Gveza Adverse Reactions

Summary of safety profile: The most commonly reported adverse reactions with GVEZA are nausea and breast pain. They occur in > 6% of users.
Serious adverse reactions are arterial and venous thromboembolism.
Tabulated list of adverse reactions: The frequencies of ADRs reported in clinical trials with ethinylestradiol/drospirenone 0.03 mg/3 mg (N=4897) are summarised in the table as follows. Within each frequency grouping, ADRs are presented in order of decreasing seriousness. Additional ADRs identified only during post-marketing surveillance, and for which a frequency could not be estimated, are listed under 'not known'. (See Table 1.)

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For venous and arterial thromboembolic events and migraine see also Contraindications, Precautions.
Adverse reactions reported in women using COCs: Adverse reactions with very low frequency or with delayed onset of symptoms which are considered to be related to the group of combined oral contraceptives are listed as follows (see also Contraindications, Precautions): Tumours: The frequency of diagnosis of breast cancer is very slightly increased among OC 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 COC use is unknown; Liver tumours (benign and malignant).
Other conditions: Erythema nodosum; Women with hypertriglyceridemia (increased risk of pancreatitis when using COCs); Hypertension; Occurrence or deterioration of conditions for which association with COC use is not conclusive: jaundice and/or pruritus related to cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; Sydenham's chorea; herpes gestationis; otosclerosis-related hearing loss; In women with hereditary angioedema exogenous estrogens may induce or exacerbate symptoms of angioedema; Liver function disturbances; Changes in glucose tolerance or effect on peripheral insulin resistance; Crohn's disease, ulcerative colitis; Chloasma; Hypersensitivity (including symptoms such as rash, urticaria).
Other side effects that had been reported with the use of COCs that have neither been confirmed nor refuted are: (See Table 2.)

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Interactions: Breakthrough bleeding and/or contraceptive failure may result from interactions of other drugs (enzyme inducers) with oral contraceptives (see lnteraction with other medicinal products and other forms of interaction under Interactions).