Note: This document contains side effect information about drospirenone / estradiol. Some dosage forms listed on this page may not apply to the brand name Angeliq.
Applies to drospirenone / estradiol: oral tablet.
Warning
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.
Serious side effects of Angeliq
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 of Angeliq
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]
