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 |
| Acalabrutinib |
Interstitial lung disease/pneumonitis: Patients should be monitored for respiratory symptoms. |
Warnings and precautions; Undesirable effects |
– |
| Acalabrutinib |
Atrial fibrillation: Where there is a high risk of thromboembolic diseases, consider anticoagulation and alternative treatments. |
Warnings and precautions |
– |
| Baloxavir marboxil |
Diarrhoea, vomiting, colitis, ischaemic colitis |
Undesirable effects |
– |
| Combination: Sodium citrate dihydrate + sodium lauryl sulfoacetate + sorbitol |
Anaphylactic reaction |
Undesirable effects |
– |
| Estradiol |
Instructions on avoiding accidental transfer to other people |
Warnings and precautions |
– |
| Fenfluramine |
Echocardiographic monitoring required due to the risk of valvular heart disease and pulmonary arterial hypertension |
Warnings and precautions; Undesirable effects |
– |
| Isotretinoin |
Acute generalised exanthemic pustulosis (AGEP) |
Warnings and precautions; Undesirable effects |
– |
| Isotretinoin |
Anal fissure |
Undesirable effects |
– |
| Tobramycin (excluding topical) |
Acute kidney injury |
Warnings and precautions; Undesirable effects |
– |
