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Flibanserin Side Effects

In 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. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to flibanserin: oral tablet

Warning

Oral route (Tablet)

Alcohol use is contraindicated in patients taking flibanserin, because concomitant use increases the risk of severe hypotension and syncope. Assess the likelihood of the patient abstaining from alcohol, taking into account the patient’s current and past drinking behavior, and other pertinent social and medical history, and counsel patients who are prescribed flibanserin about the importance of abstaining from alcohol use. Flibanserin is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ADDYI REMS Program. Flibanserin is contraindicated with moderate or strong CYP3A4 inhibitors and in patients with hepatic impairment due to risk of severe hypotension and syncope.

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
  • sweating
  • unusual tiredness or weakness
  • sleepiness or unusual drowsiness

Less Common

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

Rare

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
  • rash
  • trouble sleeping

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]

References

1. "Product Information. Addyi (flibanserin)." Sprout Pharmaceuticals, Raleigh, NC.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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