Prescription medication · Selective Norepinephrine Reuptake Inhibitor

atomoxetine

Name: atomoxetine - FDA Drug Safety & Adverse Event Data
Creator: PlainMeds
License: https://creativecommons.org/publicdomain/zero/1.0/

Also sold as Strattera. Atomoxetine is used to treat Attention-Deficit/Hyperactivity Disorder (ADHD).

Compiled by PlainMeds, Drug Information Editorial Process

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 →

NADAC price trail: ATOMOXETINE HCL 10 MG CAPSULE

Same CMS presentation as the headline generic unit price above (2 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: -7.5% vs prior release.

Effective	NADAC / unit	vs prior	NDCs
October 23, 2024	$0.4095/EA	-	1
December 18, 2024	$0.3786/EA	-7.5%	7

Compare with Another Drug → Full Side Effects Report →

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.

Side Effects (from patient reports)

Based on 3,228 FDA adverse event reports.

Nausea

431
Headache

407
Fatigue

401
Condition Aggravated

395
Hypertension

388
Insomnia

381
Vomiting

381
Pain

379
Arthralgia

374
Abdominal Discomfort

367

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.

fewest reports most reports

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

Female 1,553 (57%)

Male 1,064 (39%)

Age Distribution

0–17 582

18–44 1,400

45–64 237

65–74 56

75+ 25

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

ARTHRALGIA 327

GLOSSODYNIA 325

HYPERTENSION 325

GENERAL PHYSICAL HEALTH DETERIORATION 324

HEPATIC ENZYME INCREASED 324

ABDOMINAL DISCOMFORT 319

ANTI-CYCLIC CITRULLINATED PEPTIDE ANTIBODY POSITIVE 317

BLOOD CHOLESTEROL INCREASED 317

ALOPECIA 314

ARTHROPATHY 314

Reactions in Hospitalization Reports

CONDITION AGGRAVATED 317

HYPERTENSION 311

HEPATIC ENZYME INCREASED 308

HEADACHE 303

ARTHRALGIA 300

BLOOD CHOLESTEROL INCREASED 299

ABDOMINAL DISCOMFORT 298

ALOPECIA 295

GENERAL PHYSICAL HEALTH DETERIORATION 295

GLOSSODYNIA 294

Source: 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

moderate albuterol

( 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.

minor omeprazole

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.

minor fluoxetine

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.

minor methylphenidate

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.

minor warfarin

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.

Check all your medications →

This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.

Common Questions

Can I open the capsule and sprinkle it on food?

No, swallow the capsule whole. Do not open, crush, or chew it.

Can I stop taking atomoxetine suddenly?

You can stop taking atomoxetine without slowly decreasing the dose.

Will atomoxetine cure my ADHD?

Atomoxetine will not cure ADHD, but it can help manage your symptoms.

How long does it take for atomoxetine to work?

It may take several weeks for atomoxetine to start working.

Can atomoxetine affect my heart?

Atomoxetine can increase blood pressure and heart rate. Your doctor should check your heart before you start taking it.

Can atomoxetine cause liver problems?

In rare cases, atomoxetine can cause liver problems. Tell your doctor right away if you have yellowing of the skin or eyes, dark urine, or stomach pain.

Can atomoxetine affect my growth?

Atomoxetine can slow down growth in children. Your doctor should monitor your height and weight.

Can I drink alcohol while taking atomoxetine?

It is best to avoid alcohol while taking atomoxetine.

What should I do if I think I'm having a side effect?

Tell your doctor about any side effects you have while taking atomoxetine.

Can I take atomoxetine if I have glaucoma?

You should not take atomoxetine if you have narrow-angle glaucoma.

What are the common side effects of atomoxetine?

The registry lists Feeling sick to your stomach, Throwing up, Feeling tired, Not feeling hungry, Belly pain among the most-reported FAERS reaction terms for atomoxetine. The compiled record contains 3,228 FDA adverse-event reports. These counts are not an individual symptom assessment.

Does atomoxetine interact with other medications?

The registry has 15 documented interaction rows for atomoxetine. Notable source-record pairings include albuterol, omeprazole, fluoxetine. These rows are not a complete medication review.

What drug class is atomoxetine?

atomoxetine belongs to the Selective Norepinephrine Reuptake Inhibitor drug class. It requires a prescription (Rx). Atomoxetine is used to treat Attention-Deficit/Hyperactivity Disorder (ADHD).

Is there a generic version of atomoxetine?

Yes, generic atomoxetine is available from 8 manufacturers. The generic costs $0.38 per unit compared to $12.67 for the brand version, saving approximately 97%. Pricing is based on NADAC (National Average Drug Acquisition Cost) data from CMS.

What pregnancy or breastfeeding source fields are listed for atomoxetine?

The FDA label for atomoxetine contains product-specific pregnancy or breastfeeding language. PlainMeds does not apply that source text to an individual.

Has atomoxetine been recalled?

There are 6 recalls associated with atomoxetine products. Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule. Check the recalls section below for full details and affected products.

Active Recalls

Class II April 30, 2026

Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.

Safecor Health, LLC

Class II January 29, 2025