The article is devoted to an analytical review of studies to assess the clinical safety of omalizumab. The analysis showed that targeted therapy using genetically engineered biological drugs, which include, in particular, omalizumab, is increasingly used in the treatment of allergic diseases. In general, most studies show the clinical efficacy of omalisamab in bronchial asthma, allergic rhinitis, anaphylactic conditions, allergic urticaria, both in adults and children. However, there are isolated reports that allow us to talk about individual restrictions in the use of this drug associated with adverse reactions. Anaphylactic reactions have been most commonly reported during the administration of omalizumab. There are reports that indicate itching and rashes on the skin as undesirable reactions. In children, dyspeptic disorders are a common complaint. Reliable data on the initiation of malignancy processes against the background of the use of omalizumab have not been established. Quite rarely, as adverse reactions, the authors note eosinophilic granulomatosis with polyangiitis and thromboembolic complications. The authors draw attention to the need for a thorough collection of allergic anamnesis in patients, a clear selection of the dose of the drug, and monitoring patients in the first hours after the administration of the drug. The analysis data are the theoretical basis for improving the system for ensuring the safety of medicines and notifying supervisory authorities of adverse reactions to the use of medicines.