Qlaira Adverse Reactions

Summary of safety profile: The most commonly reported adverse reactions with Estradiol valerate + Dienogest (Qlaira) when used as an oral contraceptive or in the treatment of heavy and/or prolonged menstrual bleeding in women without organic pathology who elect to use oral contraception are nausea, breast pain, and unscheduled uterine bleeding. They occur in >2% of users.
Serious adverse reactions are arterial and venous thromboembolism.
Tabulated list of adverse reactions: The frequencies of adverse drug reactions (ADRs) reported in clinical Phase 2 and 3 studies with Estradiol valerate + Dienogest (Qlaira) as an oral contraceptive (N=2423) and in the treatment of heavy and/or prolonged menstrual bleeding in women without organic pathology who elect to use oral contraception (N=264) are summarised in the table as follows by MedDRA system organ classes (MedDRA SOCs)*. Within each frequency grouping, undesirable effects are presented in order of decreasing frequency. Frequencies are defined as common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), and rare (≥1/10,000 to <1/1,000). (See Table 2.)

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Description of selected adverse reactions: 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).
Tumors: 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 tumors (benign and malignant).
Other conditions: Erythema nodosum, Erythema multiforme; Breast discharge; 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).
Interactions: Breakthrough bleeding and/or contraceptive failure may result from interactions of other drugs (enzyme inducers) with oral contraceptives (see Interactions).