Pharmacologic class (EPC) · 4 drug pages

CTLA-4-directed blocking antibody: adverse event reports filed with FDA

45,770 reports list a drug in this class as a suspect or interacting product, 2006–2026.

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.

45,770
reports across the class: 0.2% of all reports; 3,753
reports, 12 months to June 2026: 3,774 in the 12 months before; 89.7%
marked serious by the reporter: 57.4% across all reports; 4
drugs with a page: brand and generic names counted separately

CTLA-4-directed blocking antibody 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 45,770 adverse event reports received by FDA, 0.2% of the database, from October 2006 to June 2026.

3,753 reports arrived in the 12 months to June 2026, close to the 3,774 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 89.7% of the class's reports are marked serious, 22.9% record death among the outcomes and 45.8% record hospitalisation, as reported.

Across the class the reactions recorded most often are death (10.3%), malignant neoplasm progression (8.7%) and diarrhoea (7.3%). 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
YervoyIpilimumab	brand	22,109	1,918	81.5%	Death
Ipilimumab	generic	19,614	792	97.3%	Malignant neoplasm progression
Tremelimumab	generic	2,318	351	99%	Death
ImjudoTremelimumab	brand	1,729	692	94.3%	Death

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

Deaththe patient died; cause not stated by this term10.3%4,716
Malignant neoplasm progression8.7%3,971
Diarrhoealoose or frequent stools7.3%3,349
Colitisinflamed bowel5.4%2,481
Off label useused for a purpose or in a way not on the label5.1%2,336
Pyrexiafever4.8%2,216
Rashskin rash4.2%1,903
Fatiguetiredness3.7%1,704
Nauseafeeling sick3.1%1,412
Intentional product use issuedeliberate use not as intended2.9%1,329
Immune-mediated enterocolitis2.8%1,265
Decreased appetitereduced appetite2.6%1,185
Vomitingbeing sick2.4%1,110
Hypophysitis2.4%1,086
Pneumonialung infection2.3%1,075
Dyspnoeashortness of breath2.3%1,056
Pneumonitis2.3%1,044
Adrenal insufficiencythe adrenal glands produce too little hormone2.2%1,018
Pruritusitching2.1%969
Adverse eventan unwanted medical event, type not specified2.1%947
Acute kidney injurysudden loss of kidney function2%906
Hypothyroidismunderactive thyroid1.9%878
Headachehead pain1.8%818
Anaemialow red blood cells1.7%778
Malaisegeneral feeling of being unwell1.6%753

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

Death22.9%10,493

Life-threatening7.4%3,401

Hospitalisation (initial or prolonged)45.8%20,975

Disability1.6%738

Congenital anomaly0%14

Other serious71.4%32,679

Not serious10.3%4,735

Patient age

Under 20%10

2 to 110.1%36

12 to 170.1%61

18 to 446.4%2,917

45 to 6428%12,809

65 to 7424.2%11,070

75 and over13.7%6,290

Age not given27.5%12,577

Who reported

Physician42%19,236

Pharmacist4.8%2,180

Other health professional34.4%15,734

Lawyer0%10

Consumer or non-health professional18.6%8,493

Not given0.3%117

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 CTLA-4-directed blocking antibody reports

Which drugs are in the CTLA-4-directed blocking antibody class on this site?

Yervoy, Ipilimumab, Tremelimumab and Imjudo. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

45,770 reports through June 2026, 3,753 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?

death (10.3%), malignant neoplasm progression (8.7%), diarrhoea (7.3%), colitis (5.4%) and off label use (5.1%).

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.