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What are the most common side effects of Nextstellis?

4 min read

According to clinical trials, irregular vaginal bleeding or spotting was one of the most common side effects reported by females taking Nextstellis. Understanding what are the most common side effects of Nextstellis is crucial for anyone considering this newer oral contraceptive.

Quick Summary

A comprehensive guide covering the common and serious side effects associated with Nextstellis, a newer birth control pill containing estetrol and drospirenone. Includes information on mood changes, weight gain, irregular bleeding, and critical warnings like the risk of blood clots.

Key Points

  • Common Side Effects: The most frequent issues reported with Nextstellis include irregular bleeding or spotting, mood changes, headaches, and breast tenderness.

  • Estetrol's Role: The unique plant-based estrogen in Nextstellis, estetrol, may lead to fewer instances of some side effects like mood changes and weight gain compared to older pills.

  • Bleeding Irregularities: Spotting between periods and missed withdrawal bleeding are common, especially in the first few months, but typically decrease over time.

  • Weight Gain: While reported, weight gain with Nextstellis was less frequent in clinical trials than with some older contraceptives and may sometimes be related to fluid retention.

  • Serious Risks: Potential serious side effects include blood clots, high potassium levels (hyperkalemia), and increased risk of heart attack or stroke, particularly in smokers over 35.

  • Managing Mood: Individuals with a history of depression should be monitored closely, and any worsening mood should be reported to a doctor.

  • Migraines with Aura: Nextstellis is contraindicated in females who experience migraines with aura due to an increased risk of stroke.

In This Article

Introduction to Nextstellis

Nextstellis is a prescription combination oral contraceptive used for the prevention of pregnancy. It is unique among combined hormonal birth control pills because it contains estetrol (E4), a plant-based estrogen that works differently than traditional estrogens, and the progestin drospirenone. Estetrol is the first new estrogen to be approved in over 60 years. While designed to potentially offer a better side effect profile than older hormonal contraceptives, Nextstellis still has a range of common and potentially serious side effects that users should be aware of.

The most common side effects of Nextstellis

Based on data from clinical trials and patient reports, several side effects appear more frequently than others. These are typically mild and often improve over the first few months as the body adjusts to the new hormones.

Common side effects include:

  • Irregular vaginal bleeding: Spotting or breakthrough bleeding between periods is very common, especially during the first few cycles. This tends to decrease over time.
  • Mood changes: Some individuals experience mood swings, increased agitation, anxiety, or depression.
  • Headache: Headaches are a frequently reported side effect.
  • Breast tenderness or pain: Swelling or discomfort in the breasts is another common occurrence.
  • Acne: Some users report an increase or decrease in acne.
  • Weight gain: Mild weight gain is a reported side effect, though it's often unclear if it is directly caused by the pill or other factors.
  • Decreased sex drive (libido): A reduced interest in sex can be a side effect of hormonal contraceptives.

Less common but serious side effects

While less frequent, some side effects are more serious and require immediate medical attention. It is critical to be aware of the signs and symptoms of these potential complications.

Serious side effects include:

  • Blood clots (Thromboembolic Disorders): Use of combined hormonal contraceptives increases the risk of blood clots, which can lead to a heart attack, stroke, or blood clots in the legs or lungs. The risk is higher for those who smoke, particularly if over 35.
  • Hyperkalemia (High Potassium Levels): Drospirenone has a mild anti-mineralocorticoid effect, which can increase potassium levels, especially in those with kidney, liver, or adrenal issues. Symptoms can include muscle weakness, irregular heartbeat, and fatigue.
  • High Blood Pressure: Significant increases in blood pressure have been reported in users.
  • Migraine Headaches: The onset or worsening of migraine headaches, especially with aura, is a serious risk and warrants discontinuation.
  • Liver Problems: This includes liver tumors and elevated liver enzymes. Yellowing of the skin or eyes (jaundice) can be a sign of a liver issue.
  • Gallbladder Problems: An increased risk of gallbladder disease has been linked to the use of combined oral contraceptives.
  • Depression: While a common side effect, if new or worsening depression is severe, a healthcare provider should be consulted.

Comparison of Nextstellis side effects vs. traditional birth control pills

Nextstellis is often compared to older combined hormonal contraceptives (CHCs) that use ethinyl estradiol, such as Yaz. The unique estrogen, estetrol, may offer a better-tolerated side effect profile for some users.

Side Effect Nextstellis (Estetrol/Drospirenone) Traditional CHCs (e.g., Yaz with Ethinyl Estradiol)
Breakthrough Bleeding Reported less often in clinical trials, tends to decrease over time. Also common, can be a frequent complaint for many users.
Weight Gain Reported less often in clinical trials compared to some older pills. A common concern for many users, though the cause is not always clear.
Mood Changes Reported less often in clinical trials. Can be a significant issue for some individuals.
Breast Tenderness Reported less often in clinical trials. A common side effect reported by many users.
Acne Reported less often in clinical trials. Can be a notable side effect for some.
Thrombotic Risk Present, particularly in high-risk individuals. Present, a known risk associated with all combined hormonal contraceptives.

Managing and monitoring Nextstellis side effects

If you experience any of the common side effects, there are steps you can take to manage them:

  • Wait it out: For issues like spotting or mood changes, waiting a few months can help. Side effects often resolve as your body adjusts.
  • Consistency is key: Taking the pill at the same time every day helps maintain stable hormone levels and reduces the likelihood of irregular bleeding.
  • Lifestyle modifications: Maintaining a healthy diet and exercise routine can help with concerns like weight gain and mood stability.
  • Consider a switch: If side effects persist and are bothersome, a healthcare provider may suggest switching to a different formulation of birth control.
  • Regular check-ups: For serious side effects like high blood pressure or potassium levels, regular monitoring by your doctor is essential, especially during the first few cycles of use.

When to contact a doctor

It is crucial to seek medical advice for any side effects that are severe, persistent, or cause concern. Contact your doctor immediately if you experience:

  • Signs of a blood clot: pain or swelling in the leg, shortness of breath, or chest pain.
  • Symptoms of high potassium: unexplained weakness, irregular heartbeat, or numbness.
  • Severe headache, especially a new or worsening migraine with aura.
  • Yellowing of the skin or eyes (jaundice).
  • New or severely worsening depression.
  • Sudden, severe stomach pain.

Conclusion

Nextstellis, a combined oral contraceptive featuring the novel estrogen estetrol and the progestin drospirenone, provides an effective option for pregnancy prevention. Like any hormonal medication, it comes with a range of possible side effects. The most commonly reported side effects include irregular bleeding, mood changes, headaches, and breast tenderness. Compared to some older birth control pills containing ethinyl estradiol, Nextstellis has shown a tendency for fewer occurrences of some side effects, such as breakthrough bleeding and mood swings, in clinical trials. However, it is essential to be aware of the more serious, though less frequent, risks, including blood clots and hyperkalemia. Users should work closely with their healthcare provider to monitor any side effects and ensure Nextstellis remains the right contraceptive choice for them. For more detailed prescribing information, refer to the FDA-approved Nextstellis label.

Frequently Asked Questions

Weight gain is a possible side effect of Nextstellis, though it was reported less frequently in clinical trials compared to some older oral contraceptives. Any weight changes may be due to water retention caused by the hormones, and it's best to discuss any concerns with a doctor.

Yes, breakthrough bleeding or spotting between periods is a common side effect, especially during the first few months of starting Nextstellis. This often lessens over time as your body adjusts.

Yes, mood changes, including mood swings, anxiety, and depression, have been reported as a side effect. If you have a history of depression or experience severe mood changes, it is important to contact your doctor.

The most serious side effects include an increased risk of blood clots (leading to heart attack, stroke, or deep vein thrombosis), high blood pressure, and hyperkalemia (high potassium levels), especially in high-risk individuals. Migraines with aura also increase the risk of stroke.

Yes, some individuals may miss their scheduled withdrawal bleeding while on Nextstellis, even when not pregnant. However, if you miss a period after not taking the pills as directed or miss two periods in a row, you should take a pregnancy test and contact your doctor.

Estetrol (E4) is a unique, plant-based estrogen that acts differently than ethinyl estradiol found in older pills. In clinical trials, Nextstellis containing estetrol reported some side effects, such as breakthrough bleeding, mood changes, and weight gain, less often than a pill containing ethinyl estradiol.

No, you should not take Nextstellis if you are a smoker and over 35 years of age. Cigarette smoking significantly increases the risk of serious cardiovascular events with combined hormonal contraceptives.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.