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Drug class · FAERS comparison

Programmed Death Receptor-1 Blocking Antibody side effects compared: 4 drugs, 241,537 FDA adverse event reports

Class as assigned in the FDA label (Established Pharmacologic Class) · data 2026-09-14
How to read this page. Report counts are not incidence rates: a drug with more reports is usually older, more widely used or more publicised, not more dangerous. Signals are screened against each product's FDA label on its own page; a term flagged across most of a class usually reflects the shared mechanism or the shared patient population.

Members

DrugFAERS reportsSeriousDeath outcomeBoxed warningTop labeled signalsUnlabeled (unassessed)
Pembrolizumab (Keytruda)104,59187%18,742–Immune-mediated enterocolitis; Immune-mediated hepatic disorder; Immune-mediated adverse reactionTumour pseudoprogression; Immune-mediated cholangitis
Nivolumab (Opdivo)96,08289%24,663–Immune-mediated enterocolitis; Hypophysitis; Immune-mediated hepatitisLeukoderma; Immune-mediated encephalopathy
Atezolizumab (Tecentriq)38,60096%9,820–Oesophageal varices haemorrhage; Nephritis; Immune-mediated hepatitisBleeding varicose vein; Adrenocorticotropic hormone deficiency
Dostarlimab (Jemperli)2,26486%274–Thrombocytopenia; Neuropathy peripheral; HypothyroidismNeutropenia; Hepatic cytolysis

Class-wide signals (flagged in at least 2 of 4 members)

ReactionMembers flaggedMedian PRRReports (sum)In label
Adrenocorticotropic hormone deficiency3/4123.07120/3 members' labels
Immune-mediated lung disease3/4117.81,4553/3 members' labels
Immune-mediated hepatitis3/4109.61,6123/3 members' labels
Immune-mediated encephalitis3/4108.14233/3 members' labels
Immune-mediated pneumonitis3/493.32023/3 members' labels
Immune-mediated uveitis2/4291.21752/2 members' labels
Immune-mediated hyperthyroidism2/4209.62192/2 members' labels
Immune-mediated hypothyroidism2/4207.49672/2 members' labels
Immune-mediated renal disorder2/4204.13392/2 members' labels
Immune-mediated adrenal insufficiency2/4198.26892/2 members' labels
Immune-mediated gastritis2/4193.21662/2 members' labels
Immune-mediated endocrinopathy2/4191.71332/2 members' labels
Immune-mediated hypophysitis2/4177.83882/2 members' labels
Immune-mediated thyroiditis2/4175.94222/2 members' labels
Immune-mediated hepatic disorder2/4163.91,6032/2 members' labels
Immune-mediated dermatitis2/4160.98062/2 members' labels
Immune-mediated cystitis2/4158.5911/2 members' labels
Immune-mediated cholangitis2/4157.02891/2 members' labels
Immune-mediated arthritis2/4155.03102/2 members' labels
Immune-mediated myasthenia gravis2/4153.52572/2 members' labels
Endocrine toxicity2/4152.4642/2 members' labels
Immune-mediated pancreatitis2/4148.82972/2 members' labels
Immune-mediated myocarditis2/4144.11,2312/2 members' labels
Tumour hyperprogression2/4141.61480/2 members' labels
Immune-mediated enterocolitis2/4123.42,5622/2 members' labels
Immune-mediated nephritis2/4122.73342/2 members' labels
Immune-mediated neuropathy2/4117.8822/2 members' labels
Myocarditis-myositis-myasthenia gravis overlap syndrome2/4117.01282/2 members' labels
Lymphocytic hypophysitis2/4114.11460/2 members' labels
Adrenalitis2/4100.7690/2 members' labels

Member-specific signals (flagged in exactly one drug)

ReactionDrugReportsPRRLabel screen
Fulminant type 1 diabetes mellitusNivolumab597312.0Labeled (related wording)
Immune-mediated adverse reactionPembrolizumab831267.7Labeled adverse reaction
LeukodermaNivolumab103234.8Not in label — unassessed
Transitional cell carcinoma metastaticPembrolizumab51170.1Labeled (related wording)
Tumour pseudoprogressionPembrolizumab464150.2Not in label — unassessed
Malignant neoplasm oligoprogressionPembrolizumab66121.4Labeled (related wording)
Autoimmune hypothyroidismPembrolizumab82108.3Labeled (related wording)
Autoimmune myocarditisNivolumab6082.4Labeled (related wording)
Vogt-koyanagi-harada diseaseNivolumab5880.7Labeled (related wording)
HypopituitarismNivolumab46579.4Labeled adverse reaction
Bleeding varicose veinAtezolizumab6776.6Not in label — unassessed
PseudocellulitisPembrolizumab5875.6Not in label — unassessed
Urogenital fistulaPembrolizumab6272.2Not in label — unassessed
Tumour ruptureAtezolizumab5863.6Not in label — unassessed
Hepatocellular carcinomaAtezolizumab79162.8Likely indication confounding
Oesophageal varices haemorrhageAtezolizumab22161.4Labeled adverse reaction
Tumour haemorrhageAtezolizumab18237.0Labeled (related wording)
Encephalitis autoimmuneAtezolizumab7935.3Labeled (related wording)
NephritisAtezolizumab19634.2Labeled adverse reaction
Small cell lung cancerAtezolizumab8232.3Likely indication confounding
HypothyroidismDostarlimab5917.2Labeled adverse reaction
ThrombocytopeniaDostarlimab796.6Labeled adverse reaction
Neuropathy peripheralDostarlimab666.5Labeled adverse reaction

Common questions

Which programmed death receptor-1 blocking antibody has the most FDA adverse event reports?

Pembrolizumab has the most FAERS co-reports in this class (104,591), followed by Nivolumab (96,082). Report volume tracks how widely and how long a drug has been used, and how much attention it has had, far more than its risk.

Which side effects are shared across programmed death receptor-1 blocking antibody drugs?

Reaction terms flagged in at least half of the 4 members include adrenocorticotropic hormone deficiency, immune-mediated lung disease, immune-mediated hepatitis, immune-mediated encephalitis, immune-mediated pneumonitis. A term shared across a class usually reflects the shared mechanism (or the shared patient population) rather than one product.

Does a FAERS signal mean the drug causes the reaction?

No. These are disproportionality signals from voluntary reports with no denominator. Each is screened against the FDA label (known vs unlabeled) on the drug pages; causality needs temporality, dose-response, plausibility and trial or cohort evidence.

Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, seriousness and death counts from openFDA count queries. Generated 2026-10-08. Not medical advice.