MedDRA preferred term

Drug specific antibody present: adverse event reports recording this term

6,396 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.

6,396
reports recording the term: 0% of all reports; 363
reports, 12 months to June 2026: 485 in the 12 months before; 59.1%
marked serious by the reporter: 57.4% across all reports; 1.1%
record death among outcomes, as reported: 9.1% across all reports

6,396 reports in FDA's adverse event database record the MedDRA term "Drug specific antibody present": 0% of all reports received between January 2004 and June 2026. Coders pick the term that best matches the reporter's description.

363 reports recorded it in the 12 months to June 2026, down 25% from 485 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, 59.1% are marked serious, 1.1% include death among the outcomes and 21.5% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Humira, Tysabri 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
Humira	—	1,566	0.2%
Tysabri	Integrin receptor antagonist	987	0.6%
Remicade	Tumor necrosis factor blocker	984	0.6%
Infliximab	Tumor necrosis factor blocker	754	1.4%
Inflectra	Tumor necrosis factor blocker	646	2.6%
Adalimumab	Tumor necrosis factor blocker	407	1%
Methotrexate	Folate analog metabolic inhibitor	260	0.1%
Fabrazyme	Hydrolytic lysosomal neutral glycosphingolipid-specific enzyme	174	2.1%
Enbrel	Tumor necrosis factor blocker	152	0%
Vedolizumab	Integrin receptor antagonist	136	0.2%
Nexviazyme	Hydrolytic lysosomal glycogen-specific enzyme	133	15.8%
Actemra	Interleukin-6 receptor antagonist	113	0.1%
Infliximab Recombinant	—	113	1.4%
Orencia	Selective T cell costimulation modulator	110	0.1%
Azathioprine	Purine antimetabolite	99	0.3%
Entyvio	Integrin receptor antagonist	90	0.4%
Simponi	Tumor necrosis factor blocker	89	0.1%
Rituximab	CD20-directed cytolytic antibody	87	0.1%
Anakinra	Interleukin-1 receptor antagonist	80	1.4%
Prednisone	Corticosteroid	79	0%
Lumizyme	Hydrolytic lysosomal glycogen-specific enzyme	67	3.4%
Arava	Antirheumatic agent	64	0.2%
Cimzia	Tumor necrosis factor blocker	59	0.1%
Hydroxychloroquine	Antimalarial	57	0.1%
Mesalamine	Aminosalicylate	57	0.6%

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
Tumor necrosis factor blocker	3,182	0.3%	0.1%
Integrin receptor antagonist	1,217	0.5%	0.3%
Folate analog metabolic inhibitor	308	0.1%	0%
Hydrolytic lysosomal glycogen-specific enzyme	200	7%	9.6%
Hydrolytic lysosomal neutral glycosphingolipid-specific enzyme	200	2.2%	3%
Corticosteroid	163	0%	0%
Antimalarial	141	0.2%	0%
Interleukin-6 receptor antagonist	134	0.1%	0%
Aminosalicylate	114	0.2%	0%
Purine antimetabolite	113	0.2%	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 20.5%29

2 to 113.4%220

12 to 174.1%261

18 to 4421.7%1,385

45 to 6417.2%1,100

65 to 744.7%299

75 and over1.5%98

Age not given47%3,004

Patient sex

Female45.5%2,912

Male30.8%1,970

Not given23.7%1,514

Grey bar: all 20,646,523 reports in the database. 58.8% of these reports give the United States as the country.

Questions about "Drug specific antibody present"

What does "Drug specific antibody present" 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 drug specific antibody present?

6,396 reports through June 2026 (0% of all reports), 363 of them in the latest 12 months.

Which drugs appear most often in these reports?

Humira (1,566), Tysabri (987), Remicade (984), Infliximab (754) and Inflectra (646). 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.