Daylina Adverse Reactions

For serious undesirable effects in COC users see 'Precautions'.
The following adverse drug reactions have been reported during use of drospirenone/ethinylestradiol: The list as follows reports adverse reactions by MedDRA system organ classes (MedDRA SOCs). Undesirable effects are ranked by frequency, the most frequent first, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), including isolated reports; not known (cannot be estimated from the available data.
The frequencies are based on clinical trial data. The most appropriate MedDRA term used to describe a certain reaction and its synonyms and related conditions.
Infections and infestations: Rare: Candidiasis.
Blood and lymphatic system disorders: Rare: Anaemia, thrombocythemia.
Immune system disorders: Rare: Allergic reaction.
Not known: Hypersensitivity, exacerbation of symptoms of hereditary and acquired angioedema.
Endocrine disorders: Rare: Endocrine disorder.
Metabolism and nutrition disorders: Rare: Increased appetite, anorexia, hyperkalaemia, hyponatraemia.
Psychiatric disorders: Common: Emotional lability.
Uncommon: Depression, nervousness, somnolence.
Rare: Anorgasmia, insomnia.
Nervous system disorders: Common: Headache.
Uncommon: Dizziness, paraesthesia.
Rare: Vertigo, tremor.
Eye disorders: Rare: Conjunctivitis, dry eye, eye disorder.
Cardiac disorders: Rare: Tachycardia.
Vascular disorders: Uncommon: Migraine, varicose vein, hypertension.
Rare: Venous thromboembolism (VTE), arterial thromboembolism (ATE), phlebitis, vascular disorder, epistaxis, syncope.
Gastrointestinal disorders: Common: Nausea.
Uncommon: Abdominal pain, vomiting, dyspepsia, flatulence, gastritis, diarrhoea.
Rare: Abdomen enlarged, gastrointestinal disorder, gastrointestinal fullness, hiatus hernia, oral candidiasis, constipation, dry mouth.
Hepatobiliary disorders: Rare: Biliary pain, cholecystitis.
Skin and subcutaneous tissue disorders: Uncommon: Acne, pruritus, rash.
Rare: Chloasma, eczema, alopecia, dermatitis acneiform, dry skin, erythema nodosum, hypertrichosis, skin disorder, skin striae, contact dermatitis, photosensitive dermatitis, skin nodule.
Not known: Erythema multiforme.
Musculoskeletal and connective tissue disorders: Uncommon: Back pain, pain in extremity, muscle cramps.
Reproductive system and breast disorders: Common: Breast pain, metrorrhagia (bleeding irregularities usually subside during continued treatment), amenorrhea.
Uncommon: Vaginal candidiasis, pelvic pain, breast enlargement, fibrocystic breast, uterine/vaginal bleeding (bleeding irregularities usually subside during continued treatment), genital discharge, hot flushes, vaginitis, menstrual disorder, dysmenorrhea, hypomenorrhea, menorrhagia, vaginal dryness, Papanicolaou smear suspicious, libido decreased.
Rare: Dyspareunia, vulvovaginitis, postcoital bleeding, withdrawal bleeding, breast cyst, breast hyperplasia, breast neoplasm, cervical polyp, endometrial atrophy, ovarian cyst, uterine enlargement.
General disorders and administration site conditions: Uncommon: Asthenia, sweating increased, edema (generalized edema, peripheral edema, face edema).
Rare: Malaise.
Investigations: Uncommon: Weight increase.
Rare: Weight decrease.
Description of selected adverse reactions: An increased risk of arterial and venous thrombotic and thrombo-embolic events, including myocardial infarction, stroke, transient ischemic attacks, venous thrombosis and pulmonary embolism has been observed in women using CHCs, which are discussed in more detail in 'Precautions'.
The following serious adverse events have been reported in women using COCs, which are discussed in 'Precautions': Venous thromboembolic disorders; Arterial thromboembolic disorders; Hypertension; Liver tumours; Occurrence or deterioration of conditions for which association with COC use is not conclusive: Crohn's disease, ulcerative colitis, epilepsy, uterine myoma, porphyria, systemic lupus erythematosus, herpes gestationis, Sydenham's chorea, haemolytic uremic syndrome, cholestatic jaundice; Chloasma; Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal; Exogenous estrogens may induce or exacerbate symptoms of hereditary and acquired angioedema.
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. For further information, see 'Contraindications' and 'Precautions'.
Interactions: Breakthrough bleeding and/or contraceptive failure may result from interactions of other drugs (enzyme inducers) with oral contraceptives (see Interactions).
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.