MedDRA preferred term · used for a purpose or in a way not on the label

Off label use: adverse event reports recording this term

856,363 reports to FDA record it, 2004–2026; 4.2% 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.

856,363
reports recording the term: 4.2% of all reports; 79,953
reports, 12 months to June 2026: 97,855 in the 12 months before; 53.1%
marked serious by the reporter: 57.4% across all reports; 7.2%
record death among outcomes, as reported: 9.1% across all reports

856,363 reports in FDA's adverse event database record the MedDRA term "Off label use" (in plain words, used for a purpose or in a way not on the label): 4.2% of all reports received between January 2004 and June 2026. Coders pick the term that best matches the reporter's description.

79,953 reports recorded it in the 12 months to June 2026, down 18% from 97,855 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, 53.1% are marked serious, 7.2% include death among the outcomes and 18.8% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Rituximab, Prolia and Remicade. 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
Rituximab	CD20-directed cytolytic antibody	33,629	21.6%
Prolia	RANK ligand inhibitor	33,041	24%
Remicade	Tumor necrosis factor blocker	21,533	13.9%
Methotrexate	Folate analog metabolic inhibitor	20,753	10%
Enbrel	Tumor necrosis factor blocker	20,226	3.6%
Prednisone	Corticosteroid	19,645	10.7%
Infliximab	Tumor necrosis factor blocker	19,488	37.1%
Vedolizumab	Integrin receptor antagonist	18,579	31.7%
Humira	—	14,880	2.3%
Inflectra	Tumor necrosis factor blocker	14,446	57.1%
Dexamethasone	Corticosteroid	13,497	10.4%
Mycophenolate mofetil	Antimetabolite immunosuppressant	13,417	16.3%
Actemra	Interleukin-6 receptor antagonist	13,385	16.7%
Cyclophosphamide	Alkylating drug	12,764	9%
Dupixent	Interleukin-4 receptor alpha antagonist	12,493	2.7%
Jakafi	Janus kinase inhibitor	12,310	22.2%
Revlimid	Thalidomide analog	12,167	3.4%
Hydroxychloroquine	Antimalarial	11,882	29.3%
Xeljanz	Janus kinase inhibitor	11,265	7.2%
Orencia	Selective T cell costimulation modulator	10,748	9.9%
Stelara	Interleukin-12 antagonist	10,723	12.4%
Prednisolone	Corticosteroid	9,552	10.9%
Tacrolimus	Calcineurin inhibitor immunosuppressant	9,385	9.9%
Cimzia	Tumor necrosis factor blocker	9,339	10.7%
Simponi	Tumor necrosis factor blocker	8,753	12.4%

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 4.2% 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	112,106	10.5%	13.9%
Corticosteroid	92,032	11.4%	8.8%
CD20-directed cytolytic antibody	50,723	16%	7.8%
Atypical antipsychotic	46,852	6.9%	6.9%
Nonsteroidal anti-inflammatory drug	41,433	7.6%	4.6%
Kinase inhibitor	41,182	4.8%	4.1%
RANK ligand inhibitor	34,866	20.7%	6.7%
Janus kinase inhibitor	31,141	9.6%	11.5%
Folate analog metabolic inhibitor	28,714	9.2%	4.8%
Interleukin-6 receptor antagonist	24,228	18%	16.7%

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 20.9%7,583

2 to 113.1%26,709

12 to 173.1%26,560

18 to 4413.9%119,160

45 to 6419.9%170,198

65 to 7412.2%104,826

75 and over10.2%87,706

Age not given36.6%313,621

Patient sex

Female50.2%429,778

Male33.1%283,346

Not given16.7%143,239

Grey bar: all 20,646,523 reports in the database. 63.4% of these reports give the United States as the country.

Questions about "Off label use"

What does "Off label use" mean in an adverse event report?

In plain language: used for a purpose or in a way not on the label. 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 off label use?

856,363 reports through June 2026 (4.2% of all reports), 79,953 of them in the latest 12 months.

Which drugs appear most often in these reports?

Rituximab (33,629), Prolia (33,041), Remicade (21,533), Methotrexate (20,753) and Enbrel (20,226). 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.