MedDRA preferred term · a burn from heat

Thermal burn: adverse event reports recording this term

6,987 reports to FDA record it, 2004–2026; 0% of the database.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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 "cannot be used to estimate the incidence of these events."

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.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

6,987
reports recording the term: 0% of all reports; 261
reports, 12 months to June 2026: 330 in the 12 months before; 67.4%
marked serious by the reporter: 57.4% across all reports; 5.2%
record death among outcomes, as reported: 9.1% across all reports

"Thermal burn" (in plain words, a burn from heat) is a MedDRA preferred term recorded in 6,987 adverse event reports received by FDA, 0% of the database, from January 2004 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

261 reports recorded it in the 12 months to June 2026, down 21% from 330 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Of reports recording this term, 67.4% are marked serious, 5.2% include death among the outcomes and 29.8% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Enbrel, Humira and Alprazolam. That order mostly follows how many reports each drug has overall; the table also gives the term's share within each drug's own reports. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Drugs listed as suspect products in these reports

Drug	Class	Reports with this term	Share of the drug's own reports
Enbrel	Tumor necrosis factor blocker	234	0%
Humira	—	231	0%
Alprazolam	Benzodiazepine	162	0.3%
Abilify	Atypical antipsychotic	160	0.3%
Actemra	Interleukin-6 receptor antagonist	139	0.2%
Sertraline hydrochloride	Serotonin reuptake inhibitor	119	1.1%
Oxygen	—	112	5.6%
Paroxetine hydrochloride	Serotonin reuptake inhibitor	112	1.3%
Tysabri	Integrin receptor antagonist	112	0.1%
Bupropion hydrochloride	Aminoketone	108	0.5%
Avonex	Interferon beta	99	0.1%
Quetiapine fumarate	Atypical antipsychotic	99	0.5%
Bupropion	Aminoketone	97	0.5%
Cosentyx	Interleukin-17A antagonist	90	0.1%
Dupixent	Interleukin-4 receptor alpha antagonist	84	0%
Methotrexate	Folate analog metabolic inhibitor	78	0%
Nicorette	Cholinergic nicotinic agonist	73	0.6%
Azithromycin	Macrolide antimicrobial	71	0.4%
Piroxicam	Nonsteroidal anti-inflammatory drug	69	4%
Lyrica	—	64	0.1%
Quetiapine	Atypical antipsychotic	63	0.1%
Gilenya	Sphingosine 1-phosphate receptor modulator	61	0.1%
OxyContin	Opioid agonist	60	0%
Seroquel	Atypical antipsychotic	59	0.1%
Xolair	Anti-IgE	59	0.1%

Drugs with a page on this site, ordered by the number of their reports recording this term. The last column is the term's share within that drug's own reports, against 0% across the whole database. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

By pharmacologic class

Class	Reports with this term	Share of class reports	Median drug in class
Atypical antipsychotic	473	0.1%	0%
Serotonin reuptake inhibitor	389	0.1%	0%
Opioid agonist	356	0%	0%
Tumor necrosis factor blocker	334	0%	0%
Aminoketone	259	0.4%	0.3%
Nonsteroidal anti-inflammatory drug	231	0%	0%
Benzodiazepine	227	0.1%	0%
Kinase inhibitor	170	0%	0%
Interleukin-6 receptor antagonist	143	0.1%	0%
Cholinergic nicotinic agonist	142	0.3%	0.1%

Classes ordered by count. Class shares follow the class's overall report volume as much as anything else.

Patients in these reports

Patient age

Under 20.6%42

2 to 111.7%117

12 to 172.1%150

18 to 4415%1,050

45 to 6425.4%1,777

65 to 7410%698

75 and over7%492

Age not given38.1%2,661

Patient sex

Female62.4%4,358

Male30.5%2,128

Not given7.2%501

Grey bar: all 20,646,523 reports in the database. 67.3% of these reports give the United States as the country.

Questions about "Thermal burn"

What does "Thermal burn" mean in an adverse event report?

In plain language: a burn from heat. It is a MedDRA preferred term, the dictionary FDA uses to code what a reporter described. The report's own description is not published by openFDA and is not shown here.

How many reports record thermal burn?

6,987 reports through June 2026 (0% of all reports), 261 of them in the latest 12 months.

Which drugs appear most often in these reports?

Enbrel (234), Humira (231), Alprazolam (162), Abilify (160) and Actemra (139). Drugs with many reports overall lead almost every term's list. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Does a drug appearing here mean it was responsible for this reaction?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

I have this symptom. What should I do?

This site cannot assess anyone. A pharmacist or clinician can; for an emergency, call the local emergency number. Nothing on this page is medical advice.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. Terms are pooled across spelling and capitalisation variants of one MedDRA preferred term. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.