulfasalazineAminosalicylate6,000
SutentKinase inhibitor2,795
Tecfidera8,585
TrulicityGLP-1 receptor agonist9,526
Tymlos3,831
TysabriIntegrin receptor antagonist3,955
UptraviProstacyclin receptor agonist3,153
VedolizumabIntegrin receptor antagonist2,684
VictozaGLP-1 receptor agonist5,162
WegovyGLP-1 receptor agonist2,743
XeljanzJanus kinase inhibitor7,934
XelodaNucleoside metabolic inhibitor3,371
XtandiAndrogen receptor inhibitor2,652
XyremCentral nervous system depressant4,269
ZejulaPoly(ADP-Ribose) polymerase inhibitor3,838
ZepboundGLP-1 receptor agonist7,115

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 52 pharmacologic classes with 5,000 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 Nausea name, in order of name
ClassReports with this term
Alkylating drug9,646
Aminosalicylate7,113
Angiotensin 2 receptor blocker8,576
Angiotensin converting enzyme inhibitor5,058
Anti-epileptic agent9,466
Antimalarial11,426
Antirheumatic agent10,297
Aromatase inhibitor5,748
Atypical antipsychotic14,355
Benzodiazepine6,912
beta-Adrenergic blocker7,139
Biguanide6,442
Bisphosphonate9,104
CD20-directed cytolytic antibody16,275
Central nervous system depressant5,874
Corticosteroid35,489
Endothelin receptor antagonist9,114
Fluoroquinolone antibacterial5,168
Folate analog metabolic inhibitor22,145
GLP-1 receptor agonist58,348
HER2/neu receptor antagonist6,257
Histamine-1 receptor antagonist9,997
HMG-CoA reductase inhibitor8,355
Integrin receptor antagonist8,025
Interferon alpha5,638
Interleukin-17A antagonist6,671
Interleukin-4 receptor alpha antagonist5,015
Interleukin-6 receptor antagonist10,953
Janus kinase inhibitor13,576
Kinase inhibitor61,181
Microtubule inhibitor8,416
Nonsteroidal anti-inflammatory drug28,078
Nucleoside analog antiviral6,746
Nucleoside metabolic inhibitor18,021
Opioid agonist27,115
Osmotic laxative6,184
Parathyroid hormone analog8,570
Partial cholinergic nicotinic agonist13,603
Phosphodiesterase 4 inhibitor22,684
Platinum-based drug15,599
Poly(ADP-Ribose) polymerase inhibitor9,885
Progestin9,652
Programmed death Receptor-1 blocking antibody6,950
Prostacycline vasodilator13,936
Proton pump inhibitor14,533
Pyridone5,028
Selective T cell costimulation modulator7,955
Serotonin and norepinephrine reuptake inhibitor9,063
Serotonin reuptake inhibitor13,822
Thalidomide analog12,845
Tumor necrosis factor blocker51,080
Vascular endothelial growth factor inhibitor6,571

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

Reports by month

Reports that record Nausea, by month, five years to June 2026
05,00010,00020222023202420252026

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 Nausea
AgeReportsShareShare as a bar
Under 25870.1%
2 to 115,1460.7%
12 to 179,7061.3%
18 to 44125,63116.2%
45 to 64203,39226.2%
65 to 7496,02912.4%
75 and over61,1547.9%
Age not given274,38535.4%
Sex of the patient in the reports that record Nausea
SexReportsShareShare as a bar
Female515,15866.4%
Male192,53724.8%
Unknown or not given68,3358.8%

Age and sex are as the report gives them. 72.1% of these reports give the United States as the country.

Terms near this one

These are the next terms in the A to Z list. The links are for navigation.

Official pages

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Reported Reactions. Nausea: adverse event reports that record this term. https://reportedreactions.com/reaction/nausea/ 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 Nausea mean in an adverse event report?

In plain words: feeling sick. 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 .