Note: This document contains side effect information about drospirenone / estradiol. Some of the dosage forms listed on this page may not apply to the brand name Angeliq.
Applies to drospirenone / estradiol: oral tablet
Oral route (Tablet)
Unopposed estrogens increase the risk of endometrial cancer in women without a uterus. Estrogen alone or with a progestin should not be used for the prevention of cardiovascular disease or dementia. Increased risks of stroke and DVT have been reported with estrogen-alone therapy, along with increased risk for endometrial cancer in a woman with a uterus who uses unopposed estrogens. Increased risks of stroke, DVT, pulmonary embolism, myocardial infarction, and invasive breast cancer have been reported with estrogen plus progestin therapy. An increased risk of probable dementia in postmenopausal women aged 65 and older has been reported with estrogen plus progestin therapy. Risks should be assumed to be similar for other doses, combinations, and dosage forms of estrogens and progestins. Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration possible.
Along with its needed effects, drospirenone / estradiol may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking drospirenone / estradiol:
Incidence not known
Some side effects of drospirenone / estradiol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Applies to drospirenone / estradiol: oral tablet
The most common adverse events were gastrointestinal and abdominal pain, female genital bleeding, breast pain, and headache.
Very common (10% or more): Breast pain or discomfort (17.9%), female genital tract bleeding (14%)
Common (1% to 10%): Breast enlargement, uterine fibroids enlarged, menstrual disorder, vaginal discharge, leukorrhea, vulvovaginal fungal infections,cervical polyp
Uncommon (0.1% to 1%): Urinary tract disorder, urinary tract infection, endometrial hyperplasia, fibrocystic breast, uterine disorder, ovarian disorder, cervix disorder, pelvic pain, vulvovaginal disorder, vaginal candidiasis, vaginitis, vulvovaginitis, dysmenorrhea, ovarian cyst, vaginal dryness
Rare (less than 0.1%): Salpingitis, galactorrhea
Common (1% to 10%): Nausea, gastrointestinal and abdominal pain, diarrhea, abdomen enlarged, abdominal bloating
Uncommon (0.1% to 1%): Gastrointestinal disorder, constipation, vomiting, dry mouth, flatulence, taste disturbance
Common (1% to 10%): Migraine, headache
Uncommon (0.1% to 1%): Dizziness, paresthesia, concentration ability impaired, vertigo
Common (1% to 10%): Depression, nervousness, emotional lability, mood swings
Uncommon (0.1% to 1%): Libido decreased, anxiety, sleep disorder
Common (1% to 10%): Peripheral edema, asthenia, localized edema, hot flushes
Uncommon (0.1% to 1%): Weight gain, weight loss, generalized edema, chest pain, malaise, chills, laboratory test abnormal, taste disturbance
Rare (less than 0.1%): Tinnitus
Uncommon (0.1% to 1%): Palpitation, hypertension, thrombophlebitis, varicose vein, venous thrombosis, superficial thrombophlebitis, vasodilation
Rare (less than 0.1%): Venous and arterial thromboembolic events
Frequency not reported: Cardiac failure, atrial flutter, QT interval prolonged, cardiomegaly
Venous and arterial thromboembolic events include peripheral deep vein occlusion, thrombosis and embolism/pulmonary vascular occlusion, thrombosis, embolism, infarction, myocardial infarction, cerebral infarction, and stroke not specified as hemorrhagic.
Common (1% to 10%): Benign breast neoplasm, benign neoplasm of cervix uteri
Uncommon (0.1% to 1%): Breast carcinoma, benign uterine neoplasm
Postmarketing reports: Breast cancer
Common (1% to 10%): Pain in extremity
Uncommon (0.1% to 1%): Back pain, pain in pelvis, arthralgia, muscle cramps
Rare (less than 0.1%): Myalgia
Uncommon (0.1% to 1%): Dyspnea
Postmarketing reports: Hypersensitivity reactions (including rash, pruritus, and urticaria)
Uncommon (0.1% to 1%): Skin disorder, acne, alopecia, pruritus, rash, hirsutism, hair disorder, sweating increased
Uncommon (0.1% to 1%): Eye disorder, visual disturbance
Rare (less than 0.1%): Increased appetite, anorexia, hyperlipidemia,
Frequency not reported: Hyperkalemia
Uncommon (0.1% to 1%): Liver function test abnormal
Rare (less than 0.1%): Anemia
Frequency not reported: Blood aldosterone increased
Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.
Source: Drugs.com Angeliq