Dostarlimab side effects: what 2,264 FDA adverse event reports show
Drug class
Programmed Death Receptor-1 Blocking Antibody
Brand names
Jemperli
Who reports
2,264 reports · 86% serious · 274 with death outcome · 95% female
Used for
JEMPERLI is a programmed death receptor-1 (PD-1)–blocking antibody indicated: Endometrial Cancer • in combination with carboplatin and paclitaxel, followed by JEMPERLI as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial cancer (EC).
What it is
Dostarlimab-gxly is a programmed death receptor-1 (PD-1)–blocking IgG 4 humanized monoclonal antibody. Dostarlimab‑gxly is produced in Chinese hamster ovary cells and has a calculated molecular weight of about 144 kDa.
Boxed warning
None in the current label
Causality screen of the 28 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 22 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Myocarditis | 43 | 35.3 26.2–47.5ROR 36.0 · χ² 1,394 / p <1e-300 | 34.7 EB05 26.8 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 23.5 · 93% clinician | no trial data cached |
| Adrenal insufficiency | 44 | 34.2 25.5–45.8ROR 34.8 · χ² 1,379 / p <1e-300 | 33.6 EB05 26.1 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 22.9 · 100% clinician | no trial data cached |
| Toxic skin eruption | 35 | 32.2 23.2–44.7ROR 32.7 · χ² 1,024 / p 7e-225 | 31.6 EB05 23.7 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.4 · 97% clinician | no trial data cached |
| Malignant neoplasm progression | 229 | 20.9 18.5–23.6ROR 23.1 · χ² 4,323 / p <1e-300 | 20.8 EB05 18.6 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 14.1 · 94% clinician | no trial data cached |
| Hepatic cytolysis | 24 | 18.2 12.2–27.1ROR 18.4 · χ² 373 / p 2e-83 | 17.9 EB05 12.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 · 100% clinician | no trial data cached |
| Hypothyroidism | 59 | 17.2 13.4–22.1ROR 17.6 · χ² 883 / p 2e-194 | 17.1 EB05 13.7 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.6 · 93% clinician | no trial data cached |
| Rash maculo-papular | 41 | 17.2 12.7–23.3ROR 17.5 · χ² 608 / p 2e-134 | 17.0 EB05 13.0 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.0 · 100% clinician | no trial data cached |
| Hyperthyroidism | 22 | 14.1 9.3–21.4ROR 14.2 · χ² 255 / p 1e-57 | 13.5 EB05 9.0 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.1 · 95% clinician | no trial data cached |
| Polyneuropathy | 15 | 11.7 7.1–19.4ROR 11.8 · χ² 136 / p 1e-31 | 10.4 EB05 6.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Pneumonitis | 31 | 10.6 7.5–15.1ROR 10.8 · χ² 261 / p 5e-59 | 10.0 EB05 7.2 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.4 · 100% clinician | no trial data cached |
| Hepatitis (liver inflammation) | 28 | 10.1 7.0–14.7ROR 10.3 · χ² 222 / p 2e-50 | 9.4 EB05 6.6 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 · 100% clinician | no trial data cached |
| Ischaemic stroke | 19 | 9.9 6.3–15.4ROR 9.9 · χ² 142 / p 4e-33 | 8.7 EB05 5.6 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Colitis | 40 | 9.8 7.2–13.4ROR 10.0 · χ² 309 / p 2e-69 | 9.3 EB05 7.0 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.0 · 98% clinician | no trial data cached |
| Tubulointerstitial nephritis | 18 | 8.9 5.6–14.1ROR 9.0 · χ² 119 / p 7e-28 | 7.8 EB05 5.0 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 | no trial data cached |
| Diabetic ketoacidosis | 20 | 7.7 5.0–12.0ROR 7.8 · χ² 111 / p 4e-26 | 6.8 EB05 4.6 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.2 · 100% clinician | no trial data cached |
| Myelodysplastic syndrome | 12 | 7.7 4.4–13.5ROR 7.7 · χ² 63 / p 9e-16 | 6.2 EB05 3.7 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Thyroid disorder | 11 | 6.6 3.7–11.9ROR 6.6 · χ² 47 / p 4e-12 | 5.3 EB05 3.2 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Ankle fracture | 11 | 6.6 3.6–11.9ROR 6.6 · χ² 47 / p 4e-12 | 5.3 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Thrombocytopenia (low platelets) | 79 | 6.6 5.3–8.2ROR 6.8 · χ² 369 / p 2e-82 | 6.3 EB05 5.2 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 · 97% clinician | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 18 | 6.5 4.1–10.3ROR 6.6 · χ² 79 / p 3e-19 | 5.7 EB05 3.8 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.3 | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 66 | 6.5 5.1–8.2ROR 6.6 · χ² 301 / p 1e-67 | 6.2 EB05 5.0 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 | no trial data cached |
| Mucosal inflammation | 18 | 6.4 4.0–10.1ROR 6.4 · χ² 77 / p 1e-18 | 5.6 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Interstitial lung disease | 28 | 5.4 3.7–7.8ROR 5.4 · χ² 95 / p 8e-23 | 5.0 EB05 3.6 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 · 100% clinician | no trial data cached |
| Hepatotoxicity (liver damage) | 12 | 5.0 2.9–8.8ROR 5.0 · χ² 35 / p 2e-9 | 4.3 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Stevens-johnson syndrome (severe blistering skin reaction) | 10 | 4.2 2.2–7.7ROR 4.2 · χ² 21 / p 2e-6 | 3.6 EB05 2.1 · IC025 +0.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 44 | 3.0 2.2–4.0ROR 3.0 · χ² 57 / p 2e-14 | 2.9 EB05 2.3 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.0 · 98% clinician | no trial data cached |
| Neoplasm progression | 10 | 2.6 1.4–4.9ROR 2.6 · χ² 9 / p 0.002 | 2.4 EB05 1.4 · IC025 +0.2 | Not in label — unassessed | serious PRR 1.9 | no trial data cached |
| Vaginal haemorrhage | 12 | 2.6 1.5–4.6ROR 2.6 · χ² 10 / p 6e-4 | 2.4 EB05 1.5 · IC025 +0.3 | Labeled (related wording) related wording | serious PRR 3.7 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Malignant neoplasm progression | 229 | 20.9 18.5–23.6ROR 23.1 · χ² 4,323 / p <1e-300 | 20.8 EB05 18.6 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 14.1 · 94% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 79 | 6.6 5.3–8.2ROR 6.8 · χ² 369 / p 2e-82 | 6.3 EB05 5.2 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 · 97% clinician | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 66 | 6.5 5.1–8.2ROR 6.6 · χ² 301 / p 1e-67 | 6.2 EB05 5.0 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 | no trial data cached |
| Hypothyroidism | 59 | 17.2 13.4–22.1ROR 17.6 · χ² 883 / p 2e-194 | 17.1 EB05 13.7 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.6 · 93% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 44 | 3.0 2.2–4.0ROR 3.0 · χ² 57 / p 2e-14 | 2.9 EB05 2.3 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.0 · 98% clinician | no trial data cached |
| Adrenal insufficiency | 44 | 34.2 25.5–45.8ROR 34.8 · χ² 1,379 / p <1e-300 | 33.6 EB05 26.1 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 22.9 · 100% clinician | no trial data cached |
| Myocarditis | 43 | 35.3 26.2–47.5ROR 36.0 · χ² 1,394 / p <1e-300 | 34.7 EB05 26.8 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 23.5 · 93% clinician | no trial data cached |
| Rash maculo-papular | 41 | 17.2 12.7–23.3ROR 17.5 · χ² 608 / p 2e-134 | 17.0 EB05 13.0 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.0 · 100% clinician | no trial data cached |
| Colitis | 40 | 9.8 7.2–13.4ROR 10.0 · χ² 309 / p 2e-69 | 9.3 EB05 7.0 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.0 · 98% clinician | no trial data cached |
| Toxic skin eruption | 35 | 32.2 23.2–44.7ROR 32.7 · χ² 1,024 / p 7e-225 | 31.6 EB05 23.7 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.4 · 97% clinician | no trial data cached |
| Pneumonitis | 31 | 10.6 7.5–15.1ROR 10.8 · χ² 261 / p 5e-59 | 10.0 EB05 7.2 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.4 · 100% clinician | no trial data cached |
| Interstitial lung disease | 28 | 5.4 3.7–7.8ROR 5.4 · χ² 95 / p 8e-23 | 5.0 EB05 3.6 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 · 100% clinician | no trial data cached |
| Hepatitis (liver inflammation) | 28 | 10.1 7.0–14.7ROR 10.3 · χ² 222 / p 2e-50 | 9.4 EB05 6.6 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 · 100% clinician | no trial data cached |
| Hepatic cytolysis | 24 | 18.2 12.2–27.1ROR 18.4 · χ² 373 / p 2e-83 | 17.9 EB05 12.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 · 100% clinician | no trial data cached |
| Hyperthyroidism | 22 | 14.1 9.3–21.4ROR 14.2 · χ² 255 / p 1e-57 | 13.5 EB05 9.0 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.1 · 95% clinician | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Hepatic cytolysis — n=24, PRR 18.2
- Neutropenia — n=44, PRR 3.0
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Dostarlimab?
In FDA FAERS, the most frequently co-reported reaction terms for Dostarlimab are thrombocytopenia, neuropathy peripheral, hypothyroidism, neutropenia, adrenal insufficiency, myocarditis. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Dostarlimab have an FDA boxed warning?
No. The FDA label retrieved for Dostarlimab has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Dostarlimab causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 095eab9f-545a-4f12-bfb7-19477fb901a5, effective 20250902; matched on
openfda.generic_name.exact:"DOSTARLIMAB") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 50 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.