Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Candesartan Cilexetil, Amlodipine Besilate | Unisia | 4.4 special warnings and precautions for use, 4.8. Undesirable effects | Intestinal angioedemka , Hypertension management | Nov, 2025 |
| Leflunomide | Arava | 4.4 special warnings and precautions for use 4.8 undesirable effects 6.6 Special Precautions for Disposal and Handling | Skin ulcers , Handling Hazardous drug | Nov, 2025 |
| Vandetanib | Caprelsa | 4.4 special warnings and precautions for use 4.8. Undesirable effects | Osteonecrosis | Oct, 2025 |
| Hydroxychloroquine Sulphate | Plaquenil | 4.4 special warnings and precautions for use | Reactivation of infections | Oct, 2025 |
| Meropenem; Vaborbactam | Vabomere | 4.4 special warnings and precautions for use 4.8. Undesirable effects | Rhabdomyolysis | Oct, 2025 |
| Vortioxetine | Brintellix | 4.8. Undesirable effects | Hallucinations | Oct, 2025 |