Drug
Cemiplimab-rwlc
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 | 49 | 45.4 | 46.5 | signal |
| 2 | Adrenal Insufficiency | 24 | 21.0 | 21.2 | signal |
| 3 | Hepatic Cytolysis | 23 | 19.7 | 19.9 | signal |
| 4 | Squamous Cell Carcinoma | 16 | 17.8 | 17.9 | signal |
| 5 | Cholestasis | 26 | 14.2 | 14.4 | signal |
| 6 | Pneumonitis | 35 | 13.5 | 13.8 | signal |
| 7 | Disease Progression | 152 | 13.5 | 14.5 | signal |
| 8 | Hypothyroidism | 36 | 11.8 | 12.0 | signal |
| 9 | Metastases To Lung | 12 | 10.9 | 10.9 | signal |
| 10 | Hyperthyroidism | 15 | 10.8 | 10.9 | signal |
| 11 | Interstitial Lung Disease | 46 | 10.0 | 10.2 | signal |
| 12 | Basal Cell Carcinoma | 13 | 8.7 | 8.7 | signal |
| 13 | Hypercalcaemia | 10 | 8.5 | 8.5 | signal |
| 14 | Colitis | 30 | 8.3 | 8.4 | signal |
| 15 | Ischaemic Stroke | 14 | 8.2 | 8.2 | signal |
| 16 | Hepatitis | 20 | 8.2 | 8.2 | signal |
| 17 | Neoplasm | 9 | 8.2 | 8.2 | signal |
| 18 | Toxic Epidermal Necrolysis | 11 | 7.6 | 7.7 | signal |
| 19 | Hepatocellular Injury | 10 | 7.3 | 7.4 | signal |
| 20 | Polyneuropathy | 8 | 7.0 | 7.1 | signal |
| 21 | Rash Maculo-papular | 14 | 6.6 | 6.6 | signal |
| 22 | Hepatotoxicity | 14 | 6.6 | 6.6 | signal |
| 23 | Skin Lesion | 17 | 6.5 | 6.6 | signal |
| 24 | Metastases To Central Nervous System | 7 | 5.7 | 5.7 | signal |
| 25 | Transaminases Increased | 12 | 5.6 | 5.7 | signal |
| 26 | Autoimmune Disorder | 5 | 5.5 | 5.5 | signal |
| 27 | Pharyngeal Oedema | 8 | 5.4 | 5.4 | signal |
| 28 | Hospice Care | 5 | 5.3 | 5.3 | signal |
| 29 | Stevens-johnson Syndrome | 11 | 5.2 | 5.2 | signal |
| 30 | Eyelid Ptosis | 5 | 5.1 | 5.1 | signal |
| 31 | Infusion Related Reaction | 31 | 4.9 | 5.0 | signal |
| 32 | Therapy Partial Responder | 7 | 4.9 | 4.9 | signal |
| 33 | Wound Infection | 5 | 4.8 | 4.8 | signal |
| 34 | Neoplasm Progression | 16 | 4.8 | 4.8 | signal |
| 35 | Blood Thyroid Stimulating Hormone Increased | 4 | 4.5 | 4.5 | signal |
| 36 | Skin Reaction | 6 | 4.5 | 4.5 | signal |
| 37 | Pemphigus | 5 | 4.2 | 4.2 | signal |
| 38 | Diabetic Ketoacidosis | 9 | 3.9 | 3.9 | signal |
| 39 | Eosinophilia | 6 | 3.6 | 3.6 | signal |
| 40 | Cytokine Release Syndrome | 6 | 3.3 | 3.3 | signal |
| 41 | Uveitis | 3 | 2.3 | 2.3 | no signal |