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Serious side effects: See also The Pill and blood clots and The Pill and cancer under Precautions for side effects, including serious reactions, associated with the use of the Pill and Contraindications. Please read these sections carefully and consult the doctor at once where appropriate.
The following side effects were reported in the studies of originator product that use for oral contraceptive, for the treatment of moderate acne in women who decided to use oral contraception and for the treatment of symptoms of Premenstrual Dysphoric Disorder (PMDD) in women who decided to use oral contraception.
Common side effects (may affect up to 1 in 10): emotional lability (mood swings), depression/depressive mood; migraine; nauseaa; breast paina, unscheduled uterine bleeding (bleeding between periods)a, genital tract bleeding (vaginal bleeding) not further specified.
Uncommon side effects (may affect up to 1 in 100 people): decrease and loss of libido (reduced or loss of sex drive)b.
Rare side effects (may affect up to 1 in 1,000 people): venous and arterial thromboembolic events*.
* Estimated frequency, from epidemiological studies of originator product that encompassing a group of combined oral contraceptives. Frequency was borderline to Very Rare.
The term venous and arterial thromboembolic events covers the following: any blockage or clot in a deep peripheral vein, clots which travel through the venous blood system (e.g. to the lung known as pulmonary embolism or as pulmonary infarction), heart attack caused by blood clots, stroke caused by blockage of the blood supply to or in the brain.
a Incidence in trials evaluating PMDD was Very Common > 10/100.
b Incidence in trials evaluating PMDD was Common ≥1/100.
Side effects that have been reported with the use of the Pill, without knowing their precise frequency: erythema multiforme (a skin condition characterized by itchy red blotches or swollen patches of skin).
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: Tumors: The frequency of diagnosis of breast cancer is very slightly increased among users of oral contraceptives. 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. It is not known whether there is a direct link to users of combined oral contraceptives.
Liver tumors (benign and malignant).
Other conditions: erythema nodosum (a skin condition characterized by tender red nodules).
Women with hypertriglyceridemia (increased blood fats resulting in an increased risk of pancreatitis when using combined oral contraceptives).
High blood pressure.
Occurrence or worsening of conditions for which a link to combined oral contraceptives is not definite: jaundice and/or itching related to cholestasis (blocked bile flow); gallstone formation; a metabolic condition called porphyria; systemic lupus erythematosus (a chronic autoimmune disease); hemolytic uremic syndrome (a blood clotting disease); a neurological condition called Sydenham's chorea; herpes gestationis (a type of skin condition that occurs during pregnancy); otosclerosis-related hearing loss.
In women with hereditary angioedema (characterized by sudden swelling of e.g. the eyes, mouth, throat etc.) external estrogens may induce or worsen symptoms of angioedema.
Disturbed liver function.
Changes in glucose tolerance or effect on peripheral insulin resistance.
Crohn's disease, ulcerative colitis.
Chloasma.
Hypersensitivity (including symptoms such as rash, urticaria).
Interactions: Unexpected bleeding and/or contraceptive failure may result from interactions of other drugs with oral contraceptives (e.g. the herbal remedy St. John's wort, or drugs for epilepsy, tuberculosis, HIV infections and other infections).
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