Prescription medication · Selective Norepinephrine Reuptake Inhibitor
atomoxetine
Also sold as Strattera. Atomoxetine is used to treat Attention-Deficit/Hyperactivity Disorder (ADHD).
Data updated 2026-05-15
- 3,228
- FDA reportsLightly reported
- 15
- InteractionsSeveral interactions
- 97% less
- Generic vs brandHuge savings
- 6
- Recall records
What the data shows
atomoxetine (Strattera) is a prescription Selective Norepinephrine Reuptake Inhibitor, among the least-reported drugs the FDA tracks (3,228 FDA reports), whose generic costs a fraction of the brand (about 97% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
atomoxetine (Strattera) is a prescription Selective Norepinephrine Reuptake Inhibitor. Atomoxetine is used to treat Attention-Deficit/Hyperactivity Disorder (ADHD).
Atomoxetine (Strattera) is a medicine that can help people with Attention-Deficit/Hyperactivity Disorder (ADHD). It works by affecting a chemical in the brain called norepinephrine.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$12.67/unit
Generic Price
$0.38/unit
Generic Savings
97%
Generic Available
Yes (8 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Atomoxetine is used to treat Attention-Deficit/Hyperactivity Disorder (ADHD).
Common side effects
Feeling sick to your stomach, Throwing up, Feeling tired
Key warnings
Atomoxetine can increase the risk of suicidal thoughts in children and teenagers.
The sections below are summarized in plain English from atomoxetine's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Atomoxetine works by increasing the amount of norepinephrine in your brain. Norepinephrine is a chemical that helps you pay attention and control your impulses. By increasing norepinephrine, atomoxetine can improve ADHD symptoms.
How to Take It
Take atomoxetine capsules exactly as your doctor tells you. You can take it with or without food. The usual starting dose is based on your weight. Your doctor may change your dose over time.
This is a plain-language summary of atomoxetine's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant. It is not known if atomoxetine will harm your unborn baby. There is a pregnancy registry for women who take ADHD medicines during pregnancy. Talk to your doctor about how to register.
This is a plain-language summary of atomoxetine's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.
This is a plain-language summary of atomoxetine's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store atomoxetine capsules at room temperature, away from moisture and heat.
Side Effects (from patient reports)
Based on 3,228 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for atomoxetine, by number of reports
- Feeling sick to your stomach
Feeling sick to your stomach
431 reports
- Head pain
Head pain
407 reports
- Feeling tired
Feeling tired
401 reports
- The health problem got worse
The health problem got worse
395 reports
- High blood pressure
High blood pressure
388 reports
- Trouble sleeping
Trouble sleeping
381 reports
- Throwing up
Throwing up
381 reports
- Hurting
Hurting
379 reports
- Joint pain
Joint pain
374 reports
- Belly feels uneasy
Belly feels uneasy
367 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for atomoxetine each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where atomoxetine sits
atomoxetine has more FDA adverse-event reports than 19% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is atomoxetine; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 3,228 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
3,228
Reports Mentioning Death
879
27.2% of reports — not proof of cause
Hospitalization Reports
1,203
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 3 | NAUSEA | 431 |
| 5 | HEADACHE | 407 |
| 6 | FATIGUE | 401 |
| 7 | CONDITION AGGRAVATED | 395 |
| 8 | HYPERTENSION | 388 |
| 9 | INSOMNIA | 381 |
| 10 | VOMITING | 381 |
| 11 | PAIN | 379 |
| 12 | ARTHRALGIA | 374 |
| 13 | ABDOMINAL DISCOMFORT | 367 |
| 14 | HEPATIC ENZYME INCREASED | 367 |
| 15 | HYPOAESTHESIA | 360 |
| 16 | ABDOMINAL PAIN UPPER | 350 |
| 17 | ALOPECIA | 350 |
| 18 | GENERAL PHYSICAL HEALTH DETERIORATION | 350 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Atomoxetine can increase the risk of suicidal thoughts in children and teenagers. Watch carefully for worsening mood or any unusual changes in behavior. Tell your doctor right away if you have any suicidal thoughts or feelings.
Known Drug Interactions
( 7.3 ) • Albuterol (or other beta 2 agonists) - Action of albuterol on cardiovascular system can be potentiated. 7.4 Albuterol Atomoxetine should be administered with caution to patients being treated with systemically-administered (oral or intravenous) albuterol (or other beta 2 agonists) because the action of albuterol on the cardiovascular system can be potentiated resulting in increases in heart rate and blood pressure. Albuterol (600 mcg iv over 2 hours) induced increases in heart rate and blood pressure.
Mechanism: Atomoxetine can make the effects of albuterol on your heart and blood vessels much stronger. This can cause your heart to beat faster and your blood pressure to rise.
What to do: Use these medications together with caution and under a doctor's supervision. Your provider should regularly check your heart rate and blood pressure.
7.9 Drugs that Affect Gastric pH Drugs that elevate gastric pH (magnesium hydroxide/aluminum hydroxide, omeprazole) had no effect on atomoxetine bioavailability.
Mechanism: Omeprazole changes the acid levels in the stomach, but this does not change how the body absorbs atomoxetine.
What to do: No special changes are needed when taking these two drugs together.
7.2 Effect of CYP2D6 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). In EM individuals treated with paroxetine or fluoxetine, the AUC of atomoxetine is approximately 6- to 8-fold and C ss, max is about 3- to 4-fold greater than atomoxetine alone.
Mechanism: Fluoxetine blocks the liver enzyme that breaks down atomoxetine, which causes the levels of atomoxetine in your blood to rise significantly.
What to do: Your doctor may need to lower your dose of atomoxetine to prevent side effects.
7.7 Methylphenidate Coadministration of methylphenidate with atomoxetine did not increase cardiovascular effects beyond those seen with methylphenidate alone.
Mechanism: Taking these two drugs together does not seem to cause extra stress on the heart compared to taking methylphenidate by itself.
What to do: These drugs can be taken together, but your doctor should still monitor your heart rate and blood pressure.
Atomoxetine did not affect the binding of warfarin, acetylsalicylic acid, phenytoin, or diazepam to human albumin.
Mechanism: Atomoxetine does not interfere with how warfarin attaches to proteins in the blood, so it should not change how well the blood thinner works.
What to do: No dosage adjustments are typically required for this combination.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I open the capsule and sprinkle it on food?
Can I stop taking atomoxetine suddenly?
Will atomoxetine cure my ADHD?
How long does it take for atomoxetine to work?
Can atomoxetine affect my heart?
Can atomoxetine cause liver problems?
Can atomoxetine affect my growth?
Can I drink alcohol while taking atomoxetine?
What should I do if I think I'm having a side effect?
Can I take atomoxetine if I have glaucoma?
What are the common side effects of atomoxetine?
Does atomoxetine interact with other medications?
What drug class is atomoxetine?
Is there a generic version of atomoxetine?
Is atomoxetine safe during pregnancy?
Has atomoxetine been recalled?
Active Recalls
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Safecor Health, LLC
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA
Related Medications in Selective Norepinephrine Reuptake Inhibitor
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alprazolam
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amitriptyline
Elavil
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amphetamine/dextroamphetamine
Adderall, Adderall XR
Adderall XR is a stimulant medicine.
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aripiprazole
Abilify
Aripiprazole (Abilify) is a medicine used to treat certain mental disorders and mood problems.
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for atomoxetine
The FDA label for atomoxetine (sold under brand names such as Strattera) classifies it as a prescription-only medication in the Selective Norepinephrine Reuptake Inhibitor class. Atomoxetine is used to treat Attention-Deficit/Hyperactivity Disorder (ADHD). Official labeling lists 11 commonly reported side effects, including Feeling sick to your stomach, Throwing up, Feeling tired.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 3,228 voluntary reports. The database also lists 15 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $0.38 versus $12.67 for the brand - a 97% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 6 recall records on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: November 1, 2023
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages