Related Experiment Video
Updated: Feb 26, 2026

Utilizing an Orally Dissolving Strip for Pharmacological and Toxicological Studies: A Simple and Humane Alternative to Oral Gavage for Animals
Published on: March 23, 2016
Evaluation of dose and outcomes for pediatric vilazodone ingestions
Christopher E Gaw1,2, Henry A Spiller3,4, Jason L Russell3,4
1a Center for Injury Research and Policy , Research Institute at Nationwide Children's Hospital , Columbus , OH , USA.
Insights
Pediatric vilazodone ingestions can cause severe effects, even at low doses. Prompt clinical evaluation is crucial for children under 6 exposed to vilazodone, and off-label use should be reconsidered.
Area of Science:
- Pediatric Toxicology
- Pharmacovigilance
- Clinical Pharmacology
Background:
- Selective serotonin reuptake inhibitors (SSRIs) are generally safe in young children.
- Vilazodone, an SSRI, is increasingly used off-label and may cause more severe effects in children.
- This study investigates vilazodone ingestion outcomes in children under 6.
Purpose of the Study:
- To evaluate the dose-response relationship and clinical outcomes of vilazodone ingestions in children younger than 6 years.
- To inform clinical management and safety guidelines for pediatric vilazodone exposure.
Main Methods:
- Retrospective analysis of single-substance vilazodone exposures in children <6 years.
- Data collected from the National Poison Data System (2011-2016).
Main Results:
- 753 vilazodone ingestions reported; 49% experienced clinical effects.
- Increased vilazodone dose correlated with higher rates of healthcare facility admission and serious outcomes.
- Even low doses (10mg) caused severe effects like coma, seizures, and hallucinations.
Conclusions:
- Vilazodone exposure poses a significant risk to children under 6.
- Prompt medical evaluation is essential for exposed children.
- Off-label use in this age group should be discouraged pending further safety research.
Background:
Selective serotonin reuptake inhibitor (SSRI) exposures among children younger than 6 years of age are generally well tolerated. Vilazodone is an SSRI with partial agonism at the 5-HT1A receptor with demonstrated clinical efficacy for depression whose off-label usage is likely to increase. Recent evidence suggests that unintentional ingestion of vilazodone in children under 6 years old is associated with more severe clinical effects than other SSRIs. We chose to evaluate dose and outcomes for pediatric vilazodone ingestions.
Methods:
A retrospective analysis of single-substance exposures associated with vilazodone among children younger than 6 years of age from 2011 through 2016 was conducted using data from the National Poison Data System.
Results:
During 2011-2016, 753 vilazodone ingestions among children <6 years old were reported to US poison control centers. A near majority (49.0%, n = 369) experienced one or more clinical effects. The dose ingested was reported for 596 children (79%). The median dose associated with major effects was 50.0mg (Mean: 106.0) compared with 40.0mg (Mean 81.1) for moderate effects. Half (50.0%) of children with a major effect and 54.0% with a moderate effect ingested ≤40 mg of vilazodone. As the dose of vilazodone ingested increased, the proportions of exposures admitted to a healthcare facility (HCF) (p < .001) and with serious outcomes (p < .001) both increased. Children ≤2 years had higher proportions of HCF admission (33.8% vs 23.1%) and serious outcomes (27.0% vs 17.7%) than children 3-5 years of age. Clinical effects, such as coma, seizures, ataxia, and hallucinations/delusions, were observed among children ingesting doses of vilazodone as low as 10 mg.
Conclusions:
Exposure to vilazodone poses a unique and potentially serious threat to children <6 years of age. Children in this age group who are exposed to vilazodone should be evaluated promptly in a clinical setting. Off-label use of vilazodone in children under 6 years should be discouraged until further research is conducted regarding its safety in this population.
More Related Videos
Related Concept Videos
Drug Dosing: Infants and Children
Pharmacokinetics in Pediatric Patients: Drug Excretion
Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption
Pharmacokinetics in Pediatric Patients: Drug Metabolism
Pharmaceutical Poisoning: Treatment Strategies
Pharmacokinetics in Pediatric Patients: Drug Distribution

