Addyi Side Effects
Generic Name: flibanserin
Note: This page contains information about the side effects of flibanserin. Some of the dosage forms included on this document may not apply to the brand name Addyi.
Common side effects of Addyi 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 (the active ingredient contained in Addyi). 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
- dizziness, fainting, or lightheadedness, especially when getting up suddenly from a lying or sitting position
- unusual tiredness or weakness
- sleepiness or unusual drowsiness
- Feeling of constant movement of self or surroundings
- sensation of spinning
- severe cramping
- stomach or lower abdominal pain
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:
- dry mouth
- normal menstrual bleeding occurring earlier, possibly lasting longer than expected
- trouble sleeping
For Healthcare Professionals
Applies to flibanserin: oral tablet
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]
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]
-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]
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]
Common (1% to 10%): Insomnia, anxiety[Ref]
Very common (10% or more): Nausea (10.4%)
Common (1% to 10%): Dry mouth, constipation
Uncommon (0.1% to 1%): Appendicitis[Ref]
Common (1% to 10%): Metrorrhagia[Ref]
Common (1% to 10%): Abdominal pain[Ref]
Common (1% to 10%): Rash[Ref]
1. "Product Information. Addyi (flibanserin)." Sprout Pharmaceuticals, Raleigh, NC.
Not all side effects for Addyi may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
More about Addyi (flibanserin)
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