What the label lists and what reports show
Atomoxetine side effects
Atomoxetine's FDA label: “Most common adverse reactions (≥5% and at least twice the incidence of placebo patients) • Child and Adolescent Clinical Trials – Nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence.” FAERS holds 26,969 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (2,250 reports).
- Generic listed
- Boxed warning
Check it at the source: the atomoxetine FDA label on DailyMed (effective May 25, 2026, Camber Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are possible side effects of atomoxetine capsules?See “What is the most important information I should know about atomoxetine capsules?” for information on reported suicidal thoughts and actions, other mental problems, severe liver damage, and heart problems. […]
Source: FDA drug label, 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 label list?
From the label: adverse reactionsMost common adverse reactions (≥5% and at least twice the incidence of placebo patients) • Child and Adolescent Clinical Trials – Nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence.
Table 5: Common Adverse Reactions a Associated in Acute Studies (up to 25 weeks) of Adult Patients with ADHD
This table is printed in the Strattera label published by Eli Lilly and Company of June 30, 2026; the label quoted above does not print one.
| Adverse Reaction | STRATTERA (N=1,697) | Placebo (N=1,560) |
|---|---|---|
| Nausea | 26% | 6% |
| Dry mouth | 20% | 5% |
| Decreased appetite | 16% | 3% |
| Insomnia b | 15% | 8% |
| Fatigue | 10% | 6% |
| Erectile dysfunction c | 8% | 1% |
| Constipation | 8% | 3% |
| Dizziness | 8% | 3% |
| Somnolence d | 8% | 5% |
| Abdominal pain e | 7% | 4% |
| Urinary hesitation f | 6% | 1% |
| Irritability | 5% | 3% |
| Ejaculation delayed c and/or ejaculation disorder c | 4% | 1% |
| Hyperhidrosis | 4% | 1% |
| Dyspepsia | 4% | 2% |
| Vomiting | 4% | 2% |
| Abnormal dreams | 4% | 3% |
| Chills | 3% | 0% |
| Paraesthesia | 3% | 0% |
| Hot flush | 3% | 0% |
| Palpitations | 3% | 1% |
| Libido decreased | 3% | 1% |
| Sleep disorder | 3% | 1% |
| Dysmenorrhea g | 3% | 2% |
| Dysuria | 2% | 0% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedMost common adverse reactions (≥5% and at least twice the incidence of placebo patients) • Child and Adolescent Clinical Trials – Nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence. ( 6.1 ) • Adult Clinical Trials – Constipation, dry mouth, nausea, decreased appetite, dizziness, erectile dysfunction, and urinary hesitation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Annora Pharma Private Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Atomoxetine was administered to 5382 children or adolescent patients with ADHD and 1007 adults with ADHD in clinical studies. During the ADHD clinical trials, 1625 children and adolescent patients were treated for longer than 1 year and 2529 children and adolescent patients were treated for over 6 months. 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. …
Source: FDA drug label, 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?
26,969 reports list atomoxetine among the medicines taken, 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. Of the 21 reactions below, 16 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Atomoxetine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions