Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Gadoteric Acid | Dotarem | 4.8. Undesirable effects | Gastrointestinal Disorders: diarrhea, salivary hypersecretion, acute pancreatitis with onset within 48 hours after GBCA administration. | Jan, 2026 |
| Quetiapine | Seroquel Xl | 4.4 Special warnings and precautions for use 4.5 Interaction with other medicinal products and other forms of interaction | Serotonin syndrome Quetiapine should be used with caution in combination with serotonergic medicinal products | Jan, 2026 |
| Dexketoprofen | Ketesse | 4.4 Special warnings and precautions for use 4.6 Fertility, pregnancy and lactation 4.8 Undesirable effects | Warnings for serious exacerbation of infections Warning on the use of DKP after pregnancy week 20 Kounis syndrome | Jan, 2026 |
| Enfortumab | Padcev | 4.4 Special warnings and precautions for use 4.8. Undesirable effects | Serious infections pneumonia Thrombocytopenia skin hyperpigmentation, skin discoloration, pigmentation disorder | Jan, 2026 |
| Clotrimazole | Canesten | 4.8. Undesirable effects | Anaphylactic reaction , Angioedema | Jan, 2026 |
| Ubrogepant | Ubrelvy | 4.6 Fertility, Pregnancy and Lactation | Lactation section updates | Jan, 2026 |