Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Warnings and Precautions (5.1)].
• Serotonin Syndrome [see Warnings and Precautions (5.2)].
• Increased Risk of Bleeding [see Warnings and Precautions (5.3)].
• Activation of Mania or Hypomania [see Warnings and Precautions (5.4)].
• Discontinuation Syndrome [see Warnings and Precautions (5.5)].
• Seizures [see Warnings and Precautions (5.6)].
• Angle-Closure Glaucoma [see Warnings and Precautions (5.7)].
• Hyponatremia [see Warnings and Precautions (5.8)].
• Sexual Dysfunction [see Warnings and Precautions (5.9)].
Most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo): diarrhea, nausea, vomiting, and insomnia (6).
5 WARNINGS AND PRECAUTIONS • Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents (e.g., SSRI, SNRI, triptans, amphetamines), but also when taken alone.
If it occurs, discontinue vilazodone hydrochloride tablets and initiate supportive treatment (5.2).
• Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk (5.3).
• Activation of Mania/Hypomania: Screen patients for bipolar disorder (5.4).
• Seizures: Can occur with treatment.
Like all medications, Vilazodone Hydrochloride can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: