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Drospirenone / estradiol Side Effects

Medically reviewed by Drugs.com. Last updated on May 30, 2023.

Applies to drospirenone / estradiol: oral tablet.

Warning

Oral route (Tablet)

Estrogen Plus Progestin TherapyCardiovascular Disorders and Probable Dementia: The Women's Health Initiative (WHI) estrogen plus progestin substudy reported an increased risk of pulmonary embolism (PE), deep vein thrombosis (DVT), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogen (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo. The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. Do not use estrogen plus progestogen therapy for the prevention of cardiovascular disease or dementia.Breast Cancer: The WHI estrogen plus progestin substudy demonstrated an increased risk of invasive breast cancer. Only daily oral 0.625 mg CE and 2.5 mg MPA were studied in the estrogen plus progestin substudy of WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events, probable dementia and breast cancer to lower CE plus other MPA doses, other routes of administration, or other estrogen plus progestin products is not known. Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. Discuss with your patient the benefits and risks of estrogen plus progestin therapy, taking into account her individual risk profile. Prescribe estrogens with or without progestogens at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.Estrogen-Alone TherapyEndometrial Cancer: There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestogen to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Perform adequate diagnostic measures, including directed or random endometrial sampling when indicated, to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.Cardiovascular Disorders and Probable DementiaThe WHI estrogen-alone substudy reported increased risks of stroke and DVT in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral CE (0.625 mg)-alone relative to placebo. The WHIMS estrogen-alone ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. Do not use estrogen-alone therapy for the prevention of cardiovascular disease or dementia. Only daily oral 0.625 mg CE was studied in the estrogen-alone substudy of WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events and dementia to lower CE doses, other routes of administration, or other estrogen-alone products is not known. Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. Discuss with your patient the benefits and risks of estrogen plus progestin therapy, taking into account her individual risk profile. Prescribe estrogens with or without progestogens at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman

Serious side effects

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:

More common

Less common

Incidence not known

Other side effects

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:

More common

For Healthcare Professionals

Applies to drospirenone / estradiol: oral tablet.

General

The most common adverse events were gastrointestinal and abdominal pain, female genital bleeding, breast pain, and headache.[Ref]

Genitourinary

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[Ref]

Gastrointestinal

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[Ref]

Nervous system

Common (1% to 10%): Migraine, headache

Uncommon (0.1% to 1%): Dizziness, paresthesia, concentration ability impaired, vertigo[Ref]

Psychiatric

Common (1% to 10%): Depression, nervousness, emotional lability, mood swings

Uncommon (0.1% to 1%): Libido decreased, anxiety, sleep disorder[Ref]

Other

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[Ref]

Cardiovascular

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[Ref]

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.[Ref]

Oncologic

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[Ref]

Musculoskeletal

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[Ref]

Respiratory

Uncommon (0.1% to 1%): Dyspnea[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity reactions (including rash, pruritus, and urticaria)[Ref]

Dermatologic

Uncommon (0.1% to 1%): Skin disorder, acne, alopecia, pruritus, rash, hirsutism, hair disorder, sweating increased[Ref]

Ocular

Uncommon (0.1% to 1%): Eye disorder, visual disturbance[Ref]

Metabolic

Rare (less than 0.1%): Increased appetite, anorexia, hyperlipidemia,

Frequency not reported: Hyperkalemia[Ref]

Hepatic

Uncommon (0.1% to 1%): Liver function test abnormal[Ref]

Hematologic

Rare (less than 0.1%): Anemia[Ref]

Endocrine

Frequency not reported: Blood aldosterone increased[Ref]

References

1. Product Information. Angeliq (drospirenone-estradiol). Berlex Laboratories. 2005.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

3. Cerner Multum, Inc. Australian Product Information.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer