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What are the side effects of dienogest adenomyosis?

4 min read

A systematic review and meta-analysis of 39 publications found that abnormal uterine bleeding is the most common side effect of dienogest, affecting 55% of patients [1.2.3]. So, what are the side effects of dienogest adenomyosis in more detail?

Quick Summary

Dienogest is an effective treatment for adenomyosis pain, but it has side effects. The most frequent is irregular bleeding, but others include headache, mood changes, weight gain, and breast tenderness.

Key Points

  • Most Common Side Effect: Abnormal uterine bleeding (spotting, irregular bleeding, or amenorrhea) is the most frequent side effect, reported in up to 55% of users [1.2.3].

  • Psychiatric and Neurological Effects: Headaches, mood changes, depression, and decreased libido are common adverse reactions to dienogest [1.2.3, 1.3.2].

  • Serious Risks: Rare but serious side effects include a decrease in bone mineral density (BMD), an increased risk of blood clots, and severe depression [1.2.3, 1.2.5].

  • Weight and Skin Changes: Weight gain and acne are other frequently reported side effects associated with dienogest treatment [1.3.2, 1.2.3].

  • Bleeding Pattern Evolution: While initial bleeding irregularities are common, many women experience lighter and less frequent bleeding over time, with a high rate of amenorrhea after six months [1.9.1].

  • Reason for Discontinuation: Intolerable side effects, including uncontrolled bleeding, headache, and depression, are a primary reason for patients to stop taking dienogest [1.2.2].

  • Comparative Side Effects: Compared to GnRH agonists, dienogest has fewer severe hypoestrogenic side effects like hot flashes but a higher incidence of irregular bleeding [1.11.3].

In This Article

Understanding Dienogest and Adenomyosis

Adenomyosis is a gynecological condition where the tissue that normally lines the uterus (endometrium) grows into the muscular wall of the uterus [1.7.2]. This can cause symptoms like severe menstrual cramps, chronic pelvic pain, and heavy menstrual bleeding (menorrhagia) [1.11.1].

Dienogest is a synthetic oral progestin, a type of hormone medication, used to manage the symptoms of adenomyosis and endometriosis [1.6.2, 1.11.4]. It works by creating a hormonal environment that suppresses the growth of endometrial tissue, thereby reducing pain and inflammation [1.6.1, 1.6.5]. While effective, it is associated with a range of side effects that patients should be aware of.

Common Side Effects of Dienogest

While many people tolerate dienogest well, a significant number experience side effects, most of which are considered mild to moderate [1.2.3, 1.9.4]. The most frequently reported adverse reactions impact the reproductive system, along with psychiatric and nervous system-related symptoms [1.2.3].

Changes in Bleeding Patterns

The most common side effect by a large margin is abnormal uterine bleeding [1.2.3]. This can manifest in several ways:

  • Irregular Bleeding and Spotting: Often called breakthrough bleeding, this is especially common during the first few months of treatment [1.3.4, 1.9.3]. Studies report this affects a high percentage of users, with one meta-analysis citing a prevalence of 55% [1.2.3].
  • Amenorrhea: Over time, many women experience a reduction in bleeding, with some stopping their periods altogether. One source notes that by the end of the sixth month of treatment, periods may stop for 9 in 10 women [1.9.1]. Another study found amenorrhea occurred in 17% of patients [1.2.3].
  • Heavy Bleeding (Menorrhagia): Although dienogest is used to reduce heavy bleeding, it can paradoxically aggravate menstrual blood loss in some women with adenomyosis. If the bleeding is heavy and continuous, it can lead to anemia [1.9.2].

Other Frequently Reported Side Effects

Beyond bleeding irregularities, a number of other common side effects have been documented in clinical studies [1.2.3, 1.3.2, 1.3.4]:

  • Headache: A very common side effect, sometimes manifesting as severe, throbbing headaches or migraines [1.3.4].
  • Breast Discomfort: This includes breast pain, tenderness, and enlargement [1.3.2, 1.3.4].
  • Mood Changes: Depression, depressed mood, mood swings, irritability, and anxiety are frequently noted. One study reported depressed mood in 5.1% of users, and another case study detailed an instance of dienogest-induced major depressive disorder with suicidal ideation [1.3.5, 1.6.5].
  • Weight Gain: An increase in weight is a commonly reported side effect [1.3.2].
  • Acne: Some individuals may experience new or worsening acne [1.3.2].
  • Gastrointestinal Issues: Nausea, vomiting, and abdominal pain are common, though often mild. Taking the medication with food can sometimes help [1.8.4].
  • Decreased Libido: A lowered interest in sex is another possible side effect [1.3.2].
  • Fatigue and Weakness: Feeling tired or weak is a reported symptom [1.3.2].

Uncommon and Serious Side Effects

While most side effects are not severe, there are less common and more serious potential reactions that require immediate medical attention [1.2.3, 1.2.1].

Serious side effects include:

  • Decreased Bone Mineral Density (BMD): Long-term use of dienogest has been associated with a reduction in bone density, particularly in the lumbar spine [1.2.3, 1.6.5]. This is a special concern for adolescents, as it may affect peak bone mass [1.2.1, 1.9.2].
  • Blood Clots: Although rare, dienogest can increase the risk of serious problems from blood clots, such as deep vein thrombosis (DVT), pulmonary embolism, stroke, or heart attack. Smoking significantly increases this risk, especially for women over 35 [1.2.5, 1.10.1].
  • Liver Problems: Signs like yellowing skin or eyes (jaundice), dark urine, and severe stomach pain can indicate serious liver issues [1.2.1, 1.3.4].
  • Severe Depression: While mood changes are common, severe depression with suicidal thoughts is a rare but documented serious adverse event [1.3.5].

Comparison of Side Effect Profiles: Dienogest vs. Other Treatments

When considering treatment for adenomyosis, it's helpful to compare the side effect profiles of different options.

Feature / Side Effect Dienogest (DNG) Levonorgestrel IUS (LNG-IUS) GnRH Agonists (e.g., Leuprolide)
Primary Mechanism Oral progestin; suppresses endometrial tissue growth [1.6.2]. Intrauterine device; releases progestin locally [1.7.3]. Injections; create a temporary menopause-like state [1.11.4].
Pain Relief Effective in reducing pelvic pain and dysmenorrhea [1.11.1]. Also effective in reducing pelvic pain [1.7.3]. Highly effective for pain, often superior to DNG initially [1.11.4].
Bleeding High incidence of irregular bleeding/spotting, especially initially [1.2.3, 1.4.2]. Superior to DNG for reducing heavy menstrual bleeding [1.7.3]. Complete relief from heavy bleeding (amenorrhea) [1.11.4].
Systemic Side Effects Headache, mood changes, weight gain, acne [1.2.3]. Fewer systemic side effects as it acts locally [1.7.1]. Significant hypoestrogenic effects: hot flashes, vaginal dryness, bone density loss [1.11.3, 1.4.1].
Bone Density Can cause a decrease in BMD with long-term use [1.6.5]. Generally considered to have minimal impact on BMD. Significant decrease in BMD, limiting long-term use [1.11.3].

Managing Side Effects

Many of the milder side effects of dienogest can be managed with lifestyle adjustments or may resolve over time. Taking the medication with food can help with nausea, and maintaining a regular sleep schedule may help with mood changes [1.8.2, 1.8.3]. For persistent or bothersome side effects, it's crucial to consult a healthcare provider. They may suggest strategies like taking a short break from treatment (for spotting) or prescribing other medications to counteract the effects [1.9.3]. Discontinuation of treatment is an option if side effects are intolerable; studies show that side effects like depression and headache are reasons for some patients to stop the medication [1.2.2].

Conclusion

Dienogest is a proven and effective medical therapy for managing the debilitating pain and heavy bleeding associated with adenomyosis [1.11.1]. However, its use is accompanied by a well-documented profile of side effects. The most prevalent issue is irregular uterine bleeding, which affects a majority of users but often improves with time [1.2.3, 1.9.1]. Other common effects like headaches, mood alterations, and weight gain are generally considered mild to moderate but can lead to discontinuation in some cases [1.2.2]. Serious risks, such as decreased bone density and blood clots, are rare but require careful consideration and monitoring, especially for long-term users [1.2.3]. The decision to use dienogest involves balancing its significant benefits for symptom control against its potential side effects, a conversation that should be had in detail with a healthcare provider.

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Frequently Asked Questions

The most common side effect is abnormal uterine bleeding, which can include irregular bleeding, spotting, or the eventual cessation of periods (amenorrhea). One meta-analysis found this affects about 55% of patients [1.2.3].

Yes, weight gain is a commonly reported side effect for patients taking dienogest for adenomyosis and other conditions [1.3.2, 1.2.3].

Yes, mood changes are a frequently reported side effect. These can include depressed mood, mood swings, irritability, and anxiety. In rare cases, severe depression has been linked to dienogest use [1.2.3, 1.3.5].

Yes, changes in bleeding patterns are very common, especially during the first few months of treatment. This often presents as spotting or irregular bleeding. For many, bleeding becomes lighter and less frequent over time [1.9.1, 1.9.3].

Long-term use of dienogest has been associated with a decrease in bone mineral density (BMD) [1.6.5]. Other side effects that can persist with long-term use include headache, weight gain, and reduced libido [1.2.3].

Smoking while taking dienogest is strongly discouraged as it significantly increases the risk of serious cardiovascular events like blood clots, stroke, and heart attack, particularly in women over 35 [1.10.1, 1.2.1].

Both are effective for pain relief in adenomyosis. However, the LNG-IUS is generally superior for reducing heavy menstrual bleeding, while dienogest may offer a better improvement in overall quality of life. Dienogest has more systemic side effects like headaches and mood changes, as the LNG-IUS acts more locally [1.7.3].

References

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Medical Disclaimer

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