The adverse events reported with mifepristone and a prostaglandin analogue such as GyMiso®, classified according to frequency and system organ class, are summarised as shown in Table 1. Table 1: Adverse Events for the Combined Use of Mifepristone and Misoprostol MedDRA Adverse events (frequency) System Organ Very common Common Uncommon Rare Class > 1/10 > 1/100 to > 1/1000 to > 1/10000 to < < 1/10 < 1/100 1/1000 and very rare (< 1/10000)* Infections and Infection shock syndrome infestations Neoplasms Elevated alpha-foeto benign, protein malignant and Elevated unspecified carcinoembryonic antigen Blood and Thrombotic lymphatic thrombocytopenic system purpura disorders Thrombocytopenia Induced systemic lupus erythematosus Psychiatric Mania disorders Headache Epilepsy Nervous system Neurogenic tinnitus disorders Eye disorders Ophthalmoplegia Cardiac Myocardial infarction disorders Induced syndrome Vascular Hot flush Superficial disorders Hypotension thrombophlebitis (0.25%) Bronchospasm Respiratory, Induced bronchial thoracic and asthma mediastinal disorders
The adverse events reported with mifepristone and a prostaglandin analogue such as GyMiso®, classified according to frequency and system organ class, are summarised as shown in Table 1. Table 1: Adverse Events for the Combined Use of Mifepristone and Misoprostol MedDRA Adverse events (frequency) System Organ Class Very common > 1/10 Common > 1/100 to < 1/10 Uncommon > 1/1000 to < 1/100 Rare > 1/10000 to < 1/1000 and very rare (< 1/10000)* Infections and infestations Infection shock syndrome Neoplasms benign, malignant and unspecified Elevated alpha-foeto protein Elevated carcinoembryonic antigen Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura Thrombocytopenia Induced systemic lupus erythematosus Psychiatric disorders Mania Nervous system disorders Headache Epilepsy Neurogenic tinnitus Eye disorders Ophthalmoplegia Cardiac disorders Myocardial infarction Induced syndrome Vascular disorders Hot flush Hypotension (0.25%) Superficial thrombophlebitis Respiratory, thoracic and mediastinal disorders Bronchospasm Induced bronchial asthma
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