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.
The frequencies of ADRs reported in clinical trials with Yasmin (N=4897) are summarized in the following text. Within each frequency grouping, ADRs are presented in order of decreasing seriousness. Frequencies are defined as common (≥1/100 to <1/10) and rare (≥1/10,000 to <1/1,000). 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, decrease and loss of libido.
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.
Skin and Subcutaneous Tissue Disorders: Not Known: Erythema multiforme.
Reproductive System and Breast Disorders: Common: Breast pain, unscheduled uterine bleeding, genital tract bleeding not further specified.
Adverse events in clinical studies were coded using the MedDRA dictionary (version 12.1). The MedDRA preferred term is used to describe a certain reaction and its synonyms and related conditions. 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.
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