Drug
Dostarlimab
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Myocarditis | 43 | 35.3 | 36.0 | signal |
| 2 | Adrenal Insufficiency | 44 | 34.2 | 34.8 | signal |
| 3 | Toxic Skin Eruption | 35 | 32.2 | 32.7 | signal |
| 4 | Malignant Neoplasm Progression | 229 | 20.9 | 23.1 | signal |
| 5 | Hepatic Cytolysis | 24 | 18.2 | 18.4 | signal |
| 6 | Hypothyroidism | 59 | 17.2 | 17.6 | signal |
| 7 | Rash Maculo-papular | 41 | 17.2 | 17.5 | signal |
| 8 | Hyperthyroidism | 22 | 14.1 | 14.2 | signal |
| 9 | Polyneuropathy | 15 | 11.7 | 11.8 | signal |
| 10 | Pneumonitis | 31 | 10.6 | 10.8 | signal |
| 11 | Hepatitis | 28 | 10.1 | 10.3 | signal |
| 12 | Ischaemic Stroke | 19 | 9.9 | 9.9 | signal |
| 13 | Colitis | 40 | 9.8 | 10.0 | signal |
| 14 | Tubulointerstitial Nephritis | 18 | 8.9 | 9.0 | signal |
| 15 | Diabetic Ketoacidosis | 20 | 7.7 | 7.8 | signal |
| 16 | Myelodysplastic Syndrome | 12 | 7.7 | 7.7 | signal |
| 17 | Renal Tubular Necrosis | 8 | 7.5 | 7.6 | signal |
| 18 | Haematotoxicity | 7 | 7.0 | 7.0 | signal |
| 19 | Thrombotic Microangiopathy | 7 | 6.7 | 6.7 | signal |
| 20 | Thyroid Disorder | 11 | 6.6 | 6.6 | signal |
| 21 | Ankle Fracture | 11 | 6.6 | 6.6 | signal |
| 22 | Thrombocytopenia | 79 | 6.6 | 6.8 | signal |
| 23 | Drug Reaction With Eosinophilia And Systemic Symptoms | 18 | 6.5 | 6.6 | signal |
| 24 | Neuropathy Peripheral | 66 | 6.5 | 6.6 | signal |
| 25 | Mucosal Inflammation | 18 | 6.4 | 6.4 | signal |
| 26 | Metastases To Central Nervous System | 8 | 5.8 | 5.8 | signal |
| 27 | Intestinal Perforation | 7 | 5.8 | 5.8 | signal |
| 28 | Interstitial Lung Disease | 28 | 5.4 | 5.4 | signal |
| 29 | Hepatotoxicity | 12 | 5.0 | 5.0 | signal |
| 30 | Metastases To Lung | 6 | 4.8 | 4.8 | signal |
| 31 | Drug Eruption | 8 | 4.2 | 4.2 | signal |
| 32 | Stevens-johnson Syndrome | 10 | 4.2 | 4.2 | signal |
| 33 | Uveitis | 6 | 4.1 | 4.1 | signal |
| 34 | Skin Reaction | 6 | 4.0 | 4.0 | signal |
| 35 | Eye Inflammation | 4 | 3.9 | 3.9 | signal |
| 36 | Cholestasis | 8 | 3.9 | 3.9 | signal |
| 37 | Eyelid Ptosis | 4 | 3.6 | 3.6 | signal |
| 38 | Inappropriate Antidiuretic Hormone Secretion | 4 | 3.6 | 3.6 | signal |
| 39 | Dermatitis | 8 | 3.6 | 3.6 | signal |
| 40 | Metastases To Bone | 6 | 3.4 | 3.4 | signal |
| 41 | Neurotoxicity | 6 | 3.2 | 3.2 | signal |
| 42 | Cytopenia | 4 | 3.1 | 3.1 | no signal |
| 43 | Blood Thyroid Stimulating Hormone Increased | 3 | 3.0 | 3.0 | no signal |
| 44 | Neutropenia | 44 | 3.0 | 3.0 | signal |
| 45 | Metastases To Liver | 5 | 2.6 | 2.6 | no signal |
| 46 | Neoplasm Progression | 10 | 2.6 | 2.6 | signal |
| 47 | Vaginal Haemorrhage | 12 | 2.6 | 2.6 | signal |
| 48 | Nephropathy Toxic | 3 | 2.5 | 2.5 | no signal |
| 49 | Palmar-plantar Erythrodysaesthesia Syndrome | 6 | 2.4 | 2.4 | no signal |
| 50 | Dermatitis Atopic | 6 | 1.1 | 1.1 | no signal |