MedDRA preferred term · a cut in the skin

Skin laceration: adverse event reports recording this term

10,614 reports to FDA record it, 2004–2026; 0.1% 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.

10,614
reports recording the term: 0.1% of all reports; 886
reports, 12 months to June 2026: 822 in the 12 months before; 68.8%
marked serious by the reporter: 57.4% across all reports; 4.2%
record death among outcomes, as reported: 9.1% across all reports

10,614 reports in FDA's adverse event database record the MedDRA term "Skin laceration" (in plain words, a cut in the skin): 0.1% of all reports received between January 2004 and June 2026. Coders pick the term that best matches the reporter's description.

886 reports recorded it in the 12 months to June 2026, close to the 822 of 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, 68.8% are marked serious, 4.2% include death among the outcomes and 35.9% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Humira, Enbrel and Actemra. 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
Humira	—	767	0.1%
Enbrel	Tumor necrosis factor blocker	441	0.1%
Actemra	Interleukin-6 receptor antagonist	345	0.4%
Dupixent	Interleukin-4 receptor alpha antagonist	257	0.1%
Methotrexate	Folate analog metabolic inhibitor	256	0.1%
Prednisone	Corticosteroid	236	0.1%
Imbruvica	Kinase inhibitor	219	0.3%
Eliquis	Factor Xa inhibitor	209	0.2%
Rituximab	CD20-directed cytolytic antibody	195	0.1%
Skyrizi	Interleukin-23 antagonist	183	0.2%
Remicade	Tumor necrosis factor blocker	168	0.1%
Ocrevus	CD20-directed cytolytic antibody	156	0.3%
Human immunoglobulin g	Human immunoglobulin G	146	0.9%
Rinvoq	Janus kinase inhibitor	138	0.2%
Revlimid	Thalidomide analog	136	0%
Orencia	Selective T cell costimulation modulator	132	0.1%
Hemlibra	—	120	1.1%
Avonex	Interferon beta	117	0.1%
Xeljanz	Janus kinase inhibitor	112	0.1%
Clonazepam	Benzodiazepine	110	0.3%
Omalizumab	Anti-IgE	110	1.1%
Arava	Antirheumatic agent	106	0.3%
Vioxx	—	103	0.3%
Inflectra	Tumor necrosis factor blocker	98	0.4%
Tysabri	Integrin receptor antagonist	94	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 0.1% 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
Tumor necrosis factor blocker	959	0.1%	0.1%
Corticosteroid	486	0.1%	0%
CD20-directed cytolytic antibody	456	0.1%	0%
Kinase inhibitor	455	0.1%	0%
Interleukin-6 receptor antagonist	369	0.3%	0.1%
Factor Xa inhibitor	359	0.1%	0.1%
Janus kinase inhibitor	320	0.1%	0.1%
Folate analog metabolic inhibitor	293	0.1%	0%
Interleukin-4 receptor alpha antagonist	268	0.1%	0.1%
Opioid agonist	259	0%	0%

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 20.2%20

2 to 111.2%125

12 to 171.2%126

18 to 4410.6%1,121

45 to 6421.6%2,291

65 to 7414.9%1,585

75 and over14.5%1,542

Age not given35.8%3,804

Patient sex

Female51.8%5,503

Male39.3%4,166

Not given8.9%945

Grey bar: all 20,646,523 reports in the database. 69.3% of these reports give the United States as the country.

Questions about "Skin laceration"

What does "Skin laceration" mean in an adverse event report?

In plain language: a cut in the skin. 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 skin laceration?

10,614 reports through June 2026 (0.1% of all reports), 886 of them in the latest 12 months.

Which drugs appear most often in these reports?

Humira (767), Enbrel (441), Actemra (345), Dupixent (257) and Methotrexate (256). 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.