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.

June 2026

Wirkstoff(e) Neue Sicherheitsinformation Angepasste Rubrik(en) (D)HPC
Cladribin Cladribin passes into breast milk. Pregnancy, lactation
Combination: paracetamol + codeine Sphincter of Oddi dysfunction Undesirable effects
Dexketoprofen Fixed drug eruption Undesirable effects
Isoniazid Severe drug-induced skin reactions (Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction (rash) with eosinophilia and systemic symptoms (DRESS), acute generalised exanthematous pustulosis (AGEP)): Inform patients of possible skin reactions and monitor for relevant symptoms; discontinue immediately when first symptoms appear; if confirmed, never use again Warnings and precautions, Undesirable effects
Isoniazid Lupus-like syndrome Undesirable effects
Leuprorelin Sudden cardiac death, QT prolongation, various arrhythmias, other cardiovascular diseases  Warnings and precautions, Undesirable effects
Leuprorelin Depression, suicidal tendencies Warnings and precautions, Undesirable effects
Leuprorelin Transient ischaemic attack Undesirable effects
Leuprorelin Dry skin, pigmentation disorders Undesirable effects
Leuprorelin Anorexia Undesirable effects
Leuprorelin Increased urinary frequency, urinary incontinence Undesirable effects
Levetiracetam Risk of medication error with Keppra, 100 mg/mL oral solution, due to new delivery syringe  Packs DHPC – Keppra® (Levetiracetam)
Lisdexamfetamine dimesylate Contraindication for patients with phaeochromocytoma Contraindications HPC – Lisdexamfetamindimesylat
Midazolam Kounis syndrome Undesirable effects
Ocrelizumab Liver damage: Perform liver function tests before starting treatment and during treatment if symptoms occur; where liver damage is confirmed, discontinue ocrelizumab and only resume after symptoms have fully resolved and if another aetiology has been confirmed Warnings and precautions, Undesirable effects DHPC – Ocrevus® (Ocrelizumab)
Osimertinib+B21:E34 Hepatitis B reactivation: Monitoring of patients with positive HBV serology for clinically observed and laboratory-detected symptoms of reactivation Warnings and precautions, Undesirable effects
Stimulants (dexamfetamine, dexmethylphenidate, lisdexamfetamine, methylphenidate) Increased intraocular pressure, glaucoma: If symptoms occur, contact doctor, stop therapy if necessary; ophthalmological monitoring where there is a history of increased intraocular pressure Warnings and precautions, Undesirable effects
Stimulants (dexamfetamine, dexmethylphenidate, lisdexamfetamine, methylphenidate) Obsessive-compulsive disorder Undesirable effects
Stimulants (dexamfetamine, dexmethylphenidate, lisdexamfetamine, methylphenidate) Dry eye Undesirable effects
Teriflunomide There is an increased risk of haematological diseases in cases of preexisting blood count changes or restricted bone marrow function. If these occur, accelerated elimination procedures should be considered. Warnings and precautions
Teriflunomide Caution is advised when switching between teriflunomide and other multiple sclerosis therapies due to potential additive immune effects. Washout periods must be observed depending on previous or subsequent therapy. Warnings and precautions
Teriflunomide Falsely decreased ionised calcium levels may occur depending on the type of blood analyser.  Warnings and precautions
Teriflunomide Teriflunomide should be discontinued in women who wish to become pregnant and an accelerated elimination procedure is recommended. Before becoming pregnant, the teriflunomide plasma level must be measured twice at least 14 days apart and both values must be below 0.02 mg/L. Pregnancy, lactation
Testosterone (topical) Instructions on avoiding accidental transfer to other people (particularly children) Dosage/use, Warnings and precautions
Vancomycin Kounis syndrome: Cardiovascular symptoms due to allergic or hypersensitivity reactions with narrowing of the coronary arteries, can potentially result in myocardial infarction. Warnings and precautions, Undesirable effects
Vancomycin Haemolytic anaemia  Undesirable effects
Vancomycin Alanine transferase elevated, aspartate aminotransferase elevated  Undesirable effects
Vasodilators (indication pulmonary hypertension) Pulmonary oedema in patients with pulmonary vein occlusion: If signs of pulmonary oedema occur, check for possibility of pulmonary vein occlusion; if confirmed, stop treatment Warnings and precautions