Feeling of body temperature change 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 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 March 2004 to June 2026, FDA received 5,791 adverse event reports that record the MedDRA preferred term Feeling of body temperature change. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 255 reports in the 12 months to June 2026 and 349 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 1,279 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, 255 (under 0.1%) record this term. Reports for female patients were 67.8% 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 10 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 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.

Drugs that the reports with the term Feeling of body temperature change name as a suspect product, in order of name
Drug	Class	Reports with this term
Actemra	Interleukin-6 receptor antagonist	21
Adalimumab	Tumor necrosis factor blocker	10
Alemtuzumab	CD52-directed cytolytic antibody	14
Ambrisentan	Endothelin receptor antagonist	14
Amitriptyline		53
Amitriptyline hydrochloride	Tricyclic antidepressant	21
Amlodipine	Calcium channel blocker	22
Amoxicillin	Penicillin-class antibacterial	14
Ampyra	Potassium channel blocker	22
Atorvastatin		24
Aubagio	Pyrimidine synthesis inhibitor	17
Avonex	Interferon beta	124
Butrans	Partial opioid agonist	13
Caplyta	Atypical antipsychotic	26
Carbamazepine	Mood stabilizer	11
Champix		10
Chantix	Partial cholinergic nicotinic agonist	22
Ciprofloxacin	Fluoroquinolone antibacterial	27
Ciprofloxacin Lactate		10
Citalopram	Serotonin reuptake inhibitor	22
Clarithromycin	Macrolide antimicrobial	22
Clonazepam	Benzodiazepine	78
Codeine		41
Codeine phosphate		27
Copaxone		11
Copegus		16
Cosentyx	Interleukin-17A antagonist	28
Cymbalta		100
Desvenlafaxine succinate	Serotonin and norepinephrine reuptake inhibitor	15
Diazepam	Benzodiazepine	65
Domperidone		64
Doxazosin	alpha-Adrenergic blocker	13
Dupixent	Interleukin-4 receptor alpha antagonist	35
Duragesic		11
Duragesic-100		16
Effexor	Serotonin and norepinephrine reuptake inhibitor	18
Enbrel	Tumor necrosis factor blocker	162
Erythromycin		10
Euthyrox		11
Fentanyl	Opioid agonist	25
Fentanyl Transdermal System		36
Fluoxetine	Serotonin reuptake inhibitor	11
Forteo	Parathyroid hormone analog	54
Gabapentin	Anti-epileptic agent	47
Gilenya	Sphingosine 1-phosphate receptor modulator	32
Humira		162
Hydrocortisone	Corticosteroid	15
Ibrance	Kinase inhibitor	47
Ibuprofen	Nonsteroidal anti-inflammatory drug	16
Incivek		32
Inflectra	Tumor necrosis factor blocker	31
Infliximab	Tumor necrosis factor blocker	20
Jakafi	Janus kinase inhibitor	19
Kesimpta	CD20-directed cytolytic antibody	106
Kisqali	Kinase inhibitor	25
Latuda	Atypical antipsychotic	11
Letairis	Endothelin receptor antagonist	16
Levaquin		21
Levothyroxine		15
Lorazepam	Benzodiazepine	69
Lupron Depot		15
Lyrica		194
Metformin	Biguanide	15
Methotrexate	Folate analog metabolic inhibitor	28
Metronidazole	Nitroimidazole antimicrobial	15
Mirena	Progestin	18
Mirtazapine		92
Mometasone furoate	Corticosteroid	11
Morphine	Opioid agonist	17
Morphine sulfate	Opioid agonist	12
Mounjaro	GLP-1 receptor agonist	15
Nexium	Proton pump inhibitor	11
Niaspan		18
Novothyrox		44
Ocrevus	CD20-directed cytolytic antibody	23
Omalizumab	Anti-IgE	17
Omeprazole	Proton pump inhibitor	75
Opsumit	Endothelin receptor antagonist	12
Orenitram	Prostacycline vasodilator	18
Orgovyx	Gonadotropin releasing hormone receptor antagonist	82
Otezla	Phosphodiesterase 4 inhibitor	19
Oxycodone hydrochloride	Opioid agonist	18
OxyContin	Opioid agonist	55
Ozempic	GLP-1 receptor agonist	11
Paroxetine	Serotonin reuptake inhibitor	56
Paroxetine hydrochloride	Serotonin reuptake inhibitor	50
Paxlovid		13
Pegasys	Interferon alpha	68
Phosphorus		49
Plegridy	Interferon beta	14
Prednisone	Corticosteroid	39
Pregabalin		14
Procyclidine		43
Procyclidine hydrochloride		17
Prolia	RANK ligand inhibitor	24
Prozac	Serotonin reuptake inhibitor	13
Quetiapine	Atypical antipsychotic	55
Quetiapine fumarate	Atypical antipsychotic	22
Ramipril	Angiotensin converting enzyme inhibitor	20
Rebif	Interferon beta	54
Remicade	Tumor necrosis factor blocker	37
Remodulin	Prostacycline vasodilator	17
Repatha	PCSK9 inhibitor	20
Revlimid	Thalidomide analog	56
Rezolsta		11
Ribavirin	Nucleoside analog antiviral	57
Rituxan	CD20-directed cytolytic antibody	11
Rituximab	CD20-directed cytolytic antibody	39
Seroquel	Atypical antipsychotic	43
Seroxat		13
Sertraline	Serotonin reuptake inhibitor	22
Skyrizi	Interleukin-23 antagonist	16
Stelara	Interleukin-12 antagonist	13
Sublocade	Partial opioid agonist	16
Suboxone	Opioid antagonist	111
Suboxone Film		14
Subutex		11
Sumatriptan	Serotonin-1b and Serotonin-1d receptor agonist	10
Synthroid	l-Thyroxine	24
Tecfidera		86
Tramadol		54
Tramadol hydrochloride	Opioid agonist	33
Trazodone		10
Tymlos		17
Tysabri	Integrin receptor antagonist	56
Tyvaso DPI	Prostacycline vasodilator	11
Uptravi	Prostacyclin receptor agonist	14
Vedolizumab	Integrin receptor antagonist	20
Vivitrol		48
Xarelto	Factor Xa inhibitor	11
Xeljanz	Janus kinase inhibitor	33
Xolair	Anti-IgE	17
Xyrem	Central nervous system depressant	45
Xywav	Central nervous system depressant	12

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 36 pharmacologic classes with 25 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 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.

Pharmacologic classes of the drugs that the reports with the term Feeling of body temperature change name, in order of name
Class	Reports with this term
Angiotensin converting enzyme inhibitor	30
Anti-epileptic agent	57
Anti-IgE	34
Atypical antipsychotic	214
Benzodiazepine	234
Calcium channel blocker	26
CD20-directed cytolytic antibody	185
Central nervous system depressant	64
Corticosteroid	99
Endothelin receptor antagonist	42
Fluoroquinolone antibacterial	32
Folate analog metabolic inhibitor	33
GLP-1 receptor agonist	49
Gonadotropin releasing hormone receptor antagonist	84
Integrin receptor antagonist	76
Interferon alpha	68
Interferon beta	198
Interleukin-17A antagonist	31
Interleukin-4 receptor alpha antagonist	37
Janus kinase inhibitor	58
Kinase inhibitor	114
l-Thyroxine	36
Nonsteroidal anti-inflammatory drug	39
Nucleoside analog antiviral	57
Opioid agonist	209
Opioid antagonist	118
Parathyroid hormone analog	54
Partial opioid agonist	38
Progestin	31
Prostacycline vasodilator	66
Proton pump inhibitor	96
Serotonin and norepinephrine reuptake inhibitor	67
Serotonin reuptake inhibitor	190
Sphingosine 1-phosphate receptor modulator	38
Thalidomide analog	58
Tumor necrosis factor blocker	278

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

Reports by month

Reports that record Feeling of body temperature change, 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.

Patients in these reports

Age of the patient in the reports that record Feeling of body temperature change
Age	Reports	Share
Under 2	3	0.1%
2 to 11	19	0.3%
12 to 17	52	0.9%
18 to 44	1,301	22.5%
45 to 64	1,677	29%
65 to 74	541	9.3%
75 and over	310	5.4%
Age not given	1,888	32.6%

Sex of the patient in the reports that record Feeling of body temperature change
Sex	Reports	Share
Female	3,926	67.8%
Male	1,407	24.3%
Unknown or not given	458	7.9%

Age and sex are as the report gives them. 70.9% 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

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. Feeling of body temperature change: adverse event reports that record this term. https://reportedreactions.com/reaction/feeling-of-body-temperature-change/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 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 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 Feeling of body temperature change 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 2 Oct 2026.

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.

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 2 Oct 2026.

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