Addyi Side Effects: Everything You Need to Know

What Is Addyi & How Is it Used?

Addyi (flibanserin) is a medication FDA-approved for treating hypoactive sexual desire disorder (HSDD) in premenopausal women. A persistent and distressing lack of sexual desire or interest characterizes HSDD. Addyi is specifically designed to address low sexual desire in women who have not undergone menopause. Addyi is not intended to treat other sexual dysfunctions or enhance sexual performance.

Addyi works by changing chemicals in the brain to help improve sexual desire. Currently, Addyi is unavailable as a generic medicine, and it does not have any off-label uses. An off-label use of a medication is a use that is not FDA-approved. Prescribers can decide to use a medication off-label because, in their professional judgment, they believe it may benefit someone.¹

Serious Side Effects of Addyi

While Addyi can be effective for some individuals, it may have serious side effects in some. Some serious side effects caused by Addyi can include low blood pressure and nerve system suppression (e.g. decreased heart rate, decreased rate of breathing, confusion). If you notice any of these side effects while taking Addyi, you should contact your doctor or pharmacist or seek professional help immediately. There are additional serious side effects related to alcohol consumption and may be interactions with the other medications you are taking. Be sure to communicate an entire medication and health history with your doctor and pharmacist before taking Addyi.¹

Serious side effects of Addyi can include:*

• Low blood pressure
• Decreased heart rate
• Decreased rate of breathing
• Confusion
• Appendicitis
• Severe allergic reaction

Severe Allergic Reaction

An allergic reaction to Addyi (flibanserin) can be a mild reaction or a serious and potentially life-threatening reaction triggered by the body’s immune system in response to the medication. These allergic responses can differ in intensity and can present in various ways, including rash, itching, shortness of breath, edema, and even coma. It’s crucial to recognize the signs and symptoms of an allergic reaction to Addyi and seek immediate medical attention if you suspect they are experiencing one of these side effects.¹

Low Blood Pressure

Addyi can potentially cause low blood pressure (hypotension). Low blood pressure is characterized by a drop in the normal blood pressure range and can result in symptoms such as dizziness, lightheadedness, and even falling. Hypotension is generally defined as having a systolic blood pressure (the top number in a blood pressure reading) below 90 mmHg or a diastolic blood pressure (the bottom number in a blood pressure reading) below 60 mmHg. With each individual patient’s situation, the symptoms vary. Patients should monitor possible symptoms of low blood pressure caused by Addyi to prevent emergencies and hospital admission.^{1, 3, 4}

Infection

An upper respiratory infection (URI) is another potential side effect of Addyi. URIs are contagious bacterial or viral infections that primarily affect the upper portion of the respiratory system. This includes the nose and throat and sometimes also affects the sinuses and ears. If patients get a URI while taking Addyi, they may contact their doctor or pharmacist to ask if additional treatment is necessary.⁶

Insomnia

Insomnia, characterized by trouble sleeping, can occasionally appear with Addyi use in some individuals. Insomnia can lead to daytime fatigue, reduced alertness, mood disturbances, and impaired cognitive function. While occasional sleepless nights are ordinary, chronic insomnia, which persists for an extended period, can significantly impact one’s overall health and quality of life. Patients may need to discontinue Addyi or seek medical help if insomnia negatively affects activities of daily life.^{1, 3}

Sleepiness

Drowsiness or sleepiness is another side effect associated with Addyi. This medication acts on specific chemicals in the brain, which can impact both sleep patterns and mood. It is imperative to emphasize safety, particularly when doing tasks demanding full alertness, such as driving or operating machinery while using Addyi. If patients notice that excessive sleepiness substantially affects daily activities, it is advised to seek guidance from their doctor or pharmacist to explore potential adjustments to the treatment plan.^{1, 3, 4}

Appendicitis 

Appendicitis is a medical condition characterized by inflammation of the appendix, a small, finger-shaped pouch located at the lower right side of the abdomen. This condition is considered a medical emergency and requires immediate diagnosis and treatment. The most common symptom of appendicitis is severe abdominal pain that migrates to the lower right side of the abdomen. Recognizing symptoms and seeking prompt medical attention is essential to prevent complications.^{1, 3, 4, 5}

*All medications, including Addyi, can cause side effects which can be mild or serious. This is not a comprehensive list of all possible side effects. You should talk with your doctor or pharmacist about any questions you have and to understand the potential side effects and benefits of any medication.

Common Side Effects of Addyi

Common side effects of Addyi (flibanserin) may include dry mouth, back pain, headache, fatigue, nausea, and constipation. The side effects of Addyi appear to be dose-dependent (the higher the dose, the more common or more severe the side effects).

These side effects may not affect every patient on Addyi, and their intensity can differ from individual to individual. With ongoing use, side effects may lessen or disappear as the body becomes accustomed to the medication. These common side effects of Addyi are typically mild, though some may require medical attention, especially if the side effects affect the quality of life or daily activities. You may contact your pharmacist about your side effects for possible over-the-counter treatment options, possible discontinuation, and alternative treatment options.^{1, 3, 4}
Common side effects of Addyi can include:*

• Dry mouth
• Back Pain
• Headache
• Tiredness
• Dizziness
• Constipation
• Nausea

*All medications, including Addyi, can cause side effects which can be mild or serious. This is not a comprehensive list of all possible side effects. You should talk with your doctor or pharmacist about any questions you have and to understand the potential side effects and benefits of any medication.

Frequently Asked Questions (FAQ) About Addyi Side Effects

While taking Addyi, patients should avoid alcohol and other drugs that interact with Addyi because it may cause serious side effects. As a reminder, many of the common side effects for Addyi may lessen or disappear with time.¹

Can I Take Addyi While Drinking Alcohol?

No, you should not drink alcohol while taking Addyi. According to the black box warning (the most severe warning from the FDA), drinking alcohol while using Addyi can result in a potentially risky interaction. Both Addyi and alcohol can influence the central nervous system, resulting in increased dizziness, drowsiness, and decreased blood pressure. When taken together, these effects may become more prominent and increase the chances of accidents or harm.⁸

Does Addyi Cause Weight Gain?

No, Addyi was not reported to cause weight gain or weight loss in clinical trials. If you have having a unexplainable change in your weight while taking Addyi, talk with your doctor.

What Should I Not Take With Addyi?

Addyi should not be taken with alcohol. Patients need to wait at least two hours to take Addyi after having 1 or 2 standard drinks. If you’ve had 3 or more alcoholic drinks, you should skip your Addyi dose. And in some cases, healthcare providers may recommend abstaining from alcohol entirely while taking Addyi to minimize the risk of interactions and side effects if the patient has additional risk factors. Patients should also avoid grapefruit and grapefruit juice while taking Addyi because grapefruit may affect the body’s metabolism of Addyi. There are also other medications that can interact with Addyi. Be sure to carefully discuss your complete medical history and medication list with your doctor and pharmacist before taking Addyi.^{1, 5}

How Safe Is Addyi?

Addyi is FDA-approved for the treatment of HSDD. This approval followed extensive clinical research trials and evaluations to assess its safety and effectiveness for this specific indication. Addyi may not be safe or appropriate for everyone. Patients should communicate with doctors and pharmacists about the benefits of Addyi compared to the risks associated with this medication.^{1, 3}

When Should I Take Addyi Each Day?

Addyi is typically taken once daily at bedtime. The bedtime timing is recommended to reduce the potential for side effects, including dizziness and drowsiness, while awake. Maintaining a consistent nightly routine while taking Addyi is recommended for maximum effectiveness.¹

Will the Side Effects of Addyi Disappear Gradually?

The side effects of Addyi will vary from person to person. Some side effects may decrease or disappear gradually as your body adjusts to the medication. This may not be true for everyone, and some individuals may continue to experience side effects throughout their treatment. Patients may contact their doctor or pharmacist to switch to an alternative medication if the medication needs to be discontinued. It is important to talk to your doctor and pharmacist about ways to decrease the risk of side effects from Addyi.¹

How to Manage Side Effects of Addyi

Numerous strategies are available to address many of the side effects linked to Addyi. To effectively manage these side effects, engaging in a conversation with your healthcare providers is crucial. They can provide advice and solutions based on your unique circumstances.¹

Fatigue

Sleepiness and tiredness are the most common side effects of Addyi. Most care providers suggest administering Addyi at bedtime to synchronize the effects of Addyi with normal sleep patterns. This will prevent feeling sleepy during the day. Research indicates that there are many mental health benefits to exercise. Regular exercise can decrease depression and anxiety and increase sleep quality.^{1, 4}

Dizziness

Dizziness is another common side effect of Addyi. Patients should follow the prescribed instructions to take Addyi at bedtime to lower the chance of dizziness during the day and reduce the feeling of dizziness. If you encounter dizziness with Addyi, please refrain from driving or doing other tasks that demand full alertness.^{1, 4}

Low Blood Pressure

Low blood pressure is a serious side effect of Addyi. Limiting or avoiding alcohol consumption is important, as alcohol can lower blood pressure. Taking Addyi with other medicines, especially the other medications that can lower blood pressure, can bring the blood pressure to dangerously low levels. Your provider or pharmacist may recommend that you regularly check your blood pressure at home to monitor for this risk.^{1, 3}

Insomnia

Most care providers suggest taking Addyi at bedtime to avoid tiredness and sleepiness, Patients may want to avoid coffee or other food and drinks with caffeine to improve sleep quality. Melatonin supplements are over-the-counter and may be used to regulate sleep-wake cycles. Ask your pharmacist if melatonin would be a good option for you. Herbal teas, such as chamomile, valerian, or lavender, may also have mild sedative effects and can promote relaxation before bedtime. Patients may ask pharmacists to gain more information to manage insomnia.^{1, 3, 4}

Nausea

If patients experience nausea while taking Addyi, taking Addyi with a meal could alleviate nausea. Smaller, more frequent meals during the day may also be beneficial in preventing sickness. Some over-the-counter medications, like Pepto-Bismol, may help relieve nausea, indigestion, and upset stomach. Ask your pharmacist if this is a good option for your nausea before starting Pepto-Bismol. If nausea is severe, persistent, or accompanied by additional concerning symptoms, it’s necessary to consult a healthcare provider.^{1, 2}

Dry Mouth

Dry mouth is another possible side effect of Addyi. To address dry mouth associated with Addyi, maintaining hydration is essential. Patients need to stay well-hydrated by drinking plenty of water throughout the day. Sipping water can alleviate dryness and improve oral comfort. If dry mouth persists or becomes bothersome, have a conversation with the healthcare provider. They can evaluate the condition and explore potential medication or treatment plan adjustments as necessary.¹

Questions to Ask Your Healthcare Provider About Addyi Side Effects

Before taking Addyi, you need to tell your medical care team about your past medical history, other medications you are on, and daily habits to exclude the risk factors and decrease serious side effects.¹

Questions to ask your care team about Addyi side effects:

• When should I take Addyl to manage side effects?
• How long will it take for me to adjust to taking Addyi?
• Am I at risk for more serious side effects if I am taking other medications?
• What is the best dosage to ensure the fewest side effects?
• Is there any food that I need to avoid to prevent side effects?
• Can I drive after taking Addyi?
• What over-the-counter medication can I take to relieve the side effects of Addyi?
• If I feel sleepy during the day, do I need to switch to a different medication?

In My Experience

In my experience, Addyi fills a long-term gap in HSDD treatment. It’s exciting to see this additional option for premenopausal women. Research trials have proven the safety and effectiveness of Addyi, and females may enjoy an increased quality of life with Addyi treatment. Be sure to keep an open communication line between you, your doctor, and your pharmacist to prevent serious side effects from Addyi. If you have side effects while taking Addyi, avoid discontinuing Addyi or modifying your dosage without consulting your doctor or pharmacist. Your healthcare providers can offer individualized advice on handling side effects and enhancing treatment effectiveness.¹

I typically recommend lifestyle changes and relationship counseling in addition to Addyi treatment to maximize its effectiveness. If Addyi isn’t proving effective to you, there are additional options available for treatment, including hormone replacement, acupuncture, supplements, and mindfulness practices. It is important to remember that every individual is unique, and what works for one person may not work for another. Consulting with your doctor and pharmacist is crucial in determining the most appropriate treatment options for you.