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Flibanserin Side Effects

Medically reviewed by Drugs.com. Last updated on Nov 28, 2024.

Applies to flibanserin: oral tablet.

Important warnings This medicine can cause some serious health issues

Oral route (tablet)

The use of flibanserin and alcohol together close in time increases the risk of severe hypotension and syncope.

Counsel patients to wait at least 2 hours after consuming 1 or 2 standard alcoholic drinks before taking flibanserin at bedtime or to skip their bedtime flibanserin dose if they have consumed 3 or more standard alcoholic drinks that evening.

Flibanserin is contraindicated with moderate or strong CYP3A4 inhibitors and in patients with hepatic impairment due to risk of severe hypotension and syncope.

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 side effects

  • 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 side effects

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

Rare side effects

  • 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 side effects

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

Managing side effects (general information)

For healthcare professionals

Applies to flibanserin: oral tablet.

General adverse events

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]

Nervous system

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

Hypersensitivity

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]

Psychiatric

Gastrointestinal

Hematologic

Musculoskeletal

Dermatologic

References

1. (2015) "Product Information. Addyi (flibanserin)." Sprout Pharmaceuticals

Frequently asked questions

Further information

Flibanserin side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer