Applies to ethinyl estradiol / etonogestrel: vaginal insert extended release.

Serious side effects

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

Incidence not known

• Blurred vision
• changes in skin color
• chest pain or discomfort
• confusion
• constipation
• diarrhea
• dizziness
• gaseous stomach pain
• headache
• inability to speak
• nausea
• nervousness
• numbness of the hands
• pain in the chest, groin, or legs, especially calves of the legs
• pain or discomfort in the arms, jaw, back, or neck
• pounding in the ears
• prominent superficial veins over the affected area with tenderness and warmth
• recurrent fever
• seizures
• severe headache of sudden onset
• slow or fast heartbeat
• stomach fullness
• stomach pain or tenderness usually after eating a meal
• sudden loss of coordination
• sudden onset of slurred speech
• sudden vision changes
• sudden and severe weakness in the arm or leg on one side
• sweating
• swelling of the foot or leg on one side of the body
• temporary blindness
• vomiting with or without blood
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking ethinyl estradiol / etonogestrel:

Symptoms of overdose

• Menstrual changes
• nausea
• vaginal bleeding

Other side effects

Some side effects of ethinyl estradiol / etonogestrel 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

• Cough
• fever
• itching of the vagina or genital area
• pain during sexual intercourse
• pain or tenderness around the eyes and cheekbones
• sore throat
• stuffy or runny nose
• thick, white vaginal discharge with or without a mild odor
• tightness of the chest
• weight gain

Less common

• Crying
• depersonalization
• false or unusual sense of well-being
• hoarseness
• mental depression
• paranoia
• quick to react or overreact emotionally
• rapidly changing moods, mild feeling of sadness or discouragement that come and go

Incidence not known

• Absent, missed, or irregular menstrual periods
• bloody vaginal discharge
• brown, blotchy spots on exposed skin
• chills
• clay-colored stools
• contact lens intolerance
• dark urine
• decreased amount or quality of milk
• dry mouth
• dry skin
• fruit-like or unpleasant breath odor
• increased hunger
• increased thirst
• increased urination
• loss of appetite
• medium to heavy, irregular vaginal bleeding between regular monthly periods, which may require the use of a pad or a tampon
• rash
• soreness, swelling, or discharge from the breast or breasts
• trouble getting pregnant
• unexplained weight loss
• unusual tiredness or weakness

For Healthcare Professionals

Applies to ethinyl estradiol / etonogestrel: vaginal ring.

General

Adverse reactions leading to study discontinuation occurred in 13% of the women during clinical trials. The most common adverse reactions leading to discontinuation were device-related events (2.7%), mood changes (1.7%), headache/migraine (1.5%), and vaginal symptoms (1.2%).^[Ref]

Genitourinary

Very common (10% or more): Vaginitis (13.8%)

Common (1% to 10%): Vaginal discharge, vaginal discomfort, breast pain/discomfort/tenderness, dysmenorrhea, genital pruritus, vaginal discomfort, pelvic pain, leucorrhoea, vaginal infection

Uncommon (0.1% to 1%): Dysuria, micturition urgency, pollakiuria, urinary tract infection, amenorrhea, breast enlargement, breast mass, cervical polyp, cervicitis, coital bleeding, coital discomfort, dyspareunia, ectropion of cervix, fibrocystic breast disease, menorrhagia, metrorrhagia, pelvic discomfort, premenstrual syndrome, uterine spasm, vaginal burning sensation, vaginal odor, vaginal pain, vulvovaginal discomfort, vulvovaginal dryness

Frequency not reported: Penile disorder, galactorrhea, uterine bleeding irregular

Postmarketing reports: Local reaction to penis, vaginal injury (including associated pain, discomfort, and bleeding) associated with ring breakage^[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Blood pressure increased, hot flush

Rare (less than 0.1%): Venous thromboembolism, arterial thromboembolism

Frequency not reported: Deep vein thrombosis

Postmarketing reports: Arterial event, myocardial infarction, varicose vein aggravated^[Ref]

In studies that were required or sponsored by regulatory agencies, this combined hormonal combination vaginal ring showed a VTE risk similar to combined oral contraceptive use (8.3 per 10,000 women-years versus 9.2 per 10,000 women-years).^[Ref]

Hypersensitivity

Frequency not reported: Anaphylaxis, angioedema

Local

Common (1% to 10%): Medical device discomfort, discomfort/foreign body sensation^[Ref]

Gastrointestinal

Common (1% to 10%): Nausea/vomiting, abdominal pain, diarrhea, toothache

Uncommon (0.1% to 1%): Abdominal distention, constipation, abdomen enlarged^[Ref]

Oncologic

Uncommon (0.1% to 1%): Breast fibroadenosis

Frequency not reported: Hormone dependent tumors, liver tumor^[Ref]

Respiratory

Common (1% to 10%): Bronchitis, coughing, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection^[Ref]

Dermatologic

Common (1% to 10%): Acne

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

Frequency not reported: Urticaria, chloasma

Postmarketing reports: Angioedema^[Ref]

Hepatic

Frequency not reported: Cholelithiasis, liver disease^[Ref]

Ocular

Uncommon (0.1% to 1%): Visual disturbance^[Ref]

Immunologic

Common (1% to 10%): Allergic reaction

Frequency not reported: Hypersensitivity

Postmarketing reports: Anaphylaxis^[Ref]

Musculoskeletal

Common (1% to 10%): Back pain

Uncommon (0.1% to 1%): Muscle spasm, pain in extremity^[Ref]

Metabolic

Uncommon (0.1% to 1%): Appetite increased^[Ref]

Psychiatric

Common (1% to 10%): Mood changed/altered, depression, mood swings, affect lability, libido decreased

Uncommon (0.1% to 1%): Anxiety, irritability^[Ref]

Other

Common (1% to 10%): Expulsion of contraceptive device, device-related event, weight increased, fatigue, fever, influenza-like symptoms

Uncommon (0.1% to 1%): Device breakage, device complication, cervicitis, herpes simplex, malaise, edema^[Ref]

Nervous system

Very common (10% or more): Headache/migraine (11.2%)

Uncommon (0.1% to 1%): Dizziness, hypoesthesia

Postmarketing reports: Stroke/cerebrovascular accident^[Ref]

Renal

Uncommon (0.1% to 1%): Cystitis^[Ref]