The frequencies with which adverse reactions have been reported are defined as follows: Very Common
(Affecting >1 in 10 Users): Nausea, vaginal discharge, menstrual pain, amenorrhea, breakthrough bleeding, spotting, headache, pain in the breasts.
Common (Affecting <1 in 10, but >1 in 100 Users): Ovarian cyst, benign tumours (fibroadenomas), feeling of tension in the breasts, depression, irritability, nervousness, dizziness, migraine (and/or aggravation of these), visual disorders, vomiting, acne, pain in the belly, tiredness, feeling of heaviness in the legs, water retention; increased weight, blood pressure.
Uncommon (Affecting <1 in 100, but >1 in 1,000 Users): Stomachache, stomach and bowel problems, drug hypersensitivity including allergic skin reaction, rumbling in the bowels, diarrhoea, pigmentation problems, brown blotches on the face (chloasma) that become worse on long periods of sunbathing, hair loss, dry skin, back pain, muscle problems, secretion from the breasts, benign changes in the connective tissues of the breasts, fungal infection of the vagina, decrease in libido, tendency to sweat, changes in blood fats including increased triglycerides.
Rare (Affecting <1 in 1,000, but >1 in 10,000 Users): Conjunctivitis, discomfort when wearing contact lenses, deafness, tinnitus, high and low blood pressure, blood circulation collapse, varicose veins, venous thrombosis, hives, nettlerash, eczema, dermatitis (inflamed skin), itching, fleeting acne, worsening of psoriasis, excessive hair on the body or on the face, breast enlargement, inflammation of the vagina, longer and/or more intense menstruation, premenstrual syndrome (physical and emotional problems before the start of menstruation), increased appetite.
Very Rare (Affecting <1 in 10,000 Users) including isolated cases erythema nodosum.
Combined Oral Contraceptives Have Also Been Linked With An Increase of Risks for Serious Diseases and Side-Effects:
Risk of blockage of the veins and arteries; diseases of the bile tract and tumours (eg, liver tumours, which in isolated cases cause life-threatening bleeding into the abdominal cavity, cancer of the neck of the womb or breasts); aggravation of chronic inflammation of the bowels (Crohn's disease, ulcerative colitis).
Cycle-Specific Adverse Reactions:
Spotting: Spotting may occur particularly during the 1st few intake cycles of Chariva; in such cases, the patient should generally continue taking Chariva. If heavy spotting that is similar to normal menstrual bleeding happened, the patient should seek medical help because such bleeding may have organic causes.
The same applies to spotting occurring at irregular intervals in several successive cycles, or for the 1st time after taking Chariva for a long time. Such spotting may also occur as a result of interactions with other medicines taken at the same time (see Interactions).
Absence of Withdrawal Bleeding: If in very rare cases there is no withdrawal bleeding during the medication free day, the patient may continue taking Chariva if pregnancy is ruled out within the first 10 days of the new medication cycle. If withdrawal bleeding does not occur in 2 successive cycles, the patient should seek medical help whether to continue taking Chariva or not.
Effect on the Development of Breast Cancer:
Sex hormones have an effect on breast tissue. Altering the hormone balance (eg, by taking hormonal contraceptives) may make the breast tissue more sensitive to other factors that encourage cancer, which in itself may encourage cancer. Analyses of the results of epidemiological studies on the possibility of a connection between taking hormonal contraceptives and cancer of the breast indicate that the occurrence of cancer of the breast in women up to middle age is more frequently associated with the long term use of oral contraceptives started at an early age. However, this is only of several possible risk factors. Breast secretion and enlargement have been observed in isolated cases.
Effect on Laboratory Tests:
Normal laboratory values may be affected by hormonal contraceptive (eg, blood sedimentation rate may rise without illness). Increased levels of serum copper and iron or alkaline leukocyte phosphatase, have been reported, in addition to change in other values.