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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, sedation, and hypotension. Other side effects include: insomnia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to flibanserin: oral tablet

In addition to its needed effects, some unwanted effects may be caused by flibanserin. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when 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
  • Bloating
  • fever
  • nausea
  • severe cramping
  • stomach or lower abdominal pain
  • vomiting

Minor Side Effects

Some of the side effects that can occur with flibanserin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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.

Not all side effects for flibanserin may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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