Summary of the safety profile: The most commonly reported adverse reactions with Yasmin 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 Yasmin (N=4897) are summarised in the table as follows (see Table 3). Within each frequency grouping, ADRs are presented in order of decreasing seriousness. 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). Additional ADRs identified only during postmarketing surveillance, and for which a frequency could not be estimated, are listed under 'not known'.
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Adverse events in clinical studies were coded using the MedDRA dictionary. Different MedDRA terms representing the same medical phenomenon have been grouped together as single adverse reactions to avoid diluting or obscuring the true effect.
*: 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.
For venous and arterial thromboembolic events and migraine, see 'Contraindications' and 'Warnings'.
The MedDRA preferred term is used to describe a certain reaction and its synonyms and related conditions. ADR term representation is based on MedDRA version 12.1.
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 "Contraindications" and "Warnings"): 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: Venous thromboembolic disorders; arterial thromboembolic disorders; 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: acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal; 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).
Side effects that may occur during administration should be reported to a Doctor.