Nextstellis Adverse Reactions

Summary of the safety profile: The most commonly reported adverse reactions with Nextstellis are metrorrhagia (4.3%), headache (3.2%), acne (3.2%), vaginal haemorrhage (2.7%) and dysmenorrhoea (2.4%).
Tabulated list of adverse reactions: Adverse reactions that have been identified are listed as follows (see Table 3).
Adverse reactions are listed according to the MedDRA system organ class and ranked under frequency groupings using the following convention: common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and rare (≥1/10,000 to <1/1,000). (See Table 3.)

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Description of selected adverse reactions: An increased risk of arterial and venous thrombotic and thromboembolic events, including myocardial infarction, stroke, transient ischemic attacks, venous thrombosis and pulmonary embolism has been observed in women using CHCs, which is discussed in more detail in Precautions.
The following serious adverse events have been reported in women using CHCs, which are discussed in Precautions: Venous thromboembolic disorders; Arterial thromboembolic disorders; Hypertension; Liver tumours; Occurrence or deterioration of conditions for which association with CHC use is not conclusive: Crohn's disease, ulcerative colitis, epilepsy, uterine myoma, porphyria, systemic lupus erythematosus, herpes gestationis, Sydenham's chorea, haemolytic uremic syndrome, cholestatic jaundice; Chloasma; Acute or chronic disturbances of liver function may necessitate the discontinuation of CHC use until markers of liver function return to normal; In women with hereditary angioedema exogenous oestrogens may induce or exacerbate symptoms of angioedema.
The frequency of diagnosis of breast cancer is very slightly increased among CHC users. As breast cancer is rare in women under 40 years of age the excess number is small in relation to the overall risk of breast cancer. Causation with CHC use is unknown. For further information, see Contraindications and Precautions.
Interactions: Breakthrough bleeding and/or contraceptive failure may result from interactions of other medicinal products (enzyme inducers) with oral contraceptives (see Interactions).
Reporting of adverse reactions: Healthcare professionals are asked to report any suspected adverse reactions to Food and Drug Administration.