Programmed Death Receptor-1 Blocking Antibody side effects compared: 4 drugs, 241,537 FDA adverse event reports
Members
| Drug | FAERS reports | Serious | Death outcome | Boxed warning | Top labeled signals | Unlabeled (unassessed) |
|---|---|---|---|---|---|---|
| Pembrolizumab (Keytruda) | 104,591 | 87% | 18,742 | – | Immune-mediated enterocolitis; Immune-mediated hepatic disorder; Immune-mediated adverse reaction | Tumour pseudoprogression; Immune-mediated cholangitis |
| Nivolumab (Opdivo) | 96,082 | 89% | 24,663 | – | Immune-mediated enterocolitis; Hypophysitis; Immune-mediated hepatitis | Leukoderma; Immune-mediated encephalopathy |
| Atezolizumab (Tecentriq) | 38,600 | 96% | 9,820 | – | Oesophageal varices haemorrhage; Nephritis; Immune-mediated hepatitis | Bleeding varicose vein; Adrenocorticotropic hormone deficiency |
| Dostarlimab (Jemperli) | 2,264 | 86% | 274 | – | Thrombocytopenia; Neuropathy peripheral; Hypothyroidism | Neutropenia; Hepatic cytolysis |
Class-wide signals (flagged in at least 2 of 4 members)
| Reaction | Members flagged | Median PRR | Reports (sum) | In label |
|---|---|---|---|---|
| Adrenocorticotropic hormone deficiency | 3/4 | 123.0 | 712 | 0/3 members' labels |
| Immune-mediated lung disease | 3/4 | 117.8 | 1,455 | 3/3 members' labels |
| Immune-mediated hepatitis | 3/4 | 109.6 | 1,612 | 3/3 members' labels |
| Immune-mediated encephalitis | 3/4 | 108.1 | 423 | 3/3 members' labels |
| Immune-mediated pneumonitis | 3/4 | 93.3 | 202 | 3/3 members' labels |
| Immune-mediated uveitis | 2/4 | 291.2 | 175 | 2/2 members' labels |
| Immune-mediated hyperthyroidism | 2/4 | 209.6 | 219 | 2/2 members' labels |
| Immune-mediated hypothyroidism | 2/4 | 207.4 | 967 | 2/2 members' labels |
| Immune-mediated renal disorder | 2/4 | 204.1 | 339 | 2/2 members' labels |
| Immune-mediated adrenal insufficiency | 2/4 | 198.2 | 689 | 2/2 members' labels |
| Immune-mediated gastritis | 2/4 | 193.2 | 166 | 2/2 members' labels |
| Immune-mediated endocrinopathy | 2/4 | 191.7 | 133 | 2/2 members' labels |
| Immune-mediated hypophysitis | 2/4 | 177.8 | 388 | 2/2 members' labels |
| Immune-mediated thyroiditis | 2/4 | 175.9 | 422 | 2/2 members' labels |
| Immune-mediated hepatic disorder | 2/4 | 163.9 | 1,603 | 2/2 members' labels |
| Immune-mediated dermatitis | 2/4 | 160.9 | 806 | 2/2 members' labels |
| Immune-mediated cystitis | 2/4 | 158.5 | 91 | 1/2 members' labels |
| Immune-mediated cholangitis | 2/4 | 157.0 | 289 | 1/2 members' labels |
| Immune-mediated arthritis | 2/4 | 155.0 | 310 | 2/2 members' labels |
| Immune-mediated myasthenia gravis | 2/4 | 153.5 | 257 | 2/2 members' labels |
| Endocrine toxicity | 2/4 | 152.4 | 64 | 2/2 members' labels |
| Immune-mediated pancreatitis | 2/4 | 148.8 | 297 | 2/2 members' labels |
| Immune-mediated myocarditis | 2/4 | 144.1 | 1,231 | 2/2 members' labels |
| Tumour hyperprogression | 2/4 | 141.6 | 148 | 0/2 members' labels |
| Immune-mediated enterocolitis | 2/4 | 123.4 | 2,562 | 2/2 members' labels |
| Immune-mediated nephritis | 2/4 | 122.7 | 334 | 2/2 members' labels |
| Immune-mediated neuropathy | 2/4 | 117.8 | 82 | 2/2 members' labels |
| Myocarditis-myositis-myasthenia gravis overlap syndrome | 2/4 | 117.0 | 128 | 2/2 members' labels |
| Lymphocytic hypophysitis | 2/4 | 114.1 | 146 | 0/2 members' labels |
| Adrenalitis | 2/4 | 100.7 | 69 | 0/2 members' labels |
Member-specific signals (flagged in exactly one drug)
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.