Safety Update – product information updates
When new safety information comes to light about medicinal products, Swissmedic works closely with marketing authorisation holders to update the corresponding product information (Information for healthcare professionals and Patient information). As a result, healthcare professionals gain timely access to safety-related findings.
The following overview is updated monthly and provides information about selected active substances or active substance groups whose Information for healthcare professionals has been, or will be, updated with new safety-related information.
These updates are currently available in German, French, or Italian.
Important information
The updates to product information for generics are delayed as these are adapted at a later date to those of the original product. Please note that this is not a complete overview since not all changes to individual Information for healthcare professionals are presented in detail, and the safety information listed for individual medicinal products containing an active substance or substance class may already be included in the Information for healthcare professionals.
The information is subject to possible legal remedies. In all cases, the current versions of the Information for healthcare professionals available at www.swissmedicinfo-pro.ch are binding.
All Safety Updates since November 2025
Safety of medicines – always up to date
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The “Safety of medicines” newsletter provides monthly updates on the most important revisions to the product information for selected active substances or substance groups.
| Active substance(s) |
New safety information |
Updated section(s) |
(D)HPC |
| Cenobamate |
Liver damage: Liver function tests before starting and during treatment |
Dosage/use; Warnings and precautions; Undesirable effects |
DHPC – Ontozry (Cenobamat) |
| Combination: nirmatrelvir + ritonavir |
Risk of medication errors in paediatric patients (≥ 6 years with body weight ≥20 to <40 kg): Take only 1 nirmatrelvir tablet together with 1 ritonavir tablet every 12 hours; 1 nirmatrelvir tablet remains in the blister per administration |
Dosage/use |
DHPC – Paxlovid® (Nirmatrelvir/Ritonavir) |
| Daridorexant |
Angioedema |
Undesirable effects |
– |
| Epcoritamab |
Haemophagocytic lymphohistiocytosis (HLH) |
Warnings and precautions; Undesirable effects |
– |
| GLP-1 receptor agonists |
Bowel obstruction |
Undesirable effects |
– |
| GnRH analogues |
Severe cutaneous adverse reactions (SCARs): Inform patients of possible skin reactions; if symptoms occur, discontinue treatment immediately, do not take again and consider an alternative therapy. |
Warnings and precautions; Undesirable effects |
– |
| Inavolisib |
Hyperglycaemia: Patients also receiving corticosteroid therapy or who have conditions with intensified blood glucose management require more frequent fasting glucose monitoring; ketone monitoring is recommended. |
Warnings and precautions |
– |
| JAK inhibitors (indication: myeloproliferative neoplasias) |
Exacerbation of symptoms following suspension or discontinuation of treatment: Do not suspend or discontinue without consulting a doctor; consider gradual tapering |
Warnings and precautions |
– |
| Ocrelizumab |
Interstitial lung disease |
Undesirable effects |
– |
| Oxaliplatin |
Liver disease: In the event of abnormal liver enzyme levels, splenomegaly or portal hypertension that is not obviously due to liver metastases, the very rare occurrence of drug-induced hepatic vascular disease should be considered. |
Warnings and precautions |
– |
| Platinum-based chemotherapy agents |
Microangiopathic haemolytic anaemia associated with haemolytic uraemic syndrome or Coombs-positive haemolytic anaemia |
Undesirable effects |
– |
| Proton pump inhibitors (PPIs) |
Interaction between PPIs and pemetrexed with risk of increased toxicity of pemetrexed |
Interactions |
– |
| Quetiapine |
Hyponatraemia |
Undesirable effects |
– |
| Rocuronium |
Risk of hypertensive crisis: Use with caution in patients with pheochromocytoma |
Warnings and precautions |
– |
| Rotavirus vaccine |
Anaphylactic reaction: An appropriate medical treatment option should be available immediately. |
Warnings and precautions; Undesirable effects |
– |
| RSV vaccine (Abrysvo) |
Reformulation of the indication to prevent incorrect administration in newborns. |
Indications/uses |
– |
| RSV vaccine (mRNA) |
Contraindication for children under 8 months due to increased risk of severe and life-threatening RSV-associated enhanced respiratory diseases |
Dosage/use; Contraindication; Undesirable effects |
– |
| Testosterone |
Interaction with SGLT-2 inhibitors: Increased risk of erythrocytosis; monitoring of haematocrit and haemoglobin levels recommended |
Interactions |
– |
| Testosterone (i.m.) |
Pulmonary oil microembolism |
Warnings and precautions; Undesirable effects |
– |
| Testosterone (transdermal) |
Instructions on avoiding accidental transfer to pets |
Dosage/use; Warnings and precautions |
– |
| Topiramate |
Drug reaction with eosinophilia and systemic symptoms (DRESS): In the event of symptoms, patients should be examined immediately and topiramate discontinued if necessary. |
Warnings and precautions; Undesirable effects |
– |
| Topiramate |
Hypersensitivity reactions (including anaphylaxis and angioedema): Provide patients with information; in the event of severe hypersensitivity reactions, medical assistance should be sought immediately. |
Contraindications; Warnings and precautions; Undesirable effects |
– |
