This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER All STRATTERA-treated pediatric patients 6 years of age or older should be monitored and observed closely for suicidal thoughts and behavior, clinical worsening, or unusual changes in behavior, especially during the initial months of therapy or at times of dosage changes. Families and caregivers should be advised of the need for close observation and communication with the health care provider. Consider stopping STRATTERA in patients who experience emergent suicidal thoughts and behavior [see Warnings and Precautions ( 5.1 )]. 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. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER See full prescribing information for complete boxed warning. All STRATTERA-treated pediatric patients 6 years of age or older should be monitored and observed closely for suicidal thoughts and behavior, clinical worsening, or unusual changes in behavior, especially during the initial months of therapy or at time...
is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD. STRATTERA ® is a selective norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of ADHD in adults and pediatric patients 6 years of age and older. ( 1 )
is contraindicated in patients: With known hypersensitivity reaction to atomoxetine or other constituents of STRATTERA. Hypersensitivity reactions 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, STRATTERA 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 STRATTERA. With severe cardiac or vascular disorders whose condition would be expected to deteriorate if they had a 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 or other constituents of STRATTERA Taking or within 14 days of stopping, a monoamine oxidase inhibitor (MAOI) With narrow a...
Severe Liver Injury: STRATTERA should be discontinued and not restarted in patients with jaundice or laboratory evidence of liver injury. ( 5.2 ) Serious Cardiovascular Reactions: Prior to STRATTERA treatment, patients should have a careful history and physical exam to assess for presence of cardiovascular (CV) disease. STRATTERA generally should not be used in pediatric patients with known serious cardiac abnormalities, cardiomyopathy, serious arrhythmias. Consideration should be given to not using STRATTERA in adults with clinically significant cardiac abnormalities. Patients who develop symptoms suggestive of cardiac disease during STRATTERA treatment should stop STRATTERA and undergo a prompt cardiac evaluation. ( 5.3 ) Increase in Blood Pressure and Heart Rate: Heart rate and blood pressure should be measured at baseline, following STRATTERA dosage increase, and periodically while on therapy. ( 5.4 ) New Psychotic or Manic Symptoms and Activation of Mania: If psychotic or manic symptoms occur, consider discontinuing STRATTERA. ( 5.5 ) Aggressive Behavior or Hostility: Monitor for the appearance or worsening of aggressive behavior or hostility. ( 5.7 ) Effects on Urine Outflow:...
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 STRATTERA. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) 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. STRATTERA was administered to 5,382 pediatric patients 6 years of age and older in clinical ADHD studies (Studies 1, 2, 3, 4, and 5) [see Clinical Studies ( 14.1 )] and 1,007 adults in clin...
Source: FDA SPL label for Strattera (Eli Lilly and Company), effective 20260630. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 667 | 616 | 579 | 615 | 810 | 1,252 | 1,800 | 677 |
11,328 reports blaming this drug for every million Medicare prescriptions filled, which is 4.1× the typical drug on this site. (3,710 reports in 2024–2026, against 327,499 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 04/2026 | Class II | Safecor Health, LLC | Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule. |
| 01/2025 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. |
| 01/2025 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. |
| 01/2025 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. |
| 01/2025 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. |
| 01/2025 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. |
| 01/2025 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. |
| 01/2025 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $0 in payments to US physicians and hospitals tied to this drug across 0 transactions.
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Atomoxetine HCl | 325,761 | $100 |
| Strattera | 1,738 | $783 |
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.