Atomoxetine is a norepinephrine reuptake inhibitor sold in the U.S. under 3 brand and generic names, for attention deficit disorder with hyperactivity. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Atoncy (application NDA220320). Other atomoxetine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Prior to initiating treatment with atomoxetine oral solution: Screen patients for a personal or family history of bipolar disorder, mania, or hypomania. ( 2.1 , 5.6 ) Consider genetic testing to determine the patient’s CYP2D6 metabolizer status prior to dosing. ( 2.1 , 2.5 ) See table below for the recommended atomoxetine oral solution dosage. ( 2.3 ) Age and Body Weight Starting Dosage Target Dosage 1 Maximum Total Daily Dose 1 Pediatrics who weigh less than 70 kg 0.5 mg/kg/day 1.2 mg/kg/day 1.4 mg/kg/day or 100 mg/day (whichever is less) Pediatrics who weigh 70 kg or more and adults 40 mg/day 80 mg/day 100 mg/day 1 Administer either as once daily dosage in the morning or as evenly divided twice daily dosage in the morning and late afternoon/early evening For the recommended dosage in patients with hepatic impairment, see Full Prescribing Information. ( 2.4 ) For the recommended dosage with concomitant use of a strong CYP2D6 inhibitor or in CYP2D6 poor metabolizers, see Full Prescribing Information. ( 2.5 ) 2.1 Recommendations Prior to Initiating Atomoxetine Oral Solution Treatment Prior to initiating treatment with atomoxetine oral solution: Screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.6) ] . Consider genetic testing to determine the patient’s CYP2D6 metabolizer status [see Dosage and…
Most common adverse reactions (≥5% and at least twice the incidence of placebo patients): Pediatric Clinical Studies: Nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence. ( 6.1 ) Adult Clinical Studies: Constipation, dry mouth, nausea, decreased appetite, dizziness, erectile dysfunction, and urinary hesitation. ( 6.1 ) Patients should be instructed to use caution when driving a car or operating hazardous machinery (because of somnolence) until they are reasonably certain that their performance is not affected by atomoxetine oral solution ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Advagen Pharma Ltd, at 1-866-488-0312 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of atomoxetine oral solution has been established from adequate and well-controlled studies of atomoxetine capsules (also referred to as another atomoxetine product) in patients 6 years of age and older with ADHD [see Clinical Studies (14) ] . Below is a display of the adverse reactions of [atomoxetine capsules in these adequate and well-controlled studies. Atomoxetine…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
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| 1 | 70/100 | Prescription | Capsule | Generic | $15 | View → | |
| 2 |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| LILLY;3227;10;mg | 10 mg | white | capsule | — |
| LILLY;3238;18;mg | 18 mg | white, yellow | capsule | — |
| LILLY;3228;25;mg | 25 mg | white, blue | capsule | — |
| LILLY;3229;40;mg | 40 mg | blue | capsule | — |
| LILLY;3239;60;mg | 60 mg | blue, yellow | capsule | — |
| LILLY;3250;80;mg |
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Atomoxetine Capsules HCL
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Safecor Health, LLC · Apr 30, 2026
Atomoxetine Capsules
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Jan 29, 2025
Atomoxetine Capsules
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Jan 29, 2025
Atomoxetine Capsules
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Jan 29, 2025
Atomoxetine Capsules
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Jan 29, 2025
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Atomoxetine oral solution is contraindicated in patients: With known hypersensitivity reaction to atomoxetine oral solution or other components of atomoxetine oral solution. Hypersensitivity reactions that occurred with atomoxetine oral solution use included anaphylaxis, angioneurotic edema, urticaria, and rash [see Warnings and Precautions (5.8) ] . Taking, or within 14 days of stopping, a monoamine oxidase inhibitor (MAOI) [see Drug Interactions (7) ] . With narrow angle glaucoma. In clinical trials, atomoxetine oral solution use was associated with an increased risk of mydriasis. With pheochromocytoma or a history of pheochromocytoma. Serious reactions, including elevated blood pressure and tachyarrhythmia, have been reported in patients with pheochromocytoma or a history of pheochromocytoma who received atomoxetine oral solution. With severe cardiac or vascular disorders whose condition would be expected to deteriorate if they had clinically important increase in blood pressure or heart rate (e.g., 15 to 20 mm Hg in blood pressure or 20 beats per minute in heart rate) [see Warnings and Precautions (5.4) ] . Contraindicated in patients ( 4 ): With known hypersensitivity to atomoxetine oral solution or other components of atomoxetine oral solution Taking or within 14 days of stopping, a monoamine oxidase inhibitor (MAOI) With narrow angle glaucoma. With pheochromocytoma or…
See Table 9 for clinically significant drug interactions with atomoxetine oral solution and other drugs. Table 9: Clinically Significant Drug Interactions with Atomoxetine Oral Solution and Other Drugs Monoamine Oxidase Inhibitors (MAOIs) Prevention or Management Atomoxetine oral solution 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. Mechanism and Clinical Effect(s) As with other drugs affecting brain monoamine concentrations, there have been reports of serious, sometimes fatal reactions (hyperthermia, rigidity, myoclonus, autonomic instability with fluctuations of vital signs, extreme agitation progressing to delirium/coma) with concomitant use of atomoxetine oral solution and an MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. Strong CYP2D6 Inhibitors Prevention or Management With concomitant use of atomoxetine oral solution and a strong CYP2D6 inhibitor 1 , increase the titration interval [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3) ] . Mechanism and Clinical Effect(s) Atomoxetine is a CYP2D6 substrate. Concomitant use of atomoxetine oral solution and a strong CYP2D6 inhibitor increases atomoxetine exposure [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3) ] .…
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| Solution |
| Generic |
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| 3 | Not yet rated | Prescription | Capsule | Generic | $15 | View → |
| 80 mg |
| white, brown |
| capsule |
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| LILLY;3251;100;mg | 100 mg | brown | capsule | — |
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| APO;AM25 | 25 mg | white, blue | capsule | — |
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| APO;AM40 | 40 mg | blue | capsule | — |
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| APO;AM60 | 60 mg | yellow, blue | capsule | — |
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