Summary

Commonly reported side effects of flibanserin include: syncope, central nervous system depression, dizziness, drowsiness, fatigue, nausea, sedated state, and hypotension. Other side effects include: insomnia. Continue reading for a comprehensive list of adverse effects.

Applies to flibanserin: oral tablet.

Serious side effects of Flibanserin

Along with its needed effects, flibanserin 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:

More common

• Blurred vision
• confusion
• dizziness, fainting, or lightheadedness, especially when getting up suddenly from a lying or sitting position
• sleepiness or unusual drowsiness
• sweating
• unusual tiredness or weakness

Less common

• Feeling of constant movement of self or surroundings
• sensation of spinning

Rare

• Bloating
• fever
• nausea
• severe cramping
• stomach or lower abdominal pain
• vomiting

Incidence not known

• Chest tightness
• cough
• difficulty swallowing
• dizziness
• fast heartbeat
• hives, itching, skin rash
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• unusual tiredness or weakness

Other side effects of 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:

Less common

• Constipation
• dry mouth
• nervousness
• normal menstrual bleeding occurring earlier, possibly lasting longer than expected
• trouble sleeping

For Healthcare Professionals

Applies to flibanserin: oral tablet.

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]

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]

Hypersensitivity

Postmarketing reports: Hypersensitivity reactions, including anaphylaxis, reactions consistent with angioedema (e.g., swelling of the face, lips, and mouth), pruritus, urticaria

Other

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]

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