Flibanserin Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 23, 2025.

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.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Do not use this medicine together with amprenavir, atazanavir (Reyataz®), boceprevir (Victrelis®), ciprofloxacin (Cipro®), clarithromycin (Biaxin®), conivaptan (Vaprisol®), diltiazem (Cardizem®), erythromycin (Ery-Tab®), fluconazole (Diflucan®), fosamprenavir (Lexiva®), indinavir (Crixivan®), itraconazole (Sporanox®), ketoconazole (Nizoral®), nefazodone, nelfinavir (Viracept®), posaconazole (Noxafil®), ritonavir (Norvir®), saquinavir (Invirase®), telaprevir, telithromycin (Ketek®), or verapamil (Calan®). Using these medicines together may increase risk for low blood pressure and fainting.

Lightheadedness, dizziness, or fainting may occur when you take flibanserin within 2 hours of drinking alcohol. It is recommended to wait at least 2 hours after drinking 1 or 2 standard alcoholic drinks (eg, one 12-ounce regular beer, 5 ounces of wine, or 1.5 ounces of distilled spirits or shot) before taking flibanserin at bedtime, or you may skip your dose if you drink 3 or more standard alcoholic drinks in the evening. If you have taken flibanserin at bedtime, do not drink alcohol until the following day.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that may make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using flibanserin.

If your condition does not improve within 8 weeks, or if it become worse, check with your doctor.

This medicine may cause you to feel dizzy, drowsy, or lightheaded. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert for at least 6 hours after you take this medicine and until you know how this medicine affects you. If you feel lightheaded, getting up slowing after sitting or lying down may help.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have 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, or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

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

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

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

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

• 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

• 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]

See also:

Frequently asked questions

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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