No black box warning on record for Addyi

As of the latest FDA labeling reviewed, Addyi (FLIBANSERIN) does not carry a black box warning. Standard warnings and precautions still apply — see the full Addyi medicine page for the complete safety profile.

Other warnings & precautions

5 WARNINGS AND PRECAUTIONS • Hypotension and Syncope due to an Interaction with Alcohol : After taking ADDYI at bedtime, advise patients to avoid alcohol until the following day. (5.1) • Central Nervous System (CNS) Depression (e.g., Somnolence, Sedation) : Can occur with ADDYI alone. Exacerbated by other CNS depressants, and in settings where flibanserin concentrations are increased. Patients sho
5.1 Hypotension and Syncope due to an Interaction with Alcohol Taking ADDYI within two hours after consuming alcohol increases the risk of severe hypotension and syncope. To reduce this risk, counsel patients to wait at least two hours after drinking one or two standard alcoholic drinks before taking ADDYI at bedtime [see Boxed Warning and Adverse Reactions (6.1) ] . Patients who drink three or mo
5.2 Hypotension and Syncope with CYP3A4 Inhibitors Moderate or Strong CYP3A4 Inhibitors The concomitant use of ADDYI with moderate or strong CYP3A4 inhibitors significantly increases flibanserin concentrations, which can lead to hypotension and syncope [see Adverse Reactions (6.1) ]. The concomitant use of ADDYI with a moderate or strong CYP3A4 inhibitor is contraindicated. If the patient requires
5.3 Central Nervous System Depression ADDYI can cause CNS depression (e.g., somnolence, sedation). In five 24-week, randomized, placebo-controlled, double-blind trials of premenopausal women with HSDD, the incidence of somnolence, sedation or fatigue was 21% and 8% in patients treated with 100 mg ADDYI once daily at bedtime and placebo, respectively [see Adverse Reactions (6.1) and Clinical Studie
5.4 Hypotension and Syncope with ADDYI Alone The use of ADDYI − without other concomitant medications known to cause hypotension or syncope − can cause hypotension and syncope. In five 24-week, randomized, placebo-controlled, double-blind trials of premenopausal women with HSDD, hypotension was reported in 0.2% and <0.1% of ADDYI-treated patients and placebo-treated patients, respectively; syncope

Other warnings & precautions

5 WARNINGS AND PRECAUTIONS • Hypotension and Syncope due to an Interaction with Alcohol : After taking ADDYI at bedtime, advise patients to avoid alcohol until the following day. (5.1) • Central Nervous System (CNS) Depression (e.g., Somnolence, Sedation) : Can occur with ADDYI alone. Exacerbated by other CNS depressants, and in settings where flibanserin concentrations are increased. Patients sho

5.1 Hypotension and Syncope due to an Interaction with Alcohol Taking ADDYI within two hours after consuming alcohol increases the risk of severe hypotension and syncope. To reduce this risk, counsel patients to wait at least two hours after drinking one or two standard alcoholic drinks before taking ADDYI at bedtime [see Boxed Warning and Adverse Reactions (6.1) ] . Patients who drink three or mo

5.2 Hypotension and Syncope with CYP3A4 Inhibitors Moderate or Strong CYP3A4 Inhibitors The concomitant use of ADDYI with moderate or strong CYP3A4 inhibitors significantly increases flibanserin concentrations, which can lead to hypotension and syncope [see Adverse Reactions (6.1) ]. The concomitant use of ADDYI with a moderate or strong CYP3A4 inhibitor is contraindicated. If the patient requires

5.3 Central Nervous System Depression ADDYI can cause CNS depression (e.g., somnolence, sedation). In five 24-week, randomized, placebo-controlled, double-blind trials of premenopausal women with HSDD, the incidence of somnolence, sedation or fatigue was 21% and 8% in patients treated with 100 mg ADDYI once daily at bedtime and placebo, respectively [see Adverse Reactions (6.1) and Clinical Studie

5.4 Hypotension and Syncope with ADDYI Alone The use of ADDYI − without other concomitant medications known to cause hypotension or syncope − can cause hypotension and syncope. In five 24-week, randomized, placebo-controlled, double-blind trials of premenopausal women with HSDD, hypotension was reported in 0.2% and <0.1% of ADDYI-treated patients and placebo-treated patients, respectively; syncope

Addyi Black Box Warning

No black box warning on record for Addyi

Other warnings & precautions

Addyi Black Box Warning

No black box warning on record for Addyi

Other warnings & precautions