Nextstellis Side Effects

Generic name: drospirenone / estetrol

Medically reviewed by Drugs.com. Last updated on May 25, 2024.

Note: This document provides detailed information about Nextstellis Side Effects associated with drospirenone / estetrol. Some dosage forms listed on this page may not apply specifically to the brand name Nextstellis.

Applies to drospirenone / estetrol: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may also be needed to check for unwanted effects. Your doctor may also want to check your blood pressure while taking this medicine.

Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away. Make sure your doctor knows if you have had a baby within 4 weeks before you start using this medicine.

Do not use this medicine together with medicine to treat hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (Technivie®, Viekira Pak®).

Check with your doctor right away if you miss a menstrual period. Missed periods may occur if you skip one or more tablets and have not taken your pills exactly as directed. You might need a pregnancy test.

If you suspect that you may be pregnant, check with your doctor right away.

Do not use this medicine if you smoke cigarettes or if you are over 35 years of age. If you smoke while using drospirenone and estetrol combination, you increase your risk of having a blood clot, heart attack, or stroke. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.

Using this medicine may increase your risk of having blood clotting problems. Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty with breathing, a sudden, severe headache, slurred speech, a sudden, a sudden loss of coordination, or vision changes while using this medicine.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want an eye doctor to check your eyes.

Using this medicine may increase your risk of having cervical cancer. Talk with your doctor about this risk. Check with your doctor right away if you experience abnormal vaginal bleeding, discharge, or pain.

Check with your doctor right away if you have pain or tenderness in the stomach, dark urine, pale stools, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may increase your risk of having gallbladder disease. Check with your doctor if you start to have stomach pains, nausea, and vomiting.

You might have some light bleeding or spotting, especially during the first 4 months of using this medicine. This is usually normal and should not last long. However, if you have heavy bleeding or the bleeding lasts more than a few days in a row, call your doctor.

This medicine may cause skin discoloration. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

Make sure any doctor or dentist who treats you knows that you are using this medicine. The results of some medical tests may be affected by this medicine. You may also need to stop using this medicine if you are having a surgery that requires inactivity for a long time.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Serious side effects of Nextstellis

Along with its needed effects, drospirenone / estetrol 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 / estetrol:

Other side effects of Nextstellis

Some side effects of drospirenone / estetrol 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:

For healthcare professionals

Applies to drospirenone / estetrol: oral tablet.

General adverse events

The more commonly reported adverse reactions have included bleeding irregularities, mood disturbances, headache, breast symptoms, dysmenorrhea, acne, weight gain, and decreased libido.^[Ref]

Cardiovascular

• Frequency not reported: Venous thromboembolism event (VTE), hypertension

Of the 2 prospective studies conducted with this drug in females 16 through 50 years old (n=3632), there was 1 reported VTE. This occurred in a female with a BMI less than 25 kg/m2 receiving this drug for 75 days.

Dermatologic

• Common (1% to 10%): Acne (includes acne and cystic acne)

Endocrine

• Common (1% to 10%): Breast symptoms (includes anisomastia, breast cyst, breast discoloration, breast discomfort, breast disorder, breast engorgement, breast enlargement, breast mass, breast edema, breast pain, breast swelling, breast tenderness, fibrocystic breast disease, galactorrhea, gynecomastia, mastoptosis, nipple disorder, nipple pain)

Gastrointestinal

• Common (1% to 10%): Nausea

Genitourinary

• Very common (10% or more): Unscheduled bleeding (up to 30.3%); absence of scheduled bleeding (15.5%), bleeding irregularities 10.8% (includes abnormal withdrawal bleeding, amenorrhea, cervix hemorrhage uterine, coital bleeding, dysfunctional uterine bleeding, menometrorrhagia, menorrhagia, menstrual disorder, menstruation irregular, metrorrhagia, oligomenorrhea, polymenorrhea, uterine hemorrhage, vaginal hemorrhage)
• Common (1% to 10%): Dysmenorrhea (includes adnexa uteri pain, dysmenorrhea, premenstrual cramps, pelvic discomfort, pelvic pain, uterine spasm), libido (lost/decreased)

During clinical trials, unscheduled bleeding (defined as bleeding or spotting occurring on Day 4 through Day 24 of a 28-day cycle) declined over time. During the first cycle, unscheduled bleeding was reported by 30.3% of patients compared to 17.4% at cycle 12. The mean number of unscheduled bleeding/spotting days per cycle also decreased with a mean of 0.4 bleeding days at cycle 1 and 0.2 bleeding days at cycle 12. The absence of scheduled bleeding remained constant from cycle one through cycle twelve.

Metabolic

• Common (1% to 10%): Increased weight (includes weight increased, weight fluctuation, body mass index increased, weight loss poor, and obesity)
• Frequency not reported: Hyperkalemia

Of the 2 prospective studies conducted with this drug in females 16 through 50 years old (n=3632), 7 women experienced hyperkalemia (1 discontinued due to elevated potassium levels). Most females who developed hyperkalemia had only mild potassium elevations and/or isolated increases that returned to normal while remaining on therapy.

Nervous system

• Common (1% to 10%): Headache (includes headache, premenstrual headache, and tension headache)

Six subjects (0.17%) discontinued study participation due to new onset of migraine with aura; two subjects (0.05%) discontinued due to severe migraine.

Oncologic

• Frequency not reported: Cervical cancer, breast cancer, intraepithelial neoplasia

Observational studies have reported an association with use of COCs for 5 years or more and increased cervical cancer and intraepithelial neoplasia compared to female who did not use oral hormonal contraceptives. Additionally, for females using COCs for 10 years or more, there were more cases compared to those who received COCs for 5 to 9 years. Limitations with this study included potential recall bias, differences in sexual behavior, and other factors such as data on Human Papilloma Virus infection.

Psychiatric

• Common (1% to 10%): Mood disturbance (includes adjustment disorder, affective disorder, agitation, anger, anxiety, depressed mood, depression, depressive symptom, disorientation, emotional disorder, emotional distress, euphoric mood, generalized anxiety disorder, insomnia, irritability, mood altered, mood swings, nervousness, panic attack, panic disorder, performance fear, restlessness, sleep disorder, stress, suicidal ideation, tearfulness)

In one of the clinical trials 36 (1.7%) women reported depression during therapy with this drug; 9 (0.3%) women stopped therapy due to symptoms of depression.

Other

• Very common (10% or more): Any treatment-related adverse reaction (27.1%)
• Frequency not reported: Abortion, ectopic pregnancy

See also:

Further information

Nextstellis side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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