Reported Reactions

Adverse event reports that FDA received

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Body temperature increased adverse event reports that record this term

Kind of term
MedDRA preferred term
Plain meaning
raised temperature

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 20,115 adverse event reports that record the MedDRA preferred term Body temperature increased. In plain words, the term means: raised temperature. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 774 reports in the 12 months to June 2026 and 826 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 746 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, 774 (0.1%) record this term. Reports for patients aged 18 to 44 were 20.8% of the reports that record this term and 12.3% 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

Raised temperature. 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 74 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 Body temperature increased name as a suspect product, in order of name
DrugClassReports with this term
AbataceptSelective T cell costimulation modulator104
Acetaminophen634
ActemraInterleukin-6 receptor antagonist855
AlemtuzumabCD52-directed cytolytic antibody147
AravaAntirheumatic agent504
AvonexInterferon beta192
CarboplatinPlatinum-based drug171
Cetirizine hydrochlorideHistamine-1 receptor antagonist102
Chloraprep159
Chlorhexidine412
Chlorhexidine gluconate170
Cholecalciferol135
CimziaTumor necrosis factor blocker715
CiprofloxacinFluoroquinolone antibacterial103
CisplatinPlatinum-based drug173
ClonazepamBenzodiazepine123
ClozapineAtypical antipsychotic155
ClozarilAtypical antipsychotic285
CosentyxInterleukin-17A antagonist181
CyclophosphamideAlkylating drug247
CytarabineNucleoside metabolic inhibitor161
DexamethasoneCorticosteroid210
DiclofenacNonsteroidal anti-inflammatory drug107
Diclofenac sodiumNonsteroidal anti-inflammatory drug125
Doxorubicin hydrochlorideAnthracycline topoisomerase inhibitor124
DupixentInterleukin-4 receptor alpha antagonist114
EnbrelTumor necrosis factor blocker949
FluorouracilNucleoside metabolic inhibitor118
ForteoParathyroid hormone analog106
FosamaxBisphosphonate104
GilenyaSphingosine 1-phosphate receptor modulator133
Human immunoglobulin gHuman immunoglobulin G112
Humira428
InflectraTumor necrosis factor blocker241
InfliximabTumor necrosis factor blocker271
KesimptaCD20-directed cytolytic antibody117
LeflunomideAntirheumatic agent534
MethotrexateFolate analog metabolic inhibitor974
Methotrexate sodiumFolate analog metabolic inhibitor118
MethylprednisoloneCorticosteroid102
MorphineOpioid agonist122
Morphine sulfateOpioid agonist115
OcrevusCD20-directed cytolytic antibody189
OlanzapineAtypical antipsychotic106
OmalizumabAnti-IgE190
OrenciaSelective T cell costimulation modulator636
OxaliplatinPlatinum-based drug147
OxycodoneOpioid agonist410
Oxycodone hydrochlorideOpioid agonist159
Oxycodone Terephthalate445
PaclitaxelMicrotubule inhibitor118
PantoprazoleProton pump inhibitor102
PegasysInterferon alpha132
PercocetOpioid agonist116
Periogard338
PrednisoloneCorticosteroid100
PrednisoneCorticosteroid429
PrivigenHuman immunoglobulin G124
RemicadeTumor necrosis factor blocker364
RevlimidThalidomide analog192
RibavirinNucleoside analog antiviral119
RituxanCD20-directed cytolytic antibody179
RituximabCD20-directed cytolytic antibody507
Sandostatin LAR Depot165
SertralineSerotonin reuptake inhibitor103
SimponiTumor necrosis factor blocker665
SolirisComplement inhibitor193
Sulfamethoxazole and trimethoprimDihydrofolate reductase inhibitor antibacterial193
Sulfamethoxazole, trimethoprimDihydrofolate reductase inhibitor antibacterial151
Tecfidera135
TysabriIntegrin receptor antagonist210
VedolizumabIntegrin receptor antagonist128
XeljanzJanus kinase inhibitor125
XolairAnti-IgE178

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 26 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 Body temperature increased name, in order of name
ClassReports with this term
Alkylating drug353
Anti-IgE368
Antirheumatic agent1,038
Atypical antipsychotic1,129
Benzodiazepine294
Bisphosphonate344
CD20-directed cytolytic antibody1,065
Corticosteroid1,444
Dihydrofolate reductase inhibitor antibacterial366
Folate analog metabolic inhibitor1,107
Histamine-1 receptor antagonist411
Human immunoglobulin G381
Integrin receptor antagonist392
Interferon beta302
Interleukin-6 receptor antagonist938
Janus kinase inhibitor274
Kinase inhibitor782
Nonsteroidal anti-inflammatory drug704
Nucleoside metabolic inhibitor525
Opioid agonist1,319
Platinum-based drug491
Proton pump inhibitor298
Selective T cell costimulation modulator740
Serotonin reuptake inhibitor472
Thalidomide analog285
Tumor necrosis factor blocker3,462

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

Reports by month

Reports that record Body temperature increased, 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 Body temperature increased
AgeReportsShareShare as a bar
Under 22421.2%
2 to 116433.2%
12 to 174122%
18 to 444,18420.8%
45 to 644,84024.1%
65 to 742,45112.2%
75 and over1,6338.1%
Age not given5,71028.4%
Sex of the patient in the reports that record Body temperature increased
SexReportsShareShare as a bar
Female11,18355.6%
Male7,33436.5%
Unknown or not given1,5987.9%

Age and sex are as the report gives them. 43.3% of these reports give the United States as the country.

Terms near this one

Official pages

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Reported Reactions. Body temperature increased: adverse event reports that record this term. https://reportedreactions.com/reaction/body-temperature-increased/ 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 Body temperature increased mean in an adverse event report?

In plain words: raised temperature. 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 .