Qlaira Adverse Reactions

Like all medicines, Qlaira can cause side effects, although not everybody gets them. If the patient gets any side effect, particularly if severe and persistent, or have any change to health that may be due to Qlaira, advise the doctor.
An increased risk of blood clots in the veins [venous thromboembolism (VTE)] or blood clots in the arteries [arterial thromboembolism (ATE)] is present for all women taking combined hormonal contraceptives. For more detailed information on the different risks from taking combined hormonal contraceptives, see Contraindications and Precautions.
Serious side effects: Serious reactions associated with the use of the pill, as well as the related symptoms, are described in the following sections: "Blood clots" and "Qlaira and cancer" under Precautions. Read these sections carefully and consult the doctor at once where appropriate.
Other possible side effects: The following side effects have been linked with the use of Qlaira: Common side effects (between 1 and 10 in every 100 users may be affected): headache; abdominal pain, nausea; acne; no periods, breast discomfort, painful periods, irregular bleeding (heavy irregular bleeding); weight gain.
Uncommon side effects (between 1 and 10 in every 1,000 users may be affected): fungal infections, fungal infection of the vulva and vagina, vaginal infection; increased appetite; depression, depressed mood, emotional disorder, problems sleeping, decreased interest in sex, mental disorder, mood swings; dizziness, migraine; hot flush, high blood pressure; diarrhoea, vomiting; increased liver enzymes; hair loss, excessive sweating (hyperhidrosis), itching, rash; muscle cramps; swollen breasts, lumps in the breast, abnormal cell growth on the neck of the womb (cervical dysplasia), dysfunctional genital bleeding, pain with intercourse, fibrocystic breast disease, heavy periods, menstrual disorders, ovarian cyst, pelvic pain, premenstrual syndrome, growth in the uterus, contractions of the uterus, uterine/vaginal bleeding including spotting, vaginal discharge, vulvovaginal dryness; fatigue, irritability, swelling of parts of the body, e.g. ankles (oedema); weight loss, blood pressure changes.
Rare side effects (between 1 and 10 in every 10,000 users may be affected): candida infection, oral herpes, pelvic inflammatory disease, a vessel disease of the eye resembling a fungal infection (presumed ocular histoplasmosis syndrome), a fungal infection of the skin (tinea versicolor), urinary tract infection, bacterial inflammation of the vagina; fluid retention, increase in certain blood fats (triglycerides); aggression, anxiety, feelings of unhappiness, increased interest in sex, nervousness, night mare, restlessness, problems sleeping, stress; reduced attention, "pins and needles", giddiness; contact lens intolerance, dry eye, eye swelling; heart attack (myocardial infarction), palpitations; bleeding in a varicose vein, low blood pressure, inflammation of superficial veins, painful veins; harmful blood clots in a vein or artery [for example, in a leg or foot (i.e. DVT), in a lung (i.e. PE), heart attack, stroke, mini-stroke or temporary stroke-like symptoms, known as a transient ischaemic attack (TIA), blood clots in the liver, stomach/intestine, kidneys or eye. The chance of having a blood clot may be higher if there are any other conditions that increase this risk (See Precautions for more information on the conditions that increase risk for blood clots and the symptoms of a blood clot)]; constipation, dry mouth, indigestion, heartburn; liver nodules (focal nodular hyperplasia), chronic inflammation of gallbladder; allergic skin reactions, golden brown pigment patches (chloasma) and other pigmentation disorders, male pattern hair growth, excessive hair growth, skin conditions such as dermatitis and neurodermatitis, dandruff and oily skin (seborrhoea) and other skin disorders; back pain, pain in jaw, sensation of heaviness; urinary tract pain; abnormal withdrawal bleeding, benign breast nodules, breast cancer in early stage, breast cysts, breast discharge, polyp on the neck of the womb, reddening on the neck of the womb, bleeding during intercourse, spontaneous milk flow, genital discharge, lighter periods, delayed periods, rupture of an ovarian cyst, vaginal odour, burning sensation in the vulva and vagina, vulvovaginal discomfort; swollen lymph nodes; asthma, difficulty in breathing, nose bleeding; chest pain, tiredness and feeling generally unwell, fever; abnormal smear from the neck of the womb.
Further information (taken from the diaries women kept during a Qlaira clinical trial) on the possible side effects "irregular bleeding (heavy irregular bleeding)" and "no periods" is given in the "Bleeding between periods" and "What to do if no bleeding occurs on day 26 or the following day(s)" under Precautions.
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, and could also occur during use of Qlaira, are listed as follows (see also Contraindications and Precautions: liver tumors (benign and malignant); Erythema nodosum (tender red nodules under the skin), Erythema multiforme (skin rash with red spots or lesions); hypersensitivity (including symptoms such as rash, urticaria); in women with hereditary angioedema (characterized by sudden swelling of e.g. the eyes, mouth, throat etc.) estrogens in combined oral contraceptive pills may induce or worsen symptoms of angioedema.
In case of disturbed liver function, it may be necessary to temporarily stop the use of combined oral contraceptive pills.
Reporting of side effects: If the patient gets any side effects, talk to the doctor or pharmacist. This includes any possible side effects not listed. By reporting side effects, it can help provide more information on the safety of this medicine.