Pharmacologic class (EPC) · 8 drug pages

Programmed death Receptor-1 blocking antibody: adverse event reports filed with FDA

225,959 reports list a drug in this class as a suspect or interacting product, 2011–2026.

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.

225,959
reports across the class: 1.1% of all reports; 26,144
reports, 12 months to June 2026: 26,585 in the 12 months before; 89.9%
marked serious by the reporter: 57.4% across all reports; 8
drugs with a page: brand and generic names counted separately

Programmed death Receptor-1 blocking antibody is a pharmacologic class (an FDA Established Pharmacologic Class) with 8 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 225,959 adverse event reports received by FDA, 1.1% of the database, from August 2011 to June 2026.

26,144 reports arrived in the 12 months to June 2026, close to the 26,585 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 89.9% of the class's reports are marked serious, 22.5% record death among the outcomes and 41.8% record hospitalisation, as reported.

Across the class the reactions recorded most often are malignant neoplasm progression (9.5%), death (9.3%) and off label use (5.4%). 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
KeytrudaPembrolizumab	brand	63,638	8,465	84%	Malignant neoplasm progression
OpdivoNivolumab	brand	46,610	3,753	83.6%	Death
Nivolumab	generic	45,823	2,581	96%	Malignant neoplasm progression
Pembrolizumab	generic	30,990	6,212	95.7%	Malignant neoplasm progression
Atezolizumab	generic	19,768	1,887	97.7%	Off label use
TecentriqAtezolizumab	brand	16,957	2,349	93.5%	Death
Dostarlimab	generic	1,280	475	97.5%	Malignant neoplasm progression
JemperliDostarlimab	brand	893	422	70.1%	Off label use

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

Malignant neoplasm progression9.5%21,578
Deaththe patient died; cause not stated by this term9.3%20,993
Off label useused for a purpose or in a way not on the label5.4%12,291
Diarrhoealoose or frequent stools5.1%11,493
Fatiguetiredness4.3%9,611
Pyrexiafever3.9%8,808
Rashskin rash3.2%7,274
Nauseafeeling sick3.1%6,950
Decreased appetitereduced appetite2.9%6,551
Hypothyroidismunderactive thyroid2.6%5,857
Dyspnoeashortness of breath2.5%5,711
Pneumonialung infection2.5%5,546
Anaemialow red blood cells2.4%5,338
Astheniaweakness or lack of energy2.4%5,319
Pneumonitis2.3%5,270
Colitisinflamed bowel2.2%4,901
Interstitial lung diseasescarring or inflammation of lung tissue2.2%4,895
Product use in unapproved indicationused for a purpose not on the label2.1%4,835
Acute kidney injurysudden loss of kidney function2.1%4,825
Vomitingbeing sick2%4,596
Hypertensionhigh blood pressure1.9%4,285
Intentional product use issuedeliberate use not as intended1.8%4,145
Drug ineffectivethe medicine did not work as expected1.8%4,134
Malaisegeneral feeling of being unwell1.8%4,020
Neutropenialow neutrophils, a type of white blood cell1.7%3,895

Solid bar: share of all class reports. Hollow bar: the median share across the 8 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death22.5%50,826

Life-threatening6.4%14,436

Hospitalisation (initial or prolonged)41.8%94,560

Disability1.8%4,164

Congenital anomaly0%80

Other serious65.6%148,299

Not serious10.1%22,865

Patient age

Under 20%62

2 to 110.1%201

12 to 170.1%338

18 to 445.3%11,969

45 to 6427.2%61,425

65 to 7425.3%57,272

75 and over16.4%37,017

Age not given25.5%57,675

Who reported

Physician48.8%110,169

Pharmacist6.4%14,564

Other health professional24.6%55,615

Lawyer0%74

Consumer or non-health professional19.7%44,569

Not given0.4%968

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 Programmed death Receptor-1 blocking antibody reports

Which drugs are in the Programmed death Receptor-1 blocking antibody class on this site?

Keytruda, Opdivo, Nivolumab, Pembrolizumab, Atezolizumab and Tecentriq and 2 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

225,959 reports through June 2026, 26,144 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?

malignant neoplasm progression (9.5%), death (9.3%), off label use (5.4%), diarrhoea (5.1%) and fatigue (4.3%).

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.