Pediatric safety & tolerability
Simtriyo demonstrated a consistent safety and tolerability profile across multiple clinical trials1-3
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Common adverse events in adolescents1
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Adverse events in ≥5% of pediatric patients aged 13 through 17 treated with Simtriyo and greater than placebo in a 6-week, placebo-controlled ADHD study1
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Placebo
(N=147)
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Simtriyo 280 mg
(N=151)
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Decreased appetite
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2%
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15%
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Nausea
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3%
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10%
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Rash
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1%
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8%
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Headache
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6%
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7%
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Abdominal pain
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0%
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5%
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Additional adverse reactions in ≥2% of adolescent patients 13 to 17 years of age treated with Simtriyo and greater than placebo included somnolence, fatigue, dizziness, nasopharyngitis, insomnia, irritability, dry mouth, and weight decrease.
In the pediatric study of patients aged 13 to 17, 8% of Simtriyo-treated patients discontinued treatment because of an adverse event, compared to 0% of placebo-treated patients.1
Incidence of rash most commonly occurred within the first 14 days of treatment, and rashes were typically mild and resolved within 2 weeks. There were no serious cases of rash and no severe cutaneous adverse reactions across clinical studies and populations.4
In the pediatric study of patients aged 13 to 17, 8% of Simtriyo-treated patients discontinued treatment because of an adverse event, compared to 0% of placebo-treated patients.1
Incidence of rash most commonly occurred within the first 14 days of treatment, and rashes were typically mild and resolved within 2 weeks. There were no serious cases of rash and no severe cutaneous adverse reactions across clinical studies and populations.4
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Common adverse events in children1
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Adverse events in ≥5% of pediatric patients aged 6 through 12 treated with Simtriyo and greater than placebo in a 6-week, placebo-controlled ADHD study1
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Placebo
(N=153)
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Simtriyo 280 mg*
(N=157)
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brand-yellow
Rash
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light-tan
0%
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light-orange
9%
table-item, radius-10-0-5-2
brand-yellow
Decreased appetite
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light-tan
3%
table-item, radius-2-5-10-0
light-orange
8%
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Additional adverse reactions in ≥2% of pediatric patients 6 to 12 years of age treated with Simtriyo and greater than placebo included fatigue, abdominal pain, nausea, pharyngitis streptococcal, diarrhea, and influenza.
In the pediatric study of patients aged 6 to 12, 6% of Simtriyo-treated patients discontinued treatment because of an adverse event, compared to 1% of placebo-treated patients.1
Incidence of rash most commonly occurred within the first 14 days of treatment, and rashes were typically mild and resolved within 2 weeks. There were no serious cases of rash and no severe cutaneous adverse reactions across clinical studies and populations.4
In the pediatric study of patients aged 6 to 12, 6% of Simtriyo-treated patients discontinued treatment because of an adverse event, compared to 1% of placebo-treated patients.1
Incidence of rash most commonly occurred within the first 14 days of treatment, and rashes were typically mild and resolved within 2 weeks. There were no serious cases of rash and no severe cutaneous adverse reactions across clinical studies and populations.4
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*Weight-based dose equivalent.
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Could Simtriyo help patients like Izzy?
Izzy, age 13,† is about to start ADHD treatment. See what other challenges patients like Izzy may be struggling with.
See challenges
†Hypothetical patient.
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A different way to treat ADHD
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Treat with the trio
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Simtriyo has the potential for abuse and misuse. Even though Simtriyo is a CNS stimulant, clinical studies suggest it does not produce physical dependence.1
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Simtriyo has class-related warnings for cardiovascular effects. In clinical trials, cardiovascular AEs were not among the most commonly reported AEs in pediatric patients, and there was no clinically meaningful effect on the QT interval.1
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Over 52 weeks in the pediatric OLE trial there was a low incidence of AEs and there were no new safety findings.5‡
‡The most common adverse reactions in children aged 6 to 12 included rash and decreased appetite; for adolescents aged 13 to 17, they included decreased appetite, nausea, rash, headache, and abdominal pain.
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AE=adverse event; CNS=central nervous system; OLE=open-label extension.
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TOLERABLE THROUGHOUT TREATMENT
Through 52 weeks of an open-label extension study, Simtriyo [br-d] demonstrated a safety and [br-d] tolerability profile consistent with [br-d] short-term studies5
This study found5:
- No new safety findings
- A low overall incidence of serious adverse events
In this study, the most common adverse events were decreased appetite, headache, upper respiratory tract infection, nausea, and decreased weight.5
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Learn More
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Designed with the patient in mind
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Simtriyo makes ADHD treatment simple with once-daily dosing. And, for most patients, the starting dose is the therapeutic dose.1
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Simple, once-daily treatment
Read the dosing information to learn how to prescribe Simtriyo.
See dosing
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Designed for your adult patients, too
Explore how the Simtriyo safety data stacks up in adult patients.
see safety data
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REFERENCES
- Simtriyo Prescribing Information. Otsuka America Pharmaceutical, Inc. 2026.
- Ward CL, et al. Efficacy and safety of centanafadine for ADHD treatment in children: a randomized clinical trial. Pediatr Open Sci. 2025;1(3):1-11.
- Ward CL, et al. Centanafadine for attention-deficit/hyperactivity disorder in adolescents: a randomized clinical trial. J Am Acad Child Adolesc Psychiatry. Published online July 4, 2025. doi:10.1016/j.jaac.2025.06.023
- Chepke C, et al. Characterization of adverse event timing and duration with centanafadine in children and adolescents with ADHD: pooled results from two Phase 3 trials. Poster presented at: Psych Congress 2026; September 15-19, 2026: New Orleans, LA.
- Turkoglu O, et al. Long-term safety and efficacy of centanafadine in children and adolescents with ADHD: results from a phase 3 open-label extension study. Poster presented at: APSARD 2026; January 15-18, 2026; San Diego, CA.
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