See BOXED WARNINGS, WARNINGS, AND PRECAUTIONS.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
The following are adverse events reported with ANGELIQ (drospirenone and estradiol) occurring in > 5% of subjects:
Table 4: Adverse Events Regardless of Drug Relationship Reported at a Frequency of > 5% in a 1-year Double-blind Clinical Trial
|ADVERSE EVENT||E2 1 MG
|ANGELIQ (drospirenone and estradiol)
|BODY AS A WHOLE|
|Abdominal pain||29 (12.8)||25 (11)|
|Pain in extremity||15 (6.6)||19 8 ( .4)|
|Back pain||11 (4.9)||16 (7)|
|Flu syndrome||15 (6.6)||16 (7)|
|Accidental injury||15 (6.6)||13 (5 .7)|
|Abdomen enlarged||17 (7.5)||16 (7)|
|Surgery||6 (2.7)||12 (5.3)|
|METABOLIC & NUTRITIONAL DISORDERS|
|Peripheral edema||12 (5.3)||4 (1 .8)|
|Headache||26 (11.5)||22 (9.7)|
|RESPIR ATORY SYSTEM|
|Upper respiratory infection||40 (17.7)||43 (18.9)|
|Sinusitis||8 (3.5)||12 (5.3)|
|SKIN AND APPENDAGES|
|Breast pain||34 (15)||43 (18.9)|
|Vaginal hemorrhage||43 (19)||21 (9.3 )|
|Endometrial disorder||22 (9.7)||4 (1.8)|
|Leukorrhea||14 (6.2)||3 (1.3)|
The following additional adverse reactions have been reported with estrogen and or estrogen/progestin therapy:
Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding, spotting, dysmenorrhea, increase in size of uterine leiomyomata, vaginitis, including vaginal candidiasis, change in amount of cervical secretion, changes in cervical ectropion, ovarian cancer, endometrial hyperplasia, endometrial cancer.
Tenderness, enlargement, pain, nipple discharge, galactorrhea, fibrocystic breast changes, breast cancer.
Deep and superficial venous thrombosis, pulmonary embolism, thrombophlebitis, myocardial infarction, stroke, increase in blood pressure.
Nausea, vomiting, abdominal cramps, bloating, cholestatic jaundice, increased incidence of gall bladder disease, pancreatitis, enlargement of hepatic hemangiomas.
Chloasma or melasma, which may persist when drug is discontinued, erythema multiforme, erythema nodosum, hemorrhagic eruption, loss of scalp hair, hirsutism, pruritus, rash.
Retinal vascular thrombosis, intolerance to contact lenses.
Central nervous system
Headache, migraine, dizziness, mental depression, chorea, nervousness, mood disturbances, irritability, exacerbation of epilepsy, dementia.
Increase or decrease in weight, reduced carbohydrate tolerance, aggravation of porphyria, edema, arthralgias, leg cramps, changes in libido, anaphylactoid/anaphylactic reactions including urticaria and angioedema, hypocalcemia, exacerbation of asthma, increased triglycerides.