Prescription medicine
Atomoxetine Brand names: Strattera, Atoncy
Atomoxetine (Strattera) is a prescription medicine with an FDA approval on record since 2002. FDA's NDC Directory lists it from 20 generic labelers, and pharmacies paid $0.442 per atomoxetine HCl 40 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the atomoxetine FDA label on DailyMed (effective May 25, 2026, Camber Pharmaceuticals, Inc.); the NDA 21411 record on Drugs@FDA; every atomoxetine label on DailyMed.
Highlights of the record
FDA label of May 25, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS.
Atomoxetine increased the risk of suicidal ideation in short-term studies in children or adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Anyone considering the use of atomoxetine in a child or adolescent must balance this risk with the clinical need. Co-morbidities occurring with ADHD may be associated with an increase in the risk of suicidal ideation and/or behavior. Patients who are started on therapy should be monitored closely for suicidality (suicidal thinking and behavior), clinical worsening, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Atomoxetine is approved for ADHD in pediatric and adult patients. Atomoxetine is not approved for major depressive disorder. Pooled analyses of short-term (6 to 18 weeks) placebo-controlled trials of atomoxetine in children and adolescents (a total of 12 trials involving over 2200 patients, including 11 trials in ADHD and 1 trial in enuresis) have revealed a greater risk of suicidal ideation early during treatment in those receiving atomoxetine compared to placebo. The average risk of suicidal ideation in patients receiving atomoxetine was 0.4% (5/1357 patients), compared to none in placebo-treated patients (851 patients). […]
Used for
From the label: indications and usageAtomoxetine capsule is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).
Forms and strengths
- 10 mg
- 18 mg
- 25 mg
- 40 mg
- 60 mg
- 80 mg
- 100 mg
- 4 mg/ml
Capsule; solution.
On the market
- Earliest approval on file
- November 26, 2002 Strattera, Lilly; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 9 first September 16, 2010; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 23 of which 20 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.442 per capsule Atomoxetine HCl 40 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 15 since 2013 0 Class I among all firms' recalls; latest April 30, 2026; 3 more by firms not listed as its makers
- FAERS reports
- 26,969 through July 30, 2026
What is atomoxetine used for?
From the label: indications and usageAtomoxetine capsule is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). ( 1.1 ) 1.1 Attention-Deficit/Hyperactivity Disorder (ADHD) Atomoxetine capsule is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). […]
Conditions named in the indications of atomoxetine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Norepinephrine Reuptake Inhibitor.
Source: FDA drug label (Atomoxetine), ANDA202682 (Hetero Labs Ltd V), as published by Camber Pharmaceuticals, Inc., effective May 25, 2026 (SPL set f266ab7b-5a68-42b5-b204-e3249bea0aed), via openFDA; the full label on DailyMed
What does the patient leaflet for atomoxetine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about atomoxetine capsules?The following have been reported with use of atomoxetine capsules: 1. Suicidal thoughts and actions in children and teenagers: Children and teenagers sometimes think about suicide, and many report trying to kill themselves. Results from atomoxetine capsules clinical studies with over 2200 child or teenage ADHD patients suggest that some children and teenagers may have a higher chance of having suicidal thoughts or actions. Although no suicides occurred in these studies, 4 out of every 1000 patients developed suicidal thoughts. Tell your child or teenager’s doctor if your child or teenager (or there is a family history of): • has bipolar illness (manic-depressive illness) • had suicide thoughts or actions before starting atomoxetine capsules The chance for suicidal thoughts and actions may be higher: • early during atomoxetine capsules treatment • during dose adjustments Prevent suicidal thoughts and action in your child or teenager by: • paying close attention to your child or teenager’s moods, behaviors, thoughts, and feelings during atomoxetine capsules treatment • keeping all follow-up visits with your child or teenager’s doctor as scheduled Watch for the following signs in your child or teenager during atomoxetine capsules treatment: • anxiety • agitation • panic attacks • trouble sleeping • irritability • hostility • aggressiveness • impulsivity • restlessness • mania • depression • suicide thoughts Call your child or teenager’s doctor right away if they have any of the above signs, especially if they are new, sudden, or severe. Your child or teenager may need to be closely watched for suicidal thoughts and actions or need a change in medicine. 2. Severe liver damage: Atomoxetine capsules can cause liver injury in some patients. […]
From the patient leaflet: How should I store atomoxetine capsules?Store atomoxetine capsules in a safe place at 68° to 77°F (20° to 25°C). • Keep atomoxetine capsules and all medicines out of the reach of children.
Source: FDA drug label (Atomoxetine), ANDA202682 (Hetero Labs Ltd V), as published by Camber Pharmaceuticals, Inc., effective May 25, 2026 (SPL set f266ab7b-5a68-42b5-b204-e3249bea0aed), via openFDA; the full label on DailyMed
Is there a generic for atomoxetine (Strattera)?
The FDA approved the first generic atomoxetine on September 16, 2010. 9 generic applications are approved; 9 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists atomoxetine from 20 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2002 earliest approval on file
- 2010 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for atomoxetine (Strattera)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.442 per Atomoxetine HCl 40 mg capsule, down 27% from $0.609 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Atomoxetine HCl 40 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Atomoxetine HCl 10 mg capsule | Generic | $0.322 per capsule | $9.66 | -24% |
| Atomoxetine HCl 100 mg capsule | Generic | $0.514 per capsule | $15.43 | -1% |
| Atomoxetine HCl 18 mg capsule | Generic | $0.382 per capsule | $11.45 | -22% |
| Atomoxetine HCl 25 mg capsule | Generic | $0.383 per capsule | $11.49 | -12% |
| Atomoxetine HCl 40 mg capsule | Generic | $0.442 per capsule | $13.27 | -27% |
| Atomoxetine HCl 60 mg capsule | Generic | $0.509 per capsule | $15.28 | -7% |
| Atomoxetine HCl 80 mg capsule | Generic | $0.523 per capsule | $15.68 | -7% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has atomoxetine been recalled?
The FDA's Enforcement Report lists 18 recalls naming atomoxetine since 2013: 0 Class I (the most serious), 18 Class II, 0 Class III; 15 still ongoing. 3 of them are by firms that FDA's NDC Directory does not list as a maker of atomoxetine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 30, 2026 | Class II | Safecor Health, LLC | Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule. |
| January 29, 2025 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: ATOMOXETINE HCL, Capsule, 40 mg may be potentially mis-labeled as OLANZAPINE, Tablet, 7.5 mg, NDC 60505311203, Pedigree: AD21790_76 … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: ATOMOXETINE HCL, Capsule, 18 mg, may be potentially mis-labeled as the following drug: LOVASTATIN, Tablet, 20 mg, NDC 00185007201 … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: ATOMOXETINE HCL, Capsule, 80 mg may be potentially mis-labeled as one of the following drugs: ATOMOXETINE HCL, Capsule, 18 mg, NDC … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the atomoxetine label say about other medicines?
The atomoxetine label names 15 other medicines in its interaction, contraindication or warning sections. The labels of 7 other medicines name atomoxetine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Albuterol | drug interactions | Albuterol (or other beta 2 agonists) - Action of albuterol on cardiovascular system can be potentiated. |
| Desipramine | drug interactions | CYP2D6 Substrate (e.g., Desipramine) – Coadministration of atomoxetine (40 or 60 mg BID for 13 days) with desipramine, a model compound for CYP2D6 metabolized drugs (single dose of 50 mg), did not alter the pharmacokinetics of desipramine. |
| Diazepam | drug interactions | Atomoxetine did not affect the binding of warfarin, acetylsalicylic acid, phenytoin, or diazepam to human albumin. |
| Dobutamine | drug interactions | Drugs and Pressor Agents Because of possible effects on blood pressure, atomoxetine should be used cautiously with antihypertensive drugs and pressor agents (e.g., dopamine, dobutamine) or other drugs that increase blood pressure. |
| Fluoxetine | drug interactions | Inhibitors on Atomoxetine In extensive metabolizers (EMs), inhibitors of CYP2D6 (e.g., paroxetine, fluoxetine, and quinidine) increase atomoxetine steady-state plasma concentrations to exposures similar to those observed in poor metabolizers (PMs). |
| Linezolid | drug interactions | Prevention or Management; STRATTERA is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue, or in patients who stopped an MAOI within 14 days. |
| Magnesium hydroxide | drug interactions | Drugs that Affect Gastric pH Drugs that elevate gastric pH (magnesium hydroxide/aluminum hydroxide, omeprazole) had no effect on atomoxetine bioavailability. |
| Methylene blue | drug interactions | Prevention or Management; STRATTERA is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue, or in patients who stopped an MAOI within 14 days. |
| Methylphenidate | drug interactions | Coadministration of methylphenidate with atomoxetine did not increase cardiovascular effects beyond those seen with methylphenidate alone. |
| Midazolam | drug interactions | CYP3A Substrate (e.g., Midazolam) – Coadministration of atomoxetine (60 mg BID for 12 days) with midazolam, a model compound for CYP3A4 metabolized drugs (single dose of 5 mg), resulted in 15% increase in AUC of midazolam. |
| Omeprazole | drug interactions | Drugs that Affect Gastric pH Drugs that elevate gastric pH (magnesium hydroxide/aluminum hydroxide, omeprazole) had no effect on atomoxetine bioavailability. |
| Paroxetine | drug interactions | Inhibitors on Atomoxetine In extensive metabolizers (EMs), inhibitors of CYP2D6 (e.g., paroxetine, fluoxetine, and quinidine) increase atomoxetine steady-state plasma concentrations to exposures similar to those observed in poor metabolizers (PMs). |
| Phenytoin | drug interactions | Atomoxetine did not affect the binding of warfarin, acetylsalicylic acid, phenytoin, or diazepam to human albumin. |
| Quinidine | drug interactions | Inhibitors on Atomoxetine In extensive metabolizers (EMs), inhibitors of CYP2D6 (e.g., paroxetine, fluoxetine, and quinidine) increase atomoxetine steady-state plasma concentrations to exposures similar to those observed in poor metabolizers (PMs). |
Every other medicine the atomoxetine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Warfarin | drug interactions | Atomoxetine did not affect the binding of warfarin, acetylsalicylic acid, phenytoin, or diazepam to human albumin. |
Other labels that name atomoxetine
Source: FDA drug label (Atomoxetine), ANDA202682 (Hetero Labs Ltd V), as published by Camber Pharmaceuticals, Inc., effective May 25, 2026 (SPL set f266ab7b-5a68-42b5-b204-e3249bea0aed), via openFDA; the full label on DailyMed
What do FAERS reports show for atomoxetine?
The FDA Adverse Event Reporting System holds 26,969 reports that list atomoxetine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,317 are coded as a death and 4,523 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as atomoxetine?
10 other medicines are given the same way (oral) and in the same FDA class as atomoxetine or labeled mainly for the same use (ADHD), the same class first. ADHD lists all 12 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Viloxazine | ADHD | none listed | $12.74 per capsule 200 mg capsule | No current entry |
| Methylphenidate | ADHD | 31 labelers | $0.158 per tablet 10 mg tablet | In shortage |
| Amphetamine and dextroamphetamine | ADHD | 25 labelers | $0.233 per tablet 10 mg tablet | In shortage |
| Lisdexamfetamine | ADHD | 19 labelers | $2.44 per capsule 20 mg capsule | In shortage |
| Guanfacine | ADHD | 37 labelers | $0.147 per tablet 1 mg tablet | A presentation being discontinued |
| Dexmethylphenidate | ADHD | 13 labelers | $1.45 per capsule 10 mg capsule | No current entry |
| Amphetamine | ADHD | 13 labelers | $0.449 per tablet 10 mg tablet | No current entry |
| Dextroamphetamine | ADHD | 14 labelers | $0.373 per tablet 10 mg tablet | No current entry |
Every medicine labeled for the same conditions as atomoxetine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does atomoxetine compare with medicines for the same use?
6 side-by-side pages set atomoxetine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to atomoxetine
- 10 medicines for the same use
- Other norepinephrine reuptake inhibitors
- the pharmacologic class, with prices and generics
- Atomoxetine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other