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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.
Nausea, vomiting, abdominal cramps, bloating, cholestatic jaundice, increased incidence of gall bladder disease, pancreatitis, enlargement of hepatic hemangiomas.
Retinal vascular thrombosis, intolerance to contact lenses.
Central nervous system
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.
Read the Angeliq (drospirenone and estradiol) Side Effects Center for a complete guide to possible side effects »
Drug/Laboratory Test Interactions
- Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulant activity, IX, X, XII, VII-X complex, II-VII-X complex, and beta-thromboglobulin; decreased levels of anti-factor Xa and antithrombin III, decreased antithrombin III activity; increased levels of fibrinogen and fibrinogen activity; increased plasminogen antigen and activity.
- Increased thyroid-binding globulin (TBG) levels leading to increased circulating total thyroid hormone, as measured by proteinbound iodine (PBI), T4 levels (by column or by radio immunoassay) or T3 levels by radio immunoassay. T3 resin uptake is decreased, reflecting the elevated TBG. Free T4 and free T3 concentrations are unaltered. Patients on thyroid replacement therapy may require higher doses of thyroid hormone.
- Other binding proteins may be elevated in serum (i.e., corticosteroid binding globulin (CBG), sex hormone-binding globulin (SHBG)) leading to increased circulating corticosteroids and sex steroids, respectively. Free hormone concentrations may be decreased. Other plasma proteins may be increased (angiotensinogen/ renin substrate, alpha-1-antitrypsin, ceruloplasmin).
- Increased plasma HDL and HDL-2 subfraction concentrations, reduced LDL cholesterol concentration, increased triglyceride levels.
- Impaired glucose tolerance.
- Reduced response to metyrapone test.
Last reviewed on RxList: 1/16/2009
This monograph has been modified to include the generic and brand name in many instances.
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