Ethinyl estradiol / segesterone Side Effects

Medically reviewed by Drugs.com. Last updated on Dec 18, 2023.

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

Warning

Vaginal route (Insert, Extended Release)

Warning: Cigarette Smoking and Serious Cardiovascular EventsFemales over 35 years old who smoke should not use segesterone acetate/ethinyl estradiol vaginal system. Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use.

Serious side effects

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

More common

Bladder pain
bloody or cloudy urine
chills
difficult, burning, or painful urination
fever
frequent or painful urination
headache, severe and throbbing
itching of the vagina or outside the genitals
lower back or side pain
pain during sexual intercourse
stomach pain
thick, white curd-like vaginal discharge without odor or with mild odor
upper or lower abdominal pain

Less common

Anxiety
back pain
chest pain
confusion
cough
dizziness or lightheadedness
expulsion of tissue with clots from your vagina
fainting
fast heartbeat
hives, itching, skin rash
hoarseness
irritation
joint pain, stiffness or swelling
mental depression
mood or other mental changes
numbness of the hands
pain, redness, or swelling in the arm or leg
redness of the skin
severe stomach pain
swelling of the eyelids, face, lips, hands, or feet
tightness in the chest
troubled breathing or swallowing

Other side effects

Some side effects of ethinyl estradiol / segesterone 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

Cramps
diarrhea
heavy bleeding
nausea
normal menstrual bleeding occurring earlier, possibly lasting longer than expected
vomiting

For Healthcare Professionals

Applies to ethinyl estradiol / segesterone: vaginal ring.

General

The more commonly reported adverse reactions have included headache/migraine, nausea/vomiting, vulvovaginal mycotic infection/candidiasis, upper and lower abdominal pain, dysmenorrhea, and vaginal discharge; 25% of women reported at least 1 complete expulsion of vaginal system during use.^[Ref]

Cardiovascular

Combination Hormonal Contraceptives (CHC):

Uncommon (0.1% to 1%): Venous thrombotic event (VTE) rate

Frequency not reported: Increased blood pressure

Segesterone and Ethinyl Estradiol Vaginal System:

Frequency not reported: Venous thrombotic events (VTEs)

Serious adverse reactions occurred in 2% or more of subjects in clinical trials and included VTEs (deep vein thrombosis, cerebral vein thrombosis, and pulmonary embolism). At about 50% enrollment, females with BMI greater than 29 kg/m2 were excluded from participation due to the occurrence of 2 VTEs in this subgroup.

The rate of VTE in females using CHC has been estimated at 3 to 12 cases per 10,000 women. The risk of VTE for females who are not pregnant and do not use CHC is estimated to be between 1 and 5 for 10,000 women. For pregnant women, the risk is estimated to be 5 to 20 per 10,000 women and for those through 12 weeks postpartum, 40 to 65 per 10,000 women.

Local

One complete vaginal system expulsion was experienced by 25% of women during clinical trials; 1.4% of patients discontinued use due to vaginal system expulsions.

Very common (10% or more): Vaginal system expulsion

Hypersensitivity

Frequency not reported: Hypersensitivity reactions

Serious adverse reactions occurred in 2% or more of subjects in clinical trials and included drug hypersensitivity. Hypersensitivity reactions included throat constriction, facial edema, urticaria, hives, and wheezing.

Nervous system

Very common (10% or more): Headache, including migraine (38.6%)

Hepatic

An estimate of the attributable risk of hepatic adenomas associated with CHC use is 3.3 cases per 100,000 CHC users.

Combination Hormonal Contraceptives (CHC):

Very rare (less than 0.01%): Hepatic adenomas

Segesterone and Ethinyl Estradiol Vaginal System:

Frequency not reported: Liver enzyme elevations (with concomitant hepatitis C treatment)

Gastrointestinal

Combination Hormonal Contraceptives (CHC)

Frequency not reported: Gallbladder disease (new onset or worsening)

Segesterone and Ethinyl Estradiol Vaginal System:

Very common (10% or more): Nausea/vomiting (25%), Abdominal pain/lower/upper (13.3%)

Common (1% to 10%): Diarrhea

Genitourinary

Very common (10% or more): Vulvovaginal mycotic infection/vaginal candidiasis (14.5%), dysmenorrhea (12.5%), vaginal discharge (11.8%)

Common (1% to 10%): Unscheduled (breakthrough) bleeding, amenorrhea, UTI/cystitis/pyelonephritis/genitourinary tract infection, metorrhagia/menstrual disorder, genital pruritus

Frequency not reported: Metrorrhagia, menorrhagia, abnormal withdrawal bleeding

Endocrine

Common (1% to 10%): Breast pain/discomfort

Frequency not reported: Spontaneous abortions

Serious adverse reactions occurred in 2% or more of subjects in clinical trials and included spontaneous abortions.

Psychiatric

Serious adverse reactions occurred in 2% or more of subjects in clinical trials and included psychiatric events. These events were not further defined.

Frequency not reported: Psychiatric events