Yaz Adverse Reactions

Summary of the Safety Profile: The most commonly reported adverse reactions with Yaz when used as oral contraceptive or when used in the treatment of moderate acne vulgaris in women electing to use oral contraception are nausea, breast pain, unscheduled uterine bleeding and genital tract bleeding not further specified. They occur in ≥3% of users. The most commonly reported adverse reactions with Yaz when used for the treatment of PMDD in women electing to use oral contraception are nausea, breast pain and unscheduled uterine bleeding. They occur in >10% of users.
Serious adverse reactions are arterial and venous thromboembolism.
The frequencies of ADRs reported in clinical trials with Yaz and Yaz Plus as oral contraceptives in the treatment of moderate acne vulgaris in women who elect to use oral contraception (N=3565), as well as in the treatment of symptoms of PMDD in women who elect to use oral contraception (N= 289) are summarised in the following texts. Within each frequency grouping, ADRs are presented in order of decreasing seriousness. Frequencies are defined as common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100) and rare (≥1/10,000 to <1/1000). Additional ADRs identified only during post-marketing surveillance, and for which a frequency could not be estimated, are listed under "not known".
Psychiatric Disorders: Common: Emotional lability, depression/depressive mood. Uncommon: Decrease and loss of libido (incidence in trials evaluating PMDD was common ≥1/100).
Nervous System Disorders: Common: Migraine.
Vascular Disorders: Rare: Venous and arterial thromboembolic events.
Estimated frequency, from epidemiological studies encompassing a group of combined oral contraceptives. Frequency was borderline to very rare.
Venous and arterial thromboembolic events summarizes the following medical entities: Peripheral deep venous occlusion, thrombosis and embolism/pulmonary vascular occlusion, thrombosis, embolism and infarction/myocardial infarction/cerebral infarction and stroke not specified as hemorrhagic.
Gastrointestinal Disorders: Common: Nausea (incidence in trials evaluating PMDD was very common >10/100).
Skin and Subcutaneous Tissue Disorders: Not Known: Erythema multiforme.
Reproductive System and Breast Disorders: Common: Breast pain (incidence in trials evaluating PMDD was very common >10/100), unscheduled uterine bleeding (incidence in trials evaluating PMDD was very common >10/100), genital tract bleeding not further specified.
Adverse events in clinical studies were coded using the MedDRA dictionary (version 12.1). Different MedDRA terms representing the same medical phenomenon have been grouped together as single adverse reactions to avoid diluting or obscuring the true effect.
For venous and arterial thromboembolic events and migraine see also Contraindications, Warnings and Precautions.
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, Warnings and Precautions): Tumors: The frequency of diagnosis of breast cancer is very slightly increased among OC users. As breast cancer is rare in women <40 years, 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; 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 eg, rash, urticaria).
Interactions: Breakthrough bleeding and/or contraceptive failure may result from interactions of other drugs (enzyme inducers, some antibiotics) with oral contraceptives (see Interactions).