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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.
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.
Applies to flibanserin: oral tablet
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:
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:
Applies to flibanserin: oral tablet
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
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.
-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.
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.
Common (1% to 10%): Insomnia, anxiety
Very common (10% or more): Nausea (10.4%)
Common (1% to 10%): Dry mouth, constipation
Uncommon (0.1% to 1%): Appendicitis
Common (1% to 10%): Metrorrhagia
Common (1% to 10%): Abdominal pain
Common (1% to 10%): Rash
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