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Addyi

Generic Name: flibanserin (flib AN ser in)
Brand Names: Addyi
Addyi (flibanserin) is used to treat hypoactive sexual desire disorder (HSDD) in premenopausal women. Addyi is for use only when low sexual desire is NOT caused by a medical condition, a mental disorder, relationship problems, or by using drugs or other medicines.
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Drug Information:
Addyi (flibanserin) is used to treat decreased sexual desire in women who have not gone through menopause and who have never had low sexual desire in the past. It is for use only when low sexual desire is NOT caused by a medical condition, a mental disorder, relationship problems, or by using drugs or other medicines. Addyi is not for women who have already gone through menopause. This medicine is also not for use by men. Addyi is only available through a risk evaluation and mitigation strategy (REMS) Program due to the increased risk of experiencing severe low blood pressure and fainting (loss of consciousness) with Alcohol use. You can only get this medicine from pharmacies that are enrolled in the Addyi REMS Program. Learn more

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Addyi Side Effects

Note: This document contains side effect information about flibanserin. Some of the dosage forms listed on this page may not apply to the brand name Addyi.

In Summary

Common side effects of Addyi include: syncope, central nervous system depression, dizziness, drowsiness, fatigue, nausea, sedated state, and hypotension. Other side effects include: insomnia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to flibanserin: oral tablet

Warning

Oral route (Tablet)

Alcohol use is contraindicated in patients taking flibanserin, because concomitant use increases the risk of severe hypotension and syncope. Assess the likelihood of the patient abstaining from alcohol, taking into account the patient’s current and past drinking behavior, and other pertinent social and medical history, and counsel patients who are prescribed flibanserin about the importance of abstaining from alcohol use. Flibanserin is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ADDYI REMS Program. Flibanserin is contraindicated with moderate or strong CYP3A4 inhibitors and in patients with hepatic impairment due to risk of severe hypotension and syncope.

Along with its needed effects, flibanserin (the active ingredient contained in Addyi) 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 flibanserin:

More common

  • Blurred vision
  • confusion
  • dizziness, fainting, or lightheadedness, especially when getting up suddenly from a lying or sitting position
  • sweating
  • unusual tiredness or weakness
  • sleepiness or unusual drowsiness

Less common

  • Feeling of constant movement of self or surroundings
  • sensation of spinning

Rare

  • Bloating
  • fever
  • nausea
  • severe cramping
  • stomach or lower abdominal pain
  • vomiting

Some side effects of flibanserin 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:

Less common

  • Constipation
  • dry mouth
  • nervousness
  • normal menstrual bleeding occurring earlier, possibly lasting longer than expected
  • rash
  • trouble sleeping

For Healthcare Professionals

Applies to flibanserin: oral tablet

Cardiovascular

When this drug is used alone, the incidence of hypotension is 0.2% and syncope is 0.4%. When this drug is taken with 0.4 g/kg alcohol, 17% had substantial reductions in blood pressure, resulting in hypotension and/or syncope requiring medical intervention. When 0.8 g/kg alcohol was taken in combination with this drug, 25% experienced orthostatic hypotension.

Uncommon (0.1% to 1%): Hypotension, syncope

Nervous system

Very common (10% or more): Dizziness (11.4%), somnolence (11.2%)

Common (1% to 10%): Sedation, fatigue, vertigo

Patients taking hormonal contraceptives (HC) had a greater incidence of dizziness, somnolence, and fatigue compared to patients who did not use HC.

General

-Serious adverse reactions were reported in 0.9% of patients. The discontinuation rate due to adverse reactions was 13%. The most common adverse reactions leading to discontinuation were dizziness, nausea, insomnia, somnolence, and anxiety.

-The majority of adverse reactions began within the first 14 days of treatment.

Other

Common (1% to 10%): Accidental injury

Among patients who experienced accidental injury, 21% reported adverse reactions consistent with CNS depression (e.g., somnolence, sedation, or fatigue) within the preceding 24 hours.

Psychiatric

Common (1% to 10%): Insomnia, anxiety

Gastrointestinal

Very common (10% or more): Nausea (10.4%)

Common (1% to 10%): Dry mouth, constipation

Uncommon (0.1% to 1%): Appendicitis

Hematologic

Common (1% to 10%): Metrorrhagia

Musculoskeletal

Common (1% to 10%): Abdominal pain

Dermatologic

Common (1% to 10%): Rash

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Addyi (www.drugs.com/addyi.html).