An increased risk of the following serious adverse reactions has been associated with the use of estrogen/progestogen combinations: thrombophlebitis; arterial thromboembolism; pulmonary embolism; mesenteric thrombosis; neuro-ocular lesions, e.g. retinal thrombosis and optic neuritis; myocardial infarction; cerebral thrombosis; cerebral hemorrhage; hypertension; liver tumors; gall bladder disease and congenital anomalies.
The following adverse reaction also have been reported in patients receiving estrogen/progestogen combination oral contraceptive: nausea and vomiting, usually the most common adverse reaction occurring in approximately 10% or less of patients during the first cycle. Other reactions, as a general rule, are seen less frequently or only occasionally: GI symptoms (such as abdominal cramps and bloating); break through bleeding; spotting; change in menstrual flow; dysmenorrheal; amenorrhea, during and after treatment; temporary infertility after discontinuance of treatment; edema; chloasma, or melasma which may persist; breast changes: tenderness, enlargement and secretion; change in weight (increase or decrease); change in cervical erosion and secretion; endocervical hyperplasia; possible diminution in lactation when given immediately postpartum; cholestatic jaundice; migraine; increase in size of uterine leiomyomata; rash (allergy); mental depression, reduce tolerance to carbohydrates; vaginal candidiasis, pre-menstrual syndrome; intolerance to contact lenses; change in corneal curvature (steepening); cataracts; optic neuritis; retinal thrombosis; changes in libido; chorea; changes in appetite; cystitis like syndrome; rhinitis; headache; nervousness; dizziness; hirsutism; loss of scalp hair; erythema multiforme; erythema nodosum; hemorrhagic eruption; vaginitis; porphyria; impaired renal function; Raynaud's phenomenon; auditory disturbance; hemolytic uremic syndrome and pancreatitis.
Product specific adverse reactions:
Lydia Clair was generally well tolerated in studies involving 1563 women who were treated for periods of 6-36 cycles. The most frequently reported complaint was dysmenorrheal (10.2%) which decreased over time in a manner characteristic of treatment with estrogen/progestogen combinations.
Serious post marketing adverse reaction reported with Lydia Clair include deep venous thrombosis, venous thrombosis with pulmonary embolism, arterial emboli involving the extremities and the spleen, cerebral ischemic vascular accident' cerebral venous thrombosis, sinus thrombosis, retinal vein thrombosis, hypertensive crisis' migraine, pancreatitis, focal nodular hyperplasia of the liver, sub capsular liver hematoma, liver adenoma, hepatocellular carcinoma, primary bile duct carcinoma, hepatitis, liver dystrophy, cholangitis, pseudomembranous colitis, cholestasis, abdominal pain, epileptic seizures, cerebral tumor symptoms' acute brachiofacial paresis, acute hydrocephalus, manic syndrome, hyperpathia, anaphylactoid reactions, ascites, diabetes mellitus, acute leukemia and breast cancer.
The following non serious adverse reactions, listed according to the body system, have been reported post marketing: cardiovascular: headache, migraine, superficial phlebitis, palpitations, flushing.
Focal nodular hyperplasia, liver tumor, hepatitis, jaundice, hepatomegaly without abdominal liver tests, nausea, diarrhea, flatulence, stomatitis, salivary gland swelling.
Menstrual disorder, ovarian cysts, myoma, cervix, dysplasia, vaginitis, UTI, premature birth, abortion, missed abortion and placenta insufficiency.
abnormal liver enzymes, hyper thyroidism, hyper prolactinemia.
Depression, decrease libido, nervousness, insomnia, somnolence, confusion, hypesthesia, paresthesia, seizures (in patients with a history of epilepsy), visual disturbances, symptoms of conjunctival irritation, hearing disorder.
Alopecia' acne, chloasma, exanthema, erythema nodosum, striae, neurodermitis, skin allergy, urticaria, facial edema, pruritus, photosensitivity, pigmentation, dry skin, Herpes zoster, cellulites, subcutaneous lumps, eczema, livedo, blue spots.