Skin warm 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 January 2004 to June 2026, FDA received 5,739 adverse event reports that record the MedDRA preferred term Skin warm. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 313 reports in the 12 months to June 2026 and 347 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 1,214 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, 313 (under 0.1%) record this term. Reports for female patients were 66.5% 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 148 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 Skin warm name as a suspect product, in order of name
Drug	Class	Reports with this term
Abreva	Non-Standardized chemical allergen	20
Actemra	Interleukin-6 receptor antagonist	74
Actifed		20
Adalimumab	Tumor necrosis factor blocker	19
Aleve	Nonsteroidal anti-inflammatory drug	18
Amlodipine	Calcium channel blocker	16
Amoxicillin	Penicillin-class antibacterial	17
Ampicillin	Penicillin-class antibacterial	20
Ampyra	Potassium channel blocker	12
Antivert		15
Arava	Antirheumatic agent	53
Asacol		21
Aspirin	Nonsteroidal anti-inflammatory drug	13
Avelox		14
Avonex	Interferon beta	29
Azathioprine	Purine antimetabolite	19
Bactrim	Dihydrofolate reductase inhibitor antibacterial	21
Benlysta	B lymphocyte stimulator-specific inhibitor	10
BOTOX Cosmetic	Acetylcholine release inhibitor	11
Buscopan		16
Celexa	Serotonin reuptake inhibitor	15
Cimzia	Tumor necrosis factor blocker	29
Ciprofloxacin	Fluoroquinolone antibacterial	39
Ciprofloxacin hydrochloride	Fluoroquinolone antibacterial	11
Clindamycin	Lincosamide antibacterial	10
Clindamycin hydrochloride	Lincosamide antibacterial	10
Clobetasol		16
Clonazepam	Benzodiazepine	31
Colchicine	Alkaloid	23
Compazine		21
Cortifoam	Corticosteroid	16
Cosentyx	Interleukin-17A antagonist	36
Covid-19 Vaccine		10
Cyclosporine	Calcineurin inhibitor immunosuppressant	24
Cymbalta		11
Dexamethasone	Corticosteroid	19
Diamox Sequels		25
Differin	Retinoid	17
Digoxin	Cardiac glycoside	14
Dilaudid	Opioid agonist	25
Doxycycline	Tetracycline-class drug	25
Dupilumab	Interleukin-4 receptor alpha antagonist	17
Dupixent	Interleukin-4 receptor alpha antagonist	357
Dyazide		10
Eligard	Gonadotropin releasing hormone receptor agonist	17
Elocon		12
Enbrel	Tumor necrosis factor blocker	253
Entyvio	Integrin receptor antagonist	19
Epiduo		10
Erythromycin		24
Escitalopram	Serotonin reuptake inhibitor	12
Eumovate		14
Fentanyl	Opioid agonist	13
Forteo	Parathyroid hormone analog	12
Fragmin	Anti-coagulant	23
Gabapentin	Anti-epileptic agent	19
Geodon	Atypical antipsychotic	24
Gilenya	Sphingosine 1-phosphate receptor modulator	15
Hizentra	Human immunoglobulin G	29
Humira		410
Humira 40 Mg/0 8 Ml Pen		10
Hydrocortisone	Corticosteroid	15
Hydroxychloroquine sulfate	Antimalarial	25
Ibuprofen	Nonsteroidal anti-inflammatory drug	13
Imuran	Purine antimetabolite	25
Inflectra	Tumor necrosis factor blocker	28
Infliximab	Tumor necrosis factor blocker	54
Iron		20
Keflex		20
Kevzara	Interleukin-6 receptor antagonist	21
Lacosamide		15
Lamictal	Anti-epileptic agent	17
Lamotrigine	Anti-epileptic agent	26
Lasix	Loop diuretic	27
Leflunomide	Antirheumatic agent	13
Levaquin		10
Levetiracetam		21
Levofloxacin	Fluoroquinolone antibacterial	14
Lialda	Aminosalicylate	21
Lyrica		39
Magnevist		17
Mesalamine	Aminosalicylate	14
Metformin	Biguanide	13
Methotrexate	Folate analog metabolic inhibitor	91
Methotrexate sodium	Folate analog metabolic inhibitor	15
Mirvaso	alpha-Adrenergic agonist	43
Mirvaso Topical Gel 0 33%		30
Moclobemide		15
Morphine sulfate	Opioid agonist	10
Nemluvio		15
Nexavar	Kinase inhibitor	18
Nexplanon	Progestin	11
Niaspan		121
Ocrevus	CD20-directed cytolytic antibody	15
Olanzapine	Atypical antipsychotic	14
Opsumit	Endothelin receptor antagonist	13
Orencia	Selective T cell costimulation modulator	41
Orenitram	Prostacycline vasodilator	10
Paclitaxel	Microtubule inhibitor	19
Pantoprazole	Proton pump inhibitor	18
Pantoprazole sodium	Proton pump inhibitor	12
Paxlovid		12
Pegasys	Interferon alpha	13
Phenytoin	Anti-epileptic agent	15
Plaquenil	Antimalarial	45
Potassium		14
Pradaxa	Direct thrombin inhibitor	15
Praluent	PCSK9 inhibitor	13
Prednisolone	Corticosteroid	32
Prednisone	Corticosteroid	67
Proactiv Solution Daily Protection Plus Sunscreen Spf 30		42
Prolia	RANK ligand inhibitor	34
Remicade	Tumor necrosis factor blocker	81
Remodulin	Prostacycline vasodilator	11
Revlimid	Thalidomide analog	27
Ribavirin	Nucleoside analog antiviral	10
Rinvoq	Janus kinase inhibitor	39
Risperdal	Atypical antipsychotic	12
Risperidone	Atypical antipsychotic	14
Rituxan	CD20-directed cytolytic antibody	35
Rituximab	CD20-directed cytolytic antibody	29
Sandostatin	Somatostatin analog	21
Sandostatin LAR Depot		19
Sertraline	Serotonin reuptake inhibitor	11
Simcor		27
Simponi	Tumor necrosis factor blocker	27
Simponi Aria	Tumor necrosis factor blocker	15
Skyrizi	Interleukin-23 antagonist	18
Soliris	Complement inhibitor	10
Stelara	Interleukin-12 antagonist	25
Stivarga	Kinase inhibitor	11
Sudafed		22
Sulfasalazine	Aminosalicylate	29
Tacrolimus	Calcineurin inhibitor immunosuppressant	12
Tecfidera		158
Tecta		13
Terbinafine	Allylamine antifungal	13
Trileptal	Anti-epileptic agent	22
Tysabri	Integrin receptor antagonist	27
Ultram		19
Vedolizumab	Integrin receptor antagonist	20
Xanax	Benzodiazepine	29
Xarelto	Factor Xa inhibitor	12
Xeljanz	Janus kinase inhibitor	21
Xeloda	Nucleoside metabolic inhibitor	14
Xolair	Anti-IgE	23
Zenpep		28
Zyrtec	Histamine-1 receptor antagonist	25

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 39 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 Skin warm name, in order of name
Class	Reports with this term
alpha-Adrenergic agonist	45
Aminosalicylate	64
Anti-coagulant	28
Anti-epileptic agent	99
Anti-IgE	31
Antimalarial	79
Antirheumatic agent	66
Atypical antipsychotic	78
Benzodiazepine	83
Calcineurin inhibitor immunosuppressant	42
CD20-directed cytolytic antibody	84
Corticosteroid	173
Dihydrofolate reductase inhibitor antibacterial	32
Fluoroquinolone antibacterial	69
Folate analog metabolic inhibitor	106
Histamine-1 receptor antagonist	55
Human immunoglobulin G	38
Integrin receptor antagonist	66
Interferon beta	35
Interleukin-12 antagonist	30
Interleukin-17A antagonist	50
Interleukin-4 receptor alpha antagonist	374
Interleukin-6 receptor antagonist	99
Janus kinase inhibitor	60
Kinase inhibitor	63
Loop diuretic	33
Nonsteroidal anti-inflammatory drug	77
Opioid agonist	69
Penicillin-class antibacterial	47
Prostacycline vasodilator	33
Proton pump inhibitor	45
Purine antimetabolite	57
RANK ligand inhibitor	34
Selective T cell costimulation modulator	43
Serotonin reuptake inhibitor	55
Somatostatin analog	25
Tetracycline-class drug	32
Thalidomide analog	38
Tumor necrosis factor blocker	518

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

Reports by month

Reports that record Skin warm, 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 Skin warm
Age	Reports	Share
Under 2	31	0.5%
2 to 11	101	1.8%
12 to 17	293	5.1%
18 to 44	1,234	21.5%
45 to 64	1,458	25.4%
65 to 74	640	11.2%
75 and over	373	6.5%
Age not given	1,609	28%

Sex of the patient in the reports that record Skin warm
Sex	Reports	Share
Female	3,819	66.5%
Male	1,547	27%
Unknown or not given	373	6.5%

Age and sex are as the report gives them. 72.3% 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. Skin warm: adverse event reports that record this term. https://reportedreactions.com/reaction/skin-warm/ 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 Skin warm 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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