Drug
Naldemedine
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 | Interstitial Lung Disease | 79 | 21.2 | 22.2 | signal |
| 2 | Cytokine Release Syndrome | 31 | 21.1 | 21.5 | signal |
| 3 | Hepatic Function Abnormal | 51 | 17.8 | 18.4 | signal |
| 4 | Delirium | 43 | 16.1 | 16.5 | signal |
| 5 | Malignant Neoplasm Progression | 96 | 12.2 | 12.9 | signal |
| 6 | Pneumocystis Jirovecii Pneumonia | 9 | 11.7 | 11.7 | signal |
| 7 | Erythema Multiforme | 8 | 11.1 | 11.2 | signal |
| 8 | Disseminated Intravascular Coagulation | 12 | 11.0 | 11.1 | signal |
| 9 | Adrenal Insufficiency | 10 | 10.8 | 10.9 | signal |
| 10 | Product Packaging Quantity Issue | 9 | 10.7 | 10.7 | signal |
| 11 | Ileus | 10 | 10.5 | 10.6 | signal |
| 12 | Sinus Tachycardia | 11 | 10.1 | 10.1 | signal |
| 13 | Neutrophil Count Decreased | 31 | 9.9 | 10.1 | signal |
| 14 | Cholecystitis | 9 | 9.8 | 9.9 | signal |
| 15 | Metastases To Liver | 13 | 9.6 | 9.7 | signal |
| 16 | Febrile Neutropenia | 48 | 9.4 | 9.7 | signal |
| 17 | Metastases To Central Nervous System | 9 | 9.1 | 9.2 | signal |
| 18 | Metastases To Bone | 11 | 8.7 | 8.8 | signal |
| 19 | Toxic Epidermal Necrolysis | 10 | 8.6 | 8.6 | signal |
| 20 | Inability To Afford Medication | 6 | 7.9 | 7.9 | signal |
| 21 | Altered State Of Consciousness | 13 | 7.8 | 7.9 | signal |
| 22 | Lung Neoplasm Malignant | 24 | 7.5 | 7.6 | signal |
| 23 | Cytomegalovirus Infection | 9 | 7.0 | 7.0 | signal |
| 24 | Multiple Organ Dysfunction Syndrome | 14 | 6.5 | 6.5 | signal |
| 25 | Hyperkalaemia | 17 | 6.3 | 6.4 | signal |
| 26 | Drug-induced Liver Injury | 15 | 6.3 | 6.4 | signal |
| 27 | Hyperbilirubinaemia | 5 | 6.3 | 6.3 | signal |
| 28 | Pulmonary Thrombosis | 5 | 5.9 | 5.9 | signal |
| 29 | Stevens-johnson Syndrome | 10 | 5.8 | 5.8 | signal |
| 30 | Pancreatic Carcinoma | 13 | 5.8 | 5.8 | signal |
| 31 | Intestinal Perforation | 5 | 5.8 | 5.8 | signal |
| 32 | Electrocardiogram Qt Prolonged | 16 | 5.8 | 5.8 | signal |
| 33 | Myocarditis | 5 | 5.7 | 5.7 | signal |
| 34 | Brain Neoplasm | 4 | 5.6 | 5.6 | signal |
| 35 | Covid-19 Pneumonia | 5 | 5.4 | 5.5 | signal |
| 36 | Cerebral Infarction | 10 | 5.3 | 5.3 | signal |
| 37 | Neoplasm Malignant | 27 | 5.2 | 5.3 | signal |
| 38 | Colon Cancer | 6 | 5.2 | 5.2 | signal |
| 39 | Peritonitis | 8 | 5.0 | 5.0 | signal |
| 40 | Pneumonitis | 10 | 4.8 | 4.8 | signal |
| 41 | Prescribed Underdose | 7 | 4.5 | 4.6 | signal |
| 42 | Neoplasm Progression | 12 | 4.4 | 4.5 | signal |
| 43 | Myelosuppression | 10 | 3.8 | 3.8 | signal |
| 44 | Drug Withdrawal Syndrome | 25 | 3.7 | 3.7 | signal |
| 45 | Hallucination, Auditory | 4 | 3.3 | 3.3 | signal |
| 46 | Gastric Cancer | 5 | 2.5 | 2.5 | no signal |
| 47 | Plasma Cell Myeloma | 7 | 2.3 | 2.3 | signal |