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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
(N=226)
n (%)
ANGELIQ (drospirenone and estradiol)
(N=227)
n (%)
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)
NERVOUS SYSTEM
   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)
UROGENITAL
   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:

Genitourinary system

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.

Breasts

Tenderness, enlargement, pain, nipple discharge, galactorrhea, fibrocystic breast changes, breast cancer.

Cardiovascular

Deep and superficial venous thrombosis, pulmonary embolism, thrombophlebitis, myocardial infarction, stroke, increase in blood pressure.

Gastrointestinal

Nausea, vomiting, abdominal cramps, bloating, cholestatic jaundice, increased incidence of gall bladder disease, pancreatitis, enlargement of hepatic hemangiomas.

Skin

Chloasma or melasma, which may persist when drug is discontinued, erythema multiforme, erythema nodosum, hemorrhagic eruption, loss of scalp hair, hirsutism, pruritus, rash.

Eyes

Retinal vascular thrombosis, intolerance to contact lenses.

Central nervous system

Headache, migraine, dizziness, mental depression, chorea, nervousness, mood disturbances, irritability, exacerbation of epilepsy, dementia.

Miscellaneous

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.