Endovelle Adverse Reactions

Summary of the safety profile: Undesirable effects are more common during the first months after the start of intake of ENDOVELLE, and subside with duration of treatment. The following undesirable effects have been reported in users of ENDOVELLE. The most frequently reported undesirable effects during treatment that were considered at least possibly related to ENDOVELLE were headache, breast discomfort, depressed mood and acne.
Table 2, the frequencies of adverse drug reactions (ADRs) by MedDRA system organ classes (MedDRA SOCs) reported with ENDOVELLE are summarized in the table as follows. Within each frequency grouping, undesirable effects are presented in order of decreasing frequency. Frequencies are defined as common (≥1/100 to <1/10) and uncommon (≥1/1,000 to <1/100). (See Table 2.)


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Description of selected adverse reaction: Uterine bleeding irregularities: The following bleeding patterns were observed: Amenorrhea, infrequent bleeding, frequent bleeding, irregular bleeding, prolonged bleeding, normal bleeding.