Drospirenone / Estradiol Side Effects

Medically reviewed by Drugs.com. Last updated on Mar 14, 2024.

Applies to drospirenone / estradiol: oral tablet.

Important warnings This medicine can cause some serious health issues

Oral route (tablet)

Estrogen Plus Progestin Therapy. Cardiovascular 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 Therapy. Endometrial 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 Dementia. The 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

• breast pain
• full or bloated feeling
• heavy non-menstrual vaginal bleeding
• pressure in the stomach
• surgery
• swelling of the abdominal or stomach area

Less common

• bloating or swelling of the face, arms, hands, legs, or feet
• change in vaginal discharge
• increased clear or white vaginal discharge
• pain or feeling of pressure in the pelvis
• rapid weight gain
• tingling of the hands or feet
• unusual weight gain or loss
• vaginal bleeding

Incidence not known

• anxiety
• blurred vision
• change in vision
• chest pain or discomfort
• clear or bloody discharge from nipple
• confusion
• constipation
• cough
• coughing up blood
• depression
• difficulty with speaking
• dimpling of the breast skin
• dizziness or lightheadedness
• double vision
• dry mouth
• fainting
• fast heartbeat
• headache
• headache, severe and throbbing
• inability to move the arms, legs, or facial muscles
• inability to speak
• incoherent speech
• increased urination
• inverted nipple
• loss of appetite
• lump in the breast or under the arm
• metallic taste
• muscle weakness
• nausea and vomiting
• numbness or weakness in your arm or leg, or on one side of your body
• pain or discomfort in the arms, jaw, back, or neck
• pain or redness in your lower leg (calf)
• persistent crusting or scaling of the nipple
• poor insight and judgment
• problems with memory, vision, speech, or walking
• redness or swelling of the breast
• seeing double
• slow speech
• sore on the skin of the breast that does not heal
• stomach pain
• sudden or severe headache
• sweating
• thirst
• trouble recognizing objects
• trouble thinking and planning
• trouble walking
• unusual tiredness or weakness
• weight loss

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

• accidental injury
• back pain
• body aches or pain
• chest tightness
• chills
• diarrhea
• difficulty breathing
• ear congestion
• fever
• general feeling of discomfort or illness
• joint pain
• loss of voice
• muscle aches and pains
• pain in the arms or legs
• pain or tenderness around the eyes and cheekbones
• runny nose
• shivering
• sneezing
• sore throat
• stuffy or runny nose
• sweating
• trouble sleeping

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]

Further information

Drospirenone/estradiol side effects can vary depending on the individual. 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