Key points
- The current Strattera label (June 30, 2026) indicates atomoxetine for ADHD in adults and pediatric patients 6 years and older.
- Atomoxetine is not a controlled substance, so Schedule II stimulant rules in New York and New Jersey do not apply to it.
- The boxed warning covers suicidal thoughts and behaviors in pediatric patients 6 and older.
- The label warns of rare severe liver injury after marketing, with most reported cases starting within 120 days.
- Common adult side effects include constipation, dry mouth, nausea, decreased appetite, dizziness, erectile dysfunction and urinary hesitation.
- Generic atomoxetine capsules remain available (brand Strattera is listed as discontinued in the October 2026 Orange Book), and an atomoxetine oral solution (Atoncy) was approved on March 20, 2026, for adults and children 6 and older.
Atomoxetine, sold today as generic capsules (the FDA's October 2026 Orange Book lists brand Strattera capsules as discontinued), is one of two non-stimulant medications whose FDA labels cover ADHD in adults. It works differently from Adderall-type and Ritalin-type drugs, it is not a controlled substance, and it carries its own set of warnings. This page summarizes the current FDA label (dated June 30, 2026, and checked on October 19, 2026) in plain language. It does not tell anyone whether to take atomoxetine. That is a decision for you and your prescriber.
What atomoxetine is
The label calls Strattera a selective norepinephrine reuptake inhibitor. The FDA indication reads: treatment of ADHD "in adults and pediatric patients 6 years of age and older." So, unlike several ADHD products, its use in adults is on-label.
How it works, in simple terms: norepinephrine is a chemical messenger the brain uses for attention and alertness. Atomoxetine blocks the pump (the norepinephrine transporter) that clears it away after it is released. The label states plainly that the precise mechanism behind its effect in ADHD is unknown, but it is thought to be related to that transporter.
Section 9 of the label says atomoxetine "is not a controlled substance." In a placebo-controlled abuse-potential study in adults, it was not associated with stimulant or euphoriant properties. This is the main practical difference from stimulants, and it is covered in more depth in stimulant vs nonstimulant ADHD medication.
Forms available in the US
| Feature | Atomoxetine (as of October 2026) |
|---|---|
| Class | Selective norepinephrine reuptake inhibitor (non-stimulant) |
| Adult FDA approval | Yes: adults and children 6 and older |
| Forms | Generic capsules (brand Strattera listed as discontinued); an oral solution (Atoncy), approved March 20, 2026 |
| Controlled substance | No |
| Boxed warning | Suicidal thoughts and behaviors in pediatric patients 6 and older |
| Generic available | Yes, generic capsules from several manufacturers |
Drugs@FDA lists several approved generic atomoxetine applications, and the Orange Book lists the brand Strattera capsules as discontinued; the Strattera label remains the reference label for atomoxetine. A liquid form, Atoncy (atomoxetine oral solution), was approved on March 20, 2026, and its label carries the same indication for adults and children 6 and older. Whether it is stocked or covered by a given plan is something to ask a pharmacist and the insurer.
The boxed warning, read carefully
Online summaries often say the warning covers "children, teens and young adults." The current label is narrower. The boxed warning is titled "Suicidal thoughts and behaviors in pediatric patients 6 years of age and older." It says atomoxetine increased the risk of suicidal ideation in pediatric patients with ADHD in short-term studies, and that these patients should be watched closely, especially in the first months and after dose changes.
The warning is written about pediatric patients, but adults still benefit from knowing the signs the label lists: agitation, irritability, unusual changes in behavior and new or worse thoughts of self-harm. If those happen, contact the prescriber promptly. If you are in crisis, call or text 988.
Liver injury: rare, but on the label
Section 5.2 describes severe liver injury reported after the drug was on the market. No liver injury was detected in clinical trials of about 6,000 patients, but there have been rare postmarketing cases, including liver failure and one case that led to a transplant. Most reported cases began within 120 days of starting.
The label lists early signs that should prompt liver tests: itching, dark urine, yellow skin or eyes, tenderness in the upper right abdomen, or unexplained "flu like" symptoms. It says atomoxetine should be stopped and not restarted in anyone with jaundice or lab evidence of liver injury.
Other warnings that matter to adults
- Heart and blood pressure. The label asks for a careful history and exam before treatment. It says consideration should be given to not using atomoxetine in adults with clinically significant cardiac abnormalities, and that heart rate and blood pressure should be checked at baseline, after dose increases and periodically. More on this in ADHD medication, heart health and blood pressure.
- Mania or psychosis. New psychotic or manic symptoms can occur. Prescribers usually screen for bipolar disorder first.
- Aggression or hostility should be monitored.
- Urinary retention or hesitancy may occur.
- Priapism (a painful, lasting erection) requires prompt medical attention.
- Allergic reactions, including swelling and hives, have been reported.
Common side effects in adult trials
In adult placebo-controlled trials, the most common reactions (at least 5% and at least twice the placebo rate) were constipation, dry mouth, nausea, decreased appetite, dizziness, erectile dysfunction and urinary hesitation. About 11% of adults on atomoxetine stopped because of side effects, compared with 3% on placebo. The label also notes sleepiness in some patients and advises caution with driving until you know how it affects you.
People who are genetically "poor metabolizers" of the liver enzyme CYP2D6 have higher drug levels, and in the label's adult data they reported dry mouth, decreased appetite, erectile dysfunction and insomnia more often. The UK's NICE guideline separately recommends monitoring adults for sexual dysfunction on atomoxetine.
Who should not take it
The label lists these contraindications:
- Taking an MAOI, or having stopped one within the last 14 days
- Narrow angle glaucoma
- Pheochromocytoma, now or in the past
- Severe heart or blood vessel disorders that would worsen with a clinically important rise in blood pressure or heart rate
- Known allergy to atomoxetine or the capsule ingredients
Interactions to mention to your prescriber
- MAOIs, including linezolid and intravenous methylene blue: contraindicated.
- Strong CYP2D6 inhibitors, such as paroxetine: these raise atomoxetine levels (the label reports a 6.5-fold increase in exposure with paroxetine), so prescribers adjust how they start it.
- Blood pressure medicines and pressor drugs: more frequent blood pressure checks.
- Albuterol and similar beta2 agonists taken by mouth or systemically: heart rate and blood pressure can rise.
A fuller list across ADHD medications is in ADHD medication drug interactions.
Pregnancy and breastfeeding
The label says published data are insufficient to establish a drug-associated risk of birth defects or miscarriage, and notes some adverse findings in animal studies. A pregnancy registry for ADHD medications exists. For breastfeeding, there are no data on atomoxetine in human milk; it is present in animal milk. The NIH LactMed database keeps an entry on atomoxetine that a prescriber or lactation specialist can review with you. See also ADHD medication, pregnancy and the postpartum period.
How it compares on evidence
A 2018 network meta-analysis in Lancet Psychiatry found atomoxetine better than placebo for adult ADHD symptoms on clinician ratings at about 12 weeks, with a smaller average effect than amphetamines. A 2025 analysis of 113 adult trials found that stimulants and atomoxetine were the only treatments that reduced core symptoms on both self-ratings and clinician ratings, but also that adults stopped atomoxetine more often than placebo. NICE recommends offering atomoxetine to adults who cannot tolerate, or did not respond to, trials of lisdexamfetamine and methylphenidate. The side-by-side with the other adult non-stimulant is in Strattera vs Qelbree.
New York and New Jersey prescription rules
Because atomoxetine is not a controlled substance, the Schedule II rules that govern stimulants do not apply to it: New York's limits in 10 NYCRR 80.67, New Jersey's in-person requirements for Schedule II stimulants started by telehealth under P.L.2026, c.40, and the federal DEA telemedicine rules, which concern controlled medications. For how those rules work for stimulants, see New York's rules for ADHD stimulant prescriptions and New Jersey's rules.
Questions to ask your prescriber
- Why atomoxetine rather than a stimulant or viloxazine, given my history?
- How will we check my blood pressure and heart rate?
- Do any of my current medicines inhibit CYP2D6?
- Which side effects should make me call you, and which liver symptoms mean I should be seen right away?
- How will we judge whether it is working, and when?
Dr. Shershow, a psychiatrist licensed in New York and New Jersey, evaluates adults for ADHD and manages medication when it is appropriate, including non-stimulant options. The adult ADHD treatment page explains how that works.
Questions
Is Strattera approved for adults?
Yes. The FDA label indicates atomoxetine for ADHD in adults and pediatric patients 6 years and older. Adult use is on-label.
Is atomoxetine a controlled substance?
No. Section 9 of the label states that atomoxetine is not a controlled substance, and an adult abuse-potential study found no stimulant or euphoriant properties. That means Schedule II rules, such as New York's supply limits and New Jersey's in-person visit requirements for stimulants, do not apply.
Does the Strattera boxed warning apply to adults?
The current boxed warning is written about pediatric patients 6 and older. Adults should still report agitation, unusual behavior changes or new thoughts of self-harm to their prescriber, and anyone in crisis can call or text 988.
What liver symptoms should I watch for on atomoxetine?
The label lists itching, dark urine, yellowing of the skin or eyes, upper right abdominal tenderness and unexplained flu-like symptoms. These should prompt a call to the prescriber and liver tests. Liver injury is rare, and most reported cases began within 120 days of starting.
Is there a liquid form of atomoxetine?
Yes. Atoncy, an atomoxetine oral solution, was approved on March 20, 2026, with an indication for adults and children 6 and older. Ask a pharmacist whether it is stocked and your insurer whether it is covered.
Sources
- DailyMed: Strattera (atomoxetine) prescribing information, label dated June 30, 2026
- DailyMed: Atoncy (atomoxetine oral solution) prescribing information
- openFDA Drugs@FDA: approved atomoxetine applications, including generics and Atoncy (NDA 220320, approved March 20, 2026)
- Cortese et al., Lancet Psychiatry 2018: network meta-analysis of ADHD medications in children and adults
- Ostinelli et al., Lancet Psychiatry 2025: treatments for ADHD in adults, component network meta-analysis (PubMed)
- NICE guideline NG87: Attention deficit hyperactivity disorder, diagnosis and management (recommendations 1.7.15 and 1.8.15)
- 988 Suicide and Crisis Lifeline
- NIH LactMed: Atomoxetine
- NYS Department of Health: 10 NYCRR 80.67, Schedule II and certain other substances
- New Jersey Legislature: P.L.2026, c.40 (telehealth prescribing of Schedule II drugs)
- US Food and Drug Administration: Orange Book data files (data dated October 9, 2026)
