The FDA-listed label for ZENBEXUS (iberdomide) carried a boxed warning effective 13 August 2026. The warning addressed embryo-fetal toxicity and serious venous and arterial thromboembolism.

The label stated that ZENBEXUS is contraindicated in pregnancy and is embryo-fetal toxic in animals. It warned that exposure can cause birth defects or embryo-fetal death in humans.

Background

The supplied FDA label record identifies iberdomide as the drug associated with the ZENBEXUS label. The record supports the presence of a boxed warning covering pregnancy-related fetal risk and serious venous and arterial thromboembolic events. It does not provide additional information on iberdomide’s drug class, mechanism, approved uses, dosing, or the prevalence of any related condition.

Label change

The event was recorded as an FDA label revision. The label headline identified a boxed warning as present on the ZENBEXUS label, with an effective date of 13 August 2026. The warning title included embryo-fetal toxicity and serious venous and arterial thromboembolism.

Key safety language

  • Pregnancy contraindication: The label stated that ZENBEXUS is contraindicated in pregnancy.
  • Embryo-fetal risk: The label stated that ZENBEXUS is embryo-fetal toxic in animals and can cause birth defects or embryo-fetal death in humans.
  • Thromboembolism: The boxed-warning heading identified serious venous and arterial thromboembolism as a risk.

The supplied record does not include event rates, study populations, comparative safety analyses, or further detail on the thromboembolic risk. It also does not describe monitoring instructions or risk-mitigation requirements beyond the warning language provided.

What this means

The label information places pregnancy-related fetal harm and serious venous and arterial thromboembolism among the most prominent safety warnings for ZENBEXUS. Clinicians and other readers verifying the label should consult the full FDA-listed document for the complete warning and prescribing information. The supplied data establish the warning’s presence and effective date but do not support conclusions about the frequency of either risk.

Source

Source: FDA, DailyMed prescribing-label record for ZENBEXUS, effective 13 August 2026. The source document is available through dailymed.nlm.nih.gov.