MedDRA preferred term

Tenderness: adverse event reports recording this term

10,278 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.

10,278
reports recording the term: 0.1% of all reports; 419
reports, 12 months to June 2026: 426 in the 12 months before; 62.5%
marked serious by the reporter: 57.4% across all reports; 4.1%
record death among outcomes, as reported: 9.1% across all reports

"Tenderness" is a MedDRA preferred term recorded in 10,278 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

419 reports recorded it in the 12 months to June 2026, close to the 426 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, 62.5% are marked serious, 4.1% include death among the outcomes and 25% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Enbrel, Humira and Methotrexate. 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	842	0.1%
Humira	—	701	0.1%
Methotrexate	Folate analog metabolic inhibitor	697	0.3%
Xeljanz	Janus kinase inhibitor	602	0.4%
Cosentyx	Interleukin-17A antagonist	479	0.3%
Sulfasalazine	Aminosalicylate	299	0.7%
Prednisone	Corticosteroid	270	0.1%
Simvastatin	HMG-CoA reductase inhibitor	250	0.7%
Dupixent	Interleukin-4 receptor alpha antagonist	230	0%
Actemra	Interleukin-6 receptor antagonist	216	0.3%
Zometa	—	204	0.9%
Methotrexate sodium	Folate analog metabolic inhibitor	199	0.3%
Folic acid	Vitamin B12	185	0.8%
Lyrica	—	179	0.1%
Diclofenac	Nonsteroidal anti-inflammatory drug	176	0.6%
Leflunomide	Antirheumatic agent	167	0.5%
Remicade	Tumor necrosis factor blocker	161	0.1%
Pantoprazole	Proton pump inhibitor	146	0.3%
Arava	Antirheumatic agent	143	0.4%
Diclofenac sodium	Nonsteroidal anti-inflammatory drug	142	0.3%
Plaquenil	Antimalarial	142	0.7%
Rituximab	CD20-directed cytolytic antibody	141	0.1%
Hydroxychloroquine	Antimalarial	140	0.3%
Rituxan	CD20-directed cytolytic antibody	128	0.3%
Hydroxychloroquine sulfate	Antimalarial	124	0.5%

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	1,375	0.1%	0.1%
Nonsteroidal anti-inflammatory drug	997	0.2%	0%
Folate analog metabolic inhibitor	903	0.3%	0%
Corticosteroid	727	0.1%	0%
Janus kinase inhibitor	696	0.2%	0%
Interleukin-17A antagonist	516	0.3%	0.4%
Kinase inhibitor	469	0.1%	0%
HMG-CoA reductase inhibitor	426	0.2%	0.1%
Antimalarial	406	0.4%	0%
Proton pump inhibitor	371	0.1%	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%22

2 to 111.2%122

12 to 171.1%114

18 to 4416.4%1,686

45 to 6429.3%3,014

65 to 7413.3%1,363

75 and over7.8%798

Age not given30.7%3,159

Patient sex

Female63.1%6,481

Male30.7%3,158

Not given6.2%639

Grey bar: all 20,646,523 reports in the database. 65.6% of these reports give the United States as the country.

Questions about "Tenderness"

What does "Tenderness" mean in an adverse event report?

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 tenderness?

10,278 reports through June 2026 (0.1% of all reports), 419 of them in the latest 12 months.

Which drugs appear most often in these reports?

Enbrel (842), Humira (701), Methotrexate (697), Xeljanz (602) and Cosentyx (479). 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.