The atomoxetine label: a boxed warning on suicidal thinking in children, 0.4 percent on the drug v 0 on placebo
Strattera is approved for ADHD from age 6. In 12 short trials of over 2,200 children, suicidal ideation occurred in 0.4 percent on atomoxetine and 0 percent on placebo, all in the first month. No suicides occurred.
Reasonable evidence with real limitations. how we score evidence
Caveat on this rating: Short-term pooled pediatric data with small absolute numbers; adult analysis found no increase; liver cases are rare postmarketing reports.
The FDA-approved label for atomoxetine (Strattera), a non-stimulant for ADHD, read for its boxed warning and the numbers behind it.
Significant findings
STRATTERA "is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older." It "contains atomoxetine which is not a controlled substance."
The boxed warning: "STRATTERA increased the risk of suicidal ideation in pediatric patients aged 6 years of age and older with attention-deficit/hyperactivity disorder (ADHD) in short-term studies." Section 5.1 gives the numbers: in 12 pooled placebo-controlled studies of 6 to 18 weeks with over 2,200 pediatric patients, "the mean incidence of suicidal ideation in STRATTERA-treated pediatric patients was 0.4% (5/1,357) (including one patient with a suicide attempt) compared to 0% (0/851) in placebo-treated pediatric patients. No suicides occurred in these studies. All the suicidal ideations occurred in pediatric patients 6 to 12 years of age, and all occurred during the first month of STRATTERA treatment."
Other warnings: severe liver injury, with rare postmarketing cases of liver failure including one transplant, most within 120 days of starting (5.2); a cardiac history and exam before starting (5.3); blood pressure and heart rate monitoring (5.4); new psychotic or manic symptoms (5.5); aggression (5.7); urinary hesitancy, priapism and growth monitoring in children.
The other direction
The same section says "A similar analysis in adult patients treated with STRATTERA for ADHD did not reveal an increased risk of suicidal ideation or behavior." No liver injury was detected in clinical trials of about 6,000 patients; the liver cases are rare postmarketing reports. It is unknown whether the pediatric risk extends to longer-term use. In the WHO pharmacovigilance analysis by Hamard and colleagues in this library, atomoxetine was not associated with more psychosis reports than methylphenidate.
What this does not show
It does not say how atomoxetine compares with stimulants for benefit. It is not a reason to stop or start any medicine; changes go through the prescriber.
Worth asking
In the first month, what changes in mood or behaviour should we watch for, and who do we call?
Source
STRATTERA (atomoxetine) capsules: FDA-approved prescribing information, Boxed Warning, Warnings and Precautions 5.1 to 5.11 — Eli Lilly and Company; US Food and Drug Administration (2026)
Regulator or national health body
How this was scored
- Study design
- Regulatory safety determination
- Funding
- Industry funded
- Published in
- Regulator or national health body
- Sample size
- not recorded
- Preregistered
- not recorded
- Conflicts disclosed
- not recorded
- Independent of proponent
- not recorded
- Retracted
- No
Read the full scoring rubric, including what it can't tell you.
Published October 21, 2026.
Questions
How strong is the evidence behind this?
veisund rates this source "moderate evidence". Reasonable evidence with real limitations. It scores 57 out of 100 on our published rubric. One caveat travels with that badge: Short-term pooled pediatric data with small absolute numbers; adult analysis found no increase; liver cases are rare postmarketing reports. The score is calculated from recorded facts about the source — study design, funding, publication venue, sample size, preregistration — not typed in by an editor.
What is the source for this?
STRATTERA (atomoxetine) capsules: FDA-approved prescribing information, Boxed Warning, Warnings and Precautions 5.1 to 5.11 — Eli Lilly and Company; US Food and Drug Administration (2026). Published in: Regulator or national health body. The full source is linked on this page so you can read it yourself.
Who paid for this research, and does that matter?
Study design: Regulatory safety determination. Funding: Industry funded. Independence from the proponent is not recorded. Industry sponsorship is one of the most reliably measured biases in medicine, which is why funding carries real weight in the score rather than sitting in a footnote.
Is atomoxetine (Strattera), strattera FDA approved?
Yes — this medication carries FDA approval. Approval is always for a specific indication, not for every use it is prescribed for.
Is this medical advice?
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.