Yasmin Adverse Reactions

Adverse Drug Reaction Overview: An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives: arterial and venous thromboembolism; being diagnosed with breast cancer; benign and malignant hepatic tumors; cerebral hemorrhage; cerebral thrombosis; congenital anomalies; gallbladder disease; hypertension; mesenteric thrombosis; myocardial infarction; neuro-ocular lesions (eg, retinal thrombosis); pulmonary embolism; thrombophlebitis.
The following other adverse reactions also have been reported in patients receiving oral contraceptives: Nausea and vomiting, usually the most common adverse reaction, occurs in approximately 10% or fewer of patients during the first cycle. The following other reactions, as a general rule, are seen less frequently or only occasionally: abdominal pain; amenorrhea during and after treatment; angioedema (exogenous estrogens may induce or exacerbate symptoms of angioedema in women with hereditary angioedema); auditory disturbances; breakthrough bleeding; breast changes (tenderness, enlargement, and secretion); cataracts; changes in appetite; change in corneal curvature (steepening); changes in libido; change in menstrual flow; change in weight (increase or decrease); changes in glucose tolerance or effect on peripheral insulin resistance; chloasma or melasma which may persist; cholestatic jaundice; chorea; Crohn's disease; cystitis-like syndrome; mental depression; diarrhea; dizziness; dysmenorrhea; edema; endocervical hyperplasia; erythema multiforme; erythema nodosum; gallstone formation^a; gastrointestinal symptoms (such as abdominal cramps and bloating); headache; hemolytic uremic syndrome^a; hemorrhagic eruption; herpes gestationis^a; hirsutism; hypersensitivity; hypertriglyceridemia (increased risk of pancreatitis when using COCs); hypertension; impaired renal function; increase in size of uterine leiomyomata; intolerance to contact lenses; jaundice related to cholestatis^a; liver function disturbances; loss of scalp hair; migraine; nervousness; optic neuritis; otosclerosis-related hearing loss^a; pancreatitis; porphyria^a; possible diminution in lactation when given immediately postpartum; premenstrual-like syndrome; pruritis related to cholestasis^a; rash (allergic); Raynaud's phenomenon; reduced tolerance to carbohydrates; retinal thrombosis; rhinitis; spotting; Sydenham's chorea^a; systemic lupus erythematosus^a; temporary infertility after discontinuation of treatment; ulcerative colitis; urticaria; vaginal candidiasis; vaginal discharge; vaginitis.
^a Occurrence or deterioration of conditions for which association with COC use is not conclusive.
Clinical Trial Adverse Drug Reactions: Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates.
The following are the most common adverse events reported with use of YASMIN during clinical trials, occurring in >1% of subjects and which may or may not be drug related: headache, menstrual disorder, breast pain, abdominal pain, nausea, leukorrhea, flu syndrome, acne, vaginal moniliasis, depression, diarrhea, asthenia, dysmenorrhea, back pain, infection, pharyngitis, intermenstrual bleeding, migraine, vomiting, dizziness, nervousness, vaginitis, sinusitis, cystitis, bronchitis, gastroenteritis, allergic reaction, urinary tract infection, pruritus, emotional lability, surgery, rash, upper respiratory infection.
Less Common Clinical Trial Adverse Drug Reactions: Other reactions to oral contraceptives, as a general rule, are seen less frequently or only occasionally, as follows: gastrointestinal symptoms (such as abdominal cramps and bloating), breakthrough bleeding, spotting, change in menstrual flow, dysmenorrhea, amenorrhea during and after treatment, temporary infertility after discontinuation of treatment, edema, chloasma or melasma which may persist, breast changes (tenderness, enlargement, secretion), change in weight (increase or decrease), endocervical hyperplasias, possible diminution in lactation when given immediately postpartum, cholestatic jaundice, migraine, increase in size of uterine leiomyomata, rash (allergic), mental depression, reduced tolerance to carbohydrates, vaginal candidiasis, premenstrual-like 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 disturbances, hemolytic uremic syndrome, pancreatitis.
Post-Market Adverse Drug Reactions: Cumulative postmarketing experience with YASMIN indicates a spontaneous reporting rate of venous thromboembolism of 5.1 events per 100 000 woman-years.
The following serious and unexpected adverse reactions have also been reported very rarely in users of YASMIN, but a causal relationship has not been established: pancytopenia, thrombocytopenia, arrhythmia, palpitations, tachycardia, ventricular extrasystoles, sudden hearing loss, ocular hypertension, visual disturbance, vitreous opacities, ischaemic colitis, hepatitis, hyperbilirubinemia, abnormal liver function test, decreased blood sodium, bone pain, pain in extremity, fibroadenoma of breast, seizure, dysarthria, facial paresis, hemiparesis, hypoesthesia, syncope, anxiety, nervousness, panic reaction, breast cyst, hematometra due to cervical polyp, asthma, leukocytoclastic vasculitis, lichen planus, and petechiae.
Cases of erythema nodosum, erythema multiforme, and hypersensitivity (including symptoms such as rash, urticaria) have been reported as adverse drug reactions from postmarket reporting in association with the use of YASMIN.
In addition, venous and arterial thromboembolic events (peripheral deep venous occlusion, thrombosis and embolism/pulmonary vascular occlusion, thrombosis, embolism and infarction/myocardial infarction/cerebral infarction and stroke not specified as hemorrhagic) have been identified as ADRs from postmarketing experience reported in association with the use of YASMIN (see Contraindications; Hematologic under Precautions). Because these reactions are reported voluntarily from a population of uncertain size it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following unexpected adverse events have also been reported very rarely in users of YASMIN; but a causal relationship has not been established: hot/cold sensations, muscle spasms, and muscle twitching.
Post-Market Active Surveillance Study: A prospective, controlled, noninterventional, active surveillance cohort study (EURAS) was conducted in Europe to compare risks of adverse cardiovascular and other events associated with the use of DRSP-containing OCs (YASMIN) and other OCs. In this study, 58,674 OC users were actively followed for a total of 142,475 woman-years. Loss to follow-up was 2.4%. The hazard ratios for venous thromboembolic (VTE) and for all thromboembolic (TE) events were close to 1 and thus do not suggest a higher risk for YASMIN users. The results exclude a 1.5-fold thromboembolic risk of YASMIN users compared to users of LNG-containing OCs and a 1.2-fold thromboembolic risk compared to users of other OCs. Arrhythmic events that could be suggestive of an increased serum potassium level (eg, because of the antimineralocorticoid activity of DRSP) were not observed in this Postmarket Surveillance study.
Hazard ratios and confidence limits for VTE, ATE and TE are presented as follows in Table 8. (See Table 8.)

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