Addyi

Name: Addyi

What Is Addyi?

Flibanserin is available only from a certified pharmacy under a special program.

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. Flibanserin 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.

Flibanserin is not for women who have already gone through menopause. This medicine is also not for use by men.

Flibanserin may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You must not drink alcohol while taking flibanserin. It may cause you to have dangerously low blood pressure.

You should not use flibanserin if you are allergic to it, or if you have:

  • low blood pressure;
  • a history of alcoholism or drug addiction;
  • liver disease;
  • a history of depression or mental illness; or
  • if you currently drink alcohol.

Some medicines can cause unwanted or dangerous effects when used with flibanserin. Your doctor may need to change your treatment plan if you use any of the following drugs:

  • nefazodone;
  • an antibiotic--ciprofloxacin, clarithromycin, erythromycin, telithromycin;
  • antifungal medicine--fluconazole, itraconazole, ketoconazole, posaconazole;
  • antiviral medicine to treat hepatitis C--boceprevir, telaprevir;
  • heart or blood pressure medicine--conivaptan, diltiazem, verapamil; or
  • HIV or AIDS medicine--atazanavir, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir.

To make sure flibanserin is safe for you, tell your doctor if you have:

  • history of alcoholism or drug addiction.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether flibanserin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Flibanserin is not approved for use by anyone younger than 18 years old.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking flibanserin,

  • tell your doctor and pharmacist if you are allergic to flibanserin, any other medications, or any of the ingredients in flibanserin tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: antidepressants such as fluoxetine (Prozac, Sarafem); antifungals; cimetidine (Tagamet); digoxin (Lanoxin); diphenhydramine (Benadryl); medications for anxiety or mental illness; medications for seizures such as carbamazepine (Epitol, Tegretol, Teril, others), phenobarbital, and phenytoin (Dilantin, Phenytek); opiate (narcotic) medications for pain control; oral contraceptives; proton pump inhibitors including dexlansoprazole (Dexilant), esomeprazole (Nexium, Vimovo), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), or rabeprazole (Aciphex); ranitidine (Zantac); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); sedatives; sirolimus (Rapamune); sleeping pills; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor what herbal products you are taking, especially ginkgo, resveratrol, and St. Johns wort.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking flibanserin, call your doctor. Do not breast-feed while taking flibanserin.
  • you should know that flibanserin may make you drowsy. Do not drive a car or operate machinery until at least 6 hours after your dose of flibanserin and until you know how this medication affects you.

What side effects can this medication cause?

Flibanserin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  1. nausea
  2. tiredness
  3. difficulty falling asleep or staying asleep
  4. dry mouth
  5. constipation

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING and SPECIAL PRECAUTIONS sections, call your doctor immediately:

  1. excessive sleepiness

Flibanserin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What other drugs will affect flibanserin?

Taking this medicine with other drugs that make you sleepy or lower your blood pressure can worsen this effect. Ask your doctor before taking flibanserin with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • cimetidine;

  • gingko biloba;

  • resveratrol; or

  • St. John's wort.

This list is not complete. Other drugs may interact with flibanserin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Uses for Addyi

Hypoactive Sexual Desire Disorder (HSDD)

Used in premenopausal women for treatment of acquired, generalized HSDD, which is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a coexisting medical or psychiatric condition, problems within the relationship, or the effects of medication or other drug substances.1 2 3 4 12

HSDD may be categorized as acquired if the sexual dysfunction develops only after a period of normal functioning and as generalized if it is not limited to certain types of stimulation, situations, or partners.1 12

In 3 randomized, controlled trials and an extension trial conducted in premenopausal women with HSDD, flibanserin was associated with an increased number of satisfying sexual events (SSEs), improved sexual desire, and decreased sexual distress.1 2 3 4 15

Psychotherapy and cognitive behavioral therapy also may be helpful.18

Manufacturer states not indicated for treatment of HSDD in postmenopausal women† or in men†.1

Manufacturer also states not indicated to enhance sexual performance†.1

Addyi Dosage and Administration

General

  • Allow at least 2 weeks to elapse between discontinuance of a moderate or potent CYP3A4 inhibitor and initiation of flibanserin and allow at least 2 days to elapse between discontinuance of flibanserin and initiation of a moderate or potent CYP3A4 inhibitor.1 (See Hypotension and Syncope with CYP3A4 Inhibitors under Cautions and also see Interactions.)

Restricted Distribution Program

  • Distribution of flibanserin is restricted because of the increased risk of severe hypotension and syncope if used with alcohol.1 11 (See Hypotension and Syncope with Alcohol under Cautions.)

  • Flibanserin is only available through a REMS program.1 11 Healthcare providers and pharmacies must be certified with the program before they can prescribe or dispense flibanserin.1 11

  • For further information, contact the Addyi REMS Program at 844-746-5745 or at .1 11

Administration

Oral Administration

Once daily at bedtime without regard to meals.1 Because taking flibanserin during waking hours increases the risk of hypotension, syncope, accidental injury, and CNS depression, do not administer at any other time of the day.1 (See CNS Depressant Effects under Cautions.)

Dosage

Adults

HSDD Oral

100 mg once daily at bedtime.1

Discontinue if HSDD symptoms are not improved after 8 weeks of therapy.1

Special Populations

Hepatic Impairment

Contraindicated in patients with hepatic impairment.1 (See Hypotension and Syncope in Patients with Hepatic Impairment under Cautions.)

Renal Impairment

Manufacturer provides no specific dosage recommendations at this time.1 Dosage adjustments unlikely to be necessary because of only slight increases in exposure in patients with mild to severe renal impairment.1 (See Absorption: Special Populations, under Pharmacokinetics.)

Cautions for Addyi

Contraindications

  • Alcohol use.1 (See Boxed Warning and also see Hypotension and Syncope with Alcohol under Cautions.)

  • Concurrent use of moderate or potent CYP3A4 inhibitors.1 (See Hypotension and Syncope with CYP3A4 Inhibitors under Cautions and also see Interactions.)

  • Hepatic impairment.1 (See Hypotension and Syncope in Patients with Hepatic Impairment under Cautions.)

Warnings/Precautions

Warnings

Hypotension and Syncope with Alcohol

Concomitant use of flibanserin and alcohol increases the risk of severe hypotension and syncope.1 Syncope requiring therapeutic intervention (e.g., ammonia salts and/or placement in supine or Trendelenburg position), hypotension, and somnolence occurred at a higher incidence when flibanserin was administered with alcohol in the morning during an alcohol interaction study.1

Alcohol use is contraindicated in patients taking flibanserin.1 Before prescribing flibanserin, the clinician must assess the likelihood of the patient abstaining from alcohol, taking into account the patient's social and medical history, including current and past drinking behavior.1 (See Boxed Warning and also see Specific Drugs and Foods under Interactions.)

Hypotension and Syncope with CYP3A4 Inhibitors

Moderate or potent CYP3A4 inhibitors substantially increase flibanserin exposure and the risk of hypotension and syncope; therefore, concomitant use of flibanserin and moderate or potent CYP3A4 inhibitors is contraindicated.1

If treatment with a moderate or potent CYP3A4 inhibitor is required, discontinue flibanserin at least 2 days prior to initiation of therapy.1 If the benefit of initiating therapy with a moderate or potent CYP3A4 inhibitor within 2 days of flibanserin discontinuance clearly outweighs the risk of hypotension and syncope, monitor patient for signs of hypotension and syncope.1 Allow at least 2 weeks to elapse between discontinuance of the CYP3A4 inhibitor and reinitiation of flibanserin therapy.1

Concomitant use of flibanserin with multiple weak CYP3A4 inhibitors, including dietary or herbal supplements (e.g., ginkgo, resveratrol) and OTC drugs (e.g., cimetidine), also may increase flibanserin exposure and lead to hypotension and syncope.1 (See Interactions.)

Hypotension and Syncope in Patients with Hepatic Impairment.

Use in patients with any degree of hepatic impairment substantially increases flibanserin concentrations, which can cause hypotension and syncope.1 Flibanserin is therefore contraindicated in patients with hepatic impairment.1 (See Absorption: Special Populations, under Pharmacokinetics.)

Other Warnings and Precautions

CNS Depressant Effects

Risk of somnolence and sedation when given alone;1 CNS depressant effects are most prominent approximately 1–4 hours after oral administration.9

Risk of CNS depression is increased if flibanserin is taken during waking hours, with alcohol or other CNS depressants, or with drugs that increase flibanserin concentrations (e.g., CYP3A4 inhibitors).1 (See Dosage and Administration, Interactions, and Advice to Patients.)

Hypotension and Syncope with Flibanserin Alone

Use of flibanserin alone can cause hypotension and syncope.1 In controlled studies of premenopausal women with HSDD, hypotension and syncope were reported in 0.2 and 0.4% of flibanserin-treated patients, respectively.1 The risk of hypotension and syncope is increased if taken during waking hours or in higher than recommended dosages.1

Consider the clinical benefits of flibanserin therapy and the risks of hypotension and syncope in patients with preexisting conditions that predispose to hypotension.1 (See Warnings under Cautions.)

If presyncope occurs, patient should immediately lie supine and promptly seek medical attention if symptoms do not resolve.1 If syncope occurs, patient should promptly obtain medical attention.1

Mammary Tumors in Female Mice

Dose-related increase in incidence of malignant mammary tumors observed in female mice at exposures 3 and 10 times those attained with recommended human dosage; effect not observed in male mice or in male or female rats.1 Clinical relevance not known.1

Specific Populations

Pregnancy

No studies to date in pregnant women.1 In animal studies, fetal toxicity occurred only in conjunction with substantial maternal toxicity (e.g., reduced weight gain, sedation).1 Decreased fetal weight, structural abnormalities, and increases in fetal loss occurred at exposures >15 times those achieved with recommended human dosage.1 Manufacturer states that animal studies cannot exclude potential for fetal harm.1

Lactation

Distributed into milk in rats; not known whether distributed into human milk.1 Because of the potential for serious adverse reactions, including sedation, in nursing infants, breast-feeding during flibanserin therapy not recommended.1

Pediatric Use

Not indicated for pediatric patients.1

Geriatric Use

Not FDA labeled for use in geriatric patients; safety and efficacy not established.1 Manufacturer states not indicated for treatment of HSDD in postmenopausal women†.1 (See Absorption: Special Populations, under Pharmacokinetics.)

Hepatic Impairment

Contraindicated in patients with hepatic impairment.1 (See Hypotension and Syncope in Patients with Hepatic Impairment under Cautions and also see Absorption: Special Populations, under Pharmacokinetics.)

Renal Impairment

Exposure only increases slightly in patients with mild to severe renal impairment.1 Dosage adjustment unlikely to be necessary.1 (See Absorption: Special Populations, under Pharmacokinetics.)

Poor CYP2C19 Metabolizers

Peak plasma concentrations and AUC are increased and elimination half-life is prolonged in poor CYP2C19 metabolizers compared with extensive CYP2C19 metabolizers.1 (See Pharmacokinetics.) Increased monitoring for adverse effects (e.g., hypotension) recommended.1 Approximately 2–5% of Caucasians and Africans and approximately 2–15% of Asians are poor CYP2C19 metabolizers.1

Common Adverse Effects

Dizziness,1 somnolence,1 nausea,1 fatigue,1 insomnia,1 dry mouth.1 Most of these adverse effects began during first 14 days of therapy.1

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Distribution of flibanserin is restricted.1 11 (See Restricted Distribution Program under Dosage and Administration: General.)

Flibanserin

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

100 mg

Addyi

Sprout

Uses For Addyi

Flibanserin is used to treat hypoactive sexual desire disorder (HSDD) in women who have not gone through menopause. This medicine should only be used by women who have low sexual desire that is troubling to them and is caused by a medical or mental problem, problems in the relationship, or medicine or other drug use.

Women who have gone through menopause and men should not use flibanserin. Do not use this medicine to improve sexual performance.

This medicine is available only with your doctor's prescription.

What are some other side effects of Addyi?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Feeling sleepy.
  • Upset stomach.
  • Feeling tired or weak.
  • Not able to sleep.
  • Dry mouth.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Warnings and Precautions

Hypotension and Syncope due to an Interaction with Alcohol

Alcohol use is contraindicated in patients taking Addyi. Before prescribing Addyi, the healthcare provider must assess the likelihood of the patient abstaining from alcohol use, taking into account the patient’s current and past drinking behavior, and other pertinent social and medical history. Counsel patients who are prescribed Addyi about the importance of abstaining from alcohol use [see Drug Interactions (7)].

The use of Addyi and alcohol increases the risk of severe hypotension and syncope. In a dedicated alcohol interaction study conducted in 25 subjects (23 men and 2 premenopausal women), hypotension or syncope requiring therapeutic intervention (ammonia salts and/or placement in supine or Trendelenburg position) occurred in 4 (17%) of the 23 subjects co-administered Addyi 100 mg and 0.4 g/kg alcohol (equivalent of two 12 ounce cans of beer containing 5% alcohol content, two 5 ounce glasses of wine containing 12% alcohol content, or two 1.5 ounce shots of 80-proof spirit in a 70 kg person, consumed over 10 minutes in the morning)  [see Clinical Pharmacology (12.2)]. In these four subjects, all of whom were men, the magnitude of the systolic blood pressure reductions ranged from about 28 to 54 mmHg and the magnitude of the diastolic blood pressure reductions ranged from about 24 to 46 mmHg. In addition, 6 (25%) of the 24 subjects co-administered Addyi 100 mg and 0.8 g/kg alcohol experienced orthostatic hypotension when standing from a sitting position. The magnitude of the systolic blood pressure reductions in these 6 subjects ranged from 22 to 48 mmHg, and the diastolic blood pressure reductions ranged from 0 to 27 mmHg. One of these subjects required therapeutic intervention (ammonia salts and placement supine with the foot of the bed elevated). There were no events requiring therapeutic interventions when Addyi or alcohol were administered alone.

Addyi is available only through a restricted program under a REMS [see Warnings and Precautions (5.2)].

Addyi REMS Program

Addyi is available only through a restricted program under a REMS called the Addyi REMS Program, because of the increased risk of severe hypotension and syncope due to an interaction between Addyi and alcohol [see Boxed Warning and Warnings and Precautions (5.1)].

Notable requirements of the Addyi REMS Program include the following:

• Prescribers must be certified with the program by enrolling and completing training. • Pharmacies must be certified with the program and must only dispense to patients pursuant to a prescription from a certified prescriber.

Further information, including a list of qualified pharmacies, is available at www.AddyiREMS.com or 844-746-5745.

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 a moderate or strong CYP3A4 inhibitor, discontinue Addyi at least 2 days prior to starting the moderate or strong CYP3A4 inhibitor. In cases where the benefit of initiating a moderate or strong CYP3A4 inhibitor within 2 days of stopping Addyi clearly outweighs the risk of flibanserin exposure related hypotension and syncope, monitor the patient for signs of hypotension and syncope. Discontinue the moderate or strong CYP3A4 inhibitor for 2 weeks before restarting Addyi [see Drug Interactions (7)].

Multiple Concomitant Weak CYP3A4 Inhibitors
Concomitant use of multiple weak CYP3A4 inhibitors that may include herbal supplements (e.g., ginkgo, resveratrol) or non-prescription drugs (e.g., cimetidine) could also lead to clinically relevant increases in flibanserin concentrations that may increase the risk of hypotension and syncope [see Drug Interactions (7)].

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 Studies (14.1)]. The risk of CNS depression is increased if Addyi is taken during waking hours, or if Addyi is taken with alcohol or other CNS depressants, or with medications that increase flibanserin concentrations, such as CYP3A4 inhibitors [see Contraindications (4), Warnings and Precautions (5.1, 5.3), Adverse Reactions (6.1), and Drug Interactions (7)].

Patients should not drive or engage in other activities requiring full alertness until at least 6 hours after taking Addyi and until they know how Addyi affects them [see Clinical Studies (14.2)].

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 was reported in 0.4% and 0.2% of Addyi- treated patients and placebo-treated patients, respectively. The risk of hypotension and syncope is increased if Addyi is taken during waking hours or if higher than the recommended dose is taken [see Warnings and Precautions (5.1,5.3), Adverse Reactions (6.1), Drug Interactions (7), and Use in Specific Populations (8.7)]. Consider the benefits of Addyi and the risks of hypotension and syncope in patients with pre- existing conditions that predispose to hypotension. Patients who experience pre-syncope should immediately lie supine and promptly seek medical help if the symptoms do not resolve. Prompt medical attention should also be obtained for patients who experience syncope.

Syncope and Hypotension in Patients with Hepatic Impairment

The use of Addyi in patients with any degree of hepatic impairment significantly increases flibanserin concentrations, which can lead to hypotension and syncope. Therefore, the use of Addyi is contraindicated in patients with hepatic impairment [see Contraindications (4), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

Mammary Tumors in Female Mice

In a 2-year carcinogenicity study in mice, there was a statistically significant and dose-related increase in the incidence of malignant mammary tumors in female mice at exposures 3 and 10 times the recommended clinical dose. No such increases were seen in male mice or in male or female rats [see Nonclinical Toxicology (13.1)]. The clinical significance of these findings is unknown.

Addyi Description

Addyi (flibanserin) is a tablet for oral administration.  The chemical name of flibanserin is 2H-Benzimidazol-2-one, 1,3-dihydro-1-[2-[4-[3-(trifluoromethyl)phenyl]-1-piperazinyl]ethyl].  Its empirical formula is C20H21F3N4O and its molecular weight is 390.41.

The structural formula is:

Flibanserin is a white to off-white powder, insoluble in water, sparingly soluble in methanol, ethanol, acetonitrile and toluene, soluble in acetone, freely soluble in chloroform, and very soluble in methylene chloride.

Each Addyi tablet contains 100 mg of flibanserin. Inactive ingredients consist of lactose monohydrate, microcrystalline cellulose, hypromellose, croscarmellose sodium, magnesium stearate, talc, macrogol, and the coloring agents, titanium dioxide and iron oxide.

Package label.principal display panel

Rx only

NDC 58604-214-30

Addyi®
(flibanserin) tablets
100 mg

Attention Pharmacist: Dispense in original
packaging. Dispense the accompanying
Medication Guide to each patient.

30 Tablets

Addyi 
flibanserin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:58604-214
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Flibanserin (Flibanserin) Flibanserin 100 mg
Inactive Ingredients
Ingredient Name Strength
Lactose Monohydrate  
Microcrystalline Cellulose  
Hypromellose, Unspecified  
Croscarmellose Sodium  
Magnesium Stearate  
Talc  
Polyethylene Glycol, Unspecified  
Titanium Dioxide  
Ferric Oxide Red  
Product Characteristics
Color PINK Score no score
Shape OVAL Size 14mm
Flavor Imprint Code f100
Contains     
Packaging
# Item Code Package Description
1 NDC:58604-214-30 1 BOTTLE in 1 CARTON
1 30 TABLET, FILM COATED in 1 BOTTLE
2 NDC:58604-214-03 1 BOTTLE in 1 CARTON
2 30 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022526 08/18/2015
Labeler - Sprout Pharmaceuticals, Inc. (067606232)
Establishment
Name Address ID/FEI Operations
Mikart, Inc. 030034847 MANUFACTURE(58604-214)
Revised: 08/2015   Sprout Pharmaceuticals, Inc.

What should I avoid while taking Addyi?

Do not drink alcohol while taking Addyi. Drinking alcohol with this medicine can cause dangerous or unwanted side effects.

Grapefruit and grapefruit juice may interact with flibanserin nd lead to unwanted side effects. Avoid the use of grapefruit products while taking Addyi.

Avoid taking an herbal supplement containing: ginkgo, resveratrol, or St. John's wort.

Addyi may impair your thinking or reactions. Avoid driving or operating machinery for at least 6 hours after you take this medicine, and until you know how this medicine will affect you. Dizziness or low blood pressure can cause falls or other accidents.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

In Summary

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

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.[Ref]

Uncommon (0.1% to 1%): Hypotension, syncope[Ref]

Nervous system

Very common (10% or more): Dizziness (11.4%), somnolence (11.2%)
Common (1% to 10%): Sedation, fatigue, vertigo[Ref]

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

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.[Ref]

Other

Common (1% to 10%): Accidental injury[Ref]

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.[Ref]

Psychiatric

Common (1% to 10%): Insomnia, anxiety[Ref]

Gastrointestinal

Very common (10% or more): Nausea (10.4%)
Common (1% to 10%): Dry mouth, constipation
Uncommon (0.1% to 1%): Appendicitis[Ref]

Hematologic

Common (1% to 10%): Metrorrhagia[Ref]

Musculoskeletal

Common (1% to 10%): Abdominal pain[Ref]

Dermatologic

Common (1% to 10%): Rash[Ref]

Some side effects of Addyi may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Flibanserin Pregnancy Warnings

Animal studies revealed fetal toxicity only occurred in the presence of significant maternal toxicity. Adverse reproductive and developmental effects consisted of decreased fetal weight, structural anomalies, and increased fetal loss at doses greater than 15 times the clinical exposure at the recommended human dose. In animal fertility studies, this drug slightly increased the duration of the estrus cycle but had no adverse effects on fertility or early embryonic development at doses up to 20 times the clinical exposure at the recommended human dose. There are no controlled data in human pregnancy. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

Safety has not been established during pregnancy; data from animal studies cannot rule out the potential for fetal harm. US FDA pregnancy category: Not Assigned

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