Pharmacologic class (EPC) · 4 drug pages

Integrin receptor antagonist: adverse event reports filed with FDA

258,020 reports list a drug in this class as a suspect or interacting product, 2004–2026.

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.

258,020
reports across the class: 1.3% of all reports; 12,939
reports, 12 months to June 2026: 13,913 in the 12 months before; 48.8%
marked serious by the reporter: 57.4% across all reports; 4
drugs with a page: brand and generic names counted separately

Integrin receptor antagonist is a pharmacologic class (an FDA Established Pharmacologic Class) with 4 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 258,020 adverse event reports received by FDA, 1.3% of the database, from December 2004 to June 2026.

12,939 reports arrived in the 12 months to June 2026, close to the 13,913 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 48.8% of the class's reports are marked serious, 3.5% record death among the outcomes and 22.2% record hospitalisation, as reported.

Across the class the reactions recorded most often are fatigue (9.8%), off label use (8.8%) and multiple sclerosis relapse (6.4%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
TysabriNatalizumab	brand	173,350	2,471	30.8%	Fatigue
Vedolizumab	generic	58,654	8,232	98.6%	Off label use
EntyvioVedolizumab	brand	23,511	2,171	57.5%	Off label use
Natalizumab	generic	2,505	65	48.7%	Fatigue

Ordered by report count for navigation only. 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."

Reports by month, five years

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

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Fatiguetiredness9.8%25,319
Off label useused for a purpose or in a way not on the label8.8%22,650
Multiple sclerosis relapsea flare of multiple sclerosis6.4%16,503
Drug ineffectivethe medicine did not work as expected6.2%15,897
Colitis ulcerative6%15,454
Headachehead pain5.3%13,785
Malaisegeneral feeling of being unwell4.4%11,398
Crohn's disease4.4%11,250
Diarrhoealoose or frequent stools4.1%10,461
Astheniaweakness or lack of energy3.9%9,973
Multiple sclerosis3.7%9,610
Gait disturbancedifficulty walking3.7%9,566
Falla fall3.5%9,054
Painpain, site not specified3.3%8,424
Memory impairmentmemory problems3.2%8,381
Nauseafeeling sick3.1%8,025
Abdominal painstomach or belly pain3%7,866
Arthralgiajoint pain2.9%7,462
Urinary tract infectionbladder or urinary infection2.8%7,264
Nasopharyngitisa cold2.6%6,804
Pain in extremitypain in an arm or leg2.5%6,448
Haematocheziablood in the stool2.4%6,182
Hypoaesthesianumbness2.4%6,145
Dizzinesslight-headedness or unsteadiness2.3%5,879
Pyrexiafever2.2%5,705

Solid bar: share of all class reports. Hollow bar: the median share across the 4 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death3.5%9,039

Life-threatening0.9%2,295

Hospitalisation (initial or prolonged)22.2%57,329

Disability0.7%1,710

Congenital anomaly0.3%695

Other serious32.4%83,640

Not serious51.2%132,040

Patient age

Under 20.2%476

2 to 110.2%420

12 to 170.6%1,483

18 to 4426.2%67,625

45 to 6426.9%69,416

65 to 745.1%13,133

75 and over2.1%5,491

Age not given38.7%99,976

Who reported

Physician18.3%47,137

Pharmacist1%2,692

Other health professional18.1%46,795

Lawyer0%33

Consumer or non-health professional61.5%158,701

Not given1%2,662

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Integrin receptor antagonist reports

Which drugs are in the Integrin receptor antagonist class on this site?

Tysabri, Vedolizumab, Entyvio and Natalizumab. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

258,020 reports through June 2026, 12,939 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

fatigue (9.8%), off label use (8.8%), multiple sclerosis relapse (6.4%), drug ineffective (6.2%) and colitis ulcerative (6%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

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. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.