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Flibanserin Side Effects

Adverse reactions from FDA-approved drug labeling • Also known as: Addyi

⚠ Boxed Warning

WARNING: HYPOTENSION and SYNCOPE IN CERTAIN SETTINGS Interaction with Alcohol The use of ADDYI and alcohol together close in time increases the risk of severe hypotension and syncope [see Warnings and Precautions (5.1) ]. Counsel patients to wait at least two hours after consuming one or two standard alcoholic drinks before taking ADDYI at bedtime or to skip their ADDYI dose if they have consumed three or more standard alcoholic drinks that evening. Contraindicated with Strong or Moderate CYP3A4 Inhibitors The concomitant use of ADDYI and moderate or strong CYP3A4 inhibitors increases flibanserin concentrations, which can cause severe hypotension and syncope [see Warnings and Precautions (5.2) ] . Therefore, the use of moderate or strong CYP3A4 inhibitors is contraindicated in patients taking ADDYI [see Contraindications (4) ] . Contraindicated in Patients with Hepatic Impairment The use of ADDYI in patients with hepatic impairment increases flibanserin concentrations, which can cause severe hypotension and syncope [see Warnings and Precautions (5.5) ] . Therefore, ADDYI is contraindicated in patients with hepatic impairment [see Contraindications (4) ] . WARNING: HYPOTENSION and SYNCOPE IN CERTAIN SETTINGS See full prescribing information for complete boxed warning.

  • Use of ADDYI and alcohol together close in time increases the risk of severe hypotension and syncope. Counsel patients to wait at least two hours after consuming one or two standard alcoholic drinks before taking ADDYI at bedtime or to skip their ADDYI dose if they have consumed three or more standard alcoholic drinks that evening. ( 4 , 5.1 )
  • Severe hypotension and syncope can occur when ADDYI is used with moderate or strong CYP3A4 inhibitors or in patients with hepatic impairment; therefore, ADDYI use in these settings is contraindicated. ( 4 , 5.2 , 5.5 )

    • Reported Side Effects

    6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling:

  • Hypotension and syncope [see Warnings and Precautions (5.1, 5.2, 5.4, 5.5) ]
  • CNS depression [see Warnings and Precautions (5.3) ] Most common adverse reactions (incidence ≥2%) are dizziness, somnolence, nausea, fatigue, insomnia, urinary tract infection, anxiety, sinusitis, constipation and dry mouth. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Sprout Pharmaceuticals, Inc. at 1-844-746-5745, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice. The approved 100 mg ADDYI dosage at bedtime was administered to 2,997 premenopausal women with acquired, generalized HSDD in clinical trials, of whom 1,672 received treatment for at least 6 months, 850 received treatment for at least 12 months, and 88 received treatment for at least 18 months [see Clinical Studies (14) ]. In clinical trials, ADDYI 100 mg once daily at bedtime was administered to 801 postmenopausal women less than 65 years of age with acquired, generalized HSDD, of whom 460 received ADDYI treatment for at least 6 months, and 23 received ADDYI treatment for longer than 6 months. Premenopausal Women The data presented below in Table 1 and Table 2 (left columns) are derived from five 24-week randomized, double-blind, placebo-controlled trials in premenopausal women with acquired, generalized HSDD. In these trials, the frequency and quantity of alcohol use was not recorded. Three of these trials (Studies 1, 2, and 3) also provided efficacy data [see Clinical Studies (14.1) ]. One trial (Study 5) did not evaluate the 100 mg bedtime dose. In four trials in premenopausal women (Studies 1 through 4), 100 mg ADDYI at bedtime was administered to 1543 premenopausal women with HSDD, of whom 1060 completed 24 weeks of treatment. The age range of women enrolled was 18-56 years old with a mean age of 36 years old, and 88% were Caucasian and 9% were Black. In Studies 1 through 4 in premenopausal women, serious adverse reactions were reported in 0.9% and 0.5% of ADDYI-treated patients and placebo-treated patients, respectively. Postmenopausal Women The data presented below in Table 1 and Table 2 (right columns) are derived from two randomized, double-blind, placebo-controlled trials intended to be of 24-week duration in naturally postmenopausal women with acquired, generalized HSDD (Studies 6 and 7). One trial (Study 7) was discontinued prematurely. In these trials, 100 mg ADDYI at bedtime was administered to 801 postmenopausal women less than 65 years of age with HSDD, of whom 460 completed 24 weeks of treatment. The age range of women enrolled was 34-80 years old with a mean age of 56 years old, and 91% were Caucasian, 7% were Black and 94% were less than 65 years of age. The clinical trial population had no significant comorbid medical conditions and were not taking concomitant medications. Serious adverse reactions were reported in 1.5% and 0.7% of ADDYI-treated patients and placebo-treated patients less than 65 years of age, respectively. Adverse Reactions Leading to Discontinuation Table 1 displays the most common adverse reactions leading to discontinuation in six trials of women less than 65 years of age with HSDD that evaluated the ADDYI 100 mg once daily at bedtime dosage by population studied. Table 1 Adverse Reactions Adverse reactions leading to discontinuation of > 1% of patients who received ADDYI 100 mg once daily at bedtime and at a higher incidence than placebo-treated patients in the pooled premenopausal women and postmenopausal women trials. Leading to Discontinuation in Randomized, Double-blind, Placebo-controlled Trials in Women with HSDD (< 65 Years of Age) Adverse Reaction Trials in Premenopausal Women Includes Studies 1-4 Trials in Postmenopausal Women Includes Studies 6 and 7 Placebo (N=1556) ADDYI (N=1543) Placebo (N=797) ADDYI (N=801) Overall 6% 13% 5% 9% Dizziness 0.1% 1.7% 0.3% 0.9% Nausea 0.1% 1.2% 0.3% 0.5% Insomnia 0.2% 1.1% 0.5% 1.4% Somnolence 0.3% 1.1% 0.1% 0.6% Anxiety 0.3% 1% 0.6% 1.2% Most Common Adverse Reactions Table 2 summarizes the most common adverse reactions reported in six trials of women less than 65 years of age with HSDD. This table shows adverse reactions reported in at least 2% of patients treated with ADDYI and at a higher incidence than with placebo [see Warnings and Precautions (5.3) ]. The majority of these adverse reactions began within the first 14 days of treatment. Table 2 Common Adverse Reactions Adverse reactions reported in ≥2% of patients who received ADDYI 100 mg once daily at bedtime and at a higher incidence than placebo-treated patients in premenopausal women or postmenopausal...

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    What should I do if I experience side effects?

    Contact your healthcare provider if you experience any side effects. Seek immediate medical attention for severe reactions such as difficulty breathing, severe allergic reactions, or chest pain. You can also report side effects to the FDA at 1-800-FDA-1088.

    Are all side effects listed here?

    This list includes side effects reported during clinical trials and post-marketing surveillance. Not all possible side effects are known. Individual experiences may vary.