Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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.
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 should avoid activities requiring full alertness (e.g., driving or operating machinery) until at least six hours after each dose and until they know how ADDYI affects them.
(5.3) • Hypotension and Syncope with ADDYI Alone : Patients with pre-syncope should immediately lie supine and promptly seek medical help if symptoms do not resolve.
Like all medications, Addyi can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: