Yaz 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 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 cholestasis^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; pruritus 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; urticaria; ulcerative colitis; 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 clinical development programs were conducted independently for each of the 2 indications and utilized indication-specific inclusion criteria, study designs, and settings. Thus, the safety results of the studies are presented separately and are not pooled.
The following adverse drug reactions were reported at a frequency ≥ 1% in pivotal clinical trials using YAZ as an oral contraceptive: See Table 13.

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The following adverse drug reactions were reported at a frequency ≥1% in pivotal clinical trials using YAZ in the treatment of moderate acne vulgaris: See Table 14.

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Less Common Clinical Trial Adverse Drug Reactions: The following adverse drug reactions were seen at a frequency of <1% and ≥0.1% in pivotal clinical trials using YAZ as an oral contraceptive: Body as a whole: abdominal pain, asthenia, back pain, pain in extremity, pelvic pain.
Cardiovascular system: hypertension, migraine, varicose vein.
Digestive system: diarrhea, dyspepsia, flatulence, gastritis, vomiting.
Metabolic and nutritional disorders: weight gain, edema, peripheral edema.
Musculoskeletal system: muscle cramps.
Nervous system: dizziness, paresthesia, sweating increased, depression, libido decreased, nervousness, somnolence.
Skin and appendages: breast enlargement, acne, pruritus, fibrocystic breast, rash.
Urogenital system: hypomenorrhea, leukorrhea, vaginal dryness, vaginal moniliasis, dysmenorrhea, metrorrhagia, vaginal hemorrhage, menstrual disorder, PAP smear suspicious, vaginitis, menorrhagia.
The following adverse drug reactions were seen at a frequency of <1% and ≥0.1% in pivotal clinical trials using YAZ in the treatment of moderate acne vulgaris: Body as a whole: abdominal pain, asthenia, malaise.
Cardiovascular system: hypertension, migraine.
Urogenital system: amenorrhea, leukorrhea, PAP smear suspicious, uterine enlargement, vaginal moniliasis.
The following adverse drug reactions were seen at a frequency of <0.1% and ≥0.01% in pivotal clinical trials using YAZ as an oral contraceptive: Body as a whole: abdomen enlarged, accidental injury, allergic reaction, cyst, face edema, hernia, infection, moniliasis.
Cardiovascular system: phlebitis, syncope, tachycardia, vascular disorder.
Digestive system: biliary pain, cholecystitis, constipation, gastrointestinal disorder, gastrointestinal fullness, increased appetite, liver function test abnormal, oral moniliasis.
Endocrine system: endocrine disorder.
Metabolic and nutritional disorders: generalized edema, SGPT increased, weight loss.
Nervous system: hot flashes, insomnia, vertigo.
Respiratory system: epistaxis.
Skin and appendages: alopecia, breast neoplasm, chloasma, dermatitis acneiform, dry skin, eczema, erythema nodosum, hypertrichosis, skin disorder, skin striae.
Special senses: conjunctivitis, dry eye, eye disorder.
Urogenital system: anorgasmia, cervix neoplasm, dyspareunia, endometrial disorder, ovarian cyst, vulvovaginitis, withdrawal bleeding.
Postmarket Adverse Drug Reactions: The following unexpected adverse events have also been reported very rarely in users of YAZ, but a causal relationship has not been established: hot/cold sensations, muscle spasms, muscle twitching, and erythema multiforme.
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 Adverse Drug Reactions (ADRs) from postmarketing experience reported in association with the use of YAZ (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.