Applies to drospirenone / ethinyl estradiol: oral tablet.

Serious side effects

Along with its needed effects, drospirenone/ethinyl 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/ethinyl estradiol:

More common

• Breast pain or tenderness
• headache, severe and throbbing
• heavy non-menstrual vaginal bleeding
• irregular menstrual periods
• nausea
• normal menstrual bleeding occurring earlier, possibly lasting longer than expected

Less common

• Longer or heavier menstrual periods
• unusual tiredness or weakness
• vomiting

Incidence not known

• Chills
• clay-colored stools
• dark urine
• difficulty with breathing
• dizziness
• fever
• headache
• itching
• loss of appetite
• pain in the chest, groin, or legs, especially the calves
• rash
• slurred speech
• stomach pain
• sudden loss of coordination
• sudden, severe weakness or numbness in the arm or leg
• unpleasant breath odor
• unusual tiredness or weakness
• vision changes
• vomiting of blood
• yellow eyes or skin

Other side effects

Some side effects of drospirenone / ethinyl 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:

Less common

• Crying
• decreased interest in sexual intercourse
• delusions of persecution, mistrust, suspiciousness, or combativeness
• false or unusual sense of well-being
• inability to have or keep an erection
• irritability
• loss in sexual ability, desire, drive, or performance
• mental depression
• quick to react or overreact emotionally
• rapidly changing moods
• weight gain

For Healthcare Professionals

Applies to drospirenone / ethinyl estradiol: oral tablet.

General

The most common adverse events were irregular uterine bleeding, nausea, breast tenderness, and headache.^[Ref]

Genitourinary

Very common (10% or more): Breast pain or discomfort (17.9%), menstrual disorders (17%), female genital tract bleeding (14%), premenstrual syndrome (13.2%)

Common (1% to 10%): Vaginal candidiasis, leukorrhea, intermenstrual bleeding, cystitis, unscheduled uterine bleeding/genital tract bleeding NOS, metrorrhagia, amenorrhea, breast tenderness, vaginal discharge, cervical polyp

Uncommon (0.1% to 1%): Vaginitis, pelvic pain, breast enlargement, fibrocystic breast, genital discharge, dysmenorrhea, hypomenorrhea, menorrhagia, vaginal dryness, Pap smear suspicious, breast hypertrophy

Rare (less than 0.1%): Dyspareunia, vulvovaginitis, postcoital bleeding, withdrawal bleeding, breast cyst, breast hyperplasia, endometrial atrophy, ovarian cyst, uterine enlargement, breast discharge

Frequency not reported: Cervical dysplasia^[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea, which occurs in approximately 10% of treated women and may be more frequent during the first cycles of therapy. Some early reports suggested an association between oral contraceptive use and gallbladder disease. Abdominal pain and gastroenteritis have been reported in postmarketing experience.^[Ref]

Cardiovascular

Venous and arterial thromboembolic events includes peripheral deep vein occlusion, thrombosis and embolism/pulmonary vascular occlusion, thrombosis, embolism, infarction, intracardiac thrombosis, retinal vein occlusion, myocardial infarction, cerebral infarction, and stroke.^[Ref]

Uncommon (0.1% to 1%): Hypertension, hypotension, varicose vein

Rare (less than 0.1%): Venous and arterial thromboembolic events, tachycardia, vascular disorder, phlebitis^[Ref]

Nervous system

Very common (10% or more): Headache (20%)

Common (1% to 10%): Dizziness, migraine

Uncommon (0.1% to 1%): Somnolence, dizziness, paresthesia, asthenia

Rare (less than 0.1%): Vertigo, tremor, syncope^[Ref]

Psychiatric

Common (1% to 10%): Depression/depressive mood, nervousness, emotional lability, decrease and loss of libido, libido increased, affect lability

Rare (less than 0.1%): Anorgasmia, insomnia^[Ref]

Other

Common (1% to 10%): Fatigue

Uncommon (0.1% to 1%): Weight gain, weight loss, hot flushes, edema (generalized)

Rare (less than 0.1%): Candidiasis, malaise, hypoacusis^[Ref]

Dermatologic

Common (1% to 10%): Acne

Uncommon (0.1% to 1%): Pruritus, rash, increased sweating, eczema, alopecia

Rare (less than 0.1%): Chloasma, dermatitis acneiform, dry skin, erythema nodosum, erythema multiforme, hypertrichosis, skin disorder, skin striae, contact dermatitis, photosensitive dermatitis, skin nodule

Postmarketing reports: Angioedema^[Ref]

Respiratory

Common (1% to 10%): Pharyngitis, sinusitis

Rare (less than 0.1%): Epistaxis, asthma^[Ref]

Hypersensitivity

Rare (less than 0.1%): Hypersensitivity, allergic reaction^[Ref]

Oncologic

Rare (less than 0.1%): Breast neoplasm, breast cancer, focal nodular hyperplasia

Frequency not reported: Uterine leiomyoma

Postmarketing reports: Liver tumors^[Ref]

Hepatic

Rare (less than 0.1%): Biliary pain, cholecystitis acute

Postmarketing reports: Gallbladder disease, liver function disturbances^[Ref]

Metabolic

Uncommon (0.1% to 1%): Fluid retention

Rare (less than 0.1%): Increased appetite, anorexia, hyperkalemia, hyponatremia^[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Back pain, pain in extremity, muscle cramps

Postmarketing reports: Systemic lupus erythematosus^[Ref]

Ocular

Rare (less than 0.1%): Conjunctivitis, dry eye, eye disorder, contact lens intolerance^[Ref]

Hematologic

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

Endocrine

Rare (less than 0.1%): Endocrine disorder^[Ref]