Applies to drospirenone / estradiol: oral tablet.

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

• Abdominal or stomach pain
• 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
• shortness of breath
• slow speech
• sore on the skin of the breast that does not heal
• sudden or severe headache
• sudden shortness of breath or troubled breathing
• 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
• chills
• diarrhea
• difficulty breathing
• ear congestion
• fever, sneezing, or sore throat
• 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
• stuffy or runny nose
• sweating
• tightness of the chest or wheezing
• 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

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]

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]

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]